HIV InfectionsPhase 4EBONINCT05514509
A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories
A Phase 4 study testing APRETUDE and Cabotegravir tablet in people with HIV Infections, run by ViiV Healthcare at 22 sites in United States.
Trial summary
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementation. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- APRETUDE and Cabotegravir tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 22 sitesUnited States
- Study dates
- 28 Oct 2022to 2 Sep 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be ≥18 years of age, at the time of signing the informed consent.
- HIV negative at screening. Type of HIV-1 test is per standard of care.
- No prior history of receiving oral CAB or CAB LA injections.
- PrEP provider deems CAB PrEP use to be appropriate per the applicable CAB PrEP prescribing information prior to enrollment in the study.
- Female at birth or self-identified Transgender Female.
- Self-identified as African American/Black
- Capable of giving signed informed consent
Who cannot join
- HIV indeterminate or positive test result during screening.
- A participant of concurrent interventional clinical or implementation science study at any time during the study.
- Cis-gender or Transgender male
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
GSK Investigational Site
Atlanta, Georgia, 30303
GSK Investigational Site
Atlanta, Georgia, 30309
GSK Investigational Site
Atlanta, Georgia, 30312
GSK Investigational Site
Bridgeport, Kansas, 06605
GSK Investigational Site
Brooklyn, New York, 10001
GSK Investigational Site
Dallas, Texas, 75201
GSK Investigational Site
Detroit, Michigan, 48201
GSK Investigational Site
Houston, Texas, 77006
GSK Investigational Site
Houston, Texas, 77021
GSK Investigational Site
Las Vegas, Nevada, 89104
GSK Investigational Site
Memphis, Tennessee, 38104
GSK Investigational Site
Miami, Florida, 33137
GSK Investigational Site
New York, New York, 10029
GSK Investigational Site
Norfolk, Virginia, 23510
GSK Investigational Site
Orlando, Florida, 32808
GSK Investigational Site
Philadelphia, Pennsylvania, 19114
GSK Investigational Site
Philadelphia, Pennsylvania, 19147
GSK Investigational Site
Tampa, Florida, 33611
GSK Investigational Site
Washington D.C., District of Columbia, 20005
GSK Investigational Site
Washington D.C., District of Columbia, 20010
GSK Investigational Site
Washington D.C., District of Columbia, 20017-2149
GSK Investigational Site
West Palm Beach, Florida, 33401
About this study
Official title: A Phase 4, Randomized, Open-label, Three-arm Study to Evaluate Implementation Strategies for the Delivery of CAB for HIV Pre-exposure Prophylaxis (PrEP) Across Clinical Settings for Adult (≥18 Years) Black cis-and Transgender Women Without HIV Infection Living in the United States Ending the Epidemic (EHE) Territories
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementation. The first of two participant types in the study are the Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available CAB PrEP via prescription from the PrEP provider. The second are Staff Study Participants (SSPs) who are site staff involved in the administrative and clinical aspects of offering and administering PrEP to PSPs at the clinical site.
- Conditions
- HIV Infections
- Being tested
- APRETUDE, Cabotegravir tablet
- Keywords
- Cabotegravir, Long acting injectables, Implementation science, HIV, PrEP, HIV Disparities, Ending the Epidemic, Engaging Black Women on APRETUDE by Optimizing Novel Implementation Strategies (EBONI)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APRETUDEDrug
Available as intramuscular injection.
Cabotegravir tabletDrug
Available as marketed orally administered tablets.
| Study group | Role | What they receive |
|---|---|---|
| Standard Implementation (SI) | Active comparator | The SI arm evaluated cabotegravir long-acting injectable (CAB LA) for pre-exposure prophylaxis (PrEP) delivery using standard toolkits made available with the commercial release of CAB LA for providers and patients to use as needed, along with implementation monitoring. Receives: Drug: APRETUDE; Drug: Cabotegravir tablet |
| Enhanced Implementation (EI) | Experimental | The EI arm evaluated CAB LA delivery using the standard toolkits plus enhanced supports to use as needed, along with implementation monitoring. EI sites received supports like patient-provider discussion tools, informational tools, and provider education. Receives: Drug: APRETUDE; Drug: Cabotegravir tablet |
| Enhanced Collaborative Implementation (ECI) | Experimental | The ECI arm evaluated CAB LA delivery using the standard toolkits plus enhanced supports to use as needed, along with implementation monitoring. ECI sites received supports like a sexual health assessment, provider education, videos, informational tools, persistence support, and peer ambassadors. Receives: Drug: APRETUDE; Drug: Cabotegravir tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intervention Appropriateness Measure (IAM) Score Assessed for SSPs at Month 12
The IAM was used to assess among SSPs the appropriateness of APRETUDE for PSPs using a four-item measure (1. APRETUDE seems fitting for Black women at our clinic/practice 2. APRETUDE seems suitable for Black women at our clinic/practice 3.APRETUDE seems applicable for Black women at our clinic/practice 4.APRETUDE seems like a good match for Black women at our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least appropriate and 5 the most appropriate. Timeframe for evaluation of this outcome measure is Month (M)12 (equivalent to M13 for SSPs who assessed PSPs receiving Optional oral Lead in [OLI])
Measured: At Month 12
Secondary outcomes (161)
Mean IAM Score Assessed for SSPs Over Time
Timeframe for evaluation of this outcome measure is Baseline (BL), M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI)
Measured: At Baseline (Month 1), Month 4 and Month 12
Change From Baseline in IAM Score Assessed for SSPs
This outcome assesses the change in IAM score for SSPs over time. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI) compared to BL.
Measured: At Month 4 and Month 12 compared to Baseline (Month 1)
Number of SSPs With Responses to Appropriateness of APRETUDE Assessed by Implementation Science Questionnaire (ISQs) at Baseline
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on the appropriateness of APRETUDE gathered through the ISQ at baseline are displayed in this outcome measure. In this Outcome Measure SSPs indicated their level of concern (ranging from "Not at all concerned" to "Extremely concerned") regarding identifying eligible individuals for APRETUDE, staff resourcing to ensure appropriate clinic flow, number of exam rooms for injections and clinic staff to administer injections.
Measured: At Baseline (Month 1)
Number of SSPs With Responses to Appropriateness of APRETUDE Assessed by ISQs at Month 4
SSP perceptions on the appropriateness of APRETUDE gathered through the ISQ are displayed in this outcome measure. Timeframe for evaluation of this outcome measure is M4 (equivalent to M5 for SSPs who assessed PSPs receiving OLI). In this Outcome Measure SSPs indicated their level of concern (ranging from "Not at all concerned" to "Extremely concerned") regarding identifying eligible individuals for APRETUDE, staff resourcing to ensure appropriate clinic flow, number of exam rooms for injections and clinic staff to administer injections.
Measured: At Month 4
Number of SSPs With Responses to Appropriateness of APRETUDE Assessed by ISQs at Month 12
SSP perceptions on the appropriateness of APRETUDE gathered through the ISQ are displayed in this outcome measure. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). In this Outcome Measure SSPs indicated their level of concern (ranging from "Not at all concerned" to "Extremely concerned") regarding identifying eligible individuals for APRETUDE, staff resourcing to ensure appropriate clinic flow, number of exam rooms for injections and clinic staff to administer injections.
Measured: At Month 12
Number of SSPs With Responses to APRETUDE Staffing Sufficiency Assessed by ISQs at Months 4 and 12
SSP perceptions on the appropriateness of APRETUDE gathered through the ISQ are displayed in this outcome measure. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). In this Outcome Measure SSPs evaluated staff sufficiency to manage the current or anticipated number of APRETUDE patients on an ongoing basis.
Measured: At Month 4 and Month 12
Number of SSPs With Responses to Appropriateness of APRETUDE Assessed by Semi-structured Interview (SSI) at Month 4
Semi-structured interview (SSI) guides were designed to support discussion surrounding the experience of SSPs implementing and administering APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the Consolidated Framework for Implementation Research (CFIR). Timeframe for evaluation of this outcome measure is M4 (equivalent to M5 for SSPs who assessed PSPs receiving OLI).
Measured: At Month 4
Number of SSPs With Responses to Appropriateness of APRETUDE Assessed by SSI at Month 12
SSI guides were designed to support discussion surrounding the experience of SSPs implementing and administering APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the CFIR. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Measured: At Month 12
Mean IAM Score Assessed for PSPs
The IAM was used to assess the appropriateness of APRETUDE for PSPs using a four-item measure (1. APRETUDE seems fitting for me, 2. APRETUDE seems suitable for my lifestyle, 3. APRETUDE seems applicable in my life, 4. APRETUDE seems like a good match) with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5, with 1 indicating the least appropriate and 5 the most appropriate. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI).
Measured: At Baseline (Month 1), Month 4 and Month 12
Change From Baseline in IAM Score Assessed for PSPs
This outcome assesses the change in IAM for PSPs over time. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI) compared to BL.
Measured: At Month 4 and Month 12 compared to Baseline (Month 1)
Number of SSPs With Responses to Perceived Appropriateness of APRETUDE for Different Patient Characteristics Assessed by ISQ
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on the appropriateness of APRETUDE for PSPs gathered through the ISQ are displayed in this outcome measure. Timeframe for evaluation is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents SSP perceptions on the appropriateness of APRETUDE for patients, including specific patient groups or characteristics influencing appropriateness.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs Reporting That APRETUDE is More Appropriate for Specific Demographic Groups Assessed by ISQ
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. The number of SSPs reporting in the ISQ that APRETUDE is more appropriate for specific patient demographic groups is displayed in this outcome measure. Timeframe for evaluation is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs Reporting Specific Demographic Groups for Which APRETUDE May be More Appropriate Assessed by ISQ
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions of the appropriateness of APRETUDE for specific patient demographics groups as reported in the ISQ are displayed in this outcome measure. Timeframe for evaluation is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs Reporting Appropriateness of APRETUDE Via Level of Concern Surrounding Patient Beliefs and Experiences Assessed by ISQ
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on the appropriateness of APRETUDE for PSPs gathered through the ISQ are displayed in this outcome measure. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). In this outcome measure, appropriateness of APRETUDE for patients was reported by SSPs by rating in the ISQ their level of concern (ranging from "Not at all concerned" to "Extremely concerned") surrounding patients' belief in the efficacy of APRETUDE and experience with pain.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of PSPs With Responses to Perception of Appropriateness of APRETUDE Assessed by SSI at Baseline
SSI guides were designed to support discussion surrounding the experience of PSPs receiving APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the Consolidated Framework for Implementation Research (CFIR). PSPs perceptions on the appropriateness of APRETUDE gathered during SSIs at baseline are displayed. This outcome measure presents common concepts identified from qualitative analysis of PSPs' perceived appropriateness of APRETUDE. The categories below are neither mutually exclusive nor exhaustive, given the variation in probe exposure and discussion patterns inherent to semi-structured qualitative data collection.
Measured: At Baseline (Month 1)
Number of PSPs With Responses to Perception of Appropriateness of APRETUDE Assessed by SSI at Month 12
Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents common concepts identified from qualitative analysis of interview data. The categories below are neither mutually exclusive nor exhaustive, given the variation in probe exposure and discussion patterns inherent to semi-structured qualitative data collection.
Measured: At Month 12
Number of Cis- and Trans Black Women Who Complete a Sexual Health Assessment in ECI Arm
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. The number of PSPs who completed the Sexual Health Assessment tool (available only to the ECI arm) are displayed by gender. Per protocol planned analysis, data for this outcome measure was to be collected via PreRP Information Questionnaire. Data was however collected from PSPs via ISQ due to a programming error in the PrEP Information Questionnaire. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Measured: Up to Month 12
Number of PSPs Who Complete a Sexual Health Assessment in ECI Arm
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. The number of PSPs who completed the Sexual Health Assessment tool (available only to the ECI arm) are displayed by clinic type to represent differences across clinical settings. Per protocol planned analysis, data for this outcome measure was to be collected via PreRP Information Questionnaire. Data was however collected from PSPs via ISQ due to a programming error in the PrEP Information Questionnaire. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Measured: Up to Month 12
Number of Black Women (Both Cis- and Trans) Who Initiate APRETUDE by Study Arm
Overall estimates for PrEP adoption at participating clinics were obtained via the PrEP Information Questionnaire. The timeframe for evaluation of this outcome measure is through M12.
Measured: Up to Month 12
Number of Black Women (Both Cis- and Trans) Who Initiate APRETUDE by Clinic Setting
Overall estimates for PrEP adoption at participating clinics were obtained via the PrEP Information Questionnaire. The timeframe for evaluation of this outcome measure is through M12.
Measured: Up to Month 12
Number of Black Women (Both Cis and Trans) Who Continue APRETUDE Beyond a First Dose by Study Arm
Overall estimates for PrEP adoption at participating clinics were obtained via the PrEP Information Questionnaire. The timeframe for evaluation of this outcome measure is through M12.
Measured: Up to Month 12
Number of Black Women (Both Cis and Trans) Who Continue APRETUDE Beyond a First Dose by Clinic Setting
Overall estimates for PrEP adoption at participating clinics were obtained via the PrEP Information Questionnaire. The timeframe for evaluation of this outcome measure is through M12.
Measured: Up to Month 12
Mean Feasibility of Intervention Measure (FIM) Score for PrEP Training Assessed for SSPs
The FIM was used to assess the feasibility of the PrEP training provided only to EI and ECI arms using a four-item measure (1. The PrEP training would be easily implemented as part of my continuing education 2. It would be possible to incorporate the PrEP training into my continuing education efforts 3. The PrEP training was doable as a continuing education activity 4. The PrEP training was easy to use) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Timeframe for evaluation of this outcome measure is at M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI); and was not assessed at baseline as sites had not had time to utilize the tool.
Measured: At Month 4 and Month 12
Change in FIM Score for PrEP Training Assessed for SSPs
This outcome assesses the change in FIM score for PrEP Training for SSPs over time. The change in FIM score was calculated as the longitudinal mean change from Month 4 to Month 12. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI) compared to M4 (equivalent to M5 for SSPs who assessed PSPs receiving OLI).
Measured: At Month 12 compared to Month 4
Number of SSPs With Responses to Feasibility and Ease of Clinical Tool Implementation Assessed by SSP Questionnaire Responses at Baseline
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on the feasibility of study tools gathered through the ISQ at BL, M4, and M12 are displayed. In alignment with study design, some tools were restricted to one or two arms, as noted in parentheses next to each tool below, and detailed feasibility information was only collected for a subgroup of the tools provided. Timeframe for evaluation of this outcome measure is at BL. This outcome measure presents SSPs'perception of ease of implementation of the PrEP Options Communication Tool and of the Sexual Health Assessment Tool.
Measured: At Baseline (Month 1)
Number of SSPs With Responses to Planned Frequency of Use for PrEP Options Communication and Sexual Health Assessment Tools Assessed by SSP Questionnaire Responses at Baseline
Tools were only available to select arms, and detailed feasibility information was only collected for a subgroup of the tools provided. Timeframe for evaluation of this outcome measure is at BL. This outcome measure presents the planned frequency of use of the PrEP Options Communication Tool and of the Sexual Health Assessment Tool among SSPs' clinics.
Measured: At Baseline (Month 1)
Number of SSPs With Responses to Feasibility, Ease of Use, and Implementation of PrEP Training and Clinical Tools Assessed at Month 4
Tools were only available to select arms, and detailed feasibility information was only collected for a subgroup of the tools provided. Timeframe for evaluation of this outcome measure is at M4 (equivalent to M5 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs' perception of PrEP training ease of use, of the amount of time involved in using the PrEP training, of ease of implementation of the PrEP Options Communication Tool (question for EI SSPs only) and of ease of implementation of the Sexual Health Assessment Tool (question for ECI SSPs only).
Measured: At Month 4
Number of SSPs With Responses to Feasibility, Ease of Use, and Implementation of PrEP Training and Clinical Tools Assessed at Month 12
Tools were only available to select arms, and detailed feasibility information was only collected for a subgroup of the tools provided. Timeframe for evaluation of this outcome measure is at M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs' perception of PrEP training ease of use, of the amount of time involved in using the PrEP training, of ease of implementation of the PrEP Options Communication Tool (question for EI SSPs only) and of ease of implementation of the Sexual Health Assessment Tool (question for ECI SSPs only).
Measured: At Month 12
Number of SSPs With Responses to Frequency of PrEP Options Communication Tool and Sexual Health Assessment Tool Use Assessed at Month 4
Tools were only available to select arms, and detailed feasibility information was only collected for a subgroup of the tools provided. Timeframe for evaluation of this outcome measure is at M4 (equivalent to M5 for SSPs who assessed PSPs receiving OLI). This Outcome Measure presents the SSP's perception of frequency of using the PrEP Options Communication Tool with each patient (question for EI SSPs only) and Frequency of using the Sexual Health Assessment Tool with each patient (question for ECI SSPs only).
Measured: At Month 4
Number of SSPs With Responses to Frequency of PrEP Options Communication Tool and Sexual Health Assessment Tool Use Assessed at Month 12
Tools were only available to select arms, and detailed feasibility information was only collected for a subgroup of the tools provided. Timeframe for evaluation of this outcome measure is at M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This Outcome Measure presents the SSP's perception of frequency of using the PrEP Options Communication Tool with each patient (question for EI SSPs only) and Frequency of using the Sexual Health Assessment Tool with each patient (question for ECI SSPs only).
Measured: At Month 12
Number of SSPs With Responses to Current Use of the PrEP Options Communication Tool
Tools were only available to select arms, and detailed feasibility information was only collected for a subgroup of the tools provided. Timeframe for evaluation of this outcome measure is at M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).
Measured: At Month 4 and Month 12
Number of SSPs Indicating Reasons Why the PrEP Options Communications Tool Was Not Used, Assessed at Month 4
Tools were only available to select arms, and detailed feasibility information was only collected for a subgroup of the tools provided. Timeframe for evaluation of this outcome measure is at M4 (equivalent to M5 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the reason the PrEP Options Communication Tool was not used by a clinic/practice.
Measured: At Month 4
Number of SSPs Indicating Reasons Why the PrEP Options Communications Tool Was Not Used, Assessed at Month 12
Tools were only available to select arms, and detailed feasibility information was only collected for a subgroup of the tools provided. Timeframe for evaluation of this outcome measure is at M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the reason the PrEP Options Communication Tool was not used by a clinic/practice.
Measured: At Month 12
Number of SSPs With Responses to Current Use of the Sexual Health Assessment Tool
Tools were only available to select arms, and detailed feasibility information was only collected for a subgroup of the tools provided. Timeframe for evaluation of this outcome measure is at M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).
Measured: At Month 4 and Month 12
Number of SSPs Indicating Reasons Why the Sexual Health Assessment Tool Was Not Used, Assessed at Month 4
Tools were only available to select arms, and detailed feasibility information was only collected for a subgroup of the tools provided. Timeframe for evaluation of this outcome measure is at M4 (equivalent to M5 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the reasons the Sexual Health Assessment Tool was not used by a clinic/practice.
Measured: At Month 4
Number of SSPs Indicating Reasons Why the Sexual Health Assessment Tool Was Not Used, Assessed at Month 12
Tools were only available to select arms, and detailed feasibility information was only collected for a subgroup of the tools provided. Timeframe for evaluation of this outcome measure is at M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the reasons why the Sexual Health Assessment Tool was not used by a clinic/practice.
Measured: At Month 12
Number of SSPs With Responses to Feasibility and Utility of Implementation Strategies Assessed by SSI at Month 4
SSI guides were designed to support discussion surrounding the experience of SSPs implementing and administering APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the Consolidated Framework for Implementation Research (CFIR). SSPs perceptions on the feasibility and utility of study tools were gathered. Timeframe for evaluation of this outcome measure is M4 (equivalent to M5 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the number of SSPs who found the specified tools and resources useful.
Measured: At Month 4
Number of SSPs With Responses to Feasibility and Utility of Implementation Strategies Assessed by SSI at Month 12
SSI guides were designed to support discussion surrounding the experience of SSPs implementing and administering APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the Consolidated Framework for Implementation Research (CFIR). SSPs perceptions on the feasibility and utility of study tools were gathered. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the number of SSPs who found the specified tools and resources useful.
Measured: At Month 12
Number of SSPs That Respond to PrEP Education Training and Utility of Strategies by Study Arm
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on if study tools were fit for use were gathered. Tools were only available to selected arms.Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the usage of the specified tools and completion of the PrEP Education Training (PrEPare for Black Women).
Measured: Up to Month 12
Number of SSPs That Respond to Helpfulness for Utilized Implementation Strategies by Study Arm
Tools were only available to selected arms. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents SSPs perception of the helpfulness of the specified tools.
Measured: Up to Month 12
Number of SSPs That Respond to Perceived Utility, Effectiveness, and Facilitation of PrEP Training and Clinical Tools by Study Arm
PrEP training and tools were only available to selected arms (EI and/or ECI). Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs agreement with the following sentences: "The PrEP training would be useful for my healthcare practice", "The PrEP training helped me address my patients' HIV prevention concerns effectively", "The PrEP Options Communication Tool helped to facilitate conversations about PrEP with patients" (EI only), "The Sexual Health Assessment Tool is an easy way to identify individuals interested in PrEP (ECI only)" and "The Sexual Health Assessment Tool helps to facilitate conversations about PrEP with patients" (ECI only).
Measured: Up to Month 12
Number of SSPs That Respond to PrEP Education Training and Utility of Strategies by Clinic Characteristics
Tools were only available to selected arms. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the usage of the specified tools and completion of the PrEP Education Training (PrEPare for Black Women).
Measured: Up to Month 12
Number of SSPs That Respond to Helpfulness for Utilized Implementation Strategies by Clinic Characteristics
Tools were only available to selected arms.Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents SSPs perception of the helpfulness of the specified tools.
Measured: Up to Month 12
Number of SSPs That Respond to Perceived Utility, Effectiveness, and Facilitation of PrEP Training and Clinical Tools by Clinic Characteristics
Tools were only available to selected arms. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs agreement with the following sentences: "The PrEP training would be useful for my healthcare practice", "The PrEP training helped me address my patients' HIV prevention concerns effectively", "The PrEP Options Communication Tool helped to facilitate conversations about PrEP with patients" (EI only), "The Sexual Health Assessment Tool is an easy way to identify individuals interested in PrEP (ECI only)" and "The Sexual Health Assessment Tool helps to facilitate conversations about PrEP with patients (ECI only)".
Measured: Up to Month 12
Number of PSPs by Fit-for-use Rating of APRETUDE Support Tools and Strategies, by Study Arm
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of study tools being fit for use were gathered through the ISQ. In alignment with study design, some tools were restricted to one or two arms, as noted in parentheses next to each tool below. Not all tools were assessed at all time points. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI). The outcome measure presents the usefulness of the specified APRETUDE support tools and strategies.
Measured: Up to Month 12
Number of PSPs That Respond to Helpfulness of APRETUDE Learning Materials by Study Arm
PSP perceptions of study tools being fit for use were gathered through the ISQ. In alignment with study design, some tools were restricted to one or two arms, as noted in parentheses next to each tool below. Not all tools were assessed at all time points. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI). The outcome measure presents the helpfulness of the specified APRETUDE learning materials.
Measured: Up to Month 12
Number of PSPs by Fit-for-use Rating of APRETUDE Support Tools and Strategies, by Clinic Characteristics
PSP perceptions of study tools being fit for use were gathered through the ISQ. In alignment with study design, some tools were restricted to one or two arms, as noted in parentheses next to each tool below. Not all tools were assessed at all time points. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI). The outcome measure presents the usefulness of the specified APRETUDE support tools and strategies.
Measured: Up to Month 12
Number of PSPs That Respond to Helpfulness of APRETUDE Learning Materials by Clinic Characteristics
PSP perceptions of study tools being fit for use were gathered through the ISQ. In alignment with study design, some tools were restricted to one or two arms, as noted in parentheses next to each tool below. Not all tools were assessed at all time points. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI). The outcome measure presents the helpfulness of the specified APRETUDE learning materials.
Measured: Up to Month 12
Number of PSPs With Responses to Sexual Health Assessment Completion and Result Discussion by Clinic Characteristics
PSP perceptions of study tools being fit for use were gathered through the ISQ. In alignment with study design, some tools were restricted to one or two arms, as noted in parentheses next to each tool below. Not all tools were assessed at all time points. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the PSPs agreement with the following questions: "Have you completed a Sexual Health Assessment from your provider in the last 12 months? (ECI only)" and "Did your provider or clinic staff discuss your assessment results with you? (ECI only)".
Measured: Up to Month 12
Number of PSPs With Responses to Personnel for Sexual Health Assessment Discussions by Clinic Characteristics
PSP perceptions of study tools being fit for use were gathered through the ISQ. In alignment with study design, some tools were restricted to one or two arms, as noted in parentheses next to each tool below. Not all tools were assessed at all time points. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the PSPs answers to the following question: "Who discussed the results of the assessment with you? (ECI only)".
Measured: Up to Month 12
Number of PSPs With Responses to Helpfulness of Discussing Sexual Health Assessment Results by Clinic Characteristics
PSP perceptions of study tools being fit for use were gathered through the ISQ. In alignment with study design, some tools were restricted to one or two arms, as noted in parentheses next to each tool below. Not all tools were assessed at all time points. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the PSPs answer in terms of helpfulness to the following question regarding the sexual health assessment: "How helpful was discussing your results with your provider or clinic staff? (ECI only)".
Measured: Up to Month 12
Number of PSPs Responding With Reasons Why the Sexual Health Assessment Was Not Used, by Clinic Characteristics
PSP perceptions of study tools being fit for use were gathered through the ISQ. In alignment with study design, some tools were restricted to one or two arms, as noted in parentheses next to each tool below. Not all tools were assessed at all time points. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the reason the Sexual Health Assessment tool was not used by PSPs.
Measured: Up to Month 12
Number of PSPs by Fit-for-use Rating of APRETUDE Support Tools and Strategies, by Patient Subgroups
PSP perceptions of study tools being fit for use were gathered through the ISQ. In alignment with study design, some tools were restricted to one or two arms, as noted in parentheses next to each tool below. Not all tools were assessed at all time points. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI). The outcome measure presents the usefulness of the specified APRETUDE support tools and strategies by patient gender subgroups.
Measured: Up to Month 12
Number of PSPs That Respond to Helpfulness of APRETUDE Learning Materials by Patient Subgroups
PSP perceptions of study tools being fit for use were gathered through the ISQ. In alignment with study design, some tools were restricted to one or two arms, as noted in parentheses next to each tool below. Not all tools were assessed at all time points. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI). The outcome measure presents the helpfulness of the specified APRETUDE learning materials by patient gender subgroups.
Measured: Up to Month 12
Number of PSPs With Responses to Sexual Health Assessment Completion and Result Discussion by Patient Subgroups
PSP perceptions of study tools being fit for use were gathered through the ISQ. In alignment with study design, some tools were restricted to one or two arms, as noted in parentheses next to each tool below. Not all tools were assessed at all time points. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the PSPs agreement with the following questions: "Have you completed a Sexual Health Assessment from your provider in the last 12 months? (ECI only)" and "Did your provider or clinic staff discuss your assessment results with you? (ECI only)".
Measured: Up to Month 12
Number of PSPs With Responses to Personnel for Sexual Health Assessment Discussions by Patient Subgroups
PSP perceptions of study tools being fit for use were gathered through the ISQ. In alignment with study design, some tools were restricted to one or two arms, as noted in parentheses next to each tool below. Not all tools were assessed at all time points. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the PSPs answers to the following question regarding the sexual health assessment: "Who discussed the results of the assessment with you? (ECI only)".
Measured: Up to Month 12
Number of PSPs With Responses to Helpfulness of Discussing Sexual Health Assessment Results by Patient Subgroups
PSP perceptions of study tools being fit for use were gathered through the ISQ. In alignment with study design, some tools were restricted to one or two arms, as noted in parentheses next to each tool below. Not all tools were assessed at all time points. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the PSPs answer in terms of helpfulness to the following question regarding the sexual health assessment: "How helpful was discussing your results with your provider or clinic staff? (ECI only)".
Measured: Up to Month 12
Number of PSPs Responding With Reasons Why the Sexual Health Assessment Was Not Used, by Patient Subgroups
PSP perceptions of study tools being fit for use were gathered through the ISQ. In alignment with study design, some tools were restricted to one or two arms, as noted in parentheses next to each tool below. Not all tools were assessed at all time points. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the reason the Sexual Health Assessment tool was not used by PSPs.
Measured: Up to Month 12
Number of PSPs With Responses to Perceptions of Utility of Implementation Tools and Strategies Assessed by SSI by Study Arm
SSI guides were designed to support discussion surrounding the experience of PSPs receiving APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the Consolidated Framework for Implementation Research (CFIR). PSPs perceptions on the utility of study tools and strategies were gathered using SSIs. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the PSPs perception over the specified implementation tools and strategies.
Measured: Up to Month 12
Number of PSPs With Responses to Perceptions of Utility of Implementation Tools and Strategies by Patient Subgroups
PSPs perceptions on the utility of study tools and strategies were gathered using SSIs. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the PSPs perception over the specified implementation tools and strategies by patient gender subgroups.
Measured: Up to Month 12
Number of Injections Occurring Within the Target Window From Target Date
This outcome measure evaluates the number of injections occurring within the target window. The target window is defined as +/- 7 days from target date of injection for Dose 2 and subsequent injections. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Measured: Up to Month 12
Number of PSPs With Responses to Ease of Target Appointment Date Understanding Across Traditional and Non-traditional Settings
PSP perceptions of barriers and facilitators to fidelity to APRETUDE injection windows were gathered via the ISQ. Data below are stratified by clinic type to represent difference by traditional (HIV specialty) and non-traditional (women's clinics, primary care clinics) settings. Timeframe for evaluation of this outcome measure is at BL. This outcome measure presents the PSPs responses to the following question: "How easy was it to understand the Target Appointment Date?"
Measured: At Baseline (Month 1)
Number of PSPs With Responses to Missed APRETUDE Injection Visits Assessed Traditional and Non-traditional Settings
Data below were collected by ISQ and are stratified by clinic type to represent difference by traditional (HIV specialty) and non-traditional (women's clinics, primary care clinics) settings.Timeframe for evaluation of this outcome measure is at M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs responses to the following question: "Have you missed any of your APRETUDE injection visits in the last 6 months?".
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Planned/Unplanned Nature of Missed Injection Visits Across Traditional and Non-traditional Settings
Data below were collected by ISQ and are stratified by clinic type to represent difference by traditional (HIV specialty) and non-traditional (women's clinics, primary care clinics) settings. Timeframe for evaluation of this outcome measure is at M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs responses to the following question: "Was missing your APRETUDE injection visits planned or unplanned?".
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Initiation of Oral PrEP Following Missed Visits Across Traditional and Non-traditional Settings
Data below were collected by ISQ and are stratified by clinic type to represent difference by traditional (HIV specialty) and non-traditional (women's clinics, primary care clinics) settings.Timeframe for evaluation of this outcome measure is at M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs responses to the following question: "Did you start oral PrEP after missing any of your injection visit?".
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Ease or Difficulty of Initiating Oral PrEP After a Missed Visit Across Traditional and Non-traditional Settings
Data below were collected by ISQ and are stratified by clinic type to represent difference by traditional (HIV specialty) and non-traditional (women's clinics, primary care clinics) settings. Timeframe for evaluation of this outcome measure is at M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs responses to the following question: "How easy or difficult was it to start oral PrEP after a missed injection visit?".
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Acceptability of Initiating Oral PrEP After a Missed Visit Assessed Across Traditional and Non-traditional Settings
Data below were collected by ISQ and are stratified by clinic type to represent difference by traditional (HIV specialty) and non-traditional (women's clinics, primary care clinics) settings.Timeframe for evaluation of this outcome measure is at M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs responses to the following question: "How acceptable was it to start oral PrEP after a missed injection visit?".
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Target Appointment Date Understanding and Access Across Traditional and Non-traditional Settings
Data below were collected via SSIs or interviews, and are stratified by clinic type to represent difference by traditional (HIV specialty) and non-traditional (women's clinics, primary care clinics) settings. Timeframe for evaluation of this outcome measure is at BL. This outcome measure presents the PSPs understanding and access to the target appointment date. This outcome measure presents common concepts identified from qualitative analysis of interview data. The categories below are neither mutually exclusive nor exhaustive, given the variation in probe exposure and discussion patterns inherent to semi-structured qualitative data collection.
Measured: At Baseline (Month 1)
Number of PSPs With Responses to APRETUDE Adherence and Barriers/Facilitators to Injection Fidelity Across Traditional and Non-traditional Settings
Data below were collected via SSIs or interviews, and below are stratified by clinic type to represent difference by traditional (HIV specialty) and non-traditional (women's clinics, primary care clinics) settings. Timeframe for evaluation of this outcome measure is at M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the PSP responses to the APRETUDE adherence and the specified barriers and facilitators to injection fidelity.
Measured: At Month 12
Number of SSPs With Responses to APRETUDE Patient Management Challenges and Injection Fidelity Across Traditional and Non-traditional Settings
Data below were collected by ISQ and below are stratified by clinic type to represent difference by traditional (HIV specialty) and non-traditional (women's clinics, primary care clinics) settings. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs responses for the specified items regarding patient management challenges and injection fidelity for APRETUDE.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to Injection Visits, Adherence, and Missed Doses Across Traditional and Non-traditional Settings Assessed by SSI
SSI guides were designed to support discussion surrounding the experience of SSPs implementing and administering APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the CFIR. Data displayed represent injection fidelity topics discussed by SSPs while describing the APRETUDE implementation process. SSIs were not conducted with SSPs at baseline. Data below are stratified by clinic type to represent difference by traditional (HIV specialty) and non-traditional (women's clinics, primary care clinics) settings. Timeframe for evaluation of this outcome measure is M4 (equivalent to M5 for SSPs who assessed PSPs receiving OLI).
Measured: At Month 4
Number of SSPs With Responses to Perceived Barriers/Facilitators to Injection Window Fidelity Across Traditional and Non-traditional Settings Assessed by SSI
Data below were collected via SSIs, and are stratified by clinic type to represent difference by traditional (HIV specialty) and non-traditional (women's clinics, primary care clinics) settings. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents topics surrounding managing adherence and missed doses as discussed by SSPs during SSIs. This outcome measure presents common concepts identified from qualitative analysis of interview data. The categories below are neither mutually exclusive nor exhaustive, given the variation in probe exposure and discussion patterns inherent to semi-structured qualitative data collection.
Measured: At Month 12
Number of Clinics With Responses to Implementation Monitoring Calls (IMC) Assessed Barriers/Facilitators to Injection Window Fidelity Across Traditional and Non-traditional Settings
IMCs were conducted monthly by trained qualitative researchers with one to two SSPs per study site. These calls included discussion of implementation progress, facilitators and barriers to implementation, and solutions to challenges faced. Data below summarize site-level themes related to barriers and facilitators to fidelity to APRETUDE injection windows as discussed during IMC calls. Data below are stratified by clinic type to represent difference by traditional (HIV specialty) and non-traditional (women's clinics, primary care clinics) settings. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Measured: Up to Month 12
Number of PSPs Completing Target Number of Injections by Patient Subgroups
Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Measured: Up to Month 12
Number of SSPs With Responses to APRETUDE Implementation and Patient Management Assessed by Questionnaires
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. Overall SSP perceptions of barriers, facilitators, and concerns related to APRETUDE implementation were gathered. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs responses to the specified APRETUDE implementation and patient management. Only a selection of items are applicable for BL timepoint.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to Clinic Climate and Change Readiness Assessed by Questionnaires
Overall SSP perceptions of barriers, facilitators, and concerns related to APRETUDE implementation were gathered. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs response to the specified items regarding to the clinic climate and change readiness as implementation barriers and facilitators.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to Perceived Benefits of Bi-monthly Injections Assessed by Questionnaires
Overall SSP perceptions of barriers, facilitators, and concerns related to APRETUDE implementation were gathered. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs perception of the bi-monthly injection benefits.
Measured: At Month 12
Number of PSPs With Responses to Prior Knowledge of HIV/PrEP Assessed by Questionnaires
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. Overall PSP perceptions of the barriers, facilitators, and concerns related to receipt of APRETUDE were gathered. Timeframe for evaluation of this outcome measure is at BL, M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This endpoint presents the PSPs with responses to the specified questions regarding prior knowledge of HIV/PrEP. For each timepoint assessed for this outcome measure only specific questions were applied.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of PSPs With Responses to HIV Knowledge and Misconceptions Assessed by Questionnaires
Overall PSP perceptions of the barriers, facilitators, and concerns related to receipt of APRETUDE were gathered. Timeframe for evaluation of this outcome measure is at BL, M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This endpoint presents the PSPs with responses to the specified items regarding HIV knowledge and misconceptions.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of PSPs With Responses on Social Support, Stigma, and Personal Attitudes Towards PrEP Use Assessed by Questionnaires
Overall PSP perceptions of the barriers, facilitators, and concerns related to receipt of APRETUDE were gathered. Timeframe for evaluation of this outcome measure is at BL, M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs agreement regarding the social and personal perceptions (support, stigma, attitude) towards PrEP use.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of PSPs With Responses on Community Attitude Towards PrEP Assessed by Questionnaires
Overall PSP perceptions of the barriers, facilitators, and concerns related to receipt of APRETUDE were gathered. Timeframe for evaluation of this outcome measure is at BL. This outcome measure presents the PSPs response to the following question: "In general, what kind of attitude do you think your community has toward PrEP?".
Measured: At Baseline (Month 1)
Number of PSPs With Responses to Worry Regarding APRETUDE Disclosure Assessed by Questionnaires
Overall PSP perceptions of the barriers, facilitators, and concerns related to receipt of APRETUDE were gathered. Timeframe for evaluation of this outcome measure is at M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs response to the following question: "How often are you worried that people may find out that you are taking APRETUDE?".
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Sources of Pre-enrollment APRETUDE Information Assessed by Questionnaires
Overall PSP perceptions of the barriers, facilitators, and concerns related to receipt of APRETUDE were gathered. Timeframe for evaluation of this outcome measure is at M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs responses to the sources of information for APRETUDE pre-enrollment. This outcome measure presents the PSPs response to the following question: "If you have questions about APRETUDE, where do you find information?" The answer "the study app/website" was inconsistently displayed to study arms at different time points due to a programming error.
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Perceived Benefits of In-person APRETUDE Injection Visits
Overall PSP perceptions of the barriers, facilitators, and concerns related to receipt of APRETUDE were gathered. Timeframe for evaluation of this outcome measure is at M12 (equivalent to M13 for PSPs who received OLI). The outcome measure presents the PSPs perception of the benefits of in-person APRETUDE injection visits.
Measured: At Month 12
Number of PSPs With Responses to Overall Feelings to APRETUDE Assessed by Questionnaires
Overall PSP perceptions of the barriers, facilitators, and concerns related to receipt of APRETUDE were gathered. Timeframe for evaluation of this outcome measure is at BL, M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs responses to the following question: "Overall, how are you feeling about getting APRETUDE?".
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to Facilitators and Barriers to Implementation Assessed by SSIs at Month 4
SSI guides were designed to support discussion surrounding the experience of SSPs implementing and administering APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the Consolidated Framework for Implementation Research (CFIR). Overall SSP perceptions of barriers, facilitators, and concerns related to APRETUDE implementation were gathered. Timeframe for evaluation of this outcome measure is M4 (equivalent to M5 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs responses to the specified facilitators and barriers to implementation, based on the SSI guides.
Measured: At Month 4
Number of SSPs With Responses to Facilitators and Barriers to Implementation Assessed by SSIs at Month 12
SSI guides were designed to support discussion surrounding the experience of SSPs implementing and administering APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the Consolidated Framework for Implementation Research (CFIR). Overall SSP perceptions of barriers, facilitators, and concerns related to APRETUDE implementation were gathered. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs responses to the specified facilitators and barriers to implementation, based on the SSI guides.
Measured: At Month 12
Number of Clinics With Responses to Facilitators and Barriers to Implementation Assessed by IMCs
IMCs were conducted monthly by trained qualitative researchers with one to two SSPs per study site. These calls included discussion of implementation progress, facilitators and barriers to implementation, and solutions to challenges faced. Data below summarize site-level themes related to overall SSP perceptions of facilitators and barriers to APRETUDE implementation discussed during IMC calls. The categories below are neither mutually exclusive nor exhaustive, given the variation in probe exposure and discussion patterns inherent to qualitative data collection.
Measured: Up to Month 12
Number of PSPs With Responses to Facilitators and Barriers to Implementation Assessed by SSIs at Baseline
SSI guides were designed to support discussion surrounding the experience of PSPs receiving APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the Consolidated Framework for Implementation Research (CFIR). Overall PSP perceptions of facilitators and barriers to receipt of APRETUDE and its implementation were gathered. This outcome measure presents the PSPs responses to the specified facilitators and barriers to implementation, based on the SSI guides. This outcome measure presents common concepts identified from qualitative analysis of interview data. The categories below are neither mutually exclusive nor exhaustive, given the variation in probe exposure and discussion patterns inherent to semi-structured qualitative data collection.
Measured: At Baseline (Month 1)
Number of PSPs With Responses to Facilitators and Barriers to Implementation Assessed by SSIs at Month 12
SSI guides were designed to support discussion surrounding the experience of PSPs receiving APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the Consolidated Framework for Implementation Research (CFIR). Overall PSP perceptions of facilitators and barriers to receipt of APRETUDE and its implementation were gathered. Timeframe for evaluation of this outcome measure is at M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the PSPs responses to the specified facilitators and barriers to implementation, based on the SSI guides.
Measured: At Month 12
Mean Acceptability of Intervention Measure (AIM) Score Assessed for PSPs
The AIM was used to assess among PSPs the acceptability of APRETUDE using a four-item measure (1. I believe APRETUDE will meet my approval for preventing HIV, 2. APRETUDE for the prevention of HIV is appealing to me, 3. I think I will like APRETUDE for the prevention of HIV, 4. I welcome APRETUDE for the prevention of HIV) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score was calculated using the 1 to 5 range scale responses on the AIM, and the results are presented in this outcome measure. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI)
Measured: At Baseline (Month 1), Month 4 and Month 12
Mean FIM Score Assessed for PSPs
The FIM was used to assess among PSPs the feasibility of APRETUDE using a four-item measure (1. Receiving APRETUDE injections every 2 months seems workable in my life, 2. Receiving APRETUDE injections every 2 months seems possible for me, 3. Receiving APRETUDE injections every 2 months seems doable in my life, 4. Receiving APRETUDE injections every 2 months seems easy in my life) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score was calculated using the 1 to 5 range scale responses on the FIM, and the results are presented in this outcome measure. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI).
Measured: At Baseline (Month 1), Month 4 and Month 12
Mean AIM Score Assessed for SSPs
The AIM was used to assess the acceptability of APRETUDE using a four-item measure (1. APRETUDE in our clinic/practice meets my approval, 2. APRETUDE in our clinic/practice is appealing to me, 3. I like APRETUDE in our clinic/practice, 4. I welcome APRETUDE in our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score was calculated using the 1 to 5 range scale responses on the AIM, and the results are presented in this outcome measure. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).
Measured: At Baseline (Month 1), Month 4 and Month 12
Mean FIM Score Assessed for SSPs
The FIM was used to assess the feasibility of APRETUDE using a four-item measure (1. APRETUDE seems implementable in our clinic/practice, 2. APRETUDE seems possible in our clinic/practice, 3. APRETUDE seems doable in our clinic/practice, 4. APRETUDE seems easy to use in our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score was calculated using the 1 to 5 range scale responses on the FIM, and the results are presented in this outcome measure. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to Feasibility of APRETUDE Implementation
The ISQ used a variety of questions to assess SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on the feasibility of APRETUDE gathered through the ISQ. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs with responses for the specified items regarding feasibility of APRETUDE implementation.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to Clinic Capacity for APRETUDE Patient Management
The ISQ used a variety of questions to assess SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on the feasibility of APRETUDE gathered through the ISQ. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs with responses for the specified items regarding clinic capacity for APRETUDE patient management (i.e. "Number of APRETUDE patients that the clinic can manage per week").
Measured: At Baseline (Month 1), Month 4 and Month 12
Mean Number of Staff Needed to Incorporate APRETUDE Into Clinics Per Week
The ISQ used a variety of questions to assess SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on the feasibility of APRETUDE gathered through the ISQ. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). This endpoint presents the results on mean number of staff needed to incorporate APRETUDE into clinics per week.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to Staff Time/Full-time Equivalent Hours (FTE) Requirements Per Week
The ISQ used a variety of questions to assess SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on the feasibility of APRETUDE gathered through the ISQ. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs with responses to staff time/FTE requirements per week to incorporate APRETUDE.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to Clinic/Practice Methods for Patient Tracking
The ISQ used a variety of questions to assess SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on the feasibility of APRETUDE gathered through the ISQ. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs with responses to clinic/practice methods for patient tracking.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to Clinic/Practice Methods to Remind Patients of an Upcoming Appointment
The ISQ used a variety of questions to assess SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on the feasibility of APRETUDE gathered through the ISQ. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs with responses to clinic/practice methods to remind patients of an upcoming appointment
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to Clinic/Practice Approaches for Offering Injection Appointments
The ISQ used a variety of questions to assess SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on the feasibility of APRETUDE gathered through the ISQ. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs with responses to clinic/practice approaches for offering injection appointments.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to Perceived Ease/Difficulty of Implementing APRETUDE in Clinics
The ISQ used a variety of questions to assess SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on the feasibility of APRETUDE gathered through the ISQ. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs with responses to perceived ease/difficulty of implementing APRETUDE in clinics.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to Acceptability of APRETUDE Implementation
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on the acceptability of APRETUDE gathered through the ISQ. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs with responses to acceptability of APRETUDE implementation.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to Perceived Positive Perception of Implementing APRETUDE
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on the acceptability of APRETUDE gathered through the ISQ. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs with responses to perceived positive perception of implementing APRETUDE.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to Patient Time in Waiting Room and Exam Room for APRETUDE Injection Visits
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on the acceptability of APRETUDE gathered through the ISQ. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs with responses to patient time in waiting room and exam room for APRETUDE injection visits.
Measured: At Month 12
Number of SSPs With Responses to Post-injection Observation Period for Patients After APRETUDE
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP perceptions on the acceptability of APRETUDE gathered through the ISQ. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs with responses to post-injection observation period for patients after APRETUDE.
Measured: At Month 12
Number of PSPs With Responses to Convenience Level of Clinic Hours
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's feasibility were gathered via the ISQ. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to convenience level of clinic hours.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of PSPs With Responses to Sources of First Injection Appointment Reminders at Baseline
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's feasibility were gathered via the ISQ. Timeframe for evaluation of this outcome measure is BL. This outcome measure presents the PSPs with responses to sources of first injection appointment reminders at baseline.
Measured: At Baseline (Month 1)
Number of PSPs With Responses to Sources of Injection Appointment Reminders at Month 12
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's feasibility were gathered via the ISQ. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to sources of injection appointment reminders at Month 12.
Measured: At Month 12
Number of PSPs With Responses to Preferred Appointment Reminder Types at Baseline
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's feasibility were gathered via the ISQ. Timeframe for evaluation of this outcome measure is BL. This outcome measure presents the PSPs with responses to preferred appointment reminder types at baseline (Month 1).
Measured: At Baseline (Month 1)
Number of PSPs With Responses to Most Helpful Types of Appointment Reminders at M4 and M12
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's feasibility were gathered via the ISQ. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to most helpful types of appointment reminders at M4 and M12.
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Need for Additional Care for Injection Visits
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's feasibility were gathered via the ISQ. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to need for additional care for injection visits.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of PSPs With Responses to Anticipated Time Off Work for APRETUDE Injections at Baseline
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's feasibility were gathered via the ISQ. Timeframe for evaluation of this outcome measure is BL. This outcome measure presents the PSPs with responses to anticipated time off work for APRETUDE injections at baseline.
Measured: At Baseline (Month 1)
Number of PSPs With Responses to Time Taken Off Work for Injections at M4 and M12
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's feasibility were gathered via the ISQ. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to time off work for APRETUDE injections at M4 and M12.
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Amount of Time Off Work Taken for Injections at M4 and M12
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's feasibility were gathered via the ISQ. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to amount of time off work taken for injections at M4 and M12.
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Status of Time Off Work for Injections at M4 and M12
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's feasibility were gathered via the ISQ. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to status of time off work for injections at M4 and M12.
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Frequency of Worry About Forgetting APRETUDE Injections
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's feasibility were gathered via the ISQ. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to frequency of worry about forgetting APRETUDE injections.
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Perceived Ease/Difficulty of Scheduling Injection Appointments
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's feasibility were gathered via the ISQ. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to perceived ease/difficulty of scheduling injection appointments.
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Perceived Ease/Difficulty of Rescheduling Injection Appointments
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's feasibility were gathered via the ISQ. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to perceived ease/difficulty of rescheduling injection appointments.
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Acceptability of Attending the Clinic Every 2 Months
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's feasibility were gathered via the ISQ. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to how easy or difficult it has been to get to the clinic every 2 months at M4 and M12.
Measured: At Month 4 and at Month 12
Number of PSPs With Responses to Length of Journey to the Clinic/Practice at M12
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's feasibility were gathered via the ISQ. Timeframe for evaluation of this outcome measure M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to "Approximately how long has it taken you to get to the clinic/practice from your home to receive your injection?" at M12.
Measured: At Month 12
Number of PSPs With Responses to Concerns About APRETUDE
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's acceptability were gathered via the ISQ. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to concerns about APRETUDE.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of PSPs With Responses to Specific Concerns About APRETUDE at Baseline
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's acceptability were gathered via the ISQ. This outcome measure presents data only from the subset of PSPs that had concerns about APRETUDE at baseline (M1).
Measured: At Baseline (Month 1)
Number of PSPs With Responses to Specific Concerns About APRETUDE at Month 4
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's acceptability were gathered via the ISQ. This outcome measure presents data only from the subset of PSPs that had concerns about APRETUDE at M4.
Measured: At Month 4
Number of PSPs With Responses to Specific Concerns About APRETUDE at Month 12
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's acceptability were gathered via the ISQ. This outcome measure presents data only from the subset of PSPs that had concerns about APRETUDE at M12.
Measured: At Month 12
Number of PSPs With Responses to Acceptability of Bi-monthly Clinic Visits for Injections
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's acceptability were gathered via the ISQ. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to acceptability of bi-monthly clinic visits for injections.
Measured: At Baseline (Month 1), Month 4 and Month 12
Number of PSPs With Responses to Acceptability of HIV and STI Testing Frequency
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's acceptability were gathered via the ISQ. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to acceptability of HIV and STI testing frequency.
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Local Reactions Following an APRETUDE Injection
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's acceptability were gathered via the ISQ. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to local reactions following an APRETUDE injection.
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Acceptability of Local Reactions
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's acceptability were gathered via the ISQ. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to acceptability of local reactions following an APRETUDE injection.
Measured: At Month 4 and Month 12
Number of PSPs With Responses on Return to Daily Activities Post-injection
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's acceptability were gathered via the ISQ. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses on return to daily activities post-injection (e.g., going back to work, social events, exercise, driving).
Measured: At Month 4 and Month 12
Number of PSPs Indicating How Bothered by Pain They Were During APRETUDE Injections
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's acceptability were gathered via the ISQ. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents data indicating how bothered by pain PSPs were during injection.
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Acceptability of Injection-related Pain
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's acceptability were gathered via the ISQ. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to acceptability of injection-related pain.
Measured: At Month 4 and Month 12
Number of PSPs With Responses to Pain Reduction Strategies Post-injection
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's acceptability were gathered via the ISQ. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses to pain reduction strategies post-injection.
Measured: At Month 4 and Month 12
Mean Rating of Pain/Discomfort Following First APRETUDE Injection
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's acceptability were gathered via the ISQ. This outcome measure presents the PSPs mean rating of pain/discomfort following first APRETUDE injection. The rating of pain/discomfort uses a 10-point scale, where 0=No pain and 10=Extreme pain. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI).
Measured: At Month 4 and Month 12
Mean Rating of Pain/Discomfort Following Most Recent APRETUDE Injection
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP perceptions of the APRETUDE's acceptability were gathered via the ISQ. This outcome measure presents the PSPs mean rating of pain/discomfort following the most recent APRETUDE injection. The rating of pain/discomfort uses a 10-point scale, where 0=No pain and 10=Extreme pain. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for PSPs who received OLI).
Measured: At Month 4 and Month 12
Number of SSPs With Influences on and Facilitators/Barriers of Acceptability of APRETUDE Assessed by SSI
SSI guides were designed to support discussion surrounding the experience of SSPs implementing and administering APRETUDE.
Interview guides were informed by the implementation science frameworks from Proctor and the CFIR. SSP perceptions of the acceptability of APRETUDE implementation were gathered using SSIs. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs with influences on and facilitators/barriers of acceptability of APRETUDE.
Measured: At Month 4 and Month 12
Number of SSPs With Influences on and Facilitators/Barriers of Feasibility of APRETUDE
SSI guides were designed to support discussion surrounding the experience of SSPs implementing and administering APRETUDE.
Interview guides were informed by the implementation science frameworks from Proctor and the Consolidated Framework for Implementation Research (CFIR). SSP perceptions of the feasibility of APRETUDE implementation were gathered using SSIs.
Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs with influences on and facilitators/barriers of feasibility of APRETUDE.
Measured: At Month 12
Number of PSPs With Influences of Acceptability of APRETUDE at Baseline
SSI guides were designed to support discussion surrounding the experience of PSPs receiving APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the Consolidated Framework for Implementation Research (CFIR). PSP perceptions of the acceptability of APRETUDE were gathered using SSIs. Timeframe for evaluation of this outcome measure is BL. This outcome measure presents the PSPs with influences of acceptability of APRETUDE at baseline (M1). This outcome measure presents common concepts identified from qualitative analysis of interview data. The categories below are neither mutually exclusive nor exhaustive, given the variation in probe exposure and discussion patterns inherent to semi-structured qualitative data collection.
Measured: At Baseline (Month 1)
Number of PSPs With Influences of Acceptability of APRETUDE at Month 12
SSI guides were designed to support discussion surrounding the experience of PSPs receiving APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the Consolidated Framework for Implementation Research (CFIR). PSP perceptions of the acceptability of APRETUDE were gathered using SSIs. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the PSPs with influences of acceptability of APRETUDE at M12.
Measured: At Month 12
Number of PSPs With Influences of Feasibility of APRETUDE at Baseline
SSI guides were designed to support discussion surrounding the experience of PSPs receiving APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the Consolidated Framework for Implementation Research (CFIR). PSP perceptions of the feasibility of APRETUDE were gathered using SSIs. Timeframe for evaluation of this outcome measure is BL. This outcome measure presents the PSPs with influences of feasibility of APRETUDE at baseline (M1). This outcome measure presents common concepts identified from qualitative analysis of interview data. The categories below are neither mutually exclusive nor exhaustive, given the variation in probe exposure and discussion patterns inherent to semi-structured qualitative data collection.
Measured: At Baseline (Month 1)
Number of PSPs With Influences of Feasibility of APRETUDE at Month 12
SSI guides were designed to support discussion surrounding the experience of PSPs receiving APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the Consolidated Framework for Implementation Research (CFIR). PSP perceptions of the feasibility of APRETUDE were gathered using SSIs. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the PSPs with influences of feasibility of APRETUDE at M12.
Measured: At Month 12
Number of PSPs Who Had Oral lead-in Before APRETUDE Injection - Data Collected by ISQ at Baseline
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. Self-report from PSPs of use of oral cabotegravir pills as oral lead-in to APRETUDE injections was gathered using the ISQ. Timeframe for evaluation of this outcome measure is BL. This outcome measure presents the PSPs who had OLI before APRETUDE injection.
Measured: At Baseline (Month 1)
Number of SSPs Reporting Use of Oral lead-in Before APRETUDE Injection on Baseline ISQ
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP self-reported use of oral cabotegravir pills with patient participants as OLI before APRETUDE injection were gathered. Timeframe for evaluation of this outcome measure is BL. This outcome measure presents the SSPs who chose OLI before APRETUDE injection at baseline (M1).
Measured: At Baseline (Month 1)
Number of SSPs Who Chose Oral lead-in Before APRETUDE Injection - Data Collected by ISQ at Month 4 and 12
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP self-reported use of oral cabotegravir pills with patient participants as OLI before APRETUDE injection were gathered. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs who chose OLI before APRETUDE injection at M4 and M12.
Measured: At Month 4 and Month 12
Number of SSPs With Responses on Reasons for Decision to Use Oral lead-in Assessed by SSI
SSI guides were designed to support discussion surrounding the experience of SSPs implementing and administering APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the CFIR. SSP perceptions on reasons for using oral cabotegravir pills with patient participants as OLI before APRETUDE injection were gathered using SSIs. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). SSIs were not conducted with SSPs at BL. This outcome measure presents the SSPs with responses on reasons for decision to use OLI assessed by SSI at M4 and M12.
Measured: At Month 4 and Month 12
Number of SSPs With Responses on Reasons for Decision to Use Oral lead-in Assessed by Surveys at Baseline
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP self-reported reasons for using oral cabotegravir pills with patient participants as OLI before APRETUDE injection were gathered through the ISQ. Timeframe for evaluation of this outcome measure is BL. This outcome measure presents the SSPs on reasons for decision to use OLI, assessed at baseline (M1).
Measured: At Baseline (Month 1)
Number of SSPs With Responses on Reasons for Decision to Use Oral lead-in Assessed by Surveys at Month 4
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP self-reported reasons for using oral cabotegravir pills with patient participants as OLI before APRETUDE injection were gathered through the ISQ. Timeframe for evaluation of this outcome measure is M4 (equivalent to M5 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs on reasons for decision to use OLI, assessed at M4.
Measured: At Month 4
Number of SSPs With Responses on Reasons for Decision to Use Oral lead-in Assessed by Surveys at Month 12
The ISQ used a variety of questions to assess among SSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other considerations related to the use of APRETUDE at their site. SSP self-reported reasons for using oral cabotegravir pills with patient participants as OLI before APRETUDE injection were gathered through the ISQ. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI). This outcome measure presents the SSPs on reasons for decision to use OLI, assessed at M12.
Measured: At Month 12
Number of PSPs With Responses on Reasons for Decision to Use Oral lead-in Assessed by SSI
SSI guides were designed to support discussion surrounding the experience of PSPs receiving APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the CFIR. PSP self-reported reasons for using oral cabotegravir pills as OLI to APRETUDE injections were gathered using SSIs. Timeframe for evaluation of this outcome measure is BL. This outcome measure presents the PSPs' experiences with and reasons for using OLI or direct-to-injection (DTI) approach, assessed by SSIs.
Measured: At Baseline (Month 1)
Number of PSPs With Responses on Decision Making for Use of OLI Assessed by Surveys
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. Self-report from PSPs of the reasons they used oral cabotegravir pills as OLI to APRETUDE injections was gathered via the ISQ. Timeframe for evaluation of this outcome measure is BL. This outcome measure presents the PSPs on reasons for decision to use OLI, assessed by surveys.
Measured: At Baseline (Month 1)
Number of PSPs With Responses on Reasons for Decision for Use of OLI Assessed by Surveys
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. Self-report from PSPs of the reasons they used oral cabotegravir pills as OLI to APRETUDE injections was gathered via the ISQ. Timeframe for evaluation of this outcome measure is BL. This outcome measure presents the PSPs with responses on reasons for decision for use of OLI, assessed by surveys.
Measured: At Baseline (Month 1)
Number of PSPs With PrEP History
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. Self-report from PSPs of their history of oral PrEP use before study participation was gathered via the ISQ at BL alone. Timeframe for evaluation of this outcome measure is BL.
Measured: At Baseline (Month 1)
Number of PSPs With Responses to Consistency in Oral PrEP Use in Past 6 Months
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. Self-report from PSPs of their history of oral PrEP use before study participation was gathered via the ISQ at BL alone. This outcome measure presents the PSPs responses to consistency in Oral PrEP use in past 6 months.
Measured: At Baseline (Month 1)
Number of PSPs With Responses to Oral PrEP Duration
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. Self-report from PSPs of their history of oral PrEP use before study participation was gathered via the ISQ at BL alone. This outcome measure presents the PSPs responses to Oral PrEP duration.
Measured: At Baseline (Month 1)
Number of PSPs Who Completed a SHA and Initiate APRETUDE
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. PSP use of the sexual health assessment (available only to the ECI arm) was gathered via the ISQ. Timeframe for evaluation of this outcome measure is at Baseline (BL) and M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the PSPs who completed a SHA and initiate APRETUDE. All PSPs enrolled in the study initiated APRETUDE.
Measured: At Baseline (Month 1) and Month 12
Number of PSPs With Responses to Experiences With Oral PrEP Assessed by Surveys
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. Self-report from PSPs of the reasons they chose to receive APRETUDE injections, including reasons for switching from oral PrEP to APRETUDE if relevant, was gathered via the ISQ. Timeframe for evaluation of this outcome measure is BL. This outcome measure presents the PSPs with responses to experiences with Oral PrEP, assessed by surveys.
Measured: At Baseline (Month 1)
Number of PSPs With Responses to Oral PrEP Side Effects Assessed by Surveys
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. Self-report from PSPs of the reasons they chose to receive APRETUDE injections, including reasons for switching from oral PrEP to APRETUDE if relevant, was gathered via the ISQ. Timeframe for evaluation of this outcome measure is BL. This outcome measure presents the PSPs with responses to Oral PrEP side effects, assessed by surveys.
Measured: At Baseline (Month 1)
Number of PSPs With Responses to Frequency of Worry About Oral PrEP Disclosure Assessed by Surveys
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. Self-report from PSPs of the reasons they chose to receive APRETUDE injections, including reasons for switching from oral PrEP to APRETUDE if relevant, was gathered via the ISQ. Timeframe for evaluation of this outcome measure is BL. This outcome measure presents the PSPs with responses to frequency of worry about Oral PrEP disclosure, assessed by surveys.
Measured: At Baseline (Month 1)
Number of PSPs With Responses to Reasons for Choosing APRETUDE Assessed by Surveys
The ISQ used a variety of questions to assess among PSPs demographic characteristics, implementation outcomes (e.g., facilitators and barriers, appropriateness, acceptability, feasibility), perceptions of APRETUDE, use of study tools, and other experiences related to receipt of APRETUDE. Self-report from PSPs of the reasons they chose to receive APRETUDE injections, including reasons for switching from oral PrEP to APRETUDE if relevant, was gathered via the ISQ. Timeframe for evaluation of this outcome measure is BL. This outcome measure presents the PSPs with responses to reasons for choosing APRETUDE, assessed by surveys.
Measured: At Baseline (Month 1)
Number of PSPs With Responses for Choosing or Switching to APRETUDE Assessed by SSI at Baseline
SSI guides were designed to support discussion surrounding the experience of PSPs receiving APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the CFIR. PSP self-reported reasons choosing to receive APRETUDE, including reasons for switching from oral PrEP to APRETUDE if relevant, were gathered using SSIs. This outcome measure presents common concepts identified from qualitative analysis of interview data. The categories below are neither mutually exclusive nor exhaustive, given the variation in probe exposure and discussion patterns inherent to semi-structured qualitative data collection. This outcome measure presents the PSPs with responses for choosing or switching to APRETUDE, assessed by SSI at baseline (M1).
Measured: At Baseline (Month 1)
Number of PSPs With Responses for Choosing or Switching to APRETUDE Assessed by SSI at Month 12
SSI guides were designed to support discussion surrounding the experience of PSPs receiving APRETUDE. Interview guides were informed by the implementation science frameworks from Proctor and the Consolidated Framework for Implementation Research (CFIR). PSP self-reported reasons choosing to receive APRETUDE, including reasons for switching from oral PrEP to APRETUDE if relevant, were gathered using SSIs. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for PSPs who received OLI). This outcome measure presents the PSPs with responses for choosing or switching to APRETUDE, assessed by SSI at M12.
Measured: At Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start28 Oct 2022
- Primary completion2 Sep 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514509
- Sponsor's protocol ID
- 217711
- Acronym
- EBONI
- Status last verified
- Sep 2026
- First submitted
- 22 Aug 2022
- Last updated
- 1 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
- Expanded access
- Available
Publications
Nelson KL, Evans Cooper T, Lawson Y, Baker D, Mocherla S, Dieterich M, Hodge T, Dyson A, Sutherland-Philips D, Swygard H, Petty L, Jeffery P, Sutton K, Bonner CP, Andrews SM, Chang S, Budnik P, Smith K, de Ruiter A, Czarnogorski M, Pilgrim N. Strategies for implementing long-acting cabotegravir for PrEP in US clinics serving Black women: interim healthcare provider findings from the EBONI study. J Int AIDS Soc. 2025 Jul;28 Suppl 2(Suppl 2):e26497. doi: 10.1002/jia2.26497.
PubMed 40600480
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Randomized, Open-label, Three-arm Study to Evaluate Implementation Strategies for the Delivery of CAB for HIV Pre-exposure Prophylaxis (PrEP) Across Clinical Settings for Adult (≥18 Years) Black cis-and Transgender Women Without HIV Infection Living in the United States Ending the Epidemic (EHE) Territories
- ClinicalTrials.gov ID
- NCT05514509
- Acronym / sponsor ID
- EBONI / 217711
- Conditions
- HIV Infections
- Keywords
- Cabotegravir, Long acting injectables, Implementation science, HIV, PrEP, HIV Disparities, Ending the Epidemic, Engaging Black Women on APRETUDE by Optimizing Novel Implementation Strategies (EBONI)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Posted 1 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementation. The first of two participant types in the study are the Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available CAB PrEP via prescription from the PrEP provider. The second are Staff Study Participants (SSPs) who are site staff involved in the administrative and clinical aspects of offering and administering PrEP to PSPs at the clinical site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Implementation (SI) | Active comparator | Drug: APRETUDE, Drug: Cabotegravir tabletThe SI arm evaluated cabotegravir long-acting injectable (CAB LA) for pre-exposure prophylaxis (PrEP) delivery using standard toolkits made available with the commercial release of CAB LA for providers and patients to use as needed, along with implementation monitoring. |
| Enhanced Implementation (EI) | Experimental | Drug: APRETUDE, Drug: Cabotegravir tabletThe EI arm evaluated CAB LA delivery using the standard toolkits plus enhanced supports to use as needed, along with implementation monitoring. EI sites received supports like patient-provider discussion tools, informational tools, and provider education. |
| Enhanced Collaborative Implementation (ECI) | Experimental | Drug: APRETUDE, Drug: Cabotegravir tabletThe ECI arm evaluated CAB LA delivery using the standard toolkits plus enhanced supports to use as needed, along with implementation monitoring. ECI sites received supports like a sexual health assessment, provider education, videos, informational tools, persistence support, and peer ambassadors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant must be ≥18 years of age, at the time of signing the informed consent.
- HIV negative at screening. Type of HIV-1 test is per standard of care.
- No prior history of receiving oral CAB or CAB LA injections.
- PrEP provider deems CAB PrEP use to be appropriate per the applicable CAB PrEP prescribing information prior to enrollment in the study.
- Female at birth or self-identified Transgender Female.
Key exclusion criteria (3 listed)
- HIV indeterminate or positive test result during screening.
- A participant of concurrent interventional clinical or implementation science study at any time during the study.
- Cis-gender or Transgender male
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APRETUDEAvailable as intramuscular injection. | Drug | Enhanced Collaborative Implementation (ECI), Enhanced Implementation (EI), Standard Implementation (SI) |
| Cabotegravir tabletAvailable as marketed orally administered tablets. | Drug | Enhanced Collaborative Implementation (ECI), Enhanced Implementation (EI), Standard Implementation (SI) |
Primary outcome
Mean Intervention Appropriateness Measure (IAM) Score Assessed for SSPs at Month 12
Time frame: At Month 12
The IAM was used to assess among SSPs the appropriateness of APRETUDE for PSPs using a four-item measure (1. APRETUDE seems fitting for Black women at our clinic/practice 2. APRETUDE seems suitable for Black women at our clinic/practice 3.APRETUDE seems applicable for Black women at our clinic/practice 4.APRETUDE seems like a good match for Black women at our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least appropriate and 5 the most appropriate. Timeframe for evaluation of this outcome measure is Month (M)12 (equivalent to M13 for SSPs who assessed PSPs receiving Optional oral Lead in [OLI])
161 secondary outcomes
Mean IAM Score Assessed for SSPs Over Time
Time frame: At Baseline (Month 1), Month 4 and Month 12
Change From Baseline in IAM Score Assessed for SSPs
Time frame: At Month 4 and Month 12 compared to Baseline (Month 1)
Number of SSPs With Responses to Appropriateness of APRETUDE Assessed by Implementation Science Questionnaire (ISQs) at Baseline
Time frame: At Baseline (Month 1)
Number of SSPs With Responses to Appropriateness of APRETUDE Assessed by ISQs at Month 4
Time frame: At Month 4
Number of SSPs With Responses to Appropriateness of APRETUDE Assessed by ISQs at Month 12
Time frame: At Month 12
Number of SSPs With Responses to APRETUDE Staffing Sufficiency Assessed by ISQs at Months 4 and 12
Time frame: At Month 4 and Month 12
Number of SSPs With Responses to Appropriateness of APRETUDE Assessed by Semi-structured Interview (SSI) at Month 4
Time frame: At Month 4
Number of SSPs With Responses to Appropriateness of APRETUDE Assessed by SSI at Month 12
Time frame: At Month 12
Mean IAM Score Assessed for PSPs
Time frame: At Baseline (Month 1), Month 4 and Month 12
Change From Baseline in IAM Score Assessed for PSPs
Time frame: At Month 4 and Month 12 compared to Baseline (Month 1)
Number of SSPs With Responses to Perceived Appropriateness of APRETUDE for Different Patient Characteristics Assessed by ISQ
Time frame: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs Reporting That APRETUDE is More Appropriate for Specific Demographic Groups Assessed by ISQ
Time frame: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs Reporting Specific Demographic Groups for Which APRETUDE May be More Appropriate Assessed by ISQ
Time frame: At Baseline (Month 1), Month 4 and Month 12
Number of SSPs Reporting Appropriateness of APRETUDE Via Level of Concern Surrounding Patient Beliefs and Experiences Assessed by ISQ
Time frame: At Baseline (Month 1), Month 4 and Month 12
Number of PSPs With Responses to Perception of Appropriateness of APRETUDE Assessed by SSI at Baseline
Time frame: At Baseline (Month 1)
Number of PSPs With Responses to Perception of Appropriateness of APRETUDE Assessed by SSI at Month 12
Time frame: At Month 12
Number of Cis- and Trans Black Women Who Complete a Sexual Health Assessment in ECI Arm
Time frame: Up to Month 12
Number of PSPs Who Complete a Sexual Health Assessment in ECI Arm
Time frame: Up to Month 12
Number of Black Women (Both Cis- and Trans) Who Initiate APRETUDE by Study Arm
Time frame: Up to Month 12
Number of Black Women (Both Cis- and Trans) Who Initiate APRETUDE by Clinic Setting
Time frame: Up to Month 12
Number of Black Women (Both Cis and Trans) Who Continue APRETUDE Beyond a First Dose by Study Arm
Time frame: Up to Month 12
Number of Black Women (Both Cis and Trans) Who Continue APRETUDE Beyond a First Dose by Clinic Setting
Time frame: Up to Month 12
Mean Feasibility of Intervention Measure (FIM) Score for PrEP Training Assessed for SSPs
Time frame: At Month 4 and Month 12
Change in FIM Score for PrEP Training Assessed for SSPs
Time frame: At Month 12 compared to Month 4
Number of SSPs With Responses to Feasibility and Ease of Clinical Tool Implementation Assessed by SSP Questionnaire Responses at Baseline
Time frame: At Baseline (Month 1)
Number of SSPs With Responses to Planned Frequency of Use for PrEP Options Communication and Sexual Health Assessment Tools Assessed by SSP Questionnaire Responses at Baseline
Time frame: At Baseline (Month 1)
Number of SSPs With Responses to Feasibility, Ease of Use, and Implementation of PrEP Training and Clinical Tools Assessed at Month 4
Time frame: At Month 4
Number of SSPs With Responses to Feasibility, Ease of Use, and Implementation of PrEP Training and Clinical Tools Assessed at Month 12
Time frame: At Month 12
Number of SSPs With Responses to Frequency of PrEP Options Communication Tool and Sexual Health Assessment Tool Use Assessed at Month 4
Time frame: At Month 4
Number of SSPs With Responses to Frequency of PrEP Options Communication Tool and Sexual Health Assessment Tool Use Assessed at Month 12
Time frame: At Month 12
Number of SSPs With Responses to Current Use of the PrEP Options Communication Tool
Time frame: At Month 4 and Month 12
Number of SSPs Indicating Reasons Why the PrEP Options Communications Tool Was Not Used, Assessed at Month 4
Time frame: At Month 4
Number of SSPs Indicating Reasons Why the PrEP Options Communications Tool Was Not Used, Assessed at Month 12
Time frame: At Month 12
Number of SSPs With Responses to Current Use of the Sexual Health Assessment Tool
Time frame: At Month 4 and Month 12
Number of SSPs Indicating Reasons Why the Sexual Health Assessment Tool Was Not Used, Assessed at Month 4
Time frame: At Month 4
Number of SSPs Indicating Reasons Why the Sexual Health Assessment Tool Was Not Used, Assessed at Month 12
Time frame: At Month 12
Number of SSPs With Responses to Feasibility and Utility of Implementation Strategies Assessed by SSI at Month 4
Time frame: At Month 4
Number of SSPs With Responses to Feasibility and Utility of Implementation Strategies Assessed by SSI at Month 12
Time frame: At Month 12
Number of SSPs That Respond to PrEP Education Training and Utility of Strategies by Study Arm
Time frame: Up to Month 12
Number of SSPs That Respond to Helpfulness for Utilized Implementation Strategies by Study Arm
Time frame: Up to Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40600480Nelson KL, Evans Cooper T, Lawson Y, Baker D, Mocherla S, Dieterich M, Hodge T, Dyson A, Sutherland-Philips D, Swygard H, Petty L, Jeffery P, Sutton K, Bonner CP, Andrews SM, Chang S, Budnik P, Smith K, de Ruiter A, Czarnogorski M, Pilgrim N. Strategies for implementing long-acting cabotegravir for PrEP in US clinics serving Black women: interim healthcare provider findings from the EBONI study. J Int AIDS Soc. 2025 Jul;28 Suppl 2(Suppl 2):e26497. doi: 10.1002/jia2.26497.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
ViiV Healthcare
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing APRETUDE and Cabotegravir tablet in people with HIV Infections, run by ViiV Healthcare at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Intervention Appropriateness Measure (IAM) Score Assessed for SSPs at Month 12 (time frame: At Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05514509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.