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HIV InfectionsPhase 4PILLARNCT05374525

A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States

A Phase 4 study testing APRETUDE and Cabotegravir OLI in people with HIV Infections, run by ViiV Healthcare at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a two-arm study evaluating the impact of two implementation strategy conditions, dynamic implementation and routine implementation on the feasibility of delivering of Cabotegravir PrEP in low and high-volume PrEP sites in the United States for men who have sex with men (MSM) and Transgender men ≥ 18 years of… Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
APRETUDE and Cabotegravir OLI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
287 participants
Where
17 sitesUnited States
Study dates
18 May 2022to 8 Aug 2024
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
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent.
  • No prior history of receiving CAB PrEP
  • HIV negative test result at screening
  • Capable of giving signed informed consent form

Who cannot join

  • HIV indeterminate or positive test result during screening and prior to initiation of CAB PrEP
  • A participant of concurrent interventional clinical or implementation science study at any time during the study

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • GSK Investigational Site

    Boston, Massachusetts, 02215

  • GSK Investigational Site

    Bridgeport, Kansas, 06605

  • GSK Investigational Site

    Charleston, South Carolina, 29407

  • GSK Investigational Site

    Columbia, Missouri, 65212

  • GSK Investigational Site

    Harlingen, Texas, 78550

  • GSK Investigational Site

    Los Angeles, California, 90036

  • GSK Investigational Site

    Miami, Florida, 33140

  • GSK Investigational Site

    Orlando, Florida, 32806

  • GSK Investigational Site

    Pensacola, Florida, 32503

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19123

  • GSK Investigational Site

    Rochester, New York, 14607

  • GSK Investigational Site

    San Francisco, California, 94102

  • GSK Investigational Site

    Sarasota, Florida, 34237

  • GSK Investigational Site

    Seattle, Washington, 98104

  • GSK Investigational Site

    St Louis, Missouri, 63117

  • GSK Investigational Site

    The Bronx, New York, 10467

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20005

Other trials in United States

About this study

Official title: A Phase 4, Randomized, Open-label, Two-arm Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-volume Pre-exposure Prophylaxis (PrEP) Sites in the U.S. for HIV Uninfected MSM and Transgender Men ≥ 18

This is a two-arm study evaluating the impact of two implementation strategy conditions, dynamic implementation and routine implementation on the feasibility of delivering of Cabotegravir PrEP in low and high-volume PrEP sites in the United States for men who have sex with men (MSM) and Transgender men ≥ 18 years of age. There are two types of participants in the study. Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available Cabotegravir PrEP via prescription from the PrEP provider at the corresponding site. Staff Study Participants (SSPs) will refer to site staff who are involved in administrative and clinical aspects of offering and administering PrEP to PSPs and will participate in the staff study assessments. PSPs who choose to opt for 1-month oral lead-in (OLI) will receive cabotegravir tablets for PrEP at Month 1 followed by APPRETUDE intramuscular (IM) injections on Month 2, 3 and every two months thereafter up to Month 13. PSPs who opt for Direct to injections (DTI) will receive APPRETUDE IM injections on Month 1, 2 and every two months thereafter up to Month 12. Month 6/7 refers to Month 6 (DTI)/ Month 7 (OLI). Month 12/13 refers to Month 12 (DTI)/ Month 13 (OLI).

Conditions
HIV Infections
Being tested
APRETUDE, Cabotegravir OLI
Keywords
Cabotegravir, Long-acting injectables, Implementation science, HIV, Pre-exposure prophylaxis
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 OLIDrug

    Available as marketed orally administered tablets.

Study groups in NCT05374525
Study groupRoleWhat they receive
Dynamic Implementation (DI) - PSPExperimentalMen who have sex with men (MSM) and transgender men (TGM) who were HIV negative as PSPs received APRETUDE injection (Direct to Injection - DTI) and had the choice to receive an optional cabotegravir tablets as oral lead in (OLI). PSPs had access to enhanced toolkits and digital health implementation supports.
Receives: Drug: APRETUDE; Drug: Cabotegravir OLI
Routine Implementation (RI) - PSPExperimentalMSM and transgender men who were HIV negative as PSPs received APRETUDE injection (DTI) and had the choice to use an optional cabotegravir tablets as OLI. PSPs had access to standard toolkits for APRETUDE to use as needed.
Receives: Drug: APRETUDE; Drug: Cabotegravir OLI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Feasibility of Intervention Measure (FIM) Score Assessed for SSPs

    The FIM-Intervention (INT) was a four-item measure for APRETUDE intervention (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 ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility.

    Timeframe for evaluation of this outcome measure is Month (M)12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI)

    Measured: At Month 12

Secondary outcomes (73)

  1. Change From Baseline in FIM Score Assessed for SSPs

    This outcome assesses the change in FIM-INT for SSPs over time. The FIM-INT was a four-item measure for APRETUDE intervention (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 ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility.

    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 Baseline (BL).

    Measured: At Month 4 and Month 12 compared to baseline (Month 1)

  2. Number of SSPs Assessed for Perceptions of Facilitators to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12

    Perception of facilitators to RI, DI and overall implementation of PrEP measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interviews. In this outcome measure, SSPs were asked about the facilitators of the overall implementation of APRETUDE into clinic infrastructure, evaluating feasibility of DI and RI study arms.

    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

  3. Number of SSPs Assessed for Perceptions of Barriers to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12

    Perception of barriers to RI, DI and overall implementation of PrEP measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interview. In this outcome measure, SSPs were asked about the barriers/challenges of the overall implementation of APRETUDE into clinic infrastructure, evaluating feasibility of DI and RI study arms.

    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

  4. Mean FIM Score Assessed for PSPs

    The FIM-INT was a four-item measure for APRETUDE intervention (1. Receiving APRETUDE injection every 2 months seems workable in my life 2. Receiving APRETUDE injection every 2 months seems possible in my life 3. Receiving APRETUDE injection every 2 months seems doable in my life 4. Receiving APRETUDE injection 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 ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility.

    Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).

    Measured: At Baseline (Month 1), Month 6 and Month 12

  5. Mean Acceptability of Intervention Measure (AIM) Score Assessed for PSPs

    The AIM-INT was employed to evaluate the perceived intervention acceptability among PSPs. The measure consists of four items (1. APRETUDE meets my approval for preventing HIV 2. APRETUDE for the prevention of HIV is appealing to me 3. I like APRETUDE for the prevention of HIV 4. I welcome APRETUDE for the prevention of HIV), each 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 acceptability and 5 the most acceptability.

    Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).

    Measured: At Baseline (Month 1), Month 6 and Month 12

  6. Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE

    The implementation science questionnaire (ISQ) used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs indicated their feelings about taking APRETUDE.

    Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).

    Measured: At Baseline (Month 1), Month 6 and Month 12

  7. Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection

    The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs indicated how acceptable it was for them to go to the clinic for APRETUDE injections.

    Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).

    Measured: At Baseline (Month 1), Month 6 and Month 12

  8. Number of PSPs With Responses to the ISQs Regarding Recommending APRETUDE

    The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs indicated if they would recommend APRETUDE to others.

    Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).

    Measured: At Month 6 and Month 12

  9. Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling

    The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about their opinion on the ease or difficulty of scheduling appointments at the clinic.

    Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).

    Measured: At Month 6 and Month 12

  10. Number of PSPs With Responses to the ISQs Regarding Appointment Rescheduling

    The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about their opinion on ease or difficulty of rescheduling appointments at the clinic.

    Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).

    Measured: At Month 6 and Month 12

  11. Change From Baseline in AIM Score Assessed for PSPs

    This outcome assesses the change in AIM-INT for PSPs over time. The measure consists of four items (1. APRETUDE meets my approval for preventing HIV 2. APRETUDE for the prevention of HIV is appealing to me 3. I like APRETUDE for the prevention of HIV 4. I welcome APRETUDE for the prevention of HIV), each 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 acceptability and 5 the most acceptability.

    Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI) compared to Baseline.

    Measured: At Month 6 and Month 12 compared to baseline (Month 1)

  12. Change From Baseline in FIM Score Assessed for PSPs

    This outcome assesses the change in FIM-INT for PSPs over time. The FIM-INT was a four-item measure for APRETUDE intervention (1. Receiving APRETUDE injection every 2 months seems workable in my life 2. Receiving APRETUDE injection every 2 months seems possible in my life 3. Receiving APRETUDE injection every 2 months seems doable in my life 4. Receiving APRETUDE injection 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 ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility.

    Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI) compared to baseline.

    Measured: At Month 6 and Month 12 compared to baseline (Month 1)

  13. Percentage of PSPs With Change From Baseline in ISQ Responses

    The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs indicated their feelings about taking APRETUDE and how acceptable it was for them to go to the clinic for APRETUDE injections. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI). The change from baseline is calculated as a difference of percentages resulted at each timepoint as following: M6 minus (-) BL, and M12-BL. Q2M = a schedule of injection administration at every 2 months.

    Measured: At Month 6 and Month 12 compared to Baseline (Month 1)

  14. Number of PSPs Assessed for Perception of Facilitators to Feasibility and Acceptability of APRETUDE Through Month 12

    Facilitators to feasibility and acceptability of APRETUDE measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interviews. In this outcome measure, PSPs were asked about their perception of the facilitators of feasibility and acceptability of APRETUDE intervention.

    Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  15. Number of PSPs Assessed for Perception of Barriers to Feasibility and Acceptability of APRETUDE Through Month 12

    Barriers to feasibility and acceptability of APRETUDE were measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interviews. In this outcome measure, PSPs were asked about their perspectives on the barriers and challenges of feasibility and acceptability of APRETUDE intervention.

    Timeframe for evaluation of this outcome measure is through M12 (equivalent M13 for PSPs who received OLI).

    Measured: Up to Month 12

  16. Mean FIM Score for Telehealth Delivery Assessed for SSPs

    The FIM-TEL services for SSPs were a four-item measure (1. Telehealth for APRETUDE seems implementable in our clinic/practice 2. Telehealth for APRETUDE seems possible in our clinic/practice 3. Telehealth for APRETUDE seems doable in our clinic/practice 4. Telehealth for 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 ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility.

    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

  17. Mean AIM Score for Telehealth Delivery Assessed for SSPs

    The AIM-TEL services for SSPs were a four-item measure (1. The idea of telehealth for APRETUDE in our clinic/practice meets my approval 2. The idea of telehealth for APRETUDE in our clinic/practice is appealing to me 3. I like the idea of telehealth for APRETUDE in our clinic/practice 4. I welcome the idea of telehealth for APRETUDE in our clinic/practice), each 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 acceptability and 5 the most acceptability.

    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

  18. Number of SSPs With Responses to the ISQs Regarding Use of Telehealth Delivery

    The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the use of telehealth services at their clinic/practice.

    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

  19. Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used

    The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about which telehealth services/systems were used at their clinic/practice to deliver APRETUDE during the PILLAR study.

    Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).

    Measured: At Month 4 and Month 12

  20. Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used

    The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the helpfulness of the telehealth services/systems used at their clinic/practice.

    Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).

    Measured: At Month 4 and Month 12

  21. Change From Baseline in FIM Score for Telehealth Delivery Assessed for SSPs

    The FIM telehealth services for SSPs were a four-item measure (1. Telehealth for APRETUDE seems implementable in our clinic/practice 2. Telehealth for APRETUDE seems possible in our clinic/practice 3. Telehealth for APRETUDE seems doable in our clinic/practice 4. Telehealth for 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 ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility.

    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 Baseline (BL).

    Measured: At Month 4 and Month 12 compared to baseline (Month 1)

  22. Change From Baseline in AIM Score for Telehealth Delivery Assessed for SSPs

    This outcome assesses the change in AIM telehealth services for SSPs over time. The AIM telehealth services for SSPs were a four-item measure (1. The idea of telehealth for APRETUDE in our clinic/practice meets my approval 2. The idea of telehealth for APRETUDE in our clinic/practice is appealing to me 3. I like the idea of telehealth for APRETUDE in our clinic/practice 4. I welcome the idea of telehealth for APRETUDE in our clinic/practice), each 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 acceptability and 5 the most acceptability.

    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 Baseline (BL).

    Measured: At Month 4 and Month 12 compared to baseline (Month 1)

  23. Percentage of SSPs With Change From Baseline in ISQ Responses for Telehealth Delivery

    The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the use of telehealth services at their clinic/practice.

    Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). The change from baseline is calculated as a difference of percentages resulted at each timepoint as following: M4 minus (-) BL, and M12-BL.

    Measured: At Month 4 and Month 12 compared to Baseline (Month 1)

  24. Mean FIM Score for Telehealth Delivery Assessed for PSPs

    The FIM telehealth services for PSPs were a four-item measure (1. Using telehealth for APRETUDE services seems workable in my life 2. Using telehealth for APRETUDE services seems possible in my life 3. Using telehealth for APRETUDE services seems doable in my life 4. Using telehealth for APRETUDE services 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 ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility.

    Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).

    Measured: At Baseline (Month 1), Month 6 and Month 12

  25. Mean AIM Score for Telehealth Delivery Assessed for PSPs

    The AIM Telehealth services for PSPs were a four-item measure (1. Using telehealth for APRETUDE services meets my approval 2. Using telehealth for APRETUDE services is appealing to me 3. I like telehealth for APRETUDE services 4. I welcome using telehealth for APRETUDE services), each 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 acceptability and 5 the most acceptability.

    Timepoints during which this outcome measure was evaluated were BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI)

    Measured: At Baseline (Month 1), Month 6 and Month 12

  26. Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE

    The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about the use of telehealth (TEL) services such as completing forms online, video chatting with their provider, getting reminders about their injection, or scheduling injection appointments online.

    Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).

    Measured: At Baseline (Month 1), Month 6 and Month 12

  27. Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services

    The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about how comfortable it was to use various telehealth services for APRETUDE.

    Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).

    Measured: At Month 6 and Month 12

  28. Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used

    The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about how convenient it was to use various telehealth services for APRETUDE.

    Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).

    Measured: At Month 6 and Month 12

  29. Number of PSPs With Response to the ISQs Recommending Telehealth Delivery

    The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked if they would recommend telehealth services for APRETUDE to other people.

    Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).

    Measured: At Month 6 and Month 12

  30. Change From Baseline in FIM Score for Telehealth Delivery Assessed for PSPs

    The FIM Telehealth services for PSPs were a four-item measure (1. Using telehealth for APRETUDE services seems workable in my life 2. Using telehealth for APRETUDE services seems possible in my life 3. Using telehealth for APRETUDE services seems doable in my life 4. Using telehealth for APRETUDE services 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 ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility.

    Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI) compared to BL.

    Measured: At Month 6 and Month 12 compared to baseline (Month 1)

  31. Change From Baseline in AIM Score for Telehealth Delivery Assessed for PSPs

    The AIM Telehealth services for PSPs were a four-item measure (1. Using telehealth for APRETUDE services meets my approval 2. Using telehealth for APRETUDE services is appealing to me 3. I like telehealth for APRETUDE services 4. I welcome using telehealth for APRETUDE services), each 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 acceptability and 5 the most acceptability.

    Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI) compared to BL.

    Measured: At Month 6 and Month 12 compared to baseline (Month 1)

  32. Percentage of PSPs With Change From Baseline in ISQ Responses Regarding Telehealth Delivery

    The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about the use of telehealth (TEL) services such as completing forms online, video chatting with their provider, getting reminders about their injection, or scheduling injection appointments online.

    Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI). The change from baseline is calculated as a difference of percentages resulted at each timepoint as following: M6 minus (-) BL, and M12-BL.

    Measured: At Month 6 and Month 12 compared to Baseline (Month 1)

  33. Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery

    Barriers and facilitators to the feasibility and acceptability of telehealth use for APRETUDE were measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interviews. In this outcome measure, SSPs were asked their perceptions of these facilitators and barriers for telehealth services used.

    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

  34. Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery

    Barriers and facilitators to the feasibility and acceptability of telehealth use for APRETUDE were measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interviews. In this outcome measure, PSPs were asked their perceptions of these facilitators and barriers for telehealth services used.

    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

  35. Mean AIM Score Assessed for SSPs

    AIM score for SSPs has 2 parts- AIM-INT that evaluates perceived intervention acceptability among SSPs and consists of 4 items (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 AIM-Implementation (IMP) that evaluates perceived acceptability of DI and RI approaches among SSPs and consists of 4 items (1. The implementation support has met my approval; 2. The implementation support was appealing to me; 3. I like the implementation support I have received; 4. I welcome the implementation support I have received),each with a five-point rating scale (1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree). Mean score ranges from 1 to 5 with 1=least acceptability and 5=most acceptability.

    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

  36. Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE

    The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the perceived barriers to managing delivery of APRETUDE.

    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

  37. Change From Baseline in AIM Score Assessed for SSPs

    AIM score for SSPs has 2 parts- AIM-INT that evaluates perceived intervention acceptability among SSPs and consists of 4 items (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 AIM-IMP that evaluates perceived acceptability of DI and RI approaches among SSPs and consists of 4 items (1. The implementation support has met my approval; 2. The implementation support was appealing to me; 3. I like the implementation support I have received; 4. I welcome the implementation support I have received),each with a five-point rating scale (1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree). Mean score ranges from 1 to 5 with 1=least acceptability and 5=most acceptability.

    Timeframe for evaluation 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)

  38. Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE

    The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the perceived barriers to managing delivery of APRETUDE (Item [I]1= Management of scheduling injection appointments during correct injection windows, I2= Management of rescheduling appointments during correct injection windows, I3= Ability to schedule/reschedule patients who missed APRETUDE visits, I4= Ability to identify and flag missed injection visits to providers (in a timely manner), I5= Ability to manage patients presenting to APRETUDE appointments with other care needs).

    Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). The change from baseline is calculated as a difference of percentages resulted at each timepoint as following: M4 minus (-) BL, and M12-BL.

    Measured: At Month 4 and 12 compared to Baseline (Month 1)

  39. Mean AIM Score Assessed for PSPs

    The AIM-INT was employed to evaluate the perceived intervention acceptability among PSPs. The measure consists of four items (1. APRETUDE meets my approval for preventing HIV 2. APRETUDE for the prevention of HIV is appealing to me 3. I like APRETUDE for the prevention of HIV 4. I welcome APRETUDE for the prevention of HIV), each 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 acceptability and 5 the most acceptability.

    Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).

    Measured: At Baseline (Month 1), Month 6 and Month 12

  40. Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline

    The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about the helpfulness of various knowledge materials used in learning about APRETUDE.

    Measured: At Baseline (Month 1)

  41. Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6

    The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about the helpfulness of various knowledge materials used in learning about APRETUDE.

    Timeframe for evaluation of this outcome measure is M6 (equivalent to M7 for PSPs who received OLI).

    Measured: At Month 6

  42. Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12

    The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about the helpfulness of various knowledge materials used in learning about APRETUDE.

    Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for PSPs who received OLI).

    Measured: At Month 12

  43. Change From Baseline in Mean AIM Score in PSPs

    This outcome assesses the change in AIM-INT for PSPs over time. The measure consists of four items (1. APRETUDE meets my approval for preventing HIV 2. APRETUDE for the prevention of HIV is appealing to me 3. I like APRETUDE for the prevention of HIV 4. I welcome APRETUDE for the prevention of HIV), each 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 acceptability and 5 the most acceptability.

    Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI) compared to Baseline.

    Measured: At Month 6 and Month 12 compared to baseline (Month 1)

  44. Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy

    In this outcome measure, usong the ISQ, PSPs were asked about the helpfulness of various knowledge materials (I1= Getting Started Brochure that gives an overview of how to get started with APRETUDE, I2 = Patient Brochure helps understand the process of receiving APRETUDE, I3 = HIV \& PrEP video gives key facts about HIV and PrEP options (DI), I4 = APRETUDE Myths and Facts video, addressing common myths about APRETUDE (DI), I5 = The What to Expect video which shows what to expect during the APRETUDE process (DI), I6 = The ViiV Connect program Video and frequently asked questions (DI), I7 = The study website to access APRETDUE information (RI), I8 = The study app to access APRETUDE information (DI). Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI). The change from baseline is calculated as a difference of percentages resulted at each timepoint as following: M6 minus (-) BL, and M12-BL.

    Measured: At Month 6 and Month 12 compared to Baseline (Month 1)

  45. Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use

    The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the usefulness of various implementation strategies used for implementing APRETUDE in their clinic/practice.

    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

  46. Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use

    The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about how useful various implementation strategies have been in supporting them while taking APRETUDE.

    Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  47. Number of SSPs Assessed for Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI

    Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interview. In this outcome measure, SSPs provided their insights on the tools and strategies used for implementing APRETUDE during the PILLAR study.

    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

  48. Number of PSPs Assessed for Perceptions of Utility of Implementation Strategies Through Semi-Structured Interviews (SSIs)

    Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interview. In this outcome measure, PSPs provided their insights regarding the tools and strategies used for delivering APRETUDE.

    Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  49. Number of Injections Occurring Within 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

  50. Number of PSPs Completing Target Number of Injections

    Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  51. Number of PSPs With Perceptions of Facilitators to Fidelity to Injections

    Perceptions of utility of implementation strategies and facilitators and barriers to acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, PSPs provided their insights into how APRETUDE has been incorporated into their daily lives, including factors that supported its delivery.

    Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  52. Number of PSPs With Perceptions of Barriers to Fidelity to Injections

    Perceptions of utility of implementation strategies and facilitators and barriers to acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, PSPs reported several challenges related to incorporating APRETUDE into their daily lives.

    Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  53. Number of SSPs With Perceptions of Facilitators to Fidelity to Injections

    Perceptions of utility of implementation strategies and facilitators and barriers to acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, SSPs provided insights regarding the facilitators for adherence to APRETUDE and the support provided to enable patient adherence. These facilitators were categorized as resources, support, patient communication and patient feasibility.

    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

  54. Number of SSPs With Perceptions of Barriers to Fidelity to Injections

    Perceptions of utility of implementation strategies and facilitators and barriers to acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, SSPs provided insights regarding the barriers and challenges in enabling patient adherence to APRETUDE. The barriers were categorized as patient barriers and staff challenges.

    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

  55. Number of SSPs Who Administer Sexual Health Assessment (SHA)

    In this outcome measure, SSPs answered questions about their administration of the sexual health assessment (SHA). The SHA was only administered by SSPs at the DI sites, hence it was not assessed for RI sites.

    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

  56. Number of Eligible PSPs for Which SHA Are Administered

    In this outcome measure, data shown below describes the number of PSPs to which the SHA was administered.

    Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  57. Number of Men Who Have Sex With Men (MSM) and Transgender Men (TGM) Who Take the SHA Through M12

    The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach.

    Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  58. Number of MSM and TGM Who Report Having Had Sex in the Last 6 Months on the SHA

    In this outcome measure, data shown below describes the number of MSM and TGM who reported having had sex in the last 6 months.

    Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  59. Number of PSPs Who Expressed Interest in PrEP or Never Heard of PrEP Out of Those Who Report Having Had Sex in the Last 6 Months

    In this outcome measure, data presented below shows the number of PSPs who expressed interest in PreP by responding to the question "Have you taken oral PreP in the last 6 months" and number of PSPs who had not heard of PreP.

    Measured: Up to Month 12

  60. Number of PSPs Who Initiate APRETUDE After Taking the SHA

    In this outcome measure, PSPs were asked if they had taken oral PreP in the last 6 months. PSPs who answered 'No' or 'I prefer not to answer' were further asked if they had ever taken oral PreP.

    Timeframe for evaluation of this outcome measure is through M12(equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  61. Number of PSPs With Perceptions of SHA

    Perceptions of the sexual health assessment (SHA) among PSPs were measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews.

    Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  62. Number of SSPs With Perceptions of SHA

    In this outcome measure, SSPs provided insights regarding the use and implementation of SHA tool in their clinic/practice. The SHA was only administered by SSPs at the DI sites, hence it was not assessed for RI sites.

    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

  63. Number of Modifications Reported by SSPs Using FRAME-IS

    The Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) is a measure that provides a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes. Data below summarize all modifications reported by SSPs during PILLAR study.

    Timeframe for evaluation of this outcome measure is from M2 to M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).

    Measured: At Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

  64. Number of Modifications for Each Category Reported by SSPs Using FRAME-IS

    The FRAME-IS is a measure that provides a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes. Data below summarize the types of modifications and adaptations reported by SSPs during PILLAR study.

    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

  65. Number of Modifications Made for Adaptations to Implementation Reported by SSPs Using FRAME-IS

    The FRAME-IS is a measure that provides a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes. Data below summarize the perceptions and motivations of adaptations to implementation reported by SSPs using FRAME-IS.

    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

  66. Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies

    PSP perceptions of adaptations to implementation strategies were measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, PSPs discussed their use of study resources and recommendations to staff for delivery of APRETUDE.

    Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  67. Number of PSPs With History of PrEP Use That Complete the SHA and ISQ and Start APRETUDE

    In this outcome measure, PSPs who completed the SHA and ISQ, describe the history of PrEP use and of sexual health assessment use for determination of PreP use during PILLAR study.

    Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  68. Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by Semi-Structured Interviews (SSIs)

    Reasons for choosing and switching to APRETUDE were measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews among PSPs. In this outcome measure, PSPs shared previous oral PrEP experiences, comparisons of other forms of PrEP to APRETUDE, and reasons for preferring APRETUDE.

    Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  69. Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by ISQs

    The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs answered ISQ regarding reasons for choosing to take APRETUDE.

    Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  70. Number of PSPs Assessed for Perception of Facilitators

    General perceptions of facilitators for APRETUDE delivery and use were measured among PSPs from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, PSPs discuss views of long-term use of APRETUDE, reasons to choose APRETUDE, and experiences with clinic staff.

    Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  71. Number of PSPs Assessed for Perception of Barriers

    General perceptions of barriers for APRETUDE delivery and use were measured among PSPs from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, PSPs discuss challenging views of or experiences with APRETUDE receipt.

    Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).

    Measured: Up to Month 12

  72. Number of SSPs Assessed for Perception of Facilitators

    General perceptions of facilitators for APRETUDE intervention and implementation were measured among SSPs from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, SSPs discuss clinic culture and implementation motivations.

    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

  73. Number of SSPs Assessed for Perception of Barriers

    General perceptions of barriers for APRETUDE intervention and implementation were measured among SSPs from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, SSPs discuss feelings and perspectives while implementing APRETUDE.

    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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2022
  2. Study start18 May 2022
  3. Primary completion8 Aug 2024
  4. Study completion8 Aug 2024

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
287 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05374525
Sponsor's protocol ID
217710
Acronym
PILLAR
Status last verified
Nov 2025
First submitted
10 May 2022
Last updated
15 Dec 2025
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

  • Pilgrim N, Holder H, Torres JA, Ortiz R, Valenti W, Dandachi D, Shalit P, Kingcade A, Ruane P, Mercado L, Li B, Gaudion A, Merrill D, Gibbons E, Barnes N, Stassek L, Moodley R, McKeon T, Nelson KL, Garges HP, Brown K, Czarnogorski M. Implementation Journey with CAB LA for PrEP Among Men Who Have Sex with Men and Transgender Men: Insights from the PILLAR Trial Through 12 Months. AIDS Behav. 2026 Jul 12. doi: 10.1007/s10461-026-05216-0. Online ahead of print.

    PubMed 42437832

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing APRETUDE and Cabotegravir OLI in people with HIV Infections, run by ViiV Healthcare at 17 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 4 inclusion and 2 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 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 15 Dec 2025). 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 Feasibility of Intervention Measure (FIM) Score Assessed for SSPs (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 NCT05374525, 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 15 Dec 2025.

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