HivNCT05152953
Preparing for Pharmacy-based Delivery of Long-acting Injectable Antiretroviral Therapy (LAI-ART)
An observational study of Hiv, run by University of California, San Francisco at 4 sites in United States.
Trial summary
BACKGROUND: Long-acting injectable antiretroviral therapy (LAI-ART) is poised to revolutionize HIV treatment and prevention. Community pharmacies could serve as another place for people with HIV to get their ART injections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv
- Type of treatment
- Injection or infusion
- How many people
- 63 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Jun 2022to 15 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- Adult, Older adult
Study population: Patients/persons with HIV will be recruited from local HIV clinics in the San Francisco Bay Area, Corpus Christy Texas Area, Montgomery/Opelika Alabama Area, and Miami/Hollywood Florida Areas. Clinic Staff Members will be recruited from HIV local clinics in the San Francisco Bay Area, Corpus Christy Texas Area, Montgomery/Opelika Alabama Area, and Miami/Hollywood Florida Areas. Pharmacy Staff Members will be recruited from community pharmacies serving persons with HIV that are physically located in the San Francisco Bay Area, Corpus Christy Texas Area, Montgomery/Opelika Alabama Area, and Miami/Hollywood Florida Areas.
Who may be able to join
- Aged 18 years or over
- Access to telephone (at minimum), access to internet/email preferred
- Pharmacy staff members must meet the following additional criteria:
- Currently employed at a community (retail, independent, specialty, chain) or outpatient health system pharmacy.
- Self-reported likelihood or potential to be involved with some aspect (e.g. billing, scheduling, administering, advertising, training) of implementing long-acting injectable antiretroviral therapy in pharmacies.
- Patients (persons with HIV) must meet the following additional criteria:
Show all 12Show fewer
- Self-reported diagnosis of HIV, currently taking antiretroviral therapy (LAI-ART or oral or other)
- Self-reported undetectable HIV-1 viral load (Note: if potential participant does not know they will be encouraged to contact their health care provider to ask)
- Access to telephone
- Clinic staff must meet the following additional criteria:
- Currently employed in a clinic practice where HIV-positive patients comprise > 10% of clinic population
- Self-reported likelihood or potential to be involved with some aspect (e.g. billing, scheduling, administering, advertising, training, referring patients to other clinics) of implementing long-acting injectable antiretroviral therapy in their own clinic setting.
Who cannot join
- Pharmacy staff with no forseeable involvement in implementation of a long-acting injectable antiretroviral therapy administration program.
- Patients/persons who are not diagnosed with HIV, who are candidates for long-acting cabotegravir as HIV pre-exposure prophylaxis.
- Clinic staff members with no current or forseeable involvement in supporting patients to receive long-acting injectable antiretroviral therapies.
- Persons who do not speak English to a degree that would allow full comprehension of and participation in the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Auburn University Harrison School of Pharmacy
Auburn, Alabama, 36849
Nova Southeastern University College of Pharmacy
Fort Lauderdale, Florida, 33314
Texas A&M Irma Lerma Rangel College of Pharmacy
Kingsville, Texas, 78363
University of California San Francisco School of Pharmacy
San Francisco, California, 94143
About this study
BACKGROUND: Long-acting injectable antiretroviral therapy (LAI-ART) is poised to revolutionize HIV treatment and prevention. Community pharmacies could serve as another place for people with HIV to get their ART injections. However, pharmacist and healthcare practitioner attitudes towards pharmacist administration of LAI-ART are understudied. Financial and human resources, pharmacist training, or changes in workflow have not been outlined. Little is known about whether patients will accept ART injections given in pharmacies.
OBJECTIVE: The purpose of this project is to address the above knowledge gaps. The information generated can assist in the development of tools that can help scale community pharmacy-based delivery of LAI-ART.
METHODS: Using a mixed-methods approach to better understand the pre-implementation environment, the study will employ electronic surveys and will administer semi-structured interviews via telephone for three key stakeholder groups: HIV clinic staff members, community pharmacists, and persons with HIV. Surveys will assess the appropriateness, acceptability, and feasibility of LAI-ART administration in community pharmacies. A semi-structured interview guide has been developed using constructs from the Consolidated Framework for Implementation Research (CFIR). Comparisons between and across stakeholder groups will be performed, looking for common themes as well as discrepancies.
Read the detailed description
The objective of this study is to facilitate the future delivery of long-acting injectable antiretroviral therapy in community pharmacies by developing an in-depth understanding of attitudes, barriers, and facilitators for implementing this intervention. The mixed-methods approach will incorporate three quantitative implementation outcome measures (Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure) and semi-structured qualitative individual interviews which will be analyzed for relevant themes. This would be considered pure implementation research of the pre-implementation stage of LAI-ART administration in community pharmacies. Participants will be purposively sampled from four different geographical sites (San Francisco Bay Area, Corpus Christi Texas Area, Montgomery Alabama Area, and Miami/Hollywood Area) and over three different key stakeholder groups (pharmacists, patients, clinic staff) to obtain a variety of experiences, attitudes, and opinions. Most participants will have a single study visit which consists of their interview. A small proportion of pharmacists will have a second study visit for a follow up interview and questionnaire if their pharmacies have implemented a program to administer LAI-ART or are close to launching one.
- Conditions
- Hiv
- Keywords
- pharmacy, implementation science, cabotegravir, rilpivirine, antiretroviral therapy
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Persons with HIV | Persons with HIV who are currently taking antiretroviral therapy who reside in the study's target geographical areas. | |
| Pharmacy staff members | Pharmacists, pharmacy technicians, pharmacy managers, or clerks employed at a community pharmacy who would potentially be involved in program development, scheduling, financial aspects, planning or administration of long-acting injectable antiretroviral therapy in the pharmacy. | |
| Clinic staff members | Physicians, clinic managers, nurses, medical assistants, social work staff or case managers, therapists, and other clinic personnel who are involved or would potentially be involved in any aspect of long-acting antiretrovirals in the clinic facility including financial aspects, planning, scheduling patients, educating patients, ordering medication, or administering medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of intervention measure (AIM)
a 5-point Likert scale of agreement (1= Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree). No items are reverse coded. Higher scores indicate greater acceptability for LAI-ART in pharmacies.
Measured: Baseline
Intervention appropriateness measure (IAM)
a 5-point Likert scale of agreement (1= Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree). No items are reverse coded. Higher scores indicate greater perceived appropriateness for LAI-ART in pharmacies.
Measured: Baseline
Feasibility of intervention measure (FIM)
a 5-point Likert scale of agreement (1= Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree). No items are reverse coded. Higher scores indicate greater perceived feasibility for LAI-ART in pharmacies.
Measured: Baseline
Interview
Semi-structured interviews will be conducted, audio-recorded, and transcribed. Themes derived from these semi-structured individual interviews will be organized via the Consolidated Framework for Implementation Research (CFIR) and compared across the three key stakeholder groups (persons with HIV, pharmacy staff, and clinic staff).
- Characteristics of the intervention
- Inner setting
- Outer setting
- Individuals involved
- Implementation process
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start8 Jun 2022
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare, Texas A&M University, Auburn University, Nova Southeastern University
- Responsible party
- Sponsor
- Investigators
- Jennifer Cocohoba, PharmD, Principal investigator, University of California San Francisco School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152953
- Sponsor's protocol ID
- 2179
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data from baseline surveys and redacted interview transcripts will be made available for collaborative research
Publications
Cocohoba J, Cuca Y, Sherman E, Hester K, Udeani G, Sigua M, Saberi P. Preparing for pharmacy-based delivery of long-acting injectable antiretrovirals: a pre-implementation study. BMC Health Serv Res. 2025 Jun 5;25(1):808. doi: 10.1186/s12913-025-12971-8.
PubMed 40474134
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing for Pharmacy-based Delivery of Long-acting Injectable Antiretroviral Therapy (LAI-ART)
- ClinicalTrials.gov ID
- NCT05152953
- Acronym / sponsor ID
- 2179
- Conditions
- Hiv
- Keywords
- pharmacy, implementation science, cabotegravir, rilpivirine, antiretroviral therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- ViiV Healthcare, Texas A&M University, Auburn University, Nova Southeastern University
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND: Long-acting injectable antiretroviral therapy (LAI-ART) is poised to revolutionize HIV treatment and prevention. Community pharmacies could serve as another place for people with HIV to get their ART injections. However, pharmacist and healthcare practitioner attitudes towards pharmacist administration of LAI-ART are understudied. Financial and human resources, pharmacist training, or changes in workflow have not been outlined. Little is known about whether patients will accept ART injections given in pharmacies.
OBJECTIVE: The purpose of this project is to address the above knowledge gaps. The information generated can assist in the development of tools that can help scale community pharmacy-based delivery of LAI-ART.
METHODS: Using a mixed-methods approach to better understand the pre-implementation environment, the study will employ electronic surveys and will administer semi-structured interviews via telephone for three key stakeholder groups: HIV clinic staff members, community pharmacists, and persons with HIV. Surveys will assess the appropriateness, acceptability, and feasibility of LAI-ART administration in community pharmacies. A semi-structured interview guide has been developed using constructs from the Consolidated Framework for Implementation Research (CFIR). Comparisons between and across stakeholder groups will be performed, looking for common themes as well as discrepancies.
Detailed description
The objective of this study is to facilitate the future delivery of long-acting injectable antiretroviral therapy in community pharmacies by developing an in-depth understanding of attitudes, barriers, and facilitators for implementing this intervention. The mixed-methods approach will incorporate three quantitative implementation outcome measures (Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure) and semi-structured qualitative individual interviews which will be analyzed for relevant themes. This would be considered pure implementation research of the pre-implementation stage of LAI-ART administration in community pharmacies. Participants will be purposively sampled from four different geographical sites (San Francisco Bay Area, Corpus Christi Texas Area, Montgomery Alabama Area, and Miami/Hollywood Area) and over three different key stakeholder groups (pharmacists, patients, clinic staff) to obtain a variety of experiences, attitudes, and opinions. Most participants will have a single study visit which consists of their interview. A small proportion of pharmacists will have a second study visit for a follow up interview and questionnaire if their pharmacies have implemented a program to administer LAI-ART or are close to launching one.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Persons with HIV | – | –Persons with HIV who are currently taking antiretroviral therapy who reside in the study's target geographical areas. |
| Pharmacy staff members | – | –Pharmacists, pharmacy technicians, pharmacy managers, or clerks employed at a community pharmacy who would potentially be involved in program development, scheduling, financial aspects, planning or administration of long-acting injectable antiretroviral therapy in the pharmacy. |
| Clinic staff members | – | –Physicians, clinic managers, nurses, medical assistants, social work staff or case managers, therapists, and other clinic personnel who are involved or would potentially be involved in any aspect of long-acting antiretrovirals in the clinic facility including financial aspects, planning, scheduling patients, educating patients, ordering medication, or administering medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients/persons with HIV will be recruited from local HIV clinics in the San Francisco Bay Area, Corpus Christy Texas Area, Montgomery/Opelika Alabama Area, and Miami/Hollywood Florida Areas. Clinic Staff Members will be recruited from HIV local clinics in the San Francisco Bay Area, Corpus Christy Texas Area, Montgomery/Opelika Alabama Area, and Miami/Hollywood Florida Areas. Pharmacy Staff Members will be recruited from community pharmacies serving persons with HIV that are physically located in the San Francisco Bay Area, Corpus Christy Texas Area, Montgomery/Opelika Alabama Area, and Miami/Hollywood Florida Areas.
Key inclusion criteria (12 listed)
- Aged 18 years or over
- Access to telephone (at minimum), access to internet/email preferred
- Currently employed at a community (retail, independent, specialty, chain) or outpatient health system pharmacy.
- Self-reported likelihood or potential to be involved with some aspect (e.g. billing, scheduling, administering, advertising, training) of implementing long-acting injectable antiretroviral therapy in pharmacies.
- Self-reported diagnosis of HIV, currently taking antiretroviral therapy (LAI-ART or oral or other)
Key exclusion criteria (4 listed)
- Pharmacy staff with no forseeable involvement in implementation of a long-acting injectable antiretroviral therapy administration program.
- Patients/persons who are not diagnosed with HIV, who are candidates for long-acting cabotegravir as HIV pre-exposure prophylaxis.
- Clinic staff members with no current or forseeable involvement in supporting patients to receive long-acting injectable antiretroviral therapies.
- Persons who do not speak English to a degree that would allow full comprehension of and participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acceptability of intervention measure (AIM)
Time frame: Baseline
a 5-point Likert scale of agreement (1= Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree). No items are reverse coded. Higher scores indicate greater acceptability for LAI-ART in pharmacies.
Intervention appropriateness measure (IAM)
Time frame: Baseline
a 5-point Likert scale of agreement (1= Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree). No items are reverse coded. Higher scores indicate greater perceived appropriateness for LAI-ART in pharmacies.
Feasibility of intervention measure (FIM)
Time frame: Baseline
a 5-point Likert scale of agreement (1= Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree). No items are reverse coded. Higher scores indicate greater perceived feasibility for LAI-ART in pharmacies.
Interview
Time frame: Baseline
Semi-structured interviews will be conducted, audio-recorded, and transcribed. Themes derived from these semi-structured individual interviews will be organized via the Consolidated Framework for Implementation Research (CFIR) and compared across the three key stakeholder groups (persons with HIV, pharmacy staff, and clinic staff). * Characteristics of the intervention * Inner setting * Outer setting * Individuals involved * Implementation process
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 40474134Cocohoba J, Cuca Y, Sherman E, Hester K, Udeani G, Sigua M, Saberi P. Preparing for pharmacy-based delivery of long-acting injectable antiretrovirals: a pre-implementation study. BMC Health Serv Res. 2025 Jun 5;25(1):808. doi: 10.1186/s12913-025-12971-8.
- Individual participant dataSharing planned: Yes. De-identified data from baseline surveys and redacted interview transcripts will be made available for collaborative research
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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.
Jennifer Cocohoba, PharmD principal investigator
University of California San Francisco School of Pharmacy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv, run by University of California, San Francisco at 4 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 12 inclusion and 4 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acceptability of intervention measure (AIM) (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT05152953, 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 29 Nov 2023.