NCT05152953Completed
Preparing for Pharmacy-based Delivery of Long-acting Injectable Antiretroviral Therapy (LAI-ART)
Source: ClinicalTrials.gov · Last updated 29 Nov 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 63 (actual)
- First submitted
- 29 Nov 2021
- Start date
- 8 Jun 2022
- Primary completion date
- 15 Nov 2023
- Lead sponsor
- University of California, San Francisco
- Diseases
- HIV
- NCT number
- NCT05152953
What you commit to
- Study type: Observational
- Participants enrolled: 63
- From 8 Jun 2022 to the primary completion date, 15 Nov 2023
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pharmacy staff with no forseeable involvement in implementation of a long-acting injectable antiretroviral therapy administration program.
- Clinic staff members with no current or forseeable involvement in supporting patients to receive long-acting injectable antiretroviral therapies.
Other illness
- Patients/persons who are not diagnosed with HIV, who are candidates for long-acting cabotegravir as HIV pre-exposure prophylaxis.
Other
- Persons who do not speak English to a degree that would allow full comprehension of and participation in the study.
Who the study is looking for
- 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:
- 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.
Age in the registry: 18 years to - · Sex: All
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Auburn University Harrison School of Pharmacy Coordinator of this site? Confirm its status | Auburn | United States | Unknown status |
| Nova Southeastern University College of Pharmacy Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Texas A&M Irma Lerma Rangel College of Pharmacy Coordinator of this site? Confirm its status | Kingsville | United States | Unknown status |
| University of California San Francisco School of Pharmacy Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.