Preparing for Pharmacy-based Delivery of Long-acting Injectable Antiretroviral Therapy (LAI-ART)
NCT ID: NCT05152953
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
63 participants
OBSERVATIONAL
2022-06-08
2023-11-15
Brief Summary
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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
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Persons with HIV
Persons with HIV who are currently taking antiretroviral therapy who reside in the study's target geographical areas.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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ViiV Healthcare
INDUSTRY
Texas A&M University
OTHER
Auburn University
OTHER
Nova Southeastern University
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Jennifer Cocohoba, PharmD
Role: PRINCIPAL_INVESTIGATOR
University of California San Francisco School of Pharmacy
Locations
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Auburn University Harrison School of Pharmacy
Auburn, Alabama, United States
University of California San Francisco School of Pharmacy
San Francisco, California, United States
Nova Southeastern University College of Pharmacy
Fort Lauderdale, Florida, United States
Texas A&M Irma Lerma Rangel College of Pharmacy
Kingsville, Texas, United States
Countries
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Other Identifiers
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2179
Identifier Type: -
Identifier Source: org_study_id