Preparing for Pharmacy-based Delivery of Long-acting Injectable Antiretroviral Therapy (LAI-ART)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preparing for Pharmacy-based Delivery of Long-acting Injectable Antiretroviral Therapy (LAI-ART)

Conditions
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Hiv

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Persons with HIV<br>Persons with HIV who are currently taking antiretroviral therapy who reside in the study's target geographical areas. | |
| Pharmacy staff members<br>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<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacy, implementation science, cabotegravir, rilpivirine, antiretroviral therapy