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

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.

Study Overview

• Status: Completed
• Conditions: Hiv

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 Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Auburn, Alabama, United States, 36849
      • Auburn University Harrison School of Pharmacy
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco School of Pharmacy
  • Florida
    • Fort Lauderdale, Florida, United States, 33314
      • Nova Southeastern University College of Pharmacy
  • Texas
    • Kingsville, Texas, United States, 78363
      • Texas A&M Irma Lerma Rangel College of Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Texas A&M University; ViiV Healthcare; Auburn University; Nova Southeastern University
• Investigators: Principal Investigator: Jennifer Cocohoba, PharmD, University of California San Francisco School of Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: implementation science; antiretroviral therapy; pharmacy; rilpivirine; cabotegravir
• Other Study ID Numbers: 2179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data from baseline surveys and redacted interview transcripts will be made available for collaborative research
• IPD Sharing Time Frame: Data available upon request 6 months after initial study publication.
• IPD Sharing Access Criteria: Principal investigator will review data requests on an individual basis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP