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

NCT05152953 | Completed

• 1 other identifier: 2179
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Hiv

Keywords

pharmacy; implementation science; cabotegravir; rilpivirine; antiretroviral therapy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• ViiV Healthcare: collaborator
• Texas A&M University: collaborator
• Auburn University: collaborator
• Nova Southeastern University: collaborator

Study Sites (4)

Auburn University Harrison School of Pharmacy

Auburn, Alabama, 36849, United States

Location

University of California San Francisco School of Pharmacy

San Francisco, California, 94143, United States

Location

Nova Southeastern University College of Pharmacy

Fort Lauderdale, Florida, 33314, United States

Location

Texas A&M Irma Lerma Rangel College of Pharmacy

Kingsville, Texas, 78363, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jennifer Cocohoba, PharmD

  University of California San Francisco School of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: June 8, 2022
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data available upon request 6 months after initial study publication.
• Access Criteria: Principal investigator will review data requests on an individual basis.

Locations

US (4)