Clinical trial NCT05152953: Preparing for Pharmacy-based Delivery of Long-acting Injectable Antiretroviral Therapy (LAI-ART)
Official title: Preparing for Pharmacy-based Delivery of Long-acting Injectable Antiretroviral Therapy (LAI-ART)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hiv
Keywords: pharmacy
implementation science
cabotegravir
rilpivirine
antiretroviral therapy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
name: Texas A&M University
name: Auburn University
name: Nova Southeastern University
First posted: 2021-12-10
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of intervention measure (AIM)
timeFrame: Baseline
measure: Intervention appropriateness measure (IAM)
timeFrame: Baseline
measure: Feasibility of intervention measure (FIM)
timeFrame: Baseline
measure: Interview
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University Harrison School of Pharmacy
state: Alabama
city: San Francisco
country: United States
facility: University of California San Francisco School of Pharmacy
state: California
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University College of Pharmacy
state: Florida
city: Kingsville
country: United States
facility: Texas A&M Irma Lerma Rangel College of Pharmacy
state: Texas
Study officials:
affiliation: University of California San Francisco School of Pharmacy
name: Jennifer Cocohoba, PharmD
role: PRINCIPAL_INVESTIGATOR
References: