Pharmacy-based Pre-exposure Prophylaxis

NCT ID: NCT04393935

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-19
• Study Completion Date: 2024-05-11

Brief Summary

The proposed research will develop a culturally appropriate pharmacy pre-exposure prophylaxis (PrEP) delivery model for black men who have sex with men (BMSM) who live in high poverty, racial minority neighborhoods. Increasing access to PrEP through pharmacies has the potential to increase PrEP uptake among BMSM thereby reducing HIV incidence and racial inequities in HIV.

Detailed Description

Black men who have sex with men (BMSM) bear the highest burden of HIV in the US. PrEP is the single most effective HIV prevention strategy yet under-utilized among BMSM. When taken every day PrEP can prevent up to 92% of HIV infections. Studies estimate that 48-70% of BMSM are willing to use PrEP, yet, uptake among blacks remains low (~10%). Lower insurance rates among blacks compared to whites may be a barrier to PrEP, but, evidence of insurance rates, as well as prescription payment programs that cover most or all of the costs of PrEP do not completely explain significant disparities in PrEP uptake. Indeed, limited access to PrEP, distrust of physicians and stigma are noted as critical barriers to PrEP that must be improved to reduce HIV.

Neighborhood residence shapes BMSM HIV exposure and access to HIV prevention resources. Census tracts with high HIV had 20% higher poverty and 200% larger MSM populations. High poverty neighborhoods also have the fewest HIV physicians. While most census tracts are within 15 minutes of an HIV physician by car, residents in HIV prevalent areas have low rates of car ownership and commute time more than doubles when traveling by public transportation, which is unavailable in some areas.

There is a strong scientific premise for increasing PrEP delivery in pharmacies for BMSM. About 95% of Americans live within 5 miles of a pharmacy; pharmacies have flexible hours and pharmacists have high credibility with community members. Studies have shown pharmacies can engage with high risk populations including people who inject drugs (PWID) to reduce HIV risk behaviors and provide primary prevention services including immunizations, blood pressure screenings and HIV testing. PrEP has also been sustainably offered in a Seattle pharmacy, but mostly to white MSM (85%). Nevertheless, almost 100% initiated PrEP and 75% followed up for continued PrEP. Following this, Walgreens across the US have offered PrEP through their existing clinics.

Existing pharmacy PrEP models have limited potential for reaching BMSM. In Seattle, state regulations give pharmacists authority to administer biological screenings (HIV, sexually transmitted infections (STIs) and creatinine) and prescribe PrEP. Many states do not have legislation that expand pharmacists' purview in service delivery. Walgreens has overcome this regulatory limitation by using nurse practitioners to screen and prescribe PrEP in their existing clinics. While Collaborative Practice Agreements between pharmacists and physicians are another route to deliver services through pharmacies, they are time-consuming and thus infeasible for community pharmacists in high morbidity neighborhoods who already have a hectic workflow; and for chain pharmacies these partnerships are determined on a corporate rather than individual pharmacy level.

Accomplishing the study aims will be done through three steps: conducting interviews and workflow assessments with stakeholders, developing an intervention to deliver a culturally relevant pharmacy PrEP model, and perform a pilot test to study the delivery model in pharmacies in high poverty, racial minority neighborhoods.

In the pilot test phase, pharmacies will be chosen to test the pharmacy PrEP delivery model by informing pharmacy clients of the study and performing their study activities. Pharmacists and technicians will complete a pharmacy-based HIV prevention training to equip them with the tools needed for optimal PrEP delivery. During the training, pharmacists and technicians will learn how to engage pharmacy clients for recruitment into the study. Black race is not included in the eligibility criteria to avoid profiling and potentially stigmatizing one racial group. However, since the pharmacies selected to be a part of the study are located in racial minority neighborhoods, the researchers anticipate that most customers will be racial minorities. Male sex is also not included in the eligibility criteria. The researchers will be collecting both qualitative and quantitative data to assess the impact of the pharmacy PrEP intervention on the pharmacy environment, personnel, and business flow. Among the pharmacy clients, this study will assess feasibility, acceptability and safety of the intervention activities, satisfaction with the activities and participation in activities without stigmatization, discomfort or harm.

The study pharmacies will deliver the PrEP intervention. Pharmacy client participants will receive a 3-month follow-up phone call to see if they are continuing to use PrEP.

Conditions

Human Immunodeficiency Virus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pharmacy Delivered PrEP Intervention

Clients of the study pharmacies who participate in the intervention to receive PrEP through the pharmacy.

Group Type: EXPERIMENTAL

Pharmacy Delivered PrEP Intervention

Intervention Type: BEHAVIORAL

Pharmacy client participants who are eligible and agree to the HIV test will be provided with a pre-packaged kit of a self-administered test for HIV and directed back to the private area of the pharmacy to perform their screening. Pharmacy client participants who test HIV negative will be provided with their results and be given a 30-day prescription for PrEP, culturally appropriate PrEP counseling and a follow-up appointment with a PrEP prescribing physician. Pharmacy client participants will be contacted after 3 months to determine whether they continued PrEP use.

Interventions

Pharmacy Delivered PrEP Intervention

Pharmacy client participants who are eligible and agree to the HIV test will be provided with a pre-packaged kit of a self-administered test for HIV and directed back to the private area of the pharmacy to perform their screening. Pharmacy client participants who test HIV negative will be provided with their results and be given a 30-day prescription for PrEP, culturally appropriate PrEP counseling and a follow-up appointment with a PrEP prescribing physician. Pharmacy client participants will be contacted after 3 months to determine whether they continued PrEP use.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Consent to participate in the online screener
• Can speak and read English without any help
• Test negative for HIV
• Agree to receive medication from the pharmacy

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Natalie Crawford

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Natalie Crawford, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R34MH119007-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00106370

Identifier Type: -

Identifier Source: org_study_id