Pharmacy-based Pre-exposure Prophylaxis

May 12, 2025 updated by: Natalie Crawford, Emory University

Advancing Pre-exposure Prophylaxis (PrEP) Access in Pharmacies to Improve PrEP Uptake in Disadvantaged Areas

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharmacy Delivered PrEP Intervention
Clients of the study pharmacies who participate in the intervention to receive PrEP through the pharmacy.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Continuing PrEP
Time Frame: Month 3
Participants who were prescribed PrEP through the pharmacy intervention were contacted after 3 months to see if they continued PrEP use.
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Natalie Crawford, PhD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2022

Primary Completion (Actual)

May 11, 2024

Study Completion (Actual)

May 11, 2024

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00106370
  • 1R34MH119007-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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