Pharmacy-based Pre-exposure Prophylaxis

NCT04393935 | Completed Results

• 2 other identifiers: IRB001063701R34MH119007-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Keywords

Behavioral intervention

Outcome Measures

Primary Outcomes (1)

• Number of Participants Continuing PrEP

  Participants who were prescribed PrEP through the pharmacy intervention were contacted after 3 months to see if they continued PrEP use.

  Month 3

Study Arms (1)

Pharmacy Delivered PrEP Intervention

EXPERIMENTAL

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

Behavioral: Pharmacy Delivered PrEP Intervention

Interventions

Pharmacy Delivered PrEP Intervention 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.

Pharmacy Delivered PrEP Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, 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

Results Point of Contact

• Title: Natalie Crawford, PhD
• Organization: Emory University

ndcrawford@emory.edu

404-712-9445

Study Officials

• Natalie Crawford, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 19, 2020
• Study Start: May 19, 2022
• Primary Completion: May 11, 2024
• Study Completion: May 11, 2024
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)