Loading clinical trials...
Loading clinical trials...
Tragically, HIV infections among Black sexual minority men (BSMM) in the U.S. persist. Despite the availability of pre-exposure prophylaxis (PrEP) for HIV prevention, effective uptake among BSMM remains low. It is imperative to support PrEP initiation among this group. The proposed multi-component interventional study is designed to increase HIV risk perceptions and subsequent PrEP initiation through the use of our team's existing mobile application called PrEPme and a peer change agent (PCA) to record and review sexual risk behaviors and subsequent PrEP interest. Few have studied whether reviewing sexual diaries with a PCA increases HIV risk perceptions and PrEP initiation among BSMM. This strategy will allow BSMM who are not using PrEP to record their sexual behaviors using a PrEPme-based diary, review their sexual histories with a PCA, and assess PrEP interest. The PCA will be trained in motivational interviewing techniques to facilitate discussions. The PCA will provide HIV prevention education, sexual risk evaluation, and PrEP navigation. BSMM who become interested in initiating PrEP will be referred to our team's ongoing PrEP tele-medicine study (PI: Jason Farley, co-investigator) or other PrEP care services in the greater Baltimore area. The proposed intervention targets a high priority population in HIV prevention and mitigates structural barriers to PrEP uptake such as perceived judgement, stigma, and discrimination from clinical providers.
The proposed multicomponent intervention will use our team's existing mobile smartphone app called PrEPme along with a peer change agent (PCA) to record and review sexual risk behaviors among 80 HIV-negative BSMM. PrEPme is an existing HIPAA compliant mobile app that is currently available in the mobile application "store" and offers PrEP navigation services in Baltimore and throughout the State of Maryland. Currently, the app contains a diary that allows users to record and review their sexual risk behaviors using a weekly "timeline" including number and gender of partners along with substance use. At the end of each week, the dashboard provides a weekly review of sexual history for four weeks until the history is displayed as a monthly overview. The app also allows users to chat with our case management team to learn more about PrEP, obtain adequate insurance coverage, and get help scheduling appointments at any time. The proposed intervention leverages the current features of the app as part of the multi-component strategy. In the intervention, pre-post assessments will include demographic information, sexual behavior, substance use, mental health (e.g., depression, gay community affiliation), and PrEP use history. HIV risk perception will be measured using an 8-item scale. The PCA will be trained to review sexual histories, highlight HIV and sexually transmitted infection risks, provide HIV prevalence information, deliver PrEP information, and encourage PrEP uptake. This intervention phase will use a single-group pretest post-test design to explore feasibility and findings will be used as the foundation for an efficacy trial among a larger sample of BSMM in different locales.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
Yes
Johns Hopkins School of Nursing
Baltimore, Maryland, United States
Start Date
September 5, 2020
Primary Completion Date
June 2, 2022
Completion Date
June 2, 2022
Last Updated
March 14, 2025
69
ACTUAL participants
Multi-component intervention strategy
BEHAVIORAL
Lead Sponsor
George Washington University
NCT07353853
NCT07127354
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions