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OpenTrials
Completed

NCT Number: NCT04533386

A Multicomponent Intervention to Increase HIV Risk Perceptions and PrEP Initiation Among Black Men Who Have Sex With Men

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.

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Key information

Conditions

HIV Risk Perception PreP

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years of age
  • Identify as cis-gender man
  • Self-reporting being HIV-negative or status unknown
  • Identify as Black or African American
  • Report anal intercourse with ≥ 1 male partner in the past 12 months
  • Has mobile smartphone
  • Not currently taking Truvada or Descovy as pre-exposure prophylaxis (PrEP)

Exclusion criteria

  • ≤18 years of age
  • Identify as woman or transgender
  • Self-reporting being HIV-positive
  • Identify as race/ethnicity other than Black or African American
  • Report no anal intercourse with male partner in the past 12 months
  • Report not having a mobile smartphone
  • Currently taking Truvada or Descovy as pre-exposure prophylaxis (PrEP)

Treatment and study plan

Multi-component intervention strategy

Behavioral

Multi-component intervention strategy using a peer change agent and mobile application to record and review sexual risk behaviors

Primary outcomes

  1. HIV risk perception as assessed by the Perceived Risk of HIV Scale

    Time frame: 1 month

    The Perceived Risk of HIV Scale is an 8-item scale with each item being scored from 1-5 (e.g., "Extremely likely" to "Extremely Unlikely," "Rarely" to "All of the time," etc.). Overall score ranges from 10 to 40 where higher scores signify increased perception of risk.

Secondary outcomes

  1. Proportion of participants who express interest in PrEP initiation

    Time frame: 1 month

    The proportion of participants who express interest in initiating PrEP at month 1 will be assessed.

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 31, 2020
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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