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

NCT04533386 | Completed DMC

• 1 other identifier: IRB00241244
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Risk Perception; PrEP

Outcome Measures

Primary Outcomes (1)

• HIV risk perception as assessed by the Perceived Risk of HIV Scale

  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.

  1 month

Secondary Outcomes (1)

• Proportion of participants who express interest in PrEP initiation

  1 month

Study Arms (1)

BSMM

EXPERIMENTAL

Intervention arm will include motivational interview-consistent discussion with a peer change agent and use of a mobile application to record and review sexual risk behaviors with participants.

Behavioral: Multi-component intervention strategy

Interventions

Multi-component intervention strategy BEHAVIORAL

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

BSMM

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: cis-gender men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• ≤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)

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location

Related Publications (4)

• Young LE, Schumm P, Alon L, Bouris A, Ferreira M, Hill B, Khanna AS, Valente TW, Schneider JA. PrEP Chicago: A randomized controlled peer change agent intervention to promote the adoption of pre-exposure prophylaxis for HIV prevention among young Black men who have sex with men. Clin Trials. 2018 Feb;15(1):44-52. doi: 10.1177/1740774517730012. Epub 2017 Sep 1.

  PMID: 28862483 BACKGROUND

• Napper LE, Fisher DG, Reynolds GL. Development of the perceived risk of HIV scale. AIDS Behav. 2012 May;16(4):1075-83. doi: 10.1007/s10461-011-0003-2.

  PMID: 21785873 BACKGROUND

• Dangerfield Ii DT, Harawa NT, McWells C, Hilliard C, Bluthenthal RN. Exploring the preferences of a culturally congruent, peer-based HIV prevention intervention for black men who have sex with men. Sex Health. 2018 Nov;15(5):424-430. doi: 10.1071/SH18057.

  PMID: 30185352 BACKGROUND

• Dangerfield Ii DT, Anderson JN, Wylie C, Bluthenthal R, Beyrer C, Farley JE. A Multicomponent Intervention (POSSIBLE) to Improve Perceived Risk for HIV Among Black Sexual Minority Men: Feasibility and Preliminary Effectiveness Pilot Study. JMIR Hum Factors. 2024 Jun 11;11:e54739. doi: 10.2196/54739.

  PMID: 38861707 DERIVED

Study Officials

• Derek Dangerfield II, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

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: PI

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 31, 2020
• Study Start: September 5, 2020
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)