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

PrEP Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04533386
• Other study ID #: IRB00241244
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV Risk Perception
• PrEP

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins School of Nursing	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of participants who express interest in PrEP initiation	The proportion of participants who express interest in initiating PrEP at month 1 will be assessed.	1 month