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

Study Overview
=================
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.

Detailed 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.

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

Conditions
-----------------
HIV Risk Perception, PrEP

Intervention / Treatment
-----------------
* Behavioral: Multi-component intervention strategy


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BSMM<br>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<br>* Multi-component intervention strategy using a peer change agent and mobile application to record and review sexual risk behaviors<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |