Development of a Telehealth-delivered Peer Navigation and Coping Skills Intervention to Increase PrEP Use in Young Black MSM

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05769270
Collaborator
Fenway Community Health (Other), National Institute of Mental Health (NIMH) (NIH)
34
1
13
2.6

Study Details

Study Description

Brief Summary

The goal of this observational study is to obtain qualitative knowledge on experiences of YBMSM ages 15-24 and specify role of peer navigator in promoting use of pre-exposure prophylaxis (PrEP). Participants at various stages of the PrEP continuum (e.g., never used, former user, and currently using PrEP) will complete in-depth interviews. Interviews will explore how contextual factors and self-change processes influence PrEP use.

The knowledge gained from these interviews will be used to inform intervention development in Aim 2.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: In-depth interviews

Detailed Description

Young Black men who have sex with men (YBMSM) ages 15-24 are heavily affected by HIV transmission and, at current rates, nearly half of Black MSM in the US will be infected with HIV in their lifetime. MSM represented 42% of all HIV diagnoses in Massachusetts from 2015-2017 and rates among Black MSM were 7 times that of White MSM. Fortunately, PrEP is highly effective at preventing HIV if adhered to in a prevention-effective (P-E) manner, which involves daily or event-based dosing specifically during periods of risk of HIV exposure (i.e., P-E adherence). Unfortunately, initiation and adherence among YBMSM is lower than other racial and age groups. According to Social Action Theory, barriers among YBMSM can be conceptualized as multifactorial, consisting of contextual factors (e.g., mood/arousal factors, structural factors, and demographics) and self-change processes (social interaction processes, motivations, generative capabilities, and problem-solving skills). An effective intervention must address contextual and self-change processes to promote PrEP uptake and P-E adherence.

The use of navigators (i.e., health workers trained to support ongoing adherence) has shown promise in promoting both PrEP uptake and sustained use in Black MSM by addressing structural barriers; however, rates of PrEP discontinuation were high. An NICHD-funded U01 study (SMILE) conducted in Boston found that peer navigation was highly acceptable for youth with HIV. The current study will use the Boston site of SMILE's peer navigation protocol. Notably, SMILE did not include behavioral components. In addition to structural barriers, YBSM often face unique barriers such as medical mistrust and disclosure concerns that affect self-change processes and impede PrEP uptake and P-E adherence. Limited knowledge exists on how these factors may impede PrEP use; however, it is clear these barriers may be addressed using problem/emotion-focused coping strategies. Many PrEP interventions require office visits, which may limit participation to those willing and able to present to a research office. Despite prevalent economic stressors, more than 90% of YMSM of color in various studies have smartphones, thus telehealth and remote study procedures may facilitate participation by YBMSM at highest HIV risk. This proposal seeks to adapt peer navigation from SMILE (adding coping skills and using telehealth) to be feasible, acceptable, and capable of supporting both PrEP uptake and P-E adherence for YBMSM ages 15-24.

This study will obtain qualitative knowledge on experiences of YBMSM ages 15-24 and specify role of peer navigator in promoting PrEP uptake and P-E adherence. We will conduct ~30 in-depth interviews with YBMSM at various stages of the PrEP continuum (e.g., never used, former user, and currently using PrEP) using a semi-structured interview guide. Interviews will explore how contextual factors and self-change processes influence PrEP uptake and P-E adherence. It will specify the role of a peer navigator (e.g., meeting frequency, demographics of navigator, topics to discuss and how best to employ technology-based tools and strategies). The knowledge gained from these interviews will be used to inform intervention development.

Study Design

Study Type:
Observational
Anticipated Enrollment :
34 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Development and Pilot RCT of a Telehealth-delivered Peer Navigation and Coping Skills Intervention to Increase PrEP Use in Young Black Men Who Have Sex With Men
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Young Black men who have sex with men

Behavioral: In-depth interviews
Participants will complete in-depth interviews about factors influencing PrEP use and coping skills that would be useful.

Outcome Measures

Primary Outcome Measures

  1. Qualitative Interview [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 24 Years
Sexes Eligible for Study:
Male
Inclusion Criteria:
  • HIV-negative (by self-report)

  • Black race (of any ethnicity, by self-report)

  • age 15-24

  • sexually active

  • identifies as male

  • report HIV risk characterized by one or more of the following: 1) condomless anal or vaginal sex (receptive or penetrative) with a partner assigned male at birth (AMAB) of unknown HIV status in the last 6 months, 2) presence of rectal STI in the last 6 months, 3) condomless anal or vaginal sex with a known HIV-infected partner in the last 6 months (inclusive of partners who are undetectable), or 4) condomless anal or vaginal sex (receptive or penetrative) with casual partners assigned male at birth and endorsement of factors associated with not using PrEP based on my preliminary research with the MDPH (i.e., non-disclosure of same-sex behavior to provider, uninsured, history of incarceration, or lacking healthcare due to cost). For participants under the age of 18, condomless sex criteria can be met by having condomless oral sex.

Exclusion Criteria:

Those unable to complete consent in English and those with significant mental health diagnoses (e.g., uncontrolled psychosis) that would likely interfere with participation will be excluded and referred for treatment or alternative resources as necessary.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital
  • Fenway Community Health
  • National Institute of Mental Health (NIMH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Calvin Fitch, PhD, Postdoctoral Fellow, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT05769270
Other Study ID Numbers:
  • 2021P003220
  • 1K23MH129240
First Posted:
Mar 15, 2023
Last Update Posted:
Mar 20, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 20, 2023