The Shauriana Intervention for GBMSM in Kenya

Overview

The Shauriana intervention, developed from qualitative work using a community-based participatory approach, aims to integrate PrEP, sexual health, and mental health support for gay, bisexual, and other men who have sex with men in Kenya. This study consists of a brief pilot test phase with 10 participants, followed by a randomized, controlled trial with 60 participants.

Full Title of Study: “Randomized Controlled Trial of the Shauriana Intervention to Integrate PrEP, Sexual Health, and Mental Health Support for Gay, Bisexual, and Other Men Who Have Sex With Men in Kenya”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 15, 2021

Detailed Description

Gay, bisexual, and other men who have sex with men (GBMSM) are at high risk for HIV-1 acquisition, especially in rights-constrained settings such as Kenya, where men's access to HIV prevention has been impeded by homophobia, stigma, and discrimination. Pre-exposure prophylaxis (PrEP) has the potential to greatly reduce HIV acquisition risk in this key population if accessible, sustainable PrEP programming with tailored, effective adherence support can be provided. To this end, close collaboration between PrEP program implementers and GBMSM-led community-based organizations is essential. Based on preliminary qualitative work, this theory-based and culturally relevant PrEP support intervention is called Shauriana (Kiswahili for "we counsel each other"). The Shauriana intervention merges peer navigation and "integrated Next Step Counseling" (iNSC) to promote sexual health protection strategies, including PrEP uptake and adherence, among GBMSM in Kisumu. The present proposal aims to pilot the intervention among 10 participants for 3 months, and then to evaluate the Shauriana intervention for acceptability, feasibility, safety, and estimated effect on PrEP uptake and adherence, compared to standard of care, in a small randomized, controlled study with 60 participants followed for 6 months after enrollment. Results of the proposed research will have high impact by ensuring GBMSM involvement in the scale-up of effective PrEP programming for this key population in Kenya and providing a peer-led PrEP support model for GBMSM and other vulnerable and marginalized populations in African settings.

Interventions

  • Behavioral: Shauriana
    • The components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions. The four in-person health education and coaching sessions will be delivered once per week, by trained peer facilitators who identify as GBMSM. These sessions will focus on the following topics: sexual health basics (understanding how HIV and STIs are transmitted, prevented, and diagnosed/treated), relationships (types of relationships we have, characteristics of healthy relationships, communication skills), stress and coping (understanding mental health challenges, adaptive and maladaptive coping strategies), and healthy sexuality and empowerment (understanding sexual orientation and gender identity, challenging stereotypes about GBMSM, making sexual choices).

Arms, Groups and Cohorts

  • Experimental: Intervention
    • The Shauriana intervention is aimed at promoting sexual health and preventing HIV through a comprehensive prevention toolbox including PrEP. Components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions.
  • Active Comparator: Standard care
    • Standard care includes clinic-based HIV counseling and testing, screening for symptoms of sexually transmitted infections (STI), and individual counseling about HIV prevention methods. Standard of care counseling for HIV prevention in Kenya includes general information about HIV transmission and discussions of risk reduction including condom use. PrEP counseling sessions focus on PrEP knowledge, adherence tips, and strategies to address adherence barriers.

Clinical Trial Outcome Measures

Primary Measures

  • Intervention acceptability
    • Time Frame: up to Month 6
    • 5-point Likert scales (1 to 5, with 5 being optimal) evaluating acceptability of the Shauriana intervention components collected by ACASI
  • Intervention feasibility
    • Time Frame: up to Month 6
    • Intervention session attendance
  • Intervention safety
    • Time Frame: up to Month 6
    • Adverse events reported by participants

Secondary Measures

  • PrEP uptake
    • Time Frame: up to Month 6
    • Ongoing PrEP use (yes or no) assessed by ACASI
  • PrEP adherence
    • Time Frame: up to Month 6
    • 3-question self-reported adherence assessment scale (Wilson et al) asked by ACASI
  • PrEP refills
    • Time Frame: up to Month 6
    • Number of documented PrEP refills
  • PrEP drug levels
    • Time Frame: Month 6
    • Urine tenofovir levels

Participating in This Clinical Trial

Inclusion Criteria

  • Biologically male at birth and identifies as male, according to self-report
  • 18 to 35 years of age
  • Resident in the Kisumu area for ≥12 months
  • Reports anal intercourse with a man in the past 3 months
  • Not currently taking PrEP for HIV prevention in the past 3 months
  • Willing to provide complete locator information
  • Willing to undergo all study procedures, including HIV testing and counselling
  • Not currently participating in any HIV prevention or vaccine study
  • Planning to remain in the study area for at least 6 months

For the pilot study only, men will be required to speak English, in order to expedite the study team's analysis of feedback from these participants in preparation for the randomized controlled trial (RCT). Of note, approximately 50%-60% of young MSM in Kisumu speak English.

Exclusion Criteria

  • Unable to understand the study purpose and procedures
  • Unwilling to adhere to study procedures
  • Currently under the influence of alcohol or drugs
  • Prior diagnosis of HIV infection

Gender Eligibility: Male

Biologically male at birth and identifies as male, according to self-report

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Collaborator
    • National Institute of Mental Health (NIMH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Susan Graham, Associate Professor, School of Medicine: Global Health – University of Washington
  • Overall Official(s)
    • Susan M Graham, MD, MPH, PhD, Principal Investigator, University of Washington
  • Overall Contact(s)
    • Susan M Graham, MD, MPH, PhD, 206 221-8435, grahamsm@uw.edu

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