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Completed

NCT Number: NCT04550221

The Shauriana Intervention for GBMSM in Kenya

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Anza Mapema Clinic

Kisumu, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shauriana

Behavioral

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).

Primary outcomes

  1. Completion of Exit Interview

    Time frame: Month 6

    All intervention arm participants were invited to provide qualitative feedback on intervention acceptability in an exit interview

  2. Intervention Feasibility

    Time frame: Month 6

    Intervention session attendance

  3. Intervention Safety

    Time frame: Month 6

    Adverse events reported by participants

Secondary outcomes

  1. PrEP Uptake

    Time frame: Month 1, Month 3, and Month 6

    Ongoing PrEP use (yes or no) assessed by ACASI

  2. PrEP Adherence

    Time frame: Month 1, Month 3, and Month 6

    In the last 30 days, how good a job did you do at taking your PrEP daily?

  3. PrEP Drug Levels

    Time frame: Month 3 and Month 6

    Tenofovir levels measured in dried blood spots

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2020
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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