The Shauriana Intervention for GBMSM in Kenya

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Prevention
• Intervention / Treatment: Behavioral: Shauriana

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • Anza Mapema Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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).
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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of Exit Interview	All intervention arm participants were invited to provide qualitative feedback on intervention acceptability in an exit interview	Month 6
Intervention Feasibility	Intervention session attendance	Month 6
Intervention Safety	Adverse events reported by participants	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Uptake	Ongoing PrEP use (yes or no) assessed by ACASI	Month 1, Month 3, and Month 6
PrEP Adherence	In the last 30 days, how good a job did you do at taking your PrEP daily?	Month 1, Month 3, and Month 6
PrEP Drug Levels	Tenofovir levels measured in dried blood spots	Month 3 and Month 6

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Susan M Graham, MD, MPH, PhD, University of Washington

Publications and helpful links

General Publications

• Harper GW, Lewis KA, Norwitz GA, Odhiambo EO, Jadwin-Cakmak L, Okutah F, Lauber K, Aloo T, Collins B, Gumbe E, Amico KR, Olango K, Odero W, Graham SM. "God Didn't Make a Mistake in Creating Me": Intrapersonal Resilience Processes among Gay and Bisexual Male Youth in Kenya. Adolescents. 2021 Sep;1(3):267-282. doi: 10.3390/adolescents1030020. Epub 2021 Jul 13.
• Jadwin-Cakmak L, Lauber K, Odhiambo EO, Collins B, Gumbe E, Norwitz GA, Aloo T, Lewis KA, Okutah F, Amico KR, Olango K, Odero W, Graham SM, Harper GW. "When you talk it out ... you will feel like the burden has somehow gone down, you will feel light": Social Support Received by Gay, Bisexual, and Other Men Who Have Sex with Men in Western Kenya. Int J Environ Res Public Health. 2022 Feb 1;19(3):1667. doi: 10.3390/ijerph19031667.
• Graham SM, Okall DO, Mehta SD, Obondi E, Ng'ety G, Ochieng E, Jadwin-Cakmak L, Amico KR, Harper GW, Bailey RC, Otieno FO. Challenges with PrEP Uptake and Adherence Among Gay, Bisexual, and Other Men Who Have Sex with Men in Kisumu, Kenya. AIDS Behav. 2023 Apr;27(4):1234-1247. doi: 10.1007/s10461-022-03860-w. Epub 2022 Oct 11.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): March 10, 2022
• Study Completion (Actual): March 10, 2022

Study Registration Dates

• First Submitted: August 30, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: behavioral intervention; mental health; sexual health; preexposure prophylaxis
• Other Study ID Numbers: STUDY00009441; R34MH118950 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data will be available upon request after publication of the main study manuscripts. Researchers requesting access to data/resources will be asked to submit a request in writing describing their qualifications including their certification by their local IRB, analytic plans and other uses of the data/resources, and plans to secure the confidentiality and safety of the data. They will be required to agree in writing that they will not share the data with others, will use it only for the research purpose(s) delineated, and will return or destroy the data upon completion. In order to maintain protection of our participants' privacy, no directly identifying information will be shared with outside investigators. Given the sensitive nature of the data we are collecting, including HIV diagnosis and sexual risk behavior, we will not create a public access file.
• IPD Sharing Time Frame: After reporting of the trial results
• IPD Sharing Access Criteria: Data sharing agreement with study investigators
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No