Clinical trial NCT04550221: The Shauriana Intervention for GBMSM in Kenya
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
Keywords: preexposure prophylaxis
sexual health
mental health
behavioral intervention
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-09-16
Enrollment: 63
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot study with 10 intervention participants followed by randomized controlled trial with 60 participants assigned to the intervention or to standard care.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Completion of Exit Interview
timeFrame: Month 6
measure: Intervention Feasibility
timeFrame: Month 6
measure: Intervention Safety
timeFrame: Month 6
Secondary outcomes:
measure: PrEP Uptake
timeFrame: Month 1, Month 3, and Month 6
measure: PrEP Adherence
timeFrame: Month 1, Month 3, and Month 6
measure: PrEP Drug Levels
timeFrame: Month 3 and Month 6
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Anza Mapema Clinic
Study officials:
affiliation: University of Washington
name: Susan M Graham, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.