The Shauriana Intervention for GBMSM in Kenya

HIV Prevention Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04550221
• Other study ID #: STUDY00009441
• Secondary ID: R34MH118950
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: March 10, 2022

Study information

• Verified date: September 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 10, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Prevention

Intervention

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).

Locations

Country	Name	City	State
Kenya	Anza Mapema Clinic	Kisumu

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Kenya, 

References & Publications (3)

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 — View 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 Ma — View 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": Soc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of Exit Interview	All intervention arm participants were invited to provide qualitative feedback on intervention acceptability in an exit interview	Month 6
Primary	Intervention Feasibility	Intervention session attendance	Month 6
Primary	Intervention Safety	Adverse events reported by participants	Month 6
Secondary	PrEP Uptake	Ongoing PrEP use (yes or no) assessed by ACASI	Month 1, Month 3, and Month 6
Secondary	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
Secondary	PrEP Drug Levels	Tenofovir levels measured in dried blood spots	Month 3 and Month 6