The Shauriana Intervention for GBMSM in Kenya
Condition: HIV Prevention
Study type: Interventional

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.
    

Intervention name(s): Shauriana
Intervention type(s): Behavioral
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: preexposure prophylaxis; sexual health; mental health; behavioral intervention