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 STUDY
Start: August 2020
Status: Data cleaning and analysis ongoing
Design: Randomised Clinical Trial
Study Sites: Anza Mapema Centre of Excellence, Kisumu
Sponsor: National Institutes of Health through University of Washington
IRB: Maseno University Ethical Research Committee MUERC/00849/20
Purpose: The purpose of this study is to adapt and enhance a theory-based and culturally relevant PrEP support intervention to combat stigma and promote a more holistic approach to sexual health, including but not limited to PrEP uptake and adherence, among GBM in Kisumu
Design: The Aim 1 work will be a prospective pilot of the intervention and of study procedures other than laboratory testing, in a small group of 10 men over a 3-month period, with visits at baseline, month 1, and month 3. During this pilot test, intervention and clinic visit procedures, including data collection tools, will be revised and improved as needed according to feedback on feasibility, comprehension, burden on participants, and acceptability among pilot participants. The Aim 2 work will be an RCT of the final Shauriana intervention, to test its acceptability, feasibility, and safety and estimate its initial effect size compared to standard care. The final phase of this study will consist of data analysis and dissemination activities. At the end of the trial, urine samples will be shipped on dry ice for testing utilizing the LC-MS/MS urine tenofovir (TFV) assay developed at Philadelphia FIGHT/Children’s Hospital of Philadelphia by Dr. Helen Koenig and colleagues. This assay detects TFV with greater sensitivity than plasma-based measures, with a detection window within 7 days of the last TDF/FTC dose.
Population: Men who report oral or anal sex with a man in the past 3 months, are 18-35 years of age, HIV uninfected, Not currently taking HIV PrEP and are residents of Kisumu.
Study Size: A total of approximately 70 men will be enrolled.
Study Aims: Aim 1: To pilot the Shauriana intervention among 10 participants for 3 months, in order to ensure that intervention and study procedures are optimized.
Aim 2: To determine the acceptability, feasibility, and safety of the Shauriana intervention and estimate initial effect size compared to standard care on PrEP uptake and adherence assessed by drug levels over 6 months in a pilot randomized controlled trial (RCT).