Clinical Trials Logo

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT04550221
Study type Interventional
Source University of Washington
Status Completed
Phase N/A
Start date May 10, 2021
Completion date March 10, 2022

See also
  Status Clinical Trial Phase
Completed NCT03411577 - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program N/A
Active, not recruiting NCT03112369 - Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use N/A
Not yet recruiting NCT03642314 - HIV Self-testing in Implementation PrEP Study N/A
Completed NCT01810315 - Influence of Reproductive Cycle and Menopause on HIV-1 Infection and TFV Gel Activity Phase 1
Completed NCT00984971 - Rectal Microbicide Safety and Acceptability Trial of Topically Applied Tenofovir Compared With Oral Tablet Phase 1
Completed NCT00142935 - Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1 N/A
Active, not recruiting NCT03255915 - PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study) Early Phase 1
Completed NCT05037513 - Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky N/A
Recruiting NCT05087680 - An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South N/A
Recruiting NCT05804461 - Optimizing Pre-Exposure Prophylaxis (PrEP) Among Latino Men Who Have Sex With Men (MSM) in Puerto Rico N/A
Completed NCT03148171 - Project WERK (Wellness Encouragement Respect Kinship) N/A
Completed NCT04791007 - OB-002H Gel Administered Vaginally and Rectally in HIV-1 Seronegative Adults Early Phase 1
Recruiting NCT05412433 - Clinic-based HIV Identification and Prevention Project Using Electronic Resources N/A
Active, not recruiting NCT03977181 - The Community PrEP Study to Assess the Acceptance of PrEP Delivered Through CBCT Platforms N/A
Recruiting NCT05165745 - Stick2PrEP Cisgender Women and Trans Individuals N/A
Completed NCT03719053 - Single Dose Truvada Study Phase 1
Recruiting NCT03856580 - Long-acting Biomedical HIV Prevention in Transgender Women N/A
Completed NCT02750540 - Optimization of a Tenofovir Enema for HIV Prevention Phase 1
Completed NCT01386294 - Safety and Effectiveness of Tenofovir Gel in the Prevention of Human Immunodeficiency Virus (HIV-1) Infection in Women and the Effects of Tenofovir Gel on the Incidence of Herpes Simplex Virus (HSV-2) Infection Phase 3
Completed NCT00993811 - The Shang Ring: A Novel Male Circumcision Device for HIV Prevention Phase 1