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The Shauriana Intervention for GBMSM in Kenya

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ClinicalTrials.gov Identifier: NCT04550221
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : November 17, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Susan Graham, University of Washington

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.

Condition or disease Intervention/treatment Phase
HIV Prevention Behavioral: Shauriana Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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)
Masking Description: Laboratory testing for PrEP drug levels will be conducted in a blinded fashion
Primary Purpose: Prevention
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
Actual Study Start Date : October 28, 2020
Estimated Primary Completion Date : November 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
The Shauriana intervention is aimed at promoting sexual health and preventing HIV through a comprehensive prevention toolbox including PrEP. 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.
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).

Active Comparator: Standard care
Standard care includes clinic-based HIV counseling and testing, screening for symptoms of sexually transmitted infections (STI), and individual counseling about HIV prevention methods. Standard of care counseling for HIV prevention in Kenya includes general information about HIV transmission and discussions of risk reduction including condom use. PrEP counseling sessions focus on PrEP knowledge, adherence tips, and strategies to address adherence barriers.
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).




Primary Outcome Measures :
  1. Intervention acceptability [ Time Frame: up to Month 6 ]
    5-point Likert scales (1 to 5, with 5 being optimal) evaluating acceptability of the Shauriana intervention components collected by ACASI

  2. Intervention feasibility [ Time Frame: up to Month 6 ]
    Intervention session attendance

  3. Intervention safety [ Time Frame: up to Month 6 ]
    Adverse events reported by participants


Secondary Outcome Measures :
  1. PrEP uptake [ Time Frame: up to Month 6 ]
    Ongoing PrEP use (yes or no) assessed by ACASI

  2. PrEP adherence [ Time Frame: up to Month 6 ]
    3-question self-reported adherence assessment scale (Wilson et al) asked by ACASI

  3. PrEP refills [ Time Frame: up to Month 6 ]
    Number of documented PrEP refills

  4. PrEP drug levels [ Time Frame: Month 6 ]
    Urine tenofovir levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Biologically male at birth and identifies as male, according to self-report
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04550221


Contacts
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Contact: Susan M Graham, MD, MPH, PhD 206 221-8435 grahamsm@uw.edu
Contact: Fred Otieno, MBChB +254721759867 fotieno@nrhskenya.org

Locations
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Kenya
Anza Mapema Clinic Recruiting
Kisumu, Kenya
Contact: Duncan Okall, MPH    +2540572023903    dokal@nrhskenya.org   
Principal Investigator: Fred Otieno, MBChB         
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Susan M Graham, MD, MPH, PhD University of Washington
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Responsible Party: Susan Graham, Associate Professor, School of Medicine: Global Health, University of Washington
ClinicalTrials.gov Identifier: NCT04550221    
Other Study ID Numbers: STUDY00009441
R34MH118950 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study data will be available upon request after publication of the main study manuscripts. Researchers requesting access to data/resources will be asked to submit a request in writing describing their qualifications including their certification by their local IRB, analytic plans and other uses of the data/resources, and plans to secure the confidentiality and safety of the data. They will be required to agree in writing that they will not share the data with others, will use it only for the research purpose(s) delineated, and will return or destroy the data upon completion. In order to maintain protection of our participants' privacy, no directly identifying information will be shared with outside investigators. Given the sensitive nature of the data we are collecting, including HIV diagnosis and sexual risk behavior, we will not create a public access file.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After reporting of the trial results
Access Criteria: Data sharing agreement with study investigators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susan Graham, University of Washington:
preexposure prophylaxis
sexual health
mental health
behavioral intervention