NCT04550221

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 22, 2023

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

August 30, 2020

Results QC Date

May 15, 2023

Last Update Submit

March 11, 2025

Conditions

HIV Prevention

Keywords

preexposure prophylaxissexual healthmental healthbehavioral intervention

Outcome Measures

Primary Outcomes (3)

  • Completion of Exit Interview

    All intervention arm participants were invited to provide qualitative feedback on intervention acceptability in an exit interview

    Month 6

  • Intervention Feasibility

    Intervention session attendance

    Month 6

  • Intervention Safety

    Adverse events reported by participants

    Month 6

Secondary Outcomes (3)

  • PrEP Uptake

    Month 1, Month 3, and Month 6

  • PrEP Adherence

    Month 1, Month 3, and Month 6

  • PrEP Drug Levels

    Month 3 and Month 6

Study Arms (2)

Intervention

EXPERIMENTAL

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

Standard care

ACTIVE COMPARATOR

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

Interventions

ShaurianaBEHAVIORAL

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).

InterventionStandard care

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsBiologically male at birth and identifies as male, according to self-report
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Biologically male at birth and identifies as male, according to self-report
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anza Mapema Clinic

Kisumu, Kenya

Location

Related Publications (5)

  • 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 Male Youth in Kenya. Adolescents. 2021 Sep;1(3):267-282. doi: 10.3390/adolescents1030020. Epub 2021 Jul 13.

    PMID: 35665057RESULT

  • 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": Social Support Received by Gay, Bisexual, and Other Men Who Have Sex with Men in Western Kenya. Int J Environ Res Public Health. 2022 Feb 1;19(3):1667. doi: 10.3390/ijerph19031667.

    PMID: 35162690RESULT

  • 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 Apr;27(4):1234-1247. doi: 10.1007/s10461-022-03860-w. Epub 2022 Oct 11.

    PMID: 36219270RESULT

  • Graham SM, Wang L, Jadwin-Cakmak L, Odhiambo EO, Bauman K, Okall D, Odero W, Otieno F, Amico KR, Harper GW. Acceptability, Feasibility, and Safety of the Shauriana Intervention for Young Kenyan Gay, Bisexual, and Other Men who Have Sex with Men, and Exploration of Potential Impact on Sexual Health Outcomes. AIDS Behav. 2025 Nov 25. doi: 10.1007/s10461-025-04965-8. Online ahead of print.

    PMID: 41288881DERIVED

  • Jadwin-Cakmak L, Harper GW, Ochieng E, Amico KR, Aloo T, Okutah F, Gumbe E, Olango K, Okall DO, Otieno FO, Odero W, Graham SM. Participatory development of the Shauriana program to integrate sexual health and mental health support for young gay and bisexual men and other men who have sex with men in Kenya. Adv Glob Health. 2025;4(1):2442813. doi: 10.1525/agh.2025.2442813. Epub 2025 Mar 6.

    PMID: 40296878DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Results Point of Contact

Title
Susan M. Graham
Organization
University of Washington
grahamsm@uw.edu
206-351-0414

Study Officials

  • Susan M Graham, MD, MPH, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Laboratory testing for PrEP drug levels will be conducted in a blinded fashion
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Pilot study with 10 intervention participants followed by randomized controlled trial with 60 participants assigned to the intervention or to standard care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Medicine: Global Health

Study Record Dates

First Submitted

August 30, 2020

First Posted

September 16, 2020

Study Start

May 10, 2021

Primary Completion

March 10, 2022

Study Completion

March 10, 2022

Last Updated

March 20, 2025

Results First Posted

September 22, 2023

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After reporting of the trial results
Access Criteria
Data sharing agreement with study investigators

Locations

KE(1)