HIV PreventionNCT04550221

The Shauriana Intervention for GBMSM in Kenya

A study testing Shauriana in people with HIV Prevention, run by University of Washington at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: HIV Prevention
What is being tested?: Shauriana
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteKenya
Study dates: 10 May 2021to 10 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Show all 10Show fewer

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Kenya1 site

Anza Mapema Clinic
Kisumu

Other trials in Kenya

About this study

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

Read the 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.

Conditions: HIV Prevention
Being tested: Shauriana
Keywords: preexposure prophylaxis, sexual health, mental health, behavioral intervention
Medical subject headings: Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ShaurianaBehavioural
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).

Study groups in NCT04550221
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Shauriana

What is being measured

The primary outcome is the main question the study is designed to answer.

Completion of Exit Interview
All intervention arm participants were invited to provide qualitative feedback on intervention acceptability in an exit interview
Measured: Month 6
Intervention Feasibility
Intervention session attendance
Measured: Month 6
Intervention Safety
Adverse events reported by participants
Measured: Month 6

Secondary outcomes (3)

PrEP Uptake
Ongoing PrEP use (yes or no) assessed by ACASI
Measured: Month 1, Month 3, and Month 6
PrEP Adherence
In the last 30 days, how good a job did you do at taking your PrEP daily?
Measured: Month 1, Month 3, and Month 6
PrEP Drug Levels
Tenofovir levels measured in dried blood spots
Measured: Month 3 and Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 202110 Mar 2022

First posted16 Sep 2020
Study start10 May 2021
Primary completion10 Mar 2022
Study completion10 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HIV PreventionStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Outcomes assessor
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04550221
Sponsor's protocol ID: STUDY00009441
Other IDs: R34MH118950
Status last verified: Mar 2025
First submitted: 30 Aug 2020
Last updated: 20 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 35665057
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.
PubMed 35162690
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.
PubMed 36219270
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. 2026 May;30(5):1267-1283. doi: 10.1007/s10461-025-04965-8. Epub 2025 Nov 25.
PubMed 41288881
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.
PubMed 40296878

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04550221
Acronym / sponsor ID: STUDY00009441
Conditions: HIV Prevention
Keywords: preexposure prophylaxis, sexual health, mental health, behavioral intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 10 May 2021 (actual)
Primary completion: 10 Mar 2022 (actual)
Study completion: 10 Mar 2022 (actual)
First posted: 16 Sep 2020 (actual)
Results: Posted 22 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Pilot study with 10 intervention participants followed by randomized controlled trial with 60 participants assigned to the intervention or to standard care.

Arm	Type	Receives
Intervention	Experimental	Behavioral: ShaurianaThe 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.
Standard care	Active comparator	Behavioral: ShaurianaStandard 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.

Who may qualify

Ages: 18 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ShaurianaThe 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).	Behavioural	Intervention, Standard care

Primary outcome

Completion of Exit Interview
Time frame: Month 6
All intervention arm participants were invited to provide qualitative feedback on intervention acceptability in an exit interview
Intervention Feasibility
Time frame: Month 6
Intervention session attendance
Intervention Safety
Time frame: Month 6
Adverse events reported by participants

3 secondary outcomes

PrEP Uptake
Time frame: Month 1, Month 3, and Month 6
PrEP Adherence
Time frame: Month 1, Month 3, and Month 6
PrEP Drug Levels
Time frame: Month 3 and Month 6

Results and safety

Results posted to the registry on 22 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	32	27
Standard Care	31	27

Primary outcome: Completion of Exit Interview

Time frame: Month 6. Count of participants. Unit: Participants

Measure	Intervention n = 28	Standard Care n = 0
Value	28	–

Population analysed: Exit interviews only offered to intervention participants

Primary outcome: Intervention Feasibility

Time frame: Month 6. Count of participants. Unit: Participants

Measure	Intervention n = 29	Standard Care n = 0
Completed all 5 intervention sessions only	11	0
Completed all 5 intervention sessions plus an optional session	18	0

Population analysed: Intervention feasibility was only assessed in the intervention group

Primary outcome: Intervention Safety

Time frame: Month 6. Count of participants. Unit: Participants

Measure	Intervention n = 29	Standard Care n = 31
Adverse events reported	0	0
Adverse events not reported	29	31

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected over 6 months, and focused on potential social harms of this sociobehavioral intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Standard Care	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35665057Harper 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.
Results publication: PubMed 35162690Jadwin-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.
Results publication: PubMed 36219270Graham 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.
Derived from this study: PubMed 41288881Graham 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. 2026 May;30(5):1267-1283. doi: 10.1007/s10461-025-04965-8. Epub 2025 Nov 25.
Derived from this study: PubMed 40296878Jadwin-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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susan M Graham, MD, MPH, PhD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Shauriana in people with HIV Prevention, run by University of Washington at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion of Exit Interview (time frame: Month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04550221, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.