Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R34MH118950 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shauriana | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Uptake | Ongoing PrEP use (yes or no) assessed by ACASI | 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? |
Not provided
Inclusion Criteria:
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:
Biologically male at birth and identifies as male, according to self-report
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan M Graham, MD, MPH, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anza Mapema Clinic | Kisumu | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35665057 | Result | 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. | |
| 35162690 | Result | 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. |
Not provided
Not provided
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.
After reporting of the trial results
Data sharing agreement with study investigators
Not provided
Three individuals who were assigned to the intervention arm were withdrawn from the study after the baseline visit because they moved immediately from the study area or otherwise turned out not to be available for study and/or intervention visits.
Screening and enrollment took lace between May 10 and September 8 2021 at the Anza Mapema Clinic in Kisumu, Kenya. Overall, 71 individuals were screened, of whom 11 were not eligible. Sixty-three individuals were enrolled and completed a baseline visit.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis excludes the 3 intervention participants who were withdrawn immediately after the baseline visit.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Completion of Exit Interview | All intervention arm participants were invited to provide qualitative feedback on intervention acceptability in an exit interview | Exit interviews only offered to intervention participants | Posted | Count of Participants | Participants | Month 6 |
|
Adverse event data were collected over 6 months, and focused on potential social harms of this sociobehavioral intervention.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan M. Graham | University of Washington | 206-351-0414 | grahamsm@uw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 2, 2021 | Jul 24, 2023 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
Not provided
Not provided
Pilot study with 10 intervention participants followed by randomized controlled trial with 60 participants assigned to the intervention or to standard care.
Not provided
Not provided
Laboratory testing for PrEP drug levels will be conducted in a blinded fashion
|
| Month 1, Month 3, and Month 6 |
| PrEP Drug Levels | Tenofovir levels measured in dried blood spots | Month 3 and Month 6 |
| 36219270 | Result | 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. |
| 41288881 | Derived | 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. |
| 40296878 | Derived | 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. |
| Moved from the study area after receiving the intervention |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ever married to a female | Count of Participants | Participants |
|
| Education | Highest level of education attained | Count of Participants | Participants |
|
| Sex of partners in past 3 months | Count of Participants | Participants |
|
| Condom use last sex | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Primary | Intervention Feasibility | Intervention session attendance | Intervention feasibility was only assessed in the intervention group | Posted | Count of Participants | Participants | Month 6 |
|
|
|
| Primary | Intervention Safety | Adverse events reported by participants | Posted | Count of Participants | Participants | Month 6 |
|
|
|
| Secondary | PrEP Uptake | Ongoing PrEP use (yes or no) assessed by ACASI | Posted | Count of Participants | Participants | Month 1, Month 3, and Month 6 |
|
|
|
| Secondary | PrEP Adherence | In the last 30 days, how good a job did you do at taking your PrEP daily? | Posted | Count of Participants | Participants | Month 1, Month 3, and Month 6 |
|
|
|
| Secondary | PrEP Drug Levels | Tenofovir levels measured in dried blood spots | Posted | Count of Participants | Participants | Month 3 and Month 6 |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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. | 0 | 31 | 0 | 31 | 0 | 31 |
Not provided
Not provided
| Missed visit or missing data |
|
| Month 3 |
|
| Month 6 |
|
| Good |
|
| Very good |
|
| Excellent |
|
| Missing or not taking PrEP |
|
| Month 3 |
|
| Month 6 |
|
| Missing |
|
| Month 6 |
|