Sexually Transmitted Infection (STI)Vijana ShambaNCT06953310
Assessing the Effects of a Multisectoral Agricultural Intervention on the Reproductive and Sexual Health of Adolescent Girls and Young Women
A study of Sexually Transmitted Infection (STI) and HIV, run by University of California, San Francisco at 1 site in Kenya.
Trial summary
In Kenya, HIV incidence among adolescent girls and young women (AGYW) ages 15-24 years is 1-2 per 100 person-years and approximately 30% of AGYW have had at least one sexually transmitted infection (STI). Kisumu and Migori counties in Western Kenya have some of the highest HIV/STI incidence in the country. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infection (STI), HIV, Food Insecurity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteKenya
- Study dates
- 20 May 2025to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adolescent Girls and Young women (AGYW):
- AGYW assigned female at birth
- Between 15-19 years of age at enrollment
- Attending the selected schools with at least 18 months remaining of schooling
- STI-uninfected and not pregnant at baseline
- Has an adult caregiver willing to participate
Show all 12Show fewer
- Demonstrates moderate to severe FI based on the Household Food Insecurity Access Scale (HFIAS), and/or malnutrition (BMI less than two standard deviations below the mean for age-specific BMI
- Caregiver:
- At least 18 years old.
- At least 1 AGYW aged 15-19 years old attending the selected schools
- household has access to farming land
- household has available surface water in the form of lakes, rivers, ponds, or shallow wells (home is 200m from permanent water source)
Who cannot join
- AGYW or adult caregivers who have inadequate cognitive and/or hearing capacity to complete planned study procedures
- AGYW or adult caregivers who do not speak Dholuo, Kiswahili, or English
- Married AGYW and those who serve as heads of households
- AGYW who are pregnant at screening
- Adolescent girls who test positive for gonorrhea or chlamydia at screening will be invited to re-screen at least 14 days after receiving treatment and will be eligible to enroll if they have a confirmatory negative STI test.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
Kenya Medical Research Institute (KEMRI)
Kisumu
Maricianah Onono, MBChB, MS, PhD, +254732390992, maricianah@gmail.com
Elly Weke, MS, 254718441874, otielly@yahoo.com
About this study
In Kenya, HIV incidence among adolescent girls and young women (AGYW) ages 15-24 years is 1-2 per 100 person-years and approximately 30% of AGYW have had at least one sexually transmitted infection (STI). Kisumu and Migori counties in Western Kenya have some of the highest HIV/STI incidence in the country. Food insecurity (FI) and poverty are also highly prevalent in Western Kenya. FI and poverty are important drivers of vulnerability to HIV and STIs among AGYW. Poverty alleviation interventions have the potential to reduce STIs and HIV risk among AGYW but, to date, these interventions have reported mixed findings on HIV/STI outcomes, have been primarily targeted at the individual level, and none have focused on agriculture or FI. Therefore, there remains a critical need to develop sustainable, multi-level, economic and FI interventions that improve AGYW STI/HIV prevention outcomes. Our team has successfully developed a household-level agricultural intervention in Western Kenya called Shamba Maisha ("farm life" in Kiswahili; SM) to reduce household FI. In our prior pilot study with AGYW, the investigators found that SM was feasible, acceptable, and associated with less FI and improved mental health. In this proposal, the investigators will build upon our promising SM work by examining the effectiveness and implementation of our SM intervention, including provision of a water pump and agricultural implements for use at home, training in agriculture delivered at school-based demonstration farms, and adolescent-caregiver relationship strengthening training. The investigators plan to conduct this school- and home-based cluster randomized trial with 800 AGYW and their primary caregivers recruited from schools in Kisumu and Migori counties. The investigators will randomize 20 schools in Kisumu and Migori in a 1:1 ratio to intervention or control conditions and follow AGYW-caregiver dyads for 18 months with surveys and STI/pregnancy testing to assess intervention impacts. The study has the following aims: Aim 1. Determine the impact of SM on adolescent HIV prevention and sexual and reproductive health outcomes (primary outcome is gonorrhea and/or chlamydia incidence). Aim 2. Assess the effect of SM on intermediate outcomes theorized from our published conceptual framework to be on the causal pathway, including household food security and wealth, and adolescent and caregiver factors including mental health and aspects of the caregiver-AGYW relationship dyad (e.g., communication). Aim 3. Identify critical implementation facilitators and barriers influencing SM effectiveness and delivery and conduct a programmatic cost assessment. The investigators will also evaluate the extent to which SM can have "spillover" nutritional benefits for a larger population of adolescents who had access to demonstration farms at intervention schools but did not receive other aspects of the intervention. The ultimate goal is to provide an innovative household-level intervention to halt the cycle of FI, and poor HIV-related outcomes among vulnerable populations including AGYW, consistent with the "Ending the HIV Epidemic".
- Being tested
- Shamba Maisha
- Keywords
- multisectoral agriculture intervention, sexual and reproductive health, Kenya, adolescent girls and young women, HIV, food insecurity, Shamba Maisha
- Medical subject headings
- Sexually Transmitted Diseases, Psychological Well-Being, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shamba MaishaOther
The Shamba Maisha Intervention intervention has three key parts:
Farming Equipment and Training: The study will provide families with water pumps, seeds, and other farming tools to improve their ability to grow food. Caregivers and girls will also get training on how to use these tools.
School-based Farming: Girls will participate in practical farming activities at school, where they can learn and practice the farming skills. This also benefits the entire school because the crops grown can be used to provide food for students.
Caregiver and Adolescent Relationship Strengthening: Families will take part in special sessions where they will learn how to improve their communication, reduce stress, and talk about important topics like sexual health.
| Study group | Role | What they receive |
|---|---|---|
| Shamba Maisha Intervention | Experimental | The Shamba Maisha Intervention inervention has three key parts:
1. Farming Equipment and Training: The study provide families with water pumps, seeds, and other farming tools to improve their ability to grow food. Caregivers and girls will also get training on how to use these tools.
2. School-based Farming: Girls will participate in practical farming activities at school, where they can learn and practice the farming skills. This also benefits the entire school because the crops grown can be used to provide food for students.
3. Caregiver and Adolescent Relationship Strengthening: Families will take part in special sessions where they will learn how to improve their communication, reduce stress, and talk about important topics like sexual health. Receives: Other: Shamba Maisha |
| Control Arm | No intervention | Control participants and schools randomized to the control condition will have the opportunity to receive the full intervention at the conclusion of data collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
STI Incidence (gonorrhea and/or chlamydia incidence)
Biologic samples
Measured: 0, 6, 12, and 18 months
Food insecurity - Household Food Insecurity Access Scale (HFIAS).
Household Food Insecurity Access Scale (HFIAS). Scores ranges from 0-27, with higher scores indicating higher food insecurity.
Measured: 0, 6, 12, 18 months
Depression among adolescents - Patient Health Questionnaire - 9 (PHQ-9)
Patient Health Questionnaire - 9 (PHQ-9) among adolescents. Scores range from 0 - 27, with higher scores indicating more severe depression.
Measured: 0, 6, 12, and 18 months
Secondary outcomes (9)
Body Mass Index (BMI) among adolescents
Body Mass Index (BMI) among adolescents
Measured: 0, 6, 12, 18 months
Depression among caregivers - Patient Health Questionnaire - 9 (PHQ-9)
Patient Health Questionnaire - 9 (PHQ-9) among caregivers. Scores range from 0 - 27, with higher scores indicating more severe depression.
Measured: 0, 6, 12, 18 months
Anxiety among adolescents - General Anxiety Disorder-7 (GAD-7)
General Anxiety Disorder-7 (GAD-7) among adolescents. Scores range from 0 - 21, with higher scores indicating more severe anxiety.
Measured: 0, 6, 12, 18 months
Pregnancy rate among adolescents
Pregnancy rate among adolescents
Measured: 0, 6, 12, 18 months
Percent of sexually active adolescents who self-report condom use
Percent of sexually active adolescents who self-report condom use
Measured: 0, 6, 12, 18 months
WHO Domestic Violence Module - Intimate Partner Violence among adolescents
WHO Domestic Violence Module. Includes physical violence, sexual violence, and emotional abuse. Scores range from 0 to 52 with higher scores indicating more violence.
Measured: 0, 6, 12, 18 months
Parent-child communication
Parent-child communication: Families Matter! Program Tool
Measured: 0, 6, 12, 18 months
Empowerment (Self-esteem) among adolescents - Rosenberg Self-Esteem Scale (RSES)
The Rosenberg Self-Esteem Scale (RSES). The scale ranges from 0-30, with higher scores indicating higher self-esteem.
Measured: 0, 6, 12, 18 months
Educational attainment among adolescents
Self-Reported School attendance
Measured: 0, 6, 12, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start20 May 2025
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted Infection (STI)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sheri Weiser, MD, MPH, Principal investigator, University of California, San FranciscoJennifer Velloza, PhD, MPH, Principal investigator, University of Washington (UW)Maricianah Onono, MBChB, MS, PhD, Principal investigator, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953310
- Sponsor's protocol ID
- 1R01MH138256
- Other IDs
- R01MH138256
- Acronym
- Vijana Shamba
- Status last verified
- Oct 2026
- First submitted
- 17 Apr 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share individual participant data (IPD) in The National Institute of Mental Health Data Archive (NDA) and the SAP and source code will be available in a GitHub repository.
Publications
Cohen CR, Weke E, Frongillo EA, Sheira LA, Burger R, Mocello AR, Wekesa P, Fisher M, Scow K, Thirumurthy H, Dworkin SL, Shade SB, Butler LM, Bukusi EA, Weiser SD. Effect of a Multisectoral Agricultural Intervention on HIV Health Outcomes Among Adults in Kenya: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2246158. doi: 10.1001/jamanetworkopen.2022.46158.
PubMed 36508217Onono MA, Sheira L, Frongilio EA, Odhiambo G, Wekesa P, Conroy A, Bukusi EA, Cohen CR, Weiser SD. Effect of improving food security on parenting practices and caregiver-adolescent relationships: qualitative findings of an income-generating agricultural intervention in rural Kenya. BJPsych Open. 2024 Dec 26;11(1):e10. doi: 10.1192/bjo.2024.802.
PubMed 39721953Onono MA, Frongillo EA, Sheira LA, Odhiambo G, Wekesa P, Conroy AA, Cohen CR, Bukusi EA, Weiser SD. Links between Household-Level Income-Generating Agricultural Intervention and the Psychological Well-Being of Adolescent Girls in Human Immunodeficiency Virus-Affected Households in Southwestern Kenya: A Qualitative Inquiry. J Nutr. 2023 Dec;153(12):3595-3603. doi: 10.1016/j.tjnut.2023.10.008. Epub 2023 Oct 18.
PubMed 37863268Onono MA, Odhiambo G, Sheira L, Conroy A, Neilands TB, Bukusi EA, Weiser SD. The role of food security in increasing adolescent girls' agency towards sexual risk taking: qualitative findings from an income generating agricultural intervention in southwestern Kenya. BMC Public Health. 2021 Nov 6;21(1):2028. doi: 10.1186/s12889-021-12051-6.
PubMed 34742285
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of a Multisectoral Agricultural Intervention on the Reproductive and Sexual Health of Adolescent Girls and Young Women
- ClinicalTrials.gov ID
- NCT06953310
- Acronym / sponsor ID
- Vijana Shamba / 1R01MH138256
- Keywords
- multisectoral agriculture intervention, sexual and reproductive health, Kenya, adolescent girls and young women, HIV, food insecurity, Shamba Maisha
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, National Institute of Mental Health (NIMH)
- Study start
- 20 May 2025 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Kenya, HIV incidence among adolescent girls and young women (AGYW) ages 15-24 years is 1-2 per 100 person-years and approximately 30% of AGYW have had at least one sexually transmitted infection (STI). Kisumu and Migori counties in Western Kenya have some of the highest HIV/STI incidence in the country. Food insecurity (FI) and poverty are also highly prevalent in Western Kenya. FI and poverty are important drivers of vulnerability to HIV and STIs among AGYW. Poverty alleviation interventions have the potential to reduce STIs and HIV risk among AGYW but, to date, these interventions have reported mixed findings on HIV/STI outcomes, have been primarily targeted at the individual level, and none have focused on agriculture or FI. Therefore, there remains a critical need to develop sustainable, multi-level, economic and FI interventions that improve AGYW STI/HIV prevention outcomes. Our team has successfully developed a household-level agricultural intervention in Western Kenya called Shamba Maisha ("farm life" in Kiswahili; SM) to reduce household FI. In our prior pilot study with AGYW, the investigators found that SM was feasible, acceptable, and associated with less FI and improved mental health. In this proposal, the investigators will build upon our promising SM work by examining the effectiveness and implementation of our SM intervention, including provision of a water pump and agricultural implements for use at home, training in agriculture delivered at school-based demonstration farms, and adolescent-caregiver relationship strengthening training. The investigators plan to conduct this school- and home-based cluster randomized trial with 800 AGYW and their primary caregivers recruited from schools in Kisumu and Migori counties. The investigators will randomize 20 schools in Kisumu and Migori in a 1:1 ratio to intervention or control conditions and follow AGYW-caregiver dyads for 18 months with surveys and STI/pregnancy testing to assess intervention impacts. The study has the following aims: Aim 1. Determine the impact of SM on adolescent HIV prevention and sexual and reproductive health outcomes (primary outcome is gonorrhea and/or chlamydia incidence). Aim 2. Assess the effect of SM on intermediate outcomes theorized from our published conceptual framework to be on the causal pathway, including household food security and wealth, and adolescent and caregiver factors including mental health and aspects of the caregiver-AGYW relationship dyad (e.g., communication). Aim 3. Identify critical implementation facilitators and barriers influencing SM effectiveness and delivery and conduct a programmatic cost assessment. The investigators will also evaluate the extent to which SM can have "spillover" nutritional benefits for a larger population of adolescents who had access to demonstration farms at intervention schools but did not receive other aspects of the intervention. The ultimate goal is to provide an innovative household-level intervention to halt the cycle of FI, and poor HIV-related outcomes among vulnerable populations including AGYW, consistent with the "Ending the HIV Epidemic".
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shamba Maisha Intervention | Experimental | Other: Shamba MaishaThe Shamba Maisha Intervention inervention has three key parts: 1. Farming Equipment and Training: The study provide families with water pumps, seeds, and other farming tools to improve their ability to grow food. Caregivers and girls will also get training on how to use these tools. 2. School-based Farming: Girls will participate in practical farming activities at school, where they can learn and practice the farming skills. This also benefits the entire school because the crops grown can be used to provide food for students. 3. Caregiver and Adolescent Relationship Strengthening: Families will take part in special sessions where they will learn how to improve their communication, reduce stress, and talk about important topics like sexual health. |
| Control Arm | No intervention | –Control participants and schools randomized to the control condition will have the opportunity to receive the full intervention at the conclusion of data collection. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- AGYW assigned female at birth
- Between 15-19 years of age at enrollment
- Attending the selected schools with at least 18 months remaining of schooling
- STI-uninfected and not pregnant at baseline
- Has an adult caregiver willing to participate
Key exclusion criteria (5 listed)
- AGYW or adult caregivers who have inadequate cognitive and/or hearing capacity to complete planned study procedures
- AGYW or adult caregivers who do not speak Dholuo, Kiswahili, or English
- Married AGYW and those who serve as heads of households
- AGYW who are pregnant at screening
- Adolescent girls who test positive for gonorrhea or chlamydia at screening will be invited to re-screen at least 14 days after receiving treatment and will be eligible to enroll if they have a confirmatory negative STI test.
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 |
|---|---|---|
| Shamba MaishaThe Shamba Maisha Intervention intervention has three key parts: Farming Equipment and Training: The study will provide families with water pumps, seeds, and other farming tools to improve their ability to grow food. Caregivers and girls will also get training on how to use these tools. School-based Farming: Girls will participate in practical farming activities at school, where they can learn and practice the farming skills. This also benefits the entire school because the crops grown can be used to provide food for students. Caregiver and Adolescent Relationship Strengthening: Families will take part in special sessions where they will learn how to improve their communication, reduce stress, and talk about important topics like sexual health. | Other | Shamba Maisha Intervention |
Primary outcome
STI Incidence (gonorrhea and/or chlamydia incidence)
Time frame: 0, 6, 12, and 18 months
Biologic samples
Food insecurity - Household Food Insecurity Access Scale (HFIAS).
Time frame: 0, 6, 12, 18 months
Household Food Insecurity Access Scale (HFIAS). Scores ranges from 0-27, with higher scores indicating higher food insecurity.
Depression among adolescents - Patient Health Questionnaire - 9 (PHQ-9)
Time frame: 0, 6, 12, and 18 months
Patient Health Questionnaire - 9 (PHQ-9) among adolescents. Scores range from 0 - 27, with higher scores indicating more severe depression.
9 secondary outcomes
Body Mass Index (BMI) among adolescents
Time frame: 0, 6, 12, 18 months
Depression among caregivers - Patient Health Questionnaire - 9 (PHQ-9)
Time frame: 0, 6, 12, 18 months
Anxiety among adolescents - General Anxiety Disorder-7 (GAD-7)
Time frame: 0, 6, 12, 18 months
Pregnancy rate among adolescents
Time frame: 0, 6, 12, 18 months
Percent of sexually active adolescents who self-report condom use
Time frame: 0, 6, 12, 18 months
WHO Domestic Violence Module - Intimate Partner Violence among adolescents
Time frame: 0, 6, 12, 18 months
Parent-child communication
Time frame: 0, 6, 12, 18 months
Empowerment (Self-esteem) among adolescents - Rosenberg Self-Esteem Scale (RSES)
Time frame: 0, 6, 12, 18 months
Educational attainment among adolescents
Time frame: 0, 6, 12, 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 36508217Cohen CR, Weke E, Frongillo EA, Sheira LA, Burger R, Mocello AR, Wekesa P, Fisher M, Scow K, Thirumurthy H, Dworkin SL, Shade SB, Butler LM, Bukusi EA, Weiser SD. Effect of a Multisectoral Agricultural Intervention on HIV Health Outcomes Among Adults in Kenya: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2246158. doi: 10.1001/jamanetworkopen.2022.46158.
- Background: PubMed 39721953Onono MA, Sheira L, Frongilio EA, Odhiambo G, Wekesa P, Conroy A, Bukusi EA, Cohen CR, Weiser SD. Effect of improving food security on parenting practices and caregiver-adolescent relationships: qualitative findings of an income-generating agricultural intervention in rural Kenya. BJPsych Open. 2024 Dec 26;11(1):e10. doi: 10.1192/bjo.2024.802.
- Background: PubMed 37863268Onono MA, Frongillo EA, Sheira LA, Odhiambo G, Wekesa P, Conroy AA, Cohen CR, Bukusi EA, Weiser SD. Links between Household-Level Income-Generating Agricultural Intervention and the Psychological Well-Being of Adolescent Girls in Human Immunodeficiency Virus-Affected Households in Southwestern Kenya: A Qualitative Inquiry. J Nutr. 2023 Dec;153(12):3595-3603. doi: 10.1016/j.tjnut.2023.10.008. Epub 2023 Oct 18.
- Background: PubMed 34742285Onono MA, Odhiambo G, Sheira L, Conroy A, Neilands TB, Bukusi EA, Weiser SD. The role of food security in increasing adolescent girls' agency towards sexual risk taking: qualitative findings from an income generating agricultural intervention in southwestern Kenya. BMC Public Health. 2021 Nov 6;21(1):2028. doi: 10.1186/s12889-021-12051-6.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The investigators will share individual participant data (IPD) in The National Institute of Mental Health Data Archive (NDA) and the SAP and source code will be available in a GitHub repository.
Related trials for Sexually Transmitted Infection (STI)
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
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.
Sheri Weiser, MD, MPH principal investigator
University of California, San Francisco
Jennifer Velloza, PhD, MPH principal investigator
University of Washington (UW)
Maricianah Onono, MBChB, MS, PhD principal investigator
Kenya Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Sexually Transmitted Infection (STI) and HIV, run by University of California, San Francisco 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 12 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel L Burger, MHS (415-535-2650, rachel.burger@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STI Incidence (gonorrhea and/or chlamydia incidence) (time frame: 0, 6, 12, and 18 months). 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 NCT06953310, which also lists 4 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 8 Oct 2026.