[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589353":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":33,"locations":42,"responsibleParty":64,"collaborators":66,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":18,"enrollmentInfo":81,"targetDuration":18,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":45,"whyStopped":18,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Shamba Maisha Intervention","EXPERIMENTAL","The Shamba Maisha Intervention inervention has three key parts:\n\n1. 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.\n2. 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.\n3. 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.",[13],"Other: Shamba Maisha",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Shamba Maisha","The Shamba Maisha Intervention intervention has three key parts:\n\nFarming 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.\n\nSchool-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.\n\nCaregiver 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.",[9],[25,28,30],{"name":26,"affiliation":5,"role":27},"Sheri Weiser, MD, MPH","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":5,"role":27},"Jennifer Velloza, PhD, MPH",{"name":31,"affiliation":32,"role":27},"Maricianah Onono, MBChB, MS, PhD","Kenya Medical Research Institute",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":18,"email":38},"Rachel L Burger, MHS","CONTACT","415-535-2650","rachel.burger@ucsf.edu",{"name":29,"role":36,"phone":40,"phoneExt":18,"email":41},"917-392-3561","jennifer.velloza@ucsf.edu",[43],{"facility":44,"status":45,"city":46,"state":18,"zip":18,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Kenya Medical Research Institute (KEMRI)","RECRUITING","Kisumu","Kenya","KE",{"type":50,"coordinates":51},"Point",[52,53],34.76171,-0.10221,{"lat":53,"lon":52},[56,59,63],{"name":31,"role":36,"phone":57,"phoneExt":18,"email":58},"+254732390992","maricianah@gmail.com",{"name":60,"role":36,"phone":61,"phoneExt":18,"email":62},"Elly Weke, MS","254718441874","otielly@yahoo.com",{"name":31,"role":27,"phone":18,"phoneExt":18,"email":18},{"type":65,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[67,68],{"name":32,"class":6},{"name":69,"class":70},"National Institute of Mental Health (NIMH)","NIH","100589353","assessing-the-effects-of-a-multisectoral-agricultural-intervention-on-the-reproductive-and-sexual-health-of-adolescent-girls-and-young-women-100589353",false,"NCT06953310","Assessing the Effects of a Multisectoral Agricultural Intervention on the Reproductive and Sexual Health of Adolescent Girls and Young Women","Vijana Shamba","Inclusion Criteria:\n\nAdolescent Girls and Young women (AGYW):\n\n* AGYW assigned female at birth\n* Between 15-19 years of age at enrollment\n* Attending the selected schools with at least 18 months remaining of schooling\n* STI-uninfected and not pregnant at baseline\n* Has an adult caregiver willing to participate\n* Demonstrates moderate to severe FI based on the Household Food Insecurity Access Scale (HFIAS), and\u002For malnutrition (BMI less than two standard deviations below the mean for age-specific BMI\n\nCaregiver:\n\n* At least 18 years old.\n* At least 1 AGYW aged 15-19 years old attending the selected schools\n* household has access to farming land\n* household has available surface water in the form of lakes, rivers, ponds, or shallow wells (home is 200m from permanent water source)\n\nExclusion Criteria:\n\n* AGYW or adult caregivers who have inadequate cognitive and\u002For hearing capacity to complete planned study procedures\n* AGYW or adult caregivers who do not speak Dholuo, Kiswahili, or English\n* Married AGYW and those who serve as heads of households\n* AGYW who are pregnant at screening\n\nAdolescent 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.",true,"ALL","15 Years",{"count":82,"type":83},900,"ESTIMATED","INTERVENTIONAL",[86],"NA","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\u002FSTI 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\u002FSTI 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\u002FHIV 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\u002Fpregnancy 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\u002For 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\".",[89,90,91,92],"Sexually Transmitted Infection (STI)","HIV","Food Insecurity","Mental Health",[94,95,47,96,90,97,21],"multisectoral agriculture intervention","sexual and reproductive health","adolescent girls and young women","food insecurity","2026-04-06",{"date":100,"type":101},"2026-04-13","ACTUAL",{"date":103,"type":101},"2025-05-20",{"date":105,"type":83},"2028-05-30",{"name":5,"class":6},1]