Kenya Medical Research Institute (KEMRI)
Kisumu, Kenya
Location status: Recruiting
Location contact
Elly Weke, MS
CONTACT
Maricianah Onono, MBChB, MS, PhD
CONTACT
Maricianah Onono, MBChB, MS, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06953310
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".
Interested in participating?
Request Info15 year and older
All sexes
Interventional
Not applicable
Kisumu, Kenya
Location status: Recruiting
Elly Weke, MS
CONTACT
Maricianah Onono, MBChB, MS, PhD
CONTACT
Maricianah Onono, MBChB, MS, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adolescent Girls and Young women (AGYW):
Caregiver:
Exclusion criteria
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.
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.
Time frame: 0, 6, 12, and 18 months
Biologic samples
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.
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.
Time frame: 0, 6, 12, 18 months
Body Mass Index (BMI) among adolescents
Time frame: 0, 6, 12, 18 months
Patient Health Questionnaire - 9 (PHQ-9) among caregivers. Scores range from 0 - 27, with higher scores indicating more severe depression.
Time frame: 0, 6, 12, 18 months
General Anxiety Disorder-7 (GAD-7) among adolescents. Scores range from 0 - 21, with higher scores indicating more severe anxiety.
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. Includes physical violence, sexual violence, and emotional abuse. Scores range from 0 to 52 with higher scores indicating more violence.
Time frame: 0, 6, 12, 18 months
Parent-child communication: Families Matter! Program Tool
Time frame: 0, 6, 12, 18 months
The Rosenberg Self-Esteem Scale (RSES). The scale ranges from 0-30, with higher scores indicating higher self-esteem.
Time frame: 0, 6, 12, 18 months
Self-Reported School attendance
Contact information is provided by the study sponsor or research team.
Jennifer Velloza, PhD, MPH
CONTACT
Rachel L Burger, MHS
CONTACT
University of California, San Francisco
Other
Acronym: Vijana Shamba
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07089836
Bacterial Infections, Bacterial Infections and Mycoses
Lancaster, California, United States
View Trial DetailsNCT06793605
Behavior, Communicable Diseases
Hong Kong
View Trial DetailsNCT06014177
Bacterial Infections, Bacterial Infections and Mycoses
New York, United States
View Trial DetailsNCT03109431
Behavior, Chemically-Induced Disorders
Los Angeles, California, United States
View Trial Details