NCT07043647 An Agricultural Livelihood Intervention for Pregnant Women
| NCT ID | NCT07043647 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Food Insecurity |
| Study Type | INTERVENTIONAL |
| Enrollment | 410 participants |
| Start Date | 2025-09-05 |
| Primary Completion | 2029-02-19 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 410 participants in total. It began in 2025-09-05 with a primary completion date of 2029-02-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Scarcity of food is a leading cause of sickness and death in mothers and their newborns in sub-Saharan Africa. Use of locally acceptable agricultural interventions including provision of agricultural supplies, training and having model farms can go a long way to alleviate the ills of food scarcity among mothers and children in our region. This study is designed to learn whether an agricultural intervention might prevent food scarcity and illness among mothers and children. A total of 410 pregnant women will be enrolled from 9- 20 weeks of pregnancy, half living with HIV. Women will be randomly assigned to receive the intervention right away or to receive the intervention after the study is over if they are interested. Follow-up on enrolled participants will happen at a specified period of time, up to 12 months postpartum. The central hypothesis is that by empowering pregnant women with skills and commodities for sustainable farming, the intervention will lead to better maternal and infant health compared to control participants. The study intervention includes the provision of agricultural commodities (including irrigation pumps seeds, and other supplies) training on agriculture and business, and a demonstration farm where all trainings will be held and where women can harvest vegetables to bring home. The study aims to explore the impact of the intervention on health outcomes as well as socioeconomic and behavioral factors among the study population. This research will significantly advance scientific understanding of the importance of such agricultural interventions for pregnant women and their infants in the first year of life.
Eligibility Criteria
Inclusion Criteria: * Pregnant and 9-20 weeks gestation confirmed by ultrasound * singleton pregnancy * Age ≥16 years * moderate-severe household food insecurity or malnutrition (mid-upper arm circumference (MUAC) \<23 cm) * Access to land and permanent surface water * self-reported experience with farming Exclusion Criteria: * Advanced HIV disease * Unable to provide written informed consent (use of an impartial witness is satisfactory if illiterate) * Plans to relocate outside the study area within 18 months
Contact & Investigator
Craig R Cohen, MD MPH
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07043647 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Food Insecurity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07043647 currently recruiting?
Yes, NCT07043647 is actively recruiting participants. Contact the research team at rachel.burger@ucsf.edu for enrollment information.
Where is the NCT07043647 trial being conducted?
This trial is being conducted at Nairobi, Kenya.
Who is sponsoring the NCT07043647 clinical trial?
NCT07043647 is sponsored by University of California, San Francisco. The principal investigator is Craig R Cohen, MD MPH at University of California, San Francisco. The trial plans to enroll 410 participants.