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Efficacy Testing of a Multi-Level Family Planning Intervention

StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Start date: May 15, 2025 to Jun 12, 2025v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  3. Study description revisedv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this cluster randomized controlled trial is to learn if the multi-level, community-based family planning intervention, known as the Family Health=Family Wealth (FH=FW) program, can improve family planning outcomes in couples of reproductive age in Uganda. The main questions it aims to answer are: 1. Does FH=FW participation reduce unintended pregnancy and increase contraceptive uptake among couples who say they want to delay pregnancy over 24-months? 2. Does FH=FW participation reduce discontinuation of contraceptive methods for those who adopt them over 24-months? 3. What factors affect the implementation of the FH=FW intervention? Researchers will compare change in the above outcomes in couples receiving the FH=FW intervention to those who instead receive a water, sanitation, and hygiene intervention. Couples in the FH=FW arm will be asked to attend 6 groups sessions where they learn about family planning's benefits to their health and well-being alongside content to increase their shared spousal decision-making and communication skills, their access to family planning services, and their perceptions of community acceptance of family planning.
Trial Details
NCT Number NCT06923189
Lead Sponsor Boston College
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), San Diego State University, Yale University, University of North Carolina, Chapel Hill, Makerere University
Conditions
(from sponsor)		 Unintended Pregnancy, Family Planning
Enrollment 1,464 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov