Status:
RECRUITING
Efficacy Testing of a Multi-Level Family Planning Intervention
Lead Sponsor:
Boston College
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
San Diego State University
Conditions:
Unintended Pregnancy
Family Planning
Eligibility:
All Genders
15-54 years
Phase:
PHASE2
PHASE3
Brief Summary
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...
Detailed Description
In 2022, 29.7% of married women of reproductive age had an unmet need for family planning in Uganda, meaning they wanted to avoid pregnancy but were not using a modern contraceptive method. Filling th...
Eligibility Criteria
Inclusion
- Women aged 18 (or emancipated minors - those 15-17 who are married and/or have children) to 49 and men aged 18 (or emancipated minors age 15-17) to 54. The upper age limits follow those used by the Demographic and Health Surveys (DHS) to define "reproductive age."
- Married or considers themselves married and living together most of the time
- Residing in communities selected for study inclusion
- Luganda speaking
- Sexually active with spouse within the past 3 months or planning to resume sex within the next 3 months if the woman is within 2 months postpartum
- Not currently pregnant (confirmed via pregnancy test); can be eligible to enroll later once postpartum
- The woman has an unmet need for family planning, i.e., the woman reports not wanting to become pregnant within the next 2 years but is not using any effective methods (IUD, injection, oral pill, implant, vasectomy, tubal ligation, condoms 90% of the time or more) or is using only lower-efficacy methods (condoms less than 90% of the time, lactational amenorrhea, fertility-awareness based methods e.g., counting method, withdrawal).
Exclusion
- At least one person in the couple does not expect to be available for all sessions
- The woman or man is not able to reproduce due to a known medical reason (e.g., hysterectomy, as told by a doctor) or last period greater than 6 months for women that are not postpartum.
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
1464 Patients enrolled
Trial Details
Trial ID
NCT06923189
Start Date
May 15 2025
End Date
December 31 2028
Last Update
October 2 2025
Active Locations (1)
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1
Makerere School of Public Health
Kampala, Uganda