Efficacy Testing of a Multi-Level Family Planning Intervention

Recruiting now · Phase 2/Phase 3

Conditions studied: Unintended Pregnancy, Family Planning

In brief

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.

Key facts

Study ID

NCT06923189

Run by

Boston College

People needed

1464

Starts

2025-06-12

Expected to finish

2028-12-31

Last updated by the study team

2026-03-23

Who can join

Age: 15 and older, up to 54. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Makerere School of Public Health — Kampala, Uganda (enrolling)

Full record on ClinicalTrials.gov

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