Testing a multi-level family planning program called Family Health = Family Wealth
Efficacy Testing of a Multi-Level Family Planning Intervention to Increase Contraceptive Use and Reduce Unintended Pregnancy in Low Resource Settings
This trial tests whether a community-based program can help couples in Uganda who want to delay pregnancy start and keep using effective contraception over 24 months.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1464 (estimated) |
| Ages | 15 Years to 54 Years |
| Sex | All |
| Sponsor | Boston College Academic / other |
| Locations | 1 site (Kampala) |
| Trial ID | NCT06923189 on ClinicalTrials.gov |
What this trial studies
This is a cluster randomized trial comparing a multi-level, community-based family planning program (FH=FW) to a water, sanitation, and hygiene (WASH) intervention among couples in selected Ugandan communities. The FH=FW arm receives six group sessions of transformative community dialogues plus links to facility-based family planning and health system strengthening activities, while control communities receive the WASH intervention. Primary outcomes include unintended pregnancy, contraceptive uptake, and contraceptive discontinuation measured over 24 months, with parallel assessment of implementation factors. Clusters (communities) are randomized, and couples are followed longitudinally to measure behavioral and service-use changes.
Who should consider this trial
Good fit: Ideal participants are married or cohabiting Luganda-speaking couples living in the selected Ugandan communities where the woman is of reproductive age (15–49 if emancipated minor or 18–49 otherwise) and currently has an unmet need for family planning and is not pregnant.
Not a fit: People already using effective contraception consistently, those who are currently pregnant, not living together as a couple, who do not speak Luganda, or who live outside the selected communities are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the program could reduce unintended pregnancies and increase sustained use of modern contraceptives among participating couples.
How similar studies have performed: Previous community- and couples-based family planning interventions have shown mixed but promising effects on contraceptive uptake and attitudes, though large-scale cluster randomized evidence with 24-month follow-up remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Kampala
- Makerere School of Public Health — Kampala, Uganda (Recruiting)
Study contacts
- Study coordinator: Katelyn M Sileo, PhD, MPH
- Email: sileoka@bc.edu
- Phone: 860-977-8447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.