Efficacy Testing of a Multi-Level Family Planning Intervention
Efficacy Testing of a Multi-Level Family Planning Intervention to Increase Contraceptive Use and Reduce Unintended Pregnancy in Low Resource Settings
Boston College
1,464 participants
Jun 12, 2025
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria7
- 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 Criteria2
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
This multilevel intervention is comprised of community dialogues, or facilitated discussions, aimed to reshape community norms around gender roles, equity, and family size, and critically analyze the social and community influences of "family-wealth" and poverty with the overall goal of reconstructing individual attitudes and group norms on paths to/definitions of a "successful family" inclusive of family planning. Dialogues are enhanced to address knowledge, motivation, self-efficacy, and relationship dynamics, tailored to men and women. Sessions include both gender segregated and integrated groups with couples in the community. The intervention is paired with health system strengthening elements implemented with the intervention health clinics (provider training, strengthening skip the queue policies, linkage of family planning services directly to dialogues).
This intervention serves as the attention-matched control. The format and delivery will mirror that of the "Family Health = Family Wealth" intervention (i.e., number, timing, and duration of sessions). The focus of the intervention is on community sanitation and at-home hygiene (handwashing, food preparation) following an intervention manual that was developed for community groups in East Africa and tailored to the local Uganda context.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06923189