NCT06923189 Efficacy Testing of a Multi-Level Family Planning Intervention
| NCT ID | NCT06923189 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Boston College |
| Condition | Unintended Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,464 participants |
| Start Date | 2025-06-12 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,464 participants in total. It began in 2025-06-12 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06923189 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 54 Years, studying Unintended Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06923189 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06923189 currently recruiting?
Yes, NCT06923189 is actively recruiting participants. Contact the research team at sileoka@bc.edu for enrollment information.
Where is the NCT06923189 trial being conducted?
This trial is being conducted at Kampala, Uganda.
Who is sponsoring the NCT06923189 clinical trial?
NCT06923189 is sponsored by Boston College. The trial plans to enroll 1,464 participants.