NCT06923189|RecruitingPhase 2/3DMC
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Sponsor study identifier
Secondary identifiers
NIH
interventional
1,464
1 country
1
Study Start
June 12, 2025
Actual (reported)Primary Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 4, 2025
Actual (reported)April 11, 2025
Actual (reported)June 12, 2025
Actual (reported)December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change from baseline in modern contraceptive use among those with an unmet need for family planning
Proportion of couples where the woman currently wants to prevent pregnancy reporting modern contraceptive use. Measured through structured timeline follow-back (TLFB) interviews, which use cued recall techniques, e.g., identifying key dates to serve as anchors, to assess contraceptive use by week for the prior four-month period (used y/n, method). Pregnancy intentions (desire to prevent pregnancy) are reassessed and accounted for at each follow-up.
4-, 8-, 12-, 16-, 20-, 24-months
Unintended pregnancy incidence
Unintended pregnancy incidence (Yes/No) over 24 months. Measured through urine Human Chorionic Gonadotropin rapid pregnancy tests; classified as unintended if reporting they wanted to wait until later or not get pregnant at all at the time of the pregnancy test, captured through a Demographic and Health Survey item.
8-, 16-, 24-months
Change from baseline in modern contraceptive use
4-, 8-, 12-, 16-, 20-, 24-months
Change from baseline in contraceptive autonomy
4-, 8-, 12-, 16-, 20-, 24-months
Change from baseline in contraceptive continuation rate
4-, 8-, 12-, 16-, 20-, 24-months
Change from baseline in any contraceptive use among those with an unmet need for family planning
4-, 8-, 12-, 16-, 20-, 24-months
Change from baseline in knowledge of contraceptives
8-, 16-, 24-months
Change from baseline in family planning attitudes
8-, 16-, 24-months
This arm receives the Family Health = Family Wealth intervention.
This arm receives an attention-matched comparator intervention focused on water, sanitation, and hygiene (WASH).
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).
Makerere School of Public Health
Kampala, Uganda
Sileo KM, Muhumuza C, Wanyenze RK, Kershaw TS, Sekamatte S, Lule H, Kiene SM. A pilot quasi-experimental controlled trial of a community-based, multilevel family planning intervention for couples in rural Uganda: evidence of feasibility, acceptability, and effect on contraceptive uptake among those with an unmet need for family planning. Contraception. 2023 Sep;125:110096. doi: 10.1016/j.contraception.2023.110096. Epub 2023 Jun 22.
First Submitted
April 4, 2025
First Posted
April 11, 2025
Study Start
June 12, 2025
Actual (reported)Primary Completion
December 31, 2028
EstimatedAddressing Reproductive Coercion in HEalth Settings - Kenya
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.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 23, 2026
Record last verified: 2026-03
All collected quantitative IPD. For the qualitative data, we will limit the sharing to include the sharing of codes, themes, and interview guides. We will not share transcripts or segments of coded transcripts, given difficulty to fully de-identify qualitative data, to protect participant privacy and confidentiality.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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