A Phase 2/3 interventional study of Family Planning Intervention and Water, Sanitation, and Hygiene (WASH) Intervention in Unintended Pregnancy and Family Planning, sponsored by Boston College. Recruiting at 1 site in Uganda. Open to participants aged 15 Years to 54 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Boston College · Phase 2/3, Interventional, and Prevention
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:
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.
In 2022, 29.7% of married women of reproductive age had an unmet need for family planning in Uganda, meaning they wanted to avoid pregnancy but were not using a modern contraceptive method. Filling the unmet need for family planning has important public health implications, including reductions in pregnancy-related health risks and deaths, and infant mortality. On the supply-side, community platforms to deliver family planning, as well as provider capacity to provide effective methods, need to be strengthened, but such efforts will not be optimized without addressing multilevel demand-side barriers to contraceptive use. Misinformation and fear of contraceptive side-effects, relationship dynamics, peer and family influence, and broader community norms promoting large family size and traditional gender roles influence family planning. This study will test the Family Health=Family Wealth (FH=FW) multi-level, community-based intervention, which employs health system strengthening efforts alongside transformative community dialogues to alter individual attitudes and the perception of community norms that discourage family planning. Community dialogues are delivered to groups of couples over 6-sessions enhanced to simultaneously address individual and interpersonal-level determinants of family planning and serve as a platform for community-based family planning and linkage to facility-based family planning services. The study aims are to: (1) In a cluster randomized trial, compare the efficacy of the FH=FW intervention vs. a time/attention matched comparator intervention at increasing modern contraceptive use and reducing unintended pregnancy among couples with an unmet need for family planning through 24-months, and identify potential mediators of the intervention effect. (2) Determine the intervention's effect on, and determinants of, contraceptive continuation. (3) Through a mixed-methods process evaluation, explore factors affecting the implementation of the intervention in order to improve feasibility, acceptability, and the likelihood of future adoption and sustainment.
Boston College is the lead sponsor of 38 studies on the registry; 7 are open to participants now.
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This arm receives the Family Health = Family Wealth intervention.
Behavioral: Family Planning Intervention
This arm receives an attention-matched comparator intervention focused on water, sanitation, and hygiene (WASH).
Behavioral: Water, Sanitation, and Hygiene (WASH) Intervention
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.
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.
Time frame: 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.
Time frame: 8-, 16-, 24-months
Change from baseline in modern contraceptive use
Proportion of couples reporting modern contraceptive use in the full sample, regardless of pregnancy intentions. 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).
Time frame: 4-, 8-, 12-, 16-, 20-, 24-months
Change from baseline in contraceptive autonomy
Proportion of women reporting contraceptive autonomy (y/n). Contraceptive autonomy (yes) is defined as those that want to delay pregnancy with modern contraceptives reporting contraceptive use or that do not want to delay pregnancy with modern contraceptives that are not using a method (positive outcome). Contraceptive autonomy (no) is defined as those not using a modern method when wanting to delay pregnancy with a modern method or using a method when not wanting to delay pregnancy are considered not having contraceptive autonomy. Contraceptive use is 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).
Time frame: 4-, 8-, 12-, 16-, 20-, 24-months
Change from baseline in contraceptive continuation rate
Duration of continuation: The time from starting contraceptive use to discontinuation (a period of discontinuation of 1 month or more). Contraceptive use is 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).
Time frame: 4-, 8-, 12-, 16-, 20-, 24-months
Change from baseline in any contraceptive use among those with an unmet need for family planning
Proportion of couples where the woman currently wants to prevent pregnancy reporting any contraceptive use (included natural methods). 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.
Time frame: 4-, 8-, 12-, 16-, 20-, 24-months
Change from baseline in knowledge of contraceptives
Scale from the Uganda Demographic and Health Survey (DHS) aimed to assess knowledge of modern contraceptive methods; collected through interviewer-administered questionnaire. Possible range 0-1, greater scores indicate more knowledge.
Time frame: 8-, 16-, 24-months
Change from baseline in family planning attitudes
Family planning attitudes scale developed for use in Uganda to assess how participants would feel about using contraceptive methods; collected through interviewer-administered questionnaire. Scores range from 0-4 with greater scores indicating more positive attitudes towards family planning.
Time frame: 8-, 16-, 24-months
Change from baseline in perceived family planning norms
Scale adapted from the Family Planning Approval Index to assess the perceived acceptance of family planning and contraceptive use among partner, family, peers, and broader community; collected through interviewer-administered questionnaire. Scores range from 0-1 with greater scores indicating more positive perceived attitudes towards family planning among others.
Time frame: 8-, 16-, 24-months
Change from baseline in family planning intentions
Family planning intentions scale developed for use in Uganda to assess participants' plans to use contraceptives and family planning services in the future; collected through interviewer-administered questionnaire. Scores range between 0-4 with higher scores indicating greater intentions to use family planning services in the future.
Time frame: 8-, 16-, 24-months
Change from baseline in desired number of children (fertility desires)
Item from the Uganda Demographic and Health Survey (DHS) on the participants' fertility desires (i.e., desired number of additional children); collected through interviewer-administered questionnaire. This is a count variable that could range from zero upward (no limit).
Time frame: 8-, 16-, 24-months
Change from baseline in joint household decision-making
Joint household decision-making was measured with items from the Uganda DHS that ask respondents who primarily decides on: 1) how the money they earn is used; 2) how their spouses' earnings are used; 3) decisions about healthcare for yourself; and 4) decisions about major household purchases. Response options coded as self and partner jointly (1) vs. all other (0). Greater scores indicating more joint decision-making (range 0-1).
Time frame: 8-, 16-, 24-months
Change from baseline in gender inequitable attitudes
The mean of the 24-item Gender Equitable Men scale measured endorsement of traditional gender norms and attitudes on gender inequity, validated in Tanzania and Ghana, with good reliability in African settings. Domains include violence, sexual relationships, reproductive health and disease prevention, and domestic chores and daily life items. Higher scores indicate more inequitable gender attitudes. Possible score range = 1-3.
Time frame: 8-, 16-, 24-months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will be will shared at the time of publication or at the end of data analysis (anticipated by May 15, 2029)
Access criteria: Data, data analysis code, and associated meta-data (data collection tools that generated the data) will be made accessible in the NICHD Data and Specimen Hub (DASH), a centralized resource that allows researchers to share and access de-identified data from studies funded by NICHD.
Started Jun 2025 (actual). Primary completion is estimated for Dec 2028, 42 months after the start.
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