Efficacy Testing of a Multi-Level Family Planning Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1464 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multilevel Family Planning Intervention

NCT04262882

Contraceptive Usage

COMPLETED NA

Testing a Modified Family Planning Intervention for Postpartum Women in Uganda

NCT04068870

Contraceptive Usage

UNKNOWN PHASE1

Resolution of Uncertainty Through Testing

NCT03179059

Pregnancy Tests

TERMINATED NA

A Livelihood Intervention for Impoverished Women and Children in Rural Uganda

NCT02619279

Indigency

UNKNOWN NA

Providing Birth Control Through Home Health Visits

NCT00065078

Pregnancy

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Unintended Pregnancy Family Planning

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Data collectors (interviewers)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Family Health = Family Wealth

This arm receives the Family Health = Family Wealth intervention.

Group Type EXPERIMENTAL

Family Planning Intervention

Intervention Type BEHAVIORAL

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).

Time- and attention-matched WASH intervention

This arm receives an attention-matched comparator intervention focused on water, sanitation, and hygiene (WASH).

Group Type ACTIVE_COMPARATOR

Water, Sanitation, and Hygiene (WASH) Intervention

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Family Planning 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).

Intervention Type BEHAVIORAL

Water, Sanitation, and Hygiene (WASH) Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes