Clinical trial NCT06923189: Efficacy Testing of a Multi-Level Family Planning Intervention
Official title: Efficacy Testing of a Multi-Level Family Planning Intervention to Increase Contraceptive Use and Reduce Unintended Pregnancy in Low Resource Settings
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Unintended Pregnancy
Family Planning
Keywords: Unintended pregnancy
Contraceptive use
Family planning
Intervention
Cluster randomized controlled trial
Uganda
Couples
Lead sponsor: Boston College
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: San Diego State University
name: Yale University
name: University of North Carolina, Chapel Hill
name: Makerere University
First posted: 2025-04-11
Enrollment: 1464
Sex: ALL
Minimum age (years): 15
Maximum age (years): 54
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

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.

Primary outcomes:
measure: Change from baseline in modern contraceptive use among those with an unmet need for family planning
timeFrame: 4-, 8-, 12-, 16-, 20-, 24-months
measure: Unintended pregnancy incidence
timeFrame: 8-, 16-, 24-months
Secondary outcomes:
measure: Change from baseline in modern contraceptive use
timeFrame: 4-, 8-, 12-, 16-, 20-, 24-months
measure: Change from baseline in contraceptive autonomy
timeFrame: 4-, 8-, 12-, 16-, 20-, 24-months
measure: Change from baseline in contraceptive continuation rate
timeFrame: 4-, 8-, 12-, 16-, 20-, 24-months
Other outcomes:
measure: Change from baseline in any contraceptive use among those with an unmet need for family planning
timeFrame: 4-, 8-, 12-, 16-, 20-, 24-months
measure: Change from baseline in knowledge of contraceptives
timeFrame: 8-, 16-, 24-months
measure: Change from baseline in family planning attitudes
timeFrame: 8-, 16-, 24-months
measure: Change from baseline in perceived family planning norms
timeFrame: 8-, 16-, 24-months
measure: Change from baseline in family planning intentions
timeFrame: 8-, 16-, 24-months
measure: Change from baseline in desired number of children (fertility desires)
timeFrame: 8-, 16-, 24-months
measure: Change from baseline in joint household decision-making
timeFrame: 8-, 16-, 24-months
measure: Change from baseline in gender inequitable attitudes
timeFrame: 8-, 16-, 24-months
Locations:
city: Kampala
country: Uganda
facility: Makerere School of Public Health
Study officials:
References:
citation: 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.