Efficacy Testing of a Multi-Level Family Planning Intervention

NCT06923189 | Recruiting Phase 2 DMC

• 2 other identifiers: 25.018.01R01HD113806
• Study Type: interventional
• Target: 1,464
• Locations: 1 country
• Sites: 1

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. 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. 2.Does FH=FW participation reduce discontinuation of contraceptive methods for those who adopt them over 24-months?
3. 3.What factors affect the implementation of the FH=FW intervention?

Conditions

Unintended Pregnancy; Family Planning

Keywords

Unintended pregnancy; Contraceptive use; Family planning; Intervention; Cluster randomized controlled trial; Uganda; Couples

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• 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

Other Outcomes (8)

• 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

Study Arms (2)

Family Health = Family Wealth

EXPERIMENTAL

This arm receives the Family Health = Family Wealth intervention.

Behavioral: Family Planning Intervention

Time- and attention-matched WASH intervention

ACTIVE COMPARATOR

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

Behavioral: Water, Sanitation, and Hygiene (WASH) Intervention

Interventions

Family Planning Intervention 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).

Family Health = Family Wealth

Water, Sanitation, and Hygiene (WASH) Intervention 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.

Time- and attention-matched WASH intervention

Eligibility Criteria

• Age: 15 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston College: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• San Diego State University: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Makerere University: collaborator
• Yale University: collaborator

Study Sites (1)

Makerere School of Public Health

Kampala, Uganda

RECRUITING

Related Publications (1)

• 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.

  PMID: 37355086 BACKGROUND

MeSH Terms

Interventions

Water; Sanitation; Hygiene; Therapeutic Irrigation; Methods

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health; Therapeutics; Hydrotherapy; Physical Therapy Modalities; Rehabilitation; Investigative Techniques

Central Study Contacts

Katelyn M Sileo, PhD, MPH

CONTACT

860-977-8447; sileoka@bc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Data collectors (interviewers)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

UG (1)