Actively Recruiting

Phase 2
Phase 3
Age: 15Years - 54Years
All Genders
Healthy Volunteers
ID06923189

Efficacy Testing of a Multi-Level Family Planning Intervention to Increase Contraceptive Use and Reduce Unintended Pregnancy in Low Resource Settings

Led by Boston College · Updated on 2026-03-23

1464

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

B

Boston College

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the Family Health=Family Wealth (FH=FW) program, a multi-level community-based intervention designed to improve family planning outcomes among couples of reproductive age in Uganda. The study aims to see if this program can reduce unintended pregnancies and increase contraceptive use over 24 months, while also investigating factors that influence the program's implementation. The trial compares the FH=FW intervention with a water, sanitation, and hygiene (WASH) program that serves as a control. The FH=FW intervention includes six group sessions for couples, focusing on the benefits of family planning, improving spousal communication and decision-making, increasing access to family planning services, and shifting community attitudes about family size and gender roles. The WASH intervention matches the FH=FW sessions in number and duration but focuses on sanitation and hygiene topics relevant to the local context. Both interventions involve community dialogues and health system strengthening components. Participants will be assessed over 24 months, with evaluations at 4, 8, 12, 16, 20, and 24 months to track changes in contraceptive use, unintended pregnancy rates, contraceptive autonomy, and continuation rates. Researchers will use surveys and interviews to gather data on family planning behaviors and community perceptions. Safety and adherence are monitored throughout, and the study's total duration for each participant is two years.

CONDITIONS

Brief Title

Efficacy Testing of a Multi-Level Family Planning Intervention

Who Can Participate

Age: 15Years - 54Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 49, or emancipated minors aged 15 to 17 who are married and/or have children
  • Men aged 18 to 54, or emancipated minors aged 15 to 17
  • Married or considers themselves married and living together most of the time
  • Residing in communities selected for study inclusion
  • Speaks Luganda
  • Sexually active with spouse within the past 3 months or planning to resume sex within 3 months if the woman is within 2 months postpartum
  • Not currently pregnant (confirmed by pregnancy test)
  • Woman has an unmet need for family planning, meaning she does not want to become pregnant within 2 years and is not using effective contraceptive methods or is using only lower-efficacy methods
Not Eligible

You will not qualify if you...

  • At least one person in the couple does not expect to be available for all sessions
  • Woman or man is unable to reproduce due to a known medical reason or woman’s last period was more than 6 months ago if not postpartum

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Duration of 6 sessions over a period as scheduled by the study

Participants attend 6 community dialogue sessions aimed to reshape community norms and attitudes towards family planning or, for the comparator group, sessions focused on water, sanitation, and hygiene. These sessions address individual and interpersonal determinants and include health system strengthening elements linked to family planning services.

6 group sessions

Long-term Monitoring

Duration - Up to 24 months

Participants are followed for up to 24 months to assess changes in contraceptive use, unintended pregnancy incidence, contraceptive autonomy, and continuation rates.

Visits at 4, 8, 12, 16, 20, and 24 months

Trial Site Locations

Total: 1 location

1

Makerere School of Public Health

Kampala, Uganda

Actively Recruiting

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Research Team

K

Katelyn M Sileo, PhD, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

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.

Katelyn M Sileo, Christine Muhumuza, Rhoda K Wanyenze...

https://pubmed.ncbi.nlm.nih.gov/37355086