Efficacy Testing of a Multi-Level Family Planning Intervention
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age15-54
SponsorBoston College
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Family Planning Intervention
BehavioralThis 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).
Water, Sanitation, and Hygiene (WASH) Intervention
BehavioralThis 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.
Treatment groups
1,464 Participants
are divided into 2 treatment groupsGroup A: Family Health = Family WealthExperimental treatment 1 intervention
Group B: Time- and attention-matched WASH interventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-months2
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-monthsSecondary outcomes
1
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-months2
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-months3
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-monthsOther outcomes
1
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-months2
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-months3
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-months4
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-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston College
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
San Diego State University
Collaborator
Yale University
Collaborator
University of North Carolina, Chapel Hill
Collaborator
Makerere University
Collaborator
Source ClinicalTrials.gov