Multilevel Family Planning Intervention

Development, Testing and Health Effects of a Multilevel Family Planning Intervention

This study seeks to develop and evaluate a multi-level intervention to satisfy couples' unmet need for family planning in rural Uganda. The study will evaluate the acceptability, feasibility, and preliminary efficacy of the intervention at increasing contraceptive uptake and continuation and improving intermediate outcomes of knowledge, attitudes, perceived community norms, partner communication and equity among couples in rural Uganda.

Study Overview

• Status: Completed
• Conditions: Contraceptive Usage
• Intervention / Treatment: Behavioral: Multilevel Family Planning Intervention; Behavioral: Time and attention matched control

Detailed Description

In 2018, 32.6% of 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. While Uganda is scaling up efforts to reduce supply-side barriers in rural areas, such as community distribution of contraceptives, couples are still faced with multi-level demand-side barriers to contraceptive use. In addition to 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 pilot test a multi-level, community-based intervention, which employs 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 enhanced to simultaneously address individual and interpersonal-level determinants of family planning and link couples to family planning services. The aims of this project are to conduct a pilot quasi-experimental controlled trial to: 1) assess acceptability and feasibility of the trial procedures and intervention content; 2) the intervention's potential efficacy on contraceptive uptake and continuation and intermediate outcomes (knowledge, attitudes, perceived community norms, partner communication and equity) through 6-month follow up.

One village will be randomized to the multi-level intervention and one village to the control condition (attention-matched control intervention). Participation in the full study will last 6 months. Participants will first complete a questionnaire after enrollment, and female participants will take a pregnancy test at baseline. Participants in both study arms will participate in interviewer administered questionnaires at 3 months and 6 months follow-up, pregnancy testing at 6-months follow-up for women, and will permit the research team to access their medical records to extract information about their contraceptive use and use of family planning services. Participants in the intervention arm will participate in a series of group sessions with other couples from the community. Group sessions will last approximately 90 minutes, including community dialogues to reconstruct group norms that discourage contraceptive use enhanced with activities to improve knowledge, motivation, couple dynamics, and link couples to services.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Butambala
    • Gombe, Butambala, Uganda
      • Katende Villages
    • Gombe, Butambala, Uganda
      • Kyabadaza Villages

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Being in a relationship and both partners providing written informed consent; women: age 18-40 (or emancipated minor); men: age 18-50; not currently using modern contraceptives and having never used a non-reversible method; one or both partners wanting to prevent pregnancy for at least the next year; living within the selected villages; Luganda speaking.

Exclusion Criteria:

• Pregnant; Breastfeeding; Using a modern contraceptive method

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multilevel Family Planning Intervention; A multi-level, community-based intervention delivered in groups of couples to increase contraceptive uptake, reduce discontinuation, and reduce the incidence of unintended pregnancy, and improve intermediate outcomes (knowledge, attitudes, norms, communication, equity).	Behavioral: Multilevel Family Planning Intervention; The 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.
Active Comparator: Time and attention-matched control; A community sanitation intervention delivered in groups of couples to increase at-home and community hygiene practices.	Behavioral: Time and attention matched control; 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 (hand-washing, food preparation) following an intervention manual that was developed for community groups in Uganda.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Couples With Uptake of Any High Efficacy Contraceptive Method	Uptake of any high efficacy contraceptive method. High efficacy contraceptive methods are defined based on efficacy for "typical use" of methods (rather than perfect use), inclusive of pills, injection, intrauterine device, implant, tubal ligation, vasectomy; measured through women's self-report and validated through clinic records and men's self-report	7-months and 10-months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Couples That Discontinued Use of a High Efficacy Contraceptive Method at 10-months Follow-up Among Those That Started Using a Method at 7-months Follow-up	Number of couples that discontinued use of a high efficacy contraceptive method at 10-months follow-up among those that started using a method at 7-months follow-up. High efficacy contraceptive methods are defined based on efficacy for "typical use" of methods (rather than perfect use), inclusive of pills, injection, intrauterine device, implant, tubal ligation, vasectomy; measured through women's self-report and validated through clinic records and men's self-report	7 and 10 months follow-up
Number of Couples With an Unintended Pregnancy	Biological measure; human chorionic gonadotropin (hCG) rapid pregnancy tests taken by women at 10-months follow-up.	10-months follow-up
Change 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	Baseline, 7 and 10 months follow-up
Change 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.	Baseline, 7 and 10 months follow-up
Change 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	Baseline, 7 and 10 months follow-up
Change in Family Planning Intentions	Family planning intentions scale developed for use in Uganda to assess participants' plans to use contraceptives and family planning services in the future; collected through interviewer-administered questionnaire. Scores range between 0-4 with higher scores indicating greater intentions to use family planning services in the future	Baseline, 7 and 10 months follow-up
Change in Desired Number of Children (Fertility Desires)	Item from the Uganda Demographic and Health Survey (DHS) on the participants' fertility desires (i.e., desired number of additional children); collected through interviewer-administered questionnaire. This is a count variable that could range from zero upward (no limit).	Baseline, 7 and 10 months follow-up
Change in Fertility Discordance Between Partners	An item from the Uganda DHS on the participants' desired number of children, "How many more children do you want to have?" was used to calculate the couple variable fertility discordance by subtracting men and women's responses within couples. This was dichotomized for analysis; for couples where the product was zero, they were classified as having no discordance (0) and for couples where the produce was anything other than zero, they were classified as having discordance (1).	Baseline, 7 and 10 months follow-up
Change in Joint Household Decision-making	Joint household decision-making was measured with four items from the Uganda DHS that ask respondents who primarily decides on: 1) how the money they earn is used; 2) how their spouses' earnings are used; 3) decisions about healthcare for yourself; and 4) decisions about major household purchases. Response options were recoded as self and partner jointly (1) vs. all other (0). A mean score was calculated for each time point with greater scores indicating more joint decision-making (range 0-1).	Baseline, 7 and 10 months follow-up
Change in Partner Communication About Family Planning	The mean of two items on the frequency of communication with one's partner about family planning found predictive of family planning in Uganda in prior research. Participants were asked, in the last 12 months, "How often have you discussed the number of children you want with your partner?" and "How often have you discussed the spacing or timing of your/your partner's pregnancies with your partner." The four-point response options ranged from "Never" to "Regularly." At the two follow-up time points, the same questions were asked with the timeframe, "since the last interview." Higher scores indicate more communication. Possible scores range from 0.00-3.00.	Baseline, 7 and 10 months follow-up
Change in Gender Inequitable Attitudes	The mean of the 24-item Gender Equitable Men scale measured endorsement of traditional gender norms and attitudes on gender inequity, validated in Tanzania and Ghana, with good reliability in African settings. Domains include violence, sexual relationships, reproductive health and disease prevention, and domestic chores and daily life items. Higher scores indicate more inequitable gender attitudes. Possible score range = 0=3	Baseline, 7 and 10 months follow-up

Collaborators and Investigators

• Sponsor: The University of Texas at San Antonio
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); San Diego State University; Yale University; Makerere University
• Investigators: Principal Investigator: Katelyn M Sileo, PhD, MPH, University of Texas at San Antonio; Principal Investigator: Susan M Kiene, PhD, MPH, San Diego State University

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2021
• Primary Completion (Actual): May 3, 2022
• Study Completion (Actual): June 18, 2022

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1R21HD098523-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Quantitative data collected in this trial (baseline, follow-up assessments) will be made available, under the following provisions: (1)The data will be fully de-identified; (2) Access to the data will be made available first to researchers and their students at the four collaborating institutions (within 3 years of study completion): The University of Texas at San Antonio, San Diego State University, the Makerere University School of Public Health (MakSPH), and Yale University; 4) 5 years after study completion, data will be made available to those requesting access outside of the four requesting institutions. Qualitative data collected as part of this trial will not be made available, as it is difficult to fully de-identify and to interpret without knowledge of the context.
• IPD Sharing Time Frame: 3 years after study completion for researchers and students within the collaborating institutions and 5 years after study completion for those outside of the collaborating institutions upon request
• IPD Sharing Access Criteria: Upon request from the PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No