Clinical trial NCT04262882: Multilevel Family Planning Intervention
Official title: Development, Testing and Health Effects of a Multilevel Family Planning Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraceptive Usage
Lead sponsor: The University of Texas at San Antonio
Sponsor class: OTHER
Collaborators: name: Makerere University
name: San Diego State University
name: Yale University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-02-10
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Couples With Uptake of Any High Efficacy Contraceptive Method
timeFrame: 7-months and 10-months follow-up
Secondary outcomes:
measure: 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
timeFrame: 7 and 10 months follow-up
measure: Number of Couples With an Unintended Pregnancy
timeFrame: 10-months follow-up
measure: Change in Knowledge of Contraceptives
timeFrame: Baseline, 7 and 10 months follow-up
measure: Change in Family Planning Attitudes
timeFrame: Baseline, 7 and 10 months follow-up
measure: Change in Perceived Family Planning Norms
timeFrame: Baseline, 7 and 10 months follow-up
measure: Change in Family Planning Intentions
timeFrame: Baseline, 7 and 10 months follow-up
measure: Change in Desired Number of Children (Fertility Desires)
timeFrame: Baseline, 7 and 10 months follow-up
measure: Change in Fertility Discordance Between Partners
timeFrame: Baseline, 7 and 10 months follow-up
measure: Change in Joint Household Decision-making
timeFrame: Baseline, 7 and 10 months follow-up
measure: Change in Partner Communication About Family Planning
timeFrame: Baseline, 7 and 10 months follow-up
measure: Change in Gender Inequitable Attitudes
timeFrame: Baseline, 7 and 10 months follow-up
Other outcomes:
Locations:
city: Gombe
country: Uganda
facility: Katende Villages
state: Butambala
city: Gombe
country: Uganda
facility: Kyabadaza Villages
state: Butambala
Study officials:
affiliation: University of Texas at San Antonio
name: Katelyn M Sileo, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Susan M Kiene, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: