Multilevel Family Planning Intervention

Contraceptive Usage Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Contraceptive Usage

• NCT number: NCT04262882
• Study type: Interventional
• Source: The University of Texas at San Antonio
• Status: Completed
• Phase: N/A
• Start date: May 14, 2021
• Completion date: March 1, 2023