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临床试验/NCT04262882
NCT04262882已完成不适用

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

The University of Texas at San Antonio2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年5月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
2
主要终点
Number of Couples With Uptake of Any High Efficacy Contraceptive Method

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Pregnant; Breastfeeding; Using a modern contraceptive method

结局指标

主要结局

Number of Couples With Uptake of Any High Efficacy Contraceptive Method

时间窗: 7-months and 10-months follow-up

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

次要结局

  • Change in Family Planning Attitudes(Baseline, 7 and 10 months follow-up)
  • Number of Couples With an Unintended Pregnancy(10-months follow-up)
  • Change in Perceived Family Planning Norms(Baseline, 7 and 10 months follow-up)
  • Change in Family Planning Intentions(Baseline, 7 and 10 months follow-up)
  • Change in Desired Number of Children (Fertility Desires)(Baseline, 7 and 10 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(7 and 10 months follow-up)
  • Change in Knowledge of Contraceptives(Baseline, 7 and 10 months follow-up)
  • Change in Joint Household Decision-making(Baseline, 7 and 10 months follow-up)
  • Change in Gender Inequitable Attitudes(Baseline, 7 and 10 months follow-up)
  • Change in Fertility Discordance Between Partners(Baseline, 7 and 10 months follow-up)
  • Change in Partner Communication About Family Planning(Baseline, 7 and 10 months follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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