Design and impact evaluation of a digital reproductive health program in Rwanda using a cluster randomized design: study protocol.

Design and impact evaluation of a digital reproductive health program in Rwanda using a cluster randomized design: study protocol.
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DOI:
10.1186/s12889-020-09746-7
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发表时间:
2020-11-13
期刊:
影响因子:
4.5
通讯作者:
McCoy S
McCoy S
中科院分区:
医学2区
文献类型:
--
作者:
Nolan C;Packel L;Hope R;Levine J;Baringer L;Gatare E;Umubyeyi A;Sayinzoga F;Mugisha M;Turatsinze J;Naganza A;Idelson L;Bertozzi S;McCoy S

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卢旺达青少年获得高质量的计划生育和生殖健康信息和护理以防止计划外怀孕和艾滋病毒/性传播感染的机会有限。除了对健康和福祉产生直接影响外,少女怀孕还是辍学的一个重要原因,限制了女孩未来的潜力和就业机会。本研究介绍了一个直接面向消费者的数字教育计划,使用讲故事,提供适合年龄的FP/RH信息和经济赋权培训的青少年。它还促进获得高质量、对青年友好的计划生育/生殖健康护理和产品。我们评估了两种不同的以学校为基础的实施模式,以了解如何优化青少年避孕和艾滋病毒检测的使用。这项研究包括两个不同的阶段。第一个形成性干预设计阶段于2016年至2019年进行,采用以人为本的设计方法,与600多名卢旺达青少年,他们的父母,教师和医疗保健提供者一起开发干预措施。通过这种方法,我们试图最大限度地提高循证实践(采用现代避孕和艾滋病毒检测)与卢旺达青少年实施环境之间的契合度。第二阶段是影响评估,我们将使用混合试验类型2实施研究设计,以确定这种数字干预的整体有效性以及两种不同的校本实施模式的相对有效性。这是一项三臂随机分组非劣效性试验,样本为卢旺达8个区60所学校的6000名12-19岁的青年。主要结局指标包括现代避孕方法的使用、推迟开始生育和接受艾滋病毒检测。这项研究不仅将深入了解这种数字干预是否成功地实现了预期的性健康和生殖健康结果,而且还将了解哪些机制可能会推动这种有效性。所使用的方法广泛适用于低收入和中等收入国家其他基于行为的健康计划的设计,实施和评估。ClinicalTrials.gov标识符:NCT 04198272。于二零一九年十二月十三日注册。在线版本包含补充材料,可通过10.1186/s12889-020-09746-7获得。
Rwandan adolescents have limited access to high-quality family planning and reproductive health (FP/RH) information and care to prevent unplanned pregnancy and HIV/STIs. In addition to the immediate implications for health and well-being, teenage pregnancy is a significant cause of school drop-out, limiting girls’ future potential and employment opportunities. This study introduces a direct-to-consumer digital education program that uses storytelling to deliver age-appropriate FP/RH information and economic empowerment training to adolescents. It also facilitates access to high-quality, youth-friendly FP/RH care and products. We evaluate two different school-based models of its implementation to understand how to optimize the uptake of contraception and HIV testing among adolescents. The study consists of two distinct phases. The first formative intervention design phase, conducted from 2016 to 2019, used a human-centered design methodology to develop the intervention alongside over 600 Rwandan adolescents, their parents, teachers, and healthcare providers. Through this methodology, we sought to maximize the fit between evidence-based practices (uptake of modern contraception and HIV testing) and the implementation context of adolescents in Rwanda. The second phase is an impact evaluation, in which we will use a Hybrid Trial Type 2 Effectiveness-Implementation study design to determine the overall effectiveness of this digital intervention as well as the relative effectiveness of the two different school-based implementation models. This takes the form of a 3-arm cluster-randomized non-inferiority trial, with a sample of 6000 youth aged 12–19 in 60 schools across 8 districts in Rwanda. Primary outcome measures include use of modern contraception, delayed initiation of childbearing, and uptake of HIV testing. This study will yield insights into not only whether this digital intervention is successful in achieving the intended sexual and reproductive health outcomes, but also which mechanisms are likely to drive this effectiveness. The methodologies used are broadly applicable to the design, implementation, and evaluation of other behavior-based health programs in low and middle-income countries. ClinicalTrials.gov Identifier: NCT04198272. Prospectively registered 13 December 2019. The online version contains supplementary material available at 10.1186/s12889-020-09746-7.
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