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评估肯尼亚乌干达县政府卫生设施中可扩展的 ARCHES(在卫生环境中解决生殖强迫)模型:一项整群随机对照试验的研究方案。

Evaluating a scalable ARCHES (Addressing Reproductive Coercion in Health Settings) model in government health facilities in Uasin Gishu county, Kenya: study protocol for a cluster-randomized controlled trial.

机构信息

Center On Gender Equity and Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.

Population Council Kenya, Avenue 5, 3rd Floor, Rose Avenue, Nairobi, Kenya.

出版信息

Reprod Health. 2023 Oct 17;20(1):155. doi: 10.1186/s12978-023-01697-7.

DOI:10.1186/s12978-023-01697-7
PMID:37848916
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10583405/
Abstract

BACKGROUND

Since 2013, the World Health Organization has recommended that reproductive coercion (RC) and intimate partner violence (IPV) be addressed within reproductive health services and, in 2018, the Lancet Commission on Sexual and Reproductive Health and Rights found that RC and IPV were significant contributors to unmet need for family planning (FP) and unintended pregnancy. In Kenya, the Ministry of Health (MOH) has made reduction of unintended pregnancy and gender-based violence a primary objective. Despite this need and guidance, no clinic-based intervention models outside of the U.S. (apart from the one described here) have demonstrated efficacy to improve FP use and reduce IPV or RC thereby reducing unintended pregnancy. ARCHES (Addressing Reproductive Coercion in Health Settings) is a brief, clinic-based intervention delivered by existing FP providers aiming to: (1) Increase women's ability to use FP without interference, (2) Provide a safe and supportive environment for IPV disclosure and referral to support services, and (3) Improve quality of FP counseling, including addressing RC and IPV. The objective of this study is to generate evidence on scaling integrated FP services (including FP, RC, and IPV) in public sector health facilities in Uasin Gishu county, Kenya via adaptation and implementation of ARCHES in partnership with the Kenya MOH.

METHODS

A cluster-randomized controlled trial paired with concurrent implementation science assessments will test effectiveness of the ARCHES model, adapted for scale by the Kenya MOH, in reducing unintended pregnancy. Female FP clients aged 15-49 years at selected sites will complete baseline surveys (immediately prior to receiving care), immediately post-visit exit surveys, and 6-month follow-up surveys. Provider surveys will assess changes in gender-equitable attitudes and self-efficacy to address violence reported by their clients. Costs associated with scaling ARCHES will be tracked and utilized in combination with results of the effectiveness trial to assess costs and cost-effectiveness relative to the standard of care.

DISCUSSION

This study will provide evidence of the effectiveness of a facility-based intervention to address RC and IPV within public sector FP services at scale, as adapted and implemented in Uasin Gishu county, Kenya. Trial registration Trial registered on 28 September 2023 with clinicaltrials.gov NCT06059196.

摘要

背景

自 2013 年以来,世界卫生组织(WHO)建议在生殖健康服务中解决生殖胁迫(RC)和亲密伴侣暴力(IPV)问题,2018 年,柳叶刀性健康和生殖健康权利委员会发现 RC 和 IPV 是计划生育(FP)和意外怀孕未满足需求的重要因素。在肯尼亚,卫生部(MOH)已将减少意外怀孕和性别暴力作为主要目标。尽管有这种需求和指导,但在美国以外的诊所干预模式(除了这里描述的一种模式)都没有证明能够有效地提高 FP 的使用,减少 IPV 或 RC,从而减少意外怀孕。ARCHES(在卫生环境中解决生殖胁迫)是一种由现有的 FP 提供者提供的简短的基于诊所的干预措施,旨在:(1)提高妇女在不受干扰的情况下使用 FP 的能力,(2)为 IPV 披露和转介到支持服务提供安全和支持的环境,(3)改善 FP 咨询的质量,包括解决 RC 和 IPV。本研究的目的是在肯尼亚 Uasin Gishu 县的公立卫生机构中,通过与肯尼亚卫生部合作,对 ARCHES 进行适应性调整和实施,为生殖健康综合服务(包括 FP、RC 和 IPV)的扩展提供证据。

方法

一项集群随机对照试验与同期实施科学评估相结合,将测试经过肯尼亚卫生部调整以扩大规模的 ARCHES 模型的有效性,以减少意外怀孕。在选定的地点,年龄在 15-49 岁的女性 FP 客户将在接受护理前立即完成基线调查(基线调查),在就诊后立即完成退出调查,以及在 6 个月后完成随访调查。提供者调查将评估他们的客户报告的性别平等态度和解决暴力问题的自我效能感的变化。将跟踪与扩展 ARCHES 相关的成本,并将其与有效性试验的结果结合使用,以评估相对于标准护理的成本和成本效益。

讨论

本研究将提供证据,证明在肯尼亚 Uasin Gishu 县,经过适应性调整和实施的基于诊所的干预措施,在公立部门 FP 服务中,在大规模范围内解决 RC 和 IPV 的有效性。试验注册 试验于 2023 年 9 月 28 日在 clinicaltrials.gov 上注册,编号为 NCT06059196。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5ad/10583405/436d02e30832/12978_2023_1697_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5ad/10583405/436d02e30832/12978_2023_1697_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f5ad/10583405/436d02e30832/12978_2023_1697_Fig1_HTML.jpg

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本文引用的文献

1
Effects of a clinic-based reproductive empowerment intervention on proximal outcomes of contraceptive use, self-efficacy, attitudes, and awareness and use of survivor services: a cluster-controlled trial in Nairobi, Kenya.以诊所为基础的生殖权利赋权干预对避孕使用的近期结局、自我效能、态度以及对幸存者服务的认识和使用的影响:肯尼亚内罗毕的一项群组对照试验。
Sex Reprod Health Matters. 2023 Dec;31(1):2227371. doi: 10.1080/26410397.2023.2227371.
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A family planning clinic-based intervention to address reproductive coercion: a cluster randomized controlled trial.一项基于计划生育诊所的干预措施以应对生殖胁迫:一项整群随机对照试验。
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