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ARCHES(在肯尼亚内罗毕的社区诊所寻求避孕服务的妇女和女孩中解决生殖胁迫问题)配对病例对照试验方案。

Protocol for a matched-pair cluster control trial of ARCHES (Addressing Reproductive Coercion in Health Settings) among women and girls seeking contraceptive services from community-based clinics in Nairobi, Kenya.

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

出版信息

Reprod Health. 2020 May 27;17(1):77. doi: 10.1186/s12978-020-00916-9.

DOI:10.1186/s12978-020-00916-9
PMID:32460786
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7251735/
Abstract

BACKGROUND

Reproductive coercion (RC) and intimate partner violence (IPV) are prevalent forms of gender-based violence (GBV) associated with reduced female control over contraceptive use and subsequent unintended pregnancy. Although the World Health Organization has recommended the identification and support of GBV survivors within health services, few clinic-based models have been shown to reduce IPV or RC, particularly in low or middle-income countries (LMICs). To date, clinic-based GBV interventions have not been shown to reduce RC or unintended pregnancy in LMIC settings.

INTERVENTION

ARCHES (Addressing Reproductive Coercion in Health Settings) is a single-session, clinic-based model delivered within routine contraceptive counseling that has been demonstrated to reduce RC in the United States. ARCHES was adapted to the Kenyan context via a participatory process to reduce GBV and unintended pregnancy among women and girls seeking contraceptive services in this setting. Core elements of ARCHES include enhanced contraceptive counseling that addresses RC, opportunity for patient disclosure of RC and IPV (and subsequent warm referral to local services), and provision of a palm-sized educational booklet.

METHODS

A matched-pair cluster control trial is being conducted to assess whether the ARCHES intervention (treatment condition), as compared to standard-of-care contraceptive counseling (control condition), reduces RC and IPV, and improves contraceptive outcomes for woman and girls of reproductive age (15 to 49 years) seeking contraceptive services from community-based clinics in Nairobi, Kenya. All six clinics were assigned to intervention-control pairs based on similarities in patient volume and demographics, physical structure and neighborhood context. Survey data will be collected from patients immediately prior to their clinic visit (baseline, T1), immediately after their clinic visit (exit), and at 3- and 6-months post-visit (T2 and T3, respectively).

DISCUSSION

This study is the first to assess the efficacy of an adaptation of the ARCHES model to reduce GBV and improve reproductive health outside of the U.S., and one of only a small number of controlled trials to assess reductions in GBV associated with a clinic-based program in an LMIC context. Evidence from this trial will inform health system efforts to reduce GBV, and to enhance female contraceptive control and reproductive health in Kenya and globally.

TRIAL REGISTRATION

Registered May 23, 2018 - ClinicalTrials.gov, NCT03534401. Unique Protocol ID: 170084.

摘要

背景

生殖胁迫(RC)和亲密伴侣暴力(IPV)是与女性对避孕措施的控制减少以及随后意外怀孕有关的普遍形式的性别暴力(GBV)。尽管世界卫生组织已建议在卫生服务中识别和支持 GBV 幸存者,但很少有基于诊所的模式已被证明可以减少 IPV 或 RC,特别是在中低收入国家(LMIC)。迄今为止,基于诊所的 GBV 干预措施并未显示可减少 LMIC 环境中的 RC 或意外怀孕。

干预措施

ARCHES(在卫生环境中解决生殖胁迫)是一种单次就诊的基于诊所的模型,在常规避孕咨询中提供,已被证明可减少美国的 RC。ARCHES 通过参与式过程进行了调整,以适应肯尼亚的情况,旨在减少该环境中寻求避孕服务的妇女和女孩的 GBV 和意外怀孕。ARCHES 的核心要素包括强化避孕咨询,以解决 RC 问题,为患者提供 RC 和 IPV 披露的机会(随后将其转介给当地服务),并提供一本手掌大小的教育手册。

方法

正在进行一项配对簇对照试验,以评估 ARCHES 干预措施(治疗条件)与标准避孕咨询(对照条件)相比,是否可以减少 RC 和 IPV,并改善生殖年龄(15 至 49 岁)的妇女和女孩的避孕效果,她们正在内罗毕的社区诊所寻求避孕服务。所有六家诊所均根据患者数量和人口统计学,物理结构和邻里环境相似,分配到干预控制对。将在患者就诊前立即(基线,T1),就诊后立即(退出)以及就诊后 3 个月和 6 个月(分别为 T2 和 T3)收集患者的调查数据。

讨论

这项研究是首次评估 ARCHES 模型的改编版在美国以外地区减少 GBV 和改善生殖健康的功效,也是仅有的少数几个评估基于诊所的方案与中低收入国家背景下的 GBV 减少相关的对照试验之一。该试验的证据将为减少 GBV 以及增强肯尼亚和全球女性的避孕控制和生殖健康的卫生系统工作提供信息。

试验注册

于 2018 年 5 月 23 日在 ClinicalTrials.gov 注册,NCT03534401。独特的协议 ID:170084。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e746/7251735/abe3c69986fe/12978_2020_916_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e746/7251735/46bd03873d72/12978_2020_916_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e746/7251735/abe3c69986fe/12978_2020_916_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e746/7251735/46bd03873d72/12978_2020_916_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e746/7251735/abe3c69986fe/12978_2020_916_Fig2_HTML.jpg

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