Kalokhe Ameeta Shivdas, Iyer Sandhya, Gadhe Keshav, Katendra Tuman, Kolhe Ambika, Rahane Girish, Stephenson Rob, Sahay Seema
Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA, United States.
Department of Global Health, Emory Rollins School of Public Health, Atlanta, GA, United States.
JMIR Form Res. 2021 Feb 1;5(2):e26130. doi: 10.2196/26130.
The high global prevalence of intimate partner violence (IPV) and its association with poor physical and mental health underscore the need for effective primary prevention. We previously developed Ghya Bharari Ekatra (GBE), a couples-based primary prevention intervention for IPV among newly married couples residing in slum communities in Pune, India.
Through this pilot study, we aimed to explore the acceptance, safety, feasibility, and preliminary efficacy of GBE.
Between January and May 2018, we enrolled and assigned 20 couples to receive GBE plus information on IPV support services and 20 control couples to receive information on IPV support services alone. The GBE intervention was delivered over 6 weekly sessions to groups of 3 to 5 couples by lay peer educators in the communities in which the participants resided. Intervention components addressed relationship quality, resilience, communication and conflict negotiation, self-esteem, sexual communication and sexual health knowledge, and norms around IPV. Outcome evaluation included exit interviews with participants and peers to examine acceptance and feasibility challenges and baseline and 3-month follow-up interviews to examine change in IPV reporting and mental health (by women) and alcohol misuse (by men). The process evaluation examined dose delivered, dose received, fidelity, recruitment, participation rate, and context.
Half (40/83) of the eligible couples approached agreed to participate in the GBE intervention. Retention rates were high (17/20, 85% across all 6 sessions), feedback from exit interviews suggested the content and delivery methods were very well received, and the community was highly supportive of the intervention. The principal feasibility challenge involved recruiting men with the lowest income who were dependent on daily wages. No safety concerns were reported by female participants over the course of the intervention or at the 3-month follow-up. There were no reported physical or sexual IPV events in either group, but there were fewer incidents of psychological abuse in GBE participants (3/17, 18%) versus control participants (4/16, 25%) at 3-month follow-up. There was also significant improvement in the overall mental health of female intervention participants and declines in the control participants (change in mean General Health Questionnaire-12 score: -0.13 in intervention vs 0.13 in controls; P=.10).
GBE has high acceptance, feasibility, and preliminary efficacy in preventing IPV and improving mental health among women. Next steps include refining the intervention content based on pilot findings and examining intervention efficacy through a large-scale randomized trial with longer follow-up.
ClinicalTrials.gov NCT03332134; https://clinicaltrials.gov/ct2/show/NCT03332134. Clinical Trials Registry of India CTRI/2018/01/011596; http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=21443.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/11533.
亲密伴侣暴力（IPV）在全球范围内高发，且与身心健康状况不佳相关，这凸显了有效初级预防的必要性。我们之前开发了“Ghya Bharari Ekatra”（GBE），这是一种针对居住在印度浦那贫民窟社区的新婚夫妇的基于夫妻关系的IPV初级预防干预措施。
通过这项试点研究，我们旨在探讨GBE的可接受性、安全性、可行性和初步疗效。
在2018年1月至5月期间，我们招募并分配了20对夫妇接受GBE干预并获得IPV支持服务信息，另外20对对照夫妇仅接受IPV支持服务信息。GBE干预由社区中的非专业同伴教育者以小组形式进行，每组3至5对夫妇，共进行6次每周一次的课程。干预内容涉及关系质量、心理韧性、沟通与冲突协商、自尊、性沟通与性健康知识以及IPV相关规范。结果评估包括与参与者和同伴进行的退出访谈，以检查可接受性和可行性挑战，以及基线访谈和3个月随访访谈，以检查IPV报告情况的变化以及女性的心理健康状况和男性的酒精滥用情况。过程评估考察了干预剂量、实际接受剂量、保真度、招募情况、参与率和背景情况。
有一半（40/83）符合条件并被邀请的夫妇同意参与GBE干预。保留率很高（17/20，在所有6次课程中的保留率为85%），退出访谈的反馈表明内容和授课方式很受欢迎，社区对该干预给予了高度支持。主要的可行性挑战在于招募收入最低且依赖日薪的男性。在干预过程中及3个月随访时，女性参与者均未报告任何安全问题。两组均未报告身体暴力或性暴力的IPV事件，但在3个月随访时，GBE干预组的心理虐待事件（3/17，18%）少于对照组参与者（4/16，25%）。女性干预参与者的整体心理健康状况也有显著改善，而对照组参与者则有所下降（一般健康问卷-12得分的平均变化：干预组为-0.13，对照组为0.13；P = 0.10）。
GBE在预防IPV和改善女性心理健康方面具有较高的可接受性、可行性和初步疗效。下一步包括根据试点研究结果完善干预内容，并通过大规模随机试验及更长时间的随访来检验干预效果。
ClinicalTrials.gov NCT03332134；https://clinicaltrials.gov/ct2/show/NCT03332134。印度临床试验注册中心CTRI/2018/01/011596；http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=21443。
国际注册报告识别码（IRRID）：RR2-10.2196/11533。
