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临床试验/NCT06811922
NCT06811922尚未招募不适用

Primary Prevention of Intimate Partner Violence

Emory University4 个研究点 分布在 1 个国家目标入组 1,700 人开始时间: 2026年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,700
试验地点
4
主要终点
Intimate Partner Violence (IPV) Experience

研究概览

简要总结

This is a cluster randomized trial for newly married dyads, that seeks to quantify the impact of GBE's (Ghya Bharaari Ekatra's) intervention on intimate partner violence (IPV) and downstream outcomes, mental health and reproductive autonomy, examine its mechanism of action, contexts in which it may need modification, and factors associated with its future successful adoption and implementation.

详细描述

Intimate partner violence (IPV) is experienced by one-fourth of women in India and associated with poor mental, physical, sexual and reproductive health, leading many experts including the World Health Organization to call for the urgent development of effective primary IPV prevention. The investigators previously developed an evidence-based, theory-driven, dyadic intervention, Ghya Bharaari Ekatra (GBE, "Take a Flight Together," NIH/FIC K01 TW009664) for the primary prevention of IPV among newly married couples residing in slums in India. GBE is delivered over six weekly sessions by a team of lay peer educators to groups of five couples and makes use of engaging culturally tailored delivery methods to challenge norms and build knowledge and skills to address six key IPV determinants: limited relationship quality time, poor self-esteem, resilience, communication and conflict management, sexual communication and sexual/reproductive health knowledge, and conservative IPV norms and definitions. In a pilot study of 40 couples married < 1 year, it was found that GBE demonstrated high acceptance (with 85% of participants retained across all 6 sessions), feasibility, safety (no reported adverse events), and preliminary efficacy in preventing IPV and improving mental health in the female partner. The investigators now seek to quantify GBE's impact on IPV and downstream outcomes, mental health and reproductive autonomy, examine its mechanism of action, contexts in which it may need modification, and factors associated with its future successful adoption and implementation.

The research team hypothesizes that (1) GBE prevents IPV experience and enhances reproductive autonomy among women,(2) GBE improves mental health among both dyadic members, and (3) GBE's effects are mediated by the IPV determinants it was designed to address. The team, with 15 years of IPV research experience in India, proposes a cluster randomized trial of 850 newly married dyads (500 to GBE and 350 controls) in Maharashtra, India to execute the following aims: 1) to quantify the impact of the GBE intervention compared to the ethical standard of care (information on IPV and mental and reproductive/sexual health resources) in preventing IPV experience (primary outcome), enhancing reproductive autonomy among newly married women (secondary outcome) and mental health among the both members of the dyad (secondary outcome) at 12 months; 2) to conduct mediation and moderation analyses for the efficacy of the GBE intervention; and 3) to identify barriers, facilitators, and strategies for future, successful adoption and implementation of GBE through exit interviews with GBE participants and qualitative interviews, guided by Consolidated Framework for Implementation Research, with interventionists, adopters, and other stakeholders who have influence over implementation outcomes. Study findings will provide the information necessary to facilitate scale-up of GBE across India and similar resource-limited, high-burden settings globally upon study completion.

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
None

入排标准

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

入选标准

  • couples wherein both members are age ≥18 years,
  • married ≤ 1 year, in their first marriage, married to only one individual, cohabiting in a slum in Mumbai or Pune India, and
  • fluent in Marathi and/or Hindi
  • Both members of the couple must meet eligibility criteria and be present at the session for the couple to participate.

排除标准

  • As GBE was designed for primary IPV prevention, couples in which the female member screens positive for physical and/or sexual IPV (using the modified Conflict Tactics Scale (CTS-2)) at baseline will be excluded (and referred to support services)
  • those in the 3rd trimester of pregnancy (as women traditionally return to their natal home during this perinatal period).

研究组 & 干预措施

GBE (Ghya Bharaari Ekatra) Group

Experimental
  • Dyads assigned to the GBE arm will be sequentially assigned into a group composed of 5 newly married (married ≤ 1 yr) couples.
  • GBE will be delivered to groups of 5 newly married couples (husband-wife dyads) in weekly 2-hour sessions over a 6-week period, plus ethical standard of care (information about IPV resources).
  • GBE will be facilitated by a male/female pair of trained peer educators and held at a community-based venue, in the slum communities in which the couples reside.
  • The intervention is highly participatory.

干预措施: GBE (Ghya Bharaari Ekatra) intervention (Behavioral)

GBE (Ghya Bharaari Ekatra) Group

Experimental
  • Dyads assigned to the GBE arm will be sequentially assigned into a group composed of 5 newly married (married ≤ 1 yr) couples.
  • GBE will be delivered to groups of 5 newly married couples (husband-wife dyads) in weekly 2-hour sessions over a 6-week period, plus ethical standard of care (information about IPV resources).
  • GBE will be facilitated by a male/female pair of trained peer educators and held at a community-based venue, in the slum communities in which the couples reside.
  • The intervention is highly participatory.

干预措施: Ethical standard of care (Behavioral)

Control Group

Active Comparator

Control groups will solely receive the ethical standard of care (information about IPV resources).

干预措施: Ethical standard of care (Behavioral)

结局指标

主要结局

Intimate Partner Violence (IPV) Experience

时间窗: 12 months post intervention

IPV experience is defined as a woman experiencing one or more act of physical, sexual, and/or psychological IPV.

次要结局

  • Change in General Health Questionnaire-12 (GHQ-12) Score(Baseline, 6 and 12 months post intervention)
  • Change in Reproductive Autonomy Scale (RAS) Score(Baseline, 6 and 12 months post intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ameeta Kalokhe

Associate Professor

Emory University

研究点 (4)

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