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Набор скоро начнётся NCT06811922

The Primary Prevention of Intimate Partner Violence

Без фазы С лечением Intimate Partner Violence

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: GBE (Ghya Bharaari Ekatra) intervention, Ethical standard of care.
Кому может быть актуально
Состояния в реестре: Intimate Partner Violence. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Индия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Primary Prevention of Intimate Partner Violence

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое GBE (Ghya Bharaari Ekatra) intervention
    Ghya Bharaari Ekatra (Marathi for "Take a flight together") intervention The intervention consists of six sessions. Each session will cover one of 6 major modules to enhance transformation of motivation: 1) You, Me, and Us: Spending Meaningful Time Together, 2) I'm a Champion: I Can't Be Broken and I don't Accept Defeat! 3) Building Communication and conflict management strategies, and 4) Empowerment of the Couple: Planning Ahead, 5) Sexual communication and the sexual relationships, and 6) A L
  • Поведенческое Ethical standard of care
    Ethical standard of care includes information on IPV and mental and reproductive/sexual health resources) to prevent IPV experience. This intervention will be delivered to a total of 350 dyads.

Первичные конечные точки

  • Intimate Partner Violence (IPV) Experience [Срок оценки: 12 months post intervention]
Вторичные конечные точки (2)
  • Change in General Health Questionnaire-12 (GHQ-12) Score [Срок оценки: Baseline, 6 and 12 months post intervention]
  • Change in Reproductive Autonomy Scale (RAS) Score [Срок оценки: Baseline, 6 and 12 months post intervention]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Индия · 2 центра
  • Indian Council of Medical Research-National Institute for Research in Reproductive and Chi — Mumbai
  • Indian Council of Medical Research - National Institute of Translational Virology and AIDS — Pune

Публикации

  • Kalokhe AS, Begum S, Bangar S, Bhise M, Freeman MC, Katendra T, Rahane G, Ravi U, Patel SA, Prusty R, Sales JM, Wirtz S, Sahay S. 'Ghya Bharaari Ekatra': study protocol for a cluster randomized trial to evaluate a couples-based intervention for the primary prevention of intimate partner violence in India. BMC Public Health. 2026 Mar 24;26(1):1705. doi: 10.1186/s12889-026-26803-9. PMID 41872785

Идентификаторы

NCT: NCT06811922 · STUDY00007022 · 1R01HD114862-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗