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Not yet recruiting NCT06811922

The Primary Prevention of Intimate Partner Violence

No phase Interventional Intimate Partner Violence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GBE (Ghya Bharaari Ekatra) intervention, Ethical standard of care.
Who it may be relevant to
Registry conditions: Intimate Partner Violence. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Primary Prevention of Intimate Partner Violence

Overview

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.

Detailed description

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.

Interventions

  • Behavioral 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
  • Behavioral 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.

Primary outcome measures

  • Intimate Partner Violence (IPV) Experience [Time frame: 12 months post intervention]
Secondary outcome measures (2)
  • Change in General Health Questionnaire-12 (GHQ-12) Score [Time frame: Baseline, 6 and 12 months post intervention]
  • Change in Reproductive Autonomy Scale (RAS) Score [Time frame: Baseline, 6 and 12 months post intervention]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

India · 2 centers
  • 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

Publications

  • 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

Identifiers

NCT: NCT06811922 · STUDY00007022 · 1R01HD114862-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗