The Primary Prevention of Intimate Partner Violence

NCT ID: NCT06811922

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-10-31

Brief Summary

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.

Conditions

Intimate Partner Violence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GBE (Ghya Bharaari Ekatra) Group

• 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.

Group Type: EXPERIMENTAL

GBE (Ghya Bharaari Ekatra) intervention

Intervention Type: BEHAVIORAL

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 Lens into Domestic Violence. The sessions will be audio-recorded and include a combination of didactics, interactive discussions, media use, and role play. The expected durations of sessions are 2 hours.

GBE will be delivered to a total of 500 dyads.

Ethical standard of care

Intervention Type: BEHAVIORAL

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.

Control Group

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

Group Type: ACTIVE_COMPARATOR

Ethical standard of care

Intervention Type: BEHAVIORAL

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.

Interventions

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 Lens into Domestic Violence. The sessions will be audio-recorded and include a combination of didactics, interactive discussions, media use, and role play. The expected durations of sessions are 2 hours.

GBE will be delivered to a total of 500 dyads.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Ghya Bharaari Ekatra intervention; Take a flight together intervention; IPV 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Ameeta Kalokhe

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ameeta Kalokhe, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Indian Council of Medical Research-National Institute for Research in Reproductive and Child Health (ICMR-NIRRCH),

Mumbai, Maharashtra, India

Indian Council of Medical Research - National Institute of Translational Virology and AIDS Research (ICMR-NITVAR)

Pune, Maharashtra, India

Countries

India

Central Contacts

Ameeta Kalokhe, MD

Role: CONTACT

akalokh@emory.edu

404-712-1924

Other Identifiers

1R01HD114862-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007022

Identifier Type: -

Identifier Source: org_study_id