The Primary Prevention of Intimate Partner Violence

Primary Prevention of Intimate Partner Violence

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intimate Partner Violence
• Intervention / Treatment: Behavioral: GBE (Ghya Bharaari Ekatra) intervention; Behavioral: Ethical standard of care

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.

• Study Type: Interventional
• Enrollment (Estimated): 1700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ameeta Kalokhe, MD; Phone Number: 404-712-1924; Email: akalokh@emory.edu

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Indian Council of Medical Research-National Institute for Research in Reproductive and Child Health (ICMR-NIRRCH),
    • Pune, Maharashtra, India, 411026
      • Indian Council of Medical Research - National Institute of Translational Virology and AIDS Research (ICMR-NITVAR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 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.; Other Names: Ghya Bharaari Ekatra intervention; Take a flight together intervention; IPV Intervention; 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.
Active Comparator: Control Group; Control groups will solely receive the ethical standard of care (information about IPV resources).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intimate Partner Violence (IPV) Experience	IPV experience is defined as a woman experiencing one or more act of physical, sexual, and/or psychological IPV.	12 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in General Health Questionnaire-12 (GHQ-12) Score	Mental health is assessed using the General Health Questionnaire-12 (GHQ-12). The GHQ-12 is scored using a 4-point Likert scale, where each item is assigned a value from 0 to 3, resulting in a total score ranging from 0 to 36, with higher scores indicating greater psychological distress.	Baseline, 6 and 12 months post intervention
Change in Reproductive Autonomy Scale (RAS) Score	Reproductive autonomy among women is measured using a culturally-tailored version of the Reproductive Autonomy Scale (RAS). The RAS is a 14-item self-reported measure of individual experiences of ability to achieve reproductive goals, comprising of three domains: Decision-making, Freedom from Coercion, and Communication. The Decision-making subscale uses a 3-point Likert scale, where each item is assigned a value of 1 to 3. The Freedom from Coercion and Communication Subscales use a 4-point Likert scale, where each item is assigned a value of 1 to 4. Item scores are averaged to calculate subscale and total measure scores. Higher scores indicate greater levels of autonomy.	Baseline, 6 and 12 months post intervention

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Ameeta Kalokhe, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: February 2, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Enzymes; Enzymes and Coenzymes; Transferases; Hexosyltransferases; Glycosyltransferases; Glucosyltransferases; Methods; 1,4-alpha-Glucan Branching Enzyme
• Other Study ID Numbers: STUDY00007022; 1R01HD114862-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant survey data collected during the trial that underlie the results reported, after deidentification.
• IPD Sharing Time Frame: Data will be made as soon as possible, and no later than the time of publication, or end of the funding period, whichever comes first. Data will remain available indefinitely.

IPD Sharing Access Criteria

Globally available to researchers from academic institutions for intervention, program, or policy development. Restrictions will be outlined in the Restricted Data Use Agreement.

Data will be available to achieve aims in an approved proposal. Data will be deposited in Data Sharing Demographic Research (DSDR). Must be using a secure server to access data. To gain access, data requestors must ensure request conforms to restrictions outlined in the Restricted Use Data Agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No