The Primary Prevention of Intimate Partner Violence

NCT06811922 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY000070221R01HD114862-01
• Study Type: interventional
• Target: 1,700
• Locations: 1 country
• Sites: 2

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.

Conditions

Intimate Partner Violence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

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.

Behavioral: GBE (Ghya Bharaari Ekatra) intervention; Behavioral: Ethical standard of care

Control Group

ACTIVE COMPARATOR

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

Behavioral: Ethical standard of care

Interventions

GBE (Ghya Bharaari Ekatra) intervention 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.

Also known as: Ghya Bharaari Ekatra intervention, Take a flight together intervention, IPV Intervention

GBE (Ghya Bharaari Ekatra) Group

Ethical standard of care 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; GBE (Ghya Bharaari Ekatra) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Emory University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

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

Mumbai, Maharashtra, 400012, India

Location

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

Pune, Maharashtra, 411026, India

Location

MeSH Terms

Interventions

1,4-alpha-Glucan Branching Enzyme; Methods

Intervention Hierarchy (Ancestors)

Glucosyltransferases; Hexosyltransferases; Glycosyltransferases; Transferases; Enzymes; Enzymes and Coenzymes; Investigative Techniques

Study Officials

• Ameeta Kalokhe, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ameeta Kalokhe, MD

CONTACT

404-712-1924; akalokh@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Eligible dyads will be sequentially enrolled and randomly assigned within each geographic strata (slum community) of Mumbai and Pune (equal numbers in both cities) using a computer-generated randomization scheme to the GBE intervention (n=500 dyads) or control arm (n=350 dyads); total n=1,700 participants.

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 6, 2025
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

IN (2)