Clinical trial NCT06811922: The Primary Prevention of Intimate Partner Violence
Official title: Primary Prevention of Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intimate Partner Violence
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2025-02-06
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Intimate Partner Violence (IPV) Experience
timeFrame: 12 months post intervention
Secondary outcomes:
measure: Change in General Health Questionnaire-12 (GHQ-12) Score
timeFrame: Baseline, 6 and 12 months post intervention
measure: Change in Reproductive Autonomy Scale (RAS) Score
timeFrame: Baseline, 6 and 12 months post intervention
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Indian Council of Medical Research-National Institute for Research in Reproductive and Child Health (ICMR-NIRRCH),
state: Maharashtra
city: Pune
country: India
facility: Indian Council of Medical Research - National Institute of Translational Virology and AIDS Research (ICMR-NITVAR)
state: Maharashtra
Study officials:
affiliation: Emory University
name: Ameeta Kalokhe, MD
role: PRINCIPAL_INVESTIGATOR
References: