Primary Prevention of Intimate Partner Violence in India

NCT03332134 | Completed

• 1 other identifier: IRB00069846
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to test and evaluate the feasibility, acceptance, safety, and efficacy of an an intimate partner violence (IPV) intervention in recently-married, low-income husband-wife dyads in Pune, India.

Conditions

Intimate Partner Violence

Outcome Measures

Primary Outcomes (3)

• IPV Intervention Acceptability

  Acceptability of the intervention to the dyad will be collected qualitatively and gauged by extracting themes regarding acceptability of modular content, timing of the intervention, safety precautions, number and duration of the intervention sessions, and appropriateness of intervention staff through semi-structured interviews between administrators and participants.

  Duration of Study (Up to 3 Months)

• IPV Intervention Feasibility

  Intervention feasibility will be qualitatively assessed by extracting themes from post-session semi-structured interviews of difficulties in intervention delivery, participant understanding of the intervention, and logistical problems with the intervention setting, timing, staff training, and debriefings as reported by the intervention administrator.

  Duration of Study (Up to 3 Months)

• IPV Intervention Safety

  Safety of the intervention will be gauged by extracting themes of incident IPV events or changes in IPV frequency or severity reported by the wife at the three-month follow-up through semi-structured interviews between administrators and participants.

  Duration of Study (Up to 3 Months)

Secondary Outcomes (8)

• Change in Time Spent Together

  Baseline, Post-Intervention (3 Months)

• Change in Self-esteem

  Baseline, Post-Intervention (3 Months)

• Change in Communication Skills

  Baseline, Post-Intervention (3 Months)

• Change in Conflict Negotiation Skills

  Baseline, Post-Intervention (3 Months)

• Change in Sexual Communication Skills

  Baseline, Post-Intervention (3 Months)

Study Arms (2)

Married Couple Dyad

EXPERIMENTAL

Husband-wife dyads will receive the intimate partner violence (IPV) intervention program over the course of six weeks.

Behavioral: Intimate Partner Violence (IPV) Prevention Intervention

Control Group

NO INTERVENTION

Husband-wife dyads in the control group will not receive an intervention.

Interventions

Intimate Partner Violence (IPV) Prevention Intervention BEHAVIORAL

The IPV 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 session 1, 2-6, and the 3-month follow-up are 120 minutes, and 60-90 minutes, respectively.

Married Couple Dyad

Eligibility Criteria

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

You may qualify if:

• Recently married (i.e. \<1 year) husband-wife dyads
• First marriage
• Planning to reside in Pune for the majority of the next 6 months
• Marathi fluency
• Lives with partner
• Lives in a slum, slum redevelopment community, or chawl

You may not qualify if:

• Pregnant in third trimester of pregnancy
• Women who respond affirmatively to either a physical and/or sexual IPV item on the IFVCS short form

Sponsors & Collaborators

• Emory University: lead
• National AIDS Research Institute, India: collaborator

Study Sites (1)

National AIDS Research Institute

Pune, Maharashtra, 411026, India

Location

Related Publications (2)

• Kalokhe AS, Iyer S, Gadhe K, Katendra T, Kolhe A, Rahane G, Stephenson R, Sahay S. A Couples-Based Intervention (Ghya Bharari Ekatra) for the Primary Prevention of Intimate Partner Violence in India: Pilot Feasibility and Acceptability Study. JMIR Form Res. 2021 Feb 1;5(2):e26130. doi: 10.2196/26130.

  PMID: 33459278 DERIVED

• Kalokhe AS, Iyer S, Katendra T, Gadhe K, Kolhe AR, Paranjape A, Del Rio C, Stephenson R, Sahay S. Primary Prevention of Intimate Partner Violence Among Recently Married Dyads Residing in the Slums of Pune, India: Development and Rationale for a Dyadic Intervention. JMIR Res Protoc. 2019 Jan 18;8(1):e11533. doi: 10.2196/11533.

  PMID: 30664483 DERIVED

MeSH Terms

Interventions

Poliovirus Vaccine, Inactivated

Intervention Hierarchy (Ancestors)

Vaccines, Inactivated; Vaccines; Biological Products; Complex Mixtures; Poliovirus Vaccines; Viral Vaccines

Study Officials

• Ameeta Kalokhe, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 6, 2017
• Study Start: January 18, 2018
• Primary Completion: October 9, 2018
• Study Completion: October 9, 2018
• Last Updated: January 29, 2019

Record last verified: 2019-01

Locations

IN (1)