Primary Prevention of Intimate Partner Violence in India

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.

Study Overview

• Status: Completed
• Conditions: Intimate Partner Violence
• Intervention / Treatment: Behavioral: Intimate Partner Violence (IPV) Prevention Intervention

Detailed Description

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 conducted over a six week period.

Acceptability and feasibility will be assessed through semi-structured interviews with participants and staff post-intervention. Safety will be gauged through semi-structured interviews with women participants and efficacy will be gauged through change in proximal determinants of IPV in this population (i.e. time spent in the relationship, self-esteem, resilience, communication and conflict management skills, sexual communication, attitudes toward IPV acceptability, and conceptualization of IPV).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Pune, Maharashtra, India, 411026
      • National AIDS Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Married Couple Dyad; 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; 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.
No Intervention: Control Group; Husband-wife dyads in the control group will not receive an intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Time Spent Together	Change in time spent together alone with partner	Baseline, Post-Intervention (3 Months)
Change in Self-esteem	Change in score on Rosenberg Self-esteem Scale. The scale measures self-esteem on a scale of 0-30 (wherein lower scores are suggestive of lower self-esteem).	Baseline, Post-Intervention (3 Months)
Change in Communication Skills	Change in confidence in communicating about various commonly-encountered scenarios with partner	Baseline, Post-Intervention (3 Months)
Change in Conflict Negotiation Skills	Change in Revised Conflict Tactics Scale (CTS2) Negotiation Subscale score. The negotiation subscale measure actions taken to settle disagreements. The minimum score is 0 and the maximum is 150, with higher scores suggestive of better negotiation skills.	Baseline, Post-Intervention (3 Months)
Change in Sexual Communication Skills	Change in confidence in communicating to partner desire to have or not have sex	Baseline, Post-Intervention (3 Months)
Change in Reproductive Health Beliefs linked to IPV	Change in commonly held sexual and reproductive health beliefs linked to IPV perpetration.	Baseline, Post-Intervention (3 Months)
Change in Conceptualization of IPV	Change in acknowledgement of behaviors that constitute IPV. This outcome is assessed using an adaptation of the Indian Family Violence and Control Scale, wherein response choices will include "not violence," "mild violence," "moderate violence, and "severe violence." The minimal score will be 12 and the maximum 48, with greater scores being suggestive of the participant having a more comprehensive conceptualization of behaviors constituting IPV.	Baseline, Post-Intervention (3 Months)
Change in Attitudes toward IPV Acceptability	Change in attitudes toward situations in which beating a partner may be acceptable. This outcome is assessed using adapted questions from the National Family Health Survey Attitudes Towards Wife Beating module. It is assessed based on the frequency of affirmative responses to the questions, with more affirmative responses being associated with greater acceptance of IPV.	Baseline, Post-Intervention (3 Months)

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National AIDS Research Institute, India
• Investigators: Principal Investigator: Ameeta Kalokhe, MD, Emory University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2018
• Primary Completion (Actual): October 9, 2018
• Study Completion (Actual): October 9, 2018

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 27, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IRB00069846

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No