Primary Prevention of Intimate Partner Violence in India

Not Applicable

Completed

• Conditions: Intimate Partner Violence
• Interventions: Behavioral: Intimate Partner Violence (IPV) Prevention Intervention

• Registration Number: NCT03332134
• Lead Sponsor: Emory University

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.

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 Timeline

• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-06
• Study Start: 2018-01-18
• Primary Completion: 2018-10-09
• Study Completion: 2018-10-09
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-27
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Married Couple Dyad	Intimate Partner Violence (IPV) Prevention Intervention	Husband-wife dyads will receive the intimate partner violence (IPV) intervention program over the course of six weeks.

Primary Outcome Measures

Name	Time	Method
IPV Intervention Safety	Duration of Study (Up to 3 Months)	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.
IPV Intervention Acceptability	Duration of Study (Up to 3 Months)	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.
IPV Intervention Feasibility	Duration of Study (Up to 3 Months)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Sexual Communication Skills	Baseline, Post-Intervention (3 Months)	Change in confidence in communicating to partner desire to have or not have sex
Change in Time Spent Together	Baseline, Post-Intervention (3 Months)	Change in time spent together alone with partner
Change in Self-esteem	Baseline, Post-Intervention (3 Months)	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).
Change in Communication Skills	Baseline, Post-Intervention (3 Months)	Change in confidence in communicating about various commonly-encountered scenarios with partner
Change in Conceptualization of IPV	Baseline, Post-Intervention (3 Months)	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.
Change in Attitudes toward IPV Acceptability	Baseline, Post-Intervention (3 Months)	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.
Change in Conflict Negotiation Skills	Baseline, Post-Intervention (3 Months)	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.
Change in Reproductive Health Beliefs linked to IPV	Baseline, Post-Intervention (3 Months)	Change in commonly held sexual and reproductive health beliefs linked to IPV perpetration.

Trial Locations

Locations (1)

National AIDS Research Institute; 🇮🇳 Pune, Maharashtra, India