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Clinical Trials/NCT03332134
NCT03332134
Completed
Not Applicable

Primary Prevention of Intimate Partner Violence in India

Emory University1 site in 1 country80 target enrollmentJanuary 18, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intimate Partner Violence
Sponsor
Emory University
Enrollment
80
Locations
1
Primary Endpoint
IPV Intervention Safety
Status
Completed
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 18, 2018
End Date
October 9, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ameeta Kalokhe

Assistant Professor

Emory University

Eligibility Criteria

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

Outcomes

Primary Outcomes

IPV Intervention Safety

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Change in Sexual Communication Skills(Baseline, Post-Intervention (3 Months))
  • 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 Conceptualization of IPV(Baseline, Post-Intervention (3 Months))
  • Change in Attitudes toward IPV Acceptability(Baseline, Post-Intervention (3 Months))
  • Change in Conflict Negotiation Skills(Baseline, Post-Intervention (3 Months))
  • Change in Reproductive Health Beliefs linked to IPV(Baseline, Post-Intervention (3 Months))

Study Sites (1)

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