Primary Prevention of Intimate Partner Violence in India

Intimate Partner Violence Clinical Trial

Official title:

Primary Prevention of Intimate Partner Violence in India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332134
• Other study ID #: IRB00069846
• Status: Completed
• Phase: N/A
• Start date: January 18, 2018
• Est. completion date: October 9, 2018

Study information

• Verified date: January 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 9, 2018
• Est. primary completion date: October 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intimate Partner Violence

Intervention

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.

Locations

Country	Name	City	State
India	National AIDS Research Institute	Pune	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National AIDS Research Institute, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Change in Time Spent Together	Change in time spent together alone with partner	Baseline, Post-Intervention (3 Months)
Secondary	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)
Secondary	Change in Communication Skills	Change in confidence in communicating about various commonly-encountered scenarios with partner	Baseline, Post-Intervention (3 Months)
Secondary	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)
Secondary	Change in Sexual Communication Skills	Change in confidence in communicating to partner desire to have or not have sex	Baseline, Post-Intervention (3 Months)
Secondary	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)
Secondary	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)
Secondary	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)