Primary Prevention of Intimate Partner Violence in India

Study 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).

Official Title
-----------------
Primary Prevention of Intimate Partner Violence in India

Conditions
-----------------
Intimate Partner Violence

Intervention / Treatment
-----------------
* Behavioral: Intimate Partner Violence (IPV) Prevention Intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Married Couple Dyad<br>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<br>* 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.<br>|
| No Intervention: Control Group<br>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) |