Clinical trial NCT03332134: Primary Prevention of Intimate Partner Violence in India
Official title: Primary Prevention of Intimate Partner Violence in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intimate Partner Violence
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National AIDS Research Institute, India
First posted: 2017-11-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: IPV Intervention Acceptability
timeFrame: Duration of Study (Up to 3 Months)
measure: IPV Intervention Feasibility
timeFrame: Duration of Study (Up to 3 Months)
measure: IPV Intervention Safety
timeFrame: Duration of Study (Up to 3 Months)
Secondary outcomes:
measure: Change in Time Spent Together
timeFrame: Baseline, Post-Intervention (3 Months)
measure: Change in Self-esteem
timeFrame: Baseline, Post-Intervention (3 Months)
measure: Change in Communication Skills
timeFrame: Baseline, Post-Intervention (3 Months)
measure: Change in Conflict Negotiation Skills
timeFrame: Baseline, Post-Intervention (3 Months)
measure: Change in Sexual Communication Skills
timeFrame: Baseline, Post-Intervention (3 Months)
measure: Change in Reproductive Health Beliefs linked to IPV
timeFrame: Baseline, Post-Intervention (3 Months)
measure: Change in Conceptualization of IPV
timeFrame: Baseline, Post-Intervention (3 Months)
measure: Change in Attitudes toward IPV Acceptability
timeFrame: Baseline, Post-Intervention (3 Months)
Other outcomes:
Locations:
city: Pune
country: India
facility: National AIDS Research Institute
state: Maharashtra
Study officials:
affiliation: Emory University
name: Ameeta Kalokhe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.