Primary Prevention of Intimate Partner Violence in India

NCT ID: NCT03332134

Last Updated: 2019-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-18

Study Completion Date

2018-10-09

Brief Summary

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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

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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).

Conditions

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Intimate Partner Violence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Married Couple Dyad

Husband-wife dyads will receive the intimate partner violence (IPV) intervention program over the course of six weeks.

Group Type EXPERIMENTAL

Intimate Partner Violence (IPV) Prevention Intervention

Intervention Type BEHAVIORAL

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.

Control Group

Husband-wife dyads in the control group will not receive an intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National AIDS Research Institute, India

UNKNOWN

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Ameeta Kalokhe

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ameeta Kalokhe, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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National AIDS Research Institute

Pune, Maharashtra, India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED
PMID: 33459278 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30664483 (View on PubMed)

Other Identifiers

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IRB00069846

Identifier Type: -

Identifier Source: org_study_id

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