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Primary Prevention of Intimate Partner Violence in India

Primary Prevention of Intimate Partner Violence in India

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03332134
Enrollment
80
Registered
2017-11-06
Start date
2018-01-18
Completion date
2018-10-09
Last updated
2019-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intimate Partner Violence

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).

Interventions

BEHAVIORALIntimate 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.

Sponsors

National AIDS Research Institute, India
CollaboratorUNKNOWN
Emory University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
IPV Intervention SafetyDuration 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 AcceptabilityDuration 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 FeasibilityDuration 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

MeasureTime frameDescription
Change in Conflict Negotiation SkillsBaseline, Post-Intervention (3 Months)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.
Change in Sexual Communication SkillsBaseline, Post-Intervention (3 Months)Change in confidence in communicating to partner desire to have or not have sex
Change in Time Spent TogetherBaseline, Post-Intervention (3 Months)Change in time spent together alone with partner
Change in Conceptualization of IPVBaseline, Post-Intervention (3 Months)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.
Change in Attitudes toward IPV AcceptabilityBaseline, Post-Intervention (3 Months)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.
Change in Reproductive Health Beliefs linked to IPVBaseline, Post-Intervention (3 Months)Change in commonly held sexual and reproductive health beliefs linked to IPV perpetration.
Change in Self-esteemBaseline, Post-Intervention (3 Months)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).
Change in Communication SkillsBaseline, Post-Intervention (3 Months)Change in confidence in communicating about various commonly-encountered scenarios with partner

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026