Intimate Partner Violence Prevention in Nepal

NCT02942433 | Completed

• 1 other identifier: IRB00091115
• Study Type: interventional
• Target: 4,677
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Change Starts at Home (Change) is a multi-component social behavior change communication and community engagement strategy designed to prevent intimate partner violence (IPV), a significant public health issue in Nepal and throughout the world. Methods and analysis: The study uses a concurrent mixed-methods design. The quantitative aspect of the evaluation is a pair-matched, repeated cross-sectional 2-armed, single-blinded cluster trial (RCT: N=36 clusters, 1440 individuals), comparing a social behavior change communication (SBCC) strategy to radio programming alone for its impact on physical and / or sexual IPV at the end of programming (12 months' post-baseline) and 6-months post the cessation of project activities (24-months post baseline). The qualitative aspects of the design include several longitudinal approaches to understand the impact of the intervention and examine mechanisms of change including in-depth interviews with participants (N=18 couples), and focus group discussions with community leaders (N=3 groups), and family members of participants (N=12 groups). Treatment effects will be estimated with generalized logistic mixed models specified to compare differences in primary outcome from baseline to follow-up, and baseline to 24-months post following intention-to-treat principles.

Conditions

Intimate Partner Violence

Outcome Measures

Primary Outcomes (1)

• Change in Prevalence of Physical and/or Sexual Intimate Partner Violence Encounters

  The number of physical and/or sexual intimate partner violence encounters will be collected via the standard measure for Assessment of Intimate Partner Violence for the Global Program to Prevention Violence Against Women and Girls at baseline, month 12, and month 24.

  Baseline, 24 Month Follow Up

Study Arms (2)

Radio Program

EXPERIMENTAL

Married couple participants will be asked to interact with a radio program and participate in weekly, sex-separate listening and discussion groups (LDG) that each last for between 75 and 120 minutes over the course of 9 months.

Behavioral: Behavior Change Communication; Behavioral: Community Mobilization; Behavioral: Advocacy

Control

OTHER

The control group participants will be exposed to the radio program only, and will not participate in the LDGs, nor will they or their family members participate in the workshops and community activities.

Behavioral: Behavior Change Communication

Interventions

Behavior Change Communication BEHAVIORAL

9-month weekly episode behavior change radio drama with interactive voice response (IVR)/short message service (SMS) listener engagement

Control; Radio Program

Community Mobilization BEHAVIORAL

Listening and discussions groups, 2 male and 2 female groups per study site meet weekly for 39 weeks and will receive training on gender equity, intimate partner violence (IPV), life skills, community mobilization, non-violent conflict resolution for listening and discussion group (LDG) facilitators to support knowledge and skill set acquisition of LDG members. There will be a joint couple's session every month to foster mutual learning and understanding in addition to community mobilization incentives led by LDGs and encouragement of family members of LGD members to listen to the radio and attend LDG sessions once every 3 months. Participants will also receive awareness raising and street theater to engage families and community members.

Radio Program

Advocacy BEHAVIORAL

Training and 6-month follow up of religious/community leaders and religious leaders support community mobilization activity of local listening and discussion group (LGD).

Radio Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female survey participants
• Of reproductive age (between 18-49 years)
• Husband is at least 18 years of age
• Both the wife and husband reside regularly in the study area
• The wife and husband live together
• Family Members
• At least 18 years of age
• A family member of a Listening and Discussion Group member
• Community Leaders
• At least 18 years of age
• Considered to be in a position of authority or influence within the study communities per the recommendation of other community stakeholders
• Listening and Discussion Group facilitators
• Have a 12th grade standard academic qualification or better
• Be living with his/her spouse
• Have good communication skills

You may not qualify if:

• Participants must be able to communicate in Nepali
• Must not be have plans to relocate in the coming 2 years
• A physical or cognitive impairment that precludes participation for the duration requested by activity

Sponsors & Collaborators

• Emory University: lead

Related Publications (4)

• Clark CJ, Batayeh B, Shrestha PN, Morrow G, Shrestha B, Ferguson G. Diffusion in social norms change about violence against women: A longitudinal analysis of intervention data from a cluster randomised trial. Glob Public Health. 2021 Oct;16(10):1618-1630. doi: 10.1080/17441692.2020.1828984. Epub 2020 Oct 6.

  PMID: 33021877 DERIVED

• Clark CJ, Shrestha B, Ferguson G, Shrestha PN, Calvert C, Gupta J, Batayeh B, Bergenfeld I, Oakes JM. Impact of the Change Starts at Home Trial on Women's experience of intimate partner violence in Nepal. SSM Popul Health. 2019 Dec 13;10:100530. doi: 10.1016/j.ssmph.2019.100530. eCollection 2020 Apr.

  PMID: 31890850 DERIVED

• Cardoso LF, Clark CJ, Rivers K, Ferguson G, Shrestha B, Gupta J. Menstrual restriction prevalence and association with intimate partner violence among Nepali women. BMJ Sex Reprod Health. 2018 Sep 28;45(1):38-43. doi: 10.1136/bmjsrh-2017-101908. Online ahead of print.

  PMID: 30266716 DERIVED

• Clark CJ, Spencer RA, Shrestha B, Ferguson G, Oakes JM, Gupta J. Evaluating a multicomponent social behaviour change communication strategy to reduce intimate partner violence among married couples: study protocol for a cluster randomized trial in Nepal. BMC Public Health. 2017 Jan 13;17(1):75. doi: 10.1186/s12889-016-3909-9.

  PMID: 28086857 DERIVED

Study Officials

• Cari Clark, Sc.D., M.P.H.

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 24, 2016
• Study Start: March 12, 2016
• Primary Completion: August 14, 2018
• Study Completion: August 14, 2018
• Last Updated: December 14, 2018

Record last verified: 2018-12