Evaluating Violence Against Women Screening in Mexico

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Yale University
Sponsor:
Collaborators:
Innovations for Poverty Action
Mexican National Institute of Public Health
Information provided by (Responsible Party):
Jhumka Gupta, Yale University
ClinicalTrials.gov Identifier:
NCT01661504
First received: August 2, 2012
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

The overall goal of this proposed study is to develop the state of knowledge in the area of gender-based violence and reproductive health by conducting a randomized controlled trial to improve the health care provider's capacity to screen for intimate partner violence and to mitigate associated risk among women health clinic patrons of reproductive age (ages18-44) with recent experiences of physical or sexual partner violence in Mexico City and its surrounding area.

The specific research objectives are as follows:

  1. To increase mid-level health care providers' capacity to identify Intimate Partner Violence (IPV) and assist women with risk mitigation
  2. Utilizing a randomized controlled trial, to assess the impact of an enhanced health care worker screening and counselling program on (a) past year severe IPV (sexual or physical) and injuries from such IPV; (b) reproductive coercion (c) use of community-based resources and safety planning; and (d) quality of life; versus minimum standard of care
  3. To qualitatively examine which programmatic components may serve as mechanisms for observed changes stated in the second objective
  4. To synthesize study findings and a) create recommendations for clinic-based intervention programs to address IPV in low and middle income countries and b) disseminate information as reports, presentation, and peer-reviewed publications

Condition Intervention
Domestic Violence
Behavioral: Integrated Screening

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: Evaluating Violence Against Women Screening in Mexico

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change in Intimate Partner Violence Victimization from Baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Participants will be followed up at 3 months and at 15 months post-baseline to assess intimate partner violence victimization as measured by an adapted Conflict Tactics Scale - 2. This will allow for a 12 month follow-up from the booster counseling session in the intervention group which occurs at 3 months post-baseline.


Secondary Outcome Measures:
  • Change in Quality of Life Score [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Change in Use of Community Resources [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Adapted Community Resources Checklist

  • Change in Safety Planning [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Adapted Safety Behavior Checklist

  • Change in Reproductive Coercion [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: March 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Referral Card Only
Women participants at control clinics will be given a referral card containing general information on IPV and a list of resources specific to their community
Experimental: Integrated Screening
The intervention arm will consist of the following components (described in detail below): a) integrated IPV/Sexual and Reproductive Health Screening, b) supportive care, c) safety planning and harm reduction counseling, d) supported referrals, e) booster counseling sessions at 3 months post-baseline / initial counseling
Behavioral: Integrated Screening
The intervention arm will consist of the following components (described in detail below): a) integrated IPV/Sexual and Reproductive Health Screening, b) supportive care, c) safety planning and harm reduction counseling, d) supported referrals, e) booster counseling sessions

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 18-44
  • Currently in heterosexual relationship with a male partner
  • Responds in affirmative to past year sexual or physical violence

Exclusion Criteria:

  • Cognitive impairment (slurred speech, inability to follow directions)
  • Seeking treatment for life threatening emergency care
  • Intends to relocate within 2 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01661504

Contacts
Contact: Jhumka Gupta, ScD 203-737-4656 jhumka.gupta@yale.edu
Contact: Claudia Diaz Olavarrieta, PhD 011-52-55- 56-55-52-91 colavarrieta@insp.mx

Locations
Mexico
Health Clinics associated with Ministry of Health in Mexico City Recruiting
Mexico City, Mexico
Contact: Paola Campos       pcampos@poverty-action.org   
Sponsors and Collaborators
Yale University
Innovations for Poverty Action
Mexican National Institute of Public Health
Investigators
Principal Investigator: Jhumka Gupta, ScD Yale School of Public Health
Principal Investigator: Claudia Diaz Olavarrieta, PhD National Institute of Public Health - Mexico
Principal Investigator: Kathryn L Falb, ScD Yale School of Public Health
  More Information

No publications provided

Responsible Party: Jhumka Gupta, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT01661504     History of Changes
Other Study ID Numbers: W-3968
Study First Received: August 2, 2012
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 29, 2014