Evaluating Violence Against Women Screening in Mexico

Domestic Violence Clinical Trial

Official title:

Evaluating Violence Against Women Screening in Mexico

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01661504
• Other study ID #: 1202009793
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: September 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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), including severe 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 959
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Domestic Violence

Intervention

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

Locations

Country	Name	City	State
Mexico	Health Clinics associated with Ministry of Health in Mexico City	Mexico City

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Innovations for Poverty Action, Mexican National Institute of Public Health

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intimate Partner Violence Victimization from Baseline	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.	12 months
Secondary	Change in Quality of Life Score		past month
Secondary	Change in Use of Community Resources	Adapted Community Resources Checklist	12 months
Secondary	Change in Safety Planning	Adapted Safety Behavior Checklist	12 Months
Secondary	Change in Reproductive Coercion		12 months

External Links

•   protocol paper (published)