Clinical trial NCT01661504: Evaluating Violence Against Women Screening in Mexico
Official title: Evaluating Violence Against Women Screening in Mexico
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Domestic Violence
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Innovations for Poverty Action
name: Mexican National Institute of Public Health
First posted: 2012-08-09
Enrollment: 959
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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


Eligibility 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.

Primary outcomes:
measure: Change in Intimate Partner Violence Victimization from Baseline
timeFrame: 12 months
Secondary outcomes:
measure: Change in Quality of Life Score
timeFrame: past month
measure: Change in Use of Community Resources
timeFrame: 12 months
measure: Change in Safety Planning
timeFrame: 12 Months
measure: Change in Reproductive Coercion
timeFrame: 12 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Health Clinics associated with Ministry of Health in Mexico City
Study officials:
affiliation: Yale School of Public Health
name: Jhumka Gupta, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Public Health - Mexico
name: Claudia Diaz Olavarrieta, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale School of Public Health
name: Kathryn L Falb, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gupta J, Willie TC, Harris C, Campos PA, Falb KL, Garcia Moreno C, Diaz Olavarrieta C, Okechukwu CA. Intimate partner violence against low-income women in Mexico City and associations with work-related disruptions: a latent class analysis using cross-sectional data. J Epidemiol Community Health. 2018 Jul;72(7):605-610. doi: 10.1136/jech-2017-209681. Epub 2018 Mar 7.
citation: Gupta J, Falb KL, Ponta O, Xuan Z, Campos PA, Gomez AA, Valades J, Carino G, Olavarrieta CD. A nurse-delivered, clinic-based intervention to address intimate partner violence among low-income women in Mexico City: findings from a cluster randomized controlled trial. BMC Med. 2017 Jul 12;15(1):128. doi: 10.1186/s12916-017-0880-y.
citation: Falb KL, Diaz-Olavarrieta C, Campos PA, Valades J, Cardenas R, Carino G, Gupta J. Evaluating a health care provider delivered intervention to reduce intimate partner violence and mitigate associated health risks: study protocol for a randomized controlled trial in Mexico City. BMC Public Health. 2014 Jul 30;14:772. doi: 10.1186/1471-2458-14-772.