- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01661504
Evaluating Violence Against Women Screening in Mexico
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:
- To increase mid-level health care providers' capacity to identify Intimate Partner Violence (IPV) and assist women with risk mitigation
- 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
- To qualitatively examine which programmatic components may serve as mechanisms for observed changes stated in the second objective
- 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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mexico City, Mexico
- Health Clinics associated with Ministry of Health in Mexico City
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
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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
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Intimate Partner Violence Victimization from Baseline
Time Frame: 12 months
|
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.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quality of Life Score
Time Frame: past month
|
past month
|
|
Change in Use of Community Resources
Time Frame: 12 months
|
Adapted Community Resources Checklist
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12 months
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Change in Safety Planning
Time Frame: 12 Months
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Adapted Safety Behavior Checklist
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12 Months
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Change in Reproductive Coercion
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1202009793
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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