Evaluating Violence Against Women Screening in Mexico

NCT ID: NCT01661504

Last Updated: 2021-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

959 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Domestic Violence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Integrated Screening

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Innovations for Poverty Action

OTHER

Sponsor Role collaborator

Mexican National Institute of Public Health

OTHER_GOV

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jhumka Gupta, ScD

Role: PRINCIPAL_INVESTIGATOR

Yale School of Public Health

Claudia Diaz Olavarrieta, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Public Health - Mexico

Kathryn L Falb, ScD

Role: PRINCIPAL_INVESTIGATOR

Yale School of Public Health

Locations

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Health Clinics associated with Ministry of Health in Mexico City

Mexico City, , Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type DERIVED
PMID: 29514921 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28697769 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25079882 (View on PubMed)

Related Links

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Other Identifiers

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1202009793

Identifier Type: -

Identifier Source: org_study_id

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