Domestic ViolenceNCT01661504
Evaluating Violence Against Women Screening in Mexico
A study testing Integrated Screening in people with Domestic Violence, run by Yale University at 1 site in Mexico.
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… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Integrated Screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 959 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-44
- Currently in heterosexual relationship with a male partner
- Responds in affirmative to past year sexual or physical violence
Who cannot join
- Cognitive impairment (slurred speech, inability to follow directions)
- Seeking treatment for life threatening emergency care
- Intends to relocate within 2 years.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Health Clinics associated with Ministry of Health in Mexico City
Mexico City
About this study
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
- Conditions
- Domestic Violence
- Being tested
- Integrated Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated ScreeningBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Referral Card Only | No intervention | 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 |
| Integrated Screening | Experimental | 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 Receives: Behavioral: Integrated Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
Change in Quality of Life Score
Measured: past month
Change in Use of Community Resources
Adapted Community Resources Checklist
Measured: 12 months
Change in Safety Planning
Adapted Safety Behavior Checklist
Measured: 12 Months
Change in Reproductive Coercion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startMar 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 959 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Innovations for Poverty Action, Mexican National Institute of Public Health
- Responsible party
- Sponsor
- Investigators
- Jhumka Gupta, ScD, Principal investigator, Yale School of Public HealthClaudia Diaz Olavarrieta, PhD, Principal investigator, National Institute of Public Health - MexicoKathryn L Falb, ScD, Principal investigator, Yale School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661504
- Sponsor's protocol ID
- 1202009793
- Status last verified
- Sep 2021
- First submitted
- 2 Aug 2012
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29514921Gupta 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.
PubMed 28697769Falb 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.
PubMed 25079882
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Violence Against Women Screening in Mexico
- ClinicalTrials.gov ID
- NCT01661504
- Acronym / sponsor ID
- 1202009793
- Conditions
- Domestic Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 959 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Innovations for Poverty Action, Mexican National Institute of Public Health
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Referral Card Only | No intervention | –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 |
| Integrated Screening | Experimental | Behavioral: Integrated ScreeningThe 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 |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages 18-44
- Currently in heterosexual relationship with a male partner
- Responds in affirmative to past year sexual or physical violence
Key exclusion criteria (3 listed)
- Cognitive impairment (slurred speech, inability to follow directions)
- Seeking treatment for life threatening emergency care
- Intends to relocate within 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated ScreeningThe 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 | Behavioural | Integrated Screening |
Primary outcome
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.
4 secondary outcomes
Change in Quality of Life Score
Time frame: past month
Change in Use of Community Resources
Time frame: 12 months
Change in Safety Planning
Time frame: 12 Months
Change in Reproductive Coercion
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Derived from this study: PubMed 29514921Gupta 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.
- Derived from this study: PubMed 28697769Gupta 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.
- Derived from this study: PubMed 25079882Falb 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.
- protocol paper (published)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jhumka Gupta, ScD principal investigator
Yale School of Public Health
Claudia Diaz Olavarrieta, PhD principal investigator
National Institute of Public Health - Mexico
Kathryn L Falb, ScD principal investigator
Yale School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Screening in people with Domestic Violence, run by Yale University at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intimate Partner Violence Victimization from Baseline (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01661504, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.