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Partner AbusePhase 2NCT00164567

Intimate Partner Violence (IPV)Screening in Health Care Clinics in Rural South Carolina

A Phase 2 study testing Onsite IPV specialist and Empowerment focused intervention in people with Partner Abuse, run by Centers for Disease Control and Prevention at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to implement universal screening for intimate partner violence (IPV) and to test two clinic-based interventions for women who screen positive for current or recent IPV. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Partner Abuse
What is being tested?
Onsite IPV specialist and Empowerment focused intervention
How many people
1,200 participants
Where
1 siteUnited States
Study dates
Start not givento not given
Phase
Phase 2
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 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • female
  • 18 - 65 years
  • must screen positive for partner abuse

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Care South clinics (Various)

    Hartsville, South Carolina, 29551

Other trials in United States

About this study

Official title: IPV Screening in Health Care Clinics in Rural South Carolina

The purpose of this study is to implement universal screening for intimate partner violence (IPV) and to test two clinic-based interventions for women who screen positive for current or recent IPV. The study population will be implemented in Pee Dee region of the state of South Carolina and will include primarily low-income women who seek care at selected primary health care clinics in the region.

In this study, all women 18 and older receiving care at selected primary care clinics will be offered screening for IPV annually. Clinicians will use a structured screening tool to assess physical, sexual, and psychological IPV in a current relationship (IPV+) or IPV experienced by the woman in the past five years (Recent IPV). Clinics will be randomly assigned to implement a clinic-based intervention for women who screen positive for current or recent IPV. Two interventions will be implemented using a factorial design. In the Empowerment-Focused Patient Education Intervention, clinicians will conduct a 7-session intervention focusing on the health and well-being of the woman and attempt to link women's IPV experience with their health. In the IPV Services Intervention, IPV Specialists who are trained advocates from the Pee Dee Coalition Against Domestic and Sexual Assault (PDC) will be based in the clinic to (a) counsel women about IPV including safety planning, (b) provide linkages to PDC services, and (c) link women to clinic-based support groups developed specifically for this project.

We hypothesize the intervention(s) will change (a) clinician screening, referral, and IPV documentation patterns, (b) clinician IPV knowledge and perceived skills in working with women who have experienced IPV and their children (c) women's help-seeking behaviors, risk of poor mental and physical health, and (d) women's risk of subsequent IPV victimization. To evaluate these outcomes, we will survey clinicians and prospectively follow a group of consenting IPV+ women (N=300 in each intervention arm) to assess changes in their help-seeking, health behavior and status, IPV experience over two-years of follow-up.

Conditions
Partner Abuse
Being tested
Onsite IPV specialist, Empowerment focused intervention
Keywords
partner abuse, screening, intimate partner violence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Onsite IPV specialistBehavioural

  • Empowerment focused interventionBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. help-seeking

  2. physical health

  3. Psychological health

Secondary outcomes (2)
  1. revictimization from partner violence

  2. child behaviors

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)

Resources

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 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
1,200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00164567
Sponsor's protocol ID
CDC-NCIPC-3142
Other IDs
US4/CCU419014
Status last verified
Oct 2009
First submitted
12 Sep 2005
Last updated
23 Oct 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Onsite IPV specialist and Empowerment focused intervention in people with Partner Abuse, run by Centers for Disease Control and Prevention at 1 site in United States.

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 0 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 23 Oct 2009. 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 United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

help-seeking. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Oct 2009.

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