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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00164567
Other study ID # CDC-NCIPC-3142
Secondary ID US4/CCU419014
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated October 22, 2009

Study information

Verified date October 2009
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 1200
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- female

- 18 - 65 years

- must screen positive for partner abuse

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Onsite IPV specialist

Empowerment focused intervention


Locations

Country Name City State
United States Care South clinics (Various) Hartsville South Carolina

Sponsors (6)

Lead Sponsor Collaborator
Centers for Disease Control and Prevention Care South, Inc., Pee Dee Coalition, The University of Texas Health Science Center, Houston, University of North Carolina, Chapel Hill, University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary help-seeking
Primary physical health
Primary Psychological health
Secondary revictimization from partner violence
Secondary child behaviors
See also
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