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Randomized Controlled Trial of Routine Screening for IPV

This study has been completed.
Sponsor:
Collaborator:
Collaborative Research Unit John H. Stroger Hospital
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00526994
First received: September 6, 2007
Last updated: November 8, 2011
Last verified: November 2011
History of Changes
  Purpose

This is a randomized controlled trial with three arms to establish the impact of screening and referral to services for women disclosing exposure to IPV.


Condition Intervention Phase
Quality of Life
Disability
Utilization of Health Care Services
 Other: screening
Behavioral: universal education
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Routine Screening for Intimate Partner Violence

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • quality of life [ Time Frame: at one-year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • utilization of health care and IPV services [ Time Frame: during past year ] [ Designated as safety issue: No ]
  • disability [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]

Enrollment: 2700
Study Start Date: May 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Screened w/4 questions on intimate partner violence; if positive, receives referral information
 Other: screening
Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information
Active Comparator: B
receives referral information
 Behavioral: universal education
receives referral information
No Intervention: C
no screen and no referral

Detailed Description:

Approximately 2675 women* will be enrolled and randomized to one of 3 arms. In the first arm, participants will be screened, and if disclosing IPV, will receive information on available resources in the community. In arms two and three, participants will not be screened, but one group will receive information on available resources in the community and the other will not. All three groups will be assessed for quality of life, disability, and utilization of health care and IPV services at baseline and at a 12 month follow-up. A pilot study, also using a randomized controlled trial design, will establish the feasibility, acceptability, and impact on disclosure rates, use of referral resources, and potential harms of three screening and referral strategies.

*sample size calculation based n needed to detect a standardized effect size of 0.3 with an α=.05 (1-tailed)and ß=.20 if there's a 20% IPV (+) rate and 30% lost-to-follow-up rate.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women attending OB-GYN, family planning, general medicine, family medicine or HIV/STD clinic

Exclusion Criteria:

  • non-English speaking other than Spanish speakers
  • accompanied by a child >3 years of age without adequate provision for child care;
  • Visually- or hearing-impaired women;
  • without access to a telephone;
  • Severe Mental impairment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526994

Locations
United States, Illinois
Fantus Health clinic
Chicago, Illinois, United States
Sponsors and Collaborators
Centers for Disease Control and Prevention
Collaborative Research Unit John H. Stroger Hospital
Investigators
Principal Investigator: Joanne Klevens, MD, PhD Centers for Disease Control and Prevention
  More Information

No publications provided by Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joanne Klevens, CDC/NCIPC/DVP/PDEB
ClinicalTrials.gov Identifier: NCT00526994     History of Changes
Other Study ID Numbers: 200-2006-15969/200-2008-28219, IRB #4984, IRB #4985, OMB # 0920-06BM, Contract #200-2008-28219, & 200-2006-15969
Study First Received: September 6, 2007
Last Updated: November 8, 2011
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
intimate partner violence
domestic violence
spouse abuse
screening

ClinicalTrials.gov processed this record on May 23, 2013