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OMB Control No: 0920-0761	ICR Reference No: 200708-0920-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Randomized Controlled Trial for Routine Screening for Intimate Partner Violence
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/24/2008
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/09/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2011	36 Months From Approved
Responses	3,814	0	0
Time Burden (Hours)	718	0	0
Cost Burden (Dollars)	0	0	0

Abstract: Intimate partner violence (IPV) occurs frequently and has serious health, economic, and social consequences. Given the seriousness of this problem, numerous professional and health care organizations have recommended routine screening of women for IPV by health care providers in primary care settings. However, recent systematic reviews of the literature have not found evidence for the effectiveness of screening to improve health outcomes for women exposed to IPV. We are proposing to conduct a randomized controlled trial to provide this evidence. The trial will recruit 3680 women in a public obsetrics, gynecology, and family planning clinic. Women attending this clinic tend to be African American and of lower socioeconomic status. For this study (the Main Study), women will be randomly allocated to one of three arms: 1) screened for IPV, and if disclosing IPV, provided information on available IPV services; 2) not screened and all receiving information on available IPV services; or 3) a control group that will not be screened nor receive information on available IPV services. All three arms will be assessed with a self-report measure of mental health, disability, and quality of life at baseline utilizing an audio-computer-assisted structured interview (A-CASI) and at a 12-month follow-up utilizing a computerized-assisted telephone interview (CATI). A pretest with 196 women in this same clinic will be conducted to test the enrollment, randomization, interview, and follow-up procedures; provide estimates for outcome measures and a potential mediator of outcomes (contact of IPV services) and establish the concordance between measures used at baseline (in the clinic) and at a one-week follow-up over the phone. The study arms of the Pretest, which vary slightly from those of the Main Study, are designed to accomplish these intermediate objectives. The results will be used to refine the measures, procedures, and sample size requirements for the Main Study. The results from the Main Study, the Randomized Controlled Trial, will guide CDC as well as other governmental agencies, professional and health care orgniazations, and women's advocate groups in formulating its recommendations and policies regarding routine screening.

Authorizing Statute(s): US Code: 42 USC 391 Name of Law: Public Health Service Act Prevention and Control of Injuries
US Code: 42 USC 301 Name of Law: Public Health Service Act Research and Investigation General

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 42644	07/27/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 38837	07/13/2007
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	3,814	3,814
Annual Time Burden (Hours)	718	718
Annual Cost Burden (Dollars)	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new data collection.

Annual Cost to Federal Government: $482,067

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Saleda Perryman

View ICR - OIRA Conclusion