Nurse Delivered Risk Reduction Intervention for HIV-Positive Women In the South

Forms and Documents

Document Name	Status
Form 5 Follow-up Assessment Form and Instruction	New
Form 4 Baseline Assessment Form and Instruction	New
Form 3 In-Depth Interview Form and Instruction	New
Form 2 Locator Form Form	New
Form 1 Screener and Contact Forms Form and Instruction	New
ICR_NurseDeliveredRiskRedHIV_ProgramResponse (2).doc Supplementary Document	2009-10-26
ICR_NurseDeliveredRiskRedHIV.doc Supplementary Document	2009-10-26
0920-New_Supporting StatementB.doc Supporting Statement B	2009-10-26
Att 10_Consultants.doc Supplementary Document	2009-05-29
Att 9_ IRBApprovals.doc Supplementary Document	2009-05-29
Att 8_References.doc Supplementary Document	2009-05-29
Att 7i_IndepthInterviewRecruimentScript.doc Supplementary Document	2009-05-29
Att 7h_Thankyouletter.doc Supplementary Document	2009-05-29
Att 7g_ApptReminderScript.doc Supplementary Document	2009-05-29
Att 7f_ApptReminderCard.doc Supplementary Document	2009-05-29
Att 7e_RecruitmentPhoneScript.doc Supplementary Document	2009-05-29
Att 7d_BusinessCard.doc Supplementary Document	2009-05-29
Att 7c_RecruitmentFlyer.doc Supplementary Document	2009-05-29
0920-New_att7b_ConsentIn-DepthInterview.doc Supplementary Document	2009-10-26
0920-New_att7a_ConsentTrial.doc Supplementary Document	2009-10-26
0920-New_Supporting StatementA.doc Supporting Statement A	2009-10-26

IC Document Collections

IC ID	Document Title	Status
189536	Follow-up Assessment Form and Instruction	New
189535	Baseline Assessment Form and Instruction	New
189534	In-Depth Interview Form and Instruction	New
189533	Locator Form Form	New
189532	Screener and Contact Forms Form and Instruction	New

ICR Details

OMB Control No: 0920-0831	ICR Reference No: 200906-0920-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Nurse Delivered Risk Reduction Intervention for HIV-Positive Women In the South
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 with change	Conclusion Date: 11/09/2009
	Date Received in OIRA: 06/11/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2012	36 Months From Approved
Responses	1,570	0	0
Time Burden (Hours)	635	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The proposed information collection is being conducted to evaluate a brief, nurse-delivered, sexual risk reduction intervention for a growing population of HIV-positive women in the southeastern United States, and to study factors associated with risk among women. The intervention will be evaluated using a randomized wait-list comparison design with a three-month follow-up period. A brief screener form will be completed with approximately 550 women recruited from health departments, HIV/AIDS service organizations, and clinics to determine eligibility for participation in the study. Eligible participants will complete a locator form, to collect contact information to remind participants of follow-up visits. Baseline and follow-up assessment data will be collected using a combination CAPI (Computer Assisted Personal Interviewing) /ACASI (Audio-Computer Assisted Self-Interviewing) format. Qualitative in-depth interviews will also be conducted with a subset of 25-30 participants following their participation in the intervention condition. These interviews will collect information on women's experiences with the intervention, as well as factors that may have contributed to their contracting HIV. To date, the number of existing interventions with demonstrated effectiveness in reducing risk among HIV-positive women is limited. Increasing the number of evidence-based prevention interventions is a necessary requisite to decreasing HIV/AIDS among women in this region. CDC requests a three year clearance for this information collection.

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Authorizing Statute(s): US Code: 42 USC 301 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 44270	07/30/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 26248	06/01/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Screener and Contact Forms	1	Screener and Contact Forms
Locator Form	2, 2	Locator Form
In-Depth Interview	3	In-Depth Qualitative Interview Guide
Baseline Assessment	4	Baseline Assessment
Follow-up Assessment	5	Follow-up Assessment

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	1,570	0	0	1,570	0	0
Annual Time Burden (Hours)	635	0	0	635	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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 ICR

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Annual Cost to Federal Government: $280,500

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)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 06/11/2009

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