Intervention Trials To Retain HIV-Positive Patients in Medical Care

Forms and Documents

Document Name	Status
Form Tab 10 Intervention Trials- Contact/Locator Information Form and Instruction	New
Form Tab 9 Intervention Trials- Retention Specialist/Patient Navigator Encounter Form Form and Instruction	New
Form Tab 8 Intervention Trials- Retention Risk Screener Form and Instruction	New
Form Tab 7 Intervention Trials- Patient Baseline Survey Form and Instruction	New
Form Tab 6 Intervention Trials- Patient Eligibility Screener Form	New
Form Tab 4 Intervention Trials- Patient Exit Survey Form and Instruction	New
Form Tab 3 Intervention Trials- Clinic Staff Survey Form and Instruction	New
Form Tab 2 Intervention Trials- Primary Care Provider Survey Form and Instruction	New
Tab 16 Informed Consent.doc Supplementary Document	2009-11-23
11.20.09 MEMO-HRSA Response to OMB- Intervention Trials ICR.doc Supplementary Document	2009-11-23
Tabs 2 - 4.Phase 2 Skill Domains.doc Supplementary Document	2009-11-23
Tab1c.Retention in Care Study-WAIT Rm Poster3-4-09.pdf Supplementary Document	2009-11-23
Tab1c.Retention in Care Study-EXAM Rm Poster3-4-09.pdf Supplementary Document	2009-11-23
Tab1b.pocketguide for clinic staff with agency logos 3-27-09.ppt Supplementary Document	2009-11-23
Tab1b.pocketguide for clinicians with agency logos 3-27-09.ppt Supplementary Document	2009-11-23
Tab1a.Brochure_03_04_09.pdf Supplementary Document	2009-11-23
SS Part B-Retention Intervention Trials HIV.doc Supporting Statement B	2009-08-04
Tab 13 Informed Consent.doc Supplementary Document	2009-08-04
Tab 12 IRB Approval.doc Supplementary Document	2009-08-04
Tab 5 Eligibility Criteria.doc Supplementary Document	2009-08-04
Revised SS Part A based on 11.17.09 OMB comments-ICR_RetentionHIVIntervention.doc Supporting Statement A	2009-11-23

IC Document Collections

IC ID	Document Title	Status
190436	Intervention Trials- Contact/Locator Information Form and Instruction	New
190435	Intervention Trials- Retention Specialist/Patient Navigator Encounter Form Form and Instruction	New
190434	Intervention Trials- Retention Risk Screener Form and Instruction	New
190433	Intervention Trials- Patient Baseline Survey Form and Instruction	New
190432	Intervention Trials- Patient Eligibility Screener Form	New
190431	Intervention Trials- Patient Exit Survey Form and Instruction	New
190430	Intervention Trials- Clinic Staff Survey Form and Instruction	New
190429	Intervention Trials- Primary Care Provider Survey Form and Instruction	New
190428	Intervention Trials- Electronic Clinic Data Abstraction Instruction	New

ICR Details

OMB Control No: 0915-0330	ICR Reference No: 200908-0915-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HSA	Agency Tracking No:
Title: Intervention Trials To Retain HIV-Positive Patients in Medical Care
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: 11/24/2009
	Date Received in OIRA: 08/25/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2012	36 Months From Approved
Responses	24,168	0	0
Time Burden (Hours)	5,268	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This is a new request for approval for the data collection part of a clinic-based research study entitled "Increasing Retention in Care among Patients Being Treated for HIV Infection". The purpose of the project is to develop, implement and test an intervention designed to increase client appointment attendance among patients at risk of missing scheduled appointments in HIV clinics.

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Authorizing Statute(s): PL: Pub.L. 109 - 415 101-703 Name of Law: Ryan White HIV/AIDS Treatment Modernization Act of 2006
  

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 79134	12/24/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 38635	08/04/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Intervention Trials- Patient Eligibility Screener	Tab 6	Patient Eligibility Screener
Intervention Trials- Patient Baseline Survey	Tab 7	Patient Baseline Survey
Intervention Trials- Retention Risk Screener	Tab 8	Retention Risk Screener
Intervention Trials- Retention Specialist/Patient Navigator Encounter Form	Tab 9	RS/ PN Encounter Form
Intervention Trials- Contact/Locator Information	Tab 10	Contact/Location Information Form
Intervention Trials- Electronic Clinic Data Abstraction
Intervention Trials- Primary Care Provider Survey	Tab 2	Primary Care Provider Survey
Intervention Trials- Clinic Staff Survey	Tab 3	Clinic Staff Survey
Intervention Trials- Patient Exit Survey	Tab 4	Patient Exit Survey

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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	24,168	0	0	24,168	0	0
Annual Time Burden (Hours)	5,268	0	0	5,268	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 a new data collection.

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Annual Cost to Federal Government: $2,056,950

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: 08/25/2009

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