Cooperative Re-Engagement Controlled Trial (CoRECT)

Forms and Documents

Document Name	Status
Annual Cost Analysis - clinic Form	New
Annual cost analysis - health department Form	New
Start up cost analysis - clinic Form	New
Start-up cost analysis - health department Form	New
Cost analysis- baseline Form	New
Participant Eligibility Disposition Form	New
Case Conference Form for Health Department Form	New
Case Conference Form for Clinic Managers Form	New
Standard of Care Survey Form	New
Barriers to Care Survey Form and Instruction	New
Supporting Statement A.docx Supporting Statement A	2016-08-15
CoRECT protocol_May_21_2015.docx Supplementary Document	2016-03-03
Attachment 17_ Yale University IRB letter.pdf Supplementary Document	2016-03-03
Att 16_Philadelphia IRB approval.pdf Supplementary Document	2016-03-03
Att 15_MA IRB approval 11_17_15.pdf Supplementary Document	2016-03-03
Att 14_ State of Connecticut Project CoRECT IRB Approval.pdf Supplementary Document	2016-03-03
Att 2_60 Day FRN.pdf Supplementary Document	2016-03-03
Att 1_Auth Legislation.docx Supplementary Document	2016-03-03
Supporting Statement B.docx Supporting Statement B	2016-03-03

IC Document Collections

IC ID	Document Title	Status
220470	Annual Cost Analysis - clinic Form	New
220469	Annual cost analysis - health department Form	New
220468	Start up cost analysis - clinic Form	New
220466	Start-up cost analysis - health department Form	New
220465	Cost analysis- baseline Form	New
220455	Participant Eligibility Disposition Form	New
220454	Case Conference Form for Health Department Form	New
220452	Case Conference Form for Clinic Managers Form	New
220450	Standard of Care Survey Form	New
220449	Barriers to Care Survey Form and Instruction	New
220448	Transmittal of Clinic Variables Other-Variable list	New
220447	Transmittal of Surveilance Variables Other-Variable list	New

ICR Details

OMB Control No: 0920-1133	ICR Reference No: 201603-0920-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 16CM
Title: Cooperative Re-Engagement Controlled Trial (CoRECT)
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: 08/15/2016
	Date Received in OIRA: 03/10/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2019	36 Months From Approved
Responses	2,305	0	0
Time Burden (Hours)	1,731	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: CoRECT is a controlled trial to evaluate an intervention to identify HIV-infected persons who are out of care and engage them in HIV care. The trial will demonstrate the feasibility of a joint health department - clinic intervention to improve engagement in HIV medical care to identify recently out of care individuals and the efficacy of an active health department intervention to re-engage these individuals in HIV medical care.

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Authorizing Statute(s): US Code: 42 USC 241 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:
	80 FR 69683	11/10/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 12494	03/09/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 12

IC Title	Form No.	Form Name
Cost analysis- baseline	none	Cost analysis - baseline
Start-up cost analysis - health department	none	Start up cost analysis - health dept
Start up cost analysis - clinic	none	Start up cost analysis - clinic
Annual cost analysis - health department	none	Annual Cost Analysis - health dept
Annual Cost Analysis - clinic	none	Annual Cost Analysis - clinic
Standard of Care Survey	none, none, none	MA Standard of Care Survey ,   CT Standard of Care Survey ,   Phila Standard of Care Survey
Transmittal of Clinic Variables
Case Conference Form for Health Department	none	Case Conference for Health Dept
Barriers to Care Survey	none, none, none	MA Barriers to Care Survey ,   CT Barriers to Care Survey ,   Phila Barriers to Care Survey
Transmittal of Surveilance Variables
Case Conference Form for Clinic Managers	none	Case Conference - Clinic Manager
Participant Eligibility Disposition	none	Participant Eligibility Disposition

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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	2,305	0	0	2,305	0	0
Annual Time Burden (Hours)	1,731	0	0	1,731	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: $1,557,076

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

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: 03/10/2016

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