Evaluation of Free Rapid HIV at-home Testing

Forms and Documents

Document Name	Status
Study Registration Form	New
Form form Eligibility Screener Form	New
In-depth Interview Form	New
Focus Group Discussion Form	New
Reportng Test Results (completion of study) Form and Instruction	New
Follow-up Survey for HIV Positive Group Form	New
Follow-up Survey for RCT Form	New
Reporting of Test Results (during study) Form and Instruction	New
Baseline Survey for HIV-Positive Group Form	New
Baseline Survey for RCT Form	New
In-depth Interview Consent Form	New
Focus Group Consent Form	New
Consent Form	New
Att 6 Screenshots All Forms.pdf Supplementary Document	2014-05-09
SS Part B.docx Supporting Statement B	2014-05-09
Att 5b Center PD approval for 3.4.pdf Supplementary Document	2014-03-17
Att 5a IRB approval.pdf Supplementary Document	2014-03-17
Att 2b Public Comment.docx Supplementary Document	2014-03-17
Att 2_60 day FRN.docx Supplementary Document	2014-03-17
Att 1 Auth legislation.docx Supplementary Document	2014-03-17
Att 3b Study Registration.docx Supplementary Document	2014-05-09
Att 3a Eligibility Screener.docx Supplementary Document	2014-05-09
Att 3h Reporting of Self-Test results at completion.docx Supplementary Document	2014-05-09
Att 3g Follow up-HIV positive group.docx Supplementary Document	2014-03-27
Att 3f Follow up-Intervention Comparison Arms.docx Supplementary Document	2014-05-09
Att 3e Reporting of Self-Test Results.docx Supplementary Document	2014-05-09
Att 3d Baseline Survey_HIV Positive.docx Supplementary Document	2014-05-09
Att 3c Baseline Survey.docx Supplementary Document	2014-05-09
Att 4c In-depth Interview consent.docx Supplementary Document	2014-03-27
Att 4b Focus group consent.docx Supplementary Document	2014-05-09
Att 4a RCT consent form.docx Supplementary Document	2014-05-09
SS Part A.docx Supporting Statement A	2014-05-09

IC Document Collections

IC ID	Document Title	Status
211028	Study Registration Form	New
211027	Eligibility Screener Form	New
211026	In-depth Interview Form	New
211025	Focus Group Discussion Form	New
211024	Reportng Test Results (completion of study) Form and Instruction	New
211023	Follow-up Survey for HIV Positive Group Form	New
211022	Follow-up Survey for RCT Form	New
211021	Reporting of Test Results (during study) Form and Instruction	New
211020	Baseline Survey for HIV-Positive Group Form	New
211019	Baseline Survey for RCT Form	New
211018	In-depth Interview Consent Form	New
211017	Focus Group Consent Form	New
211016	Consent Form	New

ICR Details

OMB Control No: 0920-1018	ICR Reference No: 201403-0920-017
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 21551
Title: Evaluation of Free Rapid HIV at-home Testing
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: 05/16/2014
	Date Received in OIRA: 03/31/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2017	36 Months From Approved
Responses	66,592	0	0
Time Burden (Hours)	7,085	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This study is a randomized trial which aims to evaluate the use and effectiveness of home-test kits as a public health strategy for increasing testing among MSM. A secondary aim is to evaluate the extent to which MSM (both HIV-negative and HIV-positive) distribute HIV home-test kits to their social and sexual networks.

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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:
	78 FR 66008	11/04/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 14252	03/13/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
Consent	none	Consent
Focus Group Consent	none	Consent
In-depth Interview Consent	none	Consent
Baseline Survey for RCT	none	Baseline Survey
Baseline Survey for HIV-Positive Group	none	Baseline Survey
Reporting of Test Results (during study)	none	Reporting Home Test Results
Follow-up Survey for RCT	none	Follow-up Survey
Follow-up Survey for HIV Positive Group	none	Follow-up Survey
Reportng Test Results (completion of study)	none	Reporting Home Test Results completion
Focus Group Discussion	none	Focus Group Discussion Guide
In-depth Interview	none	Individual in-depth Interview Guide
Eligibility Screener	form	Eligibility Screener
Study Registration	none	Registration

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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	66,592	0	0	66,592	0	0
Annual Time Burden (Hours)	7,085	0	0	7,085	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 data collection request.

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Annual Cost to Federal Government: $545,750

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: 03/31/2014

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