The GAIN (Greater Access and Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs)
ICR 202209-0920-005 · OMB 0920-1357 · Received in OIRA
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0920-1357 can be found here:
The GAIN (Greater Access and Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs)
No material or nonsubstantive change to a currently approved collection
No
Regular
09/13/2022
Requested
Previously Approved
12/31/2024
12/31/2024
4,898
4,898
1,067
1,067
20,848
20,848
GAIN is an implementation study to compare a point-of-care nucleic acid HIV test (HIV RNA POC NAT) to standard lab-based HIV testing. These data will describe the real-world performance and clinical effects of HIV RNA POC NAT testing. CDC will not receive any personally-identifiable information. This Non-Substantive Change Request is submitted to modify the incentives provided to study groups and to improve study implementation logistics. The original plan offered varying incentives by study group which presents operational challenges. The change provides a consistent incentive plan across the primary study groups and also modifies language in consent forms. There is no change to the approved burden hours.
US Code:
42 USC 241
Name of Law: Public Health Service Act
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:
(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;
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.
Acceptability/Feasibility Assessment Among Clinical and Community Providers