Monthly Study Report Form

[NCHHSTP] 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)

Att 5_GAIN monthly study report form

Monthly Study Report Form

OMB: 0920-1357

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Form Approved

OMB No. 0920-xxxx

Exp. Date xx/xx/XXXX



GAIN Monthly Study Reporting Form



Public reporting burden of this collection of information is estimated to average 15 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; Attn: OMB-PRA (0920-New)



Report covers the following dates: [MONTH DAY, YEAR] – [MONTH DAY, YEAR]

Report completed on: [MONTH DAY, YEAR]

TABLE 1. GAIN MONTHLY ENROLLMENT BY SITE AND SAMBA TESTING RESULTS


Madison Clinic

Gay City

Total

Tested negative at GAIN visit (Qual)




Tested positive at GAIN visit




Positive Qual Test




<1000 copies/mL (Semi-Q)




>1000 copies/mL (Semi-Q)




Total






TABLE 2. GAIN CUMULATIVE ENROLLMENT BY SITE AND SAMBA TESTING RESULTS


Madison Clinic

Gay City

Total

Tested negative at GAIN visit (Qual)




Tested positive at GAIN visit




Positive Qual Test




<1000 copies/mL (Semi-Q)




>1000 copies/mL (Semi-Q)




Total






TABLE 3. RESULTS OF NEW POSITIVE PARTICIPANTS


Site

SAMBA Result

HIV-1 plasma RNA

Status

Notes

Case 1

(Madison Clinic or Gay City)

(Positive, Negative, <1000 copies/mL, >1000 copies/mL)

(n copies/mL)

(true positive or false positive)

(any extra info)

Case 2, etc.








TABLE 4. RCT CUMULATIVE ENROLLMENT BY MONTH

Month

Approached

Refused to enroll

Enrolled

January 202n




February 202n




March 202n




April 202n, etc.




Total






TABLE 5. MULTI-NAT CUMULATIVE ENROLLMENT BY MONTH

Month

Approached

Refused to enroll

Enrolled

January 202n




February 202n




March 202n




April 202n, etc.




Total







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AuthorNiemann, Lisa
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File Created2023-11-03

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