Monthly Study Report Form

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