Monthly_Report_Template_Attachment_J-12.pdf

Attachment J-12

Appendix C: Monthly Report Template

Table 1: Enrollment Data

A) Should represent the entire patient census

B) Please explain situations where a≠b and h≠i

Characteristic This month This year Total since contract award

Number of Patients presenting for HIV testing a

Number offered participation in the

Study b

Number accepting participation in Part 1 –

Risk screening c

Number identified as

High-risk and offered participation in Part 2 immediately d

Number identified as low risk and offered standard of care HIV testing at the study site e

Number of those tested with Standard of care test who screen HIV-positive and are offered enrollment in Part 2 f

Number of Part 2 participants with concordant positive results on screening assays g

Number with discordant results (at least one but not all tests produce a reactive result) in Part 2 h

Number enrolled in Part

3 follow-up i

Attachment J-12

Table 2: Part 3 Follow-Up Data

Study

ID

Appointment number Scheduled date Actual date

Number of non-reactive tests

Names of non-reactive tests

1 Part 3 enrollment + 3

2 Part 3 enrollment + 7

3 Part 3 enrollment + 10

4 Part 3 enrollment + 14

5 Part 3 enrollment + 21

6 Part 3 enrollment + 28

7 Part 3 enrollment + 42

8 Part 3 enrollment + 56

9 Part 3 enrollment + 70