Hivdr prevention and Assessment Annual Country Report Outline

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Table 3-3.1 D Specimen Tracking Variables: Required at baseline and endpoint

Dates of baseline and endpoint blood draw
Date of aliquoting or spotting of baseline and endpoint specimens
Specimen types sent at baseline and at endpoint
Condition of baseline specimen and endpoint specimen when received in genotyping lab
For plasma (and for spots if frozen): Date of freeze
Temperature of freezer
For frozen specimens: Number of subsequent thaws and re-freezes

Date form filled out, and initials of staff completing it
Table 3-3.1.E Optional Specimen tracking variables at baseline and endpoint

Time (in addition to date) of blood draw
Time (in addition to date) specimen was received in processing laboratory
Volume of plasma aliquoted for viral load and HIVDR genotyping
Date and time of centrifugation/separation of plasma
Time (in addition to date) of specimen freeze
Date and time specimen was thawed (for each thaw)

Date and time specimen was re-frozen (for each subsequent freeze)

Appendix 5

HIV Drug Resistance Threshold Survey: Classification Chart

Specimen

Number genotyped (SNG) Lower
Limit
(LL)    Running total of specimens with HIVDR (RT)      Upper
Limit (UL)      Sample
Number genotyped (SNG) Lower
Limit (LL)      Running Total of specimens with HIVDR (RT)      Upper
Limit (UL)
1       ND      ______ ND      25      ND      ______ 6
2       ND      ______ ND      26      ND      ______ 6
3       ND      ______ ND      27      ND      ______ 6
4       ND      ______ ND      28      ND      ______ 6
5       ND      ______ ND      29      ND      ______ 6
6       ND      ______ ND      30      ND      ______ 6
7       ND      ______ ND      31      ND      ______ 6
8       ND      ______ ND      32      ND      ______ 6
9       ND      ______ ND      33      ND      ______ 6
10      ND      ______ ND      34      1       ______ 6
11      ND      ______ ND      35      1       ______ 7
12      ND      ______ ND      36      1       ______ 7
13      ND      ______ ND      37      1       ______ 7
14      ND      ______ 5       38      1       ______ 7
15      ND      ______ 5       39      1       ______ 7
16      ND      ______ 5       40      1       ______ 7
17      ND      ______ 5       41      1       ______ 7
18      ND      ______ 5       42      1       ______ 7
19      ND      ______ 5       43      1       ______ 7
20      ND      ______ 5       44      2       ______ 7
21      ND      ______ 5       45      2       ______ 7
22      ND      ______ 5       46      2       ______ 8
23      ND      ______ 5       47      2       ______ 8
24      ND      ______ 5       STOP    STOP    STOP    STOP

Perform a separate analysis for each drug class.

For specimen 1, use the result from the earliest blood draw. On the line in the RT column for specimen number 1 (in the SNG column), enter a "1" if the first specimen contains a relevant resistance mutation (see the list on Page 3) and a "0" if the specimen has no relevant mutations.

For specimen 2, use the result from the second earliest blood draw. On the line in the RT column for specimen number 2, enter the total number of specimens with a relevant mutation among specimens 1 and 2 -- that is, if neither specimen 1 nor specimen 2 has a relevant mutation, enter "0" on the second line in the RT column; if specimen 1 has a relevant mutation but specimen 2 does not, enter "1" on the second line in the RT column; if specimen 2 has a relevant mutation but specimen 1 does not, enter "1" on the second line in the RT column; if both have relevant mutations, enter a "2" on the second line in the RT column.

Continue to record information based on the date and time specimens were drawn. For the third line in the chart, record the number of specimens among the first three specimens that have relevant mutations in the third line in the RT column; for the fourth line, record the number of specimens among the first four specimens, etc.

A classification of HIVDR prevalence can be made when, among the number of specimens genotyped (see the SNG column), the running total of specimens found with HIVDR (in the RT column on the same horizontal line) is less than the lower limit specified in the LL column to the left of the RT column, or greater than the upper limit specified in the UL column to the right of the RT column.

When one of these conditions occurs, HIVDR prevalence can be classified either as <5% (if the RT is < than the LL number on the same horizontal line) or >15% (if the RT is > than the UL number). If neither of these conditions has occurred after the 47^th specimen has been genotyped, prevalence is classified as >5% and < 15%. Analysis may stop before the 47th specimen is reached if a classification of HIVDR prevalence has been made on the basis of fewer specimens.

Appendix 6

WHO HIVDR-Threshold Surveillance Mutation List

Appendix 7

Eligibility criteria for HIVDR-TS
HIVDR-TS: WHO eligibility criteria

List eligibility criteria used in country each survey from among these:

Eligibility must include: Aged < twenty-five years and no previous pregnancies if female, [and/or laboratory evidence of recent infection (if reliable and valid) or seroconversion]

If numbers are sufficient, < 22 years of age

Not eligible to start ART*
No previous positive HIV test*
No known exposure to antiretroviral drugs*
No known AIDS-defining illness*
CD4 count > 500 (where available)*
First risk-defining event within the past 3 years (e.g., drug injection, STI)

Use these criteria if they are routinely available at the site

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