Hivdr prevention and Assessment Annual Country Report Outline

HIVDR Early Warning Indicators (EWI)

1. Prescribing Practices:

3. Patient Retention on First-Line ART

6. Pill count / adherence using a standard instrument

This indicator should only be used in sites where physical pill counts take place. Provider estimates or patient self-reports not based on physical pill counts, even if phrased in percentages, should not be used for this indicator. Such estimates are important to support adherence, but may not generate useful data for analysis on a population basis because they are unlikely to be collected in a standardized format.
Percentage of individuals who demonstrate > 90% adherence by pill count over a specified time period

Numerator: Number of individuals demonstrating (by pill count performed by a provider or pharmacist) at least 90% of each of their ARVS have been taken as prescribed in a specified time period. (Separate pill counts must be performed for each ARV or combination unless a fixed-dose combination is used containing all ARVs.)

Denominator: Number of individuals taking ARV drugs at the end of the specified time period.

Suggested target: 80%
7. Drug Supply Continuity
National working groups may collect one or more of these three indicators to assess drug supply continuity. a1 is preferred to a2, but is generally feasible only in sites with electronic records.
a1. Percentage of ART "stops", "substitutions", or switches for all patients on first-line ART due to stock-outs or shortages during a year

Numerator: Number of individuals on first-line ART during a year for whom lack of availability of one or more ARVs was given as the reason for a stop, a switch, a substitution, or for a non-pick-up of one or more drugs in that person's regimen

Denominator: Number of individuals on first-line ART during the year
a2. Percentage of individuals initiating ART during a selected time period whose ART was stopped, substituted, or switched during the first year of ART due to ARV stock-outs or shortages

Numerator: Number of individuals starting ART during a selected time period for whom lack of availability of one or more ARVs was given as the reason for a stop, a switch, a substitution, or for a non-pick-up of one or more drugs in that person's regimen

Denominator: Number of individuals initiating first-line ART during a selected time period

b. Percentage of months (or quarters) in which there were no drug stock outages

Numerator: Number of months or quarters in the year in which there were no ARV drug stock outages for any ARVs in any of the standard ART regimens supplied by the site or the pharmacy at which the site's patients pick up ARV drugs

Denominator: 12 months (or 4 quarters)

Countries may also monitor this indicator for each individual drug in common use for ART

1a1. Data abstractors should record the following for each patient initiating ART during the selected time period:

• 
  a patient identifier
  
• 
  The date of ART start for each patient initiating ART at the site during the time period.
  
• 
  the ART regimen initially prescribed or picked up
  

1a2. Data abstractors should record for all ART prescriptions or pick-ups during the time period:

• 
  a patient identifier
  
• 
  date of ART regimen prescription or pick-up
  
• 
  the ART regimen prescribed or picked up
  

1b. This EWI can be abstracted as a subset of a2. Individuals on second-line ART should be included in a2, but should be recorded on a separate form if "b" is also to be calculated. A method of identifying patients who have switched from first-line to second line ART because of failure of the first-line regimen must be developed and abstractors must be trained in the method of identifying them.

• 
  a patient identifier
  
• 
  the relevant information that identifies the patient as having had a first-line regimen failure and a switch to second-line ART
  
• 
  date of second-line ART regimen prescription or pick-up
  
• 
  the second-line ART regimen prescribed or picked up
  

• 
  the date of ART start,
  
• 
  the date one calendar year after that start date ("12 month date"),
  
• 
  the date 15 calendar months after that ART start date ("15 months date"),
  
• 
  the date of last clinic appointment attended before the 12 month date
  
• 
  the date of the next clinic appointment scheduled at the last clinic appointment attended before the 12 month date
  
• 
  the date of last ARV drug pick-up before the 12 month date
  
• 
  The strength and number of pills picked up at the last ARV drug pick-up before 12 months, or the date of next drug pick-up scheduled at the last drug pick-up before the 12 month date
  
• 
  the date of the last clinic appointment attended (if any) before the 15 month date,
  
• 
  The date of last ARV pick-up attended (if any) before the 15 month date.
  
• 
  The date of transfer out (if any) within the first 15 months of ART
  
• 
  The date of death (if any) within the first 15 months of ART
  

3. Percent still on first-line ART 12 months after ART start

Data abstractors should record for each ART patient starting during the specified time period:

• 
  a patient identifier
  
• 
  the date of ART start,
  
• 
  the date one calendar year after that start date ("12 month date"),
  
• 
  the date of last ARV drug pick-up before the 12 month date and the strength and number of pills picked up
  

4a.

• 
  a patient identifier
  
• 
  Date of last ARV pick-up before the designated time period ("previous pick-up")
  
• 
  ARV drugs, strengths, and pill numbers dispensed at previous pick-up
  
• 
  Date of each ARV pick-up during the designated time period
  
• 
  ARV drugs, strengths, and pill numbers dispensed at each pick-up during the time period
  

4b. Note: The data for this version of EWI 4may be extracted along with EWIs 1, 2, and 3, but it requires additional information to be extracted

• 
  a patient identifier
  

• 
  the date of ART start,
  

• 
  the date one calendar year after that start date ("12 month date"),
  
• 
  Date of each ARV pick-up before the 12 month date
  
• 
  ARV drugs, strengths, and pill numbers dispensed at each pick-up before the 12 month date
  
• 
  Date(s) of planned ART stop, if any
  
• 
  Date of transfer out
  
• 
  Date of death
  

• 
  a patient identifier
  

• 
  the date of last clinic appointment attended in the previous calendar year
  
• 
  dates of all clinic appointments scheduled in the designated calendar year
  
• 
  dates of all clinic appointments attended during the designated calendar year
  

5b. Data abstractors should record the following for each patient initiating ART during the selected time period:

• 
  the date of ART start,
  

• 
  the date one calendar year after the ART start date ("12 month date"),
  

• 
  dates of all clinic appointments scheduled between ART start and the 12 month date
  
• 
  dates of all clinic appointments attended during the designated calendar year
  

Data abstractors should record the following for all ART patients picking up drugs during the selected time period:

• 
  a patient identifier
  
• 
  Date of last ARV pick-up before the designated time period ("previous pick-up")
  
• 
  ARV drugs, strengths, and pill numbers dispensed at previous pick-up
  
• 
  Date of each ARV pick-up during the designated time period
  
• 
  For each ARV drug previously dispensed, numbers of pills remaining at each pick-up
  
• 
  ARV drugs, strengths, and pill numbers dispensed at each pick-up
  

7a1. This version of the EWI may be abstracted only where reasons for ART substitutions, switches, and planned stops are recorded in a standard format, and where "ART drug supply shortage" or equivalent is one standard reason

Data abstractors should record:

• 
  Patient identifier for each patient picking up ART during the calendar year
  
• 
  Date of each ART prescription or pick-up during designated calendar year
  
• 
  ARV drugs, strengths, and pill numbers prescribed at each prescription or dispensed at each pick-up
  
• 
  Date of substitution, switch, or planned stop noted in the medical record for each ART patient during the designated calendar year
  
• 
  Reason for substitution, switch, or planned stop noted in the medical record
  

7a2. This version of the EWI may be abstracted only where reasons for ART substitutions, switches, and planned stops are recorded in a standard format, and where "ART drug supply shortage" or equivalent is one standard reason. Note: this EWI may be extracted in conjunction with EWI 1a1, 2, 3, 4b, and/or 5b.

Data abstractors should record:

• 
  Patient identifier for each patient starting ART during the designated time period
  

• 
  the date of ART start,
  

• 
  the date one calendar year after that start date ("12 month date"),
  

• 
  Date of each ART prescription or pick-up between ART start date and the 12 month date
  
• 
  ARV drugs, strengths, and pill numbers prescribed at each prescription or dispensed at each pick-up
  
• 
  Date of substitution, switch, or planned stop noted in the medical record between ART start and the 12 month date
  
• 
  Reason for each recorded substitution, switch, or planned stop noted in the medical record
  

7b. Methods of extracting this version of the EWI should be developed in conjunction with persons implementing the ARV drug supply monitoring system at the site. A separate evaluation must be performed for each ARV drug in use in standard ARV regimens, and other regimens in common use that meet the country definition for "appropriate regimens"

• 
  Country
  
• 
  Site
  
• 
  ID (25 characters)
  
• 
  Date ART started (note: this should be based on initial ARV pick-up rather than date of initial prescription)
  
• 
  Initial ART regimen
  
• 
  Sex
  
• 
  Date of birth
  
• 
  Age (calculated field if DOB is entered)
  
• 
  Previous ARV exposure: PMTCT and/or other [Yes/No plus list of drugs if known]
  
• 
  Current pregnancy
  
• 
  Baseline (pre-ART) CD4 cell count and CD4 date (if routinely performed at site)
  
• 
  Baseline (pre-ART) CD4% and date (if routinely performed at site)
  
• 
  WHO stage
  
• 
  Viral load and viral load date
  
• 
  Baseline sequence for the protease region and the relevant portion of the reverse transcriptase region of the HIV genome [to be uploaded from genotyping lab]
  
• 
  Data entry person
  
• 
  Data entry date
  

• 
  Specific ARVs encountered in previous exposure before initial ART at site
  
• 
  Time of specimen collection
  
• 
  On tuberculosis treatment at start of ART (TB regimen if applicable)
  
• 
  Residence of patient (District/City/Region)
  
• 
  Length of stay in district
  
• 
  Education level
  
• 
  Occupation
  
• 
  Number of pregnancies
  
• 
  Date of last pregnancy
  
• 
  Weight
  
• 
  Date and time of centrifugation/separation of plasma specimen, if performed at specimen collection site
  

• 
  Name or initials of staff member drawing blood or making DBS
  

• 
  ID (25 characters)
  
• 
  Date ART started (note: this should be initial ARV pickup date rather than ART prescription date)
  
• 
  Sex
  
• 
  Date of birth
  
• 
  Age (calculated field if DOB is entered)
  
• 
  Date(s) of regimen substitution(s) prescriptions
  
• 
  ARV drugs prescribed in substitution regimen
  
• 
  Previous ARV exposure before ART start: PMTCT and/or other
  
• 
  30-day proportion of ART doses taken estimate (%) using Visual Assessment Scale at endpoint
  
• 
  Dates of scheduled clinic appointments between ART start and endpoint
  
• 
  Dates of actual visits to clinic between ART start and endpoint
  
• 
  Dates of ARV drug pick-ups
  
• 
  List of ARV drugs, strengths, and number of pills dispensed at each pick-up
  
• 
  Date of death
  
• 
  Date of transfer out
  
• 
  Date of endpoint blood draw
  
• 
  Endpoint Viral load result (and date if different from endpoint blood draw date)
  
• 
  Endpoint CD4 count (and date if different from endpoint blood draw date)
  
• 
  Endpoint sequence for the protease region and the relevant portion of the reverse transcriptase region of the HIV genome
  
• 
  Data entry person
  
• 
  Data entry date
  

• 
  Required ART pick-up dates (dates by which new ARV drug pick-up should be made to avoid ART interruptions from exhaustion of ARV drugs previously dispensed)
  
• 
  Number of required ARV drug pick-up dates between ART start and endpoint [Do not include initial ARV pickup]
  
• 
  Number of appointments scheduled between baseline and endpoint
  
• 
  Number of appointments kept on time (within 7 days of scheduled appointment) between baseline and endpoint
  
• 
  Number of drug pick-ups made on time (before next required ARV drug pick-up date) between ART start and endpoint
  
• 
  endpoint status (death, transfer out, loss to follow up, stop ART, switch, still on ART at 12 months)
  
• 
  Endpoint date