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MODULE FOR ASSESSING AND STRENGTHENING THE QUALITY OF VIRAL LOAD TESTING DATA WITHIN HIV PROGRAMMES AND PATIENT MONITORING SYSTEMS

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SEPTEMBER 2020

OF VIRAL LOAD TESTING DATA WITHIN HIV PROGRAMMES AND PATIENT MONITORING SYSTEMS

WEB ANNEX E: TOOLS FOR RECOUNTING VIRAL LOAD TESTING INDICATORS

IMPLEMENT ATION TOOL

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The objective of this tool is: (1) to understand how the site calculates the viral load (VL) coverage and suppression indicators and establish the definitions being used for these;

(2) to enable these indicators to be recalculated; and (3) to enable the verification factor to be calculated, which is a measure for comparison between recounted and reported indicators. External assessment teams are recommended to work with facility staff., such as data clerks familiar with

data systems in use, indication definitions and calculation methods to ensure that indicators are accurately verified with the required disaggregation.

Method for validating data on VL testing

Instructions for the data quality assessment team: please describe in detail the method your team used to validate each indicator.

Form 1: [COUNTRY NAME] VL indicator verification RECORDING SHEETS

1. PERCENTAGE OF PEOPLE RECEIVING ART AT LEAST 6 MONTHS WITH VL TEST RESULTS (TESTING COVERAGE)

1a. Definition of site method (how does the site collect and report this indicator?): is this different to the method used by the health ministry?

If so, how?

Definition of the site method to calculate the numerator:

Is the site method for the numerator consistent with the ministry of health method? Yes No Definition of site method to calculate denominator:

Is the site method for the denominator consistent with the ministry of health method? Yes No Overall, is the site method for this indicator consistent with the ministry of health method? Yes No 1b. Recreation of the indicator

The method used by the ministry of healtha Site method (if different to the ministry of Health method) Were you able to calculate using the method used by the ministry of health?

Yes No If no, explain:

Were you able to calculate using the site method?

Yes No If no, explain:

Which data sources did you use to calculate by the ministry of health method?

Patient medical chart ART register

Laboratory reporting forms

Electronic register or electronic medical records Laboratory information system

Other: _________________________________

Which data sources did you use to calculate by the site method?

Patient medical chart ART register

Laboratory reporting forms

Electronic register or electronic medical records Laboratory information system

Other: _________________________________

Describe how you calculated using the ministry of health method: Describe how you calculated using the site method (if it is the same as the ministry of health description above, please note that):

aThis should be the same method used by partners

Site Name Visit Date Team #

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Is the site method consistent with the ministry of health method? Yes No 2b. Recreation of the indicator using site and the ministry of health method

The method used by the ministry of healtha Site method (if different to the ministry of Health method) Were you able to calculate using the method used by the ministry of health?

Yes No If no, explain:

Were you able to calculate using the site method?

Yes No If no, explain:

Which data sources did you use to calculate by the ministry of health method?

Patient medical chart ART register

Laboratory reporting forms

Electronic register or electronic medical records Laboratory information system

Other: _________________________________

Which data sources did you use to calculate by the site method?

Patient medical chart ART register

Laboratory reporting forms

Electronic register or electronic medical records Laboratory information system

Other: _________________________________

Describe how you calculated using the ministry of health method: Describe how you calculated using the site method (if it is the same as the ministry of health description above, please note that):

aThis should be the same method used by partners

Section 1 will be completed using the national site-level reported results (such as from DHIS2 or quarterly ministry of health reports) for the specific quarter of interest and using facility-level monthly aggregate results for the months that correspond to the quarter of interest.

The results from these months for the VL indicators will be directly transcribed in Tables A5.1 and A5.2.

Section 2 will be completed by recreating the VL indicators

at the site level. The data quality assessment team should work

with the health facility staff to understand what tools and

systems are being used to calculate the national VL indicators

and to replicate that process. The results from the recreated

indicators will then be used to complete Tables A5.3 and A5.4.

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TABLE A5.1. DATA COLLECTION TOOL – REPORTED SITE DATA ON THE NUMBER AND PERCENTAGE OF PEOPLE RECEIVING ART FOR AT LEAST 6 MONTHS WITH VL TEST RESULTS (VL COVERAGE)

Health ministry data source(s) reviewed

Ministry of health monthly report (January 2020)

Ministry of health monthly report (February 2020)

Ministry of health monthly report

(March 2020)

Ministry of health quarterly total for Q1 in fiscal

year 2020

Partner quarterly total for Q1 in fiscal year

(if relevant)a Comments Total numerator:

number of people receiving ART with at least one routine VL test result during the reporting period Total denominator:

number of people receiving ART ≥6 months

% receiving ART

≥6 months with VL test resultsb Disaggregates

Age and sex disaggregation 0–4 years old (both sexes) numerator 0–4 years old (both sexes) denominator 0–4 years old (both sexes) % receiving ART ≥6 months with VL test results 5–9 years old (both sexes) numerator 5–9 years old (both sexes) denominator 5–9 years old (both sexes) % receiving ART ≥6 months with VL test results

Health ministry monthly reporting form: months X–Z Complete Tables A5.1 and A5.2 using the reported site-level

results from ministry of health for the selected period. Be sure to verify the correct time frame being reviewed. ministry of health results can be accessed using the ministry of health

monthly reports found at the health facility or through an alternative health ministry mechanism (a health information system such as DHIS2 if possible).

Site Name Visit Date Team #

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Females 10–14 years old numerator 10–14 years old denominator 10–14 years old

% receiving ART

≥6 months with VL test results 15–19 years old numerator 15–19 years old denominator 15–19 years old

% receiving ART

≥6 months with VL test results 20–24 years old numerator 20–24 years old denominator 20–24 years old

% receiving ART

≥6 months with VL test results 25–49 years old numerator 25–49 years old denominator 25–49 years old

% receiving ART

≥6 months with VL test results 50+ years old numerator 50+ years old denominator 50+ years old

% receiving ART

≥6 months with VL test results Unknown numerator Unknown denominator Unknown

% receiving ART

≥6 months with VL test results

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Ministry of health monthly report

(January 2020)

Ministry of health monthly report (February 2020)

Ministry of health monthly report

(March 2020)

Ministry of health quarterly total for Q1 in fiscal

year 2020

Partner quarterly total for Q1 in fiscal year

(if relevant)a Comments Males

10–14 years old numerator 10–14 years old denominator 10–14 years old

% receiving ART

≥6 months with VL test results 15–19 years old numerator 15–19 years old denominator 15–19 years old

% receiving ART

≥6 months with VL test results 20–24 years old numerator 20–24 years old denominator 20–24 years old

% receiving ART

≥6 months with VL test results 25–49 years old numerator 25–49 years old denominator 25–49 years old

% receiving ART

≥6 months with VL test results 50+ years old numerator 50+ years old denominator 50+ years old

% receiving ART

≥6 months with VL test results Unknown numerator Unknown denominator Unknown

% receiving ART

≥6 months with VL test results

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Pregnant women Numerator Denominator

% receiving ART

≥6 months with VL test results Breastfeeding women Numerator

Denominator

% receiving ART

≥6 months with VL test results

TB-coinfected patients Numerator

Denominator

% receiving ART

≥6 months with VL test results Sex workers Numerator Denominator

% receiving ART

≥6 months with VL test results

Men who have sex with men Numerator

Denominator

% receiving ART

≥6 months with VL test results

People in prisons and other closed settings Numerator

Denominator

% receiving ART

≥6 months with VL test results

People who inject drugs Numerator

Denominator

% receiving ART

≥6 months with VL test results Transgender people Numerator

Denominator

% receiving ART

≥6 months with VL test results

aIf the site is supported by a partner, this column enables recording of the quarterly total reported to the partner.

bThe VL coverage indicator definition used in this table should be updated to align with the ministry of health indicator if this is different.

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TABLE A5.2. DATA COLLECTION TOOL – REPORTED SITE DATA ON THE NUMBER AND PERCENTAGE OF PEOPLE LIVING WITH HIV RECEIVING ART (FOR AT LEAST 6 MONTHS) WHO HAVE SUPPRESSED VL

Ministry of health data source(s) reviewed

Ministry of health monthly report (January 2020)

Ministry of health monthly report (February 2020)

Ministry of health monthly report

(March 2020)

Ministry of health quarterly total for Q1 in fiscal

year 2020

Partner quarterly total for Q1 in fiscal year

(if relevant)a Comments Total numerator:

number receiving ART for ≥6 months with ≥1 routine VL test result who have suppressed VL during the reporting period Total denominator:

number receiving ART for ≥6 months with ≥1 routine VL test result in medical or lab record during the reporting period

% receiving ART (6 months) who have suppressed VLb

Disaggregates

Age and sex disaggregation 0–4 years old (both

sexes) numerator 0–4 years old (both sexes) denominator 0–4 years old (both sexes) % receiving ART (for at least 6 months) who have suppressed VL 5–9 years old (both sexes) numerator 5–9 years old (both sexes) denominator 5–9 years old (both sexes) % receiving ART (for at least 6 months) who have suppressed VL

Ministry of health monthly reporting form: months X–Z

Site Name Visit Date Team #

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Females 10–14 years old numerator 10–14 years old denominator 10–14 years old % receiving ART (for at least 6 months) who have suppressed VL 15–19 years old numerator 15–19 years old denominator 15–19 years old % receiving ART (for at least 6 months) who have suppressed VL 20–24 years old numerator 20–24 years old denominator 20–24 years old % receiving ART ≥6 months with VL test results

25–49 years old numerator 25–49 years old denominator 25–49 years old % receiving ART ≥6 months with VL test results% receiving ART (for at least 6 months) who have suppressed VL 50+ years old numerator 50+ years old denominator 50+ years old % receiving ART (for at least 6 months) who have suppressed VL Unknown numerator Unknown denominator Unknown % receiving ART (for at least 6 months) who have suppressed VL

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Ministry of health monthly report (January 2020)

Ministry of health monthly report (February 2020)

Ministry of health monthly report

(March 2020)

Ministry of health quarterly total for Q1 in fiscal

year 2020

Partner quarterly total for Q1 in fiscal year

(if relevant)a Comments Males

10–14 years old numerator 10–14 years old denominator 10–14 years old % receiving ART (for at least 6 months) who have suppressed VL 15–19 years old numerator 15–19 years old denominator 15–19 years old % receiving ART (for at least 6 months) who have suppressed VL 20–24 years old numerator 20–24 years old denominator 20–24 years old % receiving ART (for at least 6 months) who have suppressed VL 25–49 years old numerator 25–49 years old denominator 25–49 years old % receiving ART (for at least 6 months) who have suppressed VL 50+ years old numerator 50+ years old denominator 50+ years old % receiving ART (for at least 6 months) who have suppressed VL Unknown numerator Unknown denominator Unknown % receiving ART (for at least 6 months) who have suppressed VL

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Pregnant women Total numerator:

Total denominator:

% receiving ART (for at least 6 months) who have

suppressed VL Breastfeeding women Numerator

Denominator

% receiving ART (for at least 6 months) who have

suppressed VL TB-coinfected patients Numerator

Denominator

% receiving ART (for at least 6 months) who have

suppressed VL Sex workers Numerator Denominator

% receiving ART (for at least 6 months) who have

suppressed VL

Men who have sex with men Numerator

Denominator

% receiving ART (for at least 6 months) who have

suppressed VL

People in prisons and other closed settings Numerator

Denominator

% receiving ART (for at least 6 months) who have

suppressed VL

People who inject drugs Numerator

Denominator

% receiving ART (for at least 6 months) who have

suppressed VL Transgender people Numerator

Denominator

% receiving ART (for at least 6 months) who have

suppressed VL

aIf the site is supported by a partner, this column enables recording of the quarterly total reported to the partner.

bThe VL suppression indicator definition used in this table should be updated to align with the ministry of health indicator if this is different.

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TABLE A5.1. DATA COLLECTION TOOL – REPORTED SITE DATA ON THE NUMBER AND PERCENTAGE OF PEOPLE RECEIVING ART FOR AT LEAST 6 MONTHS WITH VL TEST RESULTS (VL COVERAGE)

If the site method differs from the national ministry of health recommended method of calculating the percentage of people receiving ART (at least 6 months) with VL test results, recount using both methods and record this in the appropriate columns.

In addition, if there is an electronic medical records system or a laboratory information management system (LIMS) but it is not used to verify the number and proportion of people with a VL result, the electronic medical records or LIMS column can be used to include these totals as an additional comparison.

The verification factor is the measure for comparison between recounted and reported indicators and is calculated as follows:

(recounted indicator/reported indicator) times 100.

Reporting period: quarter, year

Verification factor: (recounted indicator/reported indicator) times 100

Electronic medical records

(optional)

Laboratory information system (if available)

Site method

Ministry of healtha method (if different)

Comments Jan

2020 Feb 2020

Mar 2020 Total

Jan 2020

Feb 2020

Mar 2020 Total Total numerator:

number of people receiving ART with at least one routine VL test result during the reporting period Total denominator:

number of people receiving ART receiving ART ≥6 months

% receiving ART

≥6 months with VL test resultsb Pregnant Numerator Denominator

% receiving ART

≥6 months with VL test results Breastfeeding Numerator Denominator

% receiving ART

≥6 months with VL test results

Confirmed TB or TB treated Numerator

Denominator

% receiving ART

≥6 months with VL test results

Complete Tables A5.3 and A5.4 using the same methods the health facility uses for calculating the indicators (site method) when they complete the national ministry of health reporting tool and if relevant partner data collection tool.

Record the numbers recreated for each indicator in the site method section in each of the tables.

Site Name Visit Date Team #

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Age and sex disaggregation 0–4 years old (both sexes) numerator 0–4 years old (both sexes) denominator 0–4 years old (both sexes) % receiving ART ≥6 months with VL test results 5–9 years old (both sexes) numerator 5–9 years old (both sexes) denominator 5–9 years old (both sexes) % receiving ART ≥6 months with VL test results Females 10–14 years old numerator 10–14 years old denominator 10–14 years old

% receiving ART

≥6 months with VL test results 15–19 years old numerator 15–19 years old denominator 15–19 years old

% receiving ART

≥6 months with VL test results 20–24 years old numerator 20–24 years old denominator 20–24 years old

% receiving ART

≥6 months with VL test results 25+ years old numerator 25+ years old denominator 25+ years old

% receiving ART

≥6 months with VL test results Unknown numerator Unknown denominator Unknown

% receiving ART

≥6 months with VL test results

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Electronic medical records

(optional)

Laboratory information system (if available)

Site method

Ministry of healtha method (if different)

Comments Jan

2020 Feb 2020

Mar 2020 Total

Jan 2020

Feb 2020

Mar 2020 Total Males

10–14 years old numerator 10–14 years old denominator 10–14 years old

% receiving ART

≥6 months with VL test results 15–19 years old numerator 15–19 years old denominator 15–19 years old

% receiving ART

≥6 months with VL test results 20–24 years old numerator 20–24 years old denominator 20–24 years old

% receiving ART

≥6 months with VL test results 25+ years old numerator 25+ years old denominator 25+ years old

% receiving ART

≥6 months with VL test results Unknown numerator Unknown denominator Unknown

% receiving ART

≥6 months with VL test results

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Sex workers Numerator Denominator

% receiving ART

≥6 months with VL test results

Men who have sex with men Numerator

Denominator

% receiving ART

≥6 months with VL test results

People in prisons and other closed settings Numerator

Denominator

% receiving ART

≥6 months with VL test results

People who inject drugs Numerator

Denominator

% receiving ART

≥6 months with VL test results Transgender people Numerator

Denominator

% receiving ART

≥6 months with VL test results

aThis should be the same method used by partners.

bVL coverage indicator definition used in this table should be updated to align with the ministry of health indicator if this is different.

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TABLE A5.4. RECOUNTED OR VERIFIED NUMBER OF THE NUMBER AND PERCENTAGE OF PEOPLE RECEIVING ART FOR ≥6 MONTHS WHO HAVE SUPPRESSED VL

If the site method differs from the national ministry of health recommended method of calculating the percentage of people receiving ART (at least 6 months) with suppressed VL, recount using both methods and record this in the appropriate columns.

In addition, if there is an electronic medical records system or a LIMS but it is not used to verify the number and proportion of people with suppressed VL, the electronic medical records or LIMS column can be used to include these totals as an additional comparison.

The verification factor is the measure for comparison between recounted and reported indicators and is calculated as follows:

(recounted indicator/reported indicator) times 100.

Reporting period: quarter, year

Verification factor: (recounted indicator/reported indicator) times 100

Electronic medical records

(optional)

Laboratory information system (if available)

Site method

Ministry of healtha method (if different)

Comments Jan

2020 Feb 2020

Mar 2020 Total

Jan 2020

Feb 2020

Mar 2020 Total Total numerator:

number receiving ART for ≥6 months with ≥1 routine VL test result who have suppressed VL Total denominator:

number receiving ART for ≥6 months with ≥1 routine VL test result in medical or lab record

% receiving ART ≥6 months who have suppressed VLb Pregnant Numerator Denominator

% receiving ART

≥6 months who have suppressed VL Breastfeeding Numerator Denominator

% receiving ART

≥6 months who have suppressed VL Confirmed TB or TB treated Numerator

Denominator

% receiving ART

≥6 months who have suppressed VL

Site Name Visit Date Team #

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Age and sex disaggregation 0–4 years old (both sexes) numerator 0–4 years old (both sexes) denominator 0–4 years old (both sexes) % receiving ART ≥6 months who have suppressed VL 5–9 years old (both sexes) numerator 5–9 years old (both sexes) denominator 5–9 years old (both sexes) % receiving ART ≥6 months who have suppressed VL Females 10–14 years old numerator 10–14 years old denominator 10–14 years old

% receiving ART

≥6 months who have suppressed VL 15–19 years old numerator 15–19 years old denominator 15–19 years old

% receiving ART

≥6 months who have suppressed VL 20–24 years old numerator 20–24 years old denominator 20–24 years old

% receiving ART

≥6 months who have suppressed VL 25+ years old numerator 25+ years old denominator 25+ years old

% receiving ART

≥6 months who have suppressed VL Unknown numerator Unknown denominator Unknown

% receiving ART

≥6 months who have suppressed VL

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Electronic medical records

(optional)

Laboratory information system (if available)

Site method

Ministry of healtha method (if different)

Comments Jan

2020 Feb 2020

Mar 2020 Total

Jan 2020

Feb 2020

Mar 2020 Total Males

10–14 years old numerator 10–14 years old denominator 10–14 years old

% receiving ART

≥6 months who have suppressed VL 15–19 years old numerator 15–19 years old denominator 15–19 years old

% receiving ART

≥6 months who have suppressed VL 20–24 years old numerator 20–24 years old denominator 20–24 years old

% receiving ART

≥6 months who have suppressed VL 25+ years old numerator 25+ years old denominator 25+ years old

% receiving ART

≥6 months who have suppressed VL Unknown numerator Unknown denominator Unknown

% receiving ART

≥6 months who have suppressed VL

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Sex workers Numerator Denominator

% receiving ART

≥6 months who have suppressed VL

Men who have sex with men Numerator

Denominator

% receiving ART

≥6 months who have suppressed VL

People in prisons and other closed settings Numerator

Denominator

% receiving ART

≥6 months who have suppressed VL People who inject drugs Numerator

Denominator

% receiving ART

≥6 months who have suppressed VL Transgender people Numerator

Denominator

% receiving ART

≥6 months who have suppressed VL

aThis should be the same method used by partners.

bThe VL suppression indicator definition used in this table should be updated to align with the ministry of health indicator if this is different.

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E-mail: [email protected] www.who.int/hiv

ISBN 978-92-4-001043-7 (electronic version)

© World Health Organization 2020. Some rights reserved.

This work is available under the CC BY-NC-SA 3.0 IGO licence.

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