Attachment_J.10_PEPFAR_MER_Indicators_Combined_Package.pdf

PEPFAR Monitoring, Evaluation, and Reporting Indicator Reference Guide

8 October 2015

Version 2.2

U.S. DEPARTMENT OF STATE

PEPFAR Monitoring, Evaluation, and Reporting Indicator Reference Guide

Table of Contents

Chapter 1: Level 1 Indicators

Level 1 Indicators Table

Prevention Services

HTC_TST

PMTCT_STAT

PMTCT_ARV

PMTCT_EID

PMTCT_FO

VMMC_CIRC

VMMC_AE

PP_PREV

KP_PREV

KP_MAT

GEND_GBV

GEND_NORM

FPINT_SITE

Care and Support

CARE_NEW

CARE_CURR

CARE_COMM

TB_STAT

TB_ART

TB_IPT

FN_THER

OVC_SERV

OVC_ACC

Treatment

TX_NEW

TX_CURR

TX_RET

TX_VIRAL

TX_UNDETECT

Health Systems Strengthening

LAB_CAP

LAB_ACC

LAB_PT

BS_COLL

SC_STOCK

HRH_PRE

HRH_CURR

HRH_HRIS

LGF_PTT

Chapter 2: Level 2 Indicators

Level 2 Indicators Table

Prevention Services

PMTCT_CTX

Care and Support

FN_ASSESS

TB_OUTCOME

TB_SCREEN

HRH_VAC

Chapter 3: National and Subnational Indicators

National and Subnational Indicators Table

Prevention Services

PMTCT_STAT_NAT

PMTCT_STAT_SUBNAT

PMTCT_ARV_NAT

PMTCT_ARV_SUBNAT

VMMC_CIRC_NAT

VMMC_CIRC_SUBNAT

KP_MAT_NAT

KP_MAT_SUBNAT

Treatment

TX_CURR_NAT

TX_CURR_SUBNAT

Country Ownership

CO_SC_NAT

SC_COMM_NAT

CO_FIN_NAT

Chapter 4: Essential Survey Indicators

Essential Survey Indicators Table

Care and Support

OVC_HIVST

OVC_NUT

OVC_SICK

OVC_BCERT

OVC_SCHATT

OVC_PRGS

OVC_STIM

OVC_MONEY

OVC_CP

Chapter 1: Level 1 Indicators

Level 1 Indicators Table

Program Area Group Indicator Code Indicator Name

Prevention Services HTC_TST Number of individuals who received HIV Testing and Counseling (HTC) services for HIV and received their test results

Prevention Services PMTCT_STAT Percentage of pregnant women with known status (includes women who were tested for HIV and received their results)

Prevention Services PMTCT_ARV Percentage of HIV-positive pregnant women who received antiretrovirals to reduce risk for mother-to-child-transmission (MTCT) during pregnancy and delivery

Prevention Services PMTCT_EID Percentage of infants born to HIV-positive women who had a virologic HIV test done within 12 months of birth

Prevention Services PMTCT_FO Final outcomes among HIV exposed infants registered in the birth cohort

Prevention Services VMMC_CIRC Number of males circumcised as part of the voluntary medical male circumcision (VMMC) for HIV prevention program within the reporting period

Prevention Services VMMC_AE Number of males circumcised surgically or by medical device that experienced at least one moderate or severe adverse event(s) (AEs)

Prevention Services PP_PREV Percentage of individuals from priority populations who completed a standardized HIV prevention intervention, including the specified minimum components, during the reporting period

Prevention Services KP_PREV Percentage of key populations reached with individual and/or small group level HIV preventive interventions that are based on evidence and/or meet the minimum standards required

Prevention Services KP_MAT Number of people who inject drugs (PWID) on medication assisted therapy (MAT) for at least 6 months

Prevention Services GEND_GBV Number of people receiving post-GBV care

Prevention Services GEND_NORM Number of people completing an intervention pertaining to gender norms, that meets minimum criteria

Prevention Services FPINT_SITE Family Planning and HIV Integration: Percentage of HIV service delivery points supported by PEPFAR that are directly providing integrated voluntary family planning services

Care and Support CARE_NEW Number of HIV-positive adults and children newly enrolled in clinical care during the reporting period who received at least one of the following at enrollment: clinical assessment (WHO staging) OR CD4 count OR viral load

Care and Support CARE_CURR Number of HIV positive adults and children who received at least one of the following during the reporting period: clinical assessment (WHO staging) OR CD4 count OR viral load

Care and Support CARE_COMM Number of HIV positive adults and children receiving care and support services outside of the health facility

Care and Support TB_STAT Percentage of registered new and relapsed TB cases with documented HIV status

Care and Support TB_ART Percentage of registered TB cases who are HIV-positive who are on ART

Care and Support TB_IPT Percentage of PLHIV newly enrolled in HIV clinical care who start isoniazid preventative therapy (IPT)

Care and Support FN_THER Proportion of clinically undernourished PLHIV who received therapeutic or supplementary food

Care and Support OVC_SERV Number of active beneficiaries served by PEPFAR OVC programs for children and families affected by

HIV/AIDS

Care and Support OVC_ACC Number of active beneficiaries accompanied or otherwise supported for transport to HIV testing, care and/or treatment services at least once every three months

Treatment TX_NEW Number of adults and children newly enrolled on antiretroviral therapy (ART)

Treatment TX_CURR Number of adults and children currently receiving antiretroviral therapy (ART) [current]

Treatment TX_RET Percentage of adults and children known to be alive and on treatment 12 months after initiation of antiretroviral therapy (Recommended: 6, 24, 36 months)

Treatment TX_VIRAL Percentage of ART patients with a viral load result documented in the medical record within the past 12 months

Treatment TX_UNDETECT Proportion of viral load tests with an undetectable viral load (<1000 copies/ml)

Health Systems Strengthening

LAB_CAP

Number of PEPFAR-supported testing facilities with capacity to perform clinical laboratory tests

Health Systems Strengthening

LAB_ACC

Number of PEPFAR-supported testing facilities (laboratories) that are recognized by national, regional, or international standards for accreditation or have achieved a minimal acceptable level towards attainment of such accreditation

Health Systems Strengthening

LAB_PT

Percentage of laboratories and POC testing sites that perform HIV diagnostic testing that participate and successfully pass in an analyte-specific proficiency testing (PT) program

Health Systems Strengthening

BS_COLL

Number of whole blood collections each year by the NBTS network

Health Systems Strengthening

SC_STOCK

Percentage of storage sites where commodities are stocked according to plan, by level in supply system

Health Systems Strengthening

HRH_PRE

Number of new HCW who graduated from a pre-service training institution or program as a result of PEPFAR-supported strengthening efforts, within the reporting period, by select cadre

Health Systems Strengthening

HRH_HRIS

Human Resource Information Systems (HRIS) Assessment Framework

Health Systems Strengthening

LGF_PTT Key HIV/AIDS-related policies monitored through Policy Tracking Tables (PTTs)

Prevention Services October 2015

Testing and Counseling Indicator code:

HTC_TST

Number of individuals who received HIV Testing and Counseling (HTC) services for HIV and received their test results

Purpose:

This indicator is intended to monitor trends in the uptake of HTC services (regardless of the service delivery point and population group) within a country. The disaggregation by test result provides information about the yield of HTC and the effectiveness of HTC programs in identifying people living with HIV (PLHIV) over time. With the Care and Support indicator (Number of HIV positive adults and children newly enrolled in clinical care), it contributes to a proxy indicator for linkage. Data from this disaggregation also feeds into an individual-level linkage indicator.

The disaggregations are intended to monitor access to and uptake of HTC by specific populations, HIV testing yield, and HTC setting and modality. The findings can support national governments and programs to determine the coverage and identify gaps in HTC services. This data may also be useful for projecting programmatic needs such as HIV test kits and other staffing resources, although individuals are counted.

NGI Mapping: P11.1.D continuing - same indicator with modified disaggregations; no impact on trend analysis

PEPFAR Support Target/Result Type:

Both Direct Service Delivery (DSD) and Technical Assistance-Service Delivery Improvement (TA- SDI) targets and results should be reported to HQ

Numerator:

Number of individuals who received HTC services and received their test results during the PEPFAR reporting period.

Denominator: N/A

Disaggregation(s):

HIV status: HIV negative:

Age/Sex disaggregates: <1 Male, <1 Female, 1-4 Male, 1-4 Female, 5-9 Male, 5-9

Female, 10-14 Male, 10-14 Female, 15-19 Male, 15-19 Female, 20-24 Male, 20-24 Female, 25-49 Male, 25-49 Female, 50+ Male, 50+ Female

Service delivery point: Antenatal Clinic, Labor & Delivery, Under 5 Clinic, Maternal and Child Health Clinic, Tuberculosis, Sexually Transmitted Infections, Outpatient Department, Inpatient, HIV Care and Treatment Clinic, Voluntary Medical Male Circumcision, Voluntary Counseling & Testing co-located, Voluntary Counseling & Testing standalone, Mobile, Home-based, Other

HIV status: HIV positive:

Age/Sex disaggregates: <1 Male, <1 Female, 1-4 Male, 1-4 Female, 5-9 Male, 5-9

Female, 10-14 Male, 10-14 Female, 15-19 Male, 15-19 Female, 20-24 Male, 20-24 Female, 25-49 Male, 25-49 Female, 50+ Male, 50+ Female

Service delivery point: Antenatal Clinic, Labor & Delivery, Under 5 Clinic, Maternal and Child Health Clinic, Tuberculosis, Sexually Transmitted Infections, Outpatient Department, Inpatient, HIV Care and Treatment Clinic, Voluntary Medical Male Circumcision, Voluntary Counseling & Testing co-located, Voluntary Counseling & Testing standalone, Mobile, Home-based, Other

3 Previously tested during the reporting period: Yes, No

3 Type of counseling/testing: Individual, Couple*, Index client

3 Key population type/Test Result: FSW, MSM/Transgender, PWID (positive, negative)

Data Source: Existing HTC registers and reporting forms that are already being used to capture HTC services could be revised to include the disaggregation categories.

Examples of data collection forms include client intake forms, activity report forms, or health registers such as Tuberculosis, Antenatal Care, and HIV Testing and Counseling registers, health management information systems registers and non-governmental organization records.

Data Collection Frequency:

Data collection at PEPFAR-funded sites should be ongoing as part of service delivery and aggregated in time for PEPFAR reporting cycles. Data should be reviewed regularly for the purposes of program management, to monitor progress towards achieving targets, and to identify and correct any data quality issues.

Method of Measurement:

Data for the numerator should be generated by counting the total number of individuals who received HTC from any service delivery point during the PEPFAR reporting period. These individuals will include TB patients, pregnant women, men receiving voluntary medical circumcision, HIV-exposed infants, key populations, family members of index patients, etc.

The HTC_TST indicator includes targets and results from the following indicators when HTC services are provided as part of the intervention package:

PMTCT_STAT

TB_STAT

VMMC_CIRC

GEND_GBV

PP_PREV

KP_PREV

Note: Serological testing among infants should be counted under the HTC_TST indicator. HIV virologic testing of HIV exposed infants should be counted under the PMTCT_EID indicator.

The first priority of data collection and reporting of HTC services among key populations must be to do no harm. These data must be managed with confidentiality to ensure the identities of the individuals are protected to prevent further stigma and discrimination of key populations.

Service delivery settings captures testing of all age groups tested in these respective settings including pediatric and adolescent populations.

The “HIV care and treatment clinic” category within the service delivery point disaggregation is intended to capture HTC services provided to the partners and relatives of PLHIV, as part of the standard package of care. HIV tests conducted at the HIV care and treatment clinics with the purpose of confirming the diagnosis of PLHIV should not be counted under this indicator.

When developing or modifying existing M&E systems and tools to collect and report this indicator, the following information should be considered:

Demographic- Client’s name, sex, age at time of HTC services, and key population

HIV testing and counseling- HIV test results, date of HIV test, receipt of HIV test results, previously tested during the reporting period, and type of counseling/testing

Site- site’s name, district, region, province, and service delivery point

*’Couple’ is defined as two persons in an ongoing sexual relationship and each of these persons is referred to as a partner in the relationship. Couple HIV testing and counseling is when two or more partners are counseled, tested and receive their results together. Index client is defined as sexual and needle-sharing partner(s) and other family members of people diagnosed with HIV who are targeted for HTC services due to possible exposure. When couple or index case HIV testing and counseling happens data should be collected for each individual and it should be indicated on the form that this was a couple or index-case session as opposed to an individual session.

Explanation of Numerator:

The numerator captures the number of individuals who received HIV Testing and Counseling (HTC) services for HIV and received their test results. A minimum provision of the following services is required for adequate data collection for this indicator: counseling, testing, return, and receipt of test results.

Explanation of Denominator: N/A

Interpretation:

This indicator is intended to monitor individuals and trends in the uptake of testing and counseling over time. This indicator includes repeat testers and will provide information on the number of times HTC services were delivered, rather than the number of unique individuals who received HTC services. Repeat testing is common practice among most HTC programs and should be aligned with World Health Organization (WHO) guidance on re-testing.1

The detailed age disaggregation monitors uptake of HTC services among children and adolescents. HIV test results are critical to monitor yield of HTC services and to estimate the linkage to care indicators. Service delivery point and geographic area monitor access to HTC services by site type and geographic location.

The inclusion of test result data may change interpretation of this indicator, as PEPFAR prioritizes consistently high yield from testing programs.

The number of individuals who are expected to be tested and counseled within a country will vary depending on numerous factors such as, the numbers of individuals with previously confirmed positive status, or the number of people who may be perceived at risk of HIV infection, and hence this indicator should be interpreted accordingly.

Given that this indicator is intended to count individuals and not number of tests, data produced through this indicator would need further interpretation for use in commodities planning.

The type and focus of a HTC program for each respective country has an impact on its interpretation. For example, a program that targets key populations or areas with the highest HIV prevalence, may result in a smaller number of people tested, and yet yield a higher identification of HIV infections than a program providing general HTC services.

PEPFAR Support:

DSD: Individuals will be counted as receiving direct service delivery support from PEPFAR when BOTH of the below conditions are met: Provision of key staff or commodities AND frequent, at least quarterly, support to improve the quality of services.

TA-SDI: Individuals will be counted as supported through TA-SDI when the point of service delivery receives support from PEPFAR that meets the second criterion only: Frequent, at least quarterly support to improve the quality of services.

1. PEPFAR is directly interacting with the patient or beneficiary in response to their health (physical, psychological, etc.) care needs by providing key staff and/or essential commodities for routine service delivery. For individuals receiving HTC services, this can include ongoing procurement of critical HTC related commodities such as rapid HIV test kits or requisite materials (lancets, capillary tubes), samples and materials for proficiency testing, or other HIV diagnostic commodities, or funding for salaries of HCW who deliver HTC services including counselors, laboratory technicians, program managers, community health workers. Staff who are responsible for the completeness and quality of routine patient records (paper or electronic) can be counted here; however, staff who exclusively fulfill MOH and donor reporting requirements cannot be counted.

AND/OR

http://whqlibdoc.who.int/publications/2010/9789241599115_eng.pdf http://whqlibdoc.who.int/publications/2010/9789241599115_eng.pdf

2. Requires an established presence at and/or routinized, frequent (at least quarterly) support to HTC services at the point of service delivery. For HTC services, this ongoing support for service delivery improvement can include: clinical mentoring/supportive supervision, HTC training, HTC guidance development, infrastructure/renovation of facilities (fixed, mobile, and outreach sites), site level QI/QA, routine support of HTC M&E and reporting, or HIV test kits consumption forecasting and supply management.

Additional References:

1.5, Global AIDS Response Progress Reporting 2013. Construction of Core Indicators for monitoring the 2011 UN Political Declaration on HIV/AIDS. January 2013.

(http://www.unaids.org/en/media/unaids/contentassets/documents/document/2013/GARPR_2013_guidelines_en.p df)

Prevention indicator (HIV-P7), The Global Fund to Fight AIDS, Tuberculosis and Malaria Monitoring and Evaluation Toolkit: HIV, Tuberculosis and Malaria and Health Systems Strengthening Part 2: Tools for monitoring programs for HIV, tuberculosis, malaria and health systems strengthening, Fourth Edition, November 2011.

(http://www.theglobalfund.org/documents/monitoring_evaluation/ME_Part2HIV_Toolkit_en/)

Utilization/Coverage indicator C3a, Guide for Monitoring and Evaluating National HIV Testing and Counseling (HTC) Programmes: Field-Test Version. World Health Organization (WHO). March 2011.

(http://whqlibdoc.who.int/publications/2011/9789241501347_eng.pdf) http://www.unaids.org/en/media/unaids/contentassets/documents/document/2013/GARPR_2013_guidelines_en.pdf http://www.unaids.org/en/media/unaids/contentassets/documents/document/2013/GARPR_2013_guidelines_en.pdf http://www.theglobalfund.org/documents/monitoring_evaluation/ME_Part2HIV_Toolkit_en/ http://whqlibdoc.who.int/publications/2011/9789241501347_eng.pdf

Prevention of Mother-to-Child Transmission (PMTCT)

PMTCT_STAT

Percentage of pregnant women with known HIV status (includes women who were tested for HIV and received their results)

Purpose:

This indicator reflects one goal of PMTCT, which is to increase the number of pregnant women who know their HIV status. Identification of a pregnant woman’s HIV status is the key entry point into PMTCT services and other HIV care and treatment services.

These data will be important to PEPFAR Headquarters, TWGs and USG country-level managers in order to:

Identify progress toward the overarching global elimination of MTCT goal of reducing the number of AIDS-related maternal deaths by 50% and reducing the number of new HIV infections among children by 90%

Determine PEPFAR and PEPFAR-funded partners’ performance in providing HIV testing to pregnant women

Identify countries/ partners needing assistance with program implementation

NGI Mapping: P1.1.D continuing - same indicator; no impact on trend analysis

PEPFAR Support Target/Result Type:

Both Direct Service Delivery (DSD) and Technical Assistance-Service Delivery Improvement (TA- SDI) targets and results should be reported to HQ

Numerator:

Number of pregnant women who were tested for HIV and know their results plus number of pregnant women with known HIV status at entry to services.

Denominator: 1 Number of new ANC and L&D clients

Disaggregation(s): 1 Positivity status: new positives, known positives at entry

Data Source: Facility registers and other program monitoring tools.

Data Collection Frequency:

Data should be collected continuously at the facility level as part of service delivery and aggregated in time for PEPFAR reporting cycles. Data should be reviewed regularly for the purposes of program management, to monitor progress towards achieving targets, and to identify and correct any data quality issues.

Method of Measurement:

The numerator is a composite of the following two data components:

1) The number of women with known (positive) HIV infection attending ANC for a new pregnancy over the last reporting period

2) The number of women attending ANC, L&D who were tested for HIV and received results (These should also be counted in the general HTC indicator “HTC_TST”)

The numerator can be summed from categories a-d below:

a) Number of pregnant women with unknown HIV status attending ANC who received an HIV test and result during the current pregnancy

b) Pregnant women with known HIV infection attending ANC for a new pregnancy

c) Number of pregnant women with unknown HIV status attending L&D who received an HIV test and result during their current pregnancy

d) Women with unknown HIV status attending postpartum services within 72 hours of delivery who were tested for the first time in the current pregnancy and received results

A “known HIV status” is defined as a confirmed positive test result from a test during this pregnancy, an already known positive test result, or a confirmed negative test result during the current pregnancy. An indeterminate test result should not be counted or reported as a part of this indicator.

The numerator is calculated using national and/or PEPFAR program records aggregated from facility registers in the ANC and L&D. In countries with high L&D attendance rates (>90%), data can be collected from L&D registers only.

Health facility registers should reflect known HIV infection among HIV-positive pregnant women coming to the ANC for a new pregnancy, such as through a code, circle, or other method, in order for them to receive subsequent PMTCT interventions. Only pregnant women with definitive results (a known status) should be counted and reported.

Pregnant women with unknown status attending either L&D or postpartum services: women who were not tested during ANC during this pregnancy; were not already known to be HIV-infected, or did not have a definitive status recorded in the register (as in, had an indeterminate result) should be counted and reported in this indicator if they receive an HIV test during L&D or postpartum services.

Pregnant women with known HIV-infection: women who are attending ANC for a new pregnancy who were tested and confirmed HIV-positive at any point prior to the current pregnancy. Pregnant women with known HIV infection attending ANC for a new pregnancy do not need retesting if that is in line with the national guidelines and/or, as long as they bring documented proof of their positive status with them. However, these women do need subsequent PMTCT services and should be counted in the numerator.

In this case, documented proof may include (but is not limited to), a health card providing HIV status test results from another testing center, or any other document that denotes that the bearer of the document is HIV positive.

Pregnant women with known status should be counted only once in this indicator. This may be difficult if national guidelines recommend testing a pregnant woman more than once during a pregnancy or if a woman seroconverts during her pregnancy and has multiple tests. For sites that are doing cohort monitoring of pregnant women in ANC, reporting a woman’s final status at the end of pregnancy is fine.

Explanation of Denominator:

The total number of new clients attending ANC and L&D services at USG-supported sites should be used as the denominator. This total will include the number of new clients who attend PMTCT services at USG-supported ANC sites and the number of women who present at L&D sites supported by USG with unknown status (as a proxy for those who have not attended ANC with PMTCT services). The USG country team is to identify the best source of data for unduplicated individuals. If the country has high facility delivery rates (>90%), the L&D data may be used as the denominator, otherwise ANC data should be used.

Note: This indicator is meant to measure the number of pregnant women who know their HIV status and is not meant to provide programmatic guidance around the types of services that should accompany HIV testing (e.g., counseling). All HIV testing programs should be adhere to national or international standards.

Interpretation:

This indicator enables the USG PEPFAR team to monitor trends in HIV testing among pregnant women and uptake of testing at USG-funded sites.

The points at which drop-outs occur during the testing and counseling process and the reasons why they occur are not captured by this indicator.

This indicator does not measure the quality of the testing or counseling. It also does not capture the number of women who received pre- or post- test counseling.

There is a risk of double counting with this indicator, as a pregnant woman could be tested multiple times during ANC or, L&D, and postpartum. This is particularly true when pregnant women get re-tested according to some national guidelines or when they seek testing in different facilities, or when they come to the L&D without documentation of their test.

While not feasible to avoid double counting entirely, countries should ensure a data collection and reporting system is in place to minimize it, such as using patient held and facility held ANC records to document that testing took place and only counting and reporting the last test with a definitive result, or the previously known HIV-infected status.

PEPFAR Support:

DSD: Individuals will be counted as receiving direct service delivery support from PEPFAR when BOTH of the below conditions are met: Provision of key staff or commodities AND frequent, at least quarterly, support to improve the quality of services.

TA-SDI: Individuals will be counted as supported through TA-SDI when the point of service delivery receives support from PEPFAR that meets the second criterion only: Frequent, at least quarterly support to improve the quality of

1. PEPFAR is directly interacting with the patient or beneficiary in response to their health (physical, psychological, etc.) care needs by providing key staff and/or essential commodities for routine service delivery. For women receiving PMTCT services, this can include: ongoing procurement of critical commodities such as test kits, ARVs, or lab commodities, or funding for salaries of HCW. Staff who are responsible for the completeness and quality of routine patient records (paper or electronic) can be counted here; however, staff who exclusively fulfill MOH and donor reporting requirements cannot be counted.

2. PEPFAR provides an established presence at and/or routinized, frequent (at least quarterly) support for those services at the point of service delivery. For PMTCT services, this ongoing support for service delivery improvement can include: training of PMTCT service providers, clinical mentoring and supportive supervision of PMTCT service sites, infrastructure/renovation of facilities, support of PMTCT service data collection, reporting, data quality, QI/QA of PMTCT services support, ARV consumption forecasting and supply management, support of lab clinical monitoring of patients, supporting patient follow-up/retention, support of mother mentoring programs.

Additional References:

Partially harmonized with Prevention indicator (HIV-P10), The Global Fund to Fight AIDS, Tuberculosis and Malaria Monitoring and Evaluation Toolkit: HIV, Tuberculosis and Malaria and Health Systems Strengthening, Part 2: Tools for monitoring programs for HIV, tuberculosis, malaria and health systems strengthening, Fourth Edition, November 2011 (http://www.theglobalfund.org/documents/monitoring_evaluation/ME_Part2HIV_Toolkit_en/)

Global Monitoring Framework and Strategy for the Global Plan towards the elimination of new HIV infections among children by 2015 and keeping their mothers alive (EMTCT).

(http://apps.who.int/iris/bitstream/10665/75341/1/9789241504270_eng.pdf)

#7. Core Indicators for National AIDS Programmes. Guidance and Specifications for Additional Recommended Indicators. April 2008 (http://www.unaids.org/en/media/unaids/contentassets/documents/document/2010/JC1768- Additional_indicators_v2_en.pdf)

Refer to the PMTCT/Peds Treatment TWG with further inquiries.

http://www.theglobalfund.org/documents/monitoring_evaluation/ME_Part2HIV_Toolkit_en/ http://apps.who.int/iris/bitstream/10665/75341/1/9789241504270_eng.pdf http://www.unaids.org/en/media/unaids/contentassets/documents/document/2010/JC1768-Additional_indicators_v2_en.pdf http://www.unaids.org/en/media/unaids/contentassets/documents/document/2010/JC1768-Additional_indicators_v2_en.pdf

Prevention of Mother-to-Child Transmission (PMTCT)

PMTCT_ARV

Percentage of HIV-positive pregnant women who received antiretrovirals to reduce risk of mother-to-child-transmission (MTCT) during pregnancy and delivery

Purpose:

This indicator measures the provision and coverage of antiretroviral prophylaxis and treatment, by regimen type, for HIV-positive pregnant women in order to:

Identify progress toward the USG and global goals of increasing ARV coverage (prophylaxis and treatment) among pregnant women living with HIV and eliminating mother-to-child transmission of HIV

Assess progress toward implementing more efficacious PMTCT ARV regimens

Determine the coverage of HIV+ pregnant women on ARV prophylaxis and ART for life among all HIV+ pregnant women identified

Provide data for models estimating the country-specific and global impact of USG-supported PMTCT programs

NGI Mapping: P1.2.D continuing - same indicator; no impact on trend analysis

PEPFAR Support Target/Result Type:

Both Direct Service Delivery (DSD) and Technical Assistance-Service Delivery Improvement (TA- SDI) targets and results should be reported to HQ

Numerator:

Number of HIV-positive pregnant women who received antiretrovirals (ARVs) to reduce risk of mother-to-child-transmission during pregnancy

Denominator:

Number of HIV-positive pregnant women identified in the reporting period (including known HIV-positive at entry)

Disaggregation(s):

By regimen type (mutually exclusive choices):

1. Life-long ART disaggregated by

a. newly initiated on treatment during the current pregnancy

b. already on treatment at the beginning of the current pregnancy

2. Maternal triple-drug ARV regimen provided with the intention to stop at the end of the breastfeeding period

3. Maternal AZT (prophylaxis component of WHO Option A during pregnancy and delivery)

4. Single-dose nevirapine (with or without tail)

Data Source: Facility registers and other program monitoring tools

Data Collection Frequency:

Data should be collected continuously at the facility level as part of service delivery. Data should be aggregated in time for PEPFAR reporting cycles. Data should be reviewed regularly for the purposes of program management, to monitor progress towards achieving targets, and to identify and correct any data quality issues.

Method of Measurement:

Numerator: The number of HIV-positive pregnant women who received antiretrovirals for prophylaxis or treatment during pregnancy or during labor and delivery (L&D), deduplicated.

Denominator: Number of HIV-positive pregnant women identified in the reporting period (including known HIV-positive at entry)

Explanation of Numerator:

Disaggregation of regimen definitions

Categories Further clarification Common examples

1) Life-long antiretroviral therapy (including Option B+)

Required disaggregations by:

A three-drug regimen intended to provide ART for life

1a) # of HIV-positive pregnant women identified in the reporting period newly initiated on ART for life

Standard national treatment regimen, for example:

TDF+3TC (or FTC)+EFV

AZT+3TC+NVP

The following should be considered in reporting:

A woman should only be counted in a regimen category if she actually received the regimen. Referral alone for ARVs or ART should not be counted unless regimen initiation is confirmed.

Each ARV regimen category is mutually exclusive. Each pregnant woman should only be counted once. If a pregnant woman receives different ARV regimens at different points during the pregnancy, count only the most recent regimen provided to her in the reporting period.

Because ARVs can be provided to HIV-positive women at different sites including ANC, L&D and HIV care & treatment, steps should be taken to deduplicate patients counted at multiple sites. For example:

o A woman, who is already on treatment, becomes pregnant and enrolls in ANC/PMTCT because she is HIV-positive. While she may not be receiving drugs at the ANC/PMTCT site, she should be counted within the life-long ART disaggregation for this indicator.

o In settings with high facility delivery rates (>90%), countries may consider aggregating the numerator entirely from the L&D register by counting the number of HIV-positive pregnant women who received a specific ARV regimen by the time of delivery. This method likely minimizes double-counting.

The disaggregation of newly initiating on treatment during the current pregnancy vs already on treatment at the beginning of the current pregnancy are important distinctions for program planning, target setting, and forecasting. Clients who transfer in from another facility, or who temporarily stopped therapy and have started again in the time period should not be counted as new on treatment.

o A woman receives AZT prophylaxis at her first ANC visit. After receiving her CD4 results, she is moved to a life-long ART regimen. In this case she should be counted and reported only once under life-long ART

1a) newly initiated on treatment during the current pregnancy

1b) already on treatment at beginning of pregnancy

1b) # of HIV-positive pregnant women identified in the reporting period who were already on ART at their first ANC visit.

If a woman is initiating ART for life (including Option B+) at L&D then she should be counted in category 1a.

2) Maternal triple ARV prophylaxis (prophylaxis component of WHO Option B during pregnancy and delivery)

A three-drug regimen provided for MTCT prophylaxis started antenatally or as late as during L&D with the intention of stopping prophylaxis at the end of the breastfeeding period (or stopping at delivery if not breastfeeding)

If a woman is receiving ARVs for the first time at L&D then she should still be counted in this category if the facility is implementing Option B.

TDF+3TC (or FTC)+EFV

AZT+3TC+EFV

AZT+3TC+LPV/r

3) Maternal AZT (prophylaxis component of WHO Option A during pregnancy and delivery)

A prophylactic regimen that uses AZT (or another NRTI) started as early as 14 weeks or as late as during L&D to prevent HIV transmission

If a woman is receiving ARVs for the first time at L&D, then she should still be counted in this category if the facility is implementing Option A.

AZT at any point before L&D + intrapartum NVP

AZT at any point before L&D + intrapartum NVP +7 day post-partum tail of AZT/3TC

Intrapartum NVP +/- 7 day post-partum tail + extended NVP for infant

4) Single-dose nevirapine (with or without a tail)

Count SD-NVP if:

It is the ONLY option provided to an HIV-positive pregnant woman either antenatally or during L&D (this includes use of a tail*)

Do NOT count SD-NVP if:

NVP is provided as part of Option A antenatally or

An HIV+ pregnant woman is initiated on Option A, B, or B+ at labor and delivery

*The tail is used to prevent NVP resistance. It does not alter risk of transmission and therefore does not constitute a different regimen.

SD-NVP for mother ONLY at onset of labor

SD-NVP + 7 day AZT/3TC tail

ONLY

SD-NVP for mother at onset of labor and SD NVP for baby

ONLY

The number of HIV-positive pregnant women receiving ART (disaggregation of the PMTCT ARVs/ART indicator) and the number individuals newly initiated on ART who are pregnant (disaggregation of the new on treatment indicator) likely have large overlaps, but in many countries are not the same groups of women. The indicator narrative should clearly explain the source of the data for PMTCT ARVs/ART disaggregation and how it relates to what is reported in the new on treatment indicator.

Explanation of Denominator:

Number of HIV-positive pregnant women identified in the reporting period (including known HIV-positive at entry)

This denominator includes a sum of categories a-d below, at USG-supported sites:

a. Number of pregnant women who were tested and received an HIV+ result at ANC

b. Pregnant women known to be HIV-positive attending ANC for a new pregnancy

c. Pregnant women tested during L&D and received a new HIV+ result

d. Women with unknown HIV status attending postpartum services within 72 hours of delivery who were tested for

HIV and received their HIV + result

Interpretation:

It is recognized that due to the way in which data is collected and reported in many countries, some level of duplication may be inevitable. Additionally, there may be over or undercounting of certain regimens based on data collection methodologies.

PEPFAR Support:

DSD: Individuals will be counted as receiving direct service delivery support from PEPFAR when BOTH of the below conditions are met: Provision of key staff or commodities AND frequent, at least quarterly, support to improve the quality of services.

TA-SDI: Individuals will be counted as supported through TA-SDI when the point of service delivery receives support from PEPFAR that meets the second criterion only: Frequent, at least quarterly support to improve the quality of

1. PEPFAR is directly interacting with the patient or beneficiary in response to their health (physical, psychological, etc.) care needs by providing key staff and/or essential commodities for routine service delivery. For women receiving PMTCT services, this can include: ongoing procurement of critical commodities, such as test kits, ARVs, or lab commodities, or funding for salaries of HCW. Staff who are responsible for the completeness and quality of routine patient records (paper or electronic) can be counted here; however, staff who exclusively fulfill MOH and donor reporting requirements cannot be counted.

2. PEPFAR provides an established presence at and/or routinized, frequent (at least quarterly) support to those services at the point of service delivery. For PMTCT services, this ongoing support for service delivery improvement can include: training of PMTCT service providers, clinical mentoring and supportive supervision of PMTCT service sites, infrastructure/renovation of facilities, support of PMTCT service data collection, reporting, data quality, QI/QA of PMTCT services support, ARV consumption forecasting and supply management, support of lab clinical monitoring of patients, supporting patient follow-up/retention, support of mother mentoring programs.

Additional References:

Global Plan Towards the Elimination of New HIV Infections Among Children by 2015 and Keeping their Mothers Alive Monitoring Framework (http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2011/20110609_JC2137_Gl obal-Plan-elimination-HIv-Children_en.pdf)

Monitoring the Declaration of Commitment on HIV/AIDS. Guidelines on Construction of Core Indicators 2010 http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2011/20110609_JC2137_Global-Plan-elimination-HIv-Children_en.pdf http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2011/20110609_JC2137_Global-Plan-elimination-HIv-Children_en.pdf

Reporting, United Nations General Assembly Special Session [UNGASS]. March 2009.

(http://data.unaids.org/pub/manual/2009/jc1676_core_indicators_2009_en.pdf)

HIV-P13. The Global Fund to Fight AIDS, Tuberculosis and Malaria Monitoring and Evaluation Toolkit 4th Edition.

November 2011. (http://www.theglobalfund.org/en/me/documents/toolkit/)

3.1. Global AIDS Progress Reporting 2013: Construction of Core indicators for monitoring the 2011 UN Political Declaration on HIV/AIDS (http://www.unaids.org/en/media/unaids/contentassets/documents/document/2013/GARPR_2013_guidelines_en.p df) http://data.unaids.org/pub/manual/2009/jc1676_core_indicators_2009_en.pdf http://www.theglobalfund.org/en/me/documents/toolkit/ http://www.unaids.org/en/media/unaids/contentassets/documents/document/2013/GARPR_2013_guidelines_en.pdf http://www.unaids.org/en/media/unaids/contentassets/documents/document/2013/GARPR_2013_guidelines_en.pdf

Prevention of Mother-to-Child Transmission (PMTCT)/Pediatrics

PMTCT_EID

Percentage of infants born to HIV-positive women who had a virologic HIV test done within 12 months of birth

Purpose: This indicator measures the extent to which infants born to HIV-positive women receive virologic testing to determine their HIV status within the first 12 months of life. Early diagnosis of infants who acquired HIV during pregnancy, delivery or in the early postpartum period is critical as infants have an increased risk of mortality if they go undiagnosed and untreated.

NGI Mapping: C4.1 .D continuing – slightly modified indicator, limited effect on trend analysis

PEPFAR Support Target/Result Type:

Both Direct Service Delivery (DSD) and Technical Assistance-Service Delivery Improvement (TA- SDI) targets and results should be reported to HQ

Numerator:

Number of infants who had a virologic HIV test within 12 months of birth during the reporting period

Denominator:

Number of HIV-positive pregnant women identified in the reporting period (including known HIV-positive women at entry into PMTCT)

Disaggregation(s):

Infants who received a virologic test within 2 months of birth

Infants who received their first virologic HIV test between 2 and 12 months of age

Infants with a positive virologic test result within 2 months of birth

Infants with a positive virologic test result within 2 and 12 months of birth

Data Source: Lab databases, patient records, service outlet log books, HIV-exposed infant registers or other auditable source documentation at PEPFAR supported facilities.

Data Collection Frequency:

Data should be collected continuously at the facility level and aggregated in time for PEPFAR reporting cycles. Data should be reviewed regularly for the purposes of program management, to monitor progress towards achieving targets, and to identify and correct any data quality issues.

Method of Measurement:

A virologic test is a test used for HIV diagnosis in infants up to 18 months of age. The most commonly used form of virologic testing is HIV DNA PCR on dried blood spots (DBS). Tests used for clinical monitoring of children on ART, such as viral load quantification, should not be included here.

Infants tested should be counted once, even if they have had more than one virologic test done during the reporting period.

Explanation of Numerator:

The numerator is calculated from PEPFAR-supported lab databases or program records. Only infants who have received a virologic test by 12 months of birth should be counted and reported.

The numerator is calculated as follows:

The number of infants who received a virologic test within 12 months of birth

The numerator is disaggregated as follows:

The number of infants who received a test within 2 months of birth

The number of infants who received a virologic test for the first time between 2 and 12 months of age

The number of infants with a positive virologic test result within 12 months of birth

Explanation of Denominator:

Number of HIV-positive pregnant women identified during the reporting period (include known HIV-positive at entry).

This number serves as a proxy for the number of infants born to HIV-positive women. This denominator calculates a coverage estimate of PEPFAR contribution to early infant diagnosis in PEPFAR-supported countries. If a national level coverage is desired, then the national estimate of HIV-positive pregnant women should be used as the denominator.

By using the number of the HIV-positive pregnant women identified in the reporting period as the denominator, this indicator is harmonized and comparable with the PEPFAR PMTCT ARVs/ART indicator. This is a facility-based denominator and not representative of the population.

Interpretation:

WHO recommends that national programs establish the capacity to conduct early virologic testing for HIV exposed infants at 4-6 weeks, or as soon as possible thereafter, to guide clinical decision-making at the earliest possible stage.

Disaggregating this data by age provides a way for programs to track progress towards earlier testing of HIV-exposed infants and therefore earlier identification of HIV-infected infants who should then be initiated on treatment as soon as possible.

This indicator allows countries to monitor progress in reaching HIV-exposed infants with early infant testing as a critical service that enables early identification of positive infants and reinforces the importance of exclusive breastfeeding and maternal ARVs during the breastfeeding period for those with an initial negative result.

Since many countries do not have a unique patient identifier system for testing infants, and infants may receive more than one virologic test according to national testing algorithms, countries may have difficulty distinguishing between an initial virologic test and any subsequent virologic tests the infant receives (e.g., confirmatory virologic test in infant with an initial positive virologic result, second virologic test in infant with an initial negative virologic result). As a result, the data should be closely reviewed for double counting and efforts to deduplicate for reporting purposes should be made.

Double counting will overestimate the number of infants receiving a virologic test and in some instances, may more accurately reflect the number of virologic tests conducted.

The indicator does not measure the quality of testing or the system in place for testing. A low value of the indicator could, however, signal potential bottlenecks in the system, including poor management of HIV testing supply in country, poor data collection, and sample transportation issues, etc.

PEPFAR Support:

DSD: Individuals will be counted as receiving direct service delivery support from PEPFAR when BOTH of the below conditions are met: Provision of key staff or commodities AND frequent, at least quarterly, support to improve the quality of services.

TA-SDI: Individuals will be counted as supported through TA-SDI when the point of service delivery receives support from PEPFAR that meets the second criterion only: Frequent, at least quarterly support to improve the quality of

1. PEPFAR is directly interacting with the patient or beneficiary in response to their health (physical, psychological, etc.) care needs by providing key staff and/or essential commodities for routine service delivery. For infants receiving PMTCT/HEI services, this includes procurement of critical commodities such as test kits, lab commodities, or ARVs, or funding for salaries of HCW. Staff who are responsible for the completeness and quality of routine patient records (paper or electronic) can be counted here; however, staff who exclusively fulfill MOH and donor reporting requirements cannot be counted.

2. PEPFAR provides an established presence at and/or routinized, frequent (at least quarterly) support to those services at the point of service delivery. For PMTCT/HEI services, this ongoing support for service delivery improvement can include: training of PMTCT service providers, clinical mentoring and supportive supervision of

PMTCT service sites, infrastructure/renovation of facilities, support of PMTCT service data collection, reporting, data quality, QI/QA of PMTCT services support, ARV consumption forecasting and supply management, support of lab clinical monitoring of patients, supporting patient follow-up/retention, support of mother mentoring programs.

Additional References:

HIV-P15. The Global Fund to Fight AIDS, Tuberculosis and Malaria Monitoring and Evaluation Toolkit 4th Edition.

November 2011. (http://www.theglobalfund.org/en/me/documents/toolkit/)

3.2. Global AIDS Progress Reporting 2013: Construction of Core indicators for monitoring the 2011 UN Political Declaration on HIV/AIDS (http://www.unaids.org/en/media/unaids/contentassets/documents/document/2013/GARPR_2013_guidelines_en.p df) http://www.theglobalfund.org/en/me/documents/toolkit/ http://www.unaids.org/en/media/unaids/contentassets/documents/document/2013/GARPR_2013_guidelines_en.pdf http://www.unaids.org/en/media/unaids/contentassets/documents/document/2013/GARPR_2013_guidelines_en.pdf

Prevention of Mother to Child Transmission (PMTCT)/Pediatrics

PMTCT_FO

Final outcomes among HIV exposed infants registered in the birth cohort

Purpose: In settings where national guidelines support breastfeeding of HIV-exposed infants, antibody testing of all HIV-exposed children at 18 months of age and/or 6 weeks after cessation of breastfeeding is recommended to determine final HIV status (‘final outcome’/FO) of HIV-exposed children. To accomplish this goal, many countries have implemented HIV-exposed infant service delivery models that identify infants at birth or at the first infant follow-up visit and track them through the end of the breastfeeding period. In settings where national guidelines recommend HIV-antibody testing at 18 months of life, this indicator measures progress toward ensuring that all infants born to HIV-positive women have an outcome documented. In settings where it is common practice for HIV-infected women to breastfeed beyond 18 months, a different time point (eg, 24 months or later) could be considered.

NGI Mapping: N/A – this is a new indicator

PEPFAR Support Target/Result Type:

Both Direct Service Delivery (DSD) and Technical Assistance-Service Delivery Improvement (TA- SDI) targets and results should be reported to HQ

Numerator:

Number of HIV-exposed infants with a documented outcome by 18…