1. Monitoring and Evaluation of Care and Treatment Kola Oyediran, MEASURE Evaluation Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa 2-13 August 2009

2. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Session Objectives  Understand the need for simple, standardized patient monitoring systems that support integrated services for HIV/AIDS  Become familiar with the components of the Three Interlinked Patient Monitoring Systems (3ILPMS)  Become familiar with the 3ILPMS minimum data set and generic tools

3. Global Context  HIV Care and Treatment  ~ 7 million in need of ART, ~3 million have access (end 2007)  Roughly ~42% coverage  PMTCT  Every day >1400 children under 15 years are infected with HIV (mostly through MTCT)  Children represent >10 % of all new infections  In the countries most affected by HIV, women, infants and young children represent >60 % of all new HIV infections 2  TB/HIV  TB is leading cause of death among PLWHA  Many with TB do not know their HIV status- not accessing services. 1 1 World Health Organization (WHO). Towards Universal Access: Scaling up priority HIV/AIDS interventions in the health sector. Progress Report. Geneva, WHO, April 2008. 2 World Health Organization (WHO). Guidance on global scale-up of the prevention of mother to child transmission of HIV: towards universal access for women, infants and young children and eliminating HIV and AIDS among children / Inter-Agency Task Team on Prevention of HIV Infection in Pregnant Women, Mothers and their Children. Geneva, WHO, 2007. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010

4. The Domains of Comprehensive HIV/AIDS Care Human Rights & Legal Support Stigma & Discrimination Reduction Succession Planning PLWHA Participation Clinical Care VCT, PMTCT, Preventive Therapy (OIs, TB), Management of STIs and OIs, Palliative Care, Nutritional Support, ART Socioeconomic Support Material Support Economic Security Food Security Psychosocial Support Counseling, Orphan Care, Community Support Services, Spiritual Care Adults and Children Affected by HIV/AIDS Prevention Supportive Policy and Social Environment

6. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 The Continuum of Care, Support, and Treatment  Clinical care, support and treatment services may be offered by multiple providers and through different programs  Partnership and collaboration between providers is essential for a continuum of care  A holistic approach to CST should be taken  This includes clinical/facility based services and community- based services

7. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Experience Sharing and Brainstorm Share your experience with HIV/AIDS care, support and treatment services. What type of services are provided? Who provides the service(s) (e.g. NGO, government, etc)? How are service(s) provided (e.g. clinic, in the home, etc)? How are eligible clients identified? Does the program provide referrals for other services? What are some of the key M&E questions relevant to these CST programs? (15 minutes)

8. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 M&E Questions for CST Programs  Are CST services in (facilities, households and/or communities) being provided as outlined in the project plan?  How many persons in need are receiving services?  Are CST services reaching the target population?  Do the services provided adhere to minimum quality standards?  Is there a reduction in AIDS related morbidity and mortality?

9. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Scaling-up of Care, Support and Treatment  Several global initiatives have a goal to scale up the delivery of care, support, and treatment services.  Some specific objectives include:  “to provide three million people living with HIV/AIDS … antiretroviral treatment (ART) by the end of 2005 (WHO 3X5)  “ to provide antiretroviral drugs for 2 million HIV-infected people; prevent 7 million new infections, care for 10 million individuals and orphans infected and affected by the disease” (PEPFAR)  “By 2005, develop and make significant progress in implementing comprehensive care strategies to strengthen family and community-based care” (UNGASS)  Scaling up from 3x5; 2, 7, 10 (PEPFAR) to Universal Access

10. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Requirements for Scaling up of CST  Services need to be decentralized to health center level  Need simple yet effective patient monitoring systems that can be used in all types of facilities  Systems need to support longitudinal patient management (vs. acute care)  Need to closely monitor adherence to avoid drug resistance  Resources must be put into establishing these systems

11. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 What is a patient monitoring system?  Simple, scalable, harmonized systems that facilitate management of patients and monitoring of programs  Patient data is recorded and tracked longitudinally  Majority of collected data is used for patient management (also called patient tracking, clinical management)  Subset of the data is used for program monitoring and reporting  Patient monitoring systems also allow data for groups of patients (cohorts) to be analyzed to monitor the intended outcomes of the program for the cohort  Strong patient monitoring system – backbone of care and treatment

12. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Characteristics of a Good Patient Monitoring System  Patient records respect confidentiality  Data collection forms are standardized  The system as a whole is simple  The system promotes accountablity  The system promotes data use and evidence- based decision making

13. Level of data collection Objective Monitoring tools Quantity Global/ Regional National District Facility Patient Global/regional summary indicators National summary indicators District summary indicators and reporting forms Facility registers, logbooks Patient card/record Summary indicators for global reporting (e.g. 3x5, PEPFAR) Summary indicators for national planning and reporting Indicators for district and national reporting and planning Clinical team management of groups of patients, case review, audits, drug supply management Patient management Less More The Patient Monitoring System at Different Levels of the Health System Source: World Health Organization (WHO). Patient monitoring guidelines for HIV care and antiretroviral therapy (ART). Geneva, WHO, 2006.

14. Patient Monitoring Guidelines for HIV care and Antiretroviral Therapy (ART) Version 1 (2006) Collaboration between WHO, UNAIDS, PEPFAR, others Part of IMAI approach Contains minimum essential data elements and definitions Contains generic tools (e.g. patient follow up, cohort analysis and quarterly cross sectional report) for country adaptation  Adaptation guide (29 countries have adapted and are using the tools)  Training workshops and materials for clinical teams, data clerks and district managers/supervisors http://www.who.int/3by5/publications/art/en/

15. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Burkina Faso Côte d’Ivoire Ethiopia Kenya Lesotho Mozambique Namibia Nigeria Senegal South Africa Swaziland Tanzania Uganda Zambia Zimbabwe Guyana Caribbean OECS Djibouti Somalia Sudan Yemen India Indonesia Myanmar Nepal Sri Lanka Viet Nam Moldova Ukraine for 2007 annual progress report, 50% of countries reported on continuation of ART at 12 months Country Adaptations of the Generic HIV care/ART Patient Monitoring Tools

16. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Discussion Question  Describe a patient monitoring systems that you are familiar with:  What data is collected?  How is it collected and reported?  How is data used?  Break up into small groups (15 minutes)  Large group discussion (5 minutes)

17. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Three Interlinked Patient Monitoring Systems (3 ILPMS)  Version 2 (2009)  Builds on PM experience since 2006 guidelines  Includes: Updated HIV care/ART minimum data set TB/HIV minimum data set Proposed MCH/ANC/PMTCT minimum data set  Key pediatric variables  Supports patient monitoring across services  Includes Annual Patient Monitoring Review- draft guidelines to facilitate cohort analysis and quality improvement at facility level  Is for country adaptation

18. Why interlinked patient monitoring systems?  As cohorts grow, increasing number of PLWHA  PHWHAs get pregnant and develop TB disease- therefore need to manage the patient, not the disease  Failure to reach PMTCT targets: need to scale up PMTCT  Most pregnant women do not travel to hospitals for care: need to decentralize to health centers  Not enough doctors/medical officers therefore nurse/midwife led clinical teams need to be able to provide ART and AZT prophylaxis  PMTCT interventions need integrated with acute and chronic HIV care/ART

19. HIV care/ ART patient monitoring system MCH/PMTCT patient monitoring system When pregnant women tests HIV positive, start HIV card/ ART card and enter in Pre-ART register When PLHIV becomes pregnant, start Maternal Health Card and enter in ANC register Updated TB patient monitoring system with HIV variables When TB patient tests HIV positive, start HIVcard / ART card and enter in Pre- ART register When PLHIV develops TB, also start TB card and enter in TB register Check pregnancy status, counsel on reproductive choice Check TB status on each HIV care visit The 3 inter-linked patient monitoring systems Integrated primary health care Family-based approach Support co-management (and co-supervision) of HIV, TB, pregnancy and children

20. TB-HIV training courses explain how to fill patient cards, TB sputum, ANC, L&D registers Operations Manual and Forms Booklet Target: health center team (health workers, data clerk) IMAI Clinical Guideline Modules Target: health center clinical team District Addendum to the Operations Manual PMTCT M&E Guide (being undated) Patient Monitoring Guidelines (Adaptation Guide plus explanation of indicators, paper, electronic, etc.) Target: national programs, partners. cross-ref With training: How to support health center patient monitoring TB M&E guide; M&E guide for TB-HIV (04); TB recording, reporting forms 06

21. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 HIV Care/ART

22. HIV care/ARTMaternal/infant/PMTCTTB-HIV Patient-held cards HIV card  Maternal card  Child health card  TB identity card Facility-held cards HIV care/ART card  Facility-held labour and postpartum records  TB treatment card Registers tracking diagnostic tests PITC /VCT registers  ANC and L& D registers also contain testing and CD4 results  TB laboratory register  TB suspect register Longitudinal care and treatment registers  Pre-ART Register  ART register  ANC register  Labour and delivery register  HIV-exposed infant register  BMU TB register

23. Individual medical records HIV care/ART card Maternal health card Child health card Labour and delivery record TB treatment card Pre-ART ART ANC L&D HIV Exposed Infant TB suspect TB lab TB Basic Management Unit Cohort - ART Cross sectional HIV care TB-HIV: TB status, IPT TB-ART co-treatment Malaria: IPTp ANC/L&D: HIV testing, ARV prophylaxis/ART Registers Reports

25. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 HIV care/ART Card (p. 13-16 3ILPMS)  Facility held  Contain essential data elements necessary for individual patient care  Foundation for the patient monitoring systems  Data source for the pre ART and ART registers  Uses standard notation and codes  Can also be used for HIV exposed infants

26. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 HIV care/ART Card (p. 13-16 3ILPMS) Demographic information (Summary page) HIV care and ART (Summary and Encounter pages) Family status (including HIV exposed infant summary) (Summary page) Follow-up education, support and preparation for ARV therapy (Follow-up page)

27. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Registers: Pre-ART Register (p. 23 3ILPMS)  Records patients that are in HIV care  Track interventions given and clinical progression of HIV-infected persons before ART  Contains all patients ever registered in HIV care  Organized by date of enrollment  logitudinal register: One line = one patient

28. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Registers: ART Register (p. 26 3ILPMS)  Records patients that are on treatment  Monitor key patient information during treatment  Organized by ART start-up groups based on month/year start ART in program (treatment cohorts)  Each page has only one start-up group  logitudinal register: One line = one patient  Facilites outcome analysis of groups of patients at baseline, 6, 12, 24, etc. Months (cohort analysis)

29. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 MCH/PMTCT

30. HIV care/ARTMaternal/infant/PMTCTTB-HIV Patient-held cards HIV card  Maternal card  Child health card  TB identity card Facility-held cards HIV care/ART card  Facility-held labor and postpartum records  TB treatment card Registers tracking diagnostic tests PITC /VCT registers  ANC and L& D registers (also contain testing and CD4 results)  TB laboratory register  TB suspect register Longitudinal care and treatment registers.  Pre-ART Register  ART register  ANC register  Labor and delivery register  HIV-exposed infant register  BMU TB register

31. facility-held patient-held

33. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Integrated Maternal Card (p. 3 3ILPMS)  Mother held card  Contains key information related to pregnancy, labour and childbirth, and postnatal period  Mother: HIV test, WHO clinical stage, CD4 sent and result given, ART eligibility, ARV adherence counseling, ARV dispensed, ARV adherence, infant feeding counseling, infant feeding intention/practice, CTX started, ARV given during delivery and dispensed, IPT- 1, 2 and 3,, FP- counseling and/or method, congenital syphilis test and treatment  Infant: ARV prophylaxis (given at delivery and dispensed), birth weight, immunizations

34. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Integrated ANC Register (p. 9 3ILPMS)  HIV status at admission  HIV test date and result  Partner testing  ART eligibility (assessed or referred), WHO clinical stage, CD4 count, result given  ARV prophylaxis or ART (Sd-NVP, AZT, ART)  Enrolment in HIV care (date and unique ART number)  IPT for malaria prevention

35. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Integrated Labour Record and Labour and Delivery Register (p. 31-37 3ILPMS)  HIV status at admission  HIV test and result  family planning  adherence counselling  infant feeding intention and practice

36. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Integrated Child Health Card (p. 40 3ILPMS)  Maternal HIV status  Infant feeding counseling or support at delivery  Infant feeding practice  HIV test  HIV test: type and result  CTX given  Infant confirmed infected  Date infant enrolled in HIV care/ART  Unique ART #  Action needed, re: nutrition, adherence, etc.

37. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 HIV Exposed Infant (HIE) Register (p. 44 3ILPMS)  EDD/Date of Delivery  Mother’s unique HIV care/ART #  Infant’s name  Duration of ARVs during pregnancy (mother)  Infant ARVs (prophylaxis)  Age in wks/mos started CTX  Date, age at HIV test, test type and result  Date infant enrolled in HIV care (unique ID #)  Final status of infant

38. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 TB-HIV

39. HIV care/ARTMaternal/infant/PMTCTTB-HIV Patient-held cards HIV card  Maternal card  Child health card  TB identity card Facility-held cards HIV care/ART card  Facility-held labour and postpartum records  TB treatment card Registers tracking diagnostic tests PITC /VCT registers  ANC and L& D registers also contain testing and CD4 results  TB laboratory register  TB suspect register Longitudinal care and treatment registers  Pre-ART Register  ART register  ANC register  Labour and delivery register  HIV-exposed infant register  BMU TB register

40. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Indicators

41. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Patient Monitoring Indicators Access New in care and New on ART Cumulative ever in care and cumulative ever on ART Current on ART Eligible for but not yet started on ART Success % people with advanced HIV infection receiving ARV combination therapy (Core 7, UNGASS, PEPFAR) Continuation of first-line regimens at 6, 12 and 24 months after initiation (Core 8) Survival at 6, 12, 24 months after initiation of ART (Core 9, UNGASS,PEPFAR) Median CD4 and increase/% CD4 ≥ 200 at 6 and at 12 months on ART compared to baseline

42. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Patient Monitoring Indicators (cont) Early HIV drug resistance warning (EWI) % patients with good adherence to ART  Percentage of patients initiating ART at the site during a selected time period who are taking an appropriate first line regimen 12 months later  Percentage of patients initiating ART at the site during a selected time period who are initially prescribed, or who initially pick up from the pharmacy, an appropriate first-line ART regimen

43. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Reports Cross-sectional Cohort Analysis

44. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Cross-sectional vs. Cohort analysis One point in time Disaggregated by sex, age and pregnancy status New and cumulative in HIV care and on ART Total currently in HIV care and on ART Patients have same duration of treatment Patient outcomes at 6, 12, 24, etc. months Percentage alive and on ART / Mortality on ART Percentage still on a first-line regimen Median or mean CD4 counts (optional) Percentage switched to a second-line (or higher) regimen Routine analysis by facility then district or district only Allows clinical team to follow outcomes of patients

45. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Patient Monitoring Systems: Challenges  Simplification needed to decentralize to the primary health care level  Need to evaluate implementations of the system  Linkages- PMTCT, TB, <5, community-based interventions  Supportive supervision  Data quality  Paper  Electronic continuum

46. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 Patient Monitoring System: Lessons Learned  Growing cohorts, push for systems that support integrated services  Regular supportive supervision (especially right after training) is key to data quality  Importance of data clerks  Printing of the tools and registers is expensive and needs to be planned for  Planning for “backfilling” registers is also crucial  Development of tally tool(s) to help the facility level  Development of simple electronic systems should overlap with retaining a paper based system  Importance of the role of district level staff  Need to document best practices and examples of data use

47. Monitoring and Evaluation of HIV/AIDS Programs Pretoria, South Africa, 2-13 August 2010 For more information contact:  Upama Khatri (ukhatri@jsi.com)  Sisay Sirgu (sirgus@who.int)  Sandy Gove (goves@who.int)

48. MEASURE Evaluation is a MEASURE project funded by the U.S. Agency for International Development and implemented by the Carolina Population Center at the University of North Carolina at Chapel Hill in partnership with Futures Group International, ICF Macro, John Snow, Inc., Management Sciences for Health, and Tulane University. Views expressed in this presentation do not necessarily reflect the views of USAID or the U.S. Government. MEASURE Evaluation is the USAID Global Health Bureau's primary vehicle for supporting improvements in monitoring and evaluation in population, health and nutrition worldwide. Visit us online at http://www.cpc.unc.edu/measure.