Integrating PMTCT and ART N. Shaffer PMTCT/Peds TWG PEPFAR Track 1 Sept 25, 2007

1. IntegratingPMTCT and ARTN. ShafferPMTCT/Peds TWGPEPFARTrack 1 Sept 25, 2007

2. Action Steps (Track 1, Sept 2006) • Establish active framework for interaction and joint activities (PMTCT and ART) • Standardize approach to monitoring • Standardize reporting? • Commitment to comprehensive, integrated approach • Redefine/ strengthen PMTCT as part of care and treatment WE NEED YOUR HELP!

3. Key Messages • PMTCT lagging behind ART scale-up • High PMTCT coverage and impact is achievable soon, but only with renewed focus • HAART for treatment-eligible women and combination prophylaxis regimens essential for high-impact PMTCT • PEPFAR programs should intensify focus on pregnant women and families as key entry-point to achieve “2-7-10” goals • PMTCT and ART programs need to be unified and coordinated

4. Guidance on Global Scale-Up PMTCT Towards universal access for women, infants and young children • New scale-up strategy, PMTCT IATT • To be launched November, 2007 • Key principles: • National coverage and universal access • Provide ART as priority for eligible, pregnant women • Family-centered longitudinal care

5. Magnitude Annually in 15 PEPFAR focus countries: • 18 million women deliver • 13 million women receive ANC (70%) • 1.25 million HIV+ women deliver HIV prevalence range: 0.4-36%, median: 7% • ~450,000 infants become HIV-infected* (>50% of worldwide perinatal infections) *Without effective interventions, based on MTCT rate of 35%

6. FY2006 Coverage of HIV Counseling and Testing in PMTCT Settings in the 15 Focus Countries *PMTCT services defined as HIV counseled and tested and received results **Includes both direct and indirect USG support PMTCT/Peds TWG

7. % of Pregnant Women Attending at least one ANC Visit in the 15 Focus Countries who Received HIV Counseling and Testing in FY06 with USG Support, by Country PMTCT/Peds TWG

8. FY2006 Coverage of ARV Prophylaxis for PMTCT in the 15 Focus Countries *Based on HIV prevalence estimates among pregnant women **Any PMTCT ARV regimen ***Includes both direct and indirect USG support

9. % of HIV+ Pregnant Women Attending at least one ANC Visit who Received PMTCT ARV in FY06 with USG Support, by Country PMTCT/Peds TWG

10. PMTCT Core Interventions • Routine ANC and L&D T&C • Simplified pre-test, rapid same-day results • ARV prophylaxis (NVP, combination AZT, HAART) • Minimum of short prophylaxis to all • Longer ARV combinations and HAART where feasible, and when woman eligible • Infant feeding counseling • Program support for safe, feasible alternatives • Early exclusive BF, early weaning • “PMTCT-Plus” / Entry to care and treatment • Follow up of infants/ infant diagnosis • Care and treatment for mother, child, family

11. PMTCT ARV Prophylaxis / Treatment WHO, 2006 guidelines: “tiered” approach • HAART for eligible women • Combination prophylaxis (eg. AZT+SD NVP) • SD NVP where other interventions not feasible/ available • NVP resistance is continuing concern Reality: Most PMTCT based on SD NVP Few pregnant women receiving HAART

12. MTCT Risk in Women Meeting WHO Criteria*for ART Who Receive HAARTCote d’IvoireTrials Data, F. Dabis 6/05 2.4% Short AZTAZT+AZT/3TC+HAART SD NVPSD NVP * WHO Criteria for ART: WHO Stage 4 or Stage 3 and CD4<350 or Stage 1-2 and CD4<200 Slide obtained from Lynne Mofenson, NIH

13. MTCT Risk in Women Not Meeting WHO Criteria*for ART Who Receive Short-Course ARV ProphylaxisCote d’IvoireTrials Data, F. Dabis 6/05 Short AZTAZT+AZT/3TC+ SD NVPSD NVP * Does not Meet WHO criteria if: WHO Stage 3 and CD4 >350 or Stage 1-2 and CD4 >200 Slide obtained from Lynne Mofenson, NIH

14. PMTCT / HAART: Current Status • Very few pregnant women now receiving HAART in PEPFAR programs • Currently not being reported • Standard reporting is critical • With CD4 < 200:~ 20-30% of pregnant women will be eligible • With CD4 <350: ~40% of pregnant women will be eligible • Most effective intervention to decrease transmission (including postpartum breastfeeding transmission), decrease resistance, increase links with ART program.

15. HAART for HIV+ Pregnant Women: Need and Current Access • An estimated 250,000 HIV+ pregnant women (20%) need ART annually in focus countries • Assuming 20% need ART, pregnant women represent ~6% of estimated 4 million adults who need ART in the focus countries • At end FY05, pregnant women represented only 1.3% (3,061 / 249,213) of patients reported on treatment through direct PEPFAR support

16. Extension to “PMTCT-Plus” Continuum from PMTCT to care and treatment • Two models for “PMTCT-Plus” • ARV services in PMTCT programs (ANC and maternities) • Direct referrals and integration between PMCT and ARV programs • Pediatric follow-up care for HIV-exposed infants including basic care and HIV testing • Testing, counseling and treatment and care for husbands, partners, and family members

17. Comprehensive Approach with PEPFAR ART Partners • Support regional / provincial health system • Mapping of clinical sites in region • PMTCT sites? ART sites? • Levels of care and network referrals • PMTCT as HIV care site (pre-ART) • Support links between PMTCT and care and treatment • Active support for ART screening, HAART and combination prophylaxis • Active links for mother and child follow up

18. Comprehensive Approach with PMTCT and Care and Treatment • PMTCT at all ART sites and ART site networks • ART access at all PMTCT sites • Integrated approach as programs expand to district and primary health care (PHC) levels

19. Integrated Child Follow up • Major challenge • Key goal is to improve HIV-free survival, demonstrate impact of PMTCT program • Early identification of infected children • Early infant diagnosis program • Early pediatric treatment • Identification and support for HIV-exposed, uninfected children • Basic care package (CTX, malaria prevention, nutritional support, etc) • Placing HIV-exposure status on mother and child health cards helps identify HIV status and promotes appropriate HIV care and referrals

20. Early Infant Diagnosis • Tremendous progress: 13 of 15 focus countries now have PEPFAR-supported DBS PCR lab programs, all 15 by 2008. Standard protocols, testing and evaluation Examples - Botswana >10,000 DBS PCR/year - Nigeria and Malawi: multi-partner pilot programs with 2 labs - Namibia: >3,000 DBS PCR/year - Kenya: >6,000 DBS/year, 6 labs - Cote d’Ivoire: lab training completed, pilot protocol

21. PMTCT / ART Operational Issues • Support and systems for CD4 screening of pregnant women • Coordination of PMTCT and ART programs • ART supply chain for pregnant women; availability and initiation in MCH • Tracking of women and infants • Program monitoring and reporting

22. Indicators and Monitoring • Two general PEPFAR indicators # tested # receiving “complete course ARV” • Provides general program coverage • not adequate for monitoring program • not adequate to assess quality of interventions • not adequate to assess impact • Need to update, expand, standardize indicators and monitoring at national and partner level

23. Track 1 PMTCT/ART Monitoring • Subgroup met July 28, 2007, Atlanta, as part of Track 1 monitoring meeting • All Track 1 partners agreed to incorporate PMTCT indicators into Track 1 report form • Reporting should be limited, and consistent with international and national indicators • Plan to pilot PMTCT Track 1 reporting • Report form and pilot still pending • Need to finalize and pilot

24. Track 1 PMTCT/ART Monitoring Key variables for pilot report • PMTCT sites • New clients • Pregnant women tested and counseled • Pregnant women with known HIV+ status • Pregnant women assessed for ART eligibility • Pregnant women eligible for ART • Pregnant women provided with ART and other ARVs (by regimen group) • Infants on CTX • Infants tested by PCR • Infants tested by serology >12 months • Infant outcome (infected/ uninfected/ unknown)

25. PMTCT/ART Integration: Evaluation and Research Questions • How to effectively screen pregnant women for ART eligibility? • How to maximize ART for eligible women? How to best provide ART in MCH setting? • What is the appropriate CD4 cut-off for ART eligibility for pregnant women? • How to effectively implement “family-centered longitudinal HIV care and treatment”? • What is the program impact of integrated PMTCT/ART approach?

26. Summary • PMTCT scale-up is challenging, but important progress being made • PMTCT still separated from and lagging behind ART • New PMTCT guidelines: ART as priority for eligible pregnant women • PMTCT is a major entry point for care and treatment • “Comprehensive approach,” “family-centered approach” and “regionalization” -- important new opportunities • Need effective monitoring and accountability • Need to work directly with Track 1 partners

27. Action Steps (Track 1, Sept 2007) • Establish active framework for interaction and joint activities (PMTCT and ART) • Standardize approach to monitoring • Standardize reporting • Commitment to comprehensive, integrated approach • Redefine/ strengthen PMTCT as part of care and treatment WE NEED YOUR HELP!