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

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!

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

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

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: %, median: 7% ~450,000 infants become HIV-infected* (>50% of worldwide perinatal infections) *Without effective interventions, based on MTCT rate of 35%

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

% 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

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

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

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

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

MTCT Risk in Women Meeting WHO Criteria* for ART Who Receive HAART Cote d’Ivoire Trials Data, F. Dabis 6/05 Short AZT AZT+ AZT/3TC+ HAART SD NVP SD NVP 2.4% * 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

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

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.

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

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

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

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

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

Early Infant Diagnosis Tremendous progress: 13 of 15 focus countries now have PEPFAR-supported DBS PCR lab programs, all 15 by 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

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

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

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

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)

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?

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

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!