integrating pmtct and art n. shaffer pmtct/peds twg pepfar track 1 sept 25, 2007
TRANSCRIPT
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IntegratingPMTCT and ART
N. ShafferPMTCT/Peds TWG
PEPFAR Track 1 Sept 25, 2007
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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!
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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
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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
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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%
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12,820,900
2,814,729
17,895,000
0
2,000,000
4,000,000
6,000,000
8,000,000
10,000,000
12,000,000
14,000,000
16,000,000
18,000,000
20,000,000
Estimated Number of AnnualBirths
Estimated Annual Number ofPregnant Women Attending at
least 1 ANC visit
Number of Pregnant WomenReceiving PMTCT Services*
with USG Support**
(16%)
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
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0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Botswana
Guyana
Rwanda
Namibia
South Africa
Kenya
Zambia
Haiti
Tanzania
Uganda
Mozambique
Cote D'Ivoire
Vietnam
Ethiopia
Nigeria
% 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
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1,330,528
285,640
1,067,165
0
200,000
400,000
600,000
800,000
1,000,000
1,200,000
1,400,000
Estimated Number of AnnualBirths to HIV+ Women*
Estimated Annual Number ofHIV+ Pregnant Women
Attending at least 1 ANC visit
Number of HIV+ PregnantWomen Reciving a CompleteCourse of ARV Prophylaxis**
with USG Support***
(21%)
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
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0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Botswana
Rwanda
Namibia
South Africa
Kenya
Guyana
Zambia
Uganda
Tanzania
Haiti
Mozambique
Vietnam
Cote d'Ivoire
Nigeria
Ethiopia
% of HIV+ Pregnant Women Attending at least one ANC Visit who Received PMTCT ARV in FY06 with USG Support, by Country
PMTCT/Peds TWG
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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
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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
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MTCT Risk in Women Meeting WHO Criteria* for ART Who Receive HAART
Cote d’Ivoire Trials Data, F. Dabis 6/05
23.6%
13.6%8.9%
0%
10%
20%
30%
40%
50%
% M
TC
T a
t 6
Wks
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 orStage 1-2 and CD4<200
Slide obtained from Lynne Mofenson, NIH
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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
10.9%3.6% 3.5%
0%
10%
20%
30%
40%
50%
% M
TC
T a
t 6
Wks
* Does not Meet WHO criteria if: WHO Stage 3 and CD4 >350 orStage 1-2 and CD4 >200
Short AZT AZT+ AZT/3TC+ SD NVP SD NVP
Slide obtained from Lynne Mofenson, NIH
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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.
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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)
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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?
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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
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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!