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APIN Plus/Harvard PEPFAR Evaluation of PMTCT Program. Phyllis Kanki Seema Meloni. APIN Plus/Harvard PEPFAR Evaluation of PMTCT Program. 4 sites developed through Gates funded APIN program 2002-2004 Training of health care workers Development of labs
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APIN Plus/Harvard PEPFAREvaluation of PMTCT Program Phyllis Kanki Seema Meloni
APIN Plus/Harvard PEPFAREvaluation of PMTCT Program • 4 sites developed through Gates funded APIN program 2002-2004 • Training of health care workers • Development of labs • PEPFAR provided ART to eligible mothers and infected infants • 2005- PEPFAR expanded to 9 PMTCT sites • 2006 - PEPFAR expands to 16 PMTCT sites • 2007 - PEPFAR expands to 32 PMTCT sites
Program Overview • At present, conducting PMTCT activities at 29 sites and expanding to 36 by end of 2008 • PMTCT services: 174,000 cumulative • ARV prophylaxis: >5,000 cumulative
Program Evaluation • Effort to document outcomes in APIN Plus/Harvard PEPFAR PMTCT program • Collaborative evaluation of data from 4 sites: NIMR, UCH, JUTH, LUTH • Data collected from charts and electronic databases
Variables Mother • Entry point • Prophylaxis • Age • Highest level of education • CD4, VL • Type of delivery • Conditions • Site Infant • Gestational age • Prophylaxis • Feeding method • Sex • Plurality
Most patients received some ANC Number of patients
Revised Nigerian PMTCT Guidelines (2005) Entry 28-33 weeks ZDV NVP 1 wk ZDV NVP 1 wk ZDV Entry >34 weeks ZDV+3TC NVP 1 wk ZDV Entry at Labor NVP after delivery 6 weeks ZDV syrup PCR Mom Delivery NVP Baby Assess for ART eligibility
Most infants born by SVD and C/S primarily performed at tertiary sites Number of patients
Maternal Prophylaxis • 84% of HAART-eligible and 12% of HAART-ineligible mothers were on HAART
Variables Associated with Increased Risk of Transmission at 6 weeks
Maternal prophylaxis • 3% of infants HIV+ at 6 weeks (80/2,395) P<0.001 Transmission Rate Maternal Prophylaxis
Rupture of Membranes > 4 hours p=0.01 Transmission Rate Duration of membrane rupture
Undetectable viral load prior to/at delivery p=0.002 Transmission Rate
Variables not associated with transmission risk • Delivery mode • Delivery site • Mother’s age • Mother’s educational status • Episiotomy • CD4 count • Gestational age at delivery • Infant sex • Birth weight • Vaginal tear, excessive bleeding
Variables Associated with Increased Risk of Transmission at 6 months
Infant prophylaxis p=0.03 Transmission Rate
Infant feeding* P<0.001 Transmission Rate • *Combines data for all those infected at 6 months, regardless of time of infection • When limit to only those infected after 6 week timepoint, association disappears
Infant - gender* p=0,06 Transmission Rate • *Other groups have found associations with infant gender and transmission risk; our data indicate a slightly higher risk for girls
Summary • Increased risk of transmission at 6-weeks for infants whose mothers: • No prophylaxis • None>NVP only>CBV+NVP>AZT+NVP>HAART • No ANC care • Detectable VL prior to/at delivery • Increased risk of transmission at 6 months for infants that received no prophylaxis
Gender difference in viral load suppression Naïve patients or experienced patients with detectable VL at enrollment 6 months (n=11,076): Females - 60% Males - 58% (p=.008) 4292/7141 2262/3935 12 months (n=9061): Females - 63% Males - 60% (p=.002) 3748/5877 1923/3184