1. Development and pilot an automated Pregnancy and Birth Registry Kara Wools-Kaloustian M.D. M.S.

2. pMTCT Cascade Attend institutional ANC Be Offered HIV Test Accept HIV Test Obtain HIV Results Agree to prophylaxis Adhere to prophylaxis Adhere to Infant ARV Dose All women presenting for delivery HIV infected women only EM Stringer. Bulletin of the World Health Organization. January 2008, 86 (1)

3. Questions Arising in pMTCT What is the impact of maternal pMTCT on: – Birth outcomes – Infant growth and development – HIV- infected children’s response to ART 5/14/2015 Attend institutional ANC Be Offered HIV Test Accept HIV Test Obtain HIV Results Agree to prophylaxis Adhere to prophylaxis Adhere to Infant ARV Dose Infant Outcomes

4. Maternal Data Sources and Points of Data Loss # Pregnancies in population # Non-viable pregnancy outcomes Traditional Birth Attendants # pregnant accessing pre-natal care # Offered HIV Test # Accepting HIV Test # Obtain results ANC Clinic # Offered HIV Test # Accepting HIV Test # Obtain results # Provided prophylaxis # Adhere to prophylaxis pMTCT Clinic # Pregnant accessing delivery services # Non-viable pregnancy outcomes # Offered HIV Test # Accepting HIV Test # Obtain results # Provided prophylaxis # Adhere to prophylaxis HIV Treatment Program # pregnant accessing treatment services # Provided cART # Adhere to cART Labor and Delivery No standard collection system ANC Number not unique Data Not Electronically Captured Aggregate Data Reported to MOH pMTCT Number not unique Data Not Electronically Captured Aggregate Data Reported to MOH Number not unique Data Not Electronically Captured Aggregate Data Reported to MOH Min. dataset collected variable Patient loss prior to enrollment Infant identifiers not collected on maternal forms

5. Pediatric Data Sources and Points of Data Loss Birth weight Mode of Delivery ART prophylaxis Labor and Delivery ART prophylaxis HIV Status Growth Vital Status Pediatric HIV Clinic Vital Status Potential Access for HIV Testing Maternal Child Health Clinic (immunization clinic, well baby) Number not unique Data Not Electronically Captured Aggregate Data Reported to MOH Min. dataset collected variable No linkage with HIV data Data Not Electronically Captured Aggregate Data Reported to MOH Patient loss prior to enrollment Maternal Identifiers not collected on infant forms

6. Data Linkages Required to Assess Impact of pMTCT on Pediatric response to ART # Pregnancies in population # Non-viable pregnancy outcomes Traditional Birth Attendants # pregnant accessing pre-natal care # Offered HIV Test # Accepting HIV Test # Obtain results ANC Clinic # Offered HIV Test # Accepting HIV Test # Obtain results # Provided prophylaxis # Adhere to prophylaxis pMTCT Clinic # Pregnant accessing delivery services # Non-viable pregnancy outcomes # Offered HIV Test # Accepting HIV Test # Obtain results # Provided prophylaxis # Adhere to prophylaxis HIV Treatment Program # pregnant accessing treatment services # Provided cART # Adhere to cART Labor and Delivery Birth weight Mode of Delivery ART prophylaxis Labor and Delivery ART prophylaxis HIV Status Growth Vital Status Pediatric HIV Clinic Vital Status Potential Access for HIV Testing Maternal Child Health Clinic (immunization clinic, well baby)

7. Feasibility of A Medicines in Pregnancy Registry Nearly 90% of the data currently being advocated for collection in the WHO’s “Pilot Study to Assess the Feasibility of a Medicines in Pregnancy Registry” through the Pregnancy Outcome CRF are currently collected as part of routine care within the USAID-AMPATH Program. 5/14/2015

8. Objective O1: Develop and pilot an automated Pregnancy and Birth Registry within the OpenMRS and assess feasibility of transferring this registry to another openMRS-based records system 5/14/2015 Customize header: View menu/Header and Footer

9. Hypotheses H1a: An automated pregnancy and birth registry can be developed within OpenMRS, linking maternal and infant data allowing for a more complete assessment of impact of ART on pregnant women and infants. H1b: An automated pregnancy and birth registry will be transferrable from one OpenMRS site to another (USAID-AMPATH to FACES) 5/14/2015 Customize header: View menu/Header and Footer

10. Maternal Variables Cross sectional Variables: Date of Birth *Antiretroviral regimens prior to pregnancy *Start date of initial antiretroviral regimen Date of last menstrual period Pregnancy outcome EDD (estimated date of delivery) 5/14/2015

11. Maternal Variables Longitudinal variables WHO stage each visit WHO stage 3 and 4 conditions each visit Antiretroviral regimen Other medications (including OI prophylaxis) Gestational age at all visits during pregnancy * Reason for regimen stop/change * CD4 counts * Safety labs done (i.e. AST, ALT, Creat, CBC) * VL when available 5/14/2015

12. Infant Variables Cross Sectional Variables: Date of Birth Type of delivery Method of delivery gender physical exam findings at first visit (assessment of congenital abnormalities) Birth weight Estimated gestational age at delivery (i.e., pre-term or full-term) 5/14/2015

13. Infant Variables Longitudinal variables during first 24 months: Weight Length Head circumference *DNA PCR results *ELISA results *Antiretrovirals * Reason for regimen stop/change *CD4 count (HIV infected only) *VL (HIV infected only) *Safety labs (i.e. AST, ALT, Creat, CBC) 5/14/2015

14. Way Forward Year 1: Automate Registry at AMPATH Year 2: Automate registry at FACES Year 3: Is it possible to do this at other OPENMRS sites? – What barriers must be overcome in order to move forward? 5/14/2015