Harare Family Care CRS Tichaona Vhembo 1
Presentation Outline 1. Introduction to Harare Family Care CRS 2. Outreach activities 3. Informed consent process 4. Study entry procedures 5. Pharmacy considerations 6. Challenges. 2
Harare Family Care CRS Situated within Parirenyatwa Hospital Recruitment activities take place from within 40km radius, from 14 Harare City Primary Care Clinics Recruitment system has been in place since 2007 Established relationships Enrolment into 7 protocols (P1060,P1070,P1072,P1073,1077 BF, P1104,P1092) New protocols presented at City of Harare Matrons meetings P1115: Enrolled 30ppts in step 1 and 5 in step 2 3
OUTREACH ACTIVITIES Participant identification Daily up to 2 teams go to various clinics to recruit for all open protocols. City Clinics may also call study staff for potential participants Looking for “UNBOOKED” mothers who meet eligibility criteria: Pregnancy never registered at a health I. facility Test HIV positive during labour or II. soon after delivery No ART in current pregnancy. III. Review medical records and check time 1. of delivery and gestational age at delivery 4
IC Process Sensitisation of potential participants by nurse counsellors doing outreach duties. Potential participant then transported to site a.s.a.p. after delivery Second review medical records before IC process begins. IC process varies in time(3-5hrs) Participant literacy Pain threshold of ppt (after-birth pains) 5
Other Entry Procedures Mother Neonate Mother’s sample #1 for HIV History and physical exam test. Initial blood draw for neonate Subject enrolment (HIV viral load + SOE) History and physical exam Second blood draw for neonate 1hr later (for HIV Do other procedures as per DNA PCR). SOE (inc. sample #2 for HIV Issue prescription (stop NVP) test) 6
Pharmacy considerations Mother undergoes adherence counselling Adherence strategies discussed Mother selects and communicates her adherence strategy plan Mother trained on medication dosing Participant initiated on ART and given first dose 7
First Visit Timelines • Sensitization of potential participant 30min • Review of medical records s -1 hour • Informed Consent Process 3-5 hours • Maternal HIV test (Sample #1) 35min s • Maternal and Neonatal history and physical examination 40mi ns • Initial Neonate blood draw ( viral load and SOE tests) 15 mins • Confirmatory HIV test for neonate >1hour after initial blood draw 15min s • Pharmacy 30-45 mins 8
Challenges Mother accepting the new HIV diagnosis-counseling Mother concentrating on IC process despite after-birth pains- analgesics and refreshments offered Collecting adequate blood volumes in neonates- prioritise evaluations as indicated in LPC Mother apprehensive that her baby is being pricked twice- counselling on importance of accurate diagnosis 9
Thank you 10
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