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POINT-OF-CARE CREATININE TESTING WITHIN A PROGRAMMATIC PrEP DELIVERY SETTING
Jillian Pintye1, Felix Abuna2, John Kinuthia3, Harrison Lagat2, Kenneth K. Mugwanya1, Julia Dettinger1, Emily R. Begnel1, Marline Serede1, Joseph Sila2, Jared Baeten1, Grace John-Stewart1
1University of Washington, Seattle, WA, USA,2University of Washington in Kenya, Nairobi, Kenya,3Kenyatta National Hospital, Nairobi, Kenya
Creatinine (Cr) testing is recommended as part of PrEP delivery to identify pre-existing renal disease prior to PrEP initiation. Whether Cr testing is essential to assure safe use of PrEP is not yet known. We evaluated implementation of point-of-care (POC) Cr testing within a large-scale PrEP program in Western Kenya.
From June 2017 to August 2018, HIV-uninfected women seeking routine antenatal (ANC), postnatal (PNC), and family planning (FP) services were screened per national PrEP guidelines at 16 facilities in Kisumu, Kenya. Kenyan national PrEP guidelines currently recommend, but do not require, assessment of Cr clearance (CrCl) prior to PrEP initiation and annually thereafter when Cr testing is available. Prior to PrEP initiation, nurses measured height and weight, conducted Cr serum testing using validated Xpress StatSensor® POC machines (Nova Biomedical Cooperation, Waltham, MA, USA), and calculated CrCl by Cockcroft-Gault equation using a mobile application. If a single estimated CrCl measurement was below the normal range (<50mL/min according to Kenyan guidelines), the test was repeated before excluding that client from PrEP services. In a subset, we evaluated the cost and time required per test of the POC test compared to standard laboratory methods when a laboratory was present.
In total, 4007 women were evaluated for PrEP eligibility and received POC Cr testing; 41% from ANC, 50% PNC, and 10% FP. The median age was 24 years (IQR 21-28) and 200 (5%) women were ≤18 years. The median CrCl was 113 mL/min (IQR 97-132) for ANC clients, 111 mL/min (IQR 93-130) for PNC, and 99 mL/min (IQR 82-120) for FP. Overall, 8/4007 (0.2%) women had estimated CrCL <50mL/min; 1 (0.06%) from ANC, 5 (0.2%) PNC, and 2 (0.5%) FP. POC Cr testing added a median of 3 minutes to PrEP eligibility assessments and cost USD 4.5 per test; in contrast, laboratory-based results took 3 hours and cost USD 5 per test.
It was feasible to implement POC Cr testing during PrEP delivery within MCH and FP settings and low CrCl was very rare among screened women. Given the rarity of medical ineligibility and safety of short-term PrEP, our data support the recommendation of not mandating Cr testing at PrEP initiation. PrEP programs could consider conducting Cr testing at one to three months post-initiation to reduce Cr testing-related time, costs and inconvenience.