Replication Data for: High recent PrEP adherence with point-of-care urine tenofovir testing and adherence counseling among young African women: Results from the INSIGHT cohort

Background: Adolescent girls and young women (AGYW) account for two-thirds of new HIV infections in Africa. African AGYW have had high uptake of oral HIV pre-exposure prophylaxis (PrEP) but low adherence, which might be improved by point-of-care adherence monitoring with tailored counseling. Methods: From August 2022-July 2023, we conducted a PrEP demonstration project with sexually-active AGYW ages 16-30 years from 20 sites in South Africa, Eswatini, Kenya, Malawi, Uganda, and Zambia. Participants were offered oral tenofovir-based PrEP at enrollment and followed up at one, three and six months. PrEP adherence was assessed by a point-of-care qualitative lateral flow urine tenofovir (TFV) assay indicating PrEP use in the prior 4 days, which accompanied real-time adherence counseling that incorporated urine TFV results when testing was available (70.8% of month one, 35.3% of month three, and 83.9% of month six visits). We estimated overall adherence, correcting for missing test results, and analyzed the association of having received urine TFV results at month one or three with subsequent urine TFV test positivity, using modified Poisson regression. Results: Of the 3087 AGYW enrolled, the median age was 24 years (interquartile range 21-27), 75.7% were from South Africa, 2878 (93.2%) initiated PrEP at enrollment and 107 (3.5%) after enrollment. Visit retention was 92.0-96.2% for months one, three, and six and 2518 (90.1%) exited the study with a PrEP refill. Adherence, based on the point-of-care urine tenofovir test positivity rate, was estimated as 72%, 71%, and 65% at month one, three, and six, respectively. Women who received one prior urine TFV test had a 42% higher likelihood of a subsequent positive urine TFV test (adjusted Odds Ratio, OR=1.42, 95% confidence interval, CI 1.27-1.60), and those having received two prior tests had a 67% higher likelihood (adjusted OR=1.67; 95%CI 1.41-1.98). Observed HIV incidence was 1.38/100 person-years (95% CI 0.97-2.08). Conclusions: Oral PrEP uptake, recent adherence, and persistence were high in a multisite cohort of young African women over six months of follow-up. Use of a novel point-of-care tenofovir assay with tailored real-time adherence counseling was associated with increased adherence to PrEP at subsequent visits, warranting further study.