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Poor oral pre-exposure prophylaxis (PrEP) persistence in an integrated HIV PrEP program in urban Malawi Grace E. Mulholland* Grace Mulholland Mitch Matoga Jane S. Chen Esther Mathiya Griffin J. Bell Beatrice Ndalama Tapiwa Munthali Naomi Nyirenda Naomi Bonongwe Claire T. Pedersen Edward Jere Mina C. Hosseinipour Zakaliah Mphande Irving F. Hoffman Sarah E. Rutstein

An estimated 860,000 people were infected with HIV in sub-Saharan Africa (SSA) in 2022, indicating the need for effective HIV prevention strategies. HIV pre-exposure prophylaxis (PrEP) may reduce new HIV infections, but its effectiveness has been hampered by poor persistence. Few studies have described PrEP persistence in integrated PrEP programs in SSA, and persistence definitions vary across studies, complicating comparisons.

We estimate oral PrEP persistence under Malawi’s standard of care (SOC) PrEP services at a PrEP program integrated into an STI clinic in urban Malawi. The study population included 835 clients who newly initiated PrEP from March-December 2022. We define PrEP persistence as a combination of timely PrEP refills and self-reported adherence, and we assess these via routine clinical records data for visit dates, pill counts, and client-reported missed doses. We examine the sensitivity of persistence to different parameters: i.e., where the definition for persistent use allows no more than 7 days without PrEP coverage since PrEP initiation (strict), and where the definition allows up to 14 days without PrEP (flexible). We compute PrEP persistence among 662 clients who received the SOC and apply inverse probability weights to account for baseline differences in age, sex, and indication for PrEP between the SOC recipients and 173 clients who received additional services.

Median age at PrEP initiation was 28 (IQR: 24, 36), and 45% of clients were female. Under our strict definition of persistence, we estimated that had all 835 clients received the SOC, 17% (95% CI: 15%, 20%) and 4% (95% CI: 3%, 6%) would have persisted on PrEP at 1 and 6 months, respectively. Estimates were similar under our more flexible persistence definition. Under all definitions examined, persistence was incredibly low in this PrEP program in Malawi. Strategic evaluation is required to improve PrEP persistence among clients at risk of HIV acquisition in this and similar settings.