Integrating enhanced HIV pre-exposure prophylaxis into a sexually transmitted infection clinic in Lilongwe (ePrEP STI): A prospective cohort study (Preprint)

BACKGROUND Pre-exposure prophylaxis (PrEP), when taken as prescribed, reduces HIV acquisition risk by >90% and is a critical lever to reduce HIV incidence. Identifying persons most likely to benefit from PrEP and retaining them on PrEP throughout the period of HIV risk is critical to realize PrEP’s HIV prevention potential. Persons with STIs are an obvious priority PrEP population, but there is no data out of sub-Saharan Africa (SSA) confirming effectiveness of integrating PrEP into sexually transmitted infection (STI) clinics. Assisted partner notification may further enhance STI-clinic based PrEP programming, recruiting potential PrEP users from the pool of named sexual partners of persons presenting with an incident STI. However, the acceptability, feasibility, and effectiveness of these integrated and enhanced strategies are unknown. OBJECTIVE This study aims to describe the implementation outcomes of acceptability, feasibility, and effectiveness (in terms of PrEP uptake and persistence) of integrating an enhanced PrEP implementation strategy into an STI clinic in Malawi. METHODS The ePrEP STI study is a prospective cohort study enrolling PrEP-eligible patients ≥15 years who are seeking STI services at a Lilongwe-based STI clinic. Data collection will rely on a combination of in-depth interviews, patient and provider surveys, and clinic record review. All enrolled PrEP users will be screened for acute HIV infection and receive quarterly STI testing for Neisseria gonorrhea, Chlamydia trachomatis, and syphilis. Participants will be asked to name recent sexual partners for assisted notification; returning partners will be screened for PrEP eligibility and, if interested, enrolled into the cohort of PrEP initiators. We will also enroll a subset of PrEP-eligible patients from the STI clinic who choose not to initiate PrEP. Patient participants will be followed for 6-months; we will assess self-reported PrEP use, refill/pill provision, sexual behaviors, perceived HIV risk, and incident STIs. Provider participants will be interviewed at baseline and ~6 months, and will complete surveys examining perceived acceptability and feasibility of the integrated and enhanced PrEP strategy. RESULTS Enrollment began in March, 2022 and is projected to continue until February 2023 with patient participant follow-up through August 2023. The study results are expected to be reported in 2024. CONCLUSIONS This study will generate important evidence regarding the potential integration of PrEP services into STI clinics in SSA, as well as preliminary data regarding the effectiveness of an enhanced strategy that includes assisted partner notification as a strategy to identify potential PrEP users. Furthermore, this trial will provide some of the first insights into STI incidence among PrEP users recruited from an STI clinic in SSA – critical data to inform use of etiologic STI testing where syndromic management is the current standard. These findings will help design future PrEP implementation strategies in SSA. CLINICALTRIAL ClinicalTrials.gov NCT05307991; https://clinicaltrials.gov/ct2/show/NCT05307991