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Abstract Background In Kenya, 65% of sexually active unmarried women use modern contraceptives, a population at increased risk of HIV acquisition compared to other populations. Anchoring HIV prevention services, including pre-exposure prophylaxis (PrEP), to trusted contraceptive delivery settings offers opportunities to efficiently reach this important population. In Kenya, almost half (40%) of women accessing contraception services do so outside traditional healthcare facilities, such as retail pharmacies. Thus, integrating PrEP services into retail pharmacies may increase options for reaching adolescent girls and young women (AGYW) who could benefit from PrEP. Efforts are underway to define care pathways for pharmacy-delivered PrEP services in Kenya, including unsupported and supported models with nurse navigators. Methods The AGYW Pharmacy PrEP study is an unblinded 2-arm cluster-randomized controlled trial in Kisumu, Kenya. The objective is to determine the effect that unsupported versus supported pharmacy-delivered PrEP services has on PrEP initiation, persistence, and adherence among AGYW seeking contraception. Twenty retail pharmacies offering pharmacy provider-led PrEP delivery will be randomized 1:1 to either receive or not receive a nurse navigator to support PrEP delivery. Eligible AGYW (n = 1900 total, n = 950/arm) will be ≥ 15 years old, purchasing a method of contraception at the pharmacy. Trained pharmacy provider will offer eligible AGYW either daily oral PrEP or the monthly DPV vaginal ring. The primary trial outcomes are PrEP initiation (use of PrEP at 1 month), persistence (use of PrEP at 10 months), and adherence (quantified by levels of TFV or DPV in hair samples). Additionally, several secondary (STI incidence, PrEP method selection, predictors of PrEP adherence) and exploratory outcomes (HIV incidence, quality of care, contraceptive method mix) will be explored. Discussion We hypothesize pharmacy-delivered PrEP services supported with nurse navigator, versus delivered by pharmacy providers alone, will improve PrEP outcomes among AGYW seeking contraception. Our results will help policy makers better understand how to potentially implement this novel differentiated service model for PrEP and prime pharmacies for the delivery of new PrEP agents in the pipeline (e.g., long-acting injectables and multi-purpose technologies). The study was initiated on May 13, 2023, and is expected to be completed by February 2025. Trial Registration ClinicalTrials.gov (NCT05467306), with registration on July 20, 2022.

Introduction Healthcare providers are required to support people living with HIV (PLHIV) to quit tobacco use for improved health outcomes, but it is unclear to what extent they adhere to these requirements. We examined HIV care providers and PLHIV’s perceptions of support, and barriers, to providing tobacco cessation.Methods This qualitative investigation was part of a larger study seeking to integrate tobacco cessation into HIV care in Western Kenya (NCT05351606). We conducted 22 key informant interviews with HIV care providers and managers and four focus group discussions (n=28) with PLHIV. The interviews and discussions were audio-recorded, and audio files were transcribed and, when necessary, translated into English for coding and analysis.Results PLHIV rarely disclose or are screened for tobacco use unless a complaint or clinical finding prompts a provider. Despite PLHIV wanting to receive support to quit tobacco use, they feared negative reactions from their providers if they disclosed their tobacco use status. Providers cited several system-related barriers to screening for and providing cessation support for PLHIV, including workload pressure, lack of job aids, tobacco use screening not included as a performance indicator and lack of adequate counselling skills to address tobacco use.Conclusions PLHIV are not routinely screened for tobacco use despite their knowledge of the negative impact of tobacco use on overall health outcomes and desire to quit. System-related barriers hinder providers from providing cessation support. Providers should be trained and equipped with additional skills and resources to integrate tobacco cessation support into routine HIV care.

Abstract Introduction HIV self‐testing (HIVST) has the potential to support daily oral pre‐exposure prophylaxis (PrEP) delivery in private pharmacies, but many national guidelines have not approved HIVST for PrEP dispensing. In Kenya, pharmacy providers are permitted to deliver HIVST, but often do not have the required certification to deliver rapid diagnostic testing (RDT). We estimated the performance of provider‐delivered HIVST compared to RDT, the standard of care for PrEP delivery, at private pharmacies in Kenya to inform decisions on the use of HIVST for PrEP scale‐up. Methods At 20 pharmacies in Kisumu County, we trained pharmacy providers (pharmacists and pharmaceutical technologists) on blood‐based HIVST use and client assistance (if requested). We recruited pharmacy clients purchasing sexual and reproductive health‐related products (e.g. condoms) and enrolled those ≥18 years with self‐reported behaviours associated with HIV risk. Enrolled clients received HIVST with associated provider counselling, followed by RDT by a certified HIV testing services (HTS) counsellor. Pharmacy providers and clients independently interpreted HIVST results prior to RDT (results interpreted only by the HTS counsellor). We calculated the sensitivity and specificity of pharmacy provider‐delivered HIVST compared to HTS counsellor‐administered RDT. Results Between March and June 2022, we screened 1691 clients and enrolled 1500; 64% (954/1500) were female and the median age was 26 years (IQR 22–31). We additionally enrolled 40 providers; 42% (17/40) were pharmacy owners and their median years of experience was 6 (IQR 4–10). The majority (79%, 1190/1500) of clients requested provider assistance with HIVST and providers spent a median of 20 minutes (IQR 15–43) with each HIVST client. The sensitivity of provider‐delivered HIVST at the pharmacy was high when interpreted by providers (98.5%, 95% CI 97.8%, 99.1%) and clients (98.8%, 95% CI 98.0%, 99.3%), as was the specificity of HIVST in this setting (provider‐interpretation: 96.9%, 95% CI 89.2%, 99.6%; client‐interpretation: 93.8%, 95% CI 84.8%, 98.3%). Conclusions When compared to the national HIV testing algorithm, provider‐delivered blood‐based HIVST at private pharmacies in Kenya performed well. These findings suggest that blood‐based HIVST may be a useful tool to support PrEP initiation and continuation at private pharmacies and potentially other community‐based delivery settings.