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BACKGROUND: Adherence challenges with oral tenofovir-based pre-exposure prophylaxis (PrEP) are common. We developed a point-of-care assay to objectively assess tenofovir in urine and conducted a pilot trial examining the impact of counselling informed by use of this urine assay on long-term PrEP adherence. METHODS: This randomised trial enrolled women not in serodiscordant partnerships 3 months after PrEP initiation at the Kenya Medical Research Institute to compare standard-of-care adherence counselling versus counselling informed by the urine assay (urine-test counselling group) every 3 months for 12 months. In the standard of care group, urine samples were stored and tested at study end without participant feedback. Here we report the adherence primary outcome of hair concentrations of tenofovir at 12 months as a long-term metric (undetectable levels defined long-term non-adherence), as well as urine concentrations of tenofovir at each visit as a short-term adherence metric and acceptability of the assay assessed by quantitative surveys. Data were analysed by randomisation group. This completed trial was registered with ClinicalTrials.gov (NCT03935464). FINDINGS: From March 17, 2021 to Jan 18, 2022 we enrolled 49 women in the urine-test counselling group and 51 in the standard of care group; retention was 86 (86%) of 100. Nine (21%) of 42 in the urine-test counselling group had hair samples at 12 months with tenofovir concentrations below the limit of quantification compared with 15 (37%) of 41 in the standard of care group. The relative odds of long-term non-adherence in the standard of care group compared with urine-test counselling were 3·53 (95% CI 1·03-12·03; p=0·044). Pre-intervention, urine tenofovir was detectable in 65% in the urine-test counselling group and 71% in the standard of care group (p=0·68). At 12 months, 31 (72%) of 43 in the intervention group had detectable urine tenofovir compared with 19 (45%) of 42 in the standard of care group (p=0·0015). 40 (93%) of 43 participants liked the test very much and only one disliked the test. One participant in the standard of care group was withdrawn at the 6-month visit due to HIV seroconversion. INTERPRETATION: A low-cost urine tenofovir assay to inform PrEP counselling resulted in improvement in both short-term and long-term metrics of adherence. This urine tenofovir assay could help to improve long-term PrEP adherence. FUNDING: National Institute of Allergy and Infectious Diseases and National Institutes of Health.

: Introduction: Delivery of oral pre‐exposure prophylaxis (PrEP) is being scaled up in Africa, but clinic‐level barriers including lengthy clinic visits may threaten client continuation on PrEP. Methods: Between January 2020 and January 2022, we conducted a quasi‐experimental evaluation of differentiated direct‐to‐pharmacy PrEP refill visits at four public health HIV clinics in Kenya. Two clinics implemented the intervention package, which included direct‐to‐pharmacy for PrEP refill, client HIV self‐testing (HIVST), client navigator, and pharmacist‐led rapid risk assessment and dispensing. Two other clinics with comparable size and client volume served as contemporaneous controls with the usual clinic flow. PrEP continuation was evaluated by visit attendance and pharmacy refill records, and time and motion studies were conducted to determine time spent in the clinics. Dried blood spots were collected to test for tenofovir‐diphosphate (TFV‐DP) at random visits. We used logistic regression to assess the intervention effect on PrEP continuation and the Wilcoxon rank sum test to assess the effect on clinic time. Results: Overall, 746 clients were enrolled, 366 at control clinics (76 during pre‐implementation and 290 during implementation phase), and 380 at direct‐to‐pharmacy clinics (116 during pre‐implementation and 264 during implementation phase). Prior to implementation, the intervention and control clinics were comparable on client characteristics (female: 51% vs. 47%; median age: 33 vs. 33 years) and PrEP continuation (35% vs. 37% at 1 month, and 37% vs. 39% at 3 months). The intervention reduced total time spent at the clinic by 35% (median of 51 minutes at control vs. 33 minutes at intervention clinics; p Conclusions: A client‐centred PrEP delivery approach with direct‐to‐pharmacy PrEP refill visits plus client HIVST significantly reduced clinic visit time by more than one‐third and improved PrEP continuation in public health HIV clinics in Kenya., INTRODUCTION Oral pre‐exposure prophylaxis (PrEP) is a highly effective HIV prevention strategy [1–3]; however, maximizing access and continuation is a key challenge for optimizing the overall public health impact of [...]

Introduction: Post-abortion clinics located in regions with high HIV burden may ideal locations to integrate counselling and delivery of HIV pre-exposure prophylaxis (PrEP), aligning with normative goals for integrated delivery of HIV and reproductive health care. The objective of this study was to gauge the degree to which Kenyan women seeking care for a pregnancy loss, including induced abortion, are at risk for HIV and whether women would welcome an introduction to PrEP prior to discharge from post-abortion care. Methods: We conducted a mixed-methods study from August 2019 to February 2020 with women ages 15 to 30 recruited sequentially as they were accessing post-abortion care at public and private facilities in Thika and Kisumu, Kenya. Data collection was through a cross-sectional survey and laboratory testing for common sexually transmitted infections (N = 200), and in-depth interviews (N = 30). Descriptive statistics summarize PrEP knowledge and referrals and a multivariable log-link binomia model estimated correlates of receiving a referral for PrEP. Qualitative data were analysed using inductive and deductive approaches. Results: Among 200 HIV-negative women (median age 21.0, interquartile range 19.0 to 22.0), the prevalence of Chlamydia trachomatis was 18.2% and Neisseria gonorrhoeae was 2.0%. Half of the women scored [greater than or equal to]5 on a validated tool that would correspond to an expected HIV incidence of 9.5% per year. Approximately half (55.8%) of women were familiar with PrEP prior to the study and 33.3% received a referral from study staff to a clinic offering PrEP. In qualitative interviews, women expressed interest in accessing PrEP from the gynaecology ward that provided post-abortion care but they preferred alternative locations for PrEP refills. Conclusions: Kenyan women accessing post-abortion care have substantial HIV risk and were favourable about the idea of receiving support to initiate PrEP as part of care offered during post-abortion care. These settings can be integrated into national PrEP programmes as locations providing PrEP referrals and initiation. Keywords: PrEP; abortion; Kenya; young women; HIV prevention, 1 | INTRODUCTION Young women living in settings with a high HIV burden face intersecting risks for unintended pregnancy, HIV and other sexually transmitted infections. To combat this, a priority [...]

HIV self-testing (HIVST) has the potential to reduce barriers associated with clinic-based preexposure prophylaxis (PrEP) delivery. We conducted a substudy nested in a prospective, pilot implementation study evaluating patient-centered differentiated care services. Clients chose either a blood-based or oral fluid HIVST kit at the first refill visit. Data were abstracted from program files and surveys were administered to clients. We purposively sampled a subset of PrEP clients and their providers to participate in in-depth interviews. We surveyed (n = 285). A majority (269/285, 94%) reported HIV risk. Blood-based HIVST was perceived as easy to use (76/140, 54%), and (41/140, 29%) perceived it to be more accurate. Oral fluid-based HIVST was perceived to be easy to use (95/107, 89%), but almost all (106/107, 99%) perceived it as less accurate. HIVST improved privacy, reduced workload, and saved time. HIVST demonstrates the potential to streamline facility-based PrEP care in busy African public health facilities. [ABSTRACT FROM AUTHOR]