"Yes, I'm reminded, but it doesn't mean I'm taking them": Experiences with Short Message Service Reminder Use in Real-time Monitoring of HIV PrEP among Young Women in Kenya.

Adherence to oral pre-exposure prophylaxis (PrEP) is challenging, and cellular technology offers a promising opportunity for support. However, a recent randomized controlled trial found that SMS reminders did not improve PrEP adherence. We used qualitative methods to explore the trial participants' experiences with the SMS intervention. We conducted serial in-depth interviews with 54 young Kenyan women, using inductive and deductive content analysis . Initially, SMS reminders were highly acceptable. Participants expressed enthusiasm with receiving the reminders because of the coded nature of the SMS reminders; they also helped in 'habit forming' with daily adherence. However, overtime, participants reported growing concerns about privacy, self-efficacy, and responsibility and SMS fatigue. Participants also reported other challenges, including phone loss, poor telephone network, and lack of electricity. Further research to explore if SMS reminders in alternative formats or with different frequency is needed, in addition to identification of alternate adherence support strategies.

Multi-level Factors Driving Pre-exposure Prophylaxis Non-initiation Among Young Women at High Risk for HIV in Kenya.

Few studies have focused on understanding pre-exposure prophylaxis (PrEP) non-initiation among young, high-risk women in sub-Saharan Africa. This study aimed to qualitatively explore why young women in Kenya at high-risk for HIV chose not to enroll in a PrEP adherence trial. We performed 40 semi-structured interviews with young high-risk women assessing concerns about PrEP and/or study participation. We also assessed community-level factors influencing decision-making around PrEP through 10 focus groups involving peers, young men, caregivers, and community leaders. Our qualitative data reflect the complexity of navigating barriers preventing PrEP initiation in settings where taking PrEP may be perceived as immoral behavior. Framed within the context of risk perception, the decision to start PrEP may run counter to the potential risk of losing support from one's community. Our findings suggest that approaches addressing social norms, while de-medicalizing HIV prevention services, are needed to further increase PrEP uptake among young Kenyan women.

The Effects of the COVID-19 Pandemic on Healthcare Providers' Mental Health: Experiences at Kenyatta National Hospital, Kenya.

BACKGROUND: In 2020, healthcare providers were expected to provide care to individuals with coronavirus disease 2019 (COVID-19), putting them at risk of acquiring COVID-19. The possibility of acquiring poorly understood infectious diseases while providing care may have an impact on the mental health of providers. We conducted a study to explore the effects of COVID-19 on the mental health of healthcare providers. METHODS: Between April and August 2021, we conducted in-depth interviews with 60 healthcare providers in the infectious disease unit (IDU) and other units of the hospital (non-IDU). The healthcare providers completed an online self-administered survey form with demographic data (age, sex, average income, and known contact with a COVID-19 patient). We used semi-structured interview guides to understand the healthcare providers' lived experiences of stress, anxiety, depression, and their associated factors. We transcribed the interviews verbatim and coded and analyzed the transcripts to derive thematic concepts related to mental health experiences. RESULTS: The healthcare providers had a median age of 37 years [IQR 20.0-58.0], and 56.7% were female, 30.0% nurses, 18.3% medical doctors, and 11.7% laboratory technologists. The healthcare providers reported increased stress during the pandemic, attributed to the high demand for patient care, changes in social life, and fear of COVID-19 infection. They also reported experiences of anxiety and depression as a result of limited knowledge at the beginning of the pandemic and the perception that "COVID-19 resulted in death". Testing positive for COVID-19, high exposure to COVID-19 risks, and the death of patients and colleagues reportedly affected the healthcare providers' mental health. Additionally, the healthcare providers reported mental health support through debriefing meetings, peer-to-peer support, and psychological counseling, with privacy and confidentiality concerns. CONCLUSIONS: Healthcare providers faced mental health issues such as stress and anxiety while taking care of COVID-19 patients. An effective mental health response requires institutional practices that address context-specific challenges such as privacy and confidentiality.

HIV Self-Testing for Efficient PrEP Delivery Is Highly Acceptable and Feasible in Public Health HIV Clinics in Kenya: A Mixed Methods Study.

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.

Acceptability and feasibility of long-term, real-time electronic adherence monitoring of HIV pre-exposure prophylaxis (PrEP) use among young women in Kenya: A mixed methods study.

Real-time electronic adherence monitoring involves "smart" pill boxes that record and monitor openings as a proxy for pill taking and may be useful in understanding and supporting PrEP use; however, acceptability and/or feasibility for PrEP users is uncertain. We sought to understand the experiences of using a real-time electronic adherence monitor for PrEP delivery among young women in Kisumu and Thika, Kenya. We used the Wisepill device to monitor PrEP use among 18-24-year-old women for two years. Half of the participants were randomized to also receive SMS adherence reminders (daily or as needed for missed doses). We assessed acceptability quantitatively and qualitatively according to the four constructs of Unified Theory of Acceptance and Use of Technology (UTAUT): performance expectancy, effort expectancy, social influence, and facilitating conditions. We assessed feasibility by monitor functionality during periods of PrEP use. We analyzed quantitative data descriptively and compared by site and over time; qualitative data were analyzed inductively and deductively. The median age was 21 years (IQR 19-22), median education was 12 years (IQR 10-13), 182 (53%) had disclosed PrEP use, and 55 (16%) reported recent intimate partner violence. Most participants reported high levels of usefulness and high interest in using the monitor with few problems or worries reported throughout follow-up. Feasibility was high overall with some differences by site (96% functional monitor days in Kisumu vs 88% in Thika). Few monitors were reported lost (N = 29; 8%) or dysfunctional (N = 11; 3%). In qualitative interviews, electronic monitoring was perceived as useful because it supported privacy, confidentiality, easy storage, and PrEP adherence. Effort was generally considered low. Participants expressed some concern for stigma from monitor and/or PrEP use. Facilitating conditions involved the monitor size, color, and battery life. Overall, real-time electronic adherence monitoring was a highly acceptable and feasible approach to understand PrEP adherence among young women in a sub-Saharan African setting.

Effect of differentiated direct-to-pharmacy PrEP refill visits supported with client HIV self-testing on clinic visit time and early PrEP continuation.

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<0.001), while time spent on HIV testing (20 vs. 20 minutes; p = 0.50) and pharmacy (8 vs. 8 minutes; p = 0.8) was unchanged. PrEP continuation was higher at intervention versus the control clinics: 45% versus 33% at month 1, 34% versus 25% at month 3 and 23% versus 16% at month 6. TFV-DP was detected in 85% (61/72) of samples, similar by the study group (83% vs. 85%). 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.

Impact of a point-of-care urine tenofovir assay on adherence to HIV pre-exposure prophylaxis among women in Kenya: a randomised pilot trial.

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.

Dynamic Perceived HIV Risk and Sexual Behaviors Among Young Women Enrolled in a PrEP Trial in Kenya: A Qualitative Study.

Background: In Kenya and elsewhere in sub-Saharan Africa, young women are disproportionately affected by the HIV epidemic compared to young men. The extent to which young women's self-perceptions about risk of HIV acquisition influence their sexual behaviors and use of HIV prevention methods remains unclear. We therefore conducted a qualitative study to explore these issues among young women enrolled in a pre-exposure prophylaxis (PrEP) trial. Methods: From January 2017 to January 2020, we conducted serial semi-structured in-depth interviews 50 purposively selected young women (18-24 years old) who were participating in the MPYA (Monitoring PrEP for Young Adult women) study-a randomized controlled trial in Thika and Kisumu, Kenya, assessing the impact of SMS reminders on PrEP adherence. Interviews were conducted at three time points (~1 week, 3, and 12 months after initiating PrEP). We used an inductive, content analytic approach to identify key themes related to risk perceptions, sexual behavior, and use of HIV prevention tools. Results: Around the time of enrollment, most of the 50 women interviewed reported being at high risk of HIV because of their own sexual behaviors, such as inconsistent condom use, multiple sexual partners, and transactional sex. Additionally, high risk perception was based on the behavior of their partners, such as refusing to use condoms and being unsure of their partner's HIV status. Young women's perceived risk of HIV acquisition was a key motivator for PrEP initiation and continuation. During PrEP use, participants reported feeling protected and at less risk compared to peers who were not taking PrEP. Some reported no longer using condoms because they were confident that PrEP provided enough protection. Over time, many young women reported reducing risky sexual behaviors because of the regular counseling and HIV testing they received as part of their PrEP services. This lowered risk perception was in most cases accompanied by discontinuation of PrEP. Conclusions: HIV risk perception among young women in Kenya was dynamic and influenced their use of PrEP and condoms over time, suggesting an often-deliberate approach to HIV prevention and sexual health.

HIV risk and pre-exposure prophylaxis interest among women seeking post-abortion care in Kenya: a cross-sectional study.

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 binomial 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 ≥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.