Low selection of HIV PrEP refills at private pharmacies among clients who initiated PrEP at public clinics: findings from a mixed-methods study in Kenya.

BACKGROUND: In Africa, the delivery of HIV pre-exposure prophylaxis (PrEP) at public healthcare clinics is challenged by understaffing, overcrowding, and HIV-associated stigma, often resulting in low PrEP uptake and continuation among clients. Giving clients the option to refill PrEP at nearby private pharmacies, which are often more convenient and have shorter wait times, may address these challenges and improve PrEP continuation. METHODS: This mixed methods study used an explanatory sequential design. At two public clinics in Kiambu County, Kenya, clients ≥ 18 years initiating PrEP were given the option to refill PrEP at the clinic where they initiated for free or at one of three nearby private pharmacies for 300 Kenyan Shillings (~ $3 US Dollars). The providers at these pharmacies (pharmacists and pharmaceutical technologists) were trained in PrEP service delivery using a prescribing checklist and provider-assisted HIV self-testing, both with remote clinician oversight. Clients were followed up to seven months, with scheduled refill visits at one, four, and seven months. The primary outcomes were selection of pharmacy-based PrEP refills and PrEP continuation. Following pilot completion, 15 in-depth interviews (IDIs) with clients who refilled PrEP were completed. We used descriptive statistics and thematic analysis to assess study outcomes. RESULTS: From November 2020 to November 2021, 125 PrEP clients were screened and 106 enrolled. The majority (59%, 63/106) of clients were women and the median age was 31 years (IQR 26-38 years). Over 292 client-months of follow-up, 41 clients (39%) refilled PrEP; only three (3%) at a participating pharmacy. All clients who completed IDIs refilled PrEP at clinics. The reasons why clients did not refill PrEP at pharmacies included: a preference for clinic-delivered PrEP services (i.e., pre-existing relationships, access to other services), concerns about pharmacy-delivered PrEP services (i.e., mistrust, lower quality care, costs), and lack of knowledge of this refill location. CONCLUSIONS: These findings suggest that clients who initiate PrEP at public clinics in Kenya may have already overcome barriers to clinic-delivered PrEP services and prefer PrEP access there. To reach new populations that could benefit from PrEP, a stand-alone model of pharmacy-delivered PrEP services may be needed. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04558554 [registered: June 5, 2020].

Peer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trial.

BACKGROUND: Oral HIV pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but uptake remains low in Africa, especially among young women who are a priority population for HIV prevention services. HIV self-testing (HIVST) has been proven to increase HIV testing in diverse populations but has been underutilized to support linkage to HIV prevention services. Most young women who initiate PrEP in Africa do so through informal peer referral. We wanted to test a model of formalized peer referral enhanced with HIVST delivery among young Kenyan women. METHODS: The Peer PrEP Trial is a two-arm hybrid effectiveness-implementation cluster-randomized controlled trial being conducted in central Kenya. Eligible participants (i.e., peer providers, n = 80) are women (≥ 16-24 years) refilling or initiating PrEP at public healthcare clinics who can identify at least four peers who could benefit from PrEP and not enrolled in another HIV study. Peer providers will be 1:1 randomized to (1) formal peer PrEP referral + HIVST delivery, where they will be encouraged to refer four peers (i.e., peer clients, ≥ 16-24 years) using educational materials and HIVST kits (two per peer client), or (2) informal peer PrEP referral, where they are encouraged to refer four peer clients using informal word-of-mouth referral. In both arms, peer providers will deliver a standard PrEP referral card with information on nearby public clinics delivering PrEP services. Peer providers will complete surveys at baseline and 3 months; peer clients will complete surveys at 3 months. Our primary outcome is PrEP initiation among peer clients, as reported by peer providers at 3 months. Secondary outcomes include PrEP continuation (any refilling), HIV testing (past 3 months), sexual behaviors (past month), and PrEP adherence (past month) among peer clients, as reported by both peer providers and clients at 3 months. Implementation outcomes will include participants' perceived acceptability, appropriateness, and feasibility of the intervention as well assessments of the intervention's fidelity and cost. DISCUSSION: Evidence from this trial will help us understand how HIVST could support health systems by facilitating linkage to PrEP services among young women who could benefit in Kenya and similar settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT04982250. Registered on July 29, 2021.

Higher rates of mental health screening of adolescents recorded after provider training using simulated patients in a Kenyan HIV clinic: results of a pilot study.

Background: Kenyan adolescent girls and young women (AGYW) experience a dual burden of HIV and common mental disorders (CMD). HIV clinics are a key entry point for AGYW in need of integrated CMD and HIV care; however, rates of screening and referral for CMDs are low. Our objective was to test an evidence-based provider training strategy, simulated patient encounters (SPEs), on CMD service delivery for AGYW in a Kenyan HIV clinic. Methods: This pilot study was conducted in a public HIV clinic in Thika, Kenya from January to November 2021. The simulated patient encounter (SPE) implementation strategy included case script development from prior qualitative work, patient actor training, and a three-day SPE training including four standardized mock clinical encounters followed by quantitative surveys assessing provider competencies for each encounter. We abstracted medical record data related to HIV and CMDs such as HIV status, reason for visit, CMD screening test performed, and counselling or referral information. We conducted an interrupted time series analysis using abstracted HIV and CMD screening rates from AGYW ages 16-25 years visiting the clinic 7 months before and 3 months after SPE training. We used generalized linear models to assess changes in CMD screening rates after training. Results: A total of 10 providers participated in the training. Competency ratings improved across four mock encounters (mean score from 8.1 to 13.7) between first and fourth encounters. We abstracted all medical records (n = 1,154) including from 888 (76%) AGYW seeking HIV treatment, 243 (21%) seeking prevention services, and 34 (3%) seeking other services. CMD screening rates increased immediately following training from 8 to 21% [relative risk (RR) = 2.57, 95% confidence interval (CI) = 1.34-4.90, p < 0.01]. The 3 months following the SPE training resulted in an 11% relative increase in CMD screening proportion compared to the 7 months pre-SPE (RR: 1.11, 95% CI: 1.04-1.17, p < 0.01). Finally, 1% of all pre-SPE screens resulted in referral versus 5% of post-SPE screens (p = 0.07). Conclusion: The SPE model is a promising implementation strategy for improving HIV provider competencies and CMD service delivery for adolescents in HIV clinics. Future research is needed to explore effects on adolescent clinical outcomes in larger trials.

Stand-alone model for delivery of oral HIV pre-exposure prophylaxis in Kenya: a single-arm, prospective pilot evaluation.

INTRODUCTION: The delivery of daily, oral HIV pre-exposure prophylaxis (PrEP) at private pharmacies may overcome barriers to PrEP delivery at public healthcare facilities, including HIV-associated stigma, long wait times and overcrowding. METHODS: At five private, community-based pharmacies in Kenya, a care pathway for PrEP delivery (ClinicalTrials.gov: NCT04558554) was piloted-the first of its kind in Africa. Pharmacy providers screened clients interested in PrEP for HIV risk, then used a prescribing checklist to identify clients without medical conditions that might contraindicate PrEP safety, counsel them on PrEP use and safety, conduct provider-assisted HIV self-testing and dispense PrEP. For complex clinical cases, a remote clinician was available for consultation. Clients who did not meet the checklist criteria were referred to public facilities for free services delivered by clinicians. Pharmacy providers dispensed a 1-month PrEP supply at initiation and a 3-month supply thereafter at a client fee of 300 KES (∼$3 USD) per visit. RESULTS: From November 2020 to October 2021, pharmacy providers screened 575 clients, identified 476 who met the prescribing checklist criteria and initiated 287 (60%) on PrEP. Among pharmacy PrEP clients, the median age was 26 years (IQR 22-33) and 57% (163/287) were male. The prevalence of behaviours associated with HIV risk among clients was high; 84% (240/287) reported sexual partners with unknown HIV status and 53% (151/287) reported multiple sexual partners (past 6 months). PrEP continuation among clients was 53% (153/287) at 1 month, 36% (103/287) at 4 months and 21% (51/242) at 7 months. During the pilot observation period, 21% (61/287) of clients stopped and restarted PrEP and overall pill coverage was 40% (IQR 10%-70%). Nearly, all pharmacy PrEP clients (≥96%) agreed or strongly agreed with statements regarding the acceptability and appropriateness of pharmacy-delivered PrEP services. CONCLUSIONS: Findings from this pilot suggest that populations at HIV risk frequently visit private pharmacies and PrEP initiation and continuation at pharmacies is similar to or exceeds that at public healthcare facilities. Private pharmacy-based PrEP delivery, conducted entirely by private-sector pharmacy staff, is a promising new delivery model that has the potential to expand PrEP reach in Kenya and similar settings.

Effect of 6-Month HIV Preexposure Prophylaxis Dispensing With Interim Self-testing on Preexposure Prophylaxis Continuation at 12 Months: A Randomized Noninferiority Trial.

Importance: Daily oral HIV preexposure prophylaxis (PrEP) delivery requires quarterly clinic visits for HIV testing and drug refilling that are costly to health systems and clients. Objective: To evaluate whether 6-month PrEP dispensing supported with interim HIV self-testing (HIVST) results in noninferior PrEP continuation outcomes at 12 months compared with standard quarterly clinic visits. Design, Setting, and Participants: This randomized noninferiority trial was conducted from May 2018 to May 2021 with 12 months of follow-up among PrEP clients aged 18 years or older who were returning for their first refill at a research clinic in Kiambu County, Kenya. Intervention: Participants were randomized 2:1 to (1) 6-month PrEP dispensing with semiannual clinic visits and interim HIVST at 3 months or (2) standard-of-care (SOC) PrEP delivery with 3-month dispensing, quarterly clinic visits, and clinic-based HIV testing. Main Outcomes and Measures: Prespecified 12-month outcomes included recent HIV testing (any in past 6 months), PrEP refilling, and PrEP adherence (detectable tenofovir-diphosphate concentrations in dried blood spots). Binomial regression models were used to estimate risk differences (RDs), and a 1-sided 95% CI lower bound (LB) of -10% or greater was interpreted as noninferior. Results: A total of 495 participants were enrolled, with 329 enrolled in the intervention group and 166 enrolled in the SOC group; 330 (66.7%) were women, 295 (59.6%) were in serodifferent relationships, and the median (IQR) age was 33 (27-40) years. At 12 months, 241 individuals in the intervention group (73.3%) and 120 in the SOC group (72.3%) returned to clinic. In the intervention group, recent HIV testing was noninferior (230 individuals [69.9%]) compared with the SOC group (116 [69.9%]; RD, -0.33%, 95% CI LB, -7.44%). PrEP refilling in the intervention group (196 [59.6%]) was inconclusive compared with the SOC group (104 [62.7%]; RD, -3.25%; 95% CI LB, -10.84%), and PrEP adherence was noninferior in the intervention group (151 [45.9%]) compared with the SOC group (70 [42.2%]; RD, 4.96%; 95% CI LB, -2.46%). No HIV seroconversions were observed over the follow-up period. Conclusions and Relevance: In this analysis of secondary trial end points at 1 year, semiannual PrEP dispensing with interim HIVST resulted in noninferior recent HIV testing and PrEP adherence compared with SOC quarterly PrEP dispensing. This novel model has the potential to optimize PrEP delivery. Trial Registration: ClinicalTrials.gov Identifier: NCT03593629.

The Fidelity of a Pharmacy-Based Oral HIV Pre-Exposure Prophylaxis Delivery Model in Kenya.

BACKGROUND: HIV pre-exposure prophylaxis (PrEP) delivery at private pharmacies is a promising new differentiated service delivery model that may address barriers to PrEP delivery at public health care facilities. We measured the fidelity of this model (ie, delivery as intended) in a pilot study in Kenya. SETTING: Five private, retail pharmacies in Kisumu and Thika Counties. METHODS: Trained pharmacy providers delivered PrEP services, including identifying eligible clients, counseling on HIV risk, assessing PrEP safety, testing for HIV, and dispensing PrEP. Pharmacy clients completed surveys that assessed the fidelity of the services received after each visit. Standardized client actors (ie, mystery shoppers) were trained on 4 different case scripts, then made unannounced pharmacy visits, and then completed a 40-item checklist that assessed the fidelity and quality of service delivery components. RESULTS: From November 2020 to December 2021, 287 clients initiated and 159 (55%) refilled PrEP. At initiation, most clients were counseled on PrEP adherence (99%, 284 of 287) and potential side effects (97%, 279 of 287) and all received provider-assisted HIV self-testing before PrEP dispensing (findings consistent across refill visits). Nine standardized client actors completed 15 pharmacy visits. At each visit, most actors were asked about their behaviors associated with HIV risk (80%, 12/15) and all were counseled on PrEP safety and side effects. All actors reported that pharmacy providers treated them with respect. CONCLUSIONS: In this first pilot study of pharmacy-delivered PrEP services in Africa, the fidelity of service delivery was high, suggesting that trained providers at private pharmacies can deliver quality PrEP services.

Barriers to and strategies for early implementation of pharmacy-delivered HIV PrEP services in Kenya: An analysis of routine data.

Background: For individuals who face challenges accessing clinic-based HIV pre-exposure prophylaxis (PrEP), differentiated service delivery models are needed to expand access and reach. During a pilot study testing a novel pharmacy-delivered oral PrEP model in Kenya, we used routine programmatic data to identify early implementation barriers and actions that providers and study staff took in response to the barriers. Methods: We trained pharmacy providers at five private pharmacies in Kisumu and Kiambu Counties to initiate and continue clients at risk of HIV acquisition on PrEP for a fee of 300 KES per visit (∼$3 USD) using a prescribing checklist with remote clinician oversight. Research assistants stationed at the pharmacies completed weekly observation reports of pharmacy-delivered PrEP services using a structured template. We analyzed reports from the first 6 month of implementation using content analysis and identified multi-level early implementation barriers and actions taken to address these. We then organized the identified barriers and actions according to the Consolidated Framework for Implementation Research (CFIR). Results: From November 2020 to May 2021, research assistants completed 74 observation reports (∼18/pharmacy). During this period, pharmacy providers screened 496 potential PrEP clients, identified 425 as eligible for pharmacy-delivered PrEP services, and initiated 230 (54%) on PrEP; 125 of 197 (63%) clients eligible for PrEP continuation refilled PrEP. We identified the following early implementation barriers to pharmacy-delivered PrEP services (by CFIR domain): high costs to clients (intervention characteristics), client discomfort discussing sexual behaviors and HIV testing with providers (outer setting), provider frustrations that PrEP delivery was time-consuming and disruptive to their workflow (inner setting), and provider hesitancy to deliver PrEP due to concerns about encouraging sexual promiscuity (characteristics of individuals). To help address these, pharmacy providers implemented a self-screening option for behavioral HIV risk assessment for prospective PrEP clients, allowed flexible appointment scheduling, and conducted pharmacy PrEP trainings for newly hired staff. Conclusion: Our study provides insight into early barriers to implementing pharmacy-delivered PrEP services in Kenya and potential actions to mitigate these barriers. It also demonstrates how routine programmatic data can be used to understand the early implementation process.

Assessing young Kenyan women's willingness to engage in a peer-delivered HIV self-testing and referral model for PrEP initiation: A qualitative formative research study.

Background: Pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, but uptake remains low, especially among adolescent girls and young women (AGYW) in Kenya. A model in which trained AGYW using PrEP deliver HIV self-tests to their close friends and refer them to PrEP may help increase PrEP uptake in this population. To understand AGYW's potential willingness to engage in such a model, we conducted a qualitative formative study in Kenya. Method: We conducted semi-structured in-depth interviews (IDIs) with AGYW (16 to 24 years) in Kiambu County who were determined at risk of HIV acquisition. We purposively recruited "PrEP-naïve" (no prior PrEP use) and "PrEP-experienced" AGYW who used PrEP for at least 1 month within the previous year. We solicited perspectives on initiating/engaging in conversations about HIV risk and PrEP, distributing/receiving HIV self-test kits, and referring/following through on a referral to clinic-based HIV services. We analyzed verbatim transcripts using rapid qualitative analysis and a combination of inductive and deductive approaches, with the latter informed by the Integrated Behavior Model (IBM). Results: From August to December 2020, we conducted 30 IDIs: 15 with PrEP-experienced and 15 with PrEP-naïve AGYW. Participants' median age was 20 [interquartile range (IQR): 20-22]. Overall, most participants anticipated that they would be willing to engage in this model. PrEP-experienced AGYW emphasized the salience of their concerns about friends' HIV risk behaviors, with several noting that they are already in the habit of discussing PrEP with friends. Many additionally expressed positive attitudes toward the proposed target behaviors, perceived these to be normative among AGYW, and expressed confidence in their ability to carry out the behaviors with proper support. Although few participants had HIVST experience, nearly all anticipated they would be able to use an HIV self-test kit correctly if provided instruction. Conclusion: The Kenyan AGYW who participated in this study generally anticipated that they would be willing to engage in a formal peer PrEP referral model enhanced with peer-delivered HIV self-tests. Future research is needed to pilot test this model to determine its acceptability, feasibility, and effect on HIVST and PrEP uptake within this population.

Efficiency of 6-month PrEP dispensing with HIV self-testing in Kenya: an open-label, randomised, non-inferiority, implementation trial.

BACKGROUND: Oral pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective and is being implemented at scale at health clinics throughout sub-Saharan Africa. However, barriers to clinic-based PrEP delivery remain. We aimed to establish the efficiency of semiannual PrEP clinic visits supplemented with interim home-based HIV self-testing (HIVST) versus standard of care for HIV testing, drug refilling, and adherence among PrEP users. METHODS: This was a randomised, open-label, non-inferiority trial done at the Partners in Health and Research Development clinic in Thika, Kenya. Eligible participants were HIV-negative adults (≥18 years) at risk of acquiring HIV who had started PrEP at least 1 month before enrolment. Participants were randomly assigned (1:1:1) to 6-month PrEP dispensing plus interim blood-based HIVST (with biannual clinic visits), 6-month PrEP dispensing plus interim oral fluid-based HIVST (with biannual clinic visits), or standard of care PrEP delivery (3-month PrEP dispensing with quarterly clinic visits). The three coprimary outcomes, measured at 6 months, were HIV testing (any testing between enrolment and the 6-month visit), PrEP refilling, and PrEP adherence (detectable tenofovir diphosphate concentration in dried blood spots). All analyses were done according to the intention-to-treat principle. We used binomial regression models to estimate risk differences and one-sided 95% CIs. 6-month PrEP dispensing was considered non-inferior to standard of care if the lower limit bound of the one-sided 95% CI was greater than or equal to -10%. This study is registered with ClinicalTrials.gov, NCT03593629. FINDINGS: Between May 28, 2018, and Feb 24, 2020, 495 participants were enrolled: 165 men and 130 women in HIV serodifferent couples and 200 singly enrolled women. 166 participants were randomly assigned to the standard of care group, 163 to the 6-month PrEP dispensing plus oral-fluid HIVST group, and 166 to the 6-month PrEP dispensing plus blood-based HIVST group. At 6 months, 274 (83%) of 329 participants in the combined 6-month PrEP dispensing group had tested for HIV compared with 140 (84%) of 166 participants in the standard of care group (risk difference -1·15%, 95% CI lower bound -6·89). Among participants in the combined 6-month PrEP dispensing group, 257 (78%) participants refilled PrEP compared with 134 (81%) participants in the standard of care group (-2·60%, -8·88), and 200 (61%) participants were adherent to PrEP compared with 95 (57%) participants in the standard of care group (2·37%, -5·05). No participants acquired HIV during the study. INTERPRETATION: 6-month PrEP dispensing with HIVST for interim testing reduced the number of PrEP clinic visits in half without compromising HIV testing, retention, or adherence. FUNDING: US National Institute of Mental Health.

Acceptability and Feasibility of Pharmacy-Based Delivery of Pre-Exposure Prophylaxis in Kenya: A Qualitative Study of Client and Provider Perspectives.

As countries scale up pre-exposure prophylaxis (PrEP) for HIV prevention, diverse PrEP delivery models are needed to expand access to populations at HIV risk that are unwilling or unable to access clinic-based PrEP care. To identify factors that may influence implementation of retail pharmacy-based PrEP delivery in Kenya, we conducted in-depth interviews with 40 pharmacy clients, 16 pharmacy providers, 16 PrEP clients, and 10 PrEP providers from two provinces. Most participants expressed strong support for expanding PrEP to retail pharmacies, though conditioned their acceptance on assurances that care would be private, respectful, safe, and affordable. Participant-reported determinants of feasibility centered primarily on ensuring that the intervention is compatible with retail pharmacy operations (e.g., staffing levels, documentation requirements). Future research is needed to develop and test tailored packages of implementation strategies that are most effective at integrating PrEP delivery into routine pharmacy practice in Kenya and other high HIV prevalence settings.

RESUMEN: Ya que varios países están ampliando sus programas de profilaxis previa a la exposición al VIH (PrEP, por sus siglas en inglés), se necesitan modelos diversos para ampliar el acceso a poblaciones que no están dispuestos a acceder, o que no pueden acceder, a los servicios de PrEP que se ofrecen en las instalaciones de salud. Para identificar los factores que pueden influir en la prestación de servicios de PrEP a través de farmacias privadas, realizamos entrevistas en profundidad con 40 clientes de farmacia, 16 proveedores de servicios de farmacia, 16 usuarios de PrEP, y 10 proveedores de PrEP. La mayoría de los participantes manifestó su firme apoyo a la propuesta de expandir la provisión de PrEP a las farmacias privadas, aunque condicionó su aceptación a la garantía de que la atención sea privada, respetuosa, segura, y asequible. Según los participantes, los factores determinantes de la viabilidad de ofrecer PrEP en las farmacias privadas se centran en asegurar de que la intervención sea compatible con las operaciones de las farmacias privadas (p. ej., el número de personal, los requisitos de documentación). Se necesitan investigaciones adicionales para desarrollar y evaluar diferentes paquetes de estrategias de implementación para descubrir cuáles son los más eficaces para integrar los servicios de PrEP en la prestación rutinaria de servicios de farmacia tanto en Kenia como en otros lugares de alta prevalencia del VIH.

Design of a care pathway for pharmacy-based PrEP delivery in Kenya: results from a collaborative stakeholder consultation.

INTRODUCTION: In Kenya, pre-exposure prophylaxis (PrEP) for HIV prevention is almost exclusively delivered at HIV clinics. Developing novel PrEP delivery models is important for increasing the reach of PrEP. Delivery of PrEP through pharmacies is one approach utilized in the US to improve accessibility. Retail pharmacies are commonly used as a first-line access point for medical care in Kenya, but have not been utilized for PrEP delivery. We conducted a collaborative consultative meeting of stakeholders to develop a care pathway for pharmacy-based PrEP delivery in Kenya. METHODS: In January 2020, we held a one-day meeting in Nairobi with 36 stakeholders from PrEP regulatory, professional, healthcare service delivery, civil society, and research organizations. Attendees reviewed a theory of change model, results from formative qualitative research with pharmacy providers and clients, and anticipated core components of pharmacy-based PrEP delivery: counseling, HIV testing, prescribing, and dispensing. Stakeholders participated in small and large group discussions to identify potential challenges and solutions. We synthesized the key findings from these discussions. RESULTS: Stakeholders were enthusiastic about a model for pharmacy-based PrEP delivery. Potential challenges identified included insufficient pharmacy provider knowledge and skills, regulatory hurdles to providing affordable HIV testing at pharmacies, and undefined pathways for PrEP procurement. Potential solutions identified included having pharmacy providers complete the Kenya Ministry of Health-approved PrEP training, use of a PrEP prescribing checklist with remote clinician oversight and provider-assisted HIV self-testing, and having the government provide PrEP and HIV self-testing kits to pharmacies during a pilot test. A care pathway was developed over the course of the meeting. CONCLUSIONS: PrEP delivery stakeholders in Kenya were strongly supportive of developing and testing a model for pharmacy-based PrEP delivery to increase PrEP access. We collaboratively developed a care pathway for pilot testing that has the potential to expand PrEP delivery options in Kenya and other similar settings.