Getting HIV Pre-exposure Prophylaxis (PrEP) into Private Pharmacies: Global Delivery Models and Research Directions.

PURPOSE OF REVIEW: To provide an overview of the current state of HIV pre-exposure prophylaxis (PrEP) delivery via private sector pharmacies globally, to discuss the context-specific factors that have influenced the design and implementation of different pharmacy-based PrEP delivery models in three example settings, and to identify future research directions. RECENT FINDINGS: Multiple high- and low-income countries are implementing or pilot testing PrEP delivery via private pharmacies using a variety of delivery models, tailored to the context. Current evidence indicates that pharmacy-based PrEP services are in demand and generally acceptable to clients and pharmacy providers. Additionally, the evidence suggests that with proper training and oversight, pharmacy providers are capable of safely initiating and managing clients on PrEP. The delivery of PrEP services at private pharmacies also achieves similar levels of PrEP initiation and continuation as traditional health clinics, but additionally reach individuals underserved by such clinics (e.g., young men; minorities), making pharmacies well-positioned to increase overall PrEP coverage. Implementation of pharmacy-based PrEP services will look different in each context and depend not only on the state of the private pharmacy sector, but also on the extent to which key needs related to governance, financing, and regulation are addressed. Private pharmacies are a promising delivery channel for PrEP in diverse settings. Countries with robust private pharmacy sectors and populations at HIV risk should focus on aligning key areas related to governance, financing, and regulation that have proven critical to pharmacy-based PrEP delivery while pursuing an ambitious research agenda to generate information for decision-making. Additionally, the nascency of pharmacy-based PrEP delivery in both high- and low-and-middle-income settings presents a prime opportunity for shared learning and innovation.

Increased condom use among key populations using oral PrEP in Kenya: results from large scale programmatic surveillance.

BACKGROUND: Female sex workers (FSW) and men having sex with men (MSM) in Kenya have high rates of HIV infection. Following a 2015 WHO recommendation, Kenya initiated national scale-up of pre-exposure prophylaxis (PrEP) for all persons at high-risk. Concerns have been raised about PrEP users' potential changes in sexual behaviors such adopting condomless sex and multiple partners as a result of perceived reduction in HIV risk, a phenomenon known as risk compensation. Increased condomless sex may lead to unintended pregnancies and sexually transmitted infections and has been described in research contexts but not in the programmatic setting. This study looks at changes in condom use among FSW and MSM on PrEP through a national a scale-up program. METHODS: Routine program data collected between February 2017 and December 2019 were used to assess changes in condom use during the first three months of PrEP in 80 health facilities supported by a scale-up project, Jilinde. The primary outcome was self-reported condom use. Analyses were conducted separately for FSW and for MSM. Log-Binomial Regression with Generalized Estimating Equations was used to compare the incidence proportion ("risk") of consistent condom use at the month 1, and month 3 visits relative to the initiation visit. RESULTS: At initiation, 69% of FSW and 65% of MSM reported consistent condom use. At month 3, this rose to 87% for FSW and 91% for MSM. MSM were 24% more likely to report consistent condom use at month 1 (Relative Risk [RR], 1.24, 95% Confidence Interval [CI], 1.18-1.30) and 40% more likely at month 3 (RR, 1.40, 95% CI, 1.33-1.47) compared to at initiation. FSW were 15% more likely to report consistent condom use at the month one visit (RR, 1.15, 95% CI, 1.13-1.17) and 27% more likely to report condom use on the month 3 visit (RR 1.27, 95% CI, 1.24-1.29). CONCLUSION: Condom use increased substantially among both FSW and MSM. This may be because oral PrEP was provided as part of a combination prevention strategy that included counseling and condoms but could also be due to the low retention rates among those who initiated.

Estimating the costs and perceived benefits of oral pre-exposure prophylaxis (PrEP) delivery in ten counties of Kenya: a costing and a contingent valuation study.

Background: Kenya included oral PrEP in the national guidelines as part of combination HIV prevention, and subsequently began providing PrEP to individuals who are at elevated risk of HIV infection in 2017. However, as scale-up continued, there was a recognized gap in knowledge on the cost of delivering oral PrEP. This gap limited the ability of the Government of Kenya to budget for its PrEP scale-up and to evaluate PrEP relative to other HIV prevention strategies. The following study calculated the actual costs of oral PrEP scale-up as it was being delivered in ten counties in Kenya. This costing also allowed for a comparison of various models of service delivery in different geographic regions from the perspective of service providers in Kenya. In addition, the analysis was also conducted to understand factors that indicate why some individuals place a greater value on PrEP than others, using a contingent valuation technique. Methods: Data collection was completed between November 2017 and September 2018. Costing data was collected from 44 Kenyan health facilities, consisting of 23 public facilities, 5 private facilities and 16 drop-in centers (DICEs) through a cross-sectional survey in ten counties. Financial and programmatic data were collected from financial and asset records and through interviewer administered questionnaires. The costs associated with PrEP provision were calculated using an ingredients-based costing approach which involved identification and costing of all the economic inputs (both direct and indirect) used in PrEP service delivery. In addition, a contingent valuation study was conducted at the same 44 facilities to understand factors that reveal why some individuals place a greater value on PrEP than others. Interviews were conducted with 2,258 individuals (1,940 current PrEP clients and 318 non-PrEP clients). A contingent valuation method using a "payment card approach" was used to determine the maximum willingness to pay (WTP) of respondents regarding obtaining access to oral PrEP services. Results: The weighted cost of providing PrEP was $253 per person year, ranging from $217 at health centers to $283 at dispensaries. Drop-in centers (DICEs), which served about two-thirds of the client volume at surveyed facilities, had a unit cost of $276. The unit cost was highest for facilities targeting MSM ($355), while it was lowest for those targeting FSW ($248). The unit cost for facilities targeting AGYW was $323 per person year. The largest percentage of costs were attributable to personnel (58.5%), followed by the cost of drugs, which represented 25% of all costs. The median WTP for PrEP was $2 per month (mean was $4.07 per month). This covers only one-third of the monthly cost of the medication (approximately $6 per month) and less than 10% of the full cost of delivering PrEP ($21 per month). A sizable proportion of current clients (27%) were unwilling to pay anything for PrEP. Certain populations put a higher value on PrEP services, including: FSW and MSM, Muslims, individuals with higher education, persons between the ages of 20 and 35, and households with a higher income and expenditures. Discussion: This is the most recent and comprehensive study on the cost of PrEP delivery in Kenya. These results will be used in determining resource requirements and for resource mobilization to facilitate sustainable PrEP scale-up in Kenya and beyond. This contingent valuation study does have important implications for Kenya's PrEP program. First, it indicates that some populations are more motivated to adopt oral PrEP, as indicated by their higher WTP for the service. MSM and FSW, for example, placed a higher value on PrEP than AGYW. Higher educated individuals, in turn, put a much higher value on PrEP than those with less education (which may also reflect the higher "ability to pay" among those with more education). This suggests that any attempt to increase demand or improve PrEP continuation should consider these differences in client populations. Cost recovery from existing PrEP clients would have potentially negative consequences for uptake and continuation.

Measuring the performance of computer vision artificial intelligence to interpret images of HIV self-testing results.

Introduction: HIV self-testing (HIVST) is highly sensitive and specific, addresses known barriers to HIV testing (such as stigma), and is recommended by the World Health Organization as a testing option for the delivery of HIV pre-exposure prophylaxis (PrEP). Nevertheless, HIVST remains underutilized as a diagnostic tool in community-based, differentiated HIV service delivery models, possibly due to concerns about result misinterpretation, which could lead to inadvertent onward transmission of HIV, delays in antiretroviral therapy (ART) initiation, and incorrect initiation on PrEP. Ensuring that HIVST results are accurately interpreted for correct clinical decisions will be critical to maximizing HIVST's potential. Early evidence from a few small pilot studies suggests that artificial intelligence (AI) computer vision and machine learning could potentially assist with this task. As part of a broader study that task-shifted HIV testing to a new setting and cadre of healthcare provider (pharmaceutical technologists at private pharmacies) in Kenya, we sought to understand how well AI technology performed at interpreting HIVST results. Methods: At 20 private pharmacies in Kisumu, Kenya, we offered free blood-based HIVST to clients ≥18 years purchasing products indicative of sexual activity (e.g., condoms). Trained pharmacy providers assisted clients with HIVST (as needed), photographed the completed HIVST, and uploaded the photo to a web-based platform. In real time, each self-test was interpreted independently by the (1) client and (2) pharmacy provider, with the HIVST images subsequently interpreted by (3) an AI algorithm (trained on lab-captured images of HIVST results) and (4) an expert panel of three HIVST readers. Using the expert panel's determination as the ground truth, we calculated the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for HIVST result interpretation for the AI algorithm as well as for pharmacy clients and providers, for comparison. Results: From March to June 2022, we screened 1,691 pharmacy clients and enrolled 1,500 in the study. All clients completed HIVST. Among 854 clients whose HIVST images were of sufficient quality to be interpretable by the AI algorithm, 63% (540/854) were female, median age was 26 years (interquartile range: 22-31), and 39% (335/855) reported casual sexual partners. The expert panel identified 94.9% (808/854) of HIVST images as HIV-negative, 5.1% (44/854) as HIV-positive, and 0.2% (2/854) as indeterminant. The AI algorithm demonstrated perfect sensitivity (100%), perfect NPV (100%), and 98.8% specificity, and 81.5% PPV (81.5%) due to seven false-positive results. By comparison, pharmacy clients and providers demonstrated lower sensitivity (93.2% and 97.7% respectively) and NPV (99.6% and 99.9% respectively) but perfect specificity (100%) and perfect PPV (100%). Conclusions: AI computer vision technology shows promise as a tool for providing additional quality assurance of HIV testing, particularly for catching Type II error (false-negative test interpretations) committed by human end-users. We discuss possible use cases for this technology to support differentiated HIV service delivery and identify areas for future research that is needed to assess the potential impacts-both positive and negative-of deploying this technology in real-world HIV service delivery settings.

Measuring the performance of HIV self-testing at private pharmacies in Kenya: a cross-sectional study.

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.

Online HIV prophylaxis delivery: Protocol for the ePrEP Kenya pilot study.

Background: Online pharmacies in Kenya provide sexual and reproductive health products (e.g., HIV self-testing, contraception) and could be leveraged to increase the reach of HIV pre-exposure and post-exposure prophylaxis (PrEP/PEP) to populations who do not frequently attend health facilities. To date, evidence is limited for operationalizing online PrEP/PEP delivery and the type of populations reached with this differential service delivery model. Methods: The ePrEP Kenya Pilot will deliver daily oral PrEP and PEP via MYDAWA, a private online pharmacy retailer, to clients in Nairobi for 18 months. Potential clients will obtain information about PrEP/PEP on MYDAWA's sexual wellness page and self-screen for HIV risk. Individuals ≥18 years, identified as at HIV risk, and willing to pay for a blood-based HIV self-test and PrEP/PEP delivery will be eligible for enrollment. To continue with online PrEP/PEP initiation, eligible clients will purchase a blood-based HIV self-test for 250 KES (~USD 2) [delivered to their setting of choice for 99 KES (~USD 1)], upload an image of their self-test result, and attend a telemedicine visit with a MYDAWA provider. During the telemedicine visit, providers will screen clients for PrEP/PEP eligibility, including clinical concerns (e.g., kidney disease), discuss self-test results, and complete counseling on PrEP/PEP use and safety. Providers will refer clients who self-test HIV positive or report any existing medical conditions to the appropriate services at healthcare facilities that meet their preferences. Eligible clients will be prescribed PrEP (30-day PrEP supply at initiation; 90-day PrEP supply at follow-up visits) or PEP (28-day supply) for free and have it delivered for 99 KES (~USD 1). We will measure PrEP and PEP initiation among eligible clients, PEP-to-PrEP transition, PrEP continuation, and implementation outcomes (e.g., feasibility, acceptability, and costs). Discussion: Establishing pathways to increase PrEP and PEP access is crucial to help curb new HIV infections in settings with high HIV prevalence. The findings from this study will provide evidence on the implementation of online pharmacy PrEP and PEP service delivery that can help inform guidelines in Kenya and similar settings.

Adaptation and psychometric evaluation of a scale to measure oral pre-exposure prophylaxis-related stigma among key and vulnerable populations in Kenya.

INTRODUCTION: As oral pre-exposure prophylaxis (PrEP) services scale up throughout sub-Saharan Africa (SSA), clients continue to face challenges with sustained PrEP use. PrEP-related stigma has been shown to influence engagement throughout the HIV PrEP care continuum throughout SSA. Validated quantitative measures of PrEP-related stigma in SSA are of critical importance to better understand its impacts at each stage of the HIV PrEP care continuum. This study aimed to psychometrically evaluate a PrEP-related stigma scale for use among key and vulnerable populations in the context of a Kenya national PrEP programme. METHODS: As part of a larger prospective cohort study nested within Kenya's Jilinde programme, this study used baseline data collected from 1135 participants between September 2018 and April 2020. We used exploratory factor analysis to evaluate the factor structure of a PrEP-related stigma scale. We also assessed convergent construct validity of the PrEP-Related Stigma Scale by testing for expected correlations with depression and uptake of HIV services. Finally, we examined the relationship between PrEP-related stigma and key demographic, psychosocial and behavioural characteristics. RESULTS: We identified four dimensions of PrEP-related stigma: (1) interpersonal stigma, (2) PrEP norms, (3) negative self-image and (4) disclosure concerns. The scale demonstrated strong internal consistency (α = 0.84), was positively correlated with depressive symptoms and negatively correlated with uptake of HIV services. Multivariable regression analysis demonstrated associations between PrEP-related stigma and sex worker identity. CONCLUSIONS: The adapted and validated PrEP-Related Stigma Scale can enable programmes to quantify how PrEP-related stigma and its dimensions may differentially impact outcomes on the HIV PrEP care continuum, evaluate stigma interventions and tailor programmes accordingly. Opportunities exist to validate the scale in other populations and explore further dimensions of PrEP-related stigma.

HIV prevention programme with young women who sell sex in Mombasa, Kenya: learnings for scale-up.

INTRODUCTION: In 2018, the National AIDS and sexually transmitted infection (STI) Control Programme developed a national guidelines to facilitate the inclusion of young women who sell sex (YWSS) in the HIV prevention response in Kenya. Following that, a 1-year pilot intervention, where a package of structural, behavioural and biomedical services was provided to 1376 cisgender YWSS to address their HIV-related risk and vulnerability, was implemented. METHODS: Through a mixed-methods, pre/post study design, we assessed the effectiveness of the pilot, and elucidated implementation lessons learnt. The three data sources used included: (1) monthly routine programme monitoring data collected between October 2019 and September 2020 to assess the reach and coverage; (2) two polling booth surveys, conducted before and after implementation, to determine the effectiveness; and (3) focus group discussions and key informant interviews conducted before and after intervention to assess the feasibility of the intervention. Descriptive analysis was performed to produce proportions and comparative statistics. RESULTS: During the intervention, 1376 YWSS were registered in the programme, 28% were below 19 years of age and 88% of the registered YWSS were active in the last month of intervention. In the survey, respondents reported increases in HIV-related knowledge (61.7% vs. 90%, p <0.001), ever usage of pre-exposure prophylaxis (8.5% vs. 32.2%, p < 0.001); current usage of pre-exposure prophylaxis (5.3% vs. 21.1%, p<0.002); ever testing for HIV (87.2% vs. 95.6%, p <0.04) and any clinic visit (35.1 vs. 61.1, p <0.001). However, increase in harassment by family (11.7% vs. 23.3%, p<0.04) and discrimination at educational institutions (5.3% vs. 14.4%, p<0.04) was also reported. In qualitative assessment, respondents reported early signs of success, and identified missed opportunities and made recommendations for scale-up. CONCLUSIONS: Our intervention successfully rolled out HIV prevention services for YWSS in Mombasa, Kenya, and demonstrated that programming for YWSS is feasible and can effectively be done through YWSS peer-led combination prevention approaches. However, while reported uptake of treatment and prevention services increased, there was also an increase in reported harassment and discrimination requiring further attention. Lessons learnt from the pilot intervention can inform replication and scale-up of such interventions in Kenya.

Health system opportunities and challenges for PrEP implementation in Kenya: A qualitative framework analysis.

BACKGROUND: As pre-exposure prophylaxis (PrEP) scales up in sub-Saharan Africa, governments and implementers need to understand how to best manage national programs. Kenya's national PrEP program offers an opportunity to review elements of program success within the health system and evaluate the utility of a national implementation framework. We explored health system considerations for PrEP implementation to understand how Kenya's national PrEP implementation priorities align with those of PrEP service providers, peer educators, and program or county managers. METHODS: We conducted twelve key informant interviews (KII) and nine focus group discussions (FGDs) with PrEP program and county managers (n = 12), peer educators (n = 44), and PrEP service providers (n = 48). We recruited participants across a variety of cadres and experiences with PrEP programs. KIIs and FGDs focused on PrEP service delivery and program implementation. Data were collected by trained study staff, audio recorded, translated into English, and transcribed. We used framework analysis methods to systematically apply Kenya's 2017 National PrEP Implementation Framework to the data and summarized findings according to the seven Implementation Framework domains. RESULTS: All respondents emphasized the important role of communication, coordination, training, and leadership in PrEP implementation. PrEP service providers and program and county managers highlighted the importance of efficient data collection and utilization, and improved resource allocation. Commodity security and research, while key elements of the PrEP Implementation Framework, were less commonly discussed, and research was less prioritized by respondents. Respondents highlighted the importance of coordinated PrEP service delivery across sites and programs to improve overall client experiences. CONCLUSION: In the context of a nationally-scaled PrEP program, PrEP service providers, peer educators, and program and county managers value strong leadership, close coordination of services across sites, and expedient use of data to improve strategies and services. Kenya's PrEP Implementation Framework aligns closely with the priorities of individuals involved in PrEP service delivery and management, and provides a comprehensive overview of health system considerations for effective implementation of a PrEP program at scale.

Health system adaptations and considerations to facilitate optimal oral pre-exposure prophylaxis scale-up in sub-Saharan Africa.

Following WHO's 2015 recommendation, countries in sub-Saharan Africa have progressively scaled up oral pre-exposure prophylaxis (PrEP) as part of combination HIV prevention. PrEP has potential to significantly reduce new HIV infections in sub-Saharan Africa if it is widely available, accessible, and effectively used. Initial scale-up efforts have generated progress, drawing lessons from existing HIV interventions, such as antiretroviral therapy and biomedical prevention. However, beset by unprepared health systems, scale-up has been slow, resulting in suboptimal coverage among priority groups at higher risk of HIV acqusition. Using the WHO health system building blocks framework, this Review synthesises literature on essential considerations for PrEP scale-up in sub-Saharan Africa, highlighting the importance of health system adaptability and responsiveness.

Unmet Need for Contraception Among Female Sex Workers Initiating Oral Pre-Exposure Prophylaxis for HIV Prevention During Kenya's National Scale-Up: Results From a Programmatic Surveillance Study.

Background: Female sex workers (FSWs) experience a higher risk for both HIV acquisition and unwanted pregnancies compared to women in the general population. Pre-exposure prophylaxis (PrEP) for HIV prevention offers protection against HIV infection but has no contraceptive effect. We examined the determinants of unmet need for contraception among FSWs who initiated PrEP to inform programs and policies to optimize contraceptive services and avert unwanted pregnancy among this high-risk group. Materials and Methods: A cross-sectional analysis was conducted on routine, de-identified client data from a large-scale PrEP service delivery project, from February 2017 to December 2019. Data were collected from FSWs during clinic visits using Ministry of Health approved tools. Records for all 17,456 FSWs initiated on PrEP from 79 health facilities in 10 counties across three geographic clusters with high and medium HIV incidence were examined for eligibility for the analysis. Unmet need for non-barrier contraception was defined as not being pregnant, not currently using the non-barrier contraceptive method, and not trying to conceive or intending to have a child in the near future. Univariate and multivariable regression analyses were conducted with selected variables to examine associations. Results: In the 79 sites, eligible records from 17,063 FSWs who initiated PrEP were included. Two-thirds were under 30 years, and the majority were not married and had received PrEP at drop-in centers. Overall, the unmet need for non-barrier contraception was 52.6%, higher for those under 20 years of age (60.9%) and those served in public and private health facilities (67.4 and 83.2%, respectively) rather than drop-in centers (50.6%). Women from the Nairobi and Coast cluster regions reported a higher unmet need for contraception compared to those from the Lake region. All these associations were significant (p < 0.05) at the multivariate level. Conclusions: The high unmet need for non-barrier contraception among FSWs initiating PrEP highlights the need for integrated delivery of contraception services within PrEP programs. Identifying groups with a high unmet need could lead to higher success in an integrated program. Two recommended approaches include training healthcare providers to deliver clear contraception messaging during PrEP initiation and making a range of contraceptives accessible within PrEP services for high-risk groups. Furthermore, accelerated research on multipurpose prevention technologies is necessary to reduce the burden on individuals using multiple prevention products concurrently.

HIV PrEP is more than ART-lite: Longitudinal study of real-world PrEP services data identifies missing measures meaningful to HIV prevention programming.

INTRODUCTION: Evidence indicates HIV oral pre-exposure prophylaxis (PrEP) is highly efficacious and effective. Substantial early discontinuation rates are reported by many programs, which may be misconstrued as program failure. However, PrEP use may be non-continuous and still effective, since HIV risk fluctuates. Real-world PrEP use phenomena, like restarting and cyclical use, and the temporal characteristics of these use patterns are not well described. The objective of our study was to characterize and identify predictors of use patterns observed in large PrEP scale-up programs in Africa. METHODS: We analysed demographic and clinical data routinely collected during client visits between 2017 and 2019 in three Jhpiego-supported programs in Kenya, Lesotho and Tanzania. We characterized duration on/off PrEP and, using ordinal regression, modelled the likelihood of spending additional time off and identified factors associated with increasing cycle number. The Andersen-Gill model was used to identify predictors of time to PrEP discontinuation. To analyse factors associated with a client's first return following initiation, we used a two-step Heckman probit. RESULTS: Among 47,532 clients initiating PrEP, approximately half returned for follow-up. With each increase in cycle number, time off PrEP between use cycles decreased. The Heckman first-step model showed an increased probability of returning versus not by older age groups and among key and vulnerable population groups versus the general population; in the second-step model older age groups and key and vulnerable populations were less likely in Kenya, but more likely in Lesotho, to return on-time (refill) versus delayed (restarting). CONCLUSIONS: PrEP users frequently cycle on and off PrEP. Early discontinuation and delays in obtaining additional prescriptions were common, with broad predictive variability noted. Time off PrEP decreased with cycle number in all countries, suggesting normalization of use with experience. More nuanced measures of use are needed than exist for HIV treatment if effective use of PrEP is to be meaningfully measured. Providers should be equipped with measures and counselling messages that recognize non-continuous and cyclical use patterns so that clients are supported to align fluctuating risk and use, and can readily restart PrEP after stopping, in effect empowering them further to make their own prevention choices.

An implementation model for scaling up oral pre-exposure prophylaxis in Kenya: Jilinde project.

Oral pre-exposure prophylaxis (PrEP) is an efficacious way to lower the risk of HIV acquisition among high-risk individuals. Despite the World Health Organization's 2015 recommendation that all persons at substantial risk of HIV infection be provided with access to oral PrEP, the rollout has been slow in many low- and middle-income countries. Initiatives for national rollout are few, and subtle skepticism persists in several countries about the feasibility of national PrEP implementation. We describe the conceptual design of the Jilinde project, which is implementing oral PrEP as a routine service at a public health scale in Kenya. We describe the overlapping domains of supply, demand, and government and community ownership, which combine to produce a learning laboratory environment to explore the scale-up of PrEP. We describe how Jilinde approaches PrEP uptake and continuation by applying supply and demand principles and ensures that government and community ownership informs policy, coordination, and sustainability. We describe the "learning laboratory" approach that informs strategic and continuous learning, which allows for adjustments to the project. Jilinde's conceptual model illustrates how the coalescence of these concepts can promote scale-up of PrEP in real-world conditions and offers critical lessons on an implementation model for scaling up oral PrEP in low- and middle-income countries.

Using a HIV prevention cascade for identifying missed opportunities in PrEP delivery in Kenya: results from a programmatic surveillance study.

INTRODUCTION: HIV prevention cascades have been systematically evaluated in high-income countries, but steps in the pre-exposure prophylaxis (PrEP) service delivery cascade have not been systematically quantified in sub-Saharan Africa. We analysed missed opportunities in the PrEP cascade in a large-scale project serving female sex workers (FSW), men who have sex with men (MSM) and adolescent girls and young women (AGYW) in Kenya. METHODS: Programmatic surveillance was conducted using routine programme data from 89 project-supported sites from February 2017 to December 2019, and complemented by qualitative data. Healthcare providers used nationally approved tools to document service statistics. The analyses examined proportions of people moving onto the next step in the PrEP continuum, and identified missed opportunities. Missed opportunities were defined as implementation gaps exemplified by the proportion of individuals who could have potentially accessed each step of the PrEP cascade and did not. We also assessed trends in the cascade indicators at monthly intervals. Qualitative data were collected through 28 focus group discussions with 241 FSW, MSM, AGYW and healthcare providers, and analysed thematically to identify reasons underpinning the missed opportunities. RESULTS: During the study period, 299,798 individuals tested HIV negative (211,927 FSW, 47,533 MSM and 40,338 AGYW). Missed opportunities in screening for PrEP eligibility was 58% for FSW, 45% for MSM and 78% for AGYW. Of those screened, 28% FSW, 25% MSM and 65% AGYW were ineligible. Missed opportunities for PrEP initiation were lower among AGYW (8%) compared to FSW (72%) and MSM (75%). Continuation rates were low across all populations at Month-1 (ranging from 29% to 32%) and Month-3 (6% to 8%). Improvements in average annual Month-1 (from 26% to 41%) and Month-3 (from 4% to 15%) continuation rates were observed between 2017 and 2019. While initiation rates were better among younger FSW, MSM and AGYW (<30 years), the reverse was true for continuation. CONCLUSIONS: The application of a PrEP cascade framework facilitated this large-scale oral PrEP programme to conduct granular programmatic analysis, detecting "leaks" in the cascade. These informed programme adjustments to mitigate identified gaps resulting in improvement of selected programmatic outcomes. PrEP programmes are encouraged to introduce the cascade analysis framework into new and existing programming to optimize HIV prevention outcomes.

Understanding and measuring uptake and coverage of oral pre-exposure prophylaxis delivery among adolescent girls and young women in sub-Saharan Africa.

In response to World Health Organization (WHO) guidance recommending oral pre-exposure prophylaxis (PrEP) for all individuals at substantial risk for HIV infection, significant investments are being made to expand access to oral PrEP globally, particularly in sub-Saharan Africa. Some have interpreted early monitoring reports from new programs delivering oral PrEP to adolescent girls and young women (AGYW) as suggestive of low uptake. However, a lack of common definitions complicates interpretation of oral PrEP uptake and coverage measures, because various indicators with different meanings and uses are used interchangeably. Furthermore, operationalising these measures in real-world settings is challenged by the difficulties in defining the denominator for measuring uptake and coverage among AGYW, due to the lack of data and experience required to identify the subset of AGYW at substantial risk of HIV infection. This paper proposes an intervention-centric cascade as a framework for developing a common lexicon of metrics for uptake and coverage of oral PrEP among AGYW. In codifying these indicators, approaches to clearly define metrics for uptake and coverage are outlined, and the discussion on 'low' uptake is reframed to focus on achieving the highest possible proportion of AGYW using oral PrEP when they need and want it Recommendations are also provided for making increased investments in implementation research to better quantify the sub-group of AGYW in potential need of oral PrEP.and for improving monitoring systems to more efficiently address bottlenecks in the service delivery of oral PrEP to AGYW so that implementation can be taken to scale.