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Background: The delivery of pre-exposure prophylaxis (PrEP) for HIV prevention at retail pharmacies in Kenya may help overcome barriers (e.g. long wait times, stigma) to clinic-delivered PrEP and reach individuals [...]

Background: The uptake of daily oral HIV pre-exposure prophylaxis (PrEP)-a highly effective intervention-remains low among African adolescent girls and young women (AGYW) who could benefit. AGYW who initiate PrEP often do so through informal peer referral, which may be enhanced with formalized peer referral and peer-delivered HIV self-testing (HIVST). To understand the feasibility of this PrEP referral model among AGYW, we conducted a pilot study in Kenya., Method: From March to May 2022, we recruited AGYW (≥16-24 years) using PrEP (i.e., "peer providers") from public healthcare clinics in Kiambu County and trained them on HIV prevention, HIVST use, and peer-supported linkage to clinic-based HIV services. Following training, peer providers received eight HIVST kits and were encouraged to refer four peers (i.e., "peer clients") to PrEP. We completed surveys with peer providers and clients one month following intervention delivery to assess PrEP initiation among peer clients. Later, we conducted focus group discussions (FGDs) with peer providers and clients to identify factors that facilitated or challenged intervention outcomes., Results: We trained 16 peer providers (median age: 23 years, IQR 21-24) who reported delivering the intervention to 56 peer clients; 30 peer clients (median age: 21 years, IQR 19-22) contacted the study team and were enrolled. Most of the enrolled peer clients reported behaviors associated with HIV risk (e.g., condomless sex; 80%, 24/30) and were PrEP-naïve (87%, 26/30). At one-month, PrEP initiation among eligible PrEP-naïve peer clients was high, as reported by providers (78%, 43/55) and clients (85%, 22/26); recent HIVST use was also high among peer clients (provider report: 95%, 53/56; client report: 97%, 29/30). In the FGDs, participants reported that intervention outcomes were facilitated by close preexisting relationships, HIVST assistance, and being escorted to clinic-based HIV services by peer providers; intervention barriers included conflicting priorities and limited HIVST experience., Conclusion: A formalized model of peer referral with HIVST delivery supported PrEP initiation among Kenyan AGYW. These findings demonstrate the potential for peer-delivered interventions to engage AGYW in HIV prevention services; however, more research is needed on the effectiveness and sustainability of this approach at scale., Competing Interests: PM is currently an employee of Novartis following completion of the presented research. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2024 McGowan, Wairimu, Reedy, Mogere, Culquichicon, Njeru, Malen, Jahn, Bärnighausen, Roche, Ngure and Ortblad.)

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., (© 2024. The Author(s).)

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., (© 2024. The Author(s).)

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]., (© 2024. The Author(s).)

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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Roche, Ekwunife, Mendonca, Kwach, Omollo, Zhang, Ongwen, Hattery, Smedinghoff, Morris, Were, Rech, Bukusi and Ortblad.)

Vaccine coverage for the human papillomavirus (HPV) remains low globally, and differentiated models of vaccine delivery are needed to expand access. Pharmacy-based models of the HPV vaccination may engage women who could benefit. We assessed the acceptability of such a model among pharmacy clients and providers at 20 private pharmacies in Kisumu County, Kenya. In questionnaires, participants (≥18 years) were asked the extent they agreed (5-point scale) with statements that assessed different acceptability component constructs outlined in the Theoretical Framework of Acceptability (TFA). From March to June 2022, 1500 pharmacy clients and 40 providers were enrolled and completed questionnaires. Most clients liked the intervention (TFA: affective attitude; 96%, 1435/1500) and did not think it would be hard to obtain (TFA: burden; 93%, 1399/1500). All providers agreed the intervention could reduce HPV infection (TFA: perceived effectiveness) and felt confident they could deliver it (TFA: self-efficacy). Among the clients who had received or were planning to receive the HPV vaccine in the future, half (50%, 178/358) preferred a pharmacy-based HPV vaccination. In this study, most Kenyan pharmacy clients and providers perceived a pharmacy-delivered HPV vaccination as highly acceptable; however, more research is needed to test the feasibility and effectiveness of this novel vaccine delivery model in Africa.

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., (© 2023. The Author(s).)

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., (© 2023 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

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., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

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.

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., (© 2023 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Introduction: Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV acquisition, but coverage remains low in high prevalence settings. Initiating and continuing PrEP via online pharmacies is a promising strategy to expand PrEP uptake but little is known about user preferences for this strategy. We describe methods for a discrete choice experiment (DCE) to assess preferences for PrEP delivery from an online pharmacy., Methods and Analysis: This cross-sectional study is conducted in Nairobi, Kenya, in partnership with MYDAWA, a private online pharmacy retailer with a planned sample size of >400 participants. Eligibility criteria are: ≥18 years, not known HIV-positive and interested in PrEP. Initial DCE attributes and levels were developed via literature review and stakeholder meetings. We conducted cognitive interviews to assess participant understanding of the DCE survey and refined the design. The final DCE used a D-efficient design and contained four attributes: PrEP eligibility assessment, HIV test type, clinical consultation type and user support options. Participants are presented with eight scenarios consisting of two hypothetical PrEP delivery services. The survey was piloted among 20 participants before being advertised on the MYDAWA website on pages displaying products indicating HIV risk (eg, HIV self-test kits). Interested participants call a study number and those screened eligible meet a research assistant in a convenient location to complete the survey. The DCE will be analysed using a conditional logit model to assess average preferences and mixed logit and latent class models to evaluate preference heterogeneity among subgroups., Ethics and Dissemination: This study was approved by the University of Washington Human Research Ethics Committee (STUDY00014011), the Kenya Medical Research Institute, Nairobi County (EOP/NMS/HS/128) and the Scientific and Ethics Review Unit in Kenya (KEMRI/RES/7/3/1). Participation in the DCE is voluntary and subject to completion of an electronic informed consent. Findings will be shared at international conferences and peer-reviewed publications, and via engagement meetings with stakeholders., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Objective: We evaluated preexposure prophylaxis (PrEP) uptake, initiation, and continuation within a nurse-facilitated pharmacy-based delivery model for Kenyan adolescent girls and young women (AGYW) seeking contraception at retail pharmacies., Methods: From October 2020 to March 2021, PrEP-trained nurses were stationed at three retail pharmacies in Kisumu, Kenya. AGYW (aged 15-24 years) purchasing contraception (emergency contraception, oral contraceptive pills, injectables, implants, condoms) were counseled on PrEP, completed HIV testing, and offered a free 1-month supply of PrEP pills per national guidelines by nurses under supervision of a remote physician. We evaluated uptake among all AGYW offered PrEP. At 30 days after uptake, we evaluated PrEP use initiation and plans for continuation., Results: We enrolled 235 AGYW clients who were HIV-negative and purchasing contraception at pharmacies. Emergency contraception was the most frequently purchased contraceptive (35%). Median age was 22 years (IQR 19-23), 44% were currently in school, and 33% currently had multiple sexual partners. One-fourth (24%) exchanged sex for money or favors and 14% had sex while intoxicated in the prior 6 months. Overall, PrEP uptake was 85%; at 1 month, 82% had initiated PrEP use and 68% planned to continue use. Among those initiating PrEP, 69% were willing to pay for PrEP at retail pharmacies (median KES 150, IQR 100-200) even if available for free at public sector facilities., Conclusion: In this evaluation of nurse-facilitated PrEP delivery at pharmacies in Kenya, a substantial proportion of AGYW who purchased contraception subsequently initiated PrEP, planned to continue use, and were willing to pay for PrEP., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Kiptinness, Naik, Thuo, Malen, Dettinger, Pintye, Rafferty, Jomo, Nyamasyo, Wood, Isabelli, Morris, Hattery, Stergachis, Were, Sharma, Ngure, Mugambi and Ortblad.)

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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Nakambale, Roche, Mogere, Omollo, Kuo, Stergachis, Baeten, Bukusi, Ngure, Mugambi and Ortblad.)

We reviewed the literature on the assessment of acceptability of HIV prevention and treatment interventions and service delivery strategies. Following PRISMA guidelines, we screened 601 studies published from 2015 to 2020 and included 217 in our review. Of 384 excluded studies, 21% were excluded because they relied on retention as the sole acceptability indicator. Of 217 included studies, only 16% were rated at our highest tier of methodological rigor. Operational definitions of acceptability varied widely and failed to comprehensively represent the suggested constructs in current acceptability frameworks. Overall, 25 studies used formal quantitative assessments (including four adapted measures used in prior studies) and six incorporated frameworks of acceptability. Findings suggest acceptability assessment in recent HIV intervention and service delivery research lacks harmonization and rigor. We offer guidelines for best practices and future research, which are timely and critical in this era of informed choice and novel options for HIV prevention and treatment., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: Many Kenyan adolescent girls and young women (AGYW) with behaviors associated with HIV acquisition access contraception at retail pharmacies. Offering oral pre-exposure prophylaxis (PrEP) in pharmacies could help reach AGYW with PrEP services., Methods: We piloted PrEP delivery at 3 retail pharmacies in Kisumu, Kenya. AGYW purchasing contraception were offered PrEP by nurses with remote prescriber oversight. AGYW who accepted were provided with a free 1-month supply. We conducted in-depth interviews with AGYW 30 days postobtaining PrEP. Transcripts were analyzed to explore experiences of AGYW accessing PrEP at pharmacies., Results: We conducted 41 interviews. AGYW preferred pharmacies for accessing PrEP and they were willing to pay for PrEP even if available for free at clinics. Reasons for this preference included accessibility, lack of queues, and medication stockouts, privacy, anonymity, autonomy, and high-quality counseling from our study nurses., Conclusions: Pharmacies may be an important PrEP access option for this population., Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Purpose of Review: A paradigm shift is needed in how we think about biomedical HIV prevention product effectiveness. Often, we expect randomized trial findings to be generalizable across populations and settings where products will be delivered, without consideration of key contextual drivers that could impact effectiveness. Moreover, researchers and policy-makers generally discount products with varied effect sizes across contexts, rather than explicating the drivers of these differences and using them to inform equitable product choice and delivery. We conducted a review of the recent HIV prevention research to advance considerations of context in choices of when, why, and how to implement biomedical HIV prevention products, with a particular focus on daily oral preexposure prophylaxis (PrEP) and the dapivirine vaginal ring (DPV)., Recent Findings: Findings across recent studies of PrEP and DPV emphasize that products that do not work well in one context might be highly desirable in another. Key contextual drivers of PrEP and DPV effectiveness, use, and implementation include population, health system, cultural, and historical factors. We recommend conceptualization, measurement, and analysis approaches to fully understand the potential impact of context on prevention product delivery. Execution of these approaches has real-world implications for HIV prevention product choice and could prevent the field from dismissing biomedical HIV prevention products based on trial findings alone., Summary: Ending the HIV epidemic will require tailored, person-centered, and equitable approaches to design, implement, and evaluate HIV prevention products which necessitates considerations of context in ongoing research and implementation., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 McGowan, Casmir, Wairimu, Mogere, Jahn, Ngure, Ortblad and Roche.)

Introduction: Private pharmacies are an understudied setting for differentiated delivery of HIV services that may address barriers to clinic-delivered services, such as stigma and long wait times. To understand the potential for pharmacy-delivered HIV services in sub-Saharan Africa, we conducted a scoping review of the published and grey literature., Methods: Using a modified Cochrane approach, we searched electronic databases through March 2022 and HIV conference abstracts in the past 5 years for studies that: (1) focused on the delivery of HIV testing, antiretroviral therapy (ART) and/or pre-exposure prophylaxis (PrEP) at private pharmacies in sub-Saharan Africa; (2) reported on effectiveness outcomes (e.g. HIV incidence) or implementation outcomes, specifically feasibility and/or acceptability; and (3) were published in English. Two authors identified studies and extracted data on study setting, population, design, outcomes and findings by HIV service type., Results and Discussion: Our search identified 1646 studies. After screening and review, we included 28 studies: seven on HIV testing, nine on ART delivery and 12 on PrEP delivery. Most studies (n = 16) were conducted in East Africa, primarily in Kenya. Only two studies evaluated effectiveness outcomes; the majority (n = 26) reported on feasibility and/or acceptability outcomes. The limited effectiveness data (n = 2 randomized trials) suggest that pharmacy-delivered HIV services can increase demand and result in comparable clinical outcomes (e.g. viral load suppression) to standard-of-care clinic-based models. Studies assessing implementation outcomes found actual and hypothetical models of pharmacy-delivered HIV services to be largely feasible (e.g. high initiation and continuation) and acceptable (e.g. preferable to facility-based models and high willingness to pay/provide) among stakeholders, providers and clients. Potential barriers to implementation included a lack of pharmacy provider training on HIV service delivery, costs to clients and providers, and perceived low quality of care., Conclusions: The current evidence suggests that pharmacy-delivered HIV services may be feasible to implement and acceptable to clients and providers in parts of sub-Saharan Africa. However, limited evidence outside East Africa exists, as does limited evidence on the effectiveness of and costs associated with pharmacy-delivered HIV services. More research of this nature is needed to inform the scale-up of this new differentiated service delivery model throughout the region., (© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Purpose of Review: HIV self-testing (HIVST) has the potential to expand access to and uptake of HIV pre-exposure prophylaxis (PrEP) delivery. We conducted a systematic literature review to understand the evidence on HIVST use for PrEP delivery., Recent Findings: After screening 1055 records, we included eight: three randomized trials and five values and preferences studies. None measured PrEP initiation. Most studies occurred in Sub-Saharan Africa (7/8) and included different populations. One trial found that HIVST use between quarterly clinic visits as part of an adherence package with biofeedback slightly increased adherence; the other two trials found that HIVST use between or in lieu of quarterly clinic visits had no significant or non-inferior effects on adherence. HIVST to support PrEP delivery was acceptable, feasible, and preferred. HIVST use for PrEP continuation largely resulted in similar outcomes to standard-of-care delivery and was perceived acceptable and feasible. Further research is needed to optimize HIVST use within PrEP programming., (© 2022. The Author(s).)

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., Competing Interests: Declaration of interests JMB is a current employee of Gilead Sciences and has received consulting fees from Gilead Sciences and Merck, outside the submitted work. All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Introduction: Pregnant women in sub-Saharan Africa have high risk of HIV acquisition, yet approaches for measuring maternal HIV incidence using routine surveillance systems are undefined. We used programmatic data from routine antenatal care (ANC) HIV testing in Botswana to measure real-world HIV incidence during pregnancy., Methods: From January 2018 to September 2019, the Botswana Ministry of Health and Wellness implemented an HIV testing program at 139 ANC clinics. The program captured information on testers' age, testing date and result, and antiretroviral treatment (ART) initiation. In our analysis, we excluded individuals who previously tested HIV-positive prior to their first ANC visit. We defined incident HIV infection as testing HIV-positive at an ANC visit after a prior HIV-negative result within ANC., Results: Overall, 29,570 pregnant women (median age 26 years, IQR 22-31) tested for HIV at ANC clinics: 3% (836) tested HIV-positive at their first recorded ANC visit and 97% tested HIV-negative (28,734). Of those who tested HIV-negative, 28% (7940/28,734) had a repeat HIV test recorded at ANC. The median time to HIV re-testing was 92 days (IQR 70-112). In total, 17 previously undiagnosed HIV infections were detected (HIV incidence 8 per 1000 person-years, 95% CI 0.5-1.3). ART initiation among women newly diagnosed with HIV at ANC (853) was 88% (671/762)., Conclusions: In Botswana, real-world HIV incidence among pregnant women at ANC remains above levels of HIV epidemic control (≤ 1 per 1000 person-years). This study shows how HIV programmatic data can answer timely population-level epidemiological questions and inform ongoing implementation of HIV prevention and treatment programs., (© 2022. The Author(s).)

Background: Female sex workers (FSWs) have tightly connected peer networks and remain at high risk of HIV acquisition. Peer delivery of HIV prevention interventions, such as HIV self-testing (HIVST), is a recommended implementation strategy for increasing intervention uptake and continuation among FSWs. We analyzed qualitative data from a peer-delivered HIVST intervention among FSWs in urban Uganda to understand the ways social support within this peer network can motivate or discourage the uptake of peer-delivered HIVST., Methods: Between February and April 2017, we conducted in-depth interviews (IDIs) with FSWs (n = 30) and focus group discussions (FGDs) with FSW peer educators (PEs, n = 5) finishing participation in a four-month randomized implementation trial testing models of peer-delivered HIVST in Kampala. FSW participants were ≥ 18 years old, self-reported exchanging sex for money or goods (past month) and had not recently tested for HIV (past 3 months). FSW PEs either directly distributed HIVST kits to participants or provided coupons exchangeable for HIVST kits from specified healthcare facilities. In the IDIs and FGDs, we asked participants to share their experiences receiving or delivering peer-delivered HIVST, respectively. Using a hybrid deductive and inductive coding approach, we arranged findings along the dimensions of an established social support theory: informational, instrumental, and emotional support., Results: The median age of participants was 30 years (IQR: 27-33) and PEs was 33 years (IQR: 29-37). We found that social support within FSW peer networks both motivated and discouraged uptake of peer-delivered HIVST. For example, sharing positive HIVST experiences (informational support), directly delivering HIVST kits (instrumental support), and encouraging linkage to care (emotional support) motivated HIVST uptake among FSWs. Conversely, the spread of misinformation (informational support), limited HIVST kit availability fostering mistrust of PEs (instrumental support), and fear of social exclusion following HIV status disclosure (emotional support) discouraged HIVST uptake among FSWs., Conclusions: In Uganda, social support (e.g., informational, instrumental, and emotional support) among FSW peers can work in ways that both motivate and discourage peer-delivered intervention uptake. Future FSW peer-delivered HIV prevention interventions should be designed around the dimensions of social support within FSW peer networks to maximize initial and repeat intervention delivery and uptake., (© 2022. The Author(s).)

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., (© 2021. The Author(s).)

ABSTRACT Female sex workers (FSWs) are at increased risk of HIV and face significant barriers to clinic-based HIV testing, including provider stigma and privacy constraints. HIV self-testing (HIVST) has been proven to significantly increase HIV testing among FSWs. Less is known, however, about how FSWs make meaning of oral-fluid HIV self-tests, and the unintended ways they use and understand this novel technology. From October 2016 to March 2017, we conducted 61 in-depth interviews with FSWs ( n  = 31) in Kampala, Uganda. Eligible participants were: female, ≥18 years, exchanged sex for money or goods, and had not recently tested for HIV. We used inductive coding to identify emerging themes and re-arranged these into an adapted framework. Unintended desirable ways FSWs described self-testing included as a means to test others, to bolster their reputation as a health-conscious sex worker, and to avoid bearing witness to suffering at health facilities. Unintended undesirable meanings ascribed to self-testing included misunderstandings about how HIV is transmitted (via saliva versus blood) and whether self-tests also test for other infections. HIVST can increase FSWs' knowledge of their own HIV status and that of their sexual partners, but messaging and intervention design must address misunderstandings and misuses of self-testing. Trial registration: ClinicalTrials.gov identifier: NCT02846402.

Abstract: Among 130,161 HIV testing records from unique individuals at 149 programmatic sites in Botswana, frequency of detecting undiagnosed HIV infection within emergency departments (EDs) was 4.7% (455/9695), 2-fold higher than other clinic-based HIV counseling and testing. Men and noncitizens less frequently initiated same-day antiretroviral therapy after testing HIV positive within emergency departments., Competing Interests: Conflict of Interest and Sources of Funding: The authors declare that no conflicts of interest exist., (Copyright © 2020 American Sexually Transmitted Diseases Association. All rights reserved.)

HIV self-testing (HIVST) increases HIV testing in diverse populations, but little is known about the experiences of individuals who self-test. We used a five-step framework approach to analyze 62 qualitative interviews with 33 female sex workers (FSWs) participating in an HIVST trial in urban Uganda. Notions of empowerment emerged from the data, and findings were interpreted based on Kabeer's empowerment framework of resources, agency, and achievements. We found that access to HIVST bolstered empowerment because it increased participant's time and money (resources), control of testing circumstances and status disclosure (agency), and sense of competency (achievements). In addition, we found that knowledge of HIV status empowered participants to better control HIV-related behaviors (agency) and recognize a new sense of self (achievements). This suggests that the availability of HIVST can facilitate feelings of empowerment, meriting a higher awareness for benefits outside of linkage to HIV treatment and prevention services.

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.

Recent studies among men who have sex with men suggest that sexual behaviors associated with risk of sexually transmitted infections increase following initiation of pre-exposure prophylaxis (PrEP) for HIV prevention. We used longitudinal data from HIV-uninfected participants (n = 1013) enrolled in an open-label study of PrEP delivered to Ugandan and Kenyan heterosexual HIV serodiscordant couples to understand the association between PrEP initiation and HIV risk-related sexual behaviors among these couples. In the month following PrEP initiation, the mean number of monthly sex acts within couples decreased from 7.9 to 6.9 (mean difference: - 1.1; 95% CI - 1.5, - 0.7) and the proportion of couples having condomless sex decreased from 65% to 32% (percentage point change: - 33%; 95% CI - 37%, - 30%); these behaviors then remained relatively constant over 2 years. We found no evidence of sexual risk compensation following PrEP initiation within African serodiscordant couples. However, roughly a third of couples continued to engage in condomless sex during follow up, emphasizing the importance of continued PrEP use to sustain HIV protection.

Knowledge of HIV status is a necessary pre-condition for most HIV interventions, including treatment as well as biomedical and behavioral prevention interventions. We used data from a female sex worker (FSW) cohort in three Zambian transit towns to understand the effect that knowledge of HIV status has on FSWs' HIV risk-related sexual behaviors with clients. The cohort was formed from an HIV self-testing trial that followed participants for 4 months. Participants completed three rounds of data collection at baseline, 1 month, and 4 months where they reported their perceived knowledge of HIV status, number of clients on an average working night, and consistent condom use with clients. We measured the effect of knowledge of HIV status on participants' sexual behaviors by using linear regression models with individual fixed effects. The majority of the 965 participants tested for HIV at least once during the observation period (96%) and changed their knowledge of HIV status (79%). Knowledge of HIV status did not affect participants' number of clients, but it did affect their consistency of condom use. Compared with unknown HIV status, knowledge of HIV-negative status significantly increased participants' consistent condom use by 8.1% points [95% confidence interval (CI): 2.7-13.4, p  = 0.003] and knowledge of HIV-positive status increased participants' consistent condom use by 6.1% points (95% CI: -0.1 to 12.9, p  = 0.08); however, this latter effect was not statistically significant. FSWs in Zambia engaged in safer sex with clients when they learned their HIV status. The expansion of HIV testing programs may serve as a behavioral HIV prevention measure among FSWs.

Background: Knowledge of HIV-positive status may result in depressive symptoms, which may be a concern to scaling novel HIV testing interventions that move testing outside the health system and away from counselor support., Setting: Uganda and Zambia., Methods: We used longitudinal data from 2 female sex worker (FSW) cohorts in Uganda (n = 960) and Zambia (n = 965). Over 4 months, participants had ample opportunity to HIV testing using standard-of-care services or self-tests. At baseline and 4 months, we measured participants' perceived knowledge of HIV status, severity of depressive symptoms (continuous PHQ-9 scale, 0-27 points), and prevalence of likely depression (PHQ-9 scores ≥10). We estimated associations using individual fixed-effects estimation., Results: Compared with unknown HIV status, knowledge of HIV-negative status was significantly associated with a decrease in depressive symptoms of 1.06 points in Uganda (95% CI -1.79 to -0.34) and 1.68 points in Zambia (95% CI -2.70 to -0.62). Knowledge of HIV-positive status was significantly associated with a decrease in depressive symptoms of 1.01 points in Uganda (95% CI -1.82 to -0.20) and 1.98 points in Zambia (95% CI -3.09 to -0.88). The prevalence of likely depression was not associated with knowledge of HIV status in Uganda but was associated with a 14.1% decrease with knowledge of HIV-negative status (95% CI -22.1% to -6.0%) and a 14.3% decrease with knowledge of HIV-positive status (95% CI -23.9% to -4.5%) in Zambia., Conclusions: Knowledge of HIV status, be it positive or negative, was significantly associated with a decrease in depressive symptoms in 2 FSW populations. The expansion of HIV testing programs may have mental health benefits for FSWs.

In sub-Saharan Africa, female bar workers (FBWs) often serve as informal sex workers. Little is known about the prevalence of HIV and HIV-related risk factors among FBWs in Dar es Salaam (DSM), Tanzania. Using an adapted Structural HIV Determinants Framework, we identified structural, interpersonal, psychosocial, and behavioral risk factors for HIV acquisition. We compared the prevalence of HIV and HIV-related risk factors among a random sample of 66 FBWs from DSM to an age-standardized, representative sample of female DSM-residents from the 2016 Demographic and Health and 2011-2012 AIDS Indicator Surveys. Compared to other women in DSM, FBWs had elevated prevalence of all four groups of risk factors. Key risk factors included gender and economic inequalities (structural); sexual violence and challenges negotiating condom use (interpersonal); depression, post-traumatic stress disorder, and low social support (psychosocial); and history of unprotected sex, multiple sex partners, and high alcohol consumption (behavioral). HIV prevalence did not differ between FBWs (7.1%, 95% CI 3.7-13.3%) and survey respondents (7.7%, 95% CI: 5.3-11.1%), perhaps due to FBWs' higher - though sub-optimal - engagement with HIV prevention strategies. Elevated exposure to HIV-related risk factors but low HIV prevalence suggests economic, psychosocial, and biomedical interventions may prevent HIV among FBWs in DSM.

Purpose of Review: The aim of this review is to examine the emerging results from the HIV universal test and treat (UTT) cluster-randomized trials in sub-Saharan Africa, discuss how expanding access to HIV clinical services is likely to reshape the arc of HIV epidemics, and consider implications for HIV prevention and control strategies in the coming decade., Recent Findings: The effect of universal HIV testing followed by immediate antiretroviral treatment (ART) on community-level HIV incidence remains unclear upon completion of five randomized trials. Only two of the four trials that measured HIV incidence found significant reductions in community-level incidence. Even in these trials, HIV incidence remained above levels required for epidemic control (≤1 case per 1000 person-years) despite high levels of ART coverage and viral suppression. These findings may indicate that community-delivered HIV services are not reaching the high-frequency transmitters who sustain HIV epidemics and are likely members of marginalized or hard to engage core groups., Summary: With expanded access to HIV services in sub-Saharan Africa, HIV epidemics are transitioning from hyperendemic to declining/endemic epidemic phases, characterized increasingly by the reconcentration of HIV in marginalized or hard to engage core groups. To move toward epidemic control, novel HIV service delivery models and technologies are needed to engage those who continue to drive HIV incidence in this new epidemic phase.

Background: The introduction of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus-1 (HIV-1) prevention in Africa presents new challenges for health systems that are already overburdened because PrEP delivery requires frequent clinic visits (generally every 3 months) for HIV-1 testing and PrEP refills. HIV-1 self-testing (HIVST) has the potential to improve the efficiency of PrEP delivery by decreasing the number of clinic visits. Here, we describe the rationale and design of a randomized, noninferiority trial designed to test the effectiveness and safety of using HIVST to support PrEP delivery in Kenya., Methods: The JiPime-JiPrEP (Kiswahili for 'Test Yourself, PrEP Yourself') study is a three-arm randomized trial taking place in Thika, Kenya. Participants (n = 495) are eligible for enrollment if they are at least 18 years old, HIV-1 seronegative, and have been taking PrEP for 1 month. Three distinct participant types will be enrolled: men (n = 165) and women (n = 165) who are in mutually disclosed HIV-1 serodiscordant relationships, and women (n = 165) who are at HIV-1 risk and not in a known serodiscordant relationship. Participants in each of these subpopulations will be 1:1:1 randomized to: 1) the standard of care, with quarterly clinic visits; 2) oral HIVST, with biannual clinic visits plus oral HIVSTs to use at the quarters between those visits; or 3) blood-based HIVST, with biannual clinic visits plus blood-based HIVSTs. All participants will complete quantitative surveys and provide blood samples for the objective measurement of PrEP adherence at baseline, 6 months, and 12 months. The primary outcomes are PrEP adherence, PrEP continuation, and HIV-1 testing, measured at 6 months and secondarily at 12 months., Discussion: The findings from this trial can help to understand how HIVST-a new HIV-1 testing technology-can support health systems in sub-Saharan Africa. Additionally, the findings can inform policy aimed at improving the efficiency of PrEP implementation and scale-up in Kenya., Trial Registration: ClinicalTrials.gov, NCT03593629 . Retrospectively registered on 20 July 2018.

Introduction: Female sex workers (FSWs) have strong economic incentives for sexual risk-taking behaviour. We test whether knowledge of HIV status affects such behaviours among FSWs., Methods: We used longitudinal data from a FSW cohort in urban Uganda, which was formed as part of an HIV self-testing trial with four months of follow-up. Participants reported perceived knowledge of HIV status, number of clients per average working night, and consistent condom use with clients at baseline, one month, and four months. We measured the association between knowledge of HIV status and FSWs' sexual behaviours using linear panel regressions with individual fixed effects, controlling for study round and calendar time., Results: Most of the 960 participants tested for HIV during the observation period (95%) and experienced a change in knowledge of HIV status (71%). Knowledge of HIV status did not affect participants' number of clients but did affect their consistent condom use. After controlling for individual fixed effects, study round and calendar month, knowledge of HIV-negative status was associated with a significant increase in consistent condom use by 9.5 percentage points (95% CI 5.2 to 13.5, p < 0.001), while knowledge of HIV-positive status was not associated with a significant change in consistent condom use (2.5 percentage points, 95% CI -8.0 to 3.1, p = 0.38)., Conclusions: In urban Uganda, FSWs engaged in safer sex with clients when they perceived that they themselves were not living with HIV. Even in communities with very high HIV prevalence, the majority of the population will test HIV-negative. Our results thus imply that expansion of HIV testing programmes may serve as a behavioural HIV prevention measure among FSWs., (© 2019 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

HIV self-testing increases recent and frequent HIV testing among female sex workers (FSWs) in urban Uganda. Using results from a randomized controlled trial, we aim to establish the effect of HIV self-testing delivery models on FSWs' sexual behaviors in this setting. Clusters of one peer educator and eight participants were 1:1:1 randomized to: (1) direct provision of an HIV self-test, (2) provision of a coupon for facility collection of an HIV self-test, or (3) referral to standard-of-care HIV testing services. Sexual behaviors were self-reported at 1 and 4 months. From October to November 2016, 960 participants were enrolled and randomized. At 4 months, there were no statistically significant differences in participants' sexual behaviors, including inconsistent condom use, across study arms. We do not find any changes in sexual risk-taking among FSWs in response to the delivery of HIV self-tests. Routine policies for HIV self-testing are likely a behaviorally safe component of comprehensive HIV prevention strategies.

Objective: Female bar workers (FBW) in East Africa often conduct sex work to supplement their incomes, and may be vulnerable to HIV acquisition. Pre-exposure prophylaxis (PrEP) offers protection against HIV acquisition. However, there is little research on FBW's sexual health. Our objective was to determine HIV risk behaviours and interest in PrEP among FBW in the largest city in East Africa., Design: Cross-sectional survey covering respondents' work and personal lives, including social and behavioural risk factors for HIV. The survey aimed to determine the feasibility of working with FBW and HIV prevalence estimates. Those who did not report being HIV positive were asked about their knowledge of and interest in PrEP. All women were offered free on-site HIV testing and counselling (HTC)., Setting: Eight randomly selected workplaces, that is, bars, in Kinondoni district, Dar es Salaam (DSM)., Participants: 66 FBW (≥18 years) selected at random from all women working in selected bars on the day of visit., Results: Half of respondents reported having had sex for money: 20% with bar clients only, 15% with other men only and 15% with both. Almost all (98%) reported ≥1 non-commercial partners in the past 12 months; only 30% reported using condoms with these partners. 85% of respondents had ever been pregnant; 44% had had an unintended pregnancy. Only 5% of respondents had ever heard of PrEP. However, 54% were somewhat/very interested in daily-pill PrEP and 79% were somewhat/very interested in long-acting injectable PrEP. When asked to rank modalities, long-acting injectable PrEP was the most preferred. Seven per cent of the 56 respondents who completed HTC tested HIV positive., Conclusions: FBW in DSM have elevated risk factors for HIV acquisition, and PrEP appears highly acceptable. Studies developing PrEP delivery models and assessing PrEP initiation and adherence in FBW appear warranted., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Interviewers can substantially affect self-reported data. This may be due to random variation in interviewers' ability to put respondents at ease or in how they frame questions. It may also be due to systematic differences such as social distance between interviewer and respondent (e.g., by age, gender, ethnicity) or different perceptions of what interviewers consider socially desirable responses. Exploration of such variation is limited, especially in stigmatized populations., Methods: We analyzed data from a randomized controlled trial of HIV self-testing amongst 965 female sex workers (FSWs) in Zambian towns. In the trial, 16 interviewers were randomly assigned to respondents. We used hierarchical regression models to examine how interviewers may both affect responses on more and less sensitive topics, and confound associations between key risk factors and HIV self-test use., Results: Model variance (ICC) at the interviewer level was over 15% for most topics. ICC was lower for socio-demographic and cognitively simple questions, and highest for sexual behaviour, substance use, violence and psychosocial wellbeing questions. Respondents reported significantly lower socioeconomic status and more sex-work related violence to female interviewers. Not accounting for interviewer identity in regressions predicting HIV self-test behaviour led to coefficients moving from non-significant to significant., Conclusions: We found substantial interviewer-level effects for prevalence and associational outcomes among Zambian FSWs, particularly for sensitive questions. Our findings highlight the importance of careful training and response monitoring to minimize inter-interviewer variation, of considering social distance when selecting interviewers and of evaluating whether interviewers are driving key findings in self-reported data., Trial Registration: clinicaltrials.gov NCT02827240 . Registered 11 July 2016.

Background: Voluntary medical male circumcision reduces men's risk of HIV acquisition and may thus increase HIV risk-related sexual behaviors through risk compensation. We analyze longitudinal data from one of Africa's largest population cohorts using fixed-effects panel estimation to measure the effect of incident circumcision on sexual behaviors., Setting: KwaZulu-Natal, South Africa., Methods: An open population cohort of men was followed from 2009 to 2015. Men self-reported their circumcision status and sexual behavior annually. We used linear regression models with individual-level fixed effects to measure the effect of incident circumcision on recent sex (past 12 months) and sexual behaviors that increase HIV risk (not using a condom at last sex, never using condoms with the most recent sexual partner, concurrent sexual partners at present, and multiple sexual partners in the past 12 months). We controlled for potential time-varying confounders: calendar year, age, education, and sexual debut., Results: The 5127 men in the cohort had a median age of 18 years (interquartile range 16-24) at cohort entry. Over the study period, almost 1 in 5 of these men (19.4%) became newly circumcised. Incident circumcision affected neither recent sex [percentage point (PP) change 0.0, 95% confidence interval: -1.2 to 1.3] nor sexual behaviors that increase HIV risk (PP -1.6, 95% confidence interval: -4.5 to 1.4)., Conclusions: The data from this study strongly reject the hypothesis that circumcision affects sexual risk-taking. Risk compensation should not serve as an argument against increased and accelerated scale-up of circumcision in this and similar communities in South Africa.

Background: Voluntary medical male circumcision has been promoted in high HIV prevalence settings to prevent HIV acquisition in males. However, the uptake of circumcision in many sub-Saharan African settings remains low. While many studies have measured circumcision prevalence, understanding circumcision incidence and its predictors is vital to achieving ambitious circumcision prevalence targets., Setting: Rural KwaZulu-Natal, South Africa., Methods: We measured circumcision incidence over the period 2009-2014 in a longitudinal population-based cohort with high HIV prevalence and low circumcision prevalence. Multivariable survival models with Weibull distributions were used to assess socio-demographic, behavioral and biological predictors of circumcision incidence., Results: Between 2009 and 2014, circumcision prevalence among males 15-49 years in the cohort increased from 3% to 24%. Among 6,203 males 15-49 years, 873 new circumcisions occurred over 13,678 person-years (incidence rate: 6.4/100 person-years, 95% CI 6.0-6.8). Circumcision incidence was substantially higher amongst young males: 15-19 year olds were twice as likely to circumcise as older males. In the survival model, shorter household distance to the nearest healthcare facility, knowledge of HIV status and biological HIV-negative status were associated with an increased likelihood of circumcision incidence., Conclusions: Circumcision prevalence among males in rural KwaZulu-Natal remains well below South Africa's national 80% coverage target across age groups. In this population, distance to the nearest healthcare facility and knowledge of HIV status were important independent predictors of circumcision incidence. Mobile circumcision clinics and innovative HIV testing services may be important tools to help achieve circumcision targets., Competing Interests: The authors have declared that no competing interests exist.

Background: Intimate partner violence (IPV) is common among female sex workers (FSW) globally. Here, we prospectively assessed the relationship between IPV and engagement in HIV care in a cohort of FSW who had been newly diagnosed with HIV., Methods: Data arose from the Zambian Peer Educators for HIV Self-Testing study, a randomized controlled trial of HIV self-test distribution among FSW in 3 transit towns in Zambia. Participants were self-reported to be HIV-uninfected or unaware of their status at baseline. IPV in the previous 12 months was assessed at baseline. At 4 months, participants were asked the results of their last HIV test and those who reported testing positive were asked whether they had engaged in HIV-related care and started antiretroviral therapy (ART)., Results: Of 964 participants, 234 (24.3%) reported that they were living with HIV at 4 months. Of these 234 participants, 142 (60.7%) reported a history of IPV (past 12 months) at baseline and at 4 months, 152 (65.0%) reported that they were in HIV-related care, and 132 (56.7%) reported that they had initiated ART. Participants who reported IPV had significantly reduced odds of engagement in care (adjusted odds ratio = 0.48, 95% confidence interval: 0.26 to 0.91) and ART initiation (adjusted odds ratio = 0.40, 95% confidence interval: 0.22 to 0.72)., Conclusions: FSW living with HIV in Zambia reported very high rates of IPV. Structural and individual interventions for violence prevention are urgently needed to better protect this population. Given the strong negative relationship between IPV and engagement in HIV-related care, such interventions could also substantially improve HIV-related health outcomes.

Objective: To evaluate HIV self-testing performance and results interpretation among female sex workers (FSWs) in Kampala, Uganda, who performed unassisted HIV self-testing., Methods: In October 2016, 104 participants used an oral HIV self-test while under observation by research assistants. Participants were not assisted on HIV self-test use prior to or during testing, and were only given the manufacturer's pictorial and written instructions to guide them. Research assistants recorded if participants completed and/or had difficulties with steps in the HIV self-testing process on a prespecified checklist. Randomly drawn, used HIV self-tests were interpreted by FSWs. We calculated the concordance between FSWs' interpretations of self-test results with those indicated in the manufacturer's instructions., Results: Only 33% (34/104) of participants completed all of the key steps in the HIV self-testing process, and the majority (86%, 89/104) were observed having difficulties with at least one of these steps. Misinterpretation of HIV self-test results were common among FSWs: 23% (12/56) of FSWs interpreted HIV-negative self-test results as HIV positive and 8% (3/37) of FSWs interpreted HIV-positive self-test results as HIV negative. The concordance between FSWs' interpretations of self-test results and that indicated in the instructions was 73% (95% CI 56% to 86%) for HIV-positive self-tests and 68% (95% CI 54% to 80%) for HIV-negative self-tests., Conclusions: FSWs in Kampala, who performed unassisted HIV self-testing, skipped steps in the HIV self-testing process and had difficulties correctly interpreting self-test results. Training on use and interpretation of HIV self-tests may be necessary to prevent errors in the HIV self-testing process and to avoid the negative consequences of false-positive and false-negative HIV self-test results among FSWs., Trial Registration Number: NCT02846402., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ.)