HIV Prevention Tools Across the Pregnancy Continuum: What Works, What Does Not, and What Can We Do Differently?

PURPOSE OF REVIEW: Multiple tools exist to support the primary prevention of HIV in pregnant and postpartum women; however, there are opportunities to enhance their use and impact. This review summarizes the current status of HIV prevention tools and existing gaps and opportunities to improve their use along the pregnancy care continuum. RECENT FINDINGS: HIV screening efforts have steadily improved with close to universal screening of pregnant women in several East and Southern African countries. Strategies to implement partner testing through the distribution of HIV self-test kits are promising though linkage to care remains challenging. Syphilis screening rates are increasing though detection of other sexually transmitted infections could benefit from improved diagnostic capacity. Male and female condoms are rarely used and are often not the optimal tool of choice during pregnancy. Oral pre-exposure prophylaxis (PrEP) is a promising tool, although barriers such as the need for daily adherence, side effects, and stigma may limit its use. There is a growing pipeline of PrEP agents with alternative delivery platforms that might suit women's preferences better and supports the notion that choice is vital to improving HIV prevention coverage during the pregnancy-postpartum continuum. Clear guidance on which tools to use and how to use them, safety data supporting their use, and surveillance data documenting the scale and effectiveness of the tools will be imperative in establishing a path to more impactful prevention efforts among pregnant and postpartum women.

Key influences on the decision to initiate PrEP among adolescent girls and young women within routine maternal child health and family planning clinics in Western Kenya.

We sought to understand influences on PrEP uptake among Kenyan adolescent girls and young women (AGYW) whose decision on PrEP use was misaligned with their risk for HIV acquisition. In-depth interviews were conducted with 47 Kenyan HIV-negative AGYW aged 15-24 years who were offered PrEP during routine maternal and child health and family planning services. AGYW were sampled from two groups (1) declined PrEP and had ≥1 sexual partner(s) of unknown HIV status and (2) initiated PrEP and reported having one HIV-negative partner. AGYW with HIV-negative partners initiated PrEP due to known or suspected infidelity. AGYW with partners of unknown HIV status recognized PrEP as a helpful HIV prevention tool, yet worried about partner reactions and prioritized avoiding uncomfortable or unsafe situations over PrEP. Among pregnant AGYW, the responsibility of motherhood and providing a future for one's family, through staying healthy and remaining HIV-free, was a strong PrEP use motivator. Among AGYW who desired future motherhood, fears that PrEP could negatively impact fertility or reduce contraceptive effectiveness led to declining PrEP. Peers positively influenced PrEP decision-making, especially personally knowing a PrEP user. Strategies are needed to enhance messaging and delivery approaches that are tailored to AGYW, including peer-led strategies.

Making Smarter Decisions Faster: Systems Engineering to Improve the Global Public Health Response to HIV.

PURPOSE OF REVIEW: This review offers an operational definition of systems engineering (SE) as applied to public health, reviews applications of SE in the field of HIV, and identifies opportunities and challenges of broader application of SE in global health. RECENT FINDINGS: SE involves the deliberate sequencing of three steps: diagnosing a problem, evaluating options using modeling or optimization, and providing actionable recommendations. SE includes diverse tools (from process improvement to mathematical modeling) applied to decisions at various levels (from local staffing decisions to planning national-level roll-out of new interventions). Contextual factors are crucial to effective decision-making, but there are gaps in understanding global decision-making processes. Integrating SE into pre-service training and translating SE tools to be more accessible could increase utilization of SE approaches in global health. SE is a promising, but under-recognized approach to improve public health response to HIV globally.

Women's preferences for HIV prevention service delivery in pharmacies during pregnancy in Western Kenya: a discrete choice experiment.

INTRODUCTION: Pharmacy-delivered HIV prevention services might create more options for pregnant women to use HIV prevention tools earlier and more consistently during pregnancy. We quantified preferences for attributes of potential HIV prevention services among women of childbearing age in Western Kenya. METHODS: From June to November 2023, we administered a face-to-face discrete choice experiment survey to women aged 15-44 in Kenya's Homa Bay, Kisumu and Siaya counties. The survey evaluated preferences for HIV prevention services, described by seven attributes: service location, travel time, type of HIV test, sexually transmitted infection (STI) testing, partner HIV testing, pre-exposure prophylaxis (PrEP) and service fee. Participants answered a series of 12-choice questions. Each question asked them to select one of two service options or no services-an opt-out option. We used hierarchical Bayesian modelling levels to estimate each attribute level's coefficient and understand how attributes influenced service choice. RESULTS: Overall, 599 participants completed the survey, among whom the median age was 23 years (IQR: 18-27); 33% were married, 20% had a job and worked regularly, and 52% had been pregnant before. Participants, on average, strongly preferred having any HIV prevention service option over none (opt-out preference weight: -5.84 [95% CI: -5.97, -5.72]). The most important attributes were the availability of PrEP (relative importance 27.04% [95% CI: 25.98%, 28.11%]), followed by STI testing (relative importance 20.26% [95% CI: 19.52%, 21.01%]) and partner HIV testing (relative importance: 16.35% [95% CI: 15.79%, 16.90%]). While, on average, participants preferred obtaining services at the clinic more than pharmacies, women prioritized the availability of PrEP, STI testing and partner HIV testing more than the location or cost. CONCLUSIONS: These findings suggest the importance of providing comprehensive HIV prevention services and ensuring PrEP, STI testing and partner HIV testing are available. If pharmacies can offer these services, women are likely to access those services at pharmacies even if they prefer clinics.

Enhancing HIV pre-exposure prophylaxis outcomes among Kenyan adolescent girls and young women with a novel pharmacy-based PrEP delivery platform: protocol for a cluster-randomized controlled trial.

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.

Nurse-facilitated preexposure prophylaxis delivery for adolescent girls and young women seeking contraception at retail pharmacies in Kisumu, Kenya.

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.

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

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

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

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

Assessing preferences for HIV pre-exposure prophylaxis (PrEP) delivery services via online pharmacies in Kenya: protocol for a discrete choice experiment.

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.

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.

Understanding factors influencing home pregnancy test use among women in western Kenya: A qualitative analysis.

Background: There are limited data on home pregnancy test use among women in low-and-middle-income countries. A prior survey found that only 20% of women in western Kenya used a home pregnancy test to confirm their pregnancies before going to antenatal care. This qualitative study aims to understand why women do not use home pregnancy tests in early pregnancy. Methods: From April 2021 to July 2021, we interviewed women from four antenatal care clinics in Homa Bay and Siaya counties. We recruited women previously enrolled in the PrEP Implementation for Mothers in Antenatal care (PrIMA) study, a cluster-randomized trial that evaluated the best approaches to implementing PrEP in maternal and child health clinics in Western Kenya (NCT03070600). Interviews were conducted via phone, audio recorded, translated, and transcribed verbatim. We coded and analyzed the transcripts to capture factors influencing women's capability, opportunity, and motivation to use home pregnancy tests. Results: We conducted 48 semistructured interviews with women aged 21-42 years. Twenty-seven women did not use a home pregnancy test in their most recent pregnancy. Seventeen of these women reported not using a home pregnancy test before. Lack of knowledge, mistrust in the accuracy of tests, preferring to rely on signs and symptoms of pregnancy or get a test from the health facility, cost, and accessibility were key barriers to home pregnancy test use. Conclusion: Improving the uptake of home pregnancy testing during early pregnancy will require efforts to enhance community knowledge of test use and associated benefits and reduce cost burdens by making tests more affordable and accessible.

"Pharmacies are Everywhere, and You can get it at any Time": Experiences With Pharmacy-Based PrEP Delivery Among Adolescent Girls and Young Women in Kisumu, Kenya.

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.

The effectiveness, feasibility and acceptability of HIV service delivery at private pharmacies in sub-Saharan Africa: a scoping review.

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.

Fee for home delivery and monitoring of antiretroviral therapy for HIV infection compared with standard clinic-based services in South Africa: a randomised controlled trial.

BACKGROUND: Home delivery and monitoring of antiretroviral therapy (ART) is convenient, overcomes logistical barriers, and could increase individual ART adherence and viral suppression. With client payment and sufficient health benefits, this strategy could be scalable. The aim of the Deliver Health Study was to test the acceptability and efficacy of a user fee for home ART monitoring and delivery. METHODS: We conducted a randomised trial, the Deliver Health Study, of a fee for home delivery of ART compared with free clinic ART delivery in South Africa. People with HIV who were 18 years or older and clinically stable (including CD4 count >100 cells per µL and WHO HIV stage 1-3) were randomly assigned to: (1) fee for home delivery and monitoring of ART, including community ART initiation if needed; or (2) clinic-based ART (standard of care). The one-time fee for home delivery (ZAR 30, 60, and 90; equivalent to US$2, 4, 6) was tiered on the basis of participant income. The primary outcomes were recorded fee payment and acceptability assessed via questionnaire. The key virological secondary outcome was viral suppression with the difference between study groups assessed through robust Poisson regression including participants with viral load measured at exit (modified intention-to-treat analysis). This trial is registered on ClinicalTrials.gov (NCT04027153) and is complete, with analyses ongoing. FINDINGS: From Oct 7, 2019, to Jan 30, 2020, 162 participants were enrolled; 82 were randomly assigned to the fee for home delivery group and 80 to the clinic-based group, with similar characteristics at baseline. Overall, 87 (54%) participants were men, 101 (62%) were on ART, and 98 (60%) were unemployed. In the home delivery group, 40 (49%), 33 (40%), and nine (11%) participants qualified for the ZAR 30, 60, and 90 fee, respectively. Median follow-up was 47 weeks (IQR 43-50) with 96% retention. 80 (98%) participants paid the user fee, with high acceptability and willingness to pay. In the modified intention-to-treat analysis of 155 (96%) participants who completed follow-up, fee for home delivery and monitoring statistically significantly increased viral suppression from 74% to 88% overall (RR 1·21, 95% CI 1·02-1·42); and from 64% to 84% among men (1·31, 1·01-1·71). INTERPRETATION: Among South African adults with HIV, a fee for home delivery and monitoring of ART significantly increased viral suppression compared with clinic-based ART. Clients' paying a fee for home delivery and monitoring of ART was highly acceptable in the context of low income and high unemployment, and improved health outcomes as a result. Home ART delivery and monitoring, potentially with a user fee to offset costs, should be evaluated as a differentiated service delivery strategy to increase access to care. FUNDING: National Institutes of Mental Health.

Design and evaluation of strategies to implement HIV prevention interventions for pregnant women in community pharmacy settings in western Kenya: a mixed-methods study protocol.

INTRODUCTION: Community pharmacies play an important role in the healthcare system: they are frequently accessed and have increasing capacity to deliver HIV prevention services. In communities where the prevalence of HIV is high and access to antenatal care clinics is delayed or irregular, there is a unique opportunity to leverage pharmacies to enhance early and sustained access to HIV prevention among pregnant women. This study will identify women's preferences for delivery of HIV prevention services and provider-level and system-level strategies to design a new pharmacy-based model of care for pregnant women. The overall objective of this study is to design and evaluate strategies to implement HIV prevention interventions for pregnant women in community pharmacy settings in western Kenya. METHODS AND ANALYSIS: We propose to conduct a discrete choice experiment to quantify preferences for delivery of HIV prevention interventions (including pre-exposure prophylaxis, partner testing and sexually transmitted infection screening and treatment) for pregnant women in community pharmacy settings. Latent class analysis will be used to quantify women's stated preferences and identify packages of intervention components that will optimise uptake among different subgroups of women. We will apply the Theoretical Domains Framework to identify provider-level and system-level factors that might influence the implementation of the optimal intervention packages. We will then use the Behaviour Change Wheel and survey a panel of experts to select and gain consensus on strategies to improve implementation. Finally, we will evaluate the potential costs of extending the implementation of HIV prevention interventions from the clinic to community pharmacy settings. ETHICS AND DISSEMINATION: The protocol was approved by the Kenyatta National Hospital-University of Nairobi Ethics Research Committee and the University of Washington Institutional Review Board. The results of this research will be published in peer-reviewed journals and shared with various stakeholders, including community members, policymakers and researchers, through local and international conferences.

Prevalence and correlates of pregnancy self-testing among pregnant women attending antenatal care in western Kenya.

In sub-Saharan Africa little is known about how often women use pregnancy self-tests or characteristics of these women despite evidence that pregnancy self-testing is associated with early antenatal care (ANC) initiation. Understanding the characteristics of women who use pregnancy self-tests can facilitate more targeted efforts to improve pregnancy testing experiences and entry into the ANC pathway. We conducted a cross-sectional survey among pregnant women enrolling in a pre-exposure prophylaxis (PrEP) implementation study to determine the prevalence and factors associated with pregnancy self-testing among women in western Kenya. Overall, in our study population, 17% of women obtained a pregnancy self-test from a pharmacy. Pregnancy test use was higher among employed women, women with secondary and college-level educated partners, and women who spent 30 minutes or less traveling to the maternal and child health (MCH) clinic. The most reported reasons for non-use of pregnancy self-tests included not thinking it was necessary, lack of knowledge, and money to pay for the test. Future research should focus on understanding the knowledge and attitudes of women toward pregnancy self-testing as well as developing community-based models to improve access to pregnancy testing and ANC.

Influences on Early Discontinuation and Persistence of Daily Oral PrEP Use Among Kenyan Adolescent Girls and Young Women: A Qualitative Evaluation From a PrEP Implementation Program.

BACKGROUND: Discontinuation of daily oral pre-exposure prophylaxis (PrEP) is frequent among adolescent girls and young women (AGYW) in African settings. We explored factors influencing early PrEP discontinuation and persistence among Kenyan AGYW who accepted PrEP within a programmatic setting. METHODS: We conducted in-depth interviews with AGYW (aged 15-24 years) who accepted PrEP from 4 maternal child health (MCH) and family planning (FP) clinics. AGYW were identified by nurses at routine clinic visits and purposively sampled based on 4 categories: (1) accepted PrEP pills, but never initiated PrEP use (eg, never swallowed PrEP pills), (2) discontinued PrEP <1 month after initiation, (3) discontinued PrEP within 1-3 months, and (4) persisted with PrEP use >3 months. Informed by the Stages of Change Model, thematic analysis characterized key influences on PrEP discontinuation/persistence. RESULTS: We conducted 93 in-depth interviews with AGYW who accepted pills. Median age was 22 years, 71% were married; 89% were from MCH, and 11% were from FP clinics. Early PrEP use was positively influenced by encouragement from close confidants and effective concealment of PrEP pill-taking when necessary to avoid stigma or negative reactions from partners. Pregnancy helped conceal PrEP use because pill-taking is normalized during pregnancy, but concealment became more difficult postpartum. AGYW found keeping up with daily PrEP pill-taking challenging, and many noted only episodic periods of the HIV risk. Frequently testing HIV-negative reassured AGYW that PrEP was working and motivated persistence. DISCUSSION: As PrEP programs scale-up in MCH/FP, it is increasingly important to enhance protection-effective PrEP use through approaches tailored to AGYW, with special considerations during pregnancy and postpartum.

How to implement new diagnostic products in low-resource settings: an end-to-end framework.

Diagnostics developers often face challenges introducing in-vitro diagnostic (IVD) products to low- and middle-income countries (LMICs) because of difficulty in accessing robust market data, navigating policy and regulatory requirements and implementing and supporting products in healthcare systems with limited infrastructure. Best practices recommend the use of a phase-gate model with defined activities and milestones by phase to successfully move a product from concept to commercialisation. While activities for commercialisation of products in high-income countries (HICs) are well understood, the activities required for introduction of IVDs in LMICs are not. In this paper, we identify the key activities needed for IVD product development and implementation and map them to the various phases of the model, paying particular attention to those activities that might be conducted differently in LMICs.

Estimating Weekly Call Volume to a National Nurse Telephone Triage Line in an Influenza Pandemic.

Telephone nurse triage lines, such as the Centers for Disease Control and Prevention's (CDC) Flu on Call®, a national nurse triage line, may help reduce the surge in demand for health care during an influenza pandemic by triaging callers, providing advice about clinical care and information about the pandemic, and providing access to prescription antiviral medication. We developed a Call Volume Projection Tool to estimate national call volume to Flu on Call® during an influenza pandemic. The tool incorporates 2 influenza clinical attack rates (20% and 30%), 4 different levels of pandemic severity, and different initial "seed numbers" of cases (10 or 100), and it allows variation in which week the nurse triage line opens. The tool calculates call volume by using call-to-hospitalization ratios based on pandemic severity. We derived data on nurse triage line calls and call-to-hospitalization ratios from experience with the 2009 Minnesota FluLine nurse triage line. Assuming a 20% clinical attack rate and a case hospitalization rate of 0.8% to 1.5% (1968-like pandemic severity), we estimated the nationwide number of calls during the peak week of the pandemic to range from 1,551,882 to 3,523,902. Assuming a more severe 1957-like pandemic (case hospitalization rate = 1.5% to 3.0%), the national number of calls during the peak week of the pandemic ranged from 2,909,778 to 7,047,804. These results will aid in planning and developing nurse triage lines at both the national and state levels for use during a future influenza pandemic.

Exploring the Case for a Global Alliance for Medical Diagnostics Initiative.

In recent years, the private and public sectors have increased investments in medical diagnostics for low- and middle-income countries (LMICs). Despite these investments, numerous barriers prevent the adoption of existing diagnostics and discourage the development and introduction of new diagnostics in LMICs. In the late 1990s, the global vaccine community had similar challenges, as vaccine coverage rates stagnated and the introduction of new vaccines was viewed as a distraction to delivering existing vaccines. To address these challenges, the international community came together and formed the Global Alliance for Vaccines Initiative (GAVI). Sixteen years after the formation of GAVI, we see evidence of a healthier global vaccine landscape. We discuss how GAVI's four guiding principles (product, health systems strengthening, financing and market shaping) might apply to the advancement of medical diagnostics in LMICs. We present arguments for the international community and existing organizations to establish a Global Alliance for Medical Diagnostics Initiative (GAMDI).