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

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

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

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

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

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

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.

Adolescent, caregiver and provider perspectives on tuberculosis treatment adherence: a qualitative study from Lima, Peru.

OBJECTIVES: To understand the perspectives of adolescents (10-19 years old), their caregivers and healthcare providers regarding factors that impact adherence to tuberculosis (TB) treatment among adolescents. DESIGN: We conducted in-depth interviews using semistructured interview guides based on the World Health Organization (WHO)'s Five Dimensions of Adherence framework, which conceptualises adherence as being related to the health system, socioeconomic factors, patient, treatment and condition. We applied framework thematic analysis. SETTING: Between August 2018 and May 2019, at 32 public health centres operated by the Ministry of Health in Lima, Peru. PARTICIPANTS: We interviewed 34 adolescents who completed or were lost to follow-up from treatment for drug-susceptible pulmonary TB disease in the preceding 12 months; their primary caregiver during treatment; and 15 nurses or nurse technicians who had ≥6 months' experience supervising TB treatment. RESULTS: Participants reported numerous treatment barriers, the most common of which were the inconvenience of health facility-based directly observed therapy (DOT), long treatment duration, adverse treatment events and symptom resolution. The support of adult caregivers was critical for helping adolescents overcome these barriers and carry out the behavioural skills (eg, coping with the large pill burden, managing adverse treatment events and incorporating treatment into daily routines) needed to adhere to treatment. CONCLUSION: Our findings support a three-pronged approach to improve TB treatment adherence among adolescents: (1) reduce barriers to adherence (eg, home-based or community-based DOT in lieu of facility-based DOT, reducing pill burden and treatment duration when appropriate), (2) teach adolescents the behavioural skills required for treatment adherence and (3) strengthen caregivers' ability to support adolescents.

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.

Provider perspectives on service delivery modifications to maintain access to HIV pre-exposure prophylaxis during the COVID-19 pandemic: qualitative results from a PrEP implementation project in Kenya.

INTRODUCTION: HIV pre-exposure prophylaxis (PrEP) is an essential prevention strategy being scaled up for priority populations in Kenya, including for HIV serodiscordant couples. The COVID-19 pandemic posed challenges to PrEP rollout. We conducted a qualitative study of PrEP providers to understand how clinics adjusted PrEP delivery during the COVID-19 pandemic. METHODS: Since 2017, the Partners Scale-Up Project has integrated PrEP into 25 HIV clinics in Central and Western Kenya. We conducted qualitative interviews with 40 purposively sampled clinic personnel. We interviewed personnel once during the first pandemic wave (May-Aug 2020) and again after some decline in COVID-19 rates (Nov-Jan 2021). We analysed data using inductive memo-writing and summarized data by themes along the PrEP delivery cascade, guided by the Framework for Reporting Adaptation and Modifications (FRAME). RESULTS: We interviewed 27 clinical officers, five nurses, four health records and information officers, and four counsellors from Central (n = 20) and Western (n = 20) Kenya. About half (n = 19) were female, with a median age of 32 (IQR: 29-34) and 2.3 years of experience delivering PrEP (IQR: 2-3). All participants reported clinic changes in PrEP demand creation and service delivery during the pandemic. Modifications occurred during PrEP implementation and sustainment phases, were partly reactive to the pandemic and also facilitated by interim Ministry of Health guidance on PrEP delivery during COVID, and were made by PrEP delivery teams, clients and clinic managers. Commonly reported modifications included dispensing multiple-month PrEP refills, intensifying phone-based client engagement and collaborating with other HIV clinics to ensure that clients with prolonged stays in other regions could continue to access PrEP. Some clinics also adopted practices to streamline visits, such as within clinical-room PrEP dispensing, pre-packing PrEP and task-shifting. Most providers liked these changes and hoped they would continue after the pandemic subsides. CONCLUSIONS: COVID-19 served as a catalyst for PrEP delivery innovations in Kenya. HIV clinics successfully and rapidly adapted their PrEP demand creation, refill and retention strategies to promote PrEP uptake and effective use. These modified implementation strategies highlight opportunities to streamline the delivery of PrEP, as well as other HIV and chronic care services, and strengthen engagement with populations post-pandemic.

Advancing considerations of context in the evaluation and implementation of evidence-based biomedical HIV prevention interventions: a review of recent research.

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.

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

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

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.

Barriers and Expectations of Adolescents Regarding the Identification and Management of Their Psychoactive Substance Use by Their General Practitioner.

AIMS: General practitioners (GPs), who are the most frequently consulted health professionals by adolescents, play a key role in screening for psychoactive substance (PAS) use. The purpose of our study was to determine the barriers and expectations of adolescents regarding the identification and management of their PAS use by their general practitioner. METHODS: Descriptive, cross-sectional study of a population of adolescents aged 12 to 17 years, followed up in general practice in France. Adolescents were recruited from general practice offices by open-access questionnaires. An opaque box was provided to ensure the anonymity of the adolescents. RESULTS: A total of 277 adolescents were included: 155 girls, mean age 14.5 ± 1.7 years, 113 adolescents (41%) had used a PAS at least once in the past 12 months. Alcohol was the most used PAS, followed by tobacco and cannabis. Three groups were identified: the nonusers group (n = 134); the group of moderate users (n = 71); the group of users at risk of substance abuse or misusing (n = 38). Regardless of group, adolescents felt that their GP was attentive, responsive, competent, understanding, and took the time to ask the appropriate questions in their role. The at-risk group was less confident and less comfortable, and they felt more judged and more afraid of the GP telling their parents. Despite this, the at-risk group was the most willing to talk to their GP about their PAS. Almost half of the adolescents surveyed found it useful to use a questionnaire to discuss PAS. CONCLUSIONS: Reminding each consultation of the principles of the relationship of trust and confidentiality while maintaining an empathetic attitude would make it easier for GPs to remove adolescents' inhibitions about communicating about their PAS use.

Provider-client rapport in pre-exposure prophylaxis delivery: a qualitative analysis of provider and client experiences of an implementation science project in Kenya.

Daily oral pre-exposure prophylaxis (PrEP) is being incorporated into services frequented by adolescent girls and young women (AGYW) in sub-Saharan Africa who are at a significant risk of HIV. In non-PrEP studies, positive provider-client rapport has been shown to improve patient decision-making and use of medication in clinical care. We examined AGYW and healthcare provider (HCP) perspectives on the value of and strategies for building positive provider-client rapport. We conducted in-depth interviews from January 2018 to December 2019 with 38 AGYW and 15 HCPs from two family planning clinics in Kisumu, Kenya where PrEP was being delivered to AGYW as part of the Prevention Options for Women Evaluation Research (POWER) study. We used semi-structured interview guides and audio-recorded interviews with participant consent. Verbatim transcripts were analysed using thematic content analysis. HCPs and AGYW emphasised the importance of positive provider-client rapport to meet AGYW support needs in PrEP service delivery. HCPs described how they employed rapport-building strategies that strengthened AGYW PrEP uptake and continuation, including: (1) using friendly and non-judgmental tones; (2) maintaining client confidentiality (to build client trust); (3) adopting a conversational approach (to enable accurate risk assessment); (4) actively listening and tailoring counselling (to promote client knowledge, skills, and self-efficacy); and (5) supporting client agency. Positive provider-client relationships and negative experiences identified in this analysis have the potential to facilitate/deter AGYW from using PrEP while at risk. The strategies to enhance provider-client rapport identified in this study could be integrated into PrEP provider training and delivery practices.

Impact of prolonged isolation on adolescents with drug-susceptible tuberculosis in Lima, Peru: a qualitative study.

OBJECTIVES: Patients with tuberculosis (TB) generally are instructed to isolate at the beginning of treatment in order to prevent disease transmission. The duration of isolation varies and may be prolonged (ie, lasting 1 month or more). Few studies have examined the impact of isolation during TB treatment on adolescents, who may be more vulnerable to its negative effects. METHODS: This study took place from 2018 through 2019 in Lima, Peru, where the Ministry of Health mandates the exclusion of patients with TB from educational institutions for at least 2 months. Using semi-structured guides, we conducted individual in-depth interviews with adolescents who received treatment for drug-susceptible TB, their primary caregivers and health providers. We performed thematic analysis of the transcribed interviews. RESULTS: We interviewed 85 participants: 34 adolescents, 36 caregivers and 15 healthcare workers. At the time of their TB diagnoses, 28 adolescents were in secondary, postsecondary, vocational or military school. Adolescents with drug-susceptible TB were prescribed home isolation usually for 2 (and occasionally for 1) months. Consequently, they could neither attend school nor socialise with family members or friends. Two primary themes emerged from the interviews. First, as a result of their exclusion from school, most adolescents fell behind academically and had to repeat a semester or academic year. Second, absence from school, separation from friends and loved ones, and reinforcement of TB-related stigma (arising from fear of TB transmission) harmed adolescents' mental health. CONCLUSION: Prolonged isolation led to educational setbacks and emotional trauma among adolescents with TB. Prolonged isolation is not supported by current evidence on TB transmission and is problematic from a human rights perspective, as it violates adolescents' rights to education and freedom of movement. Isolation recommendations should be re-evaluated to align with data on TB transmission and the principles of patient-centred care.

Patient and Clinician Perceptions of Factors Relevant to Ideal Specialty Consultations.

Importance: Inpatient subspecialty consultations, a common and expensive practice within inpatient medicine, do not always go well; however, little is known about the failure modes of consultation, thus making it difficult to identify interventions to improve consultation quality. Objective: To understand how stakeholders envision the ideal inpatient consultation and identify how and why consultations commonly fall short of this ideal. Design, Setting, and Participants: This qualitative study used in-depth, semistructured interviews collected from April to October 2017 and analyzed from January 2018 to February 2020 using conventional content analysis. The setting was a single academic medical center in Boston, Massachusetts. Participants were hospitalists and specialists who had requested or performed a consultation for a non-intensive care unit patient in the previous 4 months, patients who had received a consultation while hospitalized at the medical center in the previous 15 months, and family members of such patients. Main Outcomes and Measures: Consultation experiences reported by participants. Clinicians were asked about characteristics of the ideal consultation, positive and negative consultation experiences, costs and benefits, and suggested improvements. Patients and family members were asked about their consultation experience, changes in care, communication preferences, and suggested improvements. Results: The study included 38 participants: 17 specialists, 13 hospitalists, 4 patients, and 4 family members. More than half (21 of 38) of the participants were female. There were 11 key information exchanges identified that occur among the specialist team, primary team, and patient/family during an ideal consultation. These exchanges are time sensitive and primarily carried out through unwritten protocols. We also identified 6 defects (process failures) that commonly derail information exchanges (complete omission, exclusion of a key stakeholder, poor timing, incomplete or inaccurate information, and misinterpretation) and 5 contextual factors (roles and boundaries, professionalism, team hierarchy, availability, and operational know-how) that influence how information exchange unfolds, making some consultations more prone to defects. Conclusions and Relevance: Successful inpatient consultation requires a complicated, sequenced series of time-sensitive information exchanges that are highly vulnerable to failure. Maximizing the benefit of consultations will likely entail not only minimizing low-value consultations but also actively preventing defects, such as information inaccuracies and misinterpretation, that commonly derail the consultation process.

Understanding how social support influences peer-delivered HIV prevention interventions among Ugandan female sex workers: a case study from HIV self-testing.

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.

Implementation strategies for integrating pre-exposure prophylaxis for HIV prevention and family planning services for adolescent girls and young women in Kenya: a qualitative study.

INTRODUCTION: Across sub-Saharan Africa, ministries of health have proposed integrating pre-exposure prophylaxis (PrEP) for HIV prevention into family planning (FP) services to reach adolescent girls and young women (AGYW); however, evidence on effective implementation strategies is still limited. We conducted a qualitative study of integrated PrEP-FP service implementation at two FP clinics in Kisumu, Kenya. METHODS: From June 2017 to May 2020, the Prevention Options for Women Evaluation Research (POWER) study enrolled 1000 sexually active, HIV-negative AGYW age 16 to 25. Actions taken to implement PrEP were captured prospectively in 214 monitoring and evaluation documents and 15 interviews with PrEP implementers. We analysed data using conventional and directed content analysis, with the latter informed by the Consolidated Framework for Implementation Research (CFIR) and the Expert Recommendations for Implementing Change (ERIC) compilation. RESULTS: POWER deployed a variety of implementation strategies to train and educate stakeholders (e.g., having new providers shadow PrEP providers); develop stakeholder interrelationships (e.g., organizing support teams with protected time to reflect on implementation progress and make refinements); provide technical assistance; and change physical infrastructure and workflow. Although these strategies reportedly influenced contextual factors across four of the five CFIR domains, they primarily interacted with contextual factors relevant to inner setting, especially implementation climate and readiness for implementation. Overall, implementing PrEP proved easier and less labor-intensive at a private, youth-friendly clinic than a public FP clinic, largely because the baseline structural characteristics (e.g., space, workflow) and organizational mission of the former were more conducive to offering AGYW-centered care. Nevertheless, adoption of PrEP delivery among non-study staff at both sites was low, likely due to the widespread perception that PrEP was not within their scope of work. CONCLUSIONS: Some FP clinics may be "lower-hanging fruit" than others for PrEP implementation. Approaching PrEP implementation as a behavioral intervention for FP providers may help ensure that providers have the requisite capability, opportunity, and motivation to adopt the clinical innovation. In particular, PrEP implementers should assess the need for implementation strategies that support providers' clinical decision-making, establish worker expectations and accountability, and address workload constraints. TRIAL REGISTRATION: Clinical Trial Number: NCT03490058 .

A one-stop shop model for improved efficiency of pre-exposure prophylaxis delivery in public clinics in western Kenya: a mixed methods implementation science study.

INTRODUCTION: In public clinics in Kenya, separate, sequential delivery of the component services of pre-exposure prophylaxis (PrEP) (e.g. HIV testing, counselling, and dispensing) creates long wait times that hinder clients' ability and desire to access and continue PrEP. We conducted a mixed methods study in four public clinics in western Kenya to identify strategies for operationalizing a one-stop shop (OSS) model and evaluate whether this model could improve client wait time and care acceptability among clients and providers without negatively impacting uptake or continuation. METHODS: From January 2020 through November 2020, we collected and analysed 47 time-and-motion observations using Mann-Whitney U tests, 29 provider and client interviews, 68 technical assistance reports, and clinic flow maps from intervention clinics. We used controlled interrupted time series (cITS) to compare trends in PrEP initiation and on-time returns from a 12-month pre-intervention period (January-December 2019) to an 8-month post-period (January-November 2020, excluding a 3-month COVID-19 wash-out period) at intervention and control clinics. RESULTS: From the pre- to post-period, median client wait time at intervention clinics dropped significantly from 31 to 6 minutes (p = 0.02), while median provider contact time remained around 23 minutes (p = 0.4). Intervention clinics achieved efficiency gains by moving PrEP delivery to lower volume departments, moving steps closer together (e.g. relocating supplies; cross-training and task-shifting), and differentiating clients based on the subset of services needed. Clients and providers found the OSS model highly acceptable and additionally identified increased privacy, reduced stigma, and higher quality client-provider interactions as benefits of the model. From the pre- to post-period, average monthly initiations at intervention and control clinics increased by 6 and 2.3, respectively, and percent of expected follow-up visits occurring on time decreased by 18% and 26%, respectively; cITS analysis of PrEP initiations (n = 1227) and follow-up visits (n = 2696) revealed no significant difference between intervention and control clinics in terms of trends in PrEP initiation and on-time returns (all p>0.05). CONCLUSIONS: An OSS model significantly improved client wait time and care acceptability without negatively impacting initiations or continuations, thus highlighting opportunities to improve the efficiency of PrEP delivery efficiency and client-centredness.

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

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

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

Health Care Providers as Agents of Change: Integrating PrEP With Other Sexual and Reproductive Health Services for Adolescent Girls and Young Women.

Background: Successful integration of pre-exposure prophylaxis (PrEP) with existing reproductive health services will require iterative learning and adaptation. The interaction between the problem-solving required to implement new interventions and health worker motivation has been well-described in the public health literature. This study describes structural and motivational challenges faced by health care providers delivering PrEP to adolescent girls and young women (AGYW) alongside other SRH services, and the strategies used to overcome them. Methods: We conducted in-depth interviews (IDIs) and focus group discussions (FGDs) with HCWs from two demonstration projects delivering PrEP to AGYW alongside other SRH services. The Prevention Options for the Women Evaluation Research (POWER) is an open label PrEP study with a focus on learning about PrEP delivery in Kenyan and South African family planning, youth mobile services, and public clinics at six facilities. PrIYA focused on PrEP delivery to AGYW via maternal and child health (MCH) and family planning (FP) clinics in Kenya across 37 facilities. IDIs and FGDs were transcribed verbatim and analyzed using a combination of inductive and deductive methods. Results: We conducted IDIs with 36 participants and 8 FGDs with 50 participants. HCW described a dynamic process of operationalizing PrEP delivery to better respond to patient needs, including modifying patient flow, pill packaging, and counseling. HCWs believed the biggest challenge to sustained integration and scaling of PrEP for AGYW would be lack of health care worker motivation, primarily due to a misalignment of personal and professional values and expectations. HCWs frequently described concerns of PrEP provision being seen as condoning or promoting unprotected sex among young unmarried, sexually active women. Persuasive techniques used to overcome these reservations included emphasizing the social realities of HIV risk, health care worker professional identities, and vocational commitments to keeping young women healthy. Conclusion: Sustained scale-up of PrEP will require HCWs to value and prioritize its incorporation into daily practice. As with the provision of other SRH services, HCWs may have moral reservations about providing PrEP to AGYW. Strategies that strengthen alignment of HCW personal values with professional goals will be important for strengthening motivation to overcome delivery challenges.

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

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