Does type of antiretroviral therapy pick-up point influence 12-month virologic suppression in South Africa?

We assessed the impact of community- versus clinic-based medication pick-up on rates of virologic suppression in an observational cohort of adults on ART enrolled in a decentralized antiretroviral therapy program (CCMDD) in South Africa. Participants either attended clinics where they were given the choice to pick up ART in community venues or traditional clinics, or clinics where this pathway was assigned. Among 1856 participants, 977 (53%) opted for community ART pick-up at enrollment, and 1201 (86%) were virologically suppressed at one year. Because of missing data on virologic suppression, primary results are based on a model incorporating multiple imputation. In addition to age and gender, distance from clinic and year of HIV diagnosis were included in the multivariable model. There was no difference in opting for clinic- vs. community-based pick-up with regard to achieving 12-month virologic suppression (aRR 1.02, 95% CI 0.98-1.05) in clinics offering choice. There was no impact of assigning all participants to an external pick-up point (aRR 1.00, 95% CI 0.95-1.06), but virologic suppression was reduced in the clinic that assigned participants to clinic pick-up (aRR 0.87, 95% CI 0.81-0.92). These results suggest that provision of community-based ART has not reduced continued virologic suppression in the population enrolled in the CCMDD program.

Is the Differentiated Service Delivery Model Suited to the Needs of People Living with HIV in Rwanda?

The primary goal of antiretroviral treatment is to improve the health of individuals with HIV, and a secondary goal is to prevent further transmission. In 2016, Rwanda adopted the World Health Organization's "treat-all" approach in combination with the differentiated service delivery (DSD) model. The model's goal was to shorten the time from HIV diagnosis to treatment initiation, regardless of the CD4 T-cell count. This study sought to identify perceptions, enablers, and challenges associated with DSD model adoption among PLHIV.This study included selected health centers in Kigali city, Rwanda, between August and September 2022. The patients included were those exposed to the new HIV care model (DSD) model and those exposed to the previous model who transitioned to the current model. Interviews and focus group discussions were also held to obtain views and opinions on the DSD model. The data were collected via questionnaires and audio-recorded focus group discussions and were subsequently analyzed.The study identified several themes, including participants' initial emotions about a new HIV diagnosis, disclosure, experiences with transitioning to the DSD model, the effect of peer education, and barriers to and facilitators of the DSD model. Participants appreciated reduced clinic visits under the DSD model but faced transition and peer educator mobility challenges.The DSD model reduces waiting times, educates patients, and aligns with national goals. Identified barriers call for training and improved peer educator retention. Recommendations include enhancing the DSD model and future research to evaluate its long-term impact and cost-effectiveness.

Reducing time to differentiated service delivery for newly-diagnosed people living with HIV in Kigali, Rwanda: a pilot, unblinded, randomized controlled trial.

BACKGROUND: Differentiated service delivery (DSD) programs for people living with HIV (PWH) limit eligibility to patients established on antiretroviral therapy (ART), yet uncertainty exists regarding the duration on ART necessary for newly-diagnosed PWH to be considered established. We aimed to determine the feasibility, acceptability, and preliminary impact of entry into DSD at six months after ART initiation for newly-diagnosed PWH. METHODS: We conducted a pilot randomized controlled trial in three health facilities in Rwanda. Participants were randomized to: (1) entry into DSD at six months after ART initiation after one suppressed viral load (DSD-1VL); (2) entry into DSD at six months after ART initiation after two consecutive suppressed viral loads (DSD-2VL); (3) treatment as usual (TAU). We examined feasibility by examining the proportion of participants assigned to intervention arms who entered DSD, assessed acceptability through patient surveys and by examining instances when clinical staff overrode the study assignment, and evaluated preliminary effectiveness by comparing study arms with respect to 12-month viral suppression. RESULTS: Among 90 participants, 31 were randomized to DSD-1VL, 31 to DSD-2VL, and 28 to TAU. Among 62 participants randomized to DSD-1VL or DSD-2VL, 37 (60%) entered DSD at 6 months while 21 (34%) did not enter DSD because they were not virally suppressed. Patient-level acceptability was high for both clinical (mean score: 3.8 out of 5) and non-clinical (mean score: 4.1) elements of care and did not differ significantly across study arms. Viral suppression at 12 months was 81%, 81% and 68% in DSD-1VL, DSD-2VL, and TAU, respectively (p = 0.41). CONCLUSIONS: The majority of participants randomized to intervention arms entered DSD and had similar rates of viral suppression compared to TAU. Results suggest that early DSD at six months after ART initiation is feasible for newly-diagnosed PWH, and support current WHO guidelines on DSD. TRIAL REGISTRATION: Clinicaltrials.gov NCT04567693; first registered on September 28, 2020.

Cost-Effectiveness and Budget Impact Analysis of the Implementation of Differentiated Service Delivery Models for HIV Treatment in Mozambique: a Modelling Study.

INTRODUCTION: In 2018, the Mozambique Ministry of Health launched guidelines for implementing differentiated service delivery models (DSDMs) to optimize HIV service delivery, improve retention in care, and ultimately reduce HIV-associated mortality. The models were fast-track, 3-month antiretrovirals dispensing, community antiretroviral therapy groups, adherence clubs, family approach and three one-stop shop models: adolescent-friendly health services, maternal and child health, and tuberculosis. We conducted a cost-effectiveness analysis and budget impact analysis to compare these models to conventional services. METHODS: We constructed a decision tree model based on the percentage of enrolment in each model and the probability of the outcome (12-month retention in treatment) for each year of the study period-three for the cost-effectiveness analysis (2019-2021) and three for the budget impact analysis (2022-2024). Costs for these analyses were primarily estimated per client-year from the health system perspective. A secondary cost-effectiveness analysis was conducted from the societal perspective. Budget impact analysis costs included antiretrovirals, laboratory tests and service provision interactions. Cost-effectiveness analysis additionally included start-up, training and clients' opportunity costs. Effectiveness was estimated using an uncontrolled interrupted time series analysis comparing the outcome before and after the implementation of the differentiated models. A one-way sensitivity analysis was conducted to identify drivers of uncertainty. RESULTS: After implementation of the DSDMs, there was a mean increase of 14.9 percentage points (95% CI: 12.2, 17.8) in 12-month retention, from 47.6% (95% CI, 44.9-50.2) to 62.5% (95% CI, 60.9-64.1). The mean cost difference comparing DSDMs and conventional care was US$ -6 million (173,391,277 vs. 179,461,668) and -32.5 million (394,705,618 vs. 433,232,289) from the health system and the societal perspective, respectively. Therefore, DSDMs dominated conventional care. Results were most sensitive to conventional care interaction costs in the one-way sensitivity analysis. For a population of 1.5 million, the base-case 3-year financial costs associated with the DSDMs was US$550 million, compared with US$564 million for conventional care. CONCLUSIONS: DSDMs were less expensive and more effective in retaining clients 12 months after antiretroviral therapy initiation and were estimated to save approximately US$14 million for the health system from 2022 to 2024.

Cost-effectiveness of differentiated care models that incorporate economic strengthening for HIV antiretroviral therapy adherence: a systematic review.

BACKGROUND: There is some evidence that differentiated service delivery (DSD) models, which use a client-centered approach to simplify and increase access to care, improve clinical outcomes among people living with HIV (PLHIV) in high HIV prevalence countries. Integrating economic strengthening tools (e.g., microcredit, cash transfers, food assistance) within DSD models can help address the poverty-related barriers to HIV antiretroviral therapy (ART). Yet there is minimal evidence of the cost-effectiveness of these types of multilevel care delivery models, which potentially prohibits their wider implementation. METHODS: Using a qualitative systematic review, this article synthesizes the literature surrounding the cost-effectiveness of differentiated service delivery models that employ economic strengthening initiatives to improve HIV treatment adherence in low- and middle-income countries. We searched three academic databases for randomized controlled trials and observational studies published from January 2000 through March 2024 in Sub-Saharan Africa. The quality of each study was scored using a validated appraisal system. RESULTS: Eighty-nine full texts were reviewed and 3 met all eligibility criteria. Two of the three included articles were specific to adolescents living with HIV. Economic strengthening opportunities varied by care model, and included developmental savings accounts, microenterprise workshops, and cash and non-cash conditional incentives. The main drivers of programmatic and per-patient costs were ART medications, CD4 cell count testing, and economic strengthening activities. CONCLUSION: All economic evaluations in this review found that including economic strengthening as part of comprehensive differentiated service delivery was cost-effective at a willingness to pay threshold of at least 2 times the national per capita gross domestic product. Two of the three studies in this review focused on adolescents, suggesting that these types of care models may be especially cost-effective for youth entering adulthood. All studies were from the provider perspective, indicating that additional evidence is needed to inform the potential cost-savings of DSD and economic strengthening interventions to patients and society. Randomized trials testing the effectiveness of DSD models that integrate economic strengthening should place greater emphasis on costing these types of programs to inform the potential for bringing these types of multilevel interventions to scale.

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].

Human and financial resource needs for universal access to WHO-PEN interventions for diabetes and hypertension care in Eswatini: results from a time-and-motion and bottom-up costing study.

BACKGROUND: Eswatini faces persistent challenges in providing care for diabetes and hypertension, exacerbated by a shortage of healthcare workers. The implementation of WHO-PEN interventions aimed to address these issues, yet their effects on healthcare worker time requirements and associated costs remain unclear. METHODS: This study employed a time-and-motion analysis and a bottom-up cost assessment to quantify the human and financial resources required for scaling up WHO-PEN interventions nationally in Eswatini for all estimated diabetic and hypertensive patients. RESULTS: Findings reveal that healthcare workers in intervention-arm clinics reported longer workday durations compared to those in control-arm clinics, yet spent less time per patient while seeing more patients. The implementation of WHO-PEN interventions increased the workload on healthcare workers but also led to a notable increase in patient care utilization. Furthermore, a morning peak in patient visits was identified, suggesting potential opportunities for optimizing patient flow. Notably, scaling up care provision nationally with WHO-PEN interventions proved to be more cost saving than expanding standard-of-care treatment. CONCLUSION: WHO-PEN interventions hold promise in improving access to diabetes and hypertension care in Eswatini while offering an efficient solution. However, addressing challenges in healthcare workforce creation and retention is crucial for sustained effectiveness. Policy makers must consider all aspects of the WHO-PEN intervention for informed decision-making. Trial registration US Clinical Trials Registry. NCT04183413. Trial registration date: December 3, 2019. https://ichgcp.net/clinical-trials-registry/NCT04183413.

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.

Satisfaction with service delivery among HIV treatment clients enrolled in differentiated and conventional models of care in South Africa: a baseline survey.

INTRODUCTION: Differentiated service delivery (DSD) models aim to increase the responsiveness of HIV treatment programmes to the individual needs of antiretroviral therapy (ART) clients to improve treatment outcomes and quality of life. Little is known about how DSD client experiences differ from conventional care. METHODS: From May to November 2021, we interviewed adult (≥18) ART clients at 21 primary clinics in four districts of South Africa. Participants were enrolled consecutively at routine visits and stratified into four groups: conventional care-not eligible for DSD (conventional-not-eligible); conventional care eligible for but not enrolled in DSD (conventional-not-enrolled); facility pickup point DSD model; and external pickup point DSD model. Satisfaction was assessed using questions with 5-point Likert-scale responses. Mean scores were categorized as not satisfied (score ≤3) or satisfied (>3). We used logistic regression to assess differences and report crude and adjusted odds ratios (aORs). Qualitative themes were identified through content analysis. RESULTS: Eight hundred and sixty-seven participants (70% female, median age 39) were surveyed: 24% facility pick-up points; 27% external pick-up points; 25% conventional-not-eligible; and 24% conventional-not-enrolled. Seventy-four percent of all study participants expressed satisfaction with their HIV care. Those enrolled in DSD models were more likely to be satisfied, with an aOR of 6.24 (95% CI [3.18-12.24]) for external pick-up point versus conventional-not-eligible and an aOR of 3.30 (1.95-5.58) for facility pick-up point versus conventional-not-eligible. Conventional-not-enrolled clients were slightly but not significantly more satisfied than conventional-not-eligible clients (1.29, 0.85-1.96). Those seeking outside healthcare (crude OR 0.57, 0.41-0.81) or reporting more annual clinic visits (0.52, 0.29-0.93) were less likely to be satisfied. Conventional care participants reporting satisfaction with their current model of care perceived providers as helpful, respectful, and friendly and were satisfied with care despite long queues. DSD model participants emphasized ease and convenience, particularly not having to queue. CONCLUSIONS: Most adult ART clients in South Africa were satisfied with their care, but those enrolled in DSD models expressed slightly greater satisfaction than those remaining in conventional care. Efforts should focus on enrolling more eligible patients into DSD models, expanding eligibility criteria to cover a wider client base, and further improving the models' desirable characteristics.

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.

People living with HIV's perspectives of acceptability of fee for home delivery of ART: a qualitative study.

INTRODUCTION: Significant progress has been made in the HIV response in South Africa; however, gaps remain in ensuring engagement in care to support life-long medication adherence and viral suppression. The National Department of Health (NDoH) has introduced community-based and clinic-based HIV differentiated service delivery (DSD) models to tackle suboptimal adherence and retention in care. Nevertheless, differentiated care models require adaptation to better serve clients who struggle with adherence. There is limited research on the acceptability of fee for home delivery of ART in resource-constrained settings. The current study investigates the acceptability of fee for home delivery of ART among people living with HIV in South Africa. METHODS: Two mixed-gender focus group discussions (FGDs) took place between June and November 2019, consisting of 10 participants in each group. A purposive sampling strategy was employed to identify and select 10 people living with HIV who were ART-eligible but not in care, and 10 people living with HIV who were currently taking ART and in care. Participants were grouped according to their treatment status. A coding framework, informed by a priori categories and derived from topics in the interview guide, was developed and utilized to facilitate analysis. RESULTS: Participants expressed enthusiasm for having ART home-delivered, as it would save the time spent waiting in long queues at the clinic. However, some participants raised concerns about potential payment difficulties due to high unemployment rates in the community. Some participants believed this would be acceptable, as patients already incur costs for travel and food when visiting the clinic. Participants in both FGDs expressed strong concerns about home delivery of their ART based on fear of accidental disclosure, especially for those who have not disclosed to their immediate families and partners. CONCLUSION: Our study suggests that charging a fee for home delivery is an acceptable and innovative approach to supporting PLHIV in maintaining adherence to their medication and remaining in care.

HIV Pre-exposure Prophylaxis (PrEP) Care in Belgium: A mixed-methods Study on PrEP Users' Experiences and Service Delivery Preferences.

In Belgium, HIV pre-exposure prophylaxis (PrEP) services are mainly provided through specialised HIV clinics. To optimise PrEP uptake and retention in care, we require insights into users' perspectives on PrEP care. We aimed to elicit experiences with, and preferences for, PrEP service delivery among PrEP users in Belgium, including willingness to involve their family physician (FP) in PrEP care. We adopted a sequential mixed-methods design. We used a web-based longitudinal study among 326 PrEP users that consisted of two questionnaires at six-month intervals, and complemented this with 21 semi-structured interviews (September 2020-January 2022). We conducted descriptive analyses and logistic regression to examine factors associated with willingness to involve their FP in PrEP care. Interviews were analysed using thematic analysis. Survey respondents reported high satisfaction with care received in HIV clinics [median score 9 (IQR 8-10), 10='very satisfied']. Interviews revealed the importance of regular HIV/STI screening, and the expertise and stigma-free environment of HIV clinics. Yet, they also contextualised service delivery barriers reported in the questionnaire, including the burden of cost and challenges integrating PrEP visits into their private and professional lives. Although 63.8% (n = 208/326) of baseline respondents preferred attending an HIV clinic for PrEP follow-up, 51.9% (n = 108/208) of participants in the follow-up questionnaire reported to be willing to have their FP involved in PrEP care. Participants reporting trust in FPs' PrEP and sexual health expertise, or who didn't feel judged by their FP, were more likely to be willing to involve them in PrEP care. Therefore, we recommend a differentiated PrEP service delivery approach, including involving FPs, to make PrEP care more client-centred.

A Systematic Review of HIV Pre-exposure Prophylaxis (PrEP) Implementation in U.S. Emergency Departments: Patient Screening, Prescribing, and Linkage to Care.

In the pursuit of ending the HIV epidemic, U.S. emergency departments (EDs) have emerged as a valuable setting to increase HIV testing and linkage to care. There is limited data available, however, describing the incorporation of HIV prevention initiatives in U.S. EDs. Over the last decade, HIV pre-exposure prophylaxis (PrEP) has significantly changed the HIV prevention landscape globally and very little is known about the provision of PrEP in U.S. EDs. To address this gap in the literature, we conducted a systematic review of peer-reviewed quantitative studies and conference abstracts spanning July 2012 - October 2022. Of 433 citations, 11 articles and 13 abstracts meet our inclusion criteria, representing 18 unique studies addressing PrEP screening, prescribing, and/or linkage to PrEP care.Most studies describe screening processes to identify PrEP-eligible patients (n = 17); most studies leveraged a patient's STI history as initial PrEP eligibility screening criteria. Fewer studies describe PrEP prescribing (n = 2) and/or linkage to PrEP care (n = 8).Findings from this systematic review highlight the potential for U.S. EDs to increase PrEP uptake among individuals at risk for HIV infection. Despite a growing number of studies exploring processes for incorporating PrEP into the ED setting, such studies are small-scale and time limited. Models providing prescribing PrEP in the ED show higher initiation rates than post-discharge engagement models. Electronic health record (EHR)-based HIV screening is valuable, but post-ED linkage rates are low. Our findings emphasize the need to establish best practices for initiating and supporting prevention effective PrEP use in the ED setting.

Effects of Multi-Month Dispensing on Clinical Outcomes: Retrospective Cohort Analysis Conducted in Kenya.

Multi-month dispensing (MMD) has been widely adopted by national HIV programs as a key strategy for improving the quality of HIV care and treatment services while meeting the unique needs of diverse client populations. We assessed the clinical outcomes of clients receiving MMD in Kenya by conducting a retrospective cohort study using routine programmatic data in 32 government health facilities in Kenya. We included clients who were eligible for multi-month antiretroviral therapy (ART) dispensing for ≥ 3 months (≥ 3MMD) according to national guidelines. The primary exposure was enrollment into ≥ 3MMD. The outcomes were lost to follow-up (LTFU) and viral rebound. Multilevel modified-Poisson regression models with robust standard errors were used to compare clinical outcomes between clients enrolled in ≥ 3MMD and those receiving ART dispensing for less than 3 months (< 3MMD). A total of 3,501 clients eligible for ≥ 3MMD were included in the analysis, of whom 65% were enrolled in ≥ 3MMD at entry into the cohort. There was no difference in LTFU of ≥ 180 days between the two types of care (aRR 1.1, 95% CI 0.7-1.6), while ≥ 3MMD was protective for viral rebound (aRR 0.1 95% CI 0.0-0.2). As more diverse client-focused service delivery models are being implemented, robust evaluations are essential to guide the implementation, monitor progress, and assess acceptability and effectiveness to deliver optimal people-centered care.

Pathways to care with HIV-associated cryptococcal meningitis in Botswana and Uganda: Findings from a qualitative methods study.

HIV-associated cryptococcal meningitis remains a key driver of AIDS-related mortality. Mortality is twice as high in those who present later to care and with severe symptoms such as confusion. We embedded a qualitative methods study within a randomised controlled trial in Gaborone, Botswana and Kampala, Uganda with the aim of understanding pathways to care. We conducted in-depth interviews with trial participants and surrogate decision makers and analysed data thematically. Between January 2020 and June 2021 we interviewed 58 individuals. Pathways to care were prolonged because headaches were disregarded by participants and healthcare workers as a common occurrence with a broad differential diagnosis of predominantly benign aetiologies. There was also a lack of awareness of cryptococcal meningitis, and it was often after HIV was diagnosed or disclosed that the pathway accelerated, resulting in hospital admission. We outline key recommendations to reduce mortality and argue for the integration of social and behavioural interventions within differentiated service delivery models for advanced HIV disease.

Effect of Multi-Month Dispensing on Viral Suppression for Newly Enrolled Adolescents and Adults in Northern Nigeria.

Purpose: We evaluated the effect of multi-month dispensing (MMD) on viral suppression among newly enrolled adolescents and adults with HIV in 11 northern Nigerian states. Patients and Methods: We conducted a retrospective analysis of longitudinal data from 75 health facilities. We abstracted electronic medical records for patients ≥10 years, initiated on ART April 1, 2019 - June 30, 2021, and with a 6- or 12-month viral load (VL) result. We categorized participants in the MMD group to see if they received antiretroviral treatment (ART) for ≥84 days at any visit within 6 months of ART initiation. We consider cut-offs for viral suppression at 50 copies/mL. The period when the VL was performed was classified as pre-COVID-19 (before April 1, 2020) or during the COVID-19 pandemic. We estimated relative risks (RR) by comparing the unsuppressed proportion of those on MMD to those not on MMD, adjusted for age, gender, and COVID-19 period. Results: Overall, 19,859 participant records were abstracted. Median age was 33 years, 64% were female, 91% were started on a dolutegravir (DTG)-based regimen, and 65% were on MMD. Overall, 15,259 (77%) participants were followed for ≥6 months, 4136 (27%) had a VL at 6 months and 3640 (24%) had a VL at 12 months after ART initiation. A slightly higher proportion of patients on MMD had undetectable VL levels at 6 months (65% vs 58%) and 12 months (66% vs 62%). In the adjusted analysis, we found no significant differences in undetectable VL at 6 months and 12 months between newly enrolled patients on MMD and those not on MMD. Those on Protease inhibitor-based regimen had 54% lower likelihood of undetectable VL compared to those on DTG-based regimen. Conclusion: MMD does not result in poorer viral suppression among newly enrolled patients.

Implementing Differentiated and Integrated HIV Prevention Services for Adolescent Girls and Young Women: Experiences From Oral PrEP Rollout in Primary Care Services in South Africa.

PURPOSE: In South Africa, adolescent girls and young women (AGYW, aged 15-24 years) are disproportionately affected by human immunodeficiency viruses (HIV). Oral pre-exposure prophylaxis (PrEP) has been available in South Africa since 2016; however, there is limited evidence on oral PrEP implementation and integration in real-world settings, particularly among AGYW. Project PrEP is an implementation science project that sought to inform the introduction and integration of oral PrEP as part of combination HIV prevention and sexual and reproductive health services (SRH) in South Africa. The project focused on AGYW, as a priority population in need of HIV prevention. This paper presents strategies Project PrEP employed to increase oral PrEP and SRH service access and utilization. METHODS: We present strategies employed to increase oral PrEP and SRH services uptake. Using routine monitoring data, facility assessments, stakeholder engagement, training and progress reports, and observations, we share implementation lessons learned and describe how strategies can be adapted by HIV prevention programs in different contexts. RESULTS: Approximately 22, 000 people initiated on oral PrEP (December 2018-December 2021) across eight facilities and four mobile clinics. Two-thirds (67%) of initiated clients were AGYW. DISCUSSION: Lessons are to be learned from the introduction of oral PrEP as implementers prepare for the introduction of new PrEP methods. Stakeholders must be continuously engaged to ensure buy-in, and social mobilization and demand creation should be contextual, focused, and innovative. Continuous staff training is needed to reinforce knowledge, and AGYW service delivery models must be local context relevant.

A Community-Based, Mobile Electronic Medical Record System App for High-Quality, Integrated Antiretroviral Therapy in Lilongwe, Malawi: Design Process and Pilot Implementation.

BACKGROUND: Differentiated service delivery (DSD) increases antiretroviral therapy (ART) access in sub-Saharan Africa by moving clients out of congested ART clinics to communities for care. However, DSD settings challenge provider adherence to complex, chronic care treatment guidelines and have burdensome systems for client monitoring and evaluation (M&E), reducing data for decision-making. Electronic medical record systems (EMRS) improve client outcomes and reduce M&E workload. Traditional EMRS cannot operate in most DSD settings with unreliable power and poor connectivity. OBJECTIVE: This study aims to detail the human-centered design (HCD) process of developing a mobile EMRS for community-based DSD services in Lilongwe, Malawi. METHODS: Lighthouse Trust (LT) operates 2 Ministry of Health (MoH) clinics in Lilongwe, Malawi, with a combined total of >35,000 ART clients. LT's real-time, point-of-care EMRS collects complex client M&E data and provides decision-making support, ensuring adherence to integrated HIV and tuberculosis guidelines that optimize client and program outcomes. LT's EMRS scaled to all large MoH ART clinics. LT also implements a nurse-led community-based ART program (NCAP), a DSD model to provide ART and rapid assessment for 2400 stable LT clients in the community. LT, alongside collaborators, from the University of Washington's International Training and Education Center for Health and technology partner, Medic, used the open-source Community Health Toolkit (CHT) and HCD to develop an open-source, offline-first, mobile EMRS-like app, "community-based ART retention and suppression" (CARES). CARES aims to bring EMRS-like provider benefits to NCAP's DSD clients. RESULTS: CARES design took approximately 12 months and used an iterative process of highly participatory feedback sessions with provider, data manager, and M&E team inputs to ensure CARES optimization for the NCAP and LT settings. The CARES mobile EMRS prototype supports NCAP providers with embedded prompts and alerts to ensure adherence to integrated MoH ART guidelines, aiming to improve the quality of client care. CARES facilitates improved data quality and flow for NCAP M&E, aiming to reduce data gaps between community and clinic settings. The CARES pilot demonstrates the potential of a mobile, point-of-care EMRS-like app that could benefit NCAP clients, providers, and program teams with integrated client care and complete M&E data for decision-making. CARES challenges include app speed, search features to align longitudinal records, and CARES to EMRS integration that supports timely care alerts. CONCLUSIONS: Leveraging the CHT and HCD processes facilitated the design of a locally specified and optimized mobile app with the promise to bring EMRS-like benefits to DSD settings. Moving from the CARES prototype to routine NCAP implementation should result in improved client care and strengthened M&E while reducing workload. Our transparent and descriptive process shares the progress and pitfalls of the CARES design and development, helping others in this digital innovation area to learn from our experiences at this stage.

Perceptions and factors associated with the uptake of the community client-led antiretroviral therapy delivery model (CCLAD) at a large urban clinic in Uganda: a mixed methods study.

INTRODUCTION: Community Client-Led ART Delivery (CCLAD) is a community HIV care model. In this model, a group of persons living with HIV (PLHIV) in a specific location, take turns going to the HIV clinic to pick up Antiretroviral Treatment refills for members. The uptake of this model, however, remains low despite its improvements in patient retention. In this study, we explored PLHIV's perceptions of this model and identified the factors associated with its low uptake. METHODS: This was a mixed methods study based on a retrospective review of records of PLHIV and in-depth interviews. We reviewed the medical records of people receiving ART to determine their current model of ART delivery and conducted in-depth interviews with 30 participants who were eligible to be enrolled in the CCLAD model at the Mulago ISS clinic. We performed logistic regression to identify factors associated with the uptake of the CCLAD model and inductive thematic analysis to explore PLHIV's perceptions of the CCLAD model. RESULTS: A total of 776 PLHIV were sampled for the study, 545 (70.2%) of whom were female. The mean age (standard deviation) was 42 (± 9.3) years. Overall, 55 (7.1%) received ART using the CCLAD model. Compared to other ART-delivery models, CCLAD was associated with being on ART for at least eight years (AOR 3.72; 95% CI: 1.35-10.25) and having no prior missed clinic appointments (AOR 10.68; 95% CI: 3.31-34.55). Mixed perceptions were expressed about the CCLAD model. Participants interviewed appreciated CCLAD for its convenience and the opportunities it offered members to talk and support each other. Others however, expressed concerns about the process of group formation, and feeling detached from the health facility with consequences of lack of confidentiality. CONCLUSION: The current uptake of the CCLAD model is lower than the national recommended percentage of 15%. Its uptake was associated with those who had been in care for a longer period and who did not miss appointments. Despite CCLAD being perceived as convenient and as promoting support among members, several challenges were expressed. These included complexities of group formation, fear of stigma and feelings of detachment from health facilities among others. So, while CCLAD presents a promising alternative ART delivery model, more attention needs to be paid to the processes of group formation and improved patient monitoring to address the feelings of detachment from the facility and facility staff.

Sustained Retention, Viral Load Suppression and their Determinants Among Clients on HAART Enrolled Under Differentiated Service Delivery Models in Eastern Uganda.

Background: Although Uganda rolled out Differentiated Service Delivery(DSD) models in June 2017 to improve retention and viral load suppression rates among clients on Highly Active Antiretroviral Therapy (HAART), these have remained low relative to the Joint United Nations Programme on HIV/AIDS(UNAIDs) targets of achieving 95% population with HIV tested, 95% of tested positive clients for HIV to be on Highly active Antiretroviral therapy and 95% of clients On Antiretroviral therapy be suppressing by 2030(95-95-95 UNAIDS targets). The purpose of this study was to determine sustained retention, viral load suppression and their determinants among clients on HAART enrolled under different Differentiated service delivery models in Katakwi district in Eastern Uganda. Methods: A retrospective cohort study of clients enrolled on HAART in the different approaches of DSD who were active by 2017 and followed up to 2020 was done. The primary outcomes included sustained retention, viral load suppression and their determinants among clients HAART in different DSD approaches. Eight health facilities providing HAART services were purposively sampled and 771 clients on HAART were sampled out by simple random selection from a total population of 4742 clients on HAART in Katakwi district. We analysed retention, viral load suppression rates, and their determinants by logistic regression method using STATA. Results: A total of 771 participants were sampled of whom 42.7% were male and 57.3% were female, with the mean age being 40 years. Retention rates at 95% CI of participants were 99.35% at 12 months, 94.03 at 24 months, 89.88% at 36 months and 84.57% at 48 months. The viral load suppression rates were 57.3% at 12 months, 70.3% at 24 months, 70.3% at 36 months and 69% at 48 months. Retention was higher in the community based DSD model as compared to the facility-based model. Viral load suppression was higher in the community based DSD models in which Community Drug Distribution Points had the highest achievement (92%) followed by Community Client-Led ART Distribution (79%) compared to the facility based DSD models in which Facility Based Individual Management performance (34.3%) was far below the set standard of 95%, followed by Facility Based Groups (65%) with Fast Track Drug Refill having relatively better performance (80.9%). Being 40-59 years, receiving care from the general hospital, being married, having good current adherence, being on the first line of the current regime and being a female are other predictors of viral load suppression, whereas being 40-59 years of age, having good current adherence, being on the current first-line regime and having no co-morbidities were predictors of good retention. Conclusions: generally, facility and community based DSD models have demonstrated improved retention and viral load suppression. However, community-based models have shown to be more effective than facility-based models through mitigation of barriers to effective HIV/AIDS care of clients on HAART. Viral load suppression remained below the UNAIDs target of 95% by 2030, albeit it improved over time.