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AbstractIntroductionIn response to COVID‐19, national ministries of health adapted HIV service delivery guidelines to ensure uninterrupted access to antiretroviral therapy (ART) and limit the frequency of contact with health facilities. In this commentary, we summarize four ways in which differentiated service delivery (DSD) for HIV treatment has been accelerated during COVID‐19 in policy and implementation in sub‐Saharan Africa (SSA) – (i) expanding eligibility for DSD for HIV treatment, (ii) extending multi‐month dispensing (MMD) and reducing the frequency of clinical consultations, (iii) emphasizing community‐based models and (iv) integrating/aligning with TB preventative therapy (TPT), non‐communicable disease (NCD) treatments and family planning commodities.DiscussionAcross SSA in 2020, countries both adapted and emphasized policies supporting DSD for HIV treatment in response to COVID‐19. Access to DSD for HIV treatment was expanded by reducing the time required on ART before eligibility and being more inclusive of specific populations including children and adolescents, pregnant and breastfeeding women and those on second‐ and third‐line regimens. Access to extended ART refills, or MMD, was accelerated across many countries. A renewed focus was given to out‐of‐facility community‐based models of ART distribution. In some settings, there was acknowledgement of the need to integrate or align other chronic medications with ART.ConclusionsAdaptations to DSD for HIV treatment in response to COVID‐19 have resulted in rapid policy change and in some cases, acceleration of implementation in SSA. As the COVID‐19 pandemic evolves, there is a critical need to assess the impact of these adaptations and, where beneficial, ensure that policies implemented in response to COVID‐19 become the new normal.

In November 2008, a moratorium on initiating new patients onto antiretroviral (ARV) treatment was enacted by the Provincial Department of Health in the Free State province of South Africa. The moratorium, which was part of a series of cost curtailment measures, lasted for four months. During this time, an estimated thirty additional patients in the province died from AIDS each day. The moratorium contradicted national government's commitment to scaling-up of ARV treatment to 80% of those in need by 2011. This article uses the health systems components outlined by Harries et al. as crucial to the delivery of quality care as a conceptual framework to assess the causal elements of the antiretroviral moratorium. It examines the factors that contributed to the moratorium, including poor financial management systems, human resource and equipment shortages, weak monitoring and evaluation systems, and bureaucratic malfunctioning. This article describes South Africa's system of fiscal federalism and its impact on health budgeting. As the first official cessation of provincial roll-out, the moratorium served as a litmus test for government's reaction to critical challenges in the expansion of the ARV treatment programme at both national and provincial levels. It therefore provides a valuable case study for the state's response to some of the systematic and health infrastructural problems that have characterised South Africa's ARV roll-out since its inception.

In November 2008, a moratorium on initiating new patients onto antiretrovirals was enacted by the provincial Department of Health in the Free State. This paper examines the causes and implications of the Free State antiretroviral moratorium in the context of South Africa's provincial expansion of antiretroviral coverage. It argues that financial mismanagement, bureaucratic malfunctioning and a lack of monitoring and evaluation were the root causes of the moratorium. The more immediate causes are also discussed, primarily the change in financial delegations in November 2008, in which Provincial Treasury abruptly prevented health officials from further overspending. As the first official cessation of a provincial antiretroviral programme, the Free State moratorium provided a litmus test for government's reaction to a critical challenge in the provincial ART scale-up. Its therefore provides a valuable case study for the state's response to systematic and health infrastructural problems that have characterised the national roll-out since its inception.

AbstractIntroductionDifferentiated service delivery (DSD) models for HIV are a person‐centred approach to providing services across the HIV care cascade; DSD has an increasing policy and implementation support in high‐burden HIV countries. The life‐course approach to DSD for HIV treatment has focused on earlier life phases, childhood and adolescence, families, and supporting sexual and reproductive health during childbearing years. Older adults, defined as those over the age of 50, represent a growing proportion of HIV treatment cohorts with approximately 20% of those supported by PEPFAR in this age band and have specific health needs that differ from younger populations. Despite this, DSD models have not been designed or implemented to address the health needs of older adults.DiscussionOlder adults living with HIV are more likely to have significant co‐morbid medical conditions. In addition to the commonly discussed co‐morbidities of hypertension and diabetes, they are at increased risk of cognitive impairment, frailty and mental health conditions. Age and HIV‐related cognitive impairment may necessitate the development of adapted educational materials. Identifying the optimal package of differentiated services to this population, including the frequency of clinical visits, types and location of services is important as is capacitating the healthcare cadres to adapt to these challenges. Technological advances, which have made remote monitoring of adherence and other aspects of disease management easier for younger populations, may not be as readily available or as familiar to older adults. To date, adaptations to service delivery have not been scaled and are limited to nascent programmes working to integrate treatment of common co‐morbidities.ConclusionsOlder individuals living with HIV may benefit from a DSD approach that adapts care to the specific challenges of ageing with HIV. Models could be developed and validated using outcome measures, such as viral suppression and treatment continuity. DSD models for older adults should consider their specific health needs, such as high rates of co‐morbidities. This may require educational materials, health worker capacity building and outreach designed specifically to treat this age group.

The South African population is exposed to multiple forms of violence. Using nationally representative data from 4,351 South African adults, this study examined the relative risk for posttraumatic stress disorder (PTSD) associated with political, domestic, criminal, sexual and other (miscellaneous) forms of assault in the South African population. Violence exposure was assessed using the 'worst event' list from the WHO's Composite International Diagnostic Interview (CIDI) and a separate questionnaire assessing experiences of human rights abuses, and lifetime PTSD was assessed according to the APA's Diagnostic and Statistical Manual of Mental Disorders criteria using the CIDI. Findings indicated that over a third of the South African population has been exposed to some form of violence. The most common forms of violence experienced by men were criminal and miscellaneous assaults, while physical abuse by an intimate partner, childhood physical abuse and criminal assaults were most common for women. Among men, political detention and torture were the forms of violence most strongly associated with a lifetime diagnosis of PTSD, while rape had the strongest association with PTSD among women. At a population level, criminal assault and childhood abuse were associated with the greatest number of PTSD cases among men, while intimate partner violence was associated with the greatest number of PTSD cases among women. Recommendations for mental health service provision in South Africa and for future research on the relative risk for PTSD are offered.

IntroductionCommunity‐based models of antiretroviral therapy (ART) delivery have been recommended to support ART expansion and retention in resource‐limited settings. However, the evidence base for community‐based models of care is limited. We describe the implementation of community‐based adherence clubs (CACs) at a large, public‐sector facility in peri‐urban Cape Town, South Africa.MethodsStarting in May 2012, stable ART patients were down‐referred from the primary care community health centre (CHC) to CACs. Eligibility was based on self‐reported adherence, >12 months on ART and viral suppression. CACs were facilitated by four community health workers and met every eight weeks for group counselling, a brief symptom screen and distribution of pre‐packed ART. The CACs met in community venues for all visits including annual blood collection and clinical consultations. CAC patients could send a patient‐nominated treatment supporter ("buddy") to collect their ART at alternate CAC visits. Patient outcomes [mortality, loss to follow‐up and viral rebound (>1000 copies/ml)] during the first 18 months of the programme are described using Kaplan–Meier methods.Results and DiscussionFrom June 2012 to December 2013, 74 CACs were established, each with 25–30 patients, providing ART to 2133 patients. CAC patients were predominantly female (71%) and lived within 3 km of the facility (70%). During the analysis period, 9 patients in a CAC died (<0.1%), 53 were up‐referred for clinical complications (0.3%) and 573 CAC patients sent a buddy to at least one CAC visit (27%). After 12 months in a CAC, 6% of patients were lost to follow‐up and fewer than 2% of patients retained experienced viral rebound.ConclusionsOver a period of 18 months, a community‐based model of care was rapidly implemented decentralizing more than 2000 patients in a high‐prevalence, resource‐limited setting. The fundamental challenge for this out of facility model was ensuring that patients receiving ART within a CAC were viewed as an extension of the facility and part of the responsibility of CHC staff. Further research is needed to support down‐referral sooner after ART initiation and to describe patient experiences of community‐based ART delivery.

AbstractIntroduction: Increasingly, there is a need for health authority scale up of successfully piloted differentiated models of antiretroviral therapy (ART) delivery. However, there is a paucity of evidence on system‐wide outcomes after scale‐up. In the Cape Town health district, stable adult patients were referred to adherence clubs (ACs) – a group model of ART delivery with five visits per year. By the end of March 2015, over 32,000 ART patients were in an AC. We describe patient outcomes of a representative sample of AC patients during this scale‐up.Methods: Patients enrolled in an AC at non‐research supported sites between 2011 and 2014 were eligible for analysis. We sampled 10% of ACs (n = 100) in quintets proportional to the number of ACs at each facility, linking each patient to city‐wide laboratory and service access data to validate retention and virologic outcomes. We digitized registers and used competing risks regression and cross‐sectional methods to estimate outcomes: mortality, transfers, loss to follow‐up (LTFU) and viral load suppression (≤400 copies/mL). Predictors of LTFU and viral rebound were assessed using Cox proportional hazards models.Results: Of the 3216 adults contributing 4019 person years of follow‐up (89% in an AC, median 1.1 years), 70% were women. Retention was 95.2% (95% CI, 94.0‐96.4) at 12 months and 89.3% (95% CI, 87.1‐91.4) at 24 months after AC enrolment. In the 13 months prior to analysis closure, 88.1% of patients had viral load assessments and of those, viral loads ≤400 copies/mL were found in 97.2% (95% CI, 96.5‐97.8) of patients. Risk of LTFU was higher in younger patients and in patients accessing ART from facilities with larger ART cohorts. Risk of viral rebound was higher in younger patients, those that had been on ART for longer and patients that had never sent a buddy to collect their medication.Conclusions: This is the first analysis reporting patient outcomes after health authorities scaled‐up a differentiated care model across a high burden district. The findings provide substantial reassurance that stable patients on long‐term ART can safely be offered care options, which are more convenient to patients and less burdensome to services.

AbstractIntroductionThe antiretroviral therapy (ART) adherence club (AC) model has supported clinically stable HIV patients' retention with group ART refills and psychosocial support. Reducing visit frequency by increasing ART refills to six months could further benefit patients and unburden health systems. We conducted a pragmatic non‐inferiority cluster randomized trial comparing standard of care (SoC) ACs and six‐month refill intervention ACs in a primary care facility in Khayelitsha, South Africa.MethodsExisting community‐based and facility‐based ACs were randomized to either SoC or intervention ACs. SoC ACs met five times annually, receiving two‐month refills with a four‐month refill over year‐end. Blood was drawn at one AC visit with a clinical assessment at the next. Intervention ACs met twice annually receiving six‐month refills, with an individual blood collection visit before the annual clinical assessment AC visit. The first study visits were in October and November 2017 and participants followed for 27 months. We report retention in care, viral load completion and viral suppression (<400 copies/mL) 24 months after enrolment and calculated intention‐to‐treat risk differences for the primary outcomes using generalized estimating equations specifying for clustering by AC.ResultsOf 2150 participants included in the trial, 977 were assigned to the intervention arm (40 ACs) and 1173 to the SoC (48 ACs). Patient characteristics at enrolment were similar across groups. Retention in care at 24 months was similarly high in both arms: 93.6% (1098/1173) in SoC and 92.6% (905/977) in the intervention arm, with a risk difference of −1.0% (95% CI: −3.2 to 1.3). The intervention arm had higher viral load completion (90.8% (999/1173) versus 85.1% (887/977)) and suppression (87.3% (969 /1173) versus 82.6% (853/977)) at 24 months, with a risk difference for completion of 5.5% (95% CI: 1.5 to 9.5) and suppression of 4.6% (95% CI: 0.2 to 9.0).ConclusionsIntervention AC patients receiving six‐month ART refills showed non‐inferior retention in care, viral load completion and viral load suppression to those in SoC ACs, adding to a growing literature showing good outcomes with extended ART dispensing intervals.

AbstractIntroductionQuestions about the implementation of evidence‐based intervention to treat and prevent HIV have risen to the top of the field's scientific priorities. Despite the availability of highly efficacious treatment and prevention interventions, impact has fallen short of targets because these interventions are used with insufficient reach, consistency, sustainability and equity in diverse real‐world settings. At present, substantial excitement for implementation science — defined as research methods and strategies to improve use of evidence‐based interventions — has focused on developing and disseminating methods to conduct rigorous research. Yet, impactful answers depend on a sometimes less visible, but even more important, step: asking good questions about implementation.DiscussionIn this commentary, we offer several considerations for researchers formulating implementation research questions based on several distinctive features of the field. First, as findings are used not only by other researchers but by implementers, scientific questions must incorporate a range of stakeholder and community perspectives to be most relevant. Second, real‐world settings are contextually diverse, and the most relevant scientific questions must position answers to make sense within these contexts (whether geographical, organizational and sociological), rather than apart from them. Third, implementation is complex and dynamic; consequently, research questions must make use of emerging standards in describing implementation strategies and their effects whenever possible. Finally, the field of implementation science continues to evolve, so framing problems with a diverse disciplinary lens will enable researchers to pose insightful and impactful questions.ConclusionsWe are now at a juncture marked by both rich evidence‐based interventions and a persistent global pandemic. To achieve continued scientific progress against the HIV epidemic, asking the right questions might be part of the answer itself.

AbstractIntroductionLong‐acting and extended delivery (LAED) regimens for HIV treatment and prevention offer unique benefits to expand uptake, effective use and adherence. To date, research has focused on basic and clinical science around the safety and efficacy of these products. This commentary outlines opportunities in HIV prevention and treatment programmes, both for the health system and clients, that could be addressed through the inclusion of LAED regimens and the vital role of differentiated service delivery (DSD) in ensuring efficient and equitable access.DiscussionThe realities and challenges within HIV treatment and prevention programmes are different. Globally, more than 28 million people are accessing HIV treatment—the vast majority on a daily fixed‐dose combination oral pill that is largely available, affordable and well‐tolerated. Many people collect extended refills outside of health facilities with clinical consultations once or twice a year. Conversely, uptake of daily oral pre‐exposure prophylaxis (PrEP) has consistently missed global targets due to limited access with high individual cost and lack of choice contributing to substantial unmet PrEP need. Recent trends in demedicalization, simplification, additional method options and DSD for PrEP have led to accelerated uptake as its availability has become more aligned with user preferences. How people currently receive HIV treatment and prevention services and their barriers to adherence must be considered for the introduction of LAED regimens to achieve the expected improvements in access and outcomes. Important considerations include the building blocks of DSD: who (provider), where (location), when (frequency) and what (package of services). Ideally, all LAED regimens will leverage DSD models that emphasize access at the community level and self‐management. For treatment, LAED regimens may address challenges with adherence but their delivery should provide clear advantages over existing oral products to be scaled. For prevention, LAED regimens expand a potential PrEP user's choice of methods, but like other methods, need to be delivered in a manner that can facilitate frequent re‐initiation.ConclusionsTo ensure that innovative LAED HIV treatment and prevention products reach those who most stand to benefit, service delivery and client considerations during development, trial and early implementation are critical.