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.

Patterns of engagement in care during clients' first 12 months after HIV treatment initiation in South Africa: A retrospective cohort analysis using routinely collected data.

Retention on antiretroviral therapy (ART) during the early treatment period is one of the most serious challenges facing HIV programs, but the timing and patterns of early disengagement from care remain poorly understood. We describe patterns of engagement in HIV care during the first year after treatment initiation. We analysed retrospective datasets of routinely collected electronic medical register (EMR) data for ≥18-year-old clients who initiated ART at public sector clinics in South Africa after 01/01/2018 and had ≥14 months of potential follow-up. Using scheduled visit dates, we characterized engagement in care as continuous (no treatment interruption), cyclical (at least one visit >28 days late with a return visit observed) or disengaged (visit not attended and no evidence of return). We report 6- and 12-month patterns of retention in care and viral suppression. Among 35,830 participants (65% female, median age 33), in months 0-6, 59% were continuously in care, 14% had engaged cyclically, 11% had transferred to another facility, 1% had died, and 16% had disengaged from care at the initiating facility. Among disengagers in the first 6 months, 58% did not return after their initiation visit. By 12 months after initiation, the overall proportion disengaged was 23%, 45% were classified as continuously engaged in months 7-12, and only 38% of the cohort had maintained continuous engagement at both the 6- and 12-month endpoints. Participants who were cyclically engaged in months 0-6 were nearly twice as likely to disengage in months 7-12 as were continuous engagers in months 0-6 (relative risk 1.76, 95% CI:1.61-1.91) and were more likely to have an unsuppressed viral load by 12 months on ART (RR = 1.28; 95% CI1.13-1.44). The needs of continuous and cyclical engagers and those disengaging at different timepoints may vary and require different interventions or models of care.

Designing Worthy Waiting Spaces: A Cross-Cultural Study of Waiting Room Features and Their Impact on Women's Affective States.

OBJECTIVE: This study examines the impact of ambulatory waiting room characteristics on patients' emotional states and investigates whether these states are universally experienced or influenced by social and cultural factors among women aged 18-35 from the three largest demographic groups in the United States: Black, Hispanic/Latina, and White. BACKGROUND: Patients typically spend more time waiting for routine medical appointments than receiving care, and evidence suggests that waiting can reinforces power dynamics that benefit privileged groups, leading to different experiences for minority women seeking preventative care. Still, literature addressing the impact of waiting areas is largely limited to universal measures, and little is known about how different ethnic/race groups respond to waiting spaces. METHODS: This inquiry used a questionnaire assessing 15 waiting room characteristics and testing four variables (furniture arrangement, room-scale, color saturation, and quantity of positive distractions) in a 2 × 3 quasiexperiment using a fractional randomized block design with 24 waiting room images. FINDINGS: Responses from 1,114 participants revealed mutual preferences for sociopetal seating, positive distractions, neutral colors, and welcoming and calming environments. Yet, Black participants indicated significantly greater importance in seeing ethnically/racially similar patients and healthcare providers and strategies that promote transparency, including image-based provider directories and views into the clinic. CONCLUSION: By investigating the impact of the waiting room environment on patient affect and comparing perceptions across three demographic groups of women, this study offers insights into potential strategies for improving access to preventative care services by creating more welcoming ambulatory care waiting environments.

The SENTINEL study of differentiated service delivery models for HIV treatment in Malawi, South Africa, and Zambia: research protocol for a prospective cohort study.

BACKGROUND: Many countries in sub-Saharan Africa are rapidly scaling up "differentiated service delivery" (DSD) models for HIV treatment to improve the quality of care, increase access, reduce costs, and support the continued expansion and sustainability of antiretroviral therapy (ART) programs. Although there is some published evidence about the health outcomes of patients in DSD models, little is known about their impacts on healthcare providers' job satisfaction, patients' quality of life, costs to providers or patients, or how DSD models affect resource allocation at the facility level. METHODS: SENTINEL is a multi-year observational study that will collect detailed data about DSD models for ART delivery and related services from 12 healthcare facilities in Malawi, 24 in South Africa, and 12 in Zambia. The first round of SENTINEL included a patient survey, provider survey, provider time-and-motion observations, and facility resource use inventory. A survey of clients testing for HIV and a supplement to the facility resource use component to describe service delivery integration will be added for the second round. The patient survey will ask up to 10 patients enrolled in each DSD model at each study site about their experiences in HIV care and in DSD models, costs incurred seeking treatment, and preferences for HIV service delivery. The provider survey will ask up to 10 providers per site about the impact of DSD models on their positions and clinics. The time-and-motion component will directly observe the time use of a sample of providers implementing DSD models. Finally, the resource utilization component will collect facility-level data about DSD model availability and enrollment and the human and other resources needed to implement them. SENTINEL is planned to include four or more approximately annual rounds of data collection between 2021 and 2026. DISCUSSION: As national DSD programs for HIV treatment mature, it is important to understand how individual healthcare facilities are interpreting and implementing national guidelines and how healthcare workers and clients are adapting to new models of service delivery. SENTINEL will help policy makers and program managers understand the benefits and costs of differentiated service delivery and improve resource allocation going forward.

Uptake of same-day initiation of HIV treatment in Malawi, South Africa, and Zambia as reported in routinely collected data: the SPRINT retrospective cohort study.

Background: Since 2017 global guidelines have recommended "same-day initiation" (SDI) of antiretroviral treatment (ART) for patients considered ready for treatment on the day of HIV diagnosis. Many countries have incorporated a SDI option into national guidelines, but SDI uptake is not well documented. We estimated average time to ART initiation at 12 public healthcare facilities in Malawi, five in South Africa, and 12 in Zambia. Methods: We sequentially enrolled patients eligible to start ART between January 2018 and June 2019 and reviewed their medical records from the point of HIV diagnosis or first HIV-related interaction with the clinic to the earlier date of treatment initiation or 6 months. We estimated the proportion of patients initiating ART on the same day or within 7, 14, 30, or 180 days of baseline. Results: We enrolled 826 patients in Malawi, 534 in South Africa, and 1,984 in Zambia. Overall, 88% of patients in Malawi, 57% in South Africa, and 91% in Zambia were offered and accepted SDI. In Malawi, most who did not receive SDI had not initiated ART ≤6 months. In South Africa, an additional 13% initiated ≤1 week, but 21% had no record of initiation ≤6 months. Among those who did initiate within 6 months in Zambia, most started ≤1 week. There were no major differences by sex. WHO Stage III/IV and tuberculosis symptoms were associated with delays in ART initiation. Conclusions: As of 2020, SDI of ART was widespread, if not nearly universal, in Malawi and Zambia but considerably less common in South Africa. Limitations of the study include pre-COVID-19 data that do not reflect pandemic adaptations and potentially missing data for Zambia. South Africa may be able to increase overall ART coverage by reducing numbers of patients who do not initiate ≤6 months. Registration: Clinicaltrials.gov ( NCT04468399; NCT04170374; NCT04470011).

Changes in HIV treatment differentiated care uptake during the COVID-19 pandemic in Zambia: interrupted time series analysis.

INTRODUCTION: Differentiated service delivery (DSD) models aim to improve the access of human immunodeficiency virus treatment on clients and reduce requirements for facility visits by extending dispensing intervals. With the advent of the COVID-19 pandemic, minimising client contact with healthcare facilities and other clients, while maintaining treatment continuity and avoiding loss to care, has become more urgent, resulting in efforts to increase DSD uptake. We assessed the extent to which DSD coverage and antiretroviral treatment (ART) dispensing intervals have changed during the COVID-19 pandemic in Zambia. METHODS: We used client data from Zambia's electronic medical record system (SmartCare) for 737 health facilities, representing about three-fourths of all ART clients nationally. We compared the numbers and proportional distributions of clients enrolled in DSD models in the 6 months before and 6 months after the first case of COVID-19 was diagnosed in Zambia in March 2020. Segmented linear regression was used to determine whether the outbreak of COVID-19 in Zambia further accelerated the increase in DSD scale-up. RESULTS AND DISCUSSION: Between September 2019 and August 2020, 181,317 clients aged 15 or older (81,520 and 99,797 from 1 September 2019 to 1 March 2020 and from 1 March to 31 August 2020, respectively) enrolled in DSD models in Zambia. Overall participation in all DSD models increased over the study period, but uptake varied by model. The rate of acceleration increased in the second period for home ART delivery (152%), ≤ 2-month fast-track (143%) and 3-month MMD (139%). There was a significant reduction in the enrolment rates for 4- to 6-month fast-track (-28%) and "other" models (-19%). CONCLUSIONS: Participation in DSD models for stable ART clients in Zambia increased after the advent of COVID-19, but dispensing intervals diminished. Eliminating obstacles to longer dispensing intervals, including those related to supply chain management, should be prioritized to achieve the expected benefits of DSD models and minimize COVID-19 risk.

Differentiated Service Delivery Models for HIV Treatment in Malawi, South Africa, and Zambia: A Landscape Analysis.

INTRODUCTION: Many countries in Africa are scaling up differentiated service delivery (DSD) models for HIV treatment, but most existing data systems do not describe the models in use. We surveyed organizations that were supporting DSD models in 2019 in Malawi, South Africa, and Zambia to describe the diversity of DSD models being implemented at that time. METHODS: We interviewed DSD model implementing organizations for descriptive information about each of the organization's models of care. We described the key characteristics of each model, including population of patients served, location of service delivery, frequency of interactions with patients, duration of dispensing, and cadre(s) of provider involved. To facilitate analysis, we refer to 1 organization supporting 1 model of care as an "organization-model." RESULTS: The 34 respondents (8 in Malawi, 16 in South Africa, 10 in Zambia) interviewed described a total of 110 organization-models, which included 19 facility-based individual models, 21 out-of-facility-based individual models, 14 health care worker-led groups, and 3 client-led groups; jointly, these encompassed 12 specific service delivery strategies, such as multimonth dispensing, adherence clubs, home delivery, and changes to facility hours. Over two-thirds (n=78) of the organization-models were limited to clinically stable patients. Almost all organization-models (n=96) continued to provide clinical care at established health care facilities; medication pickup took place at facilities, external pickup points, and adherence clubs. Required numbers of provider interactions per year varied widely, from 2 to 12. Dispensing intervals were typically 3 or 6 months in Malawi and Zambia and 2 months in South Africa. Individual models relied more on clinical staff, while group models made greater use of lay personnel. CONCLUSIONS: As of 2019, there was a large variety of differentiated service models being offered for HIV treatment in Malawi, South Africa, and Zambia, serving diverse patient populations.

Short-term Outcomes from a Cluster Randomized Evaluation of Adherence Clubs as Part of Differentiated HIV Care in South Africa.

BACKGROUND: Differentiated care has been proposed to improve HIV treatment outcomes. In June 2016, South Africa's National Department of Health in collaboration with researchers began an evaluation of its National Adherence Guidelines for Chronic Diseases (AGL) which was being rolled-out by NDOH to public sector health facilities. METHODS: The evaluation has a cluster-randomized design with 12 intervention and 12 control facilities in 4 provinces. Follow up was by passive surveillance using clinical records. Enrollment occurred between June-December 2016. Our primary outcome was receipt of ART through Adherence Clubs (AC) within the first 4 months after AC eligibility. We compared crude results, used baseline covariate adjustment and difference-in-differences approaches to assess effects of ACs. RESULTS: We enrolled 275 patients from ACs and 294 control arm patients. About 57% were <40 years and just over 70% were female. At ART initiation average CD4 count was 268 cells (range 157-379). ACs showed a benefit in crude analyses of a 4 percentage point increase in patients picking up their medication (RD 4.4%; 95% CI: -0.6% to 9.4%) which increased to 6.7 percentage points (95% CI: 3.4% to 10.4%) after adjusting for baseline differences. The difference remained after adjusting for clusters and baseline covariates, though the confidence interval widened (RD 7.5%; 95% CI: -1.3% to 16.2%). CONCLUSIONS: We found early benefits to ACs in terms of medication pickups, though our results lacked precision. As we progress to long-term outcomes, it is important to see if these early gains translate into improved retention and viral suppression.

Fast-track treatment initiation counselling in South Africa: A cost-outcomes analysis.

INTRODUCTION: In 2016, under its new National Adherence Guidelines (AGL), South Africa formalized an existing model of fast-track HIV treatment initiation counselling (FTIC). Rollout of the AGL included an evaluation study at 24 clinics, with staggered AGL implementation. Using routinely collected data extracted as part of the evaluation study, we estimated and compared the costs of HIV care and treatment from the provider's perspective at the 12 clinics implementing the new, formalized model (AGL-FTIC) to costs at the 12 clinics continuing to implement some earlier, less formalized, model that likely varied across clinics (denoted here as early-FTIC). METHODS: This was a cost-outcome analysis using standard methods and a composite outcome defined as initiated antiretroviral therapy (ART) within 30 days of treatment eligibility and retained in care at 9 months. Using patient-level, bottom-up resource-utilization data and local unit costs, we estimated patient-level costs of care and treatment in 2017 U.S. dollars over the 9-month evaluation follow-up period for the two models of care. Resource use and costs, disaggregated by antiretroviral medications, laboratory tests, and clinic visits, are reported by model of care and stratified by the composite outcome. RESULTS: A total of 350/343 patients in the early-FTIC/AGL-FTIC models of care are included in this analysis. Mean/median costs were similar for both models of care ($135/$153 for early-FTIC, $130/$151 for AGL-FTIC). For the subset achieving the composite outcome, resource use and therefore mean/median costs were similar but slightly higher, reflecting care consistent with treatment guidelines ($163/$166 for early-FTIC, $168/$170 for AGL-FTIC). Not surprisingly, costs for patients not achieving the composite outcome were substantially less, mainly because they only had two or fewer follow-up visits and, therefore, received substantially less ART than patients who achieved the composite outcome. CONCLUSION: The 2016 adherence guidelines clarified expectations for the content and timing of adherence counseling sessions in relation to ART initiation. Because clinics were already initiating patients on ART quickly by 2016, little room existed for the new model of fast-track initiation counseling to reduce the number of pre-ART clinic visits at the study sites and therefore to reduce costs of care and treatment. TRIAL REGISTRATION: Clinical Trial Number: NCT02536768.

Retention in care and viral suppression in differentiated service delivery models for HIV treatment delivery in sub-Saharan Africa: a rapid systematic review.

INTRODUCTION: Differentiated service delivery (DSD) models for antiretroviral treatment (ART) for HIV are being scaled up in the expectation that they will better meet the needs of patients, improve the quality and efficiency of treatment delivery and reduce costs while maintaining at least equivalent clinical outcomes. We reviewed the recent literature on DSD models to describe what is known about clinical outcomes. METHODS: We conducted a rapid systematic review of peer-reviewed publications in PubMed, Embase and the Web of Science and major international conference abstracts that reported outcomes of DSD models for the provision of ART in sub-Saharan Africa from January 1, 2016 to September 12, 2019. Sources reporting standard clinical HIV treatment metrics, primarily retention in care and viral load suppression, were reviewed and categorized by DSD model and source quality assessed. RESULTS AND DISCUSSION: Twenty-nine papers and abstracts describing 37 DSD models and reporting 52 discrete outcomes met search inclusion criteria. Of the 37 models, 7 (19%) were facility-based individual models, 12 (32%) out-of-facility-based individual models, 5 (14%) client-led groups and 13 (35%) healthcare worker-led groups. Retention was reported for 29 (78%) of the models and viral suppression for 22 (59%). Where a comparison with conventional care was provided, retention in most DSD models was within 5% of that for conventional care; where no comparison was provided, retention generally exceeded 80% (range 47% to 100%). For viral suppression, all those with a comparison to conventional care reported a small increase in suppression in the DSD model; reported suppression exceeded 90% (range 77% to 98%) in 11/21 models. Analysis was limited by the extensive heterogeneity of study designs, outcomes, models and populations. Most sources did not provide comparisons with conventional care, and metrics for assessing outcomes varied widely and were in many cases poorly defined. CONCLUSIONS: Existing evidence on the clinical outcomes of DSD models for HIV treatment in sub-Saharan Africa is limited in both quantity and quality but suggests that retention in care and viral suppression are roughly equivalent to those in conventional models of care.

Will differentiated care for stable HIV patients reduce healthcare systems costs?

INTRODUCTION: South Africa's National Department of Health launched the National Adherence Guidelines for Chronic Diseases in 2015. These guidelines include adherence clubs (AC) and decentralized medication delivery (DMD) as two differentiated models of care for stable HIV patients on antiretroviral therapy. While the adherence guidelines do not suggest that provider costs (costs to the healthcare system for medications, laboratory tests and visits to clinics or alternative locations) for stable patients in these differentiated models of care will be lower than conventional, clinic-based care, recent modelling exercises suggest that such differentiated models could substantially reduce provider costs. In the context of continued implementation of the guidelines, we discuss the conditions under which provider costs of care for stable HIV patients could fall, or rise, with AC and DMD models of care in South Africa. DISCUSSION: In prior studies of HIV care and treatment costs, three main cost categories are antiretroviral medications, laboratory tests and general interaction costs based on encounters with health workers. Stable patients are likely to be on the national first-line regimen (Tenofovir/Entricitabine/Efavarinz (TDF/FTC/EFV)), so no difference in the costs of medications is expected. Laboratory testing guidelines for stable patients are the same regardless of the model of care, so no difference in laboratory costs is expected as well. Based on existing information regarding the costs of clinic visits, AC visits and DMD drug pickups, we expect that for some clinics, visit costs for DMD or AC models of care could be less, but modestly so, than for conventional, clinic-based care. For other clinics, however, DMD or AC models could have higher visit costs (see Table 2). CONCLUSIONS: The standard of care for stable patients has already been "differentiated" for years in South Africa, prior to the roll out of the new adherence guidelines. AC and DMD models of care, when implemented as envisioned in the guidelines, are unlikely to generate substantive reductions or increases in provider costs of care.

"Patients are not the same, so we cannot treat them the same" - A qualitative content analysis of provider, patient and implementer perspectives on differentiated service delivery models for HIV treatment in South Africa.

INTRODUCTION: In 2014, the South African government adopted a differentiated service delivery (DSD) model in its "National Adherence Guidelines for Chronic Diseases (HIV, TB and NCDs)" (AGL) to strengthen the HIV care cascade. We describe the barriers and facilitators of the AGL implementation as experienced by various stakeholders in eight intervention and control sites across four districts. METHODS: Embedded within a cluster-randomized evaluation of the AGL, we conducted 48 in-depth interviews (IDIs) with healthcare providers, 16 IDIs with Department of Health and implementing partners and 24 focus group discussions (FGDs) with three HIV patient groups: new, stable and those not stable on treatment or not adhering to care. IDIs were conducted from August 2016 to August 2017; FGDs were conducted in January to February 2017. Content analysis was guided by the Consolidated Framework for Implementation Research. Findings were triangulated among respondent types to elicit barriers and facilitators to implementation. RESULTS: New HIV patients found counselling helpful but intervention respondents reported sub-optimal counselling and privacy concerns as barriers to initiation. Providers felt insufficiently trained for this intervention and were confused by the simultaneous rollout of the Universal Test and Treat strategy. For stable patients, repeat prescription collection strategies (RPCS) were generally well received. Patients and providers concurred that RPCS reduced congestion and waiting times at clinics. There was confusion though, among providers and implementers, around implementation of RPCS interventions. For patients not stable on treatment, enhanced counselling and tracing patients lost-to-follow-up were perceived as beneficial to adherence behaviours but faced logistical challenges. All providers faced difficulties accessing data and identifying patients in need of tracing. Congestion at clinics and staff attitude were perceived as barriers preventing patients returning to care. CONCLUSIONS: Implementation of DSD models at scale is complex but this evaluation identified several positive aspects of AGL implementation. The positive perception of RPCS interventions and challenges managing patients not stable on treatment aligned with results from the larger evaluation. While some implementation challenges may resolve with experience, ensuring providers and implementers have the necessary training, tools and resources to operationalize AGL effectively is critical to the overall success of South Africa's HIV control strategy.

Differentiated models of service delivery for antiretroviral treatment of HIV in sub-Saharan Africa: a rapid review protocol.

BACKGROUND: To meet global targets for the treatment of HIV, high-prevalence countries are launching or expanding differentiated models of service delivery (DSD) for antiretroviral therapy (ART). Ongoing studies report on metrics specific to individual models of care, but little is known about the overall scale, impact, costs, and benefits of widespread implementation of DSD. We will conduct a rapid review of recent literature on DSD currently in use in sub-Saharan Africa and identify gaps in the literature with respect to the description of delivery models, coverage, effectiveness, and cost. METHODS: We will use an adapted version of the preferred reporting items for systematic reviews and meta-analysis protocols (PRISMA-P) for reporting. To avoid repeating earlier reviews, only sources reporting data on interventions conducted and/or patients starting antiretroviral treatment since 1 January 2016 will be included. Other inclusion criteria: must report on HIV-positive patients receiving antiretroviral therapy (ART) for the treatment of HIV/AIDS in sub-Saharan Africa; must describe an antiretroviral care intervention and identify the location, visit frequency, provider, patient group, and intervention intensity; and must report at least one of the following outcomes: population coverage, intervention uptake, treatment outcomes, cost or resource allocation, acceptability, or feasibility. EXCLUSION CRITERIA: receiving ART as part of prevention of mother-to-child transmission (PMTCT) program or receiving preventive ART (PEP or PrEP). This review will include peer-reviewed articles and conference abstracts. Publication databases to be searched include PubMed, EMBASE, and Web of Science. For analysis, where possible, we will group the DSD by key characteristics (e.g., population served, visit frequency, visit location) and then report means and/or medians of coverage and outcomes with confidence intervals or IQRs. We will also descriptively compare and contrast different models of care, implementation challenges, and other non-quantitative information. DISCUSSION: This review will provide an initial picture of the status quo for the implementation of DSD in sub-Saharan Africa and identify directions for research and implementation support in the future. This big-picture analysis will be useful for ministries of health, implementers, and donor agencies to inform decision-making on DSD scale-up. SYSTEMATIC REVIEW REGISTRATION: PROSPERO: CRD42019118230.

Differentiated HIV care in South Africa: the effect of fast-track treatment initiation counselling on ART initiation and viral suppression as partial results of an impact evaluation on the impact of a package of services to improve HIV treatment adherence.

INTRODUCTION: In response to suboptimal adherence and retention, South Africa's National Department of Health developed and implemented National Adherence Guidelines for Chronic Diseases. We evaluated the effect of a package of adherence interventions beginning in January 2016 and report on the impact of Fast-Track Treatment Initiation Counselling (FTIC) on ART initiation, adherence and retention. METHODS: We conducted a cluster-randomized mixed-methods evaluation in 4 provinces at 12 intervention sites which implemented FTIC and 12 control facilities providing standard of care. Follow-up was by passive surveillance using clinical records. We included data on subjects eligible for FTIC between 08 Jan 2016 and 07 December 2016. We adjusted for pre-intervention differences using difference-in-differences (DiD) analyses controlling for site-level clustering. RESULTS: We enrolled 362 intervention and 368 control arm patients. Thirty-day ART initiation was 83% in the intervention and 82% in the control arm (RD 0.5%; 95% CI: -5.0% to 6.0%). After adjusting for baseline ART initiation differences and covariates using DiD we found a 6% increase in ART initiation associated with FTIC (RD 6.3%; 95% CI: -0.6% to 13.3%). We found a small decrease in viral suppression within 18 months (RD -2.8%; 95% CI: -9.8% to 4.2%) with no difference after adjustment (RD: -1.9%; 95% CI: -9.1% to 5.4%) or when considering only those with a viral load recorded (84% intervention vs. 86% control). We found reduced crude 6-month retention in intervention sites (RD -7.2%; 95% CI: -14.0% to -0.4%). However, differences attenuated by 12 months (RD: -3.6%; 95% CI: -11.1% to 3.9%). Qualitative data showed FTIC counselling was perceived as beneficial by patients and providers. CONCLUSIONS: We saw a short-term ART-initiation benefit to FTIC (particularly in districts where initiation prior to intervention was lower), with no reductions but also no improvement in longer-term retention and viral suppression. This may be due to lack of fidelity to implementation and delivery of those components that support retention and adherence. FTIC must continue to be implemented alongside other interventions to achieve the 90-90-90 cascade and fidelity to post-initiation counselling sessions must be monitored to determine impact on longer-term outcomes. Understanding the cost-benefit and role of FTIC may then be warranted.

Adherence clubs and decentralized medication delivery to support patient retention and sustained viral suppression in care: Results from a cluster-randomized evaluation of differentiated ART delivery models in South Africa.

BACKGROUND: Differentiated antiretroviral therapy (ART) delivery models, in which patients are provided with care relevant to their current status (e.g., newly initiating, stable on treatment, or unstable on treatment) has become an essential part of patient-centered health systems. In 2015, the South African government implemented Chronic Disease Adherence Guidelines (AGLs), which involved five interventions: Fast Track Initiation Counseling for newly initiating patients, Enhanced Adherence Counseling for patients with an unsuppressed viral load, Early Tracing of patients who miss visits, and Adherence Clubs (ACs) and Decentralized Medication Delivery (DMD) for stable patients. We evaluated two of these interventions in 24 South African facilities: ACs, in which patients meet in groups outside usual clinic procedures and receive medication; and DMD, in which patients pick up their medication outside usual pharmacy queues. METHODS AND FINDINGS: We compared those participating in ACs or receiving DMD at intervention sites to those eligible for ACs or DMD at control sites. Outcomes were retention and sustained viral suppression (<400 copies/mL) 12 months after AC or DMD enrollment (or comparable time for controls). 12 facilities were randomly allocated to intervention and 12 to control arms in four provinces (Gauteng, North West, Limpopo, and KwaZulu Natal). We calculated adjusted risk differences (aRDs) with cluster adjustment using generalized estimating equations (GEEs) using difference in differences (DiD) with patients eligible for ACs/DMD prior to implementation (Jan 1, 2015) for comparison. For DMD, randomization was not preserved, and the analysis was treated as observational. For ACs, 275 intervention and 294 control patients were enrolled; 72% of patients were female, 61% were aged 30-49 years, and median CD4 count at ART initiation was 268 cells/µL. AC patients had higher 1-year retention (89.5% versus 81.6%, aRD: 8.3%; 95% CI: 1.1% to 15.6%) and comparable sustained 1-year viral suppression (<400 copies/mL any time ≤ 18 months) (80.0% versus 79.6%, aRD: 3.8%; 95% CI: -6.9% to 14.4%). Retention associations were apparently stronger for men than women (men RD: 13.1%, 95% CI: 0.3% to 23.5%; women RD: 6.0%, 95% CI: -0.9% to 12.9%). For DMD, 232 intervention and 346 control patients were enrolled; 71% of patients were female, 65% were aged 30-49 years, and median CD4 count at ART initiation was 270 cells/µL. DMD patients had apparently lower retention (81.5% versus 87.2%, aRD: -5.9%; 95% CI: -12.5% to 0.8%) and comparable viral suppression versus standard of care (77.2% versus 74.3%, aRD: -1.0%; 95% CI: -12.2% to 10.1%), though in both cases, our findings were imprecise. We also noted apparently increased viral suppression among men (RD: 11.1%; 95% CI: -3.4% to 25.5%). The main study limitations were missing data and lack of randomization in the DMD analysis. CONCLUSIONS: In this study, we found comparable DMD outcomes versus standard of care at facilities, a benefit for retention of patients in care with ACs, and apparent benefits in terms of retention (for AC patients) and sustained viral suppression (for DMD patients) among men. This suggests the importance of alternative service delivery models for men and of community-based strategies to decongest primary healthcare facilities. Because these strategies also reduce patient inconvenience and decongest clinics, comparable outcomes are a potential success. The cost of all five AGL interventions and possible effects on reducing clinic congestion should be investigated. CLINICAL TRIAL REGISTRATION: NCT02536768.

Effectiveness of interventions for unstable patients on antiretroviral therapy in South Africa: results of a cluster-randomised evaluation.

BACKGROUND: As loss from HIV care is an ongoing challenge globally, interventions are needed for patients who don't achieve or maintain ART stability. The 2015 South African National Adherence Guidelines (AGL) for Chronic Diseases include two interventions targeted at unstable patients: early tracing of patients who miss visits (TRIC) and enhanced adherence counselling (EAC). METHODS: As part of a cluster-randomised evaluation at 12 intervention and 12 control clinics in four provinces, intervention sites implemented the AGL interventions, while control sites retained standard care. We report on outcomes of EAC for patients with an elevated viral load (>400 copies/ml) and for TRIC patients who missed a visit by >5 days. We estimated risk differences (RD) of 3 and 12-month viral resuppression (<400 copies/ml) and 12-month retention with cluster adjustment using generalised estimating equations and controlled for imbalances using difference-in-differences compared to all eligible in 2015, prior to intervention roll-out. RESULTS: For EAC, we had 358 intervention and 505 control site patients (61% female, median ART initiation CD4 count 154 cells/µl). We found no difference between arms in 3-month resuppression (RD: -1.7%; 95%CI: -4.3% to 0.9%), but <20% of patients had a repeat viral load within 3 months (19.8% intervention, 13.5% control). Including the entire clinic population eligible for EAC with a repeat viral load at all evaluation sites (n = 934), intervention sites showed a small increase in 3-month resuppression (28% vs. 25%, RD 3.0%; 95%CI: -2.7% to 8.8%). Adjusting for baseline differences increased the RD to 8.1% (95% CI: -0.1% to 17.2%). However, we found no differences in 12-month suppression (RD: 1.5%; 95% CI: -14.1% to 17.1% but suppression was low overall at 40%) or retention (RD: 2.8%; 95% CI: -7.5% to 13.2%). For TRIC, we enrolled 155 at intervention sites and 248 at control sites (44% >40 years, 67% female, median CD4 count 212 cells/µl). We found no difference between groups in return to care by 12 months (RD: -6.8%; 95% CI: -17.7% to 4.8%). During the study period, control sites continued to use tracing within standard care, however, potentially masking intervention effects. CONCLUSIONS: Enhanced adherence counselling showed no benefit over 12 months. Implementation of the tracing intervention under the new guidelines was similar to the standard of care. Interventions that aim to return unstable patients to care should incorporate active monitoring to determine if the interventions are effective.

"My future is bright I won't die with the cause of AIDS": ten-year patient ART outcomes and experiences in South Africa.

INTRODUCTION: South Africa is moving into a new era of HIV treatment with "treat all" policies where people may be on treatment for most of their lives. We need to understand treatment outcomes and facilitators of long-term antiretroviral treatment (ART) adherence and retention-in-care in the South African context. In one of the first studies to investigate long-term treatment outcomes in South Africa, we aimed to describe ten-year patient outcomes at a large public-sector HIV clinic in Johannesburg and explore patient experiences of the treatment programme over this time in order to ascertain factors that may aid or hinder long-term adherence and retention. METHODS: We conducted a cohort analysis (n = 6644) and in-depth interviews (n = 24) among HIV-positive adults initiating first-line ART between April 2004 and March 2007. Using clinical records, we ascertained twelve-month and ten-year all-cause mortality and loss to follow-up (LTF). Cox proportional hazards regression was used to identify baseline predictors of attrition (mortality and LTF (>3 months late for the last scheduled visit)) at twelve months and ten years. Twenty-four patients were purposively selected and interviewed to explore treatment programme experiences over ten years on ART. RESULTS: Excluding transfers, 79.5% (95% confidence intervals (CI): 78.5 to 80.5) of the cohort were alive, in care at twelve months dropping to 35.1% (95% CI: 33.7 to 36.4) at ten years. Over 44% of deaths occurred within 12 months. Ten-year all-cause mortality increased, while LTF decreased slightly, with age. Year and age at ART initiation, sex, nationality, baseline CD4 count, anaemia, body mass index and initiating regimen were predictors of ten-year attrition. Among patients interviewed, the pretreatment clinic environment, feelings of gratitude and good fortune, support networks, and self-efficacy were facilitators of care; side effects, travel and worsening clinical conditions were barriers. Participants were generally optimistic about their futures and were committed to continued care. CONCLUSIONS: This study demonstrates the complexities of long-term chronic HIV treatment with declining all-cause mortality and increasing LTF over ten years. Barriers to long-term retention still present a significant challenge. As more people become eligible for ART in South Africa under "treatment for all," new healthcare delivery challenges will arise; interventions are needed to ensure long-term programme successes continue.

Assessing the impact of the National Department of Health's National Adherence Guidelines for Chronic Diseases in South Africa using routinely collected data: a cluster-randomised evaluation.

INTRODUCTION: In 2016, South Africa's National Department of Health (NDOH) launched the National Adherence Guidelines for Chronic Diseases for phased implementation throughout South Africa. Early implementation of a 'minimum package' of eight interventions in the Adherence Guidelines for patients with HIV is being undertaken at 12 primary health clinics and community health centres in four provinces. NDOH and its partners are evaluating the impact of five of the interventions in four provinces in South Africa. METHODS AND ANALYSIS: The minimum package is being delivered at the 12 health facilities under NDOH guidance and through local health authorities. The five evaluation interventions are: (1) fast track initiation counselling for patients eligible for antiretroviral therapy (ART); (2) adherence clubs for stable ART patients; (3) decentralised medication delivery for stable ART patients; (4) enhanced adherence counselling for unstable ART patients; and (5) early tracing of patients who miss an appointment by ≥5 days. For evaluation, NDOH matched the 12 intervention clinics with 12 comparison clinics and randomly allocated one member of each pair to intervention or comparison (standard of care) status within pairs, allowing evaluation of the interventions using a matched cluster-randomised design. The evaluation uses data routinely collected by the clinics, with no study interaction with subjects to prevent influencing the primary outcomes. Enrolment began on 20 June 2016 and was completed on 16 December 2016. A total of 3456 patients were enrolled and will now be followed for 14 months to estimate effects on short-term and final outcomes. Primary outcomes include viral suppression, retention and medication pickups, evaluated at two time points during follow-up. ETHICS AND DISSEMINATION: The study received approval from the University of Witwatersrand Human Research Ethics Committee and Boston University Institutional Review Board. Results will be presented to key stakeholders and at international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02536768; Pre-results.