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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: We describe CD4 count recovery among HIV positive individuals who initiated antiretroviral therapy (ART) with and without severe immune suppression using complete laboratory data from South Africa’s national HIV treatment programme between 2010 and 2014 and discuss implications for CD4 count monitoring. Methods: Retrospective analysis of routinely collected laboratory data from South Africa’s National Health Laboratory Service (NHLS). A probabilistic record linkage algorithm was used to create a cohort of HIV positive individuals who initiated ART between 2010 and 2014 based on timing of CD4 count and viral load measurements. A CD4 count < 50 copies/μl at ART initiation was considered severe immunosuppression. A multivariable piecewise mixed-effects linear regression model adjusting for age, gender, year of starting ART, viral suppression in follow up and province was used to predict CD4 counts during follow up. Results: 1,070,900 individuals had evidence of starting ART during 2010–2014 and met the criteria for inclusion in the cohort -46.6% starting ART with CD4 < 200 cells/μl and 10.1% with CD4 < 50 cells/ μl. For individuals with CD4 counts < 200 cells/μl, predicted CD4 counts > 200 cells/μl, >350 cells/μl and >500 cells/μl corresponded with mean follow up durations of 1.5 years (standard deviation [s.d] 1.1), 1.9years (s.d 1.2) and 2.1 years (s.d 1.3 years). For those with CD4 counts < 50 cells/μl, predicted CD4 count above these threshold corresponded with mean follow up durations of 2.5 years (s.d 0.9 years), 4.4 years (s.d 0.4 years) and 5.0 years (s.d 0.1years) for recovery to the same thresholds. CD4 count recovery varied mostly with duration on ART, CD4 count at the start of ART and gender. Conclusion: For individuals starting with ART with severe immunosuppression, CD4 recovery to 200cells/μl did not occur or took longer than 12 month for significant proportions. CD4 monitoring and interventions recommended for advanced HIV disease should continue until full recovery. [ABSTRACT FROM AUTHOR]

Background: Empirical studies and population-level policy simulations show the importance of voluntary medical male circumcision (VMMC) in generalized epidemics. This paper complements available scenario-based studies (projecting costs and outcomes over some policy period, typically spanning decades) by adopting an incremental approach-analyzing the expected consequences of circumcising one male individual with specific characteristics in a specific year. This approach yields more precise estimates of VMMC's cost-effectiveness and identifies the outcomes of current investments in VMMC (e.g., within a fiscal budget period) rather than of investments spread over the entire policy period.Methods/findings: The model has three components. We adapted the ASSA2008 model, a demographic and epidemiological model of the HIV epidemic in South Africa, to analyze the impact of one VMMC on HIV incidence over time and across the population. A costing module tracked the costs of VMMC and the resulting financial savings owing to reduced HIV incidence over time. Then, we used several financial indicators to assess the cost-effectiveness of and financial return on investments in VMMC. One circumcision of a young man up to age 20 prevents on average over 0.2 HIV infections, but this effect declines steeply with age, e.g., to 0.08 by age 30. Net financial savings from one VMMC at age 20 are estimated at US$617 at a discount rate of 5% and are lower for circumcisions both at younger ages (because the savings occur later and are discounted more) and at older ages (because male circumcision becomes less effective). Investments in male circumcision carry a financial rate of return of up to 14.5% (for circumcisions at age 20). The cost of a male circumcision is refinanced fastest, after 13 y, for circumcisions at ages 20 to 25. Principal limitations of the analysis arise from the long time (decades) over which the effects of VMMC unfold-the results are therefore sensitive to the discount rate applied, and more generally to the future course of the epidemic and of HIV/AIDS-related policies pursued by the government.Conclusions: VMMC in South Africa is highly effective in reducing both HIV incidence and the financial costs of the HIV response. The return on investment is highest if males are circumcised between ages 20 and 25, but this return on investment declines steeply with age. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: South Africa provides free antiretroviral therapy for almost 5 million people living with HIV, but only 71% of the eligible people are on treatment, representing a shortfall in the care cascade, especially among men and youth. Many developing countries have expanded access to smartphones; success in health apps raises the possibility of improving this cascade., Objective: SmartLink is a health app for Android smartphones providing HIV-related laboratory results, information, support, and appointment reminders to engage and link patients to care. This study aimed to evaluate the ability of SmartLink to improve linkage to care for HIV-positive smartphone owners., Methods: This study was a multisite randomized controlled trial in Johannesburg. The intervention arm received the app (along with referral to a treatment site) and the control arm received the standard of care (referral alone). Linkage to care was confirmed by an HIV-related blood test reported on the National Health Laboratory Service database between 2 weeks and 8 months after initiation., Results: A total of 345 participants were recruited into the study; 64.9% (224/345) of the participants were female and 44.1% (152/345) were aged less than 30 years. In addition, 46.7% (161/345) were employed full time, 95.9% (331/345) had at least secondary school education, and 35.9% (124/345) were from Zimbabwe. Linkage to care between 2 weeks and 8 months was 48.6% (88/181) in the intervention arm versus 45.1% (74/164) in the control (P=.52) and increased to 64.1% (116/181) and 61.0% (100/164) (P=.55), respectively, after the initial 8-month period. Moreover, youth aged 18 to 30-years showed a statistically significant 20% increase in linkage to care for the intervention group., Conclusions: Youth aged less than 30 years have been historically difficult to reach with traditional interventions, and the SmartLink app provides a proof of concept that this population reacts to mobile health interventions that engage patients in HIV care., Trial Registration: ClinicalTrials.gov NCT02756949; https://clinicaltrials.gov/ct2/show/NCT02756949 (Archived by WebCite at http://www.webcitation.org/6z1GTJCNW)., (©Willem Daniel Francois Venter, Alex Fischer, Samanta Tresha Lalla-Edward, Jesse Coleman, Vincent Lau Chan, Zara Shubber, Mothepane Phatsoane, Marelize Gorgens, Lynsey Stewart-Isherwood, Sergio Carmona, Nicole Fraser-Hurt. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 02.04.2019.)

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., (© 2018 John Wiley & Sons Ltd.)

Introduction: In 2014, city leaders from around the world endorsed the Paris Declaration on Fast-Track Cities, pledging to achieve the 2020 and 2030 HIV targets championed by UNAIDS. The City of Johannesburg - one of South Africa's metropolitan municipalities and also a health district - has over 600,000 people living with HIV (PLHIV), more than any other city worldwide. We estimate what it would take in terms of programmatic targets and costs for the City of Johannesburg to meet the Fast-Track targets, and demonstrate the impact that this would have., Methods: We applied the Optima HIV epidemic and resource allocation model to demographic, epidemiological and behavioural data on 26 sub-populations in Johannesburg. We used data on programme costs and coverage to produce baseline projections. We calculated how many people must be diagnosed, put onto treatment and maintained with viral suppression to achieve the 2020 and 2030 targets. We also estimated how treatment needs - and therefore fiscal commitments - could be reduced if the treatment targets are combined with primary HIV prevention interventions (voluntary medical male circumcision (VMMC), an expanded condom programme, and comprehensive packages for female sex workers (FSW) and young females)., Results: If current programmatic coverage were maintained, Johannesburg could expect 303,000 new infections and 96,000 AIDS-related deaths between 2017 and 2030 and 769,000 PLHIV by 2030. Achieving the Fast-Track targets would require an additional 135,000 diagnoses and 232,000 people on treatment by 2020 (an increase in around 80% over 2016 treatment numbers), but would avert 176,000 infections and 56,500 deaths by 2030. Assuming stable ART unit costs, this would require ZAR 29 billion (USD 2.15 billion) in cumulative treatment investments over the 14 years to 2030. Plausible scale-ups of other proven interventions (VMMC, condom distribution and FSW strategies) could yield additional reductions in new infections (between 4 and 15%), and in overall treatment investment needs. Scaling up VMMC in line with national targets is found to be cost-effective in the medium term., Conclusions: The scale-up in testing and treatment programmes over this decade has been rapid, but these efforts must be doubled to reach 2020 targets. Strategic investments in proven interventions will help Johannesburg achieve the treatment targets and be on track to end AIDS by 2030., (© 2018 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of the International AIDS Society.)