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 ...
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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.
BackgroundTo 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.MethodsWe 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.DiscussionThis 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 registrationPROSPERO: CRD42019118230
IntroductionIn 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.MethodsWe 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.ResultsWe 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.ConclusionsWe 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.
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