Abstract
BackgroundDifferentiated 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 findingsWe 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.ConclusionsIn 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 registrationNCT02536768.
Highlights
The benefits of the rollout of antiretroviral therapy (ART) programs in resource-limited settings have been massive, including increased survival [1,2], reduced morbidity [3,4,5,6], and potential reductions in transmission [7,8]
We found comparable Decentralized Medication Delivery (DMD) outcomes versus standard of care at facilities, a benefit for retention of patients in care with Adherence Club (AC), and apparent benefits in terms of retention and sustained viral suppression among men
Two such approaches are Adherence Clubs (ACs), in which patients meet in a small groups outside the usual clinic queues, pick up their prepacked medication, and discuss adherence, and Decentralized Medication Delivery (DMD), in which patients pick up their medication at a pick-up point (PuP) away from the clinic such as a private pharmacy or church
Summary
The benefits of the rollout of antiretroviral therapy (ART) programs in resource-limited settings have been massive, including increased survival [1,2], reduced morbidity [3,4,5,6], and potential reductions in transmission [7,8]. Under differentiated ART delivery, patients who are clinically stable on treatment and have demonstrated good adherence can be offered a repeat prescription collection strategy that allows them to pick up their medication in a less time-consuming manner than general clinic pharmacy queues as part of a package of services, including counseling and peer support Two such approaches are Adherence Clubs (ACs), in which patients meet in a small groups outside the usual clinic queues, pick up their prepacked medication, and discuss adherence, and Decentralized Medication Delivery (DMD), in which patients pick up their medication at a pick-up point (PuP) away from the clinic such as a private pharmacy or church. 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
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