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

• Published in: PLoS medicine Vol. 16; no. 7; p. e1002874
• Main Authors: Fox, Matthew P, Pascoe, Sophie, Huber, Amy N, Murphy, Joshua, Phokojoe, Mokgadi, Gorgens, Marelize, Rosen, Sydney, Wilson, David, Pillay, Yogan, Fraser-Hurt, Nicole
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 23.07.2019; Public Library of Science (PLoS)
• Subjects: Acquired immune deficiency syndrome; Adolescent; Adult; AIDS; Anti-HIV Agents - adverse effects; Anti-HIV Agents - supply & distribution; Anti-HIV Agents - therapeutic use; Antiretroviral agents; Antiretroviral drugs; Antiretroviral therapy; Beliefs, opinions and attitudes; Biology and Life Sciences; Care and treatment; CD4 antigen; Chronic diseases; Chronic illnesses; Clinical medicine; Clinical trials; Clubs; Community health services; Demographic aspects; Dosage and administration; Drug therapy; Drugstores; Epidemiology; Evaluation; Female; Health care facilities; Health counseling; Health economics; Health Knowledge, Attitudes, Practice; Health sciences; Health Services Accessibility; HIV; HIV Infections - diagnosis; HIV Infections - drug therapy; HIV Infections - psychology; HIV Infections - virology; HIV patients; Human immunodeficiency virus; Humans; Integrated delivery networks; Internal medicine; Male; Medication Adherence; Medicine; Medicine and Health Sciences; Middle Aged; Missing data; Observational studies; Patient compliance; Patient Dropouts; Patients; Peer Influence; People and places; Pharmacy; Primary health care; Public health; Queues; Randomization; Research and Analysis Methods; Retention; Retention in Care; Retirement benefits; South Africa; Studies; Supervision; Sustained Virologic Response; Time Factors; Treatment Outcome; Viral Load; Young Adult; South Africa; Washington DC; United States > US; Massachusetts; Africa; Uganda; Kenya
• ISSN: 1549-1676; 1549-1277; 1549-1676
• DOI: 10.1371/journal.pmed.1002874

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. 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. 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. NCT02536768.