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.