Background: The antiretroviral therapy (ART) adherence club (AC) model has supported clinically stable patients'' retention with group ART refills and psychosocial support. Patients and health systems could benefit from reduced visit frequency by increasing ART refills. We conducted a non-inferiority cluster randomized trial comparing standard of care (SoC) ACs and 6-month refill intervention ACs in a primary care facility in Khayelitsha, South Africa.
Methods: Existing ACs were randomized to either SoC or intervention. SoC ACs met 5 times annually, receiving 2-month refills with a 4-month refill over year-end. Blood was drawn at one AC visit with a clinical assessment at the next. Intervention ACs met twice annually receiving 6-month refills, with a third individual blood collection anytime three-30 days before the annual clinical assessment AC visit. The database closed on 15/2/2019. Retention was defined any visit within 3-months of the 12-month scheduled appointment and was described using Kaplan-Meier methods. Viral load (VL) completion and suppression (< 400copies/mL) proportions within first 12 months of follow-up are presented by group. We conducted a Cox proportional hazards regression analysis to compare retention using robust standard errors to account for clustering.
Results: A total of 2,148 patients were included in the analysis; 977 in 40 intervention ACs (22% male) and 1171 in 48 SoC ACs (24% male). Twelve-month retention was high in both arms; 96.9%(95%CI:95.7-97.8%) in intervention ACs and 96.2%(95% CI:94.8-97.3%) in SoC, with no significant difference between groups (Hazard Ratio 1.24, 95%CI: 0.71-2.16)(see figure). VL completion (944/977; 98.1% [CI:97.0-98.9%] vs. 1093/1171;94.9%[CI:93.4-96.1%]) and suppression (922/944; 97.9%[95%CI:96.8-98.8%] vs. 1053/1093; 96.5%[95%CI:95.3-97.6%]) was higher in the intervention ACs.
Conclusions: Comparable 12-month retention and favourable VL outcomes in the intervention ACs compared to SoC ACs highlight that clinically stable patients can achieve good outcomes with fewer ART visits and 6-monthly refills.

Kaplan-Meier estimates of retention in care by study arm
[Kaplan-Meier estimates of retention in care by study arm]

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