OAELB0102
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Title
Twenty-four month retention and viral load outcomes from a non-inferiority cluster randomized trial of extending ART dispensing intervals to 6-monthly in adherence clubs
Presenter
Tali Cassidy
Authors
T. Cassidy * (1,2), C. Keene (1), K. Lebelo (1), A. Grimsrud (3), B. Sibanda (4), S. Ndlovu (4), H. Hayes (5), C. Orrell (6,7), E. Roberts (5), N. Zokufa (1), T. Mutseyekwa (1), J. Voget (5), R. Gerstenhaber (4), L. Wilkinson (8)
Institutions
(1) Medecins Sans Frontieres, Khayelitsha, Cape Town, South Africa, (2) University of Cape Town, Division of Public Health Medicine, Cape Town, South Africa, (3) Internation AIDS Society, Cape Town, South Africa, (4) Medecins Sans Frontieres, Cape Town, Cape Town, South Africa, (5) Western Cape Provincial Department of Health, Cape Town, South Africa, (6) University of Cape Town, Department of Medicine, Cape Town, South Africa, (7) University of Cape Town, The Desmond Tutu HIV Centre, Cape Town, South Africa, (8) University of Cape Town, Center of Infectious Diseases and Epidemiological Research, Cape Town, South Africa

BACKGROUND: Patients and health systems could benefit from reduced visit frequency by increasing ART refills. Antiretroviral therapy (ART) adherence clubs (AC) support clinically stable patients' retention through lay healthcare worker-led group ART refills and psychosocial support. We conducted a non-inferiority cluster randomized control trial comparing standard of care (SoC) ACs and 6-month refill intervention ACs in Khayelitsha, South Africa.
METHODS: Existing ACs were randomized to either SoC or intervention ACs. SoC ACs met five times annually receiving 2-month refills with a 4-month refill over year-end; one AC visit included an annual blood draw followed by clinical assessment at the next visit. Intervention ACs met twice annually receiving 6-month refills, with an individual blood collection anytime 3-30 days before the annual clinical assessment AC visit. Study enrolment took place in 2017 with the first study visits in October/November 2017 and patients followed for 24-months. Retention was defined as a visit on or within 3-months after the 24-month scheduled appointment. Viral load (VL) completion (12-24 months after enrolment) and suppression(<400copies/mL) at analysis closure are presented by group. We conducted a Cox proportional hazards regression analysis to compare attrition (death or loss to follow-up) using robust standard errors to account for clustering.
RESULTS: A total of 2,150 patients in 88 ACs were included; 977 in 40 intervention ACs (22% male) and 1,173 in 48 SoC ACs (24% male). Twenty-four month retention was high in both arms; 93.1% (95% CI: 91.2-94.7%) in intervention ACs and 94.0% (95% CI:92.4-95.2%) in SoC ACs, with no significant difference between groups (Hazard Ratio 1.09, 95% CI: 0.54-2.19). Among those retained at 24 months, viral load completion was slightly higher in the intervention arm (848/897;94.5% [CI:92.9-95.8%] vs. 972/1089;89.3% [CI:85.6-92.1%]) and suppression was similar between arms (817/848; 96.3% [95%CI: 94.6-97.5%] vs. 948/972; 97.5%[95%CI: 96.4-98.3%]).
CONCLUSIONS: After 24-months, non-inferior retention and viral load outcomes were observed between the intervention ACs with 6-month ART refills and the SoC ACs. These findings are consistent with the 12-month outcomes and provider further reassurance that clinically stable patients can achieve good outcomes with fewer ART visits and longer ART refills.