HIV Care Retention and Cost Analysis in Multi‐Month ART Dispensing: A Randomized Controlled Trial in China

ABSTRACT Introduction Multi‐month dispensing (MMD), as a differentiated service delivery model, can reduce the frequency of clinic visits, waiting time and travel costs for clinically stable people living with HIV. This study aimed to evaluate the impact of 6‐month MMD of antiretroviral therapy (ART) on retention and conduct a cost analysis in China. Methods We conducted a randomized, non‐blind, non‐inferiority study from December 2022 to March 2023 at The First Hospital of China Medical University. Eligible participants were randomly assigned to a 3‐month dispensing group ( n = 789) or a 6‐month dispensing group ( n = 799) and followed up for 18 months. The proportion of patients continuing ART after 18 months, virological suppression rate (<50 copies/mL) and average treatment cost per patient were evaluated. Cox regression analysis was used to compare treatment retention rates and virological suppression rates between groups, while descriptive statistical analysis was applied to assess cost differences. Cost metrics comprised the average cost per clinic visit and the price of ART medications, among other factors. This trial is registered with ChiCTR2200066438. Results A total of 1588 participants were included (median age 40.0 years, IQR 34.0–50.0; 94.8% male), with no significant between‐group differences in demographic and clinical characteristics (all p >0.05). In the intention‐to‐treat analysis, treatment retention rates at 18 months were 94.9% (749/789) in the 3‐month dispensing group and 94.2% (753/799) in the 6‐month dispensing group. The risk difference (6‐month minus 3‐month) was −0.7% (95% CI −2.9% to 1.5%); non‐inferiority was demonstrated as the lower bound of the 95% CI (−2.9%) exceeded the pre‐specified margin of −5%. Viral suppression rates (<50 copies/mL) were similarly high in both groups in intent‐to‐treat analysis: 94.9% (3‐month) versus 94.2% (6‐month), with no statistically significant difference. Per‐protocol analysis confirmed these findings (viral suppression 97.59% vs. 97.75%; χ 2 = 0.0421, p = 0.8375). In terms of cost, the 6‐month dispensing group had two fewer annual outpatient visits (3 vs. 5), with total treatment costs reduced by 27.7% (¥931.82 vs. ¥1288.85) and work value loss decreased by 16.7% (¥174.20 vs. ¥209.04 yearly). Conclusions Six‐month MMD of ART did not reduce treatment retention; instead, it decreased patients’ clinic visit costs, thereby meeting cost‐effectiveness criteria. Clinical Trial Number ChiCTR2200066438.