Dermatology Hospital of Southern Medical University, Guangzhou, China.
Southern Medical University Institute for Global Health, Guangzhou, China.
BMC Med. 2023 Jul 28;21(1):279. doi: 10.1186/s12916-023-02981-w.
HCV self-testing (HCVST) may be an effective strategy to address low rates of HCV test uptake among men who have sex with men (MSM). We evaluated the effectiveness and cost of providing HCVST to increase HCV test uptake among MSM in China.
Two parallel, unmasked, individual-level randomized controlled trials were conducted. HIV-negative MSM and MSM living with HIV were enrolled from 22 cities in China. Men in both trials were randomly assigned (1:1) into standard-of-care (SOC) or HCVST arms. The primary outcome was the proportion of participants who tested for HCV during the trial period. Intervention effects were estimated using multiply imputed data in the main analysis. Costs were measured using a micro-costing approach.
A total of 84 men who were HIV-negative (trial 1) and 84 men living with HIV were enrolled (trial 2). Overall, the proportion of individuals who underwent HCV testing during the trial period was higher in the HCVST arm compared to SOC in trial 1 (estimated risk difference (RD): 71.1%, 95% CI: 54.6 to 87.7%) and trial 2 (estimated RD: 62.9%, 95% CI: 45.7 to 80.1%). Over half (58.6%, 34/58) of HCV self-testers reported the self-test was their first HCV test. The cost per person tested in trial 1 was $654.52 for SOC and $49.83 for HCVST, and in trial 2 was $438.67 for SOC and $53.33 for HCVST.
Compared to the standard of care, providing HCVST significantly increased the proportion of MSM testing for HCV in China, and was cheaper per person tested.
Chinese Clinical Trial Registry.
ChiCTR2100048379.
丙型肝炎自我检测（HCVST）可能是提高男男性行为者（MSM）丙型肝炎检测率的有效策略。我们评估了提供 HCVST 以增加中国 MSM 丙型肝炎检测率的效果和成本。
进行了两项平行、非盲、个体水平的随机对照试验。来自中国 22 个城市的 HIV 阴性 MSM 和 HIV 阳性 MSM 参与了研究。两项试验中的男性均被随机分配（1:1）到标准护理（SOC）或 HCVST 组。主要结局是试验期间参与者进行丙型肝炎检测的比例。主要分析中采用多重插补数据估计干预效果。采用微观成本法测量成本。
共有 84 名 HIV 阴性男性（试验 1）和 84 名 HIV 阳性男性（试验 2）入组。总体而言，与 SOC 相比，HCVST 组在试验期间进行 HCV 检测的人数比例更高，试验 1（估计风险差异（RD）：71.1%，95%CI：54.6 至 87.7%）和试验 2（估计 RD：62.9%，95%CI：45.7 至 80.1%）。超过一半（58.6%，34/58）的 HCV 自我检测者报告说，自我检测是他们的首次 HCV 检测。试验 1 中 SOC 的人均检测成本为 654.52 美元，HCVST 为 49.83 美元，试验 2 中 SOC 的人均检测成本为 438.67 美元，HCVST 为 53.33 美元。
与标准护理相比，提供 HCVST 显著增加了中国 MSM 进行 HCV 检测的比例，且人均检测成本更低。
中国临床试验注册中心。
ChiCTR2100048379。
