Jiao Kedi, Wang Chunmei, Liao Meizhen, Ma Jing, Kang Dianmin, Tang Weiming, Tucker Joseph D, Ma Wei
Department of Epidemiology, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, People's Republic of China.
Shandong Public Health Clinical Center, Jinan, Shandong, People's Republic of China.
BMC Med. 2022 Oct 10;20(1):341. doi: 10.1186/s12916-022-02538-3.
BACKGROUND: Antiretroviral therapy (ART) adherence is still suboptimal among some key populations, highlighting the need for innovative tailored strategies. This randomized controlled trial (RCT) aimed to evaluate the effect of a differentiated digital intervention on ART adherence among men who have sex with men (MSM) living with HIV in China. METHODS: The two-armed parallel RCT was conducted at one HIV clinic in Jinan of China from October 19, 2020, to June 31, 2021. Men were referred by health providers to join the study and then choose one of three digital strategies-text message, only instant message, or instant message plus social media. They were assigned in a 1:1 ratio to the intervention arm or control arm using block randomization, and inside each arm, there were three groups depending on the type of delivering the message. The groups were divided according to participants' preferred digital strategies. The intervention arm received ART medication messages, medication reminders, peer education, and involved in online discussion. The control arm received messages on health behavior and nutrition. The primary outcome was self-reported optimal ART adherence, defined as not missing any doses and not having any delayed doses within a one-month period. Secondary outcomes included CD4 T cell counts, viral suppression, HIV treatment adherence self-efficacy, and quality of life. Intention-to-treat analysis with generalized linear mixed models was used to evaluate the intervention's effect. RESULTS: A total of 576 participants were enrolled, including 288 participants assigned in the intervention arm and 288 assigned in the control arm. Most were ≤ 40 years old (79.9%) and initiated ART ≤ 3 years (60.4%). After intervention, the proportion of participants achieving optimal ART adherence in the intervention arm was higher than in the control arm (82.9% vs 71.1%). The differentiated digital intervention significantly improved ART adherence (RR = 1.74, 95%CI 1.21-2.50). Subgroup analysis showed one-to-one instant message-based intervention significantly improved ART adherence (RR = 2.40, 95% CI 1.39-4.17). CONCLUSIONS: The differentiated digital intervention improved ART adherence among MSM living with HIV in China, which could be integrated into people living with HIV (PLWH) management and further promoted in areas where PLWH can access text messaging and instant messaging services. TRIAL REGISTRATION: ChiCTR2000041282. Retrospectively registered on 23 December 2020.
背景：在一些关键人群中，抗逆转录病毒疗法（ART）的依从性仍未达到最佳水平，这凸显了需要创新的针对性策略。这项随机对照试验（RCT）旨在评估一种差异化数字干预措施对中国感染艾滋病毒的男男性行为者（MSM）的ART依从性的影响。 方法：双臂平行随机对照试验于2020年10月19日至2021年6月31日在中国济南的一家艾滋病毒诊所进行。男性由医疗服务提供者转介参加研究，然后选择三种数字策略之一——短信、仅即时通讯或即时通讯加社交媒体。使用区组随机化将他们以1:1的比例分配到干预组或对照组，在每组中，根据信息传递类型有三个小组。这些小组根据参与者偏好的数字策略进行划分。干预组接收ART药物信息、用药提醒、同伴教育，并参与在线讨论。对照组接收关于健康行为和营养的信息。主要结局是自我报告的最佳ART依从性，定义为在一个月内没有漏服任何一剂药物且没有任何延迟服药情况。次要结局包括CD4 T细胞计数、病毒抑制、HIV治疗依从性自我效能感和生活质量。使用广义线性混合模型进行意向性分析以评估干预效果。 结果：总共招募了576名参与者，其中288名被分配到干预组，288名被分配到对照组。大多数参与者年龄≤40岁（79.9%）且开始接受ART治疗≤3年（60.4%）。干预后，干预组达到最佳ART依从性的参与者比例高于对照组（82.9%对71.1%）。差异化数字干预显著提高了ART依从性（RR = 1.74，95%CI 1.21 - 2.50）。亚组分析显示，基于一对一即时通讯的干预显著提高了ART依从性（RR = 2.40，95%CI 1.39 - 4.17）。 结论：差异化数字干预提高了中国感染艾滋病毒的男男性行为者的ART依从性，这可以纳入艾滋病毒感染者（PLWH）的管理中，并在艾滋病毒感染者能够使用短信和即时通讯服务的地区进一步推广。 试验注册：ChiCTR2000041282。于2020年12月23日进行回顾性注册。
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