一项关于每日与每周交互式语音应答呼叫以支持印度抗逆转录病毒治疗患者依从性的试点随机对照试验（RCT）。
A pilot randomized controlled trial (RCT) of daily versus weekly interactive voice response calls to support adherence among antiretroviral treatment patients in India.
作者信息
Swendeman Dallas, Fehrenbacher Anne E, Roy Soma, Ray Protim, Sumstine Stephanie, Scheffler Aaron, Das Rishi, Jana Smaraijt
机构信息
Department of Psychiatry & Biobehavioral Sciences, Semel Institute, University of California, Los Angeles, CA, USA.
Center for HIV Identification, Prevention and Treatment Services, University of California, Los Angeles, CA 90024, USA.
出版信息
Mhealth. 2020 Oct 5;6:35. doi: 10.21037/mhealth-19-248a. eCollection 2020.
BACKGROUND
There are more than two million people living with HIV (PLH) in India, with more than 30% on antiretroviral treatment (ART) estimated to be non-adherent. This study aimed to (I) document adherence rates and related factors among ART patients in a large ART clinic in India, and (II) pilot test daily and weekly interactive voice response (IVR) calls to improve ART adherence and related outcomes.
METHODS
ART patients reporting missing at least one dose in prior 6 months (N=362) were enrolled and assessed via self-report and medical record review. Participants were randomized to one of two conditions: (I) twice-daily IVR call reminders with self-management support messaging, plus a weekly IVR adherence assessment; or (II) an attention control, with only weekly IVR adherence assessment. Participants completed study assessments at baseline, 2-, 4-, and 6-months with high retention (88% to 96%).
RESULTS
Intention-to-treat analyses found limited support for intervention effects for improving or maintaining ART adherence or CD4 counts between the two study arms over 6-months follow-up. Adherence increased significantly in the six months prior to baseline from about 65% to >95% with perfect adherence based on pill counts from medical records and consistent with patient self-report measures, which presented ceiling effects for detecting improvements in ART adherence in response to IVR intervention exposure. There was also limited support for intervention effects on secondary, self-management outcomes.
CONCLUSIONS
High levels of adherence were sustained throughout the 6-month RCT. IVR regulation changes in India delayed study launch for 6 months, which likely allowed mobilization of improved adherence at the clinic, provider and patient levels in anticipation of the study launch. Therefore, ceiling effects limited inferences on intervention effects to improve adherence. Results suggest that clinic-level adherence monitoring may be sufficient to mobilize adherence improvements by providers and patients.
TRIAL REGISTRATION
ClinicalTrials.gov registration #NCT02118454.
背景
印度有超过200万人感染艾滋病毒（PLH），估计超过30%接受抗逆转录病毒治疗（ART）的患者未坚持治疗。本研究旨在：（I）记录印度一家大型抗逆转录病毒治疗诊所中接受抗逆转录病毒治疗患者的依从率及相关因素；（II）对每日和每周的交互式语音应答（IVR）呼叫进行试点测试，以提高抗逆转录病毒治疗的依从性及相关结果。
方法
纳入在过去6个月内报告至少漏服一剂药物的抗逆转录病毒治疗患者（N = 362），通过自我报告和病历审查进行评估。参与者被随机分为两种情况之一：（I）每日两次IVR呼叫提醒并伴有自我管理支持信息，外加每周一次IVR依从性评估；或（II）注意力对照组，仅进行每周一次IVR依从性评估。参与者在基线、2个月、4个月和6个月时完成研究评估，保留率较高（88%至96%）。
结果
意向性分析发现，在6个月的随访期内，对于两个研究组在改善或维持抗逆转录病毒治疗依从性或CD4细胞计数方面的干预效果，支持有限。根据病历中的药丸计数以及与患者自我报告措施一致，基线前6个月的依从性从约65%显著提高到>95%，达到完美依从，这为检测抗逆转录病毒治疗依从性因IVR干预暴露而改善呈现出天花板效应。对于对次要的自我管理结果的干预效果，支持也有限。
结论
在整个6个月的随机对照试验中，维持了较高水平的依从性。印度IVR规定的变化使研究启动推迟了6个月，这可能促使诊所在研究启动前在诊所、医护人员和患者层面提高了依从性。因此，天花板效应限制了对改善依从性干预效果的推断。结果表明，诊所层面的依从性监测可能足以促使医护人员和患者提高依从性。
试验注册
ClinicalTrials.gov注册号#NCT02118454
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