Recruitment of Youth Living With HIV to Optimize Adherence and Virologic Suppression: Testing the Design of Technology-Based Community Health Nursing to Improve Antiretroviral Therapy (ART) Clinical Trials.
Recruitment of Youth Living With HIV to Optimize Adherence and Virologic Suppression: Testing the Design of Technology-Based Community Health Nursing to Improve Antiretroviral Therapy (ART) Clinical Trials.
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DOI：
10.2196/23480
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发表时间：
2020-12-11
影响因子：
1.7
通讯作者：
Trent M
中科院分区：
文献类型：
--
作者：
Agwu AL;Yusuf HE;D'Angelo L;Rathore M;Marchesi J;Rowell J;Smith R;Toppins J;Trexler C;Carr R;Johnson B;Selden AK;Mahmoudi S;Black S;Guadamuz J;Huettner S;Trent M
尽管艾滋病毒诊断和治疗取得了进展，但与年长的同龄人相比，12-25 岁的青少年和年轻人的艾滋病毒发病率较高，治疗参与度和保留率较低，依从率和病毒学抑制率较低。 HIV 已成为一种慢性疾病，坚持抗逆转录病毒治疗 (ART) 对于病毒学抑制和长期生存至关重要。对于许多感染艾滋病毒 (YHIV) 的青少年来说，病毒学抑制一直难以实现。旨在促进医疗保健系统在就诊期间对 YHIV 提供支持的新策略对于提高 ART 依从性、病毒学抑制和长期生存至关重要。本研究的目的是使用随机试验设计，比较技术增强的社区健康护理干预 (TECH2CHECK) 与护理标准 (SOC) 对照组在提高 ART 依从性和随后的病毒抑制方面的有效性。目标是评估 TECH2CHECK 与 SOC 相比在门诊环境中管理 HIV 的可行性、可接受性和成本效益，并检查干预期后青少年自我护理行为、依从性和病毒学抑制的可持续性。我们将招募 120 名存在依从性问题的 YHIV 患者，并在巴尔的摩-华盛顿都市区和杰克逊维尔的专门从事艾滋病毒护理的诊所进行跟踪调查。符合条件的参与者完成音频、计算机辅助自我访谈，并随机分配接受 TECH2CHECK 干预或 SOC（每组 60 名参与者）。感兴趣的主要结果是病毒学抑制（病毒载量<20拷贝/mL）和改善治疗依从性。干预组的参与者在第 2 周、6 周、10 周、14 周和 26 周时接受社区健康护理访视。干预组还接收 SMS 消息，包括每日依从性和预约提醒以及对药物依从性的积极强化，持续 2 周每天一次，持续 2 周隔日一次，持续 1 个月每周三次，持续 3 个月每周三次，以及在剩余研究期间每两周一次。对照组按照诊所协议接收预约提醒和 SOC。将进行探索性分析，以确定两组的药物依从性和病毒学抑制方面的差异，并评估成本效益以及研究的可行性和可接受性。在该研究的前 23 个月（2018 年 7 月至 2020 年 4 月），102 名符合条件的患者中的 56 名（55%）被纳入并随机分组。目前，参与的青少年主要是非裔美国人（53/56，95%）、男性（37/56，66%）和≥18岁（53/56，95%）。按照方案要求，在 1 个月、3 个月、6 个月、12 个月和 18 个月的随访中，分别有 77% (43/56)、94% (45/48)、95% (37/39)、96% (24/25) 和 100% (10/10) 的参与者完成了随访研究访问。初步的应计和保留数据表明 TECH2CHECK 是可行且可接受的。 ClinicalTrials.gov NCT03600103 https://clinicaltrials.gov/ct2/show/NCT03600103 DERR1-10.2196/23480
Despite advances in HIV diagnosis and treatment, adolescents and young adults 12-25 years old have high HIV incidence, poor engagement and retention in treatment, and low rates of adherence and virologic suppression when compared to their older counterparts. HIV has emerged as a chronic disease for which antiretroviral therapy (ART) adherence is critical for virologic suppression and long-term survival. Virologic suppression has been elusive for many youth with HIV (YHIV). Novel strategies designed to facilitate health care systems’ support for YHIV between medical visits are essential for improving ART adherence, virologic suppression, and long-term survival. The aim of this study is to compare the effectiveness of a technology-enhanced community health nursing intervention (TECH2CHECK) to a standard of care (SOC) control group for improving ART adherence and subsequent viral suppression using a randomized trial design. The objectives are to assess the feasibility, acceptability, and cost-effectiveness of TECH2CHECK as compared to SOC for management of HIV in the outpatient setting and to examine the sustainability of self-care behavior, adherence, and virologic suppression among youth following the intervention period. We will recruit 120 adherence-challenged YHIV being followed at clinics specializing in HIV care in the Baltimore-Washington metropolitan area and in Jacksonville. Eligible participants complete an audio, computer-assisted self-interview and are randomized to either TECH2CHECK intervention or the SOC (60 participants in each arm). The primary outcome of interest is virologic suppression (viral load <20 copies/mL) and improved treatment adherence. Participants in the intervention arm receive community health nursing visits at 2 weeks, 6 weeks, 10 weeks, 14 weeks, and 26 weeks. The intervention arm also receives SMS messaging comprising daily adherence and appointment reminders and positive reinforcement for medication adherence daily for 2 weeks, on alternate days for 2 weeks, thrice weekly for 1 month, weekly for 3 months, and every 2 weeks for the rest of the study duration. The control group receives appointment reminders and SOC per clinic protocol. Exploratory analysis will be conducted to determine differences in medication adherence and virologic suppression in the 2 arms and to assess cost-effectiveness and study feasibility and acceptability. In the first 23 months of the study (July 2018-April 2020), 56 (55%) of 102 eligible patients were enrolled and randomized. At present, participating youths are primarily African American (53/56, 95%), male (37/56, 66%), and ≥18 years old (53/56, 95%). Follow-up study visits, as required per the protocol, have been completed by 77% (43/56), 94% (45/48), 95% (37/39), 96% (24/25), and 100% (10/10) of participants at the 1-month, 3-month, 6-month, 12-month, and 18-month follow-ups, respectively. Preliminary accrual and retention data suggest that TECH2CHECK is feasible and acceptable. ClinicalTrials.gov NCT03600103 https://clinicaltrials.gov/ct2/show/NCT03600103 DERR1-10.2196/23480