Adaptive Antiretroviral Therapy Adherence Interventions for Youth Living with HIV through Text Messaging and Cell Phone Support Embedded within the Sequential Multiple Assignment Randomized Trial (SMART) Design

This project tested an adaptive adherence intervention to improve self-management and achieve/maintain viral load suppression while understanding the context for wide-scale implementation in an effectiveness-implementation Type 1 Hybrid trial. Primary aims: 1) Compare cell phone support (CPS) vs. text messaging (SMS) for youth living with HIV (YLH) not virally suppressed; 2) Understand the benefits of incentives for non-responders (NRsp), identify how to taper interventions for responders (Rsp), and describe potential moderators of treatment effect; 3) Study barriers and facilitators to wide-spread implementation and cost-effectiveness of treatment sequences. We hypothesized that youth randomized to CPS will have significantly greater viral load suppression (primary outcome) and self-reported medication adherence (secondary outcome) than those in the SMS group.

本项目在一项1型混合有效性-实施性试验（effectiveness-implementation Type 1 Hybrid trial）中，对一款自适应服药依从性干预方案进行了效果验证，该方案旨在改善人类免疫缺陷病毒（HIV）感染者的自我管理能力，实现并维持病毒载量抑制，同时探究其大规模推广应用的场景条件。本试验的主要研究目标如下：1） 针对病毒载量未得到抑制的青少年HIV感染者（youth living with HIV, YLH），比较手机支持干预（cell phone support, CPS）与短信（short message service, SMS）干预的效果差异；2） 明确针对无应答者（non-responders, NRsp）设置激励措施的收益，探索如何为应答者（responders, Rsp）逐步递减干预强度，并阐明治疗效应的潜在调节变量；3） 研究该治疗方案序列大规模推广的阻碍因素与促进因素，以及其成本效益。我们提出研究假设：相较于短信干预组，被随机分配至手机支持干预组的青少年HIV感染者，其病毒载量抑制率（主要结局指标）与自我报告的服药依从性（次要结局指标）均将显著更优。