The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi
The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi
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DOI：
10.1186/s13063-020-4131-8
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发表时间：
2020-02-19
期刊：
影响因子：
2.5
通讯作者：
Abrams, Elaine J.
中科院分区：
文献类型：
--
作者：
Kim, Maria H.;Tembo, Tapiwa A.;Abrams, Elaine J.
背景 提高孕产妇抗逆转录病毒治疗 (ART) 的保留率和依从性是预防艾滋病毒母婴传播 (PMTCT) 项目面临的一项关键挑战。迫切需要基于证据、具有成本效益和可扩展的干预措施来提高孕产妇的依从性和保留率，这些干预措施可以在负担过重的卫生系统中切实可行地实施。基于视频的简短干预措施是应对这场危机的一种很有前途但未得到充分利用的方法。我们描述了一项试验方案，以评估针对感染艾滋病毒的孕妇的基于标准化教育视频的干预措施的有效性和实施情况，该干预措施旨在通过在承诺终身抗逆转录病毒疗法之前提供 VITAL Start（激发终生治疗依从性的视频干预）来优化其抗逆转录病毒疗法的保留和依从性。方法 本研究是一项多中心平行组、随机对照试验，评估基于设施的简短视频干预的有效性，以优化马拉维艾滋病毒感染孕妇对抗逆转录病毒治疗的保留和依从性。总共 892 名感染 HIV 且尚未接受 ART 的孕妇将被随机分配接受标准护理的 ART 前咨询或 VITAL Start。主要结局是开始 ART 后 12 个月的保留和坚持（病毒载量 < 1000 拷贝/毫升）的综合结果。次要结果包括行为依从性评估（自我报告的依从性、药房补充和二磷酸替诺福韦浓度）、社会心理影响和资源利用。我们还将通过对患者、合作伙伴和医护人员的调查和定性访谈来检查 VITAL Start 的实施情况，并进行成本效益分析。讨论 这是对针对感染艾滋病毒的孕妇的基于设施的创新视频干预的有力评估，有可能改善孕产妇和婴儿的结局。
Background Improving maternal antiretroviral therapy (ART) retention and adherence is a critical challenge facing prevention of mother-to-child transmission (PMTCT) of HIV programs. There is an urgent need for evidence-based, cost-effective, and scalable interventions to improve maternal adherence and retention that can be feasibly implemented in overburdened health systems. Brief video-based interventions are a promising but underutilized approach to this crisis. We describe a trial protocol to evaluate the effectiveness and implementation of a standardized educational video-based intervention targeting HIV-infected pregnant women that seeks to optimize their ART retention and adherence by providing a VITAL Start (Video intervention to Inspire Treatment Adherence for Life) before committing to lifelong ART. Methods This study is a multisite parallel group, randomized controlled trial assessing the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant women living with HIV in Malawi. A total of 892 pregnant women living with HIV and not yet on ART will be randomized to standard-of-care pre-ART counseling or VITAL Start. The primary outcome is a composite of retention and adherence (viral load < 1000 copies/ml) 12 months after starting ART. Secondary outcomes include assessments of behavioral adherence (self-reported adherence, pharmacy refill, and tenofovir diphosphate concentration), psychosocial impact, and resource utilization. We will also examine the implementation of VITAL Start via surveys and qualitative interviews with patients, partners, and health care workers and conduct cost-effectiveness analyses. Discussion This is a robust evaluation of an innovative facility-based video intervention for pregnant women living with HIV, with the potential to improve maternal and infant outcomes.