Baylor College of Medicine International Pediatric AIDS Initiative, Texas Children's Hospital, Houston, TX, USA.
Baylor College of Medicine Children's Foundation Malawi, Lilongwe, Malawi.
Trials. 2020 Feb 19;21(1):207. doi: 10.1186/s13063-020-4131-8.
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.
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.
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.
ClinicalTrials.gov, NCT03654898. Registered on 31 August 2018.
提高孕产妇抗逆转录病毒疗法 (ART) 的保留率和依从性是预防艾滋病毒母婴传播 (PMTCT) 项目面临的一个关键挑战。迫切需要基于证据、具有成本效益且可扩展的干预措施，以提高孕产妇的依从性和保留率，这些干预措施在负担过重的卫生系统中可行。基于视频的简短干预措施是应对这一危机的一种有前途但尚未充分利用的方法。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标准化教育视频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接受 ART 之前提供 VITAL Start（激励终生治疗依从性的视频干预）来优化她们的 ART 保留率和依从性。
这项多地点平行组随机对照试验评估了一种简短的基于机构的视频干预措施对优化马拉维感染艾滋病毒的孕妇保留和坚持接受抗逆转录病毒治疗的效果。共有 892 名尚未接受 ART 的感染艾滋病毒的孕妇将被随机分配到标准的 ART 前咨询或 VITAL Start。主要结局是开始接受 ART 后 12 个月的保留和依从性（病毒载量 < 1000 拷贝/ml）的复合指标。次要结局包括行为依从性（自我报告的依从性、药房续药和替诺福韦二磷酸浓度）、心理社会影响和资源利用的评估。我们还将通过对患者、伴侣和卫生保健工作者进行调查和定性访谈，检查 VITAL Start 的实施情况，并进行成本效益分析。
这是对一种针对感染艾滋病毒的孕妇的创新的基于机构的视频干预措施的有力评估，有可能改善母婴结局。
ClinicalTrials.gov，NCT03654898。于 2018 年 8 月 31 日注册。
