VITAL Start (Video-intervention to Inspire Treatment Adherence for Life): Brief facility based video intervention to improve retention and adherence to ART among pregnant and breastfeeding women

摘要 我们建议评估重要的开始，一个简短的设施的影响，实施和成本效益- 在一项多中心随机对照试验中，对HIV阳性（HIV+）孕妇进行基于视频的干预 (RCT)主要复合结局为保持和依从性（病毒抑制）12 开始抗逆转录病毒治疗（ART）后3个月。 普及艾滋病毒检测和治疗可以加快人口一级抗逆转录病毒疗法的启动， 实现联合国艾滋病规划署的90-90-90目标。马拉维率先采用了备选方案B+（B+），这是一种新的测试和治疗方法 为艾滋病毒阳性孕妇和哺乳期妇女提供终身抗逆转录病毒治疗。虽然母亲接受抗逆转录病毒疗法 改善了7倍，保留和粘附仍然不理想：两年后仅保留了59%， 其中，只有三分之二的人达到了适当的抗逆转录病毒治疗依从性。其他B+国家正在观察陡峭的 保持率下降。原因是多方面的;感觉健康的女性没有准备好承诺 终身抗逆转录病毒治疗;由于对医护人员的需求增加而导致咨询不足;以及有限伴侣 影响保留和遵守的披露。迫切需要采取循证干预措施， 提高保留率和坚持率，可以很容易地纳入过度扩张的卫生系统。 使用形成性参与研究，应用理论框架和基于证据的信息 框架技术，我们创造了一个创新的37分钟的视频为基础的干预孕妇 新启动的艺术。视频通过提供一个重要的开始（视频），促进保留和坚持 在承诺之前的关键可教时刻， 初步研究结果表明，患者和HCW的满意度较高， 知识、合作伙伴披露率和保留率。有了这些有希望的结果，拟议的研究 旨在严格评估VITAL Start的影响、实施和成本效益。的样品 796名HIV阳性孕妇将按1：1的比例随机接受VITAL Start或标准治疗 在开始ART治疗前进行咨询。主要终点将是保留和依从性的复合终点 （病毒学抑制），在ART开始后12个月。次要结局包括自我报告的 依从性、药房数据和二磷酸替诺福韦试验。我们还将审查VITAL的交付情况 通过对患者、合作伙伴和HCW的调查和访谈开始，并进行成本效益分析。 如果成功的话，VITAL Start将提供一种干预措施，（1）在一定程度上改善和提高咨询服务， 关键的教学时刻，通过参与和文化敏感的经验，（2）是廉价的， 可快速扩展，而不会减缓ART扩展，以及（3）允许更有效地使用宝贵的HCW 时间在与马拉维卫生部长期合作的基础上，我们准备支持 如果结果有希望，则快速传播VITAL Start。

Abstract We propose to evaluate the impact, implementation and cost effectiveness of VITAL Start, a brief facility- based video intervention for HIV-positive (HIV+) pregnant women, in a multisite randomized controlled trial (RCT) in Malawi with the primary composite outcome of retention and adherence (viral suppression) 12 months after starting antiretroviral therapy (ART). Universal HIV testing and treatment can accelerate population-level ART initiation and is critical to realize the UNAIDS 90-90-90 goals. Malawi pioneered Option B+ (B+), a novel application of test-and-treat that provided life-long ART for HIV+ pregnant and breastfeeding women. While maternal ART uptake improved 7-fold, retention and adherence remained suboptimal: only 59% were retained after two years, and of these, only two-thirds achieved adequate ART adherence. Other B+ countries are observing steep drops in retention. Reasons are multi-factorial; women who feel healthy are unprepared to commit to lifelong ART; inadequate counseling due to increased demands on healthcare workers; and limited partner disclosure affecting retention and adherence. There is an urgent need for evidence-based interventions to improve retention and adherence that can be easily incorporated into overextended health systems. Using formative participatory research, applied theoretical frameworks, and evidence-based message framing techniques, we created an innovative 37-minute video-based intervention for pregnant women newly initiating ART. The video promotes retention and adherence by providing a VITAL Start (Video intervention to Inspire Treatment Adherence for Life) at the critical teachable moment before committing to lifelong ART. Preliminary findings suggest high levels of patient and HCW satisfaction, and improved ART knowledge, rates of partner disclosure, and retention. With these promising results, the proposed study aims to rigorously evaluate the impact, implementation, and cost-effectiveness of VITAL Start. A sample of 796 HIV+ pregnant women will be randomized on a 1:1 basis to receive VITAL Start or standard of care counseling prior to ART initiation. The primary endpoint will be a composite of retention and adherence (virologic suppression), at 12 months post ART initiation. Secondary outcomes include self-reported adherence, pharmacy data, and tenofovir diphosphate testing. We will also examine the delivery of VITAL Start via surveys and interviews with patients, partners, and HCW and conduct cost-effectiveness analyses. If successful, VITAL Start will provide an intervention that (1) standardizes and improves counseling at a critical teaching moment through an engaging and culturally sensitive experience, (2) is inexpensive and rapidly scalable without decelerating ART expansion, and (3) allows more efficient use of precious HCW time. Building on a longstanding collaboration with the Malawi Ministry of Health, we are poised to support rapid dissemination of VITAL Start if the results are promising.