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

VITAL Start（视频干预，以激发终生治疗依从性）：基于设施的简短视频干预，以提高孕妇和哺乳期妇女对 ART 的保留和依从性

• 批准号: 10089483
• 负责人: Maria Hyoun Kim
• 金额: $ 52.88万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-01 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10089483
• 关键词: 15 year old; Acquired Immunodeficiency Syndrome; Address; Adherence; Adoption; Affect; Africa; Africa South of the Sahara; Behavior; Breast Feeding; Child; Clinic; Collaborations; Cost Effectiveness Analysis; Counseling; Country; Data; Diphosphates; Disclosure; Drops; Education; Educational process of instructing; Effectiveness; Ensure; Evidence based intervention; Face; Floods; Fostering; Goals; HIV; HIV Seropositivity; HIV therapy; Health; Health Personnel; Health system; Human immunodeficiency virus test; Individual; Intervention; Interview; Knowledge; Knowledge acquisition; Life; Malawi; Maternal Health; Measures; Modeling; Motivation; Outcome; Patient Care; Patient Self-Report; Patients; Pharmacy facility; Population; Pregnant Women; Provider; Quality of Care; Randomized; Randomized Controlled Trials; Research; Resources; Sampling; Self Efficacy; Social support; Standardization; Surveys; Techniques; Tenofovir; Testing; Time; Vertical Disease Transmission; Viral; Viral Load result; Wait Time; Woman; antiretroviral therapy; base; behavior change; behavioral adherence; burnout; comparative cost effectiveness; cost; cost effective; cost effectiveness; evidence base; experience; implementation cost; improved; infant outcome; innovation; literacy; maternal outcome; multidisciplinary; novel; pandemic disease; pediatric human immunodeficiency virus; pregnant; preservation; prevent; primary endpoint; primary outcome; psychosocial; public health relevance; satisfaction; secondary outcome; service uptake; skills; standard of care; therapy adherence; tool; treatment adherence; uptake; virology

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.

抽象的 我们建议评估 VITAL Start（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，针对 HIV 阳性 (HIV+) 孕妇进行基于视频的干预 （随机对照试验）在马拉维进行，主要综合结果是保留和坚持（病毒抑制）12 开始抗逆转录病毒治疗（ART）几个月后。 普遍的艾滋病毒检测和治疗可以加速人口层面的抗逆转录病毒治疗的启动，对于 实现联合国艾滋病规划署的 90-90-90 目标。马拉维首创了选项 B+ (B+)，这是一种检测与治疗的新颖应用 为艾滋病病毒感染者孕妇和哺乳期妇女提供终身抗逆转录病毒治疗。当母亲接受 ART 治疗时 改善了 7 倍，保留率和依从性仍不理想：两年后仅保留 59%， 其中，只有三分之二的人达到了足够的 ART 依从性。其他 B+ 国家的情况也十分严峻 保留率下降。原因是多方面的；感觉健康的女性还没有准备好做出承诺 终身艺术；由于对医护人员的要求增加，咨询不足；和有限合伙人 影响保留和遵守的披露。迫切需要基于证据的干预措施 提高保留率和依从性，可以轻松纳入过度扩张的卫生系统。 利用形成性参与性研究、应用理论框架和基于证据的信息 框架技术，我们为孕妇创建了一个创新的 37 分钟视频干预 新开始ART。该视频通过提供重要的开始（视频 在承诺之前的关键教学时刻进行干预以激发终生治疗依从性） 终生的艺术。初步结果表明患者和医护人员满意度较高，并且 ART 得到改善 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。的样本 796 名 HIV+ 孕妇将按照 1:1 的比例随机分配接受 VITAL Start 或标准护理 ART 开始前的咨询。主要终点将是保留率和依从性的综合结果 （病毒学抑制），在 ART 开始后 12 个月。次要结果包括自我报告 依从性、药房数据和二磷酸替诺福韦测试。我们还将检查 VITAL 的交付情况 首先对患者、合作伙伴和医护人员进行调查和访谈，并进行成本效益分析。 如果成功，VITAL Start 将提供干预措施，(1) 标准化并改善咨询服务 通过引人入胜且文化敏感的体验来实现关键的教学时刻，(2) 成本低廉且 快速扩展，而不减慢 ART 的扩展，(3) 允许更有效地利用宝贵的 HCW 时间。基于与马拉维卫生部的长期合作，我们准备支持 如果结果有希望，则可以快速传播 VITAL Start。