Adherence to care for Zika-exposed infants in Puerto Rico.

坚持照顾波多黎各感染寨卡病毒的婴儿。

• 批准号: 10013253
• 负责人: Julie Levison
• 金额: $ 20.66万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-10 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10013253
• 关键词: Academic Medical Centers; Adherence; Affect; Age; Attention; Behavior Therapy; Behavioral; Birth; Blindness; Boston; Brain; Caregivers; Caring; Centers for Disease Control and Prevention (U.S.); Child; Child Care; Child Development; Child Health; Childhood; Clinical; Communicable Diseases; Communication Tools; Communities; Community Health Aides; Congenital Abnormality; Data; Development; Diagnosis; Diagnostic; Disease Management; Early Diagnosis; Early Intervention; Elements; Environmental Risk Factor; Epilepsy; Exposure to; Eye; Goals; Guidelines; HIV; Health; Health Communication; Health Personnel; Health Services; Health behavior; Health education; Health system; Immigrant; Individual; Infant; International; Intervention; Laboratories; Latino; Lead; Life; Logistics; Maternal-fetal medicine; Mental Health; Methods; Microcephaly; Migrant; Multimedia; National Institute of Child Health and Human Development; Neurologic; Ophthalmology; Outcome; Outcomes Research; Parents; Participant; Patients; Pediatrics; Phase; Pilot Projects; Population; Pregnancy; Pregnant Women; Problem Solving; Procedures; Protocols documentation; Public Health; Publishing; Puerto Rican; Puerto Rico; Qualitative Research; Quality of life; Randomized; Randomized Controlled Trials; Research; Self Efficacy; Services; Structure; Technology; Testing; Training; Vulnerable Populations; Work; World Health Organization; ZIKA; ZIKV infection; Zika Virus; barrier to care; base; caregiver interventions; child health care service; child services; clinical research site; disorder prevention; experience; follow-up; health care service; health related quality of life; health service use; hearing impairment; hearing screening; improved; infant outcome; informant; intervention effect; multidisciplinary; neuroimaging; novel; primary caregiver; primary outcome; public health emergency; randomized trial; reinforced behavior; research and development; research study; secondary outcome; social stigma; theories; transforming virus; trial comparing; visit adherence

Zika virus (ZIKV) infection during pregnancy, or congenital ZIKV infection (CZI), can lead to birth defects that may not be apparent at birth but are identified in follow-up care as infants grow older. Puerto Rico (PR) has the most confirmed CZI cases of any US territory. Since 2016, PR Department of Health guidelines for infants with possible CZI (pCZI) recommend follow-up from birth to age three years given the importance of early intervention on child development. Recent data for the U.S. territories show that adherence to follow-up care for these children, including recommended diagnostic studies to detect brain and eye anomalies, is sub- optimal. Interventions targeting primary caregivers (parents or close relatives) of children with pCZI could significantly improve adherence to pediatric services and clinical outcomes. Extensive evidence supports the use of both trained community health workers (CHWs) to provide basic health education in disease prevention and management, and narrative-based stories to evoke stronger attitudinal, normative, and behavioral shifts compared to traditional didactic health materials. The proposed studies will merge these two culturally-attuned elements for this novel and important indication. They build on our previous work that paired a CHW-based intervention with culturally-tailored interactive health communication content to improve HIV visit adherence in HIV+ Latino immigrants and Puerto Rican-born migrants. That intervention has demonstrated significant improvements in self-efficacy, mental health, HIV stigma and patient activation. We propose adapting this intervention and pilot testing it in Puerto Rico, with a different population, caregivers of children with pCZI, but a similar outcome, visit adherence. The research team comprises internationally-recognized leaders in infectious disease outcomes research, pediatrics, maternal-fetal medicine, child development, and qualitative research, all with extensive clinical and/or research experience in PR. In Phase 1a, we will conduct a qualitative study (~n=28) to adapt the intervention to improve pediatric visit adherence for early diagnosis of abnormalities associated with pCZI in PR. In Phase 1b, we will use the qualitative research and community advisory board input to modify the intervention protocol and health communication tool. In Phase 2, we will conduct a pilot randomized controlled trial of the adapted intervention with 50 caregiver-child dyads (n=25 intervention vs. n=25 enhanced care condition) to assess feasibility, acceptability, and preliminary evidence of effect. The study will occur within an academic medical center and public health system providing exposure to nearly 3,000 infants with pCZI in PR. The primary outcome is adherence to follow-up Zika services from baseline to weeks-24 and 52. If the intervention is feasible, acceptable, and demonstrates preliminary evidence of effect, then we will use the results to inform an R01 proposal for a fully-powered trial across the PR Department of Health Regional Pediatric Centers. This intervention is also consistent with and advances NICHD’s efforts to develop behavioral interventions within pediatric care to improve child development outcomes.

怀孕期间的寨卡病毒（ZIKV）感染或先天性ZIKV感染（CZI）会导致出生缺陷 随着婴儿的年龄增长，出生时可能并不明显，但在随访中被发现。波多黎各（PR）有 大多数确认的美国领土的CZI案件。自2016年以来，PR卫生部针对婴儿 鉴于早期的重要性，可能的CZI（PCZI）建议从出生到三岁的随访 开发儿童的干预。美国领土的最新数据表明，坚持后续护理 对于这些儿童，包括建议检测脑和眼异常的建议诊断研究，是 最佳的。针对患有PCZI儿童的初级护理人员（父母或近亲）的干预措施可以 显着提高了对小儿服务和临床结果的依从性。大量证据支持 使用两位受过训练的社区卫生工作者（CHW）来提供预防疾病的基本健康教育 和管理和基于叙事的故事，以唤起更强的态度，正常和行为转变 与传统的教学材料相比。拟议的研究将合并这两个文化属性 这个小说和重要迹象的要素。他们以我们以前的作品为基础，该作品配对了基于CHW的 使用文化范围的互动健康沟通内容进行干预，以改善艾滋病毒访问依从性 艾滋病毒+拉丁裔移民和波多黎各人出生的移民。这种干预表现出了重要的 自我效能感，心理健康，艾滋病毒污名和患者激活的改善。我们建议适应这个 干预和试点在波多黎各进行了不同人口，患有PCZI的儿童的护理人员，但 类似的结果，请参观依从性。研究团队包括国际认可的传染性领导者 疾病结果研究，儿科，母亲医学，儿童发展和定性研究， 所有这些都具有广泛的PR临床和/或研究经验。在第1A阶段，我们将进行定性研究 （〜n = 28）调整干预措施以改善儿科访问依从性以早期诊断异常 与PR中的PCZI相关。在第1B期中，我们将使用定性研究和社区顾问委员会 输入以修改干预协议和健康通信工具。在第二阶段，我们将进行飞行员 与50个护理人孩子二元组的改编干预措施的随机对照试验（n = 25干预vs。 n = 25增强的护理条件），以评估可行性，可接受性和初步效果证据。 研究将发生在一个学术医疗中心和公共卫生系统中 3,000名患有PCZI的婴儿。主要结果是遵守从基准到后续Zika服务的遵守 第24周和第52周。如果干预是可行的，可以接受的，并证明了初步的作用证据 然后，我们将使用结果为R01提案提供信息 卫生区域小儿中心。这种干预也与NICHD的努力相一致，并促进 在小儿护理中制定行为干预措施，以改善儿童成长结果。