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.

寨卡病毒（ZIKV）感染在怀孕期间，或先天性ZIKV感染（CZI），可导致出生缺陷， 出生时可能不明显，但随着婴儿长大，在后续护理中会发现。波多黎各（PR）拥有 美国境内确诊的CZI病例最多自2016年以来，PR卫生部针对患有 可能的CZI（pCZI）建议从出生到3岁进行随访，因为早期 对儿童发展的干预。美国领土的最新数据显示， 对于这些儿童，包括推荐的诊断研究，以检测大脑和眼睛异常，是低于 最佳针对pCZI儿童的主要照顾者（父母或近亲）的干预措施可能 显著提高儿科服务的依从性和临床结果。大量证据支持 使用经过培训的社区卫生工作者（CHW）提供疾病预防方面的基本卫生教育 和管理，以及基于叙事的故事，以唤起更强烈的态度，规范和行为转变 与传统的健康教育材料相比。拟议的研究将合并这两个文化协调， 这一新的重要适应症的要素。他们建立在我们以前的工作，配对一个基于CHW的 采用文化定制互动式健康传播内容进行干预，以提高艾滋病毒患者的就诊依从性， 艾滋病毒阳性拉丁裔移民和波多黎各出生的移民。这一干预行动表明， 自我效能、心理健康、艾滋病毒污名化和患者积极性的改善。我们建议调整这个 干预和试点测试它在波多黎各，与不同的人口，照顾儿童与pCZI，但 随访依从性结局相似。该研究团队由国际公认的传染病领域的领导者组成， 疾病结局研究、儿科学、母胎医学、儿童发育和定性研究， 在1a期，我们将进行定性研究， （~n=28）调整干预措施，以提高儿科访视依从性，以便早期诊断异常 在第1b阶段，我们将使用定性研究和社区咨询委员会， 修改干预方案和健康沟通工具的输入。在第二阶段，我们将进行试点 随机对照试验的适应性干预与50个双胞胎儿童（n=25干预与。 n=25增强护理条件），以评估可行性、可接受性和效果的初步证据。的 研究将在一个学术医疗中心和公共卫生系统内进行， 3，000名PR中患有pCZI的婴儿。主要结局是从基线到基线的随访Zika服务的依从性。 第24和52周。如果干预是可行的、可接受的，并显示出初步的效果证据， 然后，我们将使用结果通知R 01提案，以便在整个公关部门进行全面试验， 健康区域儿科中心。这一干预也符合并推动了NICHD的努力， 在儿科护理中制定行为干预措施，以改善儿童发展成果。