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.

怀孕期间感染寨卡病毒 (ZIKV) 或先天性 ZIKV 感染 (CZI) 可导致出生缺陷， 出生时可能并不明显，但随着婴儿长大，在后续护理中就会发现。 自 2016 年以来，美国公共卫生部针对患有 CZI 的婴儿制定了指南。 考虑到早期筛查的重要性，可能的 CZI (pCZI) 建议从出生到三岁进行随访 美国领土的最新数据表明，坚持后续护理。 对于这些儿童，包括建议的诊断研究来检测大脑和眼睛异常，是亚 针对 pCZI 儿童的主要照顾者（父母或近亲）的干预措施可能是最佳的。 显着提高儿科服务和临床结果的依从性。大量证据支持这一点。 利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健康教育 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 与传统的教学健康材料相比，拟议的研究将融合这两种文化。 这一新颖且重要的指标的元素建立在我们之前与基于 CHW 的工作相结合的基础上。 通过根据文化定制的互动健康传播内容进行干预，以提高艾滋病毒就诊依从性 艾滋病病毒感染者拉丁裔移民和波多黎各出生的移民已证明这一干预措施具有重要意义。 我们建议对此进行调整，以改善自我效能、心理健康、艾滋病毒耻辱感和患者积极性。 在波多黎各进行干预和试点测试，其中包括不同的人群、pCZI 儿童的照顾者，但 类似的结果，访问依从性，该研究团队由国际公认的传染病领域的领导者组成。 疾病结果研究、儿科、母胎医学、儿童发展和定性研究， 所有人都在 PR 方面拥有丰富的临床和/或研究经验。在 1a 阶段，我们将进行定性研究。 (~n=28) 调整干预措施以提高儿科就诊依从性，以早期诊断异常 与 PR 中的 pCZI 相关 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意见 在第二阶段，我们将进行试点。 对 50 名看护者-儿童二人组进行适应性干预的随机对照试验（n = 25 项干预 vs 25 项干预） n=25 强化护理条件）以评估可行性、可接受性和初步效果证据。 研究将在学术医疗中心和公共卫生系统内进行，提供几乎 3,000 名患有 pCZI 的婴儿处于 PR 主要结果是从基线到后续寨卡服务的依从性。 第 24 周和第 52 周。如果干预措施可行、可接受，并显示出初步效果证据， 然后我们将利用这些结果为 R01 提案提供信息，以便在公关部门进行全面的试验 该干预措施也符合并推动了 NICHD 的努力。 在儿科护理中制定行为干预措施，以改善儿童发育结果。