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临床试验/NCT05041439
NCT05041439已完成不适用

Adherence to Care for Children Born to Mothers With Laboratory Evidence of Confirmed or Possible Congenital Zika Virus Infection During Pregnancy.

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Number of Participants With Adherence to Pediatric Zika Care

研究概览

简要总结

Given the magnitude of the epidemic in Puerto Rico, congenital Zika virus infection may have devastating complications to a significant population of children, also affecting families and society at large. This proposal takes a critical first step to ensuring that children with exposure to congenital Zika virus infection receive the follow-up care they need for optimal clinical outcomes. We anticipate that lessons learned from this study may also positively impact models for adherence to early intervention services in Puerto Rico.

详细描述

Overview:

Participants will be the primary caregivers (age ≥18 years) of children with possible congenital Zika virus infection. Participants will be recruited from the pediatric services of the University of Puerto Rico Medical Sciences Campus (UPR-MSC), as well as other clinics and community-based organizations in Puerto Rico. In the intervention, a community health worker (CHW) will deliver personalized sessions framed around a multi-media health communication tool. The CHW will deliver the intervention over a 6-month period.

Study procedures:

Participants will be the primary caregivers (age ≥18 years) of children with possible congenital Zika virus infection. Participants will be recruited via provider referral, peer referral, and flyers. Once an individual expresses interest in the study, a study staff member will screen that individual to assess eligibility. Individuals who are eligible will be invited to enroll through an informed consent process and complete a baseline interview. After completion of the baseline interview, study staff will randomize participants into an enhanced control condition (ECC) or intervention condition that receives an individually-tailored community health worker intervention. At trial exit, all participants, including the ECC group, will complete an in-depth assessment to measure their barriers to follow-up Zika-related pediatric services and provide feedback about their experience in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older and able to communicate in Spanish
  • Being the primary caregiver of a child with possible congenital Zika virus infection

排除标准

  • Those who are too sick/unable to understand the implications of their participation, those who are unwilling to participate.

结局指标

主要结局

Number of Participants With Adherence to Pediatric Zika Care

时间窗: Within the first 6 months

At least one pediatric visit for developmental exam with the pediatrician within 6 months post-randomization.

次要结局

  • Number of Participants With Adherence to Pediatric Zika Care(Within the first 12 months)
  • Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality(Within the first 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julie H Levison

Assistant Physician

Massachusetts General Hospital

研究点 (2)

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