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Adherence to Care for Children With Congenital Zika Virus Infection in Puerto Rico

NCT05041439 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-12-15

Study results available
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Summary

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.

Conditions

  • Zika Virus Infection
  • Adherence, Patient

Interventions

BEHAVIORAL

Community Health Worker

Participants will receive 5 one-on-one sessions with a CHW over 6 months.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Puerto Rico

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Julie H. Levison, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2022-08-31
Completion
2022-11-06

Countries

  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05041439 on ClinicalTrials.gov