N/A N=50 Randomized Single-blind Supportive Care

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

Zika Virus Infection · Adherence, Patient

Bottom Line

View on ClinicalTrials.gov: NCT05041439 ↗

Enrolled (actual)

Serious AEs

2.0%

Results posted

Dec 2023

Primary outcome: Primary: Number of Participants With Adherence to Pediatric Zika Care — 14; 15 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Community Health Worker (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Aug 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adherence to Pediatric Zika Care	6; 5	—
SECONDARY Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality	1; 4	—
SECONDARY Number of Participants With Adherence to Pediatric Zika Care	6; 5	—
SECONDARY Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality	1; 4	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05041439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.