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

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

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.

Study Overview

• Status: Completed
• Conditions: Adherence, Patient; Zika Virus Infection
• Intervention / Treatment: Behavioral: Community Health Worker

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Inés E García García, MD; Phone Number: 787-777-3225; Email: ines.garcia@upr.edu

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00921
    • School of Medicine - Department of Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community health worker (CHW) group; Participants in the intervention arm will receive 5 one-on-one sessions over 6 months with a CHW, as well as a manual and written materials on child development. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers.	Behavioral: Community Health Worker; Participants will receive 5 one-on-one sessions with a CHW over 6 months.
No Intervention: Enhanced care condition (ECC); Participants in this arm will receive 5 outreach calls at the same interval as the intervention arm, as well as written materials on child development. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adherence to Pediatric Zika Care	At least one pediatric visit for developmental exam with the pediatrician within 6 months post-randomization.	Within the first 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality	Detection of new birth defect or neurodevelopmental abnormality between baseline to month-6.	Within the first 6 months
Number of Participants With Adherence to Pediatric Zika Care	At least two pediatric visits recorded within 12 months post-randomization, with one visit from months 0-6 and months 7-12.	Within the first 12 months
Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality	Detection of new birth defect or neurodevelopmental abnormality between baseline to month-12.	Within the first 12 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Puerto Rico
• Investigators: Principal Investigator: Julie H. Levison, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): November 6, 2022

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: November 25, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Zika virus; Puerto Rico; community health worker
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Disease Attributes; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Infections; Communicable Diseases; Virus Diseases; Zika Virus Infection
• Other Study ID Numbers: 2021p001675; 5R21HD096369-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No