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

Overview

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.

Full Title of Study: “Adherence to Care for Children Born to Mothers With Laboratory Evidence of Confirmed or Possible Congenital Zika Virus Infection During Pregnancy.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 31, 2022

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.

Interventions

  • Behavioral: Community Health Worker
    • Participants will receive 5 one-on-one sessions with a CHW over 6 months.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Collaborator
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Julie H Levison, Assistant Physician – Massachusetts General Hospital
  • Overall Official(s)
    • Julie H. Levison, MD, Principal Investigator, Massachusetts General Hospital

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