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Completed

NCT Number: NCT05041439

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

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.

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Key information

Conditions

Zika Virus Infection Adherence, Patient Arbovirus Infections Behavior Flaviviridae Infections Flavivirus Infections Health Behavior Infections Mosquito-Borne Diseases Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Treatment Adherence and Compliance Vector Borne Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Medicine - Department of Pediatrics

San Juan, PR, 00921, Puerto Rico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Community health worker

Behavioral

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

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 13, 2021
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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