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

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ClinicalTrials.gov Identifier: NCT05041439
Recruitment Status : Recruiting
First Posted : September 13, 2021
Last Update Posted : September 13, 2021
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Massachusetts General Hospital
Information provided by (Responsible Party):
University of Puerto Rico

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Zika Virus Infection Adherence, Patient Behavioral: Community Health Worker Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Adherence to Care for Children Born to Mothers With Laboratory Evidence of Confirmed or Possible Congenital Zika Virus Infection During Pregnancy.
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Detection of Zika-associated birth defect or neurodevelopmental abnormality [ Time Frame: Within the first 6 months and 12 months ]
    Detection of new birth defect or neurodevelopmental abnormality between baseline to month-6 and baseline to month-12

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05041439


Contacts
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Contact: Inés E García García, MD 787-777-3225 ines.garcia@upr.edu

Locations
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Puerto Rico
School of Medicine - Department of Pediatrics Recruiting
San Juan, Puerto Rico, 00921
Contact: Inés E García García, MD    787-777-3225    ines.garcia@upr.edu   
Sponsors and Collaborators
University of Puerto Rico
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Massachusetts General Hospital
More Information
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Responsible Party: University of Puerto Rico
ClinicalTrials.gov Identifier: NCT05041439    
Other Study ID Numbers: 0420121
5R21HD096369-02 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2021    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Puerto Rico:
Zika virus
Puerto Rico
community health worker
Additional relevant MeSH terms:
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Zika Virus Infection
Infections
Communicable Diseases
Virus Diseases
Disease Attributes
Pathologic Processes
 Arbovirus Infections
Vector Borne Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections