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

Primary Purpose

Zika Virus Infection, Adherence, Patient

Status
Unknown status
Phase
Not Applicable
Locations
Puerto Rico
Study Type
Interventional
Intervention
Community Health Worker
Sponsored by
University of Puerto Rico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Zika Virus Infection focused on measuring Zika virus, Puerto Rico, community health worker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • School of Medicine - Department of PediatricsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Community health worker (CHW) group

Enhanced care condition (ECC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adherence to pediatric Zika care
At least one pediatric visit for developmental exam with the pediatrician within 6 months post-randomization

Secondary Outcome Measures

Detection of Zika-associated birth defect or neurodevelopmental abnormality
Detection of new birth defect or neurodevelopmental abnormality between baseline to month-6 and baseline to month-12
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

Full Information

First Posted
September 2, 2021
Last Updated
September 2, 2021
Sponsor
University of Puerto Rico
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05041439
Brief Title
Adherence to Care for Children With Congenital Zika Virus Infection in Puerto Rico
Official Title
Adherence to Care for Children Born to Mothers With Laboratory Evidence of Confirmed or Possible Congenital Zika Virus Infection During Pregnancy.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Puerto Rico
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zika Virus Infection, Adherence, Patient
Keywords
Zika virus, Puerto Rico, community health worker

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Community health worker (CHW) group
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced care condition (ECC)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Community Health Worker
Intervention Description
Participants will receive 5 one-on-one sessions with a CHW over 6 months.
Primary Outcome Measure Information:
Title
Adherence to pediatric Zika care
Description
At least one pediatric visit for developmental exam with the pediatrician within 6 months post-randomization
Time Frame
Within the first 6 months
Secondary Outcome Measure Information:
Title
Detection of Zika-associated birth defect or neurodevelopmental abnormality
Description
Detection of new birth defect or neurodevelopmental abnormality between baseline to month-6 and baseline to month-12
Time Frame
Within the first 6 months and 12 months
Title
Adherence to pediatric Zika care
Description
At least two pediatric visits recorded within 12 months post-randomization, with one visit from months 0-6 and months 7-12
Time Frame
Within the first 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Inés E García García, MD
Phone
787-777-3225
Email
ines.garcia@upr.edu
Facility Information:
Facility Name
School of Medicine - Department of Pediatrics
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inés E García García, MD
Phone
787-777-3225
Email
ines.garcia@upr.edu

12. IPD Sharing Statement

Learn more about this trial

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

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