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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Zika Virus Infection, Adherence, Patient

Intervention / Treatment
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* Behavioral: Community Health Worker


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community health worker (CHW) group<br>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<br>* Participants will receive 5 one-on-one sessions with a CHW over 6 months.<br>|
| No Intervention: Enhanced care condition (ECC)<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zika virus, Puerto Rico, community health worker