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

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Community health worker (CHW) group	Community Health Worker	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adherence to Pediatric Zika Care	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	Within the first 12 months	Detection of new birth defect or neurodevelopmental abnormality between baseline to month-12.