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

Adherence, Patient Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05041439
• Other study ID #: 2021p001675
• Secondary ID: 5R21HD096369-02
• Status: Completed
• Phase: N/A
• Start date: July 6, 2021
• Est. completion date: November 6, 2022

Study information

• Verified date: November 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 6, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Adherence, Patient
• Communicable Diseases
• Infections
• Virus Diseases
• Zika Virus Infection

Intervention

Behavioral:
• Community Health Worker
Participants will receive 5 one-on-one sessions with a CHW over 6 months.

Locations

Country	Name	City	State
Puerto Rico	School of Medicine - Department of Pediatrics	San Juan

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Puerto Rico

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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