Clinical trial NCT05041439: 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
Overall status: COMPLETED
Phase: NA
Conditions: Zika Virus Infection
Adherence, Patient
Keywords: Zika virus
Puerto Rico
community health worker
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Puerto Rico
First posted: 2021-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Number of Participants With Adherence to Pediatric Zika Care
timeFrame: Within the first 6 months
Secondary outcomes:
measure: Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality
timeFrame: Within the first 6 months
measure: Number of Participants With Adherence to Pediatric Zika Care
timeFrame: Within the first 12 months
measure: Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality
timeFrame: Within the first 12 months
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: School of Medicine - Department of Pediatrics
Study officials:
affiliation: Massachusetts General Hospital
name: Julie H. Levison, MD
role: PRINCIPAL_INVESTIGATOR
References: