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

NCT ID: NCT05041439

Last Updated: 2023-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-06
• Study Completion Date: 2022-11-06

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.

Conditions

Zika Virus Infection; Adherence, Patient

Keywords

Zika virus; Puerto Rico; community health worker

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Community health worker (CHW) group

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.

Group Type: EXPERIMENTAL

Community Health Worker

Intervention Type: BEHAVIORAL

Participants will receive 5 one-on-one sessions with a CHW over 6 months.

Enhanced care condition (ECC)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Community Health Worker

Participants will receive 5 one-on-one sessions with a CHW over 6 months.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Puerto Rico

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Julie H Levison

Assistant Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie H. Levison, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

School of Medicine - Department of Pediatrics

San Juan, PR, Puerto Rico

Countries

Puerto Rico

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5R21HD096369-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2021p001675

Identifier Type: -

Identifier Source: org_study_id