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

NCT05041439 | Completed Results DMC

• 2 other identifiers: 2021p0016755R21HD096369-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Zika Virus Infection; Adherence, Patient

Keywords

Zika virus; Puerto Rico; community health worker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality

  Within the first 6 months

• Number of Participants With Adherence to Pediatric Zika Care

  Within the first 12 months

• Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality

  Within the first 12 months

Study Arms (2)

Community health worker (CHW) group

EXPERIMENTAL

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

Enhanced care condition (ECC)

NO INTERVENTION

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.

Interventions

Community Health Worker BEHAVIORAL

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

Community health worker (CHW) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older and able to communicate in Spanish
• Being the primary caregiver of a child with possible congenital Zika virus infection

You may not qualify if:

• Those who are too sick/unable to understand the implications of their participation, those who are unwilling to participate.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Puerto Rico: collaborator

Study Sites (1)

School of Medicine - Department of Pediatrics

San Juan, PR, 00921, Puerto Rico

Location

MeSH Terms

Conditions

Zika Virus Infection; Patient Compliance

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Julie H Levison
• Organization: Massachusetts General Hospital

jlevison@mgb.org

(617) 724-4698

Study Officials

• Julie H. Levison, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Physician

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 13, 2021
• Study Start: July 6, 2021
• Primary Completion: August 31, 2022
• Study Completion: November 6, 2022
• Last Updated: December 15, 2023
• Results First Posted: December 15, 2023

Record last verified: 2023-11

Locations

PR (1)