Adherence to Care for Children Born to Mothers With Laboratory Evidence of Confirmed or Possible Congenital Zika Virus Infection During Pregnancy.
Phase: NA
Conditions: Zika Virus Infection, Adherence, Patient
Sponsor: Massachusetts General Hospital

Official title: Adherence to Care for Children With Congenital Zika Virus Infection in Puerto Rico 
NCT number:  NCT05041439 
Document date: 08/18/2023 
 
 
 
Adherence to Care for Children With Congenital Zika Virus Infection in Puerto Rico 
NCT05041439 
August 18, 2023 
 
 
PI: Julie H. Levison, MD, MPhil, MPH 
R21HD096369   
 
 
Brief Study Protocol and Methods 
 
 

Official title: Adherence to Care for Children With Congenital Zika Virus Infection in Puerto Rico 
NCT number:  NCT05041439 
Document date: 08/18/2023 
 
Puerto Rico Department of Health (DOH) guidelines for follow-up of children with possible congenital Zika virus 
infection recommend developmental monitoring every 6 months from 12 to 60 months of age. We conducted a 
pilot randomized trial of Aquí Para Ti, a 5-session theory-based psychosocial intervention delivered by a 
community health worker that uses a problem-solving approach and tailored health communication tools to 
improve adherence to pediatric care. 
 
Intervention design 
 
We recruited caregiver-child dyads to observe outcomes in both. We randomly assigned 50 caregiver-child dyad 
participants through computer-generated allocation sequence to either the intervention (n=25) or an enhanced 
control condition (n=25) (ECC). This sample size is consistent with recommendations for randomized pilot 
studies for preliminary estimation of effect sizes and lower bounds. Randomization occurred at the level of the 
individual participant, stratified by clinic and the presence or absence of congenital abnormality in the child at 
the time of enrollment.  
 
Community health worker (CHW) group: The intervention, Aquí Para Ti, is by delivered community health 
workers (CHWs). In this pilot randomized trial, the CHW was a Spanish-speaking clinical research coordinator 
with experience in public health and a bachelor’s degree. Study staff devoted significant time to training the CHW 
in the intervention protocol. Members of the study staff who developed the intervention were an infectious 
diseases physician, psychologist, and pediatrician/neonatologists. They trained the CHW in the intervention 
manual. Due to public health requirements of the COVID-19 public health emergency, CHW training occurred 
by video conference and involved training in HIPAA-compliance, basic neurodevelopment, congenital Zika virus 
infection, and the intervention manual. Training occurred through didactic sessions, role-playing, and audio 
recording of practice sessions with opportunities for feedback. CHWs were supervised in weekly one-hour 
sessions by videoconference, which allowed for problem-solving issues raised in the sessions. 
 
Participants randomized to the intervention received 5 one-hour sessions with the CHW over six months. 
Sessions occurred by video conference due to the COVID-19 pandemic public health restrictions. Each session 
focused on barriers to pediatric Zika services that were raised in our preceding qualitative research. Session 1 
is an orientation to the program and focuses on setting goals and balancing priorities. Session 2 focuses on 
understanding the importance of pediatric care, child development, and the role of the Ages and Stages 
Questionnaire in monitoring child development. Session 3 focuses on communicating with the pediatrician. 
Session 4 focuses on training the caregiver in skills for telehealth. Session 5 focuses on reviewing themes from 
the prior sessions to prepare for future barriers to adherence to pediatrics services. 
 
At each session, the CHW elicits the participant’s knowledge (e.g. importance of adherence to pediatric services, 
caregiver burden, perceived need for pediatric care). The CHW evokes and selectively reinforces the 
participant’s self-motivational statements, focusing on empathy, eliciting change talk, addressing barriers 
through problem-solving, and promoting self-efficacy. A key feature is the development of activation and self-
efficacy to engage in adherence so that participants can sustain adherence behavior. Each visit closes with 
defining action steps and practice assignments (e.g. finding transportation, meeting with the pediatrician). The 
sessions incorporate multimedia health communication content developed by the research team with a 
multimedia company based on formative research with caregivers of children with congenital Zika virus infection 
in Puerto Rico and their providers. The health communication tools focus on barriers to Zika services and 
communication with pediatric providers. 
 
Enhanced care condition (ECC): In ECC, participants receive brief five locator outreach calls over 6 months. The 
CHW also offers printed educational material from the Puerto Rico Department of Health on child development. 
No navigation services are provided. We chose an ECC design with a general wellness component to reduce 
the likelihood that intervention effects detected in the intervention arm were not due to nonspecific characteristics 
such as interaction with study staff. 
 

Official title: Adherence to Care for Children With Congenital Zika Virus Infection in Puerto Rico 
NCT number:  NCT05041439 
Document date: 08/18/2023 
 
     Data elements: The primary outcome was attendance in ≥1 routine pediatric appointment in months 0–6 
post-randomization. The secondary outcomes were attendance in routine pediatric care in both months 0–6 
and 7–12 and detection of a new Zika-associated neurodevelopmental abnormalities at months 0–6 and 0–6 
and 7–12. An appointment was defined as a routine outpatient pediatric appointment for neurodevelopmental 
monitoring. A neurodevelopmental abnormality was based on consensus guidelines from the University of 
Puerto Rico School of Medicine Medical Sciences Department of Pediatrics and Puerto Rico Department of 
Health criteria, which were based on Centers for Disease Control definitions of anomalies possibly associated 
with congenital Zika virus infection. Medical records were from the Puerto Rico Department of Health and the 
University of Puerto Rico Medical Sciences Campus High Risk Clinic in the Department of Pediatrics. Two 
independent reviewers blinded to participant allocation extracted outcomes from medical records. 
    Statistical analysis: Participant sociodemographic and clinical characteristics were summarized by 
intervention allocation with Chi-square tests and t-tests. The primary analysis used the intention-to-treat 
approach. The primary analysis compared those randomized to the intervention compared with those 
randomized to the enhanced control condition. We compared the detection rate of a new birth defect or 
neurodevelopmental abnormality possibly associated with congenital Zika virus infection for each participant 
from baseline to month 6 and baseline to month 12 using Fisher’s exact tests.