Adherence, Patient, Zika Virus Infection
Conditions
Keywords
Zika virus, Puerto Rico, community health worker
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.
Interventions
BEHAVIORALCommunity Health Worker
Participants will receive 5 one-on-one sessions with a CHW over 6 months.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Puerto Rico
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adherence to Pediatric Zika Care | Within the first 6 months | At least one pediatric visit for developmental exam with the pediatrician within 6 months post-randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality | Within the first 6 months | Detection of new birth defect or neurodevelopmental abnormality between baseline to month-6. |
| Number of Participants With Adherence to Pediatric Zika Care | Within the first 12 months | At least two pediatric visits recorded within 12 months post-randomization, with one visit from months 0-6 and months 7-12. |
Countries
Puerto Rico
Participant flow
Pre-assignment details
60 participants were screened for eligibility and 50 were consented/enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Community Health Worker: Participants will receive 5 one-on-one sessions with a CHW over 6 months. | 25 |
| 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. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Community Health Worker (CHW) Group | Enhanced Care Condition (ECC) | Total |
|---|---|---|---|
| Age, Continuous | 34.9 years STANDARD_DEVIATION 7.6 | 30.2 years STANDARD_DEVIATION 5.9 | 32.6 years STANDARD_DEVIATION 7.1 |
| Baseline sociodemographic and clinical characteristics of randomized participants | 25 Participants | 25 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 25 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Amerian Indian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Multiracial | 12 Participants | 13 Participants | 25 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 7 Participants | 13 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 4 Participants | 0 Participants | 4 Participants |
| Sex: Female, Male Female | 24 Participants | 24 Participants | 48 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 1 / 25 | 0 / 25 |
Outcome results
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.
Time frame: Within the first 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Community Health Worker (CHW) Group | Number of Participants With Adherence to Pediatric Zika Care | 14 Participants |
| Enhanced Care Condition (ECC) | Number of Participants With Adherence to Pediatric Zika Care | 15 Participants |
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.
Time frame: Within the first 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Community Health Worker (CHW) Group | Number of Participants With Adherence to Pediatric Zika Care | 6 Participants |
| Enhanced Care Condition (ECC) | Number of Participants With Adherence to Pediatric Zika Care | 5 Participants |
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.
Time frame: Within the first 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Community Health Worker (CHW) Group | Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality | 1 Participants |
| Enhanced Care Condition (ECC) | Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality | 3 Participants |
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.
Time frame: Within the first 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Community Health Worker (CHW) Group | Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality | 1 Participants |
| Enhanced Care Condition (ECC) | Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality | 4 Participants |