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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21HD096369-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| University of Puerto Rico | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Health Worker | Behavioral | Participants will receive 5 one-on-one sessions with a CHW over 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within the first 6 months |
| Number of Participants With Adherence to Pediatric Zika Care |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie H. Levison, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Medicine - Department of Pediatrics | San Juan | PR | 00921 | Puerto Rico |
60 participants were screened for eligibility and 50 were consented/enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Within the first 6 months |
|
The monitoring for adverse events was over the 12 months of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complications of diabetes | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julie H Levison | Massachusetts General Hospital | (617) 724-4698 | jlevison@mgb.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2023 | Aug 27, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000071243 | Zika Virus Infection |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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| ID | Term |
|---|---|
| D003150 | Community Health Workers |
| ID | Term |
|---|---|
| D000488 | Allied Health Personnel |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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At least two pediatric visits recorded within 12 months post-randomization, with one visit from months 0-6 and months 7-12. |
| Within the first 12 months |
| 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. | Within the first 12 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Baseline sociodemographic and clinical characteristics of randomized participants | Count of Participants | Participants |
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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.
|
|
| 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. | Posted | Count of Participants | Participants | Within the first 6 months |
|
|
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| 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. | Posted | Count of Participants | Participants | Within the first 12 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | Within the first 12 months |
|
|
|
| 1 |
| 25 |
| 1 |
| 25 |
| 0 |
| 25 |
| EG001 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |