An interventional study of Community Health Worker in Zika Virus Infection and Adherence, Patient, sponsored by Massachusetts General Hospital. Completed at 1 site in Puerto Rico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-15.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 50 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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Exclusion Criteria:
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
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.
Participants will receive 5 one-on-one sessions with a CHW over 6 months.
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
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
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
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
| Milestone | Community Health Worker (CHW) Group | Enhanced Care Condition (ECC) |
|---|---|---|
| Started | 25 | 25 |
| Completed | 23 | 24 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Death | 1 | 0 |
At least one pediatric visit for developmental exam with the pediatrician within 6 months post-randomization.
| Participants | Community Health Worker (CHW) Group | Enhanced Care Condition (ECC) |
|---|---|---|
| Number of Participants With Adherence to Pediatric Zika Care | 14 | 15 |
Detection of new birth defect or neurodevelopmental abnormality between baseline to month-6.
| Participants | Community Health Worker (CHW) Group | Enhanced Care Condition (ECC) |
|---|---|---|
| Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality | 1 | 3 |
At least two pediatric visits recorded within 12 months post-randomization, with one visit from months 0-6 and months 7-12.
| Participants | Community Health Worker (CHW) Group | Enhanced Care Condition (ECC) |
|---|---|---|
| Number of Participants With Adherence to Pediatric Zika Care | 6 | 5 |
Detection of new birth defect or neurodevelopmental abnormality between baseline to month-12.
| Participants | Community Health Worker (CHW) Group | Enhanced Care Condition (ECC) |
|---|---|---|
| Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality | 1 | 4 |
Collected over The monitoring for adverse events was over the 12 months of the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Community Health Worker (CHW) Group | 1/25 (4%) | 1/25 (4%) | 0/25 (0%) |
| Enhanced Care Condition (ECC) | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Event | Community Health Worker (CHW) Group | Enhanced Care Condition (ECC) |
|---|---|---|
| Complications of diabetesMusculoskeletal and connective tissue disorders | 1/25 | 0/25 |
| Age, Continuous(years) | Community Health Worker (CHW) Group | Enhanced Care Condition (ECC) | Total |
|---|---|---|---|
| Mean | 34.9 ± 7.6 | 30.2 ± 5.9 | 32.6 ± 7.1 |
| Sex: Female, Male(Participants) | Community Health Worker (CHW) Group | Enhanced Care Condition (ECC) | Total |
|---|---|---|---|
| Female | 24 | 24 | 48 |
| Male | 1 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Community Health Worker (CHW) Group | Enhanced Care Condition (ECC) | Total |
|---|---|---|---|
| Hispanic or Latino | 25 | 25 | 50 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Community Health Worker (CHW) Group | Enhanced Care Condition (ECC) | Total |
|---|---|---|---|
| Amerian Indian | 1 | 0 | 1 |
| Black | 1 | 4 | 5 |
| White | 4 | 0 | 4 |
| Multiracial | 12 | 13 | 25 |
| Other | 6 | 7 | 13 |
| Unknown | 1 | 1 | 2 |
| Baseline sociodemographic and clinical characteristics of randomized participants(Participants) | Community Health Worker (CHW) Group | Enhanced Care Condition (ECC) | Total |
|---|---|---|---|
| Count of participants | 25 | 25 | 50 |
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