Zika Virus InfectionNCT05041439
Adherence to Care for Children With Congenital Zika Virus Infection in Puerto Rico
A study testing Community Health Worker in people with Zika Virus Infection and Adherence, Patient, run by Massachusetts General Hospital at 1 site in Puerto Rico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Zika Virus Infection, Adherence, Patient
- What is being tested?
- Community Health Worker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 6 Jul 2021to 6 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older and able to communicate in Spanish
- Being the primary caregiver of a child with possible congenital Zika virus infection
Who cannot join
- Those who are too sick/unable to understand the implications of their participation, those who are unwilling to participate.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
School of Medicine - Department of Pediatrics
San Juan, PR, 00921
About this study
Official title: Adherence to Care for Children Born to Mothers With Laboratory Evidence of Confirmed or Possible Congenital Zika Virus Infection During Pregnancy.
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.
Read the 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.
- Conditions
- Zika Virus Infection, Adherence, Patient
- Being tested
- Community Health Worker
- Keywords
- Zika virus, Puerto Rico, community health worker
- Medical subject headings
- Zika Virus Infection, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health WorkerBehavioural
Participants will receive 5 one-on-one sessions with a CHW over 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the first 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Within the first 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start6 Jul 2021
- Primary completion31 Aug 2022
- Study completion6 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Zika Virus InfectionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Puerto Rico
- Responsible party
- Principal investigator, Julie H Levison, Massachusetts General Hospital
- Investigators
- Julie H. Levison, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041439
- Sponsor's protocol ID
- 2021p001675
- Other IDs
- 5R21HD096369-02
- Status last verified
- Nov 2023
- First submitted
- 2 Sep 2021
- Last updated
- 15 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Care for Children Born to Mothers With Laboratory Evidence of Confirmed or Possible Congenital Zika Virus Infection During Pregnancy.
- ClinicalTrials.gov ID
- NCT05041439
- Acronym / sponsor ID
- 2021p001675
- Conditions
- Zika Virus Infection, Adherence, Patient
- Keywords
- Zika virus, Puerto Rico, community health worker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Puerto Rico
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 6 Nov 2022 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Posted 15 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community health worker (CHW) group | Experimental | Behavioral: Community Health WorkerParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older and able to communicate in Spanish
- Being the primary caregiver of a child with possible congenital Zika virus infection
Key exclusion criteria (1 listed)
- Those who are too sick/unable to understand the implications of their participation, those who are unwilling to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health WorkerParticipants will receive 5 one-on-one sessions with a CHW over 6 months. | Behavioural | Community health worker (CHW) group |
Primary outcome
Number of Participants With Adherence to Pediatric Zika Care
Time frame: Within the first 6 months
At least one pediatric visit for developmental exam with the pediatrician within 6 months post-randomization.
3 secondary outcomes
Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality
Time frame: Within the first 6 months
Number of Participants With Adherence to Pediatric Zika Care
Time frame: Within the first 12 months
Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality
Time frame: Within the first 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie H. Levison, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker in people with Zika Virus Infection and Adherence, Patient, run by Massachusetts General Hospital at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adherence to Pediatric Zika Care (time frame: Within the first 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.