Trial Outcomes & Findings for Adherence to Care for Children With Congenital Zika Virus Infection in Puerto Rico (NCT NCT05041439)

NCT ID: NCT05041439

Last Updated: 2023-12-15

Results Overview

At least one pediatric visit for developmental exam with the pediatrician within 6 months post-randomization.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Within the first 6 months
• Results posted on: 2023-12-15

Participant Flow

60 participants were screened for eligibility and 50 were consented/enrolled.

Participant milestones

Measure	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.	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.
Overall Study STARTED	25	25
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	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.	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.
Overall Study Withdrawal by Subject	1	1
Overall Study Death	1	0

Baseline Characteristics

Adherence to Care for Children With Congenital Zika Virus Infection in Puerto Rico

Baseline characteristics by cohort

Measure	Community Health Worker (CHW) Group n=25 Participants 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.	Enhanced Care Condition (ECC) n=25 Participants 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.	Total n=50 Participants Total of all reporting groups
Age, Continuous	34.9 years STANDARD_DEVIATION 7.6 • n=5 Participants	30.2 years STANDARD_DEVIATION 5.9 • n=7 Participants	32.6 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Amerian Indian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Multiracial	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Other	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Baseline sociodemographic and clinical characteristics of randomized participants	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within the first 6 months

At least one pediatric visit for developmental exam with the pediatrician within 6 months post-randomization.

Outcome measures

Measure	Community Health Worker (CHW) Group n=25 Participants 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.	Enhanced Care Condition (ECC) n=25 Participants 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.
Number of Participants With Adherence to Pediatric Zika Care	14 Participants	15 Participants

SECONDARY outcome

Timeframe: Within the first 6 months

Detection of new birth defect or neurodevelopmental abnormality between baseline to month-6.

Outcome measures

Measure	Community Health Worker (CHW) Group n=25 Participants 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.	Enhanced Care Condition (ECC) n=25 Participants 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.
Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Community Health Worker (CHW) Group n=25 Participants 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.	Enhanced Care Condition (ECC) n=25 Participants 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.
Number of Participants With Adherence to Pediatric Zika Care	6 Participants	5 Participants

SECONDARY outcome

Timeframe: Within the first 12 months

Detection of new birth defect or neurodevelopmental abnormality between baseline to month-12.

Outcome measures

Measure	Community Health Worker (CHW) Group n=25 Participants 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.	Enhanced Care Condition (ECC) n=25 Participants 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.
Number of Participants With Detection of Zika-associated Birth Defect or Neurodevelopmental Abnormality	1 Participants	4 Participants

Adverse Events

Community Health Worker (CHW) Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Enhanced Care Condition (ECC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Community Health Worker (CHW) Group n=25 participants at risk 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.	Enhanced Care Condition (ECC) n=25 participants at risk 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.
Musculoskeletal and connective tissue disorders Complications of diabetes	4.0% 1/25 • Number of events 1 • The monitoring for adverse events was over the 12 months of the study.	0.00% 0/25 • The monitoring for adverse events was over the 12 months of the study.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Julie H Levison

Massachusetts General Hospital

Phone: (617) 724-4698

Email: jlevison@mgb.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place