Adherence to Care for Children With Congenital Zika Virus Infection in Puerto Rico
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ClinicalTrials.gov Identifier: NCT05041439 |
Recruitment Status :
Recruiting
First Posted : September 13, 2021
Last Update Posted : September 13, 2021
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Condition or disease | Intervention/treatment | Phase |
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Zika Virus Infection Adherence, Patient | Behavioral: Community Health Worker | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Adherence to Care for Children Born to Mothers With Laboratory Evidence of Confirmed or Possible Congenital Zika Virus Infection During Pregnancy. |
Actual Study Start Date : | July 1, 2021 |
Estimated Primary Completion Date : | October 1, 2022 |
Estimated Study Completion Date : | October 1, 2022 |

Arm | Intervention/treatment |
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Experimental: 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.
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Behavioral: Community Health Worker
Participants will receive 5 one-on-one sessions with a CHW over 6 months. |
No Intervention: 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.
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- 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
- Detection of Zika-associated birth defect or neurodevelopmental abnormality [ Time Frame: Within the first 6 months and 12 months ]Detection of new birth defect or neurodevelopmental abnormality between baseline to month-6 and baseline to month-12
- Adherence to pediatric Zika care [ Time Frame: 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05041439
Contact: Inés E García García, MD | 787-777-3225 | ines.garcia@upr.edu |
Puerto Rico | |
School of Medicine - Department of Pediatrics | Recruiting |
San Juan, Puerto Rico, 00921 | |
Contact: Inés E García García, MD 787-777-3225 ines.garcia@upr.edu |
Responsible Party: | University of Puerto Rico |
ClinicalTrials.gov Identifier: | NCT05041439 |
Other Study ID Numbers: |
0420121 5R21HD096369-02 ( U.S. NIH Grant/Contract ) |
First Posted: | September 13, 2021 Key Record Dates |
Last Update Posted: | September 13, 2021 |
Last Verified: | September 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Zika virus Puerto Rico community health worker |
Zika Virus Infection Infections Communicable Diseases Virus Diseases Disease Attributes Pathologic Processes |
Arbovirus Infections Vector Borne Diseases Flavivirus Infections Flaviviridae Infections RNA Virus Infections |