Zika virus (ZIKV) infection during pregnancy, or congenital ZIKV infection (CZI), can lead to birth defects that may not be apparent at birth but are identified in follow-up care as infants grow older. Puerto Rico (PR) has the most confirmed CZI cases of any US territory. Since 2016, PR Department of Health guidelines for infants with possible CZI (pCZI) recommend follow-up from birth to age three years given the importance of early intervention on child development. Recent data for the U.S. territories show that adherence to follow-up care for these children, including recommended diagnostic studies to detect brain and eye anomalies, is sub- optimal. Interventions targeting primary caregivers (parents or close relatives) of children with pCZI could significantly improve adherence to pediatric services and clinical outcomes. Extensive evidence supports the use of both trained community health workers (CHWs) to provide basic health education in disease prevention and management, and narrative-based stories to evoke stronger attitudinal, normative, and behavioral shifts compared to traditional didactic health materials. The proposed studies will merge these two culturally-attuned elements for this novel and important indication. They build on our previous work that paired a CHW-based intervention with culturally-tailored interactive health communication content to improve HIV visit adherence in HIV+ Latino immigrants and Puerto Rican-born migrants. That intervention has demonstrated significant improvements in self-efficacy, mental health, HIV stigma and patient activation. We propose adapting this intervention and pilot testing it in Puerto Rico, with a different population, caregivers of children with pCZI, but a similar outcome, visit adherence. The research team comprises internationally-recognized leaders in infectious disease outcomes research, pediatrics, maternal-fetal medicine, child development, and qualitative research, all with extensive clinical and/or research experience in PR. In Phase 1a, we will conduct a qualitative study (~n=28) to adapt the intervention to improve pediatric visit adherence for early diagnosis of abnormalities associated with pCZI in PR. In Phase 1b, we will use the qualitative research and community advisory board input to modify the intervention protocol and health communication tool. In Phase 2, we will conduct a pilot randomized controlled trial of the adapted intervention with 50 caregiver-child dyads (n=25 intervention vs. n=25 enhanced care condition) to assess feasibility, acceptability, and preliminary evidence of effect. The study will occur within an academic medical center and public health system providing exposure to nearly 3,000 infants with pCZI in PR. The primary outcome is adherence to follow-up Zika services from baseline to weeks-24 and 52. If the intervention is feasible, acceptable, and demonstrates preliminary evidence of effect, then we will use the results to inform an R01 proposal for a fully-powered trial across the PR Department of Health Regional Pediatric Centers. This intervention is also consistent with and advances NICHD?s efforts to develop behavioral interventions within pediatric care to improve child development outcomes.
Congenital Zika virus infection (CZI) is a novel and clinically important phenomenon, with potential life-long implications for affected infants. Barriers to healthcare services in Puerto Rico could threaten clinical outcomes for these infants. We will develop and test a novel caregiver intervention to improve adherence to follow-up Zika services for early diagnosis and intervention of abnormalities possibly associated with CZI.
