# SECONDARY DATA ANALYSES AND INVESTIGATION OF RESEARCH CONCEPT PROPOSALS FROM THE PROSPECTIVE COHORT OF HIV AND ZIKA IN INFANTS AND PREGNANCY STUDY (HIV-ZIP)

> **NIH NIH N01** · WESTAT, INC. · 2022 · $1,466,424

## Abstract

The HIV ZIP study completed enrollment of 200 pregnant women (174 HIV infected and 26 HIV
uninfected) and 195 of their offspring who resided in the United States, Puerto Rico, and Brazil. For
study completion, the primary study tasks relate to supporting study monitoring activities through the
last participant visit, data cleaning, and data analysis. The last maternal delivery visit for HIV ZIP
occurred in June 2019, and the last participant (infant) visit occurred in September 2020. Data cleaning
of the final datasets and database lock were completed on December 30, 2020. Delivery of the final
dataset to the study statisticians occurred on January 20, 2021.
HIV ZIP was a feasibility study of a prospective international cohort of pregnant women and their
infants from those pregnancies. Its goals were to evaluate the feasibility of a comparative study of the
incidence of Zika virus (ZIKV) infection among pregnant women with and without Human
Immunodeficiency Virus (HIV) infection and to determine the risk of adverse outcomes associated with
ZIKV/HIV co-infection across clinical sites in the continental United States (U.S.), Puerto Rico (P.R.), and
Brazil.
The study was designed to (1) determine the feasibility of satisfactorily achieving accrual targets, (2)
confirm the adequacy of statistical assumptions for power and sample size considerations for a future
large scale study in this patient population, and (3) provide adequate statistical power to detect clinical
meaningful differences in the proportions of HIV-infected women with unsuppressed HIV viral load
between HIV-infected women with Zika and HIV-infected women without Zika infection, assuming 10%
of the HIV-infected women enrolled (and meeting Zika risk criteria) have ZIKV infection by delivery.
The primary study analysis of producing a report that addresses each of the topics enumerated above
could not be fulfilled because Phase I’s feasibility objective was not achieved (i.e., to enroll at least 10%
of women who were co-infected with HIV and Zika). Nevertheless, the protocol team developed
numerous research concepts that align with the other primary and secondary study objectives. These
research concepts address HIV treatment and disease parameter comparisons between pregnant
women living with HIV in Brazil and the U.S., general and ART-related developmental outcomes on
infants, the impact of environmental exposures on birth outcomes among women living with HIV,
cytomegalovirus shedding in HIV-infected women and infant development outcomes, and the
immunogenicity of Tdap in HIV-infected pregnant women and passively acquired antibodies in their
infants.

## Key facts

- **NIH application ID:** 10576710
- **Project number:** 275201800001I-0-759402200001-1
- **Recipient organization:** WESTAT, INC.
- **Principal Investigator:** BARBARA DRIVER
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,466,424
- **Award type:** —
- **Project period:** 2021-11-12 → 2024-11-11

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10576710

## Citation

> US National Institutes of Health, RePORTER application 10576710, SECONDARY DATA ANALYSES AND INVESTIGATION OF RESEARCH CONCEPT PROPOSALS FROM THE PROSPECTIVE COHORT OF HIV AND ZIKA IN INFANTS AND PREGNANCY STUDY (HIV-ZIP) (275201800001I-0-759402200001-1). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10576710. Licensed CC0.

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