# CAMPO Data Management and Statistical Core

> **NIH NIH U54** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2020 · $177,454

## Abstract

ABSTRACT FOR THE DATA MANAGEMENT AND STATISTICAL CORE
The California-Mexico-Puerto Rico (CAMPO) Consortium will perform three clinical research studies
focused on the prevention of cervical cancer among HIV-positive women in Mexico and Puerto Rico. Study 1
will examine new screening algorithms for cervical high-grade squamous intraepithelial lesions (HSIL) in 4000
HIV-positive women in Mexico and Puerto Rico. Study 2 will evaluate the impact of anogenital probiotic use on
anal and cervical microbiota profiles and the relationship to anal and cervical HSIL regression in 600 HIV-
positive women and men as well as reduction of high-risk HPV DNA persistence among those with no lesions.
Study 3 will evaluate the safety and efficacy of a multivalent replication-defective adenovirus-based
therapeutic HPV vaccine to treat cervical and anal HSIL in 300 HIV-positive women and men and identify
immune response correlates of HSIL regression. Working with the Administrative and Coordinating Core, the
Central Laboratory Core and the Clinical Trials Program, the Data Management and Statistical Core (DMSC)
has the following aims: (1) to support the Clinical Trials Program with rigorous methodology in study design,
data analysis and dissemination of research findings; (2) to provide data management, data collection and
quality assurance systems to efficiently meet the needs of the Clinical Trials Program and the Cores; and (3) to
support the career development of early career investigators through the provision of training and mentorship
in biostatistics, bioinformatics and clinical research study design. As with all CAMPO Cores, the CAMPO
DMSC will be led by faculty at one of the CAMPO Consortium sites, with Co-Leaders from the other two sites.
Dr. Suárez of UPR will lead the DMSC, with Drs. Hector Lamadrid of INSP and Li Zhang of UCSF as Co-
Leaders. The DMSC will provide both virtual and a physical infrastructure to support the CAMPO Consortium’s
Clinical Trials Program in the areas of biostatistics, bioinformatics, and data management. To ensure
adherence to high quality study design and rigorous statistical methodology, the DMSC will provide input at
every stage, from study design, analysis of collected data, and dissemination of results. Working under the
supervision of the DMSC, the Emmes Corporation will provide a secure, scalable, and user-friendly platform for
the collection, management, and quality assurance of study and biospecimen data. Creation of the DMSC as a
shared resource will foster emerging skills and an appreciation of basic biostatistical analysis among early
career investigators, with dedicated experts available to support more complex analyses within the Clinical
Trials Program.

## Key facts

- **NIH application ID:** 10017232
- **Project number:** 5U54CA242646-02
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Li Zhang
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $177,454
- **Award type:** 5
- **Project period:** 2019-09-12 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10017232

## Citation

> US National Institutes of Health, RePORTER application 10017232, CAMPO Data Management and Statistical Core (5U54CA242646-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10017232. Licensed CC0.

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