# SDMC: HIV Prevention Trials Network

> **NIH NIH UM1** · FRED HUTCHINSON CANCER RESEARCH CENTER · 2020 · $11,531,902

## Abstract

DESCRIPTION (provided by applicant):  This application to continue as the Statistical and Data Management Center (SDMC) for the HIV Prevention Trials Network (HPTN) is the third of three linked applications comprising the Leadership Group of the HPTN in response to RFA-AI-12-011: Leadership Group for a Clinical Research Network on Integrated Strategies to Prevent HIV infection (UMI). The HPTN scientific agenda focuses on the following two areas of inquiry: 1) integrated strategies to prevent HIV infection and 2) expanding horizons for more promising pre-exposure prophylaxis (PrEP) drugs and drug regimens. This application describes how the SDMC will achieve the responsibilities described in the RFA, (i) ensuring the integrity of study design, data management, data analyses and compliance with regulatory requirements, as appropriate; (ii) providing effective data communication systems for the network; (iii) providing data management training for network-affiliated CTUs/CRSs investigators and laboratory staff; (iv) standardizing and harmonizing statistical and data management activities both within the network and with other NIH-supported networks or other Federal and private sector clinical trial programs when required; and, (vi) collecting and storing data in accordance with   
standards of the Clinical Data Interchange Standards Consortium (C-DISC) requirements.   
   
The HPTN SDMC has extensive experience in the design, conduct and analysis of global prevention studies. The scientific leadership of the faculty engaged in the HPTN SDMC will ensure HPTN trials are designed to obtain reliable answers to the most pressing questions in the prevention science field. To help guide the complex task of developing and testing integrated strategies for HIV prevention, we will engage in a collaborative program of mathematical modeling. New PrEP drugs will be developed through a sequence of Phase 1, 2 and 3 trials. Our systems for data collection, management, monitoring and analysis are all well tested and in accordance with ICH guidelines. We will expand our data collection tools to include electronic mobile devices to facilitate assessment of communities and real-time behavioral data. We will support the leadership group with rapid, accurate reporting of HPTN studies throughout follow-up to study completion. We will continue to support the HPTN LC program through coordination of specimens and assay results, and with statistical analysis and methods development. SCHARP statisticians will develop and deploy statistical methodologies to increase the efficiency and rigor of the proposed program of HIV prevention trials.

## Key facts

- **NIH application ID:** 9828043
- **Project number:** 5UM1AI068617-14
- **Recipient organization:** FRED HUTCHINSON CANCER RESEARCH CENTER
- **Principal Investigator:** Deborah J Donnell
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $11,531,902
- **Award type:** 5
- **Project period:** 2006-06-29 → 2020-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9828043

## Citation

> US National Institutes of Health, RePORTER application 9828043, SDMC: HIV Prevention Trials Network (5UM1AI068617-14). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9828043. Licensed CC0.

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