# LC: HIV PREVENTION TRIALS NETWORK

> **NIH NIH UM1** · JOHNS HOPKINS UNIVERSITY · 2021 · $11,779,883

## Abstract

PROJECT SUMMARY
With 20 years of experience and an outstanding record of performance, the HIV Prevention Trials Network
(HPTN) Laboratory Center (LC) is optimally positioned to support the HPTN in 2020 and beyond. As part of the
HPTN leadership group, the HPTN LC will help shape the network’s scientific agenda. The HPTN LC will oversee
laboratory activities at study sites; perform Quality Assurance/Quality Control (QA/QC) and specialized testing
for HPTN protocols; evaluate and validate assays for use in HPTN studies; develop novel assays to achieve
study objectives; and perform ancillary studies related to HIV prevention. The HPTN LC has an Administrative
Core, a Protocol Operations Core, and five laboratory Cores (Virology, Pharmacology, Co-Infections, Toxicology,
Immunology). The HPTN LC also has an Early Product Development Working Group and a working group for
Point-of-Care Testing and Remote Technologies. The HPTN LC has extensive experience supporting HIV
protocols in the United States (US), Latin America, Africa, and Asia, with recent work in Eastern Europe. The
HPTN LC includes seven Protocol Specialists with >100 combined years of experience supporting HPTN studies.
The HPTN LC has led efforts to harmonize laboratory procedures across other networks and groups, and
collaborates extensively with academic, government, and industry partners. The HPTN LC has supported
protocols evaluating biomedical, behavioral, and structural interventions for HIV prevention, often delivered in
combination in a wide range of settings and venues. This includes vanguard studies, observational studies, and
Phase 1, 2, and 3 clinical trials, with interventions delivered to HIV-uninfected individuals, HIV-infected
individuals, couples, cohorts, and communities. HPTN study populations include adolescents, women, men who
have sex with men, transgender women, persons who inject drugs, and other groups at risk, with some trials
enrolling >40,000 participants. The HPTN LC has performed numerous studies under Investigational New Drug
(IND) applications for the US Food and Drug Administration. The HPTN LC’s Quality Management Team includes
a Regulatory Affairs Officer who will ensure compliance with institutional, state, federal, and other regulatory
requirements. Under the new award, the HPTN will evaluate new products for HIV pre-exposure prophylaxis,
including new drugs, new drug delivery systems, multipurpose technologies, and broadly neutralizing antibodies;
the HPTN will also perform integrated strategy studies that combine biomedical and socio-behavioral
interventions for HIV prevention. The Specific Aims of the HPTN LC are: Aim 1: To provide leadership, expertise,
and laboratory support to the HPTN; Aim 2: To support site laboratories and ensure the quality of HPTN
laboratory results; and Aim 3: To advance HIV prevention science through assay development and biomedical
research. A strong and effective HPTN LC is particularly important in the HPTN because of th...

## Key facts

- **NIH application ID:** 9986289
- **Project number:** 2UM1AI068613-15
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** SUSAN H ESHLEMAN
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $11,779,883
- **Award type:** 2
- **Project period:** 2006-06-01 → 2027-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9986289

## Citation

> US National Institutes of Health, RePORTER application 9986289, LC: HIV PREVENTION TRIALS NETWORK (2UM1AI068613-15). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9986289. Licensed CC0.

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