# HIV Prevention Trials Network Leadership and Operations Center

> **NIH NIH UM1** · FAMILY HEALTH INTERNATIONAL · 2021 · $70,307,771

## Abstract

PROJECT SUMMARY
The overarching goal of the HIV Prevention Trials Network (HPTN) is to identify acceptable, feasible, safe,
effective and scalable interventions for HIV prevention that address the needs of populations at risk in the U.S.
and around the world. The HPTN will address this goal by identifying: 1) new biomedical products and tools for
HIV prevention that have unique characteristics, such as longer duration of action, new targets for inhibition of
HIV replication, or as multipurpose prevention technologies (MPTs); and (2) integrated strategies that optimize
use of proven efficacious prevention interventions and new tools tailored to specific populations at risk to
achieve maximal public health impact. These interventions will be evaluated in priority populations for HIV
prevention including women in sub-Saharan Africa, young men and women at risk, men who have sex with
men (MSM), transgender women (TGW) who have sex with men, female sex workers (FSW) and persons who
inject drugs (PWID). The specific aims of this research will be 1) To design and conduct studies of long-acting
antiretroviral (ARV) agents and delivery systems for pre-exposure prophylaxis (PrEP); 2) To design and
conduct studies to evaluate MPTs that concurrently prevent HIV and pregnancy, sexually transmitted infections
(STIs) or opioid dependence; 3) To design and conduct studies in collaboration with the HIV Vaccine Trials
Network to evaluate broadly neutralizing antibodies (bnAbs), alone and in combination, for PrEP; 4) To design
and conduct integrated strategies for HIV prevention. For the first three aims, the HPTN will use a sequential
multi-phase drug development strategy for the evaluation of new candidates for prevention. Phase 1 and 2
studies will be conducted for the evaluation of appropriate dose, safety and tolerability of the agent(s). The
most promising systemic agents will be advanced using the criteria for a favorable target product profile for
new agents including highly effective and durable protection against HIV, minimal adverse effects and drug
interactions, high levels of user acceptability, and a high barrier to viral resistance. Efficacious biomedical
prevention interventions will be incorporated into integrated strategy study designs that also include socio-
behavioral interventions tailored to the HIV prevention imperatives and contextual needs of the specific
populations at risk for HIV infection. Socio-Behavioral research (SBR) will be integral to the success of all
aspects of the proposed HPTN HIV prevention agenda. Supportive SBR will be used to strengthen biomedical
HIV product development (i.e. to inform user preference and ultimately product design for Phase 1-3 clinical
trials), while integrative SBR will play a key role in the process of designing and adapting behavioral and
structural interventions to complement biomedical interventions in integrated strategy studies. The HPTN will
design and conduct the research through collaboration...

## Key facts

- **NIH application ID:** 9986201
- **Project number:** 2UM1AI068619-15
- **Recipient organization:** FAMILY HEALTH INTERNATIONAL
- **Principal Investigator:** MYRON Scott COHEN
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $70,307,771
- **Award type:** 2
- **Project period:** 2006-06-01 → 2027-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9986201

## Citation

> US National Institutes of Health, RePORTER application 9986201, HIV Prevention Trials Network Leadership and Operations Center (2UM1AI068619-15). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9986201. Licensed CC0.

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