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Principal Investigator: MYRON Scott COHEN
Organization: FAMILY HEALTH INTERNATIONAL
Fiscal Year: 2021
Award: $21,074,900
Funding agency: National Institute of Allergy and Infectious Diseases
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 with its scientific leadership, its research teams,
community partners, research participants, pharmaceutical companies and funders.
Terms: <2019-nCoV variant><2019-nCoV variant forms><2019-nCoV variant strains><AIDS Virus><AIDS prevention><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Address><Adverse effects><Affect><Africa South of the Sahara><Anti-Retroviral Agents><Antiretroviral Agents><Behavioral><COVID-19><COVID-19 Prevention Network><COVID-19 variant><COVID-19 variant forms><COVID-19 variant strains><COVID19><CV-19><CV19><Characteristics><Clinical Trials><CoVPN><Cognitive Discrimination><Collaborations><Communities><Complement><Complement Proteins><Discrimination><Drug Interactions><Epidemic><Evaluation><Face><Gestation><Goals><HIV><HIV Infections><HIV Prevention><HIV Vaccine Trials Network><HIV prevention trials network><HIV/AIDS prevention><HTLV-III Infections><HTLV-III-LAV Infections><HVTN><Human Immunodeficiency Viruses><Human T-Lymphotropic Virus Type III Infections><Impoverished><Individual><Injecting drug user><Injection Drug User><Intervention><Intervention Strategies><Investigators><LAV-HTLV-III><Leadership><Lymphadenopathy-Associated Virus><MSM><New Agents><Opiate Addiction><Opiate Dependence><PWID><Participant><Pharmaceutical Agent><Pharmaceuticals><Pharmacologic Substance><Pharmacological Substance><Phase><Play><Population><Populations at Risk><Poverty><PrEP><Pregnancy><Preventative intervention><Prevention><Process><Public Health><RNA vaccine><RNA-based vaccine><Randomized><Research><Research Design><Research Personnel><Researchers><Risk><SARS-CoV-2 variant><SARS-CoV-2 variant forms><SARS-CoV-2 variant strains><Safety><Sexually Transmitted Diseases><Sexually Transmitted Disorder><Sexually Transmitted Infection><Site><Social Behavior><Structure><Study Type><Sub-Saharan Africa><Subsaharan Africa><System><Technology><Venereal Diseases><Venereal Disorders><Venereal Infections><Virus-HIV><Woman><adolescent man><adolescent men><adolescent woman><adolescent women><anti-retroviral><antiretroviral><appropriate dose><corona virus disease 2019><coronavirus disease 2019><coronavirus disease 2019 prevention network><coronavirus disease 2019 variant><coronavirus disease 2019 variant forms><coronavirus disease 2019 variant strains><design><designing><drug development><faces><facial><female sex worker><intervention for prevention><interventional strategy><mRNA vaccine><mRNA-based vaccine><member><men who have sex with men><men who have sex with other men><neutralizing antibody><opioid addiction><opioid dependence><opioid dependent><optimal drug dosage><optimal drug dose><people who inject drugs><people who inject illicit drugs><persons who inject drugs><phase 1 designs><phase I designs><pre-exposure prophylaxis><preference><prevent><preventing><prevention intervention><preventional intervention strategy><preventive intervention><product development><randomisation><randomization><randomly assigned><severe acute respiratory syndrome coronavirus 2 variant><severe acute respiratory syndrome coronavirus 2 variant forms><severe acute respiratory syndrome coronavirus 2 variant strains><social stigma><sociobehavior><sociobehavioral><stigma><study design><success><tool><transgender women who have sex with men><variants of concern><viral resistance><virus resistance><young man><young woman>