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.

Public Health Relevance

The global HIV epidemic affects the lives of millions of individuals around the world, many of whom face stigma, discrimination, poverty and other challenges. The HIV Prevention Trials Network (HPTN) aims to advance the discovery of new prevention tools while striving to overcome the barriers inhibiting the optimal use and benefit of existing efficacious tools. The proposed research will be conducted at sites around the world and in partnership with researchers and community members.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
2UM1AI068619-15
Application #
9986201
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Gilbreath, Michael J
Project Start
2006-06-01
Project End
2027-11-30
Budget Start
2020-12-01
Budget End
2021-11-30
Support Year
15
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Family Health International
Department
Type
DUNS #
067180786
City
Durham
State
NC
Country
United States
Zip Code
27701
Miller, William C; Hoffman, Irving F; Hanscom, Brett S et al. (2018) A scalable, integrated intervention to engage people who inject drugs in HIV care and medication-assisted treatment (HPTN 074): a randomised, controlled phase 3 feasibility and efficacy study. Lancet 392:747-759
Rogers, Brooke G; Mendez, Noelle A; Mimiaga, Matthew J et al. (2018) ""I Wasn't in My Right Mind"": Qualitative Findings on the Impact of Alcohol on Condom Use in Patients Living with HIV/AIDS in Brazil, Thailand, and Zambia (HPTN 063). Int J Behav Med :
Zhang, Yinfeng; Sivay, Mariya V; Hudelson, Sarah E et al. (2018) Antiretroviral Drug Use and HIV Drug Resistance Among Young Women in Rural South Africa: HPTN 068. J Acquir Immune Defic Syndr 79:315-322
Shava, Emily; Lipira, Lauren E; Beauchamp, Geetha G et al. (2018) Risky Sexual Behavior Among Individuals Receiving Buprenorphine/Naloxone Opiate Dependency Treatment: HIV Prevention Trials Network (HPTN) 058. J Acquir Immune Defic Syndr 78:300-307
Hill, Lauren M; Abler, Laurie; Maman, Suzanne et al. (2018) Hope, the Household Environment, and Sexual Risk Behaviors Among Young Women in Rural South Africa (HPTN 068). AIDS Behav 22:1908-1918
Pettifor, Audrey; Stoner, Marie; Pike, Carey et al. (2018) Adolescent lives matter: preventing HIV in adolescents. Curr Opin HIV AIDS 13:265-273
Hargreaves, James R; Krishnaratne, Shari; Mathema, Hlengani et al. (2018) Individual and community-level risk factors for HIV stigma in 21 Zambian and South African communities: analysis of data from the HPTN071 (PopART) study. AIDS 32:783-793
Rosenberg, Molly; Pettifor, Audrey; Twine, Rhian et al. (2018) Evidence for sample selection effect and Hawthorne effect in behavioural HIV prevention trial among young women in a rural South African community. BMJ Open 8:e019167
Palumbo, Philip J; Fogel, Jessica M; Hudelson, Sarah E et al. (2018) HIV Drug Resistance in Adults Receiving Early vs. Delayed Antiretroviral Therapy: HPTN 052. J Acquir Immune Defic Syndr 77:484-491
Wood, Daniel; Lancaster, Kathryn E; Boily, Marie-Claude et al. (2018) Recruitment of Female Sex Workers in HIV Prevention Trials: Can Efficacy Endpoints Be Reached More Efficiently? J Acquir Immune Defic Syndr 77:350-357

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