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 the vast international scope, diversity, and complexity of HIV prevention trials. This award will enable the HPTN to continue its mission to identify effective strategies for HIV prevention that will help end the HIV/AIDS epidemic.
The goal of the HIV Prevention Trials Network (HPTN) is to identify safe, effective, implementable, and scalable interventions for HIV prevention. The HPTN Laboratory Center (LC) will provide leadership, expertise, and laboratory support to the HPTN and oversee all laboratory activities in HPTN studies. The HPTN LC will participate in all phases of science generation; oversee and support activities at study sites; perform testing for HPTN protocols; develop, evaluate, and validate new laboratory methods; and perform innovative laboratory- based research related to HIV prevention.
|Patel, Eshan U; Gaydos, Charlotte A; Packman, Zoe R et al. (2018) Prevalence and Correlates of Trichomonas vaginalis Infection Among Men and Women in the United States. Clin Infect Dis 67:211-217|
|Dize, Laura; Silver, Barbara; Gaydos, Charlotte (2018) Comparison of the Cepheid GeneXpert CT/NG assay to the Hologic Aptima Combo2 assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in self-collected rectal swabs. Diagn Microbiol Infect Dis 90:83-84|
|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|
|Grabowski, Mary K; Reynolds, Steven J; Kagaayi, Joseph et al. (2018) The validity of self-reported antiretroviral use in persons living with HIV: a population-based study. AIDS 32:363-369|
|Trent, Maria; Coleman, Jenell S; Hardick, Justin et al. (2018) Clinical and sexual risk correlates of Mycoplasma genitalium in urban pregnant and non-pregnant young women: cross-sectional outcomes using the baseline data from the Women's BioHealth Study. Sex Transm Infect 94:411-413|
|Lancaster, Kathryn E; Hoffman, Irving F; Hanscom, Brett et al. (2018) Regional differences between people who inject drugs in an HIV prevention trial integrating treatment and prevention (HPTN 074): a baseline analysis. J Int AIDS Soc 21:e25195|
|Pettifor, Audrey; Stoner, Marie; Pike, Carey et al. (2018) Adolescent lives matter: preventing HIV in adolescents. Curr Opin HIV AIDS 13:265-273|
|Melendez, Johan H; Hardick, Justin; Barnes, Mathilda et al. (2018) Molecular Characterization of Markers Associated With Antimicrobial Resistance in Neisseria gonorrhoeae Identified From Residual Clinical Samples. Sex Transm Dis 45:312-315|
|Crowell, Trevor A; Hardick, Justin; Lombardi, Kara et al. (2018) Asymptomatic lymphogranuloma venereum among Nigerian men who have sex with men. Sex Transm Infect 94:578-581|
|Buchanan, Ashley L; Vermund, Sten H; Friedman, Samuel R et al. (2018) Assessing Individual and Disseminated Effects in Network-Randomized Studies. Am J Epidemiol 187:2449-2459|
Showing the most recent 10 out of 235 publications