This application to continue as the Statistical and Data Management Center (SDMC) for the HIV Prevention Trials Network (HPTN) is the third of three linked applications comprising the Leadership Group of the HPTN in response to RFA-AI-12-011: Leadership Group for a Clinical Research Network on Integrated Strategies to Prevent HIV infection (UMI). The HPTN scientific agenda focuses on the following two areas of inquiry: 1) integrated strategies to prevent HIV infection and 2) expanding horizons for more promising pre-exposure prophylaxis (PrEP) drugs and drug regimens. This application describes how the SDMC will achieve the responsibilities described in the RFA, (i) ensuring the integrity of study design, data management, data analyses and compliance with regulatory requirements, as appropriate; (ii) providing effective data communication systems for the network; (iii) providing data management training for network-affiliated CTUs/CRSs investigators and laboratory staff; (iv) standardizing and harmonizing statistical and data management activities both within the network and with other NIH-supported networks or other Federal and private sector clinical trial programs when required; and, (vi) collecting and storing data in accordance with standards of the Clinical Data Interchange Standards Consortium (C-DISC) requirements. The HPTN SDMC has extensive experience in the design, conduct and analysis of global prevention studies. The scientific leadership of the faculty engaged in the HPTN SDMC will ensure HPTN trials are designed to obtain reliable answers to the most pressing questions in the prevention science field. To help guide the complex task of developing and testing integrated strategies for HIV prevention, we will engage in a collaborative program of mathematical modeling. New PrEP drugs will be developed through a sequence of Phase 1, 2 and 3 trials. Our systems for data collection, management, monitoring and analysis are all well tested and in accordance with ICH guidelines. We will expand our data collection tools to include electronic mobile devices to facilitate assessment of communities and real-time behavioral data. We will support the leadership group with rapid, accurate reporting of HPTN studies throughout follow-up to study completion. We will continue to support the HPTN LC program through coordination of specimens and assay results, and with statistical analysis and methods development. SCHARP statisticians will develop and deploy statistical methodologies to increase the efficiency and rigor of the proposed program of HIV prevention trials.
The HIV/AIDS epidemic continues to affect many regions of the world. The recent, proven success of using antiretrovirals for prevention of HIV transmission (through treatment of an HIV-infected person) and HIV acquisition (by using PrEP in an HIV-uninfected person): leads to a new goal: to identify and improve upon known methods of prevention, and to optimize and integrate these interventions to create strategies for reducing HIV in populations most severely affected by the HIV epidemic.
|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|
|Bekker, Linda-Gail; Roux, Surita; Sebastien, Elaine et al. (2018) Daily and non-daily pre-exposure prophylaxis in African women (HPTN 067/ADAPT Cape Town Trial): a randomised, open-label, phase 2 trial. Lancet HIV 5:e68-e78|
|Sucharitakul, Kanes; Boily, Marie-Claude; Dimitrov, Dobromir et al. (2018) Influence of model assumptions about HIV disease progression after initiating or stopping treatment on estimates of infections and deaths averted by scaling up antiretroviral therapy. PLoS One 13:e0194220|
|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|
|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|
|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|
|Ranganathan, Meghna; Heise, Lori; MacPhail, Catherine et al. (2018) 'It's because I like things… it's a status and he buys me airtime': exploring the role of transactional sex in young women's consumption patterns in rural South Africa (secondary findings from HPTN 068). Reprod Health 15:102|
|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|
|Grant, Robert M; Mannheimer, Sharon; Hughes, James P et al. (2018) Daily and Nondaily Oral Preexposure Prophylaxis in Men and Transgender Women Who Have Sex With Men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study. Clin Infect Dis 66:1712-1721|
|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|
Showing the most recent 10 out of 164 publications