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.
|Tolley, Elizabeth E; Taylor, Jamilah; Pack, Allison et al. (2018) The Role of Financial Incentives Along the Antiretroviral Therapy Adherence Continuum: A Qualitative Sub-study of the HPTN 065 (TLC-Plus) Study. AIDS Behav 22:245-257|
|Bock, Peter; Jennings, Karen; Vermaak, Redwaan et al. (2018) Incidence of Tuberculosis Among HIV-Positive Individuals Initiating Antiretroviral Treatment at Higher CD4 Counts in the HPTN 071 (PopART) Trial in South Africa. J Acquir Immune Defic Syndr 77:93-101|
|Maheu-Giroux, Mathieu; Baral, Stefan; Vesga, Juan F et al. (2018) Anal Intercourse Among Female Sex Workers in Côte d'Ivoire: Prevalence, Determinants, and Model-Based Estimates of the Population-Level Impact on HIV Transmission. Am J Epidemiol 187:287-297|
|Stoner, Marie C D; Edwards, Jessie K; Miller, William C et al. (2018) Does Partner Selection Mediate the Relationship Between School Attendance and HIV/Herpes Simplex Virus-2 Among Adolescent Girls and Young Women in South Africa: An Analysis of HIV Prevention Trials Network 068 Data. J Acquir Immune Defic Syndr 79:20-27|
|Sivay, Mariya V; Hudelson, Sarah E; Wang, Jing et al. (2018) HIV-1 diversity among young women in rural South Africa: HPTN 068. PLoS One 13:e0198999|
|Bradley, John; Floyd, Sian; Piwowar-Manning, Estelle et al. (2018) Sexually Transmitted Bedfellows: Exquisite Association Between HIV and Herpes Simplex Virus Type 2 in 21 Communities in Southern Africa in the HIV Prevention Trials Network 071 (PopART) Study. J Infect Dis 218:443-452|
|Salazar-Austin, N; Kulich, M; Chingono, A et al. (2018) Age-Related Differences in Socio-demographic and Behavioral Determinants of HIV Testing and Counseling in HPTN 043/NIMH Project Accept. AIDS Behav 22:569-579|
|Sabapathy, Kalpana; Hensen, Bernadette; Varsaneux, Olivia et al. (2018) The cascade of care following community-based detection of HIV in sub-Saharan Africa - A systematic review with 90-90-90 targets in sight. PLoS One 13:e0200737|
|Kilburn, Kelly N; Pettifor, Audrey; Edwards, Jessie K et al. (2018) Conditional cash transfers and the reduction in partner violence for young women: an investigation of causal pathways using evidence from a randomized experiment in South Africa (HPTN 068). J Int AIDS Soc 21 Suppl 1:|
|Baggaley, Rebecca F; Owen, Branwen N; Silhol, Romain et al. (2018) Does per-act HIV-1 transmission risk through anal sex vary by gender? An updated systematic review and meta-analysis. Am J Reprod Immunol 80:e13039|
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