Purpose Of The Database And Study Design: HIVNET was established in 1993 by the Division of AIDS (DAIDS), NIAID to be a multi-center, collaborative research network whose mission is to carry out HIV prevention efficacy trials. Its purpose was to evaluate the safety and effectiveness of promising interventions to prevent the transmission of HIV between sexual and/or needle-sharing partners, as well as from mother to baby during pregnancy and at birth. In most cases, the primary aim of these studies is to measure the effect of prevention interventions on reducing the number of new HIV infections.
The HIVNET has had a broad agenda that includes trials of vaccines, topical microbicides, treatment of sexually transmitted diseases, behavioral interventions, and approaches to prevent mother-to-infant transmission. It focuses primarily on efficacy trials (although it has carried out some Phase I and II studies) in an international multi-center network. Scientific collaborations with scientists in industry and academia, and NIAID staff constitute other key components of the program. The clinical research sites of the HIVNET are located in the US and abroad. Twenty-two research sites are currently located in eleven cities in the US. Eleven international sites are located in Asia, Africa, the Caribbean, and South America.
HIVNET's studies are often carried out in collaboration with other agencies that are involved in prevention research including NIMH, NIDA, the National Institute of Child Health and Human Development (NICHD), the National Institute on Alcohol Abuse and Alcoholism, Fogarty International Center, CDC, Walter Reed Army Institute of Research, the US Agency for International Development, the Population Council, the Contraceptive Research and Development Program, the United Nations AIDS program, and the World Health Organization.
In 1999, a plan for reconfiguration of the NIAID’s clinical prevention research and development program emerged from an eight-month process of evaluation and discussion involving a broad cross-section of the scientific and at-risk communities. The plan preserves important assets of the current program, minimizes disruption of ongoing and planned studies, ensures scientific and managerial continuity, creates greater opportunity for scientific creativity, and allows the possibility for institutions to participate in both areas of clinical research and development. The plan calls for the reconfiguration of HIVNET and the AIDS Vaccine Evaluation Group (AVEG) to create:
- A comprehensive, clinically-based HIV Vaccine Clinical Trials Network (HVTN) with an expanded, integrated clinical research and development agenda including domestic and international components; and
- A strengthened HIV Prevention Clinical Trials Network (HPTN) with a discreet scientific identity, a stable and predictable funding stream, and an integrated clinical research and development agenda with domestic and international components.
An orderly transition process has been undertaken to consolidate scientific responsibility for HIV vaccine research and development in the HVTN. Similarly, other areas of clinical prevention research currently under the purview of HIVNET will be consolidated in the HPTN. The transition will proceed through a two-stage process. The first stage will consist of establishing separate vaccine and prevention leadership core groups. The second stage will be the selection of the clinical sites.
Unit Of Analysis: Individuals at risk for HIV Infection
General Attributes: The Vaccine Preparedness Study (VPS) (HIVNET Protocol D01) was completed in January 1998. VPS had 4,892 participants from three groups at high risk for HIV: injection drug users, men who have anal intercourse (receptive or insertive) with other men, and women at high risk for HIV infection through heterosexual contact. In August 1997, an expansion of the VPS was launched with the recruitment of new groups of injection drug users at HIVNET sites in Philadelphia and New York City. The expansion continued in February 1998 with the start of recruitment of individuals in the three high risk groups at five pre-existing and three new HIVNET sites, in Baltimore, Los Angeles, and the Bronx.
Additional vaccine studies include: Safety Trial of Two HIV Vaccine Strategies in HIV-Negative Volunteers (HIVNET Protocol 014), HIV-Exposed But Uninfected Study (HIVNET Protocol D01.3), and the Infected Participant Cohort (IPC) (HIVNET Protocols D01.1 and 019).
Microbicide studies include: PMPA Gel Vaginal Microbicide Study (HIVNET Protocol 018), Phase 1 Rectal Microbicide Study (HIVNET Protocol 008), and the Vaginal Microbicide Study of Buffergel PRO 2000/5 Gel Study.
Behavioral studies include: HIV Early Detection Study (HEDS) (HIVNET D01.2), a trial of a behavioral intervention for men who have sex with men (HIVNET Protocol 015, "EXPLORE"), and an application of computer technology to assess risk behaviors among participants in the Vaccine Preparedness Study of HIVNET (HIVNET Protocol 005).
Strengths And Weaknesses Of The Study Design And Database: The HIVNET has a track record of carrying out important studies in the relevant areas of science and has made many significant contributions to the field of prevention research. It has had an active agenda and established systems and procedures. There is extensive integration of communities at-risk into the research program. There are well-established central laboratories and working structures for utilizing them and the data that are generated by them. The HIVNET funding structure is designed for the specific purpose of creating a network upon which a vaccine efficacy trial could be placed. It uses sites and "infrastructure" as its fundamental organizing principal, rather than science.
HIVNET has depended on additions to the infrastructure through incremental funding for particular clinical trials. This led to substantial variation in year-to-year funding levels and considerable difficulty in establishing scientific priorities when the funding base has been unpredictable. The "compartmentalization" of vaccine development, where Phase I and Phase II vaccine trials are in AVEG and Phase III in HIVNET, has made it difficult to ensure maximal efficiency and a "seamless" program of vaccine development. This has required coordination across two different organizations with varied scientific focus and priorities, laboratories, and data collection and analysis systems.
Feasibility Of Linking With Other Databases: None
Process To Access The Database And Contact Person: For additional information contact: Lawrence Corey, MD, Fred Hutchinson Cancer Research Center, University of Washington, (206) 667-6702. The HIVNET website is: http://www.hivnet.commed.net/.