The HIV Network for Prevention Trials (HIVNET) is a multi-center, collaborative research network whose mission is to carry out HIV prevention efficacy trials. The HIVNET was established in 1993 by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID). The HIVNET evaluates 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 methods being evaluated include HIV vaccines, topical gels and lubricants, treatment of other sexually transmitted diseases (such as herpes), that may increase the risk of getting HIV, use of antiviral drugs to prevent mother-to-infant transmission, and ways to help people reduce their risk of getting HIV by changing their behavior.

• The Statistical and Clinical Coordinating Center is operated by the Fred Hutchinson Cancer Research Center and the University of Washington. This center is responsible for collecting and analyzing the information obtained from HIVNET research. Center staff also are involved in day to day coordination of study operations. 
• The Central Laboratory, operated by the Viral and Rickettsial Disease Laboratory of the California Department of Health Services, provides centralized laboratory testing services for HIVNET studies. 
• The Domestic Master Contractor, Abt Associates Inc., provides funding for all study sites in the United States. Abt also helps to coordinate study operations and monitors sites to assure the consistency and quality of the research. In addition, Abt is responsible for coordination of local and national community education efforts. 
• The International Master Contractor is Family Health International, which subcontracts with study sites outside the United States and oversees their research and related community activities. 
• The Repository Contractor, Biomedical Research, Inc., provides very low temperature, long-term storage for biological specimens collected in HIVNET studies.  

All five prime contractors, all study sites, and national and local community advisory board (CAB) representatives work closely with staff from DAIDS in the overall operation of the HIVNET. Each of these groups is represented on the HIVNET Scientific Steering Group which provides scientific management of the HIVNET. In addition to the Steering Group, there are research groups called "protocol teams" and "Science Direction Working Groups" (SDWGs) that: 

• propose, develop, and evaluate ideas for new research studies; 
• regularly review the information obtained from ongoing studies to ensure the safety of participants and evaluate the progress of the studies; and
• prepare the information obtained from studies for publication in medical and scientific journals. 

Membership on protocol teams and SDWGs is mostly determined by the function of the team.

Some Useful Definitions

Efficacy Trial - A study conducted with several thousand individuals at higher risk for acquiring HIV infection to see whether or not the intervention being tested actually works, and continues to appear safe when given to a large number of people.

Vaccines - A vaccine is a substance given to protect against infection or disease by causing an immune system response. For example, an HIV vaccine would be a substance designed to protect against HIV, the virus which causes AIDS.

Sexually Transmitted Diseases - Sexually transmitted diseases (STDs), also know as sexually transmitted infections (STIs), are either viral or bacterial infections transmitted or spread through sexual contact, including vaginal, anal, and oral. Some STDs can also be transmitted through touching and kissing.

Mother to Infant Transmission - The transmission of infection from a pregnant woman to her offspring.

Risk Reduction - A form of counseling designed to assist individuals to learn how to utilize behavioral strategies that may help reduce their risk for being exposed to HIV.

Antiviral Drugs - A drug designed to reduce or eliminate virus in the body.

Behavioral Intervention - Behavioral interventions, or strategies which assist individuals change the behaviors which place them at risk for exposure to HIV infection.

Microbicides - A chemical that kills the germs ("microbes") that cause some sexually transmitted infections. Microbicides are things like gels or jellies, cream, suppositories, or film; they are put into the vagina some time before sexual intercourse. Microbicides are being studied that may kill HIV and bacterial sexually transmitted diseases such as gonorrhea and chlamydia. Some microbicides also kill sperm (are "spermicidal") and therefore can also be used as contraceptives.

Community Advisory Boards- Community Advisory Boards (CABs) are small advisory groups made up of volunteers from local communities in areas where studies are being conducted. CABs give advice on how people in the community (who are not scientists) feel about the study and ways to improve it. CABs help to plan studies as well as work to make sure studies are run well.  Community Advisory Boards (CABs) are required by all National Institute of Allergy and Infectious Diseases (NIAID) funded sites to ensure community input into the research process and to foster a partnership between researchers and persons infected and/or affected by HIV/AIDS.

HIVNET Scientific Steering Group (SSG) - The HIVNET has developed governance procedures to promote the conduct of prevention studies and to ensure that the design, implementation and analysis of HIVNET studies meet established standards. Scientific direction and oversight for the HIVNET resides with the Scientific Steering Group (SSG). The SSG is comprised of investigators representing both international and domestic clinical trial research; at least one community representative; individuals representing the domestic and international prime contractors; and individuals representing the Division of AIDS/National Institute of Allergy and infectious Disease/National Institutes of Health. The SSG is configured to allow for efficient decision making and to be representative of the diverse interests encompassed within the HIVNET.

Science Direction Working Groups (SDWG) - Science Direction Working Groups (SDWGs) are small groups of scientists responsible for analyzing and identifying research needs and reporting to the Scientific Steering Group on the progress of their efforts and advising the SSG on appropriate scientific strategies. There are three SDWGs within the HIVNET defined by broad categories of intervention strategies: Perinatal, Microbicides/Barriers/STDs, and Behavioral studies. All HIVNET investigators are encouraged to participate in one (or more) of the HIVNET working groups.

Data Safety Monitoring Board (DSMB) - An independent committee of clinical research experts and ethicists who review data while a study is going on to make sure that participants are not at undue risk. A DSMB may recommend that a study be stopped if there are safety concerns or if the study objectives are met earlier than expected.

Clinical Trials Process - Clinical trials, or the testing of prevention and treatment interventions occurs in a series of steps referred to as "phases." All together, after a pre-clinical phase where interventions are typically tested in a laboratory and/or in animals, there are three major phases of clinical trials research among humans.

During a Phase I study, the intervention is tested in a small sample of individuals who are in good health and are unlikely to develop the health problem that the vaccine or other method is supposed to prevent (i.e. they are "at low risk"). In Phase I, the question is whether or not the intervention is safe. A Phase I study can last anywhere from one to two years. If the intervention is found to be safe it will then move into Phase II studies.

During a Phase II study, researchers will test the intervention in a larger group of individuals at both low and high risk. Researchers continue to study safety but also will look to see whether the intervention being tested elicits an appropriate biological response. In a Phase II preventive vaccine trial for example, researchers will study whether the vaccine stimulates an immune response.  A Phase II study can typically last anywhere from one to two years. Interventions considered promising after careful consideration may advance into a Phase III study.

In a Phase III study, also known as an "efficacy study" researchers try to find out whether the intervention being tested "works" (it is effective.) Safety continues to be monitored. These studies are typically done in a large sample (thousands) of individuals. In a Phase III HIV vaccine study for example, researchers will design the study to learn whether the intervention actually works to prevent people from becoming infected with HIV.

Clinical Trials Chart

Related Websites

National Institute of Allergy & infectious Diseases (NIAID)
http://www.niaid.nih.gov

International AIDS Vaccine Initiative (IAVI)
http://www.iavi.org

National Institutes of Health (NIH)
http://www.nih.gov

AIDS Vaccine Advocacy Coalition (AVAC)
http://www.avac.org

Centers for Disease Control & Prevention (STD Division of Prevention) (CDC)
http://www.cdc.gov/nchstp/dstd/

American Social Health Association (ASHA)
http://www.ashastd.org

University of California San Francisco - HIVInsite
http://hivinsite.ucsf.edu

The Joint United Nations Programme on HIV / AIDS (UNAIDS)
http://www.unaids.org