(HIVNET Protocol D01)

WHAT DO WE HOPE TO LEARN FROM THIS STUDY?

The main goal of this study is to develop and evaluate ways to conduct HIV vaccine trials and other HIV prevention trials in at-risk populations in the U.S. The study is designed to recruit and maintain a large pool of appropriate volunteer participants, and to find out why people would consider enrolling in HIV prevention trials and what might prevent them from participating. The study also explores ways to provide information and knowledge about HIV vaccines and prevention trials to people at high risk of being infected with HIV.

The original VPS study, which was completed in 1997, 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 sexual contact.

In August 1997, an expansion of the VPS was launched with the recruitment of new groups of injection drug users at HIVNET site in Philadelphia and New York. The expansion continued in February 1998 with the start of recruitment at three new HIVNET sites, in Baltimore, New York, and Los Angeles, of participants from all three groups at high risk.

Original VPS:

• Denver Department of Public Health, Denver, CO
• Fenway Community Health Center, Boston, MA and Memorial & Miriam Hospitals, Pawtucket & Providence, RI
• Howard Brown Health Center and University of Illinois, Chicago, IL
• New York Blood Center, New York, NY
• New York University Medical Center,New York, NY
• University of Pennsylvania, Philadelphia, PA
• San Francisco AIDS Office/Public Health Foundation Enterprises, Inc., San Francisco, CA
• University of Washington, Seattle, WA

Expanded VPS:

• New York University Medical Center, New York, NY
• University of Pennsylvania, Philadelphia, PA
• Johns Hopkins University, Baltimore, MD
• Bronx-Lebanon Health Center, Bronx, New York
• Health Research Association, Los Angeles, CA

Participants complete an enrollment visit which includes an interview about risk behavior, HIV counseling and testing, and counseling about how to reduce the risk of exposure to HIV. In the original VPS, each participant returned for follow-up visits every six months for 18 months (with an optional 24-month visit for women participants). The expanded VPS will follow the same procedures as the original VPS, but participants will be followed for only six months.

Follow-up visits include an interview, an HIV test, and additional risk-reduction counseling. Participants also complete questionnaires and interviews about their knowledge of and attitudes toward HIV vaccines and non-vaccine prevention methods and strategies. Participants who become infected with HIV while participating in the VPS study are counseled, provided referrals for service and invited to enroll in the Infected Participant Cohort (HIVNET Protocol D01.1).

Participants in the original VPS completed Month 18 follow-up visits in August 1997. Women VPS participants were asked to return for Month 24 visits, which were completed in January 1998. Recruitment in the expanded VPS began at two of the original sites in August 1997, and at the new sites in February 1998. Recruitment of injection drug users in the expanded VPS study ended in June 1998, with 482 participants enrolled.