A nationwide study being launched in six U.S. cities is designed to answer one of the major unknowns of the AIDS epidemic: What type of one-on-one counseling is most effective in changing high-risk behavior to prevent HIV infection?
The study is one of the first large-scale research projects to focus on this question. Conducted by the HIV Network for Prevention Trials and funded by the National Institute of Allergy and Infectious Diseases, it is being coordinated by a national team headed by AIDS researchers in San Francisco and New York.
"HIV prevention counseling programs have been widespread since 1985. A few studies have evaluated their impact, but none has directly compared different approaches. Our goal is to determine the most effective prevention counseling program, so in the future resources can be put to the best use," said Patrick Barresi, MPH, project coordinator and associate specialist in the Center for AIDS Prevention Studies (CAPS) at the University of California San Francisco.
Project co-chairs are Thomas Coates, PhD, executive director of the UCSF AIDS Research Institute and director of UCSF CAPS; Margaret Chesney, PhD, UCSF professor of medicine and co-director of UCSF CAPS; and Beryl Koblin, PhD, associate member, laboratory of epidemiology, New York Blood Center.
The study, named EXPLORE, will compare two behavior interventions: standard HIV risk reduction counseling based on a research model called Project Respect that was developed by the Centers for Disease Control and Prevention, and a client-centered counseling approach developed by Coates, Chesney, and Barresi of UCSF.
Study volunteers currently are being recruited in Boston, Chicago, Denver, New York City, San Francisco, and Seattle through local health centers and departments. Participants must be men who have sex with men, are HIV-negative, are at least 16 years old, and have been sexually active within the past 12 months.
Researchers hope to enroll 725 volunteers in each city, achieving a total study population of 4,350. Each participant will be randomly assigned to one of the intervention strategies and will be informed from the beginning of his group. The endpoint of the study will be a comparison of the HIV infection rate in each group after three years.
A major contrast in the two interventions is the emphasis on making a personal connection to the message, according to Barresi. "The conventional wisdom is that a personal approach will generate more client buy-in to changing behavior, but sexuality and sexual behavior are very private matters. It might be that a less personal discussion is 'safer' and therefore more effective. This is what we are going to find out," Barresi said.
Study participants assigned to the Project Respect strategy will serve as the control group, because this model already is being used. The message focuses on factual information and setting short-term goals for behavior change. Information will cover such topics as how HIV is transmitted and correct condom use. Sessions with a counselor are scheduled every six months, and counselors are assigned according to availability, so there is no guarantee a participant will have the same counselor at subsequent sessions.
Participants assigned to the UCSF approach will serve as the experimental group, because this intervention has not yet been tested. The message will focus on personal decision-making and setting long-term goals for reducing HIV risk. A participant will be shown a menu of relevant topics, choosing items that he would like to discuss at each session. Ten sessions are scheduled during the first four months, then additional counseling visits take place every three months for the rest of the three-year study period. A participant sees the same counselor each time.
In both intervention groups, participants will take part in individual counseling sessions with trained counselors and will be tested every six months for the presence of HIV antibody in the blood, an indication of HIV infection. If a participant does become HIV positive during the course of the study, he will be referred to appropriate followup services. All participants will receive payment.
"We know the key to controlling HIV infection rates is reducing high-risk behavior, but we need to know the best way to get this message across to a new generation of young adults who are sexually active. We designed our counseling approach as a way to talk with clients--not to them--about their high-risk behavior. The results of this study will tell us if we are going in the right direction," said Coates, who with Chesney is nationally recognized in HIV prevention efforts.
"With the UCSF approach, the client is a stakeholder in his future, and discussion covers real-life behavior options, such as ways to meet people and establish relationships without risk, personal strategies to reduce the risk of infection when using alcohol or drugs, and ways to communicate with partners about risk, safety, and most important, a future that will be free of infection," Chesney added.
The National Institute of Alcohol Abuse and Alcoholism also is providing funding for the study.
Boston
Fenway Community Health Center:
Tom LaSalvia - 617-927-6028, tlasalvia@fchc.org
Chicago
Howard Brown Health Center:
Brent Hope - 773-388-8860, brenth@howardbrown.org
Scott Cook - 773-388-8885, scottc@howardbrown.org
Fred Swanson - 773-388-8884, freds@howardbrown.org
Denver
Denver Department of Public Health:
Stephanie Denning - 303-436-6606, sdenning@dhha.org
Ken Miller - 303-367266, kgmiller@dhha.org
New York City
New York Blood Center:
Beryl Koblin - 212-570-3105, bkoblin@nybc.org
Denise Goodman - 212-388-0008, dgoodman@nybc.org
San Francisco
San Francisco Department of Public Health/AIDS Office:
Joe Wright - 415-554-9065, joe_wright@dph.sf.ca.us
Seattle
Seattle HIV/Net Site:
Dennis Torres - 206-521-5812, ditorres@u.washington.edu