READINESS OF HIGH-RISK POPULATIONS IN THE HIV NETWORK FOR PREVENTION TRIALS TO PARTICIPATE IN HIV VACCINE EFFICACY TRIALS IN THE UNITED-STATES

Objective: To determine the willingness of populations at high risk of HIV-1 infection to participate in HIV vaccine efficacy trials, determ ine factors influencing decisionmaking, and evaluate knowledge levels of vaccine trial concepts. Design: Cross-sectional study. Methods: HIV -1-negative homosexual men, male and female injecting drug users and n on-injecting women at heterosexual risk were recruited in eight cities in the United States (n = 4892). Results: A substantial proportion of the study population (77%) would definitely (27%) or probably (50%) b e willing to participate in a randomized vaccine efficacy trial. Incre ased willingness was associated with high-risk behaviors, lower educat ion level, being uninsured or covered by public insurance, and not hav ing been in a previous vaccine preparedness study. Altruism and a desi re for protection from the vaccine were major motivators for participa tion. Major concerns included positive HIV-1 antibody test due to vacc ine, safety of the vaccine, and possible problems with insurance or fo reign travel. Baseline knowledge of vaccine trial concepts was low. Co nclusions: It is likely that high-risk volunteers will be willing to e nroll in HIV vaccine efficacy trials. A variety of participant and com munity educational strategies are needed to address participant concer ns, and to ensure understanding of key concepts prior to giving consen t for participation. (C) 1998 Lippincott-Raven Publishers.