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, determine factors influencing decision-making, and evaluate knowledge levels of vaccine trial concepts.


METHODS
Cross-sectional study.


METHODS
HIV-1-negative homosexual men, male and female injecting drug users and non-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%) be willing to participate in a randomized vaccine efficacy trial. Increased willingness was associated with high-risk behaviors, lower education level, being uninsured or covered by public insurance, and not having been in a previous vaccine preparedness study. Altruism and a desire for protection from the vaccine were major motivators for participation. Major concerns included positive HIV-1 antibody test due to vaccine, safety of the vaccine, and possible problems with insurance or foreign travel. Baseline knowledge of vaccine trial concepts was low.


CONCLUSIONS
It is likely that high-risk volunteers will be willing to enroll in HIV vaccine efficacy trials. A variety of participant and community educational strategies are needed to address participant concerns, and to ensure understanding of key concepts prior to giving consent for participation.
Koblin
B A
BA
Laboratory of Epidemiology, The New York Blood Center, New York 10021, USA.
Heagerty
P
P
Sheon
A
A
Buchbinder
S
S
Celum
C
C
Douglas
J M
JM
Gross
M
M
Marmor
M
M
Mayer
K
K
Metzger
D
D
Seage
G
G
D016915:AIDS Vaccines; D002986:Clinical Trials as Topic; D003430:Cross-Sectional Studies; D005260:Female; D015658:HIV Infections / Q000517:prevention & control* / Q000523:psychology*; D006266:Health Education; D006801:Humans; D008297:Male; D012307:Risk Factors; D014481:United States
D016915:AIDS Vaccines