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Issue: Several investigators are preparing to conduct efficacy trials of human immunodeficiency virus (HIV) vaccines in the developing world. Failure to adequately address the unique ethical, behavioral, and social issues that surround vaccine testing in that setting will jeopardize the success of these trials and future acquired immunodeficiency syndrome (AIDS) research in the host nation.Description Of the Project: Twelve investigators from Africa, Asia, North America, and South America reviewed previous experience with HIV trials in developing countries and explored potential solutions to these issues.Conclusions: Host country scientists, government officials, and media must be actively involved in all aspects of the trials. Minimum prerequisites for conducting the trial include the following: (1) researching vaccines active against developing world HIV isolates; (2) establishing and maintaining an adequate technological infrastructure; (3) assessing the feasibility of recruitment in countries where the existence of HIV may be denied; (4) designing methods to obtain informed consent from each individual subject, rather than exclusively from family members or community elders; (5) creating locally appropriate instruments to measure risk behavior; (6) identifying a behavioral intervention for placebo and treatment groups; (7) making available laboratory methods to distinguish between natural HIV infection and vaccine-induced seropositivity; and (8) guaranteeing that an effective vaccine is available free of charge to the placebo group and at affordable prices to other host country residents. [ABSTRACT FROM AUTHOR]

Objective: To measure the prevalence of human immunodeficiency virus (HIV) infection and high-risk behaviors among heterosexuals in alcohol treatment., Design: Cross-sectional survey., Setting: Five public alcohol treatment centers., Subjects: Consecutive sample of 888 heterosexual clients entering treatment between October 1990 and December 1991. Respondents were 51% black, 10% Hispanic, 33% white, and 76% male. The overall response rate was 68%., Measurements: Structured interview and serotesting for HIV antibodies., Results: The overall seroprevalence of HIV infection was 5% (95% confidence interval, 3% to 6%). There were no significant differences in rates of infection by age, gender, or race. The prevalence of infection in heterosexual respondents without a history of injection drug use was 3% in men and 4% in women, several times higher than published estimates from a similar community-based heterosexual sample. Unsafe sexual practices were common: 54% of respondents reported multiple sexual partners in the previous year, 97% of nonmonogamous respondents did not use condoms during all sexual encounters, and few respondents consistently asked new sexual partners about previous high-risk behaviors., Conclusions: There is a substantial prevalence of HIV infection among heterosexual clients in San Francisco (Calif) alcohol treatment programs, much of which is not associated with injection drug use. Because of this and the high prevalence of unsafe sexual behaviors, there is a relatively high likelihood of heterosexual spread of HIV among the large population of clients seeking treatment for alcohol dependency. Interventions to prevent HIV spread should become a standard part of alcohol treatment programs.