QUALITY ASSURANCE OF HIV PREVENTION COUNSELING IN A MULTICENTER RANDOMIZED CONTROLLED TRIAL

CURRENT HIV PREVENTION counseling strategies rely largely on intervent ions aimed at changing behaviors. Among these is HIV prevention counse ling and testing, which has been a prominent component in the federall y supported strategies for HIV/AIDS prevention in the United States. T o assess the efficacy of HIV counseling in reducing risk behaviors and preventing HIV infection and other sexually transmitted diseases, a m ulticenter, randomized controlled trial is being conducted among sexua lly transmitted disease clinic patients (Project RESPECT). The trial c ompares three separate HIV prevention strategies on increasing condom use and decreasing new cases of sexually transmitted diseases. The str ategies are (a) Enhanced HIV Prevention Counseling, a 4-session indivi dual counseling intervention based on behavioral and social science th eory; (b) HIV Prevention Counseling, a 2-session individual pre- and p ost test counseling strategy that attempts to increase perception of r isk and reduce risk behaviors using small, achievable steps; and (c) H IV Education, a brief 2-session pre- and post-test strategy that is pu rely informational. One difficulty in conducting randomized trials of behavioral interventions is assuring that the interventions are being conducted both as conceptualized and in a consistent manner by differe nt counselors and, for multicenter studies, at different study sites. This article describes the quality assurance measures that have been u sed for Project RESPECT. These have included development of standard t ools, standard training, frequent observation and feedback to study pe rsonnel, and process evaluation.