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Quality control and quality assurance in HIV prevention research: model from a multisite HIV prevention trial

The NIMH Multisite HIV Prevention Trial is a phase III clinical trial. The National Institutes of Health guidelines for the inclusion of women and minorities as subjects in clinical research [1] defines a clinical trial as ‘any broadly based prospective study evaluating an experimental intervention with a control or standard, or comparing two or more existing treatments or interventions where the outcome of the study is likely to contribute to change in either standard of care or public health policy’. The sine qua non of a clinical trial is the institution of excellent quality control/quality assurance (QC/QA) procedures [2,3]. Two important determinants of the internal and external validity of multisite randomized trials are the integrity and discriminability of the interventions being examined (e.g., treatment and control conditions) [4,5].