ADHERENCE IN AIDS CLINICAL-TRIALS - A FRAMEWORK FOR CLINICAL RESEARCHAND CLINICAL CARE

Assessment of adherence within AIDS clinical trials is a critical comp onent of the successful evaluation of therapeutic outcomes. Poor medic ation adherence can result in the misinterpretation of clinical trial data. Research on factors affecting adherence in AIDS clinical trials has been scarce, and few investigations have evaluated strategies for enhancing patient participation. One reason may be the absence of a co nceptual framework to guide research. Consistent with previous researc h on medical adherence, we propose a framework whereby factors affecti ng adherence in AIDS clinical trials can be categorized as characteris tics of the: (a) individual, (b) treatment regimen, (c) patient-provid er relationship, (d) clinical setting, and (e) disease. This framework is used as a heuristic for reviewing studies that examine factors aff ecting adherence in AIDS clinical trials. Suggestions for future resea rch and clinical intervention are provided. These efforts are timely b ecause adherence is now the center of attention in discourse about the efficacy of the new class of protease inhibitor drugs; non-adherence has been linked to viral resistance and drug failure. Efforts to ident ify factors that influence adherence to AIDS clinical trials can infor m future attempts to improve adherence and retention. Better adherence protects the scientific integrity of AIDS clinical trials, promoting more efficient and accurate evaluations of therapeutic value. Accelera ted access to new treatments may follow, ultimately enhancing patient care. (C) 1997 Elsevier Science Inc.