This research was supported by the multi-site adherence collaboration in HIV (MACH14) grant R01MH078773 from the National Institute of Mental Health (NIMH), Office on AIDS. The original grants of individual participating studies are: R01DA11869, MH54907, 2R01NR04749, R01NR04749, MH68197, R01 DA13826, K23MH01862, MH01584, R01 AI41413, R01 MH61173, NIH/ NIAID AI38858, AI069419, K02 DA017277, R01DA15215, NIMH P01 MH49548, MH58986, RO1MH61695, CC99-SD003, CC02-SD-003 and R01DA015679.
AIDS (Disease) -- Patients -- Clinical trials, Clinical trials -- Methodology, Antiretroviral therapy
Researchers designing clinical trials often specify usual care received by participants as the control condition expecting that all participants receive usual care regardless of group assignment. The assumption is that the groups in the study are affected similarly. We describe the assessment of usual care within the 16 studies in MACH 14, a multi-site collaboration on adherence to antiretroviral therapy. Only five of the studies in MACH 14 assessed usual care. Assessment protocols varied as did the timing and frequency of assessments. All usual care assessments addressed patient education focused on HIV, HIV medications, and medication adherence. Our findings support earlier work that calls for systematic assessments of usual care within the study design, inclusion of descriptions of usual care in reports of the study, and the influence of usual care on the experimental condition in clinical trials.
238. Erlen JA, Tamres LK, Reynolds N, Golin CE, Rosen MI, Remien RH, Banderas JW, Schneiderman N, Wagner G, Bangsberg DR, Liu H. Assessing Usual Care in Clinical Trials. West J Nurs Res. 2014 Mar 12. PubMed PMID: 24622154