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the study is a randomized controlled trial, which, in scientific terms, means that half of the participants have been randomly assigned to a group and receive the intervention, while the other half of the participants receive the standard care. the randomization is done at the patient level. it is not random which patients receive what treatment
the primary outcome measure is adherence to antiretroviral therapy as determined by patient report by means of the acasi. adherence is generally assessed in several ways, but the measurement of adherence remains controversial. laboratory tests may assess adherence, but only moderately so, and may miss some episodes, and side effects may interfere with adherence. self report seems to be the most valid method of measuring adherence but its validity has not been well studied.
intervention subjects were provided the edm printout just after their clinic visit and were told to give it to their physician. intervention subjects were also provided questions on the da used to self monitor drug use
all subjects were offered the chance to review the edm printout at any time, however, intervention subjects could only review the edm printout if they brought it to their clinic visit. in addition, intervention subjects were told by the investigator to always bring the da to their next clinic visit. all intervention subjects were sent 1 to 3 texts a week reminding them to bring the da with them to their next clinic visit. these texts were designed to be to the subject’s own liking. all subjects were told that they could ask questions of the intervention team about the edm information. participants received separate reimbursement for their edm device. participants could receive up to $20 reimbursement for their edm device.
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