| Methods |
64 patients were randomized in this study with 32 in the intervention group and 32 in the control group. Allocation concealment and method of randomization were not described |
| Participants |
Enrolled patients who were 18 years of age or older, able to self medicate, and currently receiving care at the Johns Hopkins Moore (HIV) Clinic. Subjects eligible for inclusion were either previously treatment‐naive and initiating highly active antiretroviral therapy (HAART) for the first time or antiretroviral experienced and switching HAART regimens. Among subjects in the latter group, we included only those who had received 3 or less HAART regimens before study enrolment. Exclusion criteria were inability to self medicate, presence of severe dementia, and institutionalization |
| Interventions |
All subjects participated in an individualized, 30‐minute adherence counseling session each month and received adherence feedback from a standardized transcript that provided general education about the barriers to adherence, the hazards of non‐adherence, and their prescribed HAART regimen. A clinical pharmacist with extensive experience in the field of Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) provided adherence counseling and feedback. Patients in the intervention group were also given the Disease Management Assistance System (DMAS) device for 24 weeks. The DMAS device was programmed with reminder messages and dosing times for each medication in the HAART regimen. Devices were inspected monthly and reprogrammed when the HAART regimen was changed or replaced if they were lost or malfunctioning. Patients in the control group did not receive the DMAS |
| Outcomes |
Adherence was assessed monthly with the DMAS, data from the electronic drug‐exposure monitoring (eDEM) caps and completion of the AIDS Clinical Trials Group (ACTG) Baseline Adherence Questionnaire during the initial study visit and the ACTG Follow‐up Adherence Questionnaire during subsequent visits. 4‐day average adherence was calculated as the number of prescribed doses minus the number of missed doses, divided by the number of prescribed doses. For the DMAS device, adherence was calculated as the number of times the response button was pressed divided by the number of medication prompts during the 4‐day period preceding the study visit. Clinical endpoints included CD4+ cell count and plasma HIV RNA load were assessed at baseline and at weeks 12 and 24 of follow‐up. Validated neuropsychological (NP) tests were used to assess attention, memory, new learning, psychomotor speed, and executive functions and administered twice during the study, at baseline and after 24 weeks of HAART. Symptoms of depression were assessed using the Center for Epidemiologic Studies Depression (CES‐D) scale. Patients were also questioned about active illicit drug use and alcohol use during the past 4 days |
| Notes |
The DMAS prompting device improved adherence for memory‐impaired subjects but not for memory‐intact subjects; this was shown at 24 weeks with a 20% increase in adherence for the memory‐impaired group compared with 6% for the memory‐intact patients. Although the DMAS resulted in improved adherence, the overall mean adherence score was only 77% for DMAS users with memory deficits. This is lower than the optimal adherence rate of 95% required for optimal viral suppression |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Author note: Subjects were randomized using a random number generator that produced a list of treatment slots |
| Allocation concealment (selection bias) |
Unclear risk |
No mention of allocation concealment. (pg 876) "Subjects were randomly assigned to intervention or control groups." |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available |
| Other bias |
High risk |
Low external generalizability. (pg 881) "Third, substance abuse was relatively uncommon in our study, and therefore the results might not be generalizable to populations in which drug abuse is more prevalent." |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Unclear risk |
(PRIMARY) ELECTRONIC DRUG EXPOSURE MONITORING ‐ No mention of blinding of outcome assessors |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) CD4 CELL COUNT ‐ Author note: Laboratory staff were blind |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) ELECTRONIC DRUG EXPOSURE MONITORING ‐ Participants would have known they were in the intervention group |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) CD4 CELL COUNT ‐ No mention of blinding but this outcome is objective |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) ELECTRONIC DRUG EXPOSURE MONITORING ‐ No mention of blinding of study staff |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) CD4 CELL COUNT ‐ No mention of blinding of study staff |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) ELECTRONIC DRUG EXPOSURE MONITORING ‐ Even dropouts but imputation method was unclear |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) CD4 CELL COUNT ‐ Even dropouts but the imputation method was unclear |
