DiIorio 2008.

Methods	Randomized controlled trial
Participants	The study location was a HIV/AIDS clinic in Atlanta, Georgia, USA 125 participants were randomized to the intervention group and 122 participants were randomized to the control group The inclusion criteria were 1) infected with HIV, (2) referred to the nurse educator for adherence education, (3) prescribed for the first time a multi‐drug regimen or had a recent change in their regimen, (4) 18 years of age or older, (5) able to speak English and (6) willing to talk with a Get Busy Living recruiter
Interventions	Intervention: MOTIVATIONAL INTERVIEWING Intervention group receives usual adherence education and motivational interview. Participants received 5 individual MI counseling sessions with a study nurse counselor over a 3‐month period. The goal of these sessions was to help participants gain an understanding of their medication‐taking behaviors and the actions necessary to successfully maintain a high level of adherence. The counselor used a MI script to guide the interaction with the participants. During the session participants were encouraged to identify and discuss barriers to adherence, to express and resolve ambivalence about taking medications, and to support motivation to attain or maintain adherence. After each medication was discussed and an action plan developed, the counselor ended each session by summarizing the discussion and the action plan agreed upon by the participant and counselor. Session 1 was completed in‐person for all participants. Telephone sessions (for sessions 2 though 5) were conducted as needed for participants who were unable to meet the counselor in the clinic. Participants were paid USD 10 for completing the first MI session and USD 5 for each of the remaining 4 sessions. Participants in the intervention group also received a copy of the Get Busy Living video, a journal and a calendar Control: CONTROL Participants randomized to the control group received the usual adherence education provided at the clinic. 3 nurse educators employed at the HIV clinic provide comprehensive adherence education to patients who are initiating or changing ART. They use a variety of teaching methods that are tailored for each individual based on factors such as education level, culture, type of regimen and time schedule. Patients were referred to the Get Busy Living staff when the nurse educators cleared them to begin taking their medications. Participants could continue to meet with the nurse educators for adherence assistance as needed after the initial education sessions
Outcomes	The measure of adherence was a Medication Event Monitoring System (MEMS) as the primary measure of adherence. MEMS consist of a microprocessor that is contained within the cap of the medication bottle. When the cap is opened, the date and time of opening are recorded and stored. These data are downloaded to a computer and used to calculate a variety of adherence measures. For the present study, 2 MEMS adherence rates were calculated. The first was based on the correspondence between the number of doses prescribed per day and the number of cap openings per day. The second was based on the number of cap openings occurring within one hour of the prescribed time for the dose. Each was converted to a percentage, i.e. per cent of doses taken and per cent of doses taken on schedule. Only one medication per person was monitored using MEMS. The staff selected the medication for monitoring using a predetermined list of possible medication combinations. MEMS caps have been used in a number of research studies assessing ART adherence and have been found to be a reliable and valid measure of adherence. The patient outcomes were viral load and CD4 counts, assessed based on medical records, where viral load was measured by the AMPLICOR HIV‐1 MONITOR Test, and CD4 cell count was determined by the BD FACSCalibur system. All tests were conducted by the medical center laboratory, which used appropriate techniques to ensure reliability and validity of the results of the tests
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The study was a randomized controlled trial in which participants were randomized by use of computer‐generated codes to either the usual care or intervention condition(pg 274)
Allocation concealment (selection bias)	Unclear risk	No mention of allocation concealment ‐ (pg 274) "The study was a randomized controlled trial in which participants were randomized by use of computer‐generated codes to either the usual care or intervention condition."
Selective reporting (reporting bias)	Unclear risk	No protocol available
Other bias	Unclear risk	Some questions on generalizability; no other serious or apparent bias in trial. (pg 281‐2) "...there are several limitations of this study. First, the sample was composed primarily of low‐income African American men. Thus, the results cannot be generalized to those in other groups who are also prescribed ART. Future research should focus on other groups affected by HIV, including women and gay men and other cultural groups, including Hispanic and Asian men and women. Second, all men and women who were initiating or changing ART were eligible to participate provided they met other study criteria. We did not limit participants to those who were reported difficulties taking their medications. We found that many participants maintained a high level of adherence throughout the study, limiting our ability to fully test the usefulness of MI in promoting behavioral change. Finally, we asked participants to use MEMS † caps throughout the one‐year study. This proved difficult for some individuals. In future studies, researchers might consider limiting the use of these caps to short periods of time around the follow‐up assessment periods. Finally, cost of lab tests limited our ability to fully test the effect of the intervention on viral load and CD4 counts. Although there was some indication that those in the intervention group had more favorable lab values, future research should include systematic assessment of these indices. Finally, the types and doses of medications changed over the course of the study..."
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) MEMS ‐ No mention of blinding but MEMS is unlikely to be affected by outcome assessors
Blinding of outcome assessment (detection bias) Patient outcome	Unclear risk	(PRIMARY) VIRAL LOAD ‐ The information about CD4 cell count was collected from medical records. No mention of blinding
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) MEMS ‐ No mention of patient blinding
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) VIRAL LOAD ‐ The data were abstracted from medical records; it is unlikely the patient would influence data
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) MEMS ‐ No mention of blinding of staff. Insufficient information to permit judgment of 'Low risk' or 'High risk
Blinding of personnel (performance bias) Patient outcome	Unclear risk	(PRIMARY) VIRAL LOAD ‐ it is unclear from the paper whether key personnel were blinded or not
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) MEMS ‐ Dropouts fairly balanced and reasons for withdrawals noted "A total of 23 participants actively withdrew, were withdrawn from the study at various points or died: 14 in the control and nine in the intervention group. Most of these participants had died (70%). Other reasons for withdrawal included: moved, time constraints and loss of interest. Because the primary measures of adherence were based on data obtained from MEMS cap use, participants with at least one month (4 weeks) of monitored days beyond the date of baseline assessment were included in the main analyses."
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) VIRAL LOAD ‐ Missing outcome data are balanced in numbers across intervention groups, with similar reasons for missing data across groups