Collier 2005

Methods	Randomised controlled trial conducted over a 96 week period.
Participants	Participants (n=282) with advanced HIV infection (CD4 count less than or equal to 200 cells/mm3 or >80,000 HIV RNA copies/mL of plasma at screening) who were initiating antiretroviral therapy (no previous use of lamivudine, nonnucleoside reverse transcriptase inhibitors, or protease inhibitors) were enrolled in this adherence substudy of a treatment trial. Participants were recruited from 30 sites in the United States of America, Puerto Rico and Italy, 48% identified as white, 32% black and 15% Hispanic and 19% of participants were women. There were no significant baseline differences between the intervention and control groups.
Interventions	Participants were randomised to a usual support measures group (n=140) or a telephone intervention group (n=142). Participants in the usual care support group received their study site's usual adherence support measures. These may have included 35 minutes of in‐person counselling, written material or informal telephone calls. Those in the telephone intervention group received their site's usual support measures plus up to 16 scripted telephone calls from study site members (mostly nurses) over the 96 week study period. Calls focused on each subject's medication taking behaviour and barriers to adherence, and developed individual strategies to increase adherence. Social support and assistance with medical side effects were also provided.
Outcomes	Outcomes were virologic failure and self‐reported adherence.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No mention of sequence generation in the study.
Allocation concealment (selection bias)	Unclear risk	No mention of allocation concealment in the study.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinding of participants and personnel was unlikely to be feasible in this study, but we do not think this will have affected the results.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No mention of blinding to outcome assessment in the study.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Of the 282 enrollees, 239 (85%) completed the trial, 35 (12%) discontinued prematurely, six (2%) died, and two (1%) discontinued for other reasons. The reasons for not completing the trial were similar between groups.
Selective reporting (reporting bias)	Unclear risk	Protocol of the study was unavailable.
Other bias	High risk	We judged the risk of contamination to be high. The same study site staff members were counselling participants in both groups. Subjects who were anticipated to have problems with adherence at all study sites received counselling. It is possible that the approach used for the usual support measures group may have been influenced by the additional support measures used for the calls group if the study site staff members inadvertently used counselling strategies they learned from the standardised script. According to a study site survey, 67% of study sites reported that they provided written materials to study participants as part of their usual adherence support measures. In addition, 41% of study sites reported making at least one telephone call to selected participants (who were judged by study site staff members as being at high risk for low adherence) as part of their usual support measures; telephone calls were made to a minority of participants, the number of telephone calls per subject was limited, and the content was not standardized.