Methods |
A randomised controlled trial of 12 months duration. |
Participants |
HIV positive persons (n=61) in the United States of America. In the intervention group 70.5% were black, 23.5% white, 3% Hispanic, and 3% mixed Hispanic and African American. In the control group 81% were black and 19% white. 50% of the intervention group, and 46% of the control group, were female. |
Interventions |
Participants were randomised to an intervention group (n=34) or a control group (n=27). The control group received monthly visits until their viral load was <50, including physician visit, CD4, VL and pharmacist adherence review. The intervention group received the control group intervention plus telephone calls from a pharmacist at day four, two weeks, then monthly for six months. |
Outcomes |
Outcomes were: adherence; change in CD4 lymphocyte count; and virologic response. |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
No details of random 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 analysis. |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk |
In the intervention group, one participant withdrew and five were lost to follow up. In the control group, one participant withdrew and seven were lost to follow up. Reasons for these were not mentioned in the study. |
Selective reporting (reporting bias) |
Unclear risk |
Protocol was unavailable to us. |