| Methods |
Patients were randomly allocated using a 2:1 (control:intervention) ratio. There are no details about the randomization procedure or whether it allowed for concealment of allocation. The study was not blinded |
| Participants |
There are no exclusion criteria. Inclusion criteria: all patients with HIV infection demonstrated by plasma viral load > 5000 copies/ml and CD4+ lymphocyte count < 600 X 106/L initiating treatment with indinavir (800 mg/8h), zidovudine (300 mg/12h), and lamivudine (150 mg/12h). They included all patients with HIV infection receiving prescription for this combination of agents from July 1996 to December 1997 |
| Interventions |
All patients were treated with zidovudine + lamivudine + indinavir. Control patients (n = 110) received conventional care in addition to the drug regimen (new refill every 2 months). Intervention patients (n = 60) received individualized counseling/assessments which consisted of adaptation of treatment to the patient's lifestyle, detailed information about highly active antiretroviral therapy, phone support (for questions or medication‐related problems), and monthly visits to the HIV day clinic |
| Outcomes |
Measurement of compliance: compliance was estimated every 2 months using a structured interview and by pill counts. The same person conducted all compliance evaluations blind to viral load (not to allocation). Patients were considered to be compliant when: (1) they took more than 90% of their drugs; AND (2) > 90% of pill intakes should be according to a pre‐specified schedule (hours between doses, relation between doses and meals); AND (3) fewer than 2 mistakes in pill intake per day
Measurement of clinical health outcomes: undetectable viral load was measured, as was reduction in viral load and increase in CD4+ lymphocyte count |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomization process not described |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not mentioned |
| Selective reporting (reporting bias) |
Unclear risk |
There is not protocol; insufficient information provided to permit judgment |
| Other bias |
High risk |
This was an open study with self reported adherence measures ‐ measurement bias |
| Blinding of outcome assessment (detection bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ interviewers were not blind |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) VIRAL LOAD ‐ The study was open but the outcome is not likely to be influenced by lack of blinding; objective measure |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Open study ‐ subjective measure |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) VIRAL LOAD ‐ The study was open but the outcome is not likely to be influenced by lack of blinding; objective measure |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ No mention in the study about key study personnel |
| Blinding of personnel (performance bias)
Patient outcome |
Low risk |
(PRIMARY) VIRAL LOAD ‐ The study was open but the outcome is not likely to be influenced by lack of blinding; objective measure |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ The dropouts seem balanced among the 2 groups. However, it is difficult to establish the effect on the results |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) VIRAL LOAD ‐ The dropouts seem balanced among the 2 groups. However, it is difficult to establish the effect on the results |
