| Methods |
Random allocation, not otherwise specified |
| Participants |
60 HIV patients were randomized by the researchers after giving informed consent. Inclusion and exclusion criteria: therapy containing a combination of at least 3 different antiretroviral drugs of at least 2 different drug classes, viral load below 50 copies/ml documented within the previous 3 months and at screening visit, participation in the Swiss HIV cohort study, no intravenous drug use or on stable methadone maintenance in case of drug addiction |
| Interventions |
Participants were randomly assigned to a psychotherapist and given the contact information to schedule their own first appointment. Protocol defined a minimum of 3 and a maximum of 25 sessions within the 1‐year study period. Participant and psychotherapist determined the frequency of appointments and set their own goals for future interventions. The method of intervention had to be based on concepts of cognitive behavior therapy. Both intervention and control groups continued to receive standard care. Standard care included monthly visits for 12 months with assessments of clinical and laboratory data, course of treatment, drug adverse events and HIV‐1 RNA |
| Outcomes |
An electronic medication exposure monitoring system was used to measure adherence. Outcome measures included virological and immunological outcomes, CD4 lymphocyte end‐points, change in antiretroviral therapy during study, and psychosocial measures |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
The allocation schedule for 2 treatment arms and 3 different CD4 strata (0–0.05×109/l, 0.051–0.2×109/l or >0.2×109/l) with randomly permuted block sizes of 2 and 4, was generated in advance with the program RANCODE V 3.0 (IDV Datenanalyse und Versuchsplanung, Gauting, Germany) and properly concealed from care providers (pg 86) |
| Allocation concealment (selection bias) |
Low risk |
Allocation concealment detailed. The allocation schedule for 2 treatment arms and 3 different CD4 strata (0 – 0.05 × 109/l, 0.051 – 0.2×109/l or > 0.2 × 109/l) with randomly permuted block sizes of 2 and 4, was generated in advance with the program RANCODE V 3.0 and properly concealed from care providers (pg 86) |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol |
| Other bias |
Low risk |
The study seems to be free of other types of bias |
| Blinding of outcome assessment (detection bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ STRUCTURED QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) VIRAL LOAD ‐ HIV‐1 RNA ‐ This is an objective measure of outcome |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ STRUCTURED QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) VIRAL LOAD ‐ HIV‐1 RNA ‐ This is an objective measure of outcome |
| Blinding of personnel (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ STRUCTURED QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding |
| Blinding of personnel (performance bias)
Patient outcome |
Low risk |
(PRIMARY) VIRAL LOAD ‐ HIV‐1 RNA ‐ This is an objective measure of outcome |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ STRUCTURED QUESTIONNAIRE ‐ No information given on reasons for dropouts |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) VIRAL LOAD ‐ HIV‐1 RNA ‐ No information given about dropout reasons |
