| Methods |
Randomized controlled trial. Patients were randomized into the intervention group (IG) and the control group (CG) |
| Participants |
All HIV‐infected patients who had medical follow‐up at the Nice University Hospital between September 1999 and December 1999 were approached for study participation. Patients were included if they were: 1) over 18 years of age; 2) being treated for at least 1 month by a combination of at least 1 protease inhibitor (PI) or 1 nonnucleoside reverse transcriptase inhibitor (NNRTI) or abacavir with 2 nucleoside reverse transcriptase inhibitors (NRTIs); 3) not having required hospitalization in the prior month or requiring it at the time of consultation; 4) not previously included in another protocol |
| Interventions |
The intervention combined an educational and counseling approach that was founded on the principles of motivational psychology, client centered therapy and the use of an "empathic therapeutic to enhance participants' self efficacy". The intervention focused on cognitive, emotional, social and behavioral determinants affecting adherence. The intervention consisted of 3 individually delivered sessions by nurses lasting 45 to 60 minutes. To standardize the intervention, intervention group manuals for the nurses were prepared and the nurses attended a 5‐day intensive training course given by psychologists. Some flexibility was allowed for the nurses to tailor the intervention based on the needs of the individual patient. To ensure the quality of the intervention each nurse had supervision sessions with a psychologist and a clinical supervisor to review written material filled out by the nurses. No mention was made of the care that was provided for the control group |
| Outcomes |
This data were collected using a self administered questionnaire at month 0 (M0) and month 6 (M6)
Measurement of clinical health outcomes: 1) Change in Viral Load between M0 and M6; 2) Percentage of patients achieving plasma HIV‐1 RNA levels < 40 copies ml at M6; 3)16‐item HAART related symptom scale; 4) Proportion of patients with reported toxic events; 5) Depressive mood using CES‐D scale |
| Notes |
The clinical significance of these findings is unclear ‐ adherence rate was on self report in an unblinded trial, the mean HIV RNA was no different at 6 months for the 2 groups and no actual clinical outcomes were reported |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No mention of randomization method. "Patients were randomized in an intervention group (IG) and a control group (CG)" (pg 122) |
| Allocation concealment (selection bias) |
Unclear risk |
No information was provided about how allocation was handled |
| 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 |
Low risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ According to the author, the risk of bias has been minimized since several questions were used in order to increase the sensitivity of the detection of non‐adherence |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Unclear risk |
(PRIMARY) TOXICITY AND SYMPTOM QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) TOXICITY AND SYMPTOM QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding |
| Blinding of personnel (performance bias)
Adherence measure |
Low risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ According to the author, the adherence score was computed after data entry by the research team, which was totally independent from the clinical staff |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) TOXICITY AND SYMPTOM QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding |
| Incomplete outcome data (attrition bias)
Adherence measure |
Low risk |
(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ There is a relatively high rate of missing data but similar distribution across groups (16% and 19%) |
| Incomplete outcome data (attrition bias)
Patient outcome |
Low risk |
(PRIMARY) TOXICITY AND SYMPTOM QUESTIONNAIRE ‐ There is a relatively high rate of missing data but similar distribution across groups (16% and 19%) |
