| Methods |
Patients (n = 151) were randomly assigned to either the control (n = 77) or intervention group (n = 74) and balance between groups was ensured every 4 subjects that were enrolled |
| Participants |
Patients were HIV‐infected and had a history of alcohol problems. HIV status was confirmed by laboratory tests and alcohol problems were defined as current or lifetime history of alcohol abuse or dependence and were determined by 2 or more positive responses to the CAGE alcohol screening questionnaire. Those who did not meet the CAGE criteria were eligible if one of 2 attending physicians made a clinical diagnosis of alcohol abuse. Patients also were fluent in English or Spanish, had a Mini‐Mental State Examination score of at least 21 or greater and had no plans to move from Boston area in the following 2 years |
| Interventions |
The intervention (called ADHERE) incorporated 4 distinct components: 1) assessment and discussion of the patient's alcohol and other substance use based on stage of readiness for behavioral change; 2) use of a watch as a medication timing device to improve adherence; 3) enhancement of perceived efficacy of medications; and 4) individualized HIV counseling and exploration of ways to tailor medication use to specific circumstances. Visits for the intervention group was scheduled for an initial 60‐minute appointment (within 2 weeks of randomization), a follow‐up home visit within the first 3 weeks and 2 subsequent 15‐ to 30‐minute appointments at 1 month and 3 months with the nurse interventionist who delivered the adherence enhancement intervention. Patients in the control group received standard care for HIV infection, which included verbal or written instructions about optimal medication strategies and regular medical care for HIV infection |
| Outcomes |
Adherence to antiretroviral therapy (ART) was measured using the AIDS Clinical Trials Group (ACTG) scale for both the previous 3 days and 30 days. Self reported adherence was measured using the ACTG scale. Adherence was defined as > 95% adherence over the previous 30 days and 100% adherence over the previous 3 days. In addition to the dichotomous measure of adherence, a continuous measure of adherence for the past 30 days was measured using the actual proportion of doses taken verses doses prescribed. Both adherence outcomes were assessed at 6 months (short‐term) and at 13 months or 12 months (long‐term). Self reported adherence assessment was verified with the MEMS caps of certain patients ‐ ones who reported no change in HIV medications during the assessed interval and did not use a pill‐organizing container. At 12 months, the following clinical outcomes were assessed: 1) CD4 cell count; 2) Log HIV RNA; and 3) Alcohol severity and consumption (using both the Addiction Severity Index and quantity and frequency questions assessing the previous 30 days), which was used to calculate the average number of drinks per day |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomization was not described in detail. "Subjects were randomly assigned to either the control or intervention group and balance between groups was ensured after every four subjects were enrolled." (pg 84) |
| 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 |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ The author has noted that the research assistants were not concealed to treatment group as previously stated. They facilitated getting the subjects connected with the nurse |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) CD4 CELL COUNT ‐ This is an objective measure of outcome |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ The author notes that subjects could not be blinded to the intervention |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) CD4 CELL COUNT ‐ This is an objective measure of outcome |
| Blinding of personnel (performance bias)
Adherence measure |
Low risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ The author has noted that key study personnel were not made aware of the group assignments |
| Blinding of personnel (performance bias)
Patient outcome |
Low risk |
(PRIMARY) CD4 CELL COUNT ‐ This is an objective measure of outcome |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Long‐term (12‐month) data are available for 58% and 66% of subjects only |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) CD4 CELL COUNT ‐ Long‐term (12‐month) data are available for 58% and 66% of subjects only |
