| Methods |
Consenting patients were randomized 1:1 to receive either: an EI (4 modules of the Tools for Health Empowerment course) plus routine counseling (RC) (EI + RC); or RC alone |
| Participants |
A 24‐week open‐label clinical trial was conducted in 195 HIV‐infected adults commonly under‐represented in research (35% female, 71% African American, 21% Hispanic, and 20% injection drug users (IDUs)) |
| Interventions |
The course is an 11‐module educational program for HIV‐infected patients and their informal caregivers in which there are interactive small arm sessions facilitated by a healthcare professional trained in the principles of adult learning, skills‐building exercises aimed at behavior change in participants, flip charts, videotapes, patient logbooks, and patient workbooks. Program materials are designed at a fifth‐grade reading level (English only). The goal of the THE course is to empower people living with HIV/AIDS and their informal caregivers with the knowledge, skills, attitudes, and resources to improve self care, adherence, quality of life, and satisfaction with care, leading to improved quality of care. The following 4 modules focusing on patient empowerment, HIV pathogenesis and treatment, and medication management and adherence were delivered (1 session per week) during weeks 1 through 4 of this clinical trial. "The RC consisted of provision of the following information at each study visit: names and physical descriptions of the study drugs; instructions on how best to take the study drugs, including dosage and dosage schedules (taking the patient's daily routine into account) as well as how/when to remove the medications from bottles using Medication Event Monitoring System (MEMS) TrackCaps (APREX Corporation, Union City, CA); importance of taking the study drugs exactly as prescribed; and potential adverse events as well as actions to take if study participants experienced any of these." |
| Outcomes |
Adherence was measured using MEMS track caps which monitored and electronically recorded the date and time each medication was removed from the bottle. The primary efficacy measure was the proportion of patients attaining plasma HIV‐1 RNA levels below the 40‐copy/ml lower limit of quantitation (LLOQ) of the NucliSens assay and below the 400‐copy/ml LLOQ of the HIV‐1 MONITOR version 1.0 polymerase chain reaction (PCR) assay (Roche, Nutley, NJ) at 24 weeks after starting treatment with COM + ABC. Viral load response (HIV‐1 RNA in plasma) was the primary study endpoint. A secondary efficacy measure was an assessment of changes in the number of CD4 lymphocyte counts (immunologic response). Patients were also monitored for adverse events, laboratory abnormalities and HIV‐related illnesses at week 5, 8, 12, 16, and 24 |
| Notes |
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| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomization was not described in detail. "In addition to their medication, patients were randomized 1:1 to receive either an EI (4 modules of the THE course) plus RC (EI + RC) or RC alone" (pg 175) |
| 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) MEMS ‐ This is an objective measure of outcome |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) VIRAL LOAD ‐ This is an objective measure of outcome |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) MEMS ‐ No mention of patient blinding. Blinding of patient/participant attempted, but likely that the blinding could have been broken, and the outcome is likely to be influenced by lack of blinding |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) VIRAL LOAD ‐ This is an objective measure of outcome |
| Blinding of personnel (performance bias)
Adherence measure |
Low risk |
(PRIMARY) MEMS ‐ This is an objective measure of outcome |
| Blinding of personnel (performance bias)
Patient outcome |
Low risk |
(PRIMARY) VIRAL LOAD ‐ This is an objective measure of outcome |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) MEMS ‐ High proportion of dropouts (31 (32%) and 23 (23%)) in the RC and control arm. Reasons provided. Missing data per outcome ‐ not provided, unequal distribution. Possibly, this may be large enough to affect outcome |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) VIRAL LOAD ‐ High proportion of dropouts (31 (32%) and 23 (23%)) in the RC and control arm. Reasons provided. Missing data per outcome ‐ not provided, unequal distribution. Possibly large enough to affect outcome |
