Rosen 2007.
| Methods | Randomized controlled trial | |
| Participants | The study location was HIV clinics in the greater Hartford, Connecticut, area, USA 28 participants were randomized to the intervention group and 28 participants were randomized to the control group The inclusion criteria were: prescribed antiretroviral medication, able and willing to use MEMS‐compatible bottles, had ever used an illicit drug weekly for 1 year, and had a score on the Mini Mental Status Exam 22 of 23 or higher |
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| Interventions | Intervention: CONTINGENCY MANAGEMENT (CM)
The intervention group participants were provided with 16 weeks of weekly CM‐based counseling followed by 16 additional weeks of data collection and adherence feedback to providers followed by 16 additional weeks of data collection and adherence feedback to providers. The CM intervention provided by bachelor's level staff involved review of data generated by electronic pill‐bottle caps that record bottle opening (MEMS) and brief substance abuse counseling. CM participants were reinforced for MEMS measured adherence with drawings from a bowl for prizes and bonus drawings for consecutive weeks of perfect adherence Control: SUPPORTIVE COUNSELING CONDITION The supportive counseling condition was an attention control condition. Participants were encouraged to meet with counselors weekly. In these sessions, participants were asked about their adherence, and offered support for their efforts to improve adherence. However, the counselors did not review MEMS data with the participants or conduct urine toxicology testing. There was an initial review of self reported substance abuse and referral to available treatment. In addition, providers were sent monthly letters stating the participant's self reported adherence. The same staff members delivered both interventions |
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| Outcomes | The measures of adherence were MicroElectronic Monitoring Systems (MEMS) and self reported adherence. MEMS are electronic pill‐bottle caps that record bottle opening. The data were collected at baseline and every 4 weeks thereafter for a total of 9 assessments. The MEMS recorded the date and time the pill bottle was opened. Participants in were also directly asked each month to report how many times they had opened their pill bottles without taking their medication. To test the possibility that the CM intervention was associated with opening pill bottles to obtain reinforcement but not taking the medications in the pill bottle, blood samples were drawn at week 4 to assess antiretroviral levels. Participants were not told that assessment of antiretroviral levels was the purpose of these blood draws. Samples were processed at a commercial laboratory The patient outcomes were viral load and side effects. Viral load was measured from drawing blood samples at baseline, 16 weeks, and 32 weeks. The standard assay was run using the Roche Cobas Amplicor HIV‐1 Monitor Test, Version 1.5. When the laboratory switched to an ultra‐sensitive assay sensitive to 50 HIV‐RNA copies per milliliter, viral loads below 400 were scored as 399 to be consistent with the earlier assay not having been ultra‐sensitive. Side effects was assessed using a questionnaire used by the AIDS Clinical Trial Group every 4 weeks. This questionnaire elicits ratings of 20 potential side effects rated on a Likert scale from 0 ("I do not have this symptom") to 4 ("bothers me a lot") |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information about the way randomization was performed is given: "Fifty‐six participants with histories of illicit substance use who were prescribed antiretroviral medication but evidenced suboptimal adherence during a baseline assessment were randomly assigned to 16 weeks of weekly CM‐based counseling or supportive counseling, followed by 16 additional weeks of data collection and adherence feedback to providers." (pg 30 "Randomization, with baseline adherence as a stratifying variable, was used to maximize the likelihood that baseline adherence would not differ between the two groups." (pg 31) |
| Allocation concealment (selection bias) | Unclear risk | No information about the allocation concealment is provided: No information about the way randomization was performed is given: "Fifty‐six participants with histories of illicit substance use who were prescribed antiretroviral medication but evidenced suboptimal adherence during a baseline assessment were randomly assigned to 16 weeks of weekly CM‐based counseling or supportive counseling, followed by 16 additional weeks of data collection and adherence feedback to providers." (pg 30 "Randomization, with baseline adherence as a stratifying variable, was used to maximize the likelihood that baseline adherence would not differ between the two groups." (pg 31) |
| Selective reporting (reporting bias) | Unclear risk | No reporting of CD4 cell count at 16 and 32 weeks: "The CD4 counts were reported by providers." (pg 33) Who are the providers? For the level of antiretroviral therapy in blood, they randomly selected only 4 people. In the results, they only state that "...all four participants had plasma levels consistent with having actually taken the medication, as determined by an infectious disease specialist." (pg 36). They could provide more details of the results |
| Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists |
| 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 ‐ Although this is typically considered objective data, MEMS activity was tied to rewards thus patients could be opening the bottle solely to obtain the reward. Patients were also warned that a physical measure would be used to back up MEMS data |
| 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 | Low risk | (PRIMARY) MEMS ‐ The rate of attrition was similar for both groups |
| Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) VIRAL LOAD ‐ Similar attrition numbers across both groups |