Fisher 2011.
Methods | Randomized controlled trial | |
Participants | The study location was 5 large HIV care clinics in Connecticut, USA 277 participants were randomized to the intervention group and 287 participants were randomized to the control group The inclusion criteria were 1) 18 years of age or older; 2) have English language comprehension; 3) free of marked cognitive impairment; 4) prescribed ARV therapy at study inception |
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Interventions | Intervention: LIFEWINDOWS
The intervention was computer‐based, interactive ARV adherence promotion called LifeWindows developed based on the Information‐Motivation‐Behavioral skills (IMB) model. The nature of this intervention is to identify and address, through interventions, an individual's deficits in adherence‐related information, motivation, and behavioral skills. The intervention activities consisted of 20 different interactive activities that would be selected by the participants according to their goals. Patients on average spent 26 minutes to complete the full intervention with an average of 8 minutes dedicated to adherence intervention modules. Participants received USD 20 for completion of each session. Participants completed 1 session per month over 18 months Control: STANDARD OF CARE Control patients received standard of care at the clinic they attended. Average total time spent to complete the full control session was 14 minutes. Participants received USD 20 for completion of the session per month over 18 months |
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Outcomes | The measures of adherence were the AIDS Clinical Trials Group (ACTG) 3‐day recall measure of doses taken, and a visual analog scale (VAS) 3 to 4‐week ARV adherence assessment adapted for computer delivery. These data were collected at each LifeWindows session from both intervention and control groups. Adherence to regimen was calculated as the total number of pills taken over 3 days divided by the total number of pills prescribed for all agents for that period (ACTG) and as the average per cent adherence over 3 to 4 weeks for all agents (VAS) The patient outcome was HIV viral load, measured as per standard of care, and data were extracted from patient charts at the conclusion of the research period |
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Notes | ― | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization at enrollment to control and intervention conditions involved use of randomly generated numbers, which were sequentially assigned." (pg 1637) |
Allocation concealment (selection bias) | Unclear risk | No information about the concealment of allocation is given. "Randomization at enrollment to control and intervention conditions involved use of randomly generated numbers, which were sequentially assigned." (pg 1637) |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgment of 'Low risk' or 'High risk'. No protocol available |
Other bias | Unclear risk | Insufficient information provided to make a judgment |
Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ (pg 1643) All outcome data for adherence were collected using a computer. While this limits bias of staff and personnel, they did not mentioned who had access to these data. Author's note: the research assistant at the site did not have access to the data generated by the research participant |
Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) VIRAL LOAD ‐ Outcome not likely influenced by lack of blinding |
Blinding of participants (performance bias) Adherence measure | Low risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Author's note: the participant was blind |
Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) VIRAL LOAD ‐ Outcome not likely influenced by lack of blinding |
Blinding of personnel (performance bias) Adherence measure | Low risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Author's note: only staff at the central office had access to the research data; the research assistant at the study site did not have access |
Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) VIRAL LOAD ‐ Outcome not likely influenced by lack of blinding |
Incomplete outcome data (attrition bias) Adherence measure | Low risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ (pg 5, Figure 1 and Table 2) Baselined participants (N = 594) completed from one to 18 LifeWindows sessions (Mode = 6 sessions) during their clinical care visits over approximately 18 months, taking part in an overall total of 4155 sessions of which 3924 included assessments of ARV adherence. Of 594 baselined participants, 328 (55%) met the inclusion criteria for the on protocol (OP) sample (see Figure 1). Participant characteristics for the ITT, OP‐included, and OP‐excluded samples are presented in Table 2. Those included in the OP sample are similar in most respects to those excluded with the exception that those included reflected larger numbers of women, unemployed, individuals on disability, and were slightly older. The OP sample also had a higher number of individuals with undetectable viral load at baseline. Note that these elements did not differ by study arm within the OP sample. No differences in baseline values by study arm assignment were noted in the ITT sample; study arm was not related to inclusion or exclusion in the OP sample, and the only differences between study arm in the OP sample were total income (lower income in the intervention arm) and self reported sexual orientation (lower proportion of gay participants in the intervention arm) |
Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) VIRAL LOAD ‐ While not mentioned, the authors undertook adequate procedures to take missing data into account in analyses |