Parsons 2007.
| Methods | Randomized controlled trial | |
| Participants | The study location was Behavioral Research Center, New York, USA 65 participants were randomized to the intervention group and 78 participants were randomized to the control group The inclusion criteria were HIV‐positive, at least 18 years of age, English speaking, currently taking a HAART regimen, and had scored 8 or greater on the Alcohol Use Disorder Identification Test (AUDIT), met criteria for hazardous drinking (> 16 standard drinks per week for men or > 12 standard drinks per week for women) and having alcohol problems greater than those associated with other drugs |
|
| Interventions | Intervention: PROJECT PLUS INTERVENTION
Intervention was 8, 60‐minute individual sessions based on Information Motivation Behavioral Skills model delivered by delivered by master's degree–prepared counselors. Two complementary techniques—motivational interviewing (MI) and cognitive‐behavioral skills training (CBST)—were integrated, allowing trained counselors to match targeted information and skill‐building techniques to the particulars of each client's motivation for change. The first session was delivered immediately on completion of the baseline assessment, thereby ensuring that each participant has a minimum dose of 1 session. Follow‐ups were conducted at 3 and 6 months Control: EDUCATION CONDITION 8 education sessions of 60 minutes facilitated by a health educator was the intervention. Sessions were designed to be completed weekly, but participants had 12 weeks to complete all 8 sessions. The first session was delivered immediately on completion of the baseline assessment, thereby ensuring that each participant had a minimum dose of 1 session. The sessions were video taped to ensure that motivational interview or cognitive‐behavioral skills training was not used |
|
| Outcomes | The measures of adherence were self reported adherence measured with timeline follow‐back interview. The participants were asked to explain their HAART regimen and the number of schedules doses of each medication and then required to recall, day by day, all medication doses taken and missed during the past 2 weeks. For each participant, an adherent day was defined as a day in which the participant missed none of his or her scheduled doses. Per cent day adherence was calculated as the per cent of days with perfect adherence in the past 2 weeks The patient outcomes were viral load and CD4 count calculated from laboratory blood tests conducted at 3 and 6 months. All blood draws were conducted on‐site by a certified phlebotomist and were analyzed by Specialty Laboratories. HIV viral load was measured by reverse transcriptase polymerase chain reaction (RT‐PCR) using the HIV‐1 Ultraquant assay, and results were log transformed to adjust for skew. CD4 cell counts were measured by flow cytometry. |
|
| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Urn randomization procedure was used. "Eligible participants were assigned to the 8‐session intervention or to an 8‐session educational comparison condition, using urn randomization procedures, which are systematically biased in favor of balancing groups. This procedure preserves randomization as the primary basis for assignment to condition, is less susceptible to experimenter bias or manipulation of the assignment process by staff, allows matching on several variables (in this study, viral load and AUDIT score), and most efficiently ensures multivariate equivalence of treatment groups.34 Although it is always possible to control statistically for differences between groups in later analyses, the potential removal of such differences in the randomization process increases power by reducing the number of covariates included in primary analyses." (pg 444) |
| Allocation concealment (selection bias) | Unclear risk | No information was provided about how allocation was handled |
| Selective reporting (reporting bias) | Low risk | No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol |
| Other bias | Unclear risk | "Because participants were required to have alcohol problems as part of the eligibility criteria, it is possible that perceived demands to report decreased alcohol use were stronger than those for reporting adherence changes". (pg 449) |
| Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) SELF REPORT ‐ INTERVIEW ‐ The author notes that interviews conducted by research staff not involved in the intervention |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) CD4 CELL COUNT ‐ 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) SELF REPORT ‐ INTERVIEW ‐ The author notes that participants were informed that they would be randomized to 1 of 2 groups. This outcome is subject to recall bias |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) CD4 CELL COUNT ‐ This is an objective measure of outcome |
| 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) SELF REPORT ‐ INTERVIEW ‐ The author notes that key study personnel were blind |
| Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) VIRAL LOAD ‐ This is an objective measure of outcome |
| 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 | Low risk | (PRIMARY) SELF REPORT ‐ INTERVIEW ‐ 3‐month follow‐up was not completed by 12 participants from the intervention group and 10 from the control group. At 6‐month follow‐up, 11 did not complete the follow‐up from the intervention group and 16 from the control group. Refer to Figure 1. The reasons are similar across the different groups |
| Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) CD4 CELL COUNT ‐ 3‐month follow‐up was not completed by 12 participants from the intervention group and 10 from the control group. At 6‐month follow‐up, 11 did not complete the follow‐up from the intervention group and 16 from the control group. Refer to Figure 1. The reasons are similar across the different groups |
| Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) VIRAL LOAD ‐ 3‐month follow‐up was not completed by 12 participants from the intervention group and 10 from the control group. At 6‐month follow‐up, 11 did not complete the follow‐up from intervention group and 16 from the control group. Refer to Figure 1. The reasons are similar across the different groups |