Simoni 2007.
| Methods | Randomized controlled trial | |
| Participants | The study location was The study location was Jacobi Medical Center, Bronx, New York, USA 71 participants were randomized to the intervention group and 65 participants were randomized to the control group The inclusion criteria were 18 years or older, proficient in English, on prescribed HAART regimen and without dementia or psychosis The exclusion criteria were dementia or psychosis |
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| Interventions | Intervention: PEER SUPPORT
Patients in the peer support group had 6 twice‐monthly meetings during the 3‐month peer support intervention where peers and participants met with other peers and participants to discuss shared experiences, barriers to HAART adherence, life issues, etc. The group meetings were facilitated by an A but were predominately peer‐led. Between group meetings, peers were instructed to call each of their study participants 3 times weekly to provide more in‐depth one‐on‐one attention and feedback Control: STANDARD CARE Standard of care (control) patients received no additional adherence assistance beyond the clinic's typical offerings (consultation with primary providers and social and mental health referrals when requested) |
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| Outcomes | The measures of adherence were by EDM use with the most frequently dosed medication. The EDM data were uploaded at the 3‐ and 6‐month interviews. At baseline and 3 and 6 months, participants were administered the Adult AIDS Clinical Trials Group Adherence to Antiretrovirals Instrument. For each medication prescribed, patients reported for each of the last 3 days the number of doses taken. We computed an adherence variable that consisted of the percentage of doses taken (according to self report) over those prescribed (according to medical record) for the past 3 days The patient outcomes were HIV‐1 RNA viral load, taken from the patient records, and depressive symptomatology using the 20‐item Centers for Epidemiological Studies Depression Scale administered by the research assistant during follow‐up interviews |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A computer random number generator was used for randomization. "Random assignment to condition was based on a computer‐generated allocation sequence prepared by an external statistician." (pg 489) |
| Allocation concealment (selection bias) | Low risk | "Allocation concealment involved the use of sequentially numbered, opaque, sealed envelopes containing the group assignment, which the RAs opened at the moment of randomization after participants were consented and enrolled." (pg 489) |
| Selective reporting (reporting bias) | Low risk | No protocol but expected outcomes clearly stated. "In the present study, we evaluated a peer support intervention grounded in our social support model of adherence that posits a central role for depressive symptomatology in nonadherence. The randomized controlled trial (RCT) involved men and women living with HIV/AIDS in the Bronx, New York, and included an a priori primary clinical outcome and the secondary outcomes of adherence, social support, and depressive symptomatology." (pg 489) |
| Other bias | Unclear risk | (pg 489) Study may have been underpowered according to authors ‐ "Initial calculations, based on .83 power to detect a significant difference ( p beta .05, two‐tailed), had indicated 75 patients were required for each study group." (pg 491) "Although the trial was moderately underpowered, the size of the difference in the outcomes between conditions suggests that power was not an issue." (pg 492) When EDM is not opened, cannot determine whether the participant missed a dose of medication or was not using the device: 3‐month intervention too short for participants to develop comfortable rapport with peer support ‐ low attendance at intervention meetings and phone call contact by peers (many barriers to attending and fear of having their HIV status exposed to others) ‐ sample had high substance abuse that would lead to less compliance ‐ high number had previous use of unsuccessful regimens of HAART that may have made them resistant to meds |
| Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ "RAs conducting the follow‐up assessments were blinded to the study condition of the interviewees." (pg 490) |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) HIV‐1 RNA VIRAL LOAD ‐ "RAs conducting the follow‐up assessments were blinded to the study condition of the interviewees." (pg 490) |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ "Due to the nature of the intervention, participants could not be uninformed of the study condition" (pg 490) |
| Blinding of participants (performance bias) Patient outcome | Low risk | (PRIMARY) HIV‐1 RNA VIRAL LOAD ‐ This is an objective measure of outcome |
| Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) HIV‐1 RNA VIRAL LOAD ‐ This is an objective measure of outcome |
| Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Attrition rates not balanced; reasons for attrition not known |
| Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) HIV‐1 RNA VIRAL LOAD ‐ Attrition rates not similar; reasons not available |