Pyne 2011.

Methods	Randomized controlled trial
Participants	The study location was 3 Veteran's Administration (VA) HIV treatment facilities, Little Rock, Arkansas, USA 138 participants were randomized to the intervention group and 138 participants were randomized to the control group The inclusion criteria were (1) a current 9‐item Patient Health Questionnaire (PHQ‐9) depression score of 10 or higher and (2) current treatment in the VA HIV clinic The exclusion criteria were (1) no access to a telephone, (2) current acute suicidal ideation, (3) significant cognitive impairment as indicated by a score higher than 10 on the Blessed Orientation‐Memory‐Concentration Test and (4) history of bipolar disorder or schizophrenia
Interventions	Intervention: HIV TRANSLATING INITIATIVES FOR DEPRESSION INTO EFFECTIVE SOLUTIONS (HITIDES) The purpose of the HITIDES intervention was to support HIV and mental health clinicians in delivering evidence‐based depression treatment. The HIV depression care team consisted of a registered nurse depression care manager, a clinical pharmacist, and a psychiatrist. This team was located offsite and convened once a week and as needed by telephone or in person. The depression care team communicated with treating clinicians via electronic medical record progress notes. The DCM communicated with patients via telephone. The HITIDES depression care team made treatment suggestions. Treatment decisions were made by the HIV or mental health clinicians at each site. The DCM delivered the following intervention components: participant education and activation, assessment of treatment barriers and possible resolutions, depression symptom and treatment monitoring, substance abuse monitoring, and instruction in self management. The DCM used prewritten scripts, which are standardized instruments that were supported by the web‐based decision support system during these telephone encounters. The intervention used a stepped‐care model for depression treatment. At any time, HIV health care providers were free to refer participants directly to specialty mental health care. The DCM conducted telephone‐based monitoring every 2 weeks during acute treatment and every 4 weeks during watchful waiting or continuation treatment. The NetDSS system identified potential treatment non‐response as (1) antidepressant regimen adherence of less than 80% during the past 14 days, (2) counseling non‐adherence of less than 75% during the past month, (3) participant report of severe adverse effects during 2 consecutive DCM encounters, (4) participant report of a 5‐point increase in depression severity from the enrollment PHQ‐9 score based on 2 consecutive DCM encounters, or (5) lack of participant response during an 8‐week antidepressant or 12‐week counseling trial Control: USUAL CARE Usual care depression treatment was provided by HIV or mental health clinicians without involvement of the HITIDES depression care team. Before starting the study, all HIV health care providers received 1 hour of HIV and depression training
Outcomes	The measures of adherence were using the AIDS Clinical Trial Group assessment, which asks participants to report the number of pills per day they are supposed to take and the number of pills they skipped taking for each medication for each of the past 4 days. Both HIV and depression medication adherence were measured using this assessment. The data were collected at baseline, 6 months, and 12 months by telephone interviewers who were blinded to treatment assignment The patient outcomes were 1) depression severity during the past 2 weeks, measured using the 20‐item Hopkins Symptom Checklist; 2) health status measured using the physical and mental health component summary scores from the Medical Outcomes Study Veterans 12‐Item short form health survey; 3) health‐related quality of life measured using the Quality of Well Being Self‐administered Scale; 4) severity of HIV symptoms using the 20‐item symptoms distress module which summarizes the degree to which each symptom bothered the participant in the past 4 weeks. All measures were collected by telephone interview at baseline, 6, and 12 months by telephone interviewers who were blinded to treatment assignment
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random assignment was used. "Participants were randomized to the intervention or to usual care in a 1:1 ratio according to a computer‐generated random assignment sequence stratified by clinic and generated in advance. Research assistants at each clinic were provided envelopes labeled by participant number and containing randomized assignment." (pg 24)
Allocation concealment (selection bias)	Unclear risk	The study does not specify opaque envelopes. "Research assistants at each clinic were provided envelopes labeled by participant number and containing randomized assignment." (pg 24)
Selective reporting (reporting bias)	Unclear risk	It indicates there are results not reported in this paper. "The primary outcomes listed in clinicaltrials.gov were depression severity, implementation process, and quality of care. Implementation process and quality of care will be addressed in separate reports." (pg 25)
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) AIDS CLINICAL TRIAL GROUP ASSESSMENT ‐ QUESTIONNAIRE ‐ States personnel were blinded to study group. "The assessments were done at 6 and 12 months by telephone interviewers who were blinded to treatment assignment and used scripted computer‐based assessments" (pg 25)
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) DEPRESSION SYMPTOM SEVERITY ‐ The assessments were blinded. "Baseline and 6‐ and 12‐month data were collected by telephone interviewers who were blinded to treatment assignment and used scripted computer‐based assessments." (pg 25)
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) AIDS CLINICAL TRIAL GROUP ASSESSMENT ‐ QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding
Blinding of participants (performance bias) Patient outcome	High risk	(PRIMARY) DEPRESSION SYMPTOM SEVERITY ‐ This is a subjective measure; there is no information on blinding
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) AIDS CLINICAL TRIAL GROUP ASSESSMENT ‐ 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	Unclear risk	(PRIMARY) DEPRESSION SYMPTOM SEVERITY ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) AIDS CLINICAL TRIAL GROUP ASSESSMENT ‐ QUESTIONNAIRE ‐ Missing data are relatively balanced across groups and were imputed in the analysis (pg 26)
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) DEPRESSION SYMPTOM SEVERITY ‐ Missing data are relatively balanced across the groups; missing data were imputed (pg 26)