depression therapy to improve cardiovascular risk in hiv

Conditions: Depression; HIV

Summary: this trial will determine if depression treatment will reduce cardiovascular risk in hiv-infected patients already receiving hiv treatments. half of the participants will undergo a specific computerized depression treatment with the other half receiving usual care from their hiv providers.

the objectives of this study will be met by performing a 24-week, randomized, controlled, single-blinded, two-arm, parallel group, pilot trial at a single center. a total of 200 subjects may be screened to identify 110 participants to be enrolled and randomized. these participants will be ≥ 18 years old, have been receiving antiretroviral therapy for at least one year with an hiv viral load \< 75 copies/ml at screening, and have major depression using the phq-9 questionnaire. these participants will be randomized 1:1 to either depression treatment with the beating-the-blues cognitive behavioral therapy program (n=55) or usual care (n=55).

Eligibility criteria:
inclusion criteria: * hiv-1 infection, documented by both: (1) any licensed rapid hiv test or hiv enzyme test kit at any time prior to study entry and (2) by at least one detectable hiv-1 antigen or at least one detectable plasma hiv-1 rna viral load * age equal to or greater than 18 years * receipt of antiretroviral therapy of any kind for at least 360 days prior to screening note: interruptions in art of up to 14 days total during the 360 days prior to screening are allowed * hiv-1 rna level \< 75 copies/ml at screening note: there are no cd4 cell count eligibility criteria for this trial * for women who are still of reproductive potential, a negative urine pregnancy test * depression as defined by having a score ≥ 10 on the phq-9 questionnaire exclusion criteria: * inability to complete written, informed consent * incarceration at the time of any study visit * active suicidality, as determined by the patient's hiv provider or social worker following a positive response (1, 2, or 3) to phq-9 item #9 and a positive response (yes) to one or more of the three questions on the patient suicidality form (with last suicide attempt within the past ten years) * diagnosed vascular disease (documented history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease) * history of congestive heart failure, even if currently compensated * diagnosed disease or process, besides hiv infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosis, inflammatory bowel diseases, other collagen vascular diseases) note: hepatitis b or c co-infections are not exclusionary * known or suspected malignancy requiring systemic treatment within 180 days of screening note: localized treatment for skin cancers is not exclusionary * history of raynaud's phenomenon * history of cardiac arrhythmias or cardiomyopathy * uncontrolled hyperthyroidism or hypothyroidism, defined as tsh values outside of the local reference range on most recent clinical assessment * history of carotid bruits * systolic blood pressure \> 160 mmhg or diastolic blood pressure \> 110 mmhg at screening * screening estimated glomerular filtration rate (egfr) \< 50 ml/min/1.732 (using the 2009 ckd-epi equation) using a serum creatinine level measured at screening * screening glucose ≥ 140 mg/dl or hemoglobin a1c \> 8.0% * screening total cholesterol \> 240 mg/dl * therapy for serious medical illnesses within 14 days prior to screening note: therapy for serious medical illnesses that overlaps with a main study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation * pregnancy or breastfeeding during the course of the study * receipt of investigational agents, cytotoxic chemotherapy, systemic glucocorticoids (of any dose), or anabolic steroids at screening note: physiologic testosterone replacement therapy or topical steroids is not exclusionary. inhaled/nasal steroids are not exclusionary as long as the participant is not also receiving hiv protease inhibitors * active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements * history of schizophrenia or bipolar disorder