hiv-related insomnia and inflammation

Conditions: Hiv; Insomnia

Summary: this randomized trial will determine the effects of internet cognitive behavioral therapy on measures of systemic inflammation in hiv-positive people receiving antiretroviral therapy.

the primary objective of this pilot trial is to evaluate the effects of cognitive behavioral therapy for insomnia (cbt-i) on changes in circulating levels of hscrp at 24 weeks in virologically-suppressed, hiv-positive adults with insomnia, defined as having an insomnia severity index (isi) score ≥ 11. secondary objectives include comparing changes in hscrp at 12 weeks, changes in other circulating inflammation biomarkers (il-6, scd14, scd163, cd14+cd16+ monocytes) at both 12 and 24 weeks, and isi scores and other self-reported patient outcomes at both 12 and 24 weeks.

Eligibility criteria:
inclusion criteria: * hiv-1 infection, documented as listed clinically in the participant's electronic medical record by any of the following tests: (1) any licensed rapid hiv test, (2) hiv enzyme test kit at any time prior to study entry, (3) at least one detectable hiv-1 antigen, or (4) at least one detectable plasma hiv-1 rna viral load. * age equal to or greater than 18 years. * ongoing receipt of stable antiretroviral therapy of any kind for at least 180 days prior to the date of the hiv-1 rna value determining eligibility. * hiv-1 rna level \< 75 copies/ml at screening. note: there are no cd4 cell count eligibility criteria for this trial. -isi score ≥ 11 at screening. note: use of sleeping aids/medications is permitted as long as the isi score criterion is met. exclusion criteria: * inability to complete written, informed consent. * incarceration at the time of any study visit. * active suicidality at entry, 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 (for question #3, the previous attempt must be within the past 10 years) on the patient suicidality form (see appendix). * diagnosed disease or process, besides hiv infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosus, inflammatory bowel diseases, or other collagen vascular diseases). note: hepatitis b or c co-infections are not exclusionary, but treatment for hepatitis c cannot be provided during study participation. * end stage renal disease requiring renal replacement therapy (dialysis, transplantation). * known or suspected malignancy requiring systemic treatment within 180 days of the entry visit. note: localized treatment for skin cancers is not exclusionary. -therapy for serious medical illnesses within 14 days prior to the entry visit. note: therapy for serious medical illnesses that overlaps with a 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 immunosuppressive therapies, systemic glucocorticoids (of any dose), or anabolic steroids at the entry visit. 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 bipolar disorder or a psychotic disorder, including schizophrenia. note: depressive disorders are not exclusionary. * current sleep disorder diagnosis other than insomnia disorder (e.g., sleep apnea). * have a schedule requiring a bedtime earlier than 8:00pm or later than 2:00am or arising time earlier than 4:00am or later than 10:00am (thus preventing adoption of shuti interventions).