Treating Insomnia to Reduce Inflammation in HIV

  • End date
    Aug 31, 2023
  • participants needed
  • sponsor
    Indiana University
Updated on 24 October 2022
antiretroviral therapy
hiv test
behavior therapy
HIV Vaccine
hiv-1 rna measurement


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.

Condition Hiv, Insomnia
Treatment SHUTi, Sleep Education/Hygiene
Clinical Study IdentifierNCT04721067
SponsorIndiana University
Last Modified on24 October 2022


Yes No Not Sure

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

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
Diagnosed disease or process, besides HIV infection, associated with increased
systemic inflammation (including, but not limited to, systemic lupus erythematosus
NOTE: Localized treatment for skin cancers is not exclusionary
inflammatory bowel diseases, or other collagen vascular diseases)
Therapy for serious medical illnesses within 14 days prior to the Entry Visit
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
Known or suspected malignancy requiring systemic treatment within 180 days of the
Pregnancy or breastfeeding during the course of the study
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
History of bipolar disorder or a psychotic disorder, including schizophrenia
outside of the allowed study visit timeframe will result in study discontinuation
NOTE: Depressive disorders are not exclusionary
Receipt of investigational agents, cytotoxic chemotherapy, systemic immunosuppressive
Current sleep disorder diagnosis other than insomnia disorder (e.g., sleep apnea)
therapies, systemic glucocorticoids (of any dose), or anabolic steroids at the Entry
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
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)
Clear my responses

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