Cognitive Behavioral Therapy to Treat Insomnia in Persons With HIV Infection

This is an interventional treatment trial for HIV/AIDS focused on measuring HIV, Insomnia, Cognitive Behavioral Therapy Read More

Inclusion Criteria:

1. 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.
2. Age equal to or greater than 18 years.
3. Ongoing receipt of antiretroviral therapy of any kind for at least 3 months prior to the Entry Visit.

4. HIV-1 RNA level < 75 copies/mL obtained during routine clinical care within 90 days of the Entry Visit.

   NOTE: There are no CD4 cell count eligibility criteria for this trial.

5. ISI score ≥ 15

Exclusion Criteria:

1. Inability to complete written, informed consent.
2. Incarceration at the time of any study visit.
3. 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
4. Diagnosed vascular disease (documented history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease).
5. History of congestive heart failure, even if currently compensated.

6. 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

7. Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.

   NOTE: Localized treatment for skin cancers is not exclusionary.

8. Uncontrolled hyperthyroidism or hypothyroidism, defined as TSH values outside of the local reference range on most recent clinical assessment.
9. Last known clinic-based estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2. (calculated from the 2009 CKD-EPI equation).
10. Uncontrolled diabetes defined as the last known clinic-based Hgb A1C > 8.0 g/dL.
11. Last known clinic-based total cholesterol > 240 mg/dL.

12. 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.

13. Pregnancy or breastfeeding during the course of the study.

14. Receipt of investigational agents, cytotoxic chemotherapy, 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.

15. Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.

16. History of schizophrenia, bipolar disorder, or dementia.

    NOTE: Depression is not exclusionary as long as the severity of depression does impede ability to perform the required study procedures.

17. Musculoskeletal or neurologic disorders that impede ability to perform the required study procedures.
18. History of sleep apnea or restless leg syndrome.