Cognitive Behavioral Therapy to Treat Insomnia in Persons With HIV Infection

The primary objective of this pilot trial is to compare 10-week changes in Insomnia Severity
Index (ISI) scores in HIV-infected adults with clinically relevant insomnia severity and who
are already receiving virologically suppressive antiretroviral therapy (ART) and are then
randomized to either treatment with the SHUTi cognitive behavioral therapy program or to
Usual Care (UC). A total of 100 persons with HIV may be screened to identify the 32
participants to be enrolled and randomized into the pilot trial. These participants will be ≥
18 years old, have been receiving antiretroviral therapy with an HIV viral load < 75
copies/mL within three months of the Entry Visit, and have an ISI score ≥ 15 within three
months of the Entry Visit. These participants will be randomized 1:1 (stratified by age <40
vs. ≥ 40 years) to either insomnia treatment with the SHUTi cognitive behavioral therapy
program (N=16) or usual care (N=16).

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.