HIV-related Insomnia and Inflammation

NCT04721067 | Completed Results DMC FDA Device

• 1 other identifier: 1R21MH127206-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hiv; Insomnia

Outcome Measures

Primary Outcomes (1)

• Change in hsCRP Levels at 24 Weeks

  Circulating high sensitivity C-reactive protein levels will be measured

  Baseline and 24 weeks

Secondary Outcomes (31)

• Change in IL-6 Levels at 24 Weeks

  Baseline and 24 weeks

• Change is sCD14 Levels at 24 Weeks

  Baseline and 24 weeks

• Change in sCD163 Levels at 24 Weeks

  Baseline and 24 weeks

• Change in CD14+CD16+ Monocytes at 24 Weeks

  Baseline and 24 weeks

• Change in hsCRP Levels at 12 Weeks

  Baseline and 12 weeks

Study Arms (2)

CBT-I

EXPERIMENTAL

This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.

Device: SHUTi

Sleep Education/Hygiene

ACTIVE COMPARATOR

This arm will receive best practices education on sleep hygiene.

Behavioral: Sleep Education/Hygiene

Interventions

SHUTi DEVICE

SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.

CBT-I

Sleep Education/Hygiene BEHAVIORAL

A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services.

Sleep Education/Hygiene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• End stage renal disease requiring renal replacement therapy (dialysis, transplantation).
• Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.
• 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.
• 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.
• 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).

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Indiana University Infectious Diseases Research

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sleep Initiation and Maintenance Disorders

Interventions

Hygiene

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Samir K. Gupta
• Organization: Indiana University

sgupta1@iu.edu

3172747926

Study Officials

• Samir K Gupta, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study outcomes will be analyzed and compared by blinded investigators and statisticians.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 22, 2021
• Study Start: December 2, 2021
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: May 29, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available once the primary results are analyzed and published.
• Access Criteria: Data and sample requests will be honored after submission of a short proposal that outlines an important scientific question with an appropriate statistical analysis plan that justifies the use of these datasets. In addition, the requests must also verify that confidentiality of the datasets will be ensured.

Locations

US (1)