HivNCT04721067
HIV-related Insomnia and Inflammation
A study testing SHUTi and Sleep Education/Hygiene in people with Hiv and Insomnia, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- SHUTi and Sleep Education/Hygiene
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2021to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 18Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Infectious Diseases Research
Indianapolis, Indiana, 46202
About this study
Official title: Treating Insomnia to Reduce Inflammation in HIV
This randomized trial will determine the effects of internet cognitive behavioral therapy on measures of systemic inflammation in HIV-positive people receiving antiretroviral therapy.
Read the detailed description
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.
- Being tested
- SHUTi, Sleep Education/Hygiene
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHUTiDevice
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.
Sleep Education/HygieneBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Experimental | This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population. Receives: Device: SHUTi |
| Sleep Education/Hygiene | Active comparator | This arm will receive best practices education on sleep hygiene. Receives: Behavioral: Sleep Education/Hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hsCRP Levels at 24 Weeks
Circulating high sensitivity C-reactive protein levels will be measured
Measured: Baseline and 24 weeks
Secondary outcomes (31)
Change in IL-6 Levels at 24 Weeks
Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation.
Measured: Baseline and 24 weeks
Change is sCD14 Levels at 24 Weeks
Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation.
Measured: Baseline and 24 weeks
Change in sCD163 Levels at 24 Weeks
Circulating soluble CD163 levels will be measured. Soluble CD163 is a measure of monocyte/macrophage activation.
Measured: Baseline and 24 weeks
Change in CD14+CD16+ Monocytes at 24 Weeks
Circulating intermediate monocytes as defined by flow cytometric evaluation for CD14+CD16+ monocytes will be measured. CD14+CD16+ monocytes are measured by flow cytometry and indicate the pro-inflammatory subpopulation of monocytes.
Measured: Baseline and 24 weeks
Change in hsCRP Levels at 12 Weeks
Circulating high sensitivity C-reactive protein (hsCRP) levels will be measured. hsCRP is a measure of systemic inflammation.
Measured: Baseline and 12 weeks
Change in Insomnia Severity Index (ISI) at 24 Weeks
The Insomnia Severity Index (ISI) total score will be measured. The total scale has a minimum score of 0 and a maximum score of 28, with higher scores indicating a worse outcome.
Measured: Baseline and 24 weeks
Change in Pittsburgh Sleep Quality Index (PSQI) at 24 Weeks
Changes in the Pittsburgh Sleep Quality Index (PSQI) questionnaire global scores will be measured. The global PSQI score has a range from 0 to 21, with higher numbers indicating worse sleep quality.
Measured: Baseline and 24 weeks
Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 24 Weeks
The Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) questionnaire total scores will be measured. The DBAS-16 total score ranges from 0 to 10, with higher scores indicating more dysfunctional beliefs and attitudes about sleep.
Measured: Baseline and 24 weeks
Change in Patient Health Questionnaire-9 (PHQ-9) at 24 Weeks
Patient Health Questionnaire (PHQ-9) scores will be measured. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse depression symptom severity.
Measured: Baseline and 24 weeks
Change in Hopkins Symptom Checklist (SCL-20) at 24 Weeks
The Hopkins Symptom Checklist (SCL-20) questionnaire score will be measured. The SCL-20 questionnaire scores range from 0 to 4, where higher scores indicate more severe depressive symptoms.
Measured: Baseline and 24 weeks
Change in Generalized Anxiety Disorder-7 (GAD-7) at 24 Weeks
The Generalized Anxiety Disorder-7 (GAD-7) questionnaire total score will be measured. The GAD-7 total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Measured: Baseline and 24 weeks
Change in PROMIS FACIT-F Fatigue Short Form at 24 Weeks
The Patient-Reported Outcomes Measurement Information System (PROMIS) Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) subscale questionnaire score ranges from 0 to 52, with higher scores indicating greater fatigue.
Measured: Baseline and 24 weeks
Change in Alcohol Use Disorders Identification Test (AUDIT) at 24 Weeks
Alcohol Use Disorders Identification Test (AUDIT) questionnaire total scores will be measured. The AUDIT total score ranges from 0 to 40, with higher scores indicating greater likelihood of alcohol dependence.
Measured: Baseline and 24 weeks
Change in Short Form-36 (SF-36) Health Survey and 24 Weeks
Short Form-36 (SF-36) general health total questionnaire scores will be measured. The SF-36 general health total score ranges from 0 to 100, with higher scores indicating better general health.
Measured: Baseline and 24 weeks
Use of Sleep Medications at Week 12
The number of sleep medications used by each participant at Week 12
Measured: Week 12
Use of Sleep Medications at Week 24
The number of sleep medications used by each participant at Week 24
Measured: Week 24
Insomnia Treatment Satisfaction at Week 12
An assessment of the participant's satisfaction with their assigned insomnia treatment at Week 12, ranging from 1-5, with lower scores indicating greater overall treatment satisfaction.
Measured: Week 12
Insomnia Treatment Satisfaction at Week 24
An assessment of the participant's satisfaction with their assigned insomnia treatment at Week 24, ranging from 1-5, with lower scores indicating greater overall treatment satisfaction.
Measured: Week 24
Change in Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks
Changes in the Pittsburgh Sleep Quality Index (PSQI) questionnaire global scores will be measured. The global PSQI score has a range from 0 to 21, with higher numbers indicating worse sleep quality.
Measured: Baseline and 12 weeks
Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 12 Weeks
The Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) questionnaire total scores will be measured. The DBAS-16 total score ranges from 0 to 10, with higher scores indicating more dysfunctional beliefs and attitudes about sleep.
Measured: Baseline and 12 weeks
Change in Patient Health Questionnaire-9 (PHQ-9) at 12 Weeks
Patient Health Questionnaire (PHQ-9) scores will be measured. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse depression symptom severity.
Measured: Baseline and 12 weeks
Change in Hopkins Symptom Checklist (SCL-20) at 12 Weeks
The Hopkins Symptom Checklist (SCL-20) questionnaire score will be measured. The SCL-20 questionnaire scores range from 0 to 4, where higher scores indicate more severe depressive symptoms.
Measured: Baseline and 12 weeks
Change in Generalized Anxiety Disorder-7 (GAD-7) at 12 Weeks
The Generalized Anxiety Disorder-7 (GAD-7) questionnaire total score will be measured. The GAD-7 total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Measured: Baseline and 12 weeks
Change in PROMIS FACIT-F Fatigue Short Form at 12 Weeks
The Patient-Reported Outcomes Measurement Information System (PROMIS) Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) subscale questionnaire score ranges from 0 to 52, with higher scores indicating greater fatigue.
Measured: Baseline and 12 weeks
Change in Alcohol Use Disorders Identification Test (AUDIT) at 12 Weeks
Alcohol Use Disorders Identification Test (AUDIT) questionnaire total scores will be measured. The AUDIT total score ranges from 0 to 40, with higher scores indicating greater likelihood of alcohol dependence.
Measured: Baseline and 12 weeks
Change in Short Form-36 (SF-36) Health Survey and 12 Weeks
Short Form-36 (SF-36) general health total questionnaire scores will be measured. The SF-36 general health total score ranges from 0 to 100, with higher scores indicating better general health.
Measured: Baseline and 12 weeks
Change in IL-6 Levels at 12 Weeks
Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation.
Measured: Baseline and 12 weeks
Change is sCD14 Levels at 12 Weeks
Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation.
Measured: Baseline and 12 weeks
Change in sCD163 Levels at 12 Weeks
Circulating soluble CD163 levels will be measured. Soluble CD163 is a measure of monocyte/macrophage activation.
Measured: Baseline and 12 weeks
Change in CD14+CD16+ Monocytes at 12 Weeks
Circulating intermediate monocytes as defined by flow cytometric evaluation for CD14+CD16+ monocytes will be measured. CD14+CD16+ monocytes are measured by flow cytometry and indicate the pro-inflammatory subpopulation of monocytes.
Measured: Baseline and 12 weeks
Change in Insomnia Severity Index (ISI) at 12 Weeks
The Insomnia Severity Index (ISI) total score will be measured. The total scale has a minimum score of 0 and a maximum score of 28, with higher scores indicating a worse outcome.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start2 Dec 2021
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Samir K. Gupta, MD, Indiana University
- Investigators
- Samir K Gupta, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721067
- Sponsor's protocol ID
- 1R21MH127206-01
- Other IDs
- 1R21MH127206-01
- Status last verified
- May 2025
- First submitted
- 20 Jan 2021
- Last updated
- 29 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We will fully participate in sharing our unique datasets and associated stored samples with other interested parties once the primary analyses have been completed. This dataset will include individual-level baseline, interim visit, ancillary, procedural-based, and outcome data. Data from scored assessments (e.g., psychosocial questionnaires) will include both raw data elements (e.g., individual item responses) and summary information (e.g., total scores) where feasible. Laboratory results will also be available as individual-level results from each study visit.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Insomnia to Reduce Inflammation in HIV
- ClinicalTrials.gov ID
- NCT04721067
- Acronym / sponsor ID
- 1R21MH127206-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized trial will determine the effects of internet cognitive behavioral therapy on measures of systemic inflammation in HIV-positive people receiving antiretroviral therapy.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Experimental | Device: SHUTiThis arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population. |
| Sleep Education/Hygiene | Active comparator | Behavioral: Sleep Education/HygieneThis arm will receive best practices education on sleep hygiene. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHUTiSHUTi 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. | Device | CBT-I |
| Sleep Education/HygieneA 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. | Behavioural | Sleep Education/Hygiene |
Primary outcome
Change in hsCRP Levels at 24 Weeks
Time frame: Baseline and 24 weeks
Circulating high sensitivity C-reactive protein levels will be measured
31 secondary outcomes
Change in IL-6 Levels at 24 Weeks
Time frame: Baseline and 24 weeks
Change is sCD14 Levels at 24 Weeks
Time frame: Baseline and 24 weeks
Change in sCD163 Levels at 24 Weeks
Time frame: Baseline and 24 weeks
Change in CD14+CD16+ Monocytes at 24 Weeks
Time frame: Baseline and 24 weeks
Change in hsCRP Levels at 12 Weeks
Time frame: Baseline and 12 weeks
Change in Insomnia Severity Index (ISI) at 24 Weeks
Time frame: Baseline and 24 weeks
Change in Pittsburgh Sleep Quality Index (PSQI) at 24 Weeks
Time frame: Baseline and 24 weeks
Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 24 Weeks
Time frame: Baseline and 24 weeks
Change in Patient Health Questionnaire-9 (PHQ-9) at 24 Weeks
Time frame: Baseline and 24 weeks
Change in Hopkins Symptom Checklist (SCL-20) at 24 Weeks
Time frame: Baseline and 24 weeks
Change in Generalized Anxiety Disorder-7 (GAD-7) at 24 Weeks
Time frame: Baseline and 24 weeks
Change in PROMIS FACIT-F Fatigue Short Form at 24 Weeks
Time frame: Baseline and 24 weeks
Change in Alcohol Use Disorders Identification Test (AUDIT) at 24 Weeks
Time frame: Baseline and 24 weeks
Change in Short Form-36 (SF-36) Health Survey and 24 Weeks
Time frame: Baseline and 24 weeks
Use of Sleep Medications at Week 12
Time frame: Week 12
Use of Sleep Medications at Week 24
Time frame: Week 24
Insomnia Treatment Satisfaction at Week 12
Time frame: Week 12
Insomnia Treatment Satisfaction at Week 24
Time frame: Week 24
Change in Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks
Time frame: Baseline and 12 weeks
Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 12 Weeks
Time frame: Baseline and 12 weeks
Change in Patient Health Questionnaire-9 (PHQ-9) at 12 Weeks
Time frame: Baseline and 12 weeks
Change in Hopkins Symptom Checklist (SCL-20) at 12 Weeks
Time frame: Baseline and 12 weeks
Change in Generalized Anxiety Disorder-7 (GAD-7) at 12 Weeks
Time frame: Baseline and 12 weeks
Change in PROMIS FACIT-F Fatigue Short Form at 12 Weeks
Time frame: Baseline and 12 weeks
Change in Alcohol Use Disorders Identification Test (AUDIT) at 12 Weeks
Time frame: Baseline and 12 weeks
Change in Short Form-36 (SF-36) Health Survey and 12 Weeks
Time frame: Baseline and 12 weeks
Change in IL-6 Levels at 12 Weeks
Time frame: Baseline and 12 weeks
Change is sCD14 Levels at 12 Weeks
Time frame: Baseline and 12 weeks
Change in sCD163 Levels at 12 Weeks
Time frame: Baseline and 12 weeks
Change in CD14+CD16+ Monocytes at 12 Weeks
Time frame: Baseline and 12 weeks
Change in Insomnia Severity Index (ISI) at 12 Weeks
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We will fully participate in sharing our unique datasets and associated stored samples with other interested parties once the primary analyses have been completed. This dataset will include individual-level baseline, interim visit, ancillary, procedural-based, and outcome data. Data from scored assessments (e.g., psychosocial questionnaires) will include both raw data elements (e.g., individual item responses) and summary information (e.g., total scores) where feasible. Laboratory results will also be available as individual-level results from each study visit.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir K Gupta, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHUTi and Sleep Education/Hygiene in people with Hiv and Insomnia, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hsCRP Levels at 24 Weeks (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.