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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21MH127206-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-I | Experimental | This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population. |
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| Sleep Education/Hygiene | Active Comparator | This arm will receive best practices education on sleep hygiene. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hsCRP Levels at 24 Weeks | Circulating high sensitivity C-reactive protein levels will be measured | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IL-6 Levels at 24 Weeks | Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation. | Baseline and 24 weeks |
| Change is sCD14 Levels at 24 Weeks |
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Inclusion Criteria:
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.
Exclusion Criteria:
NOTE: Hepatitis B or C co-infections are NOT exclusionary, but treatment for hepatitis C cannot be provided during study participation.
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.
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.
NOTE: Depressive disorders are not exclusionary.
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| Name | Affiliation | Role |
|---|---|---|
| Samir K Gupta, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Infectious Diseases Research | Indianapolis | Indiana | 46202 | United States |
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.
Data will become available once the primary results are analyzed and published.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | CBT-I | This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population. SHUTi: 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. |
| FG001 | Sleep Education/Hygiene | This arm will receive best practices education on sleep hygiene. Sleep Education/Hygiene: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CBT-I | This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population. SHUTi: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in hsCRP Levels at 24 Weeks | Circulating high sensitivity C-reactive protein levels will be measured | 12 and 9 participants, respectively, in the CBT-I and Sleep Education/Hygiene arms had hsCRP data collected at Week 24. The changes in hsCRP values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable. | Posted | Mean | Standard Deviation | mg/L | Baseline and 24 weeks |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBT-I | This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population. SHUTi: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Samir K. Gupta | Indiana University | 3172747926 | sgupta1@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 29, 2022 | Aug 24, 2022 | Prot_006.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 29, 2022 | Feb 10, 2025 | SAP_011.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 26, 2023 | Aug 4, 2023 | ICF_008.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006920 | Hygiene |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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The study outcomes will be analyzed and compared by blinded investigators and statisticians.
|
| 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. |
|
Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and 24 weeks |
| Use of Sleep Medications at Week 12 | The number of sleep medications used by each participant at Week 12 | Week 12 |
| Use of Sleep Medications at Week 24 | The number of sleep medications used by each participant at Week 24 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and 12 weeks |
| BG001 | Sleep Education/Hygiene | This arm will receive best practices education on sleep hygiene. Sleep Education/Hygiene: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Insomnia Severity Index (ISI) Score | 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. | Mean | Standard Deviation | units on a scale |
|
| High Sensitivity C-Reactive Protein | Mean | Standard Deviation | mg/L |
|
| OG001 | Sleep Education/Hygiene | This arm will receive best practices education on sleep hygiene. Sleep Education/Hygiene: 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. |
|
|
|
| Secondary | Change in IL-6 Levels at 24 Weeks | Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation. | The changes in IL-6 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable. | Posted | Mean | Standard Deviation | pg/mL | Baseline and 24 weeks |
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| Secondary | Change is sCD14 Levels at 24 Weeks | Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation. | The changes in sCD14 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable. | Posted | Mean | Standard Deviation | ng/mL | Baseline and 24 weeks |
|
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| Secondary | Change in sCD163 Levels at 24 Weeks | Circulating soluble CD163 levels will be measured. Soluble CD163 is a measure of monocyte/macrophage activation. | The changes in sCD163 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable. | Posted | Mean | Standard Deviation | ng/mL | Baseline and 24 weeks |
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| Secondary | 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. | The changes in CD14+CD16+ monocyte values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable. | Posted | Mean | Standard Deviation | percentage of total monocytes | Baseline and 24 weeks |
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| Secondary | 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. | The changes in hsCRP values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable. | Posted | Mean | Standard Deviation | mg/L | Baseline and 12 weeks |
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| Secondary | 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. | The changes in ISI values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 24 weeks |
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| Secondary | 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. | The changes in PSQI values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 24 weeks |
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| Secondary | 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. | The changes in DBAS-16 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 24 weeks |
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| Secondary | 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. | The changes in PHQ-9 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 24 weeks |
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| Secondary | 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. | The changes in SCl-20 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 24 weeks |
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| Secondary | 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. | The changes in GAD-7 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 24 weeks |
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| Secondary | 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. | The changes in PROMIS FACIT-F values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 24 weeks |
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| Secondary | 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. | The changes in AUDIT values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 24 weeks |
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| Secondary | 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. | The changes in SF-36 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 24 weeks |
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| Secondary | Use of Sleep Medications at Week 12 | The number of sleep medications used by each participant at Week 12 | This measure was mistakenly not collected by the study team and is considered a protocol deviation. | Posted | Week 12 |
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| Secondary | Use of Sleep Medications at Week 24 | The number of sleep medications used by each participant at Week 24 | This measure was mistakenly not collected by the study team and is considered a protocol deviation. | Posted | Week 24 |
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| Secondary | 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. | The changes in insomnia treatment satisfaction values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable. | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
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| Secondary | 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. | The changes in insomnia treatment satisfactin values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable. | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
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| Secondary | 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. | The changes in PSQI values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
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| Secondary | 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. | The changes in DBAS-16 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
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| Secondary | 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. | The changes in PHQ-9 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
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| Secondary | 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. | The changes in SCL-20 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
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| Secondary | 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. | The changes in GAD-7 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
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| Secondary | 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. | The changes in PROMIS FACIT-F values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
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| Secondary | 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. | The changes in AUDIT values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
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| Secondary | 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. | The changes in SFl-36 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
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| Secondary | Change in IL-6 Levels at 12 Weeks | Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation. | The changes in IL-6 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable. | Posted | Mean | Standard Deviation | pg/mL | Baseline and 12 weeks |
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| Secondary | Change is sCD14 Levels at 12 Weeks | Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation. | The changes in sCD14 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable. | Posted | Mean | Standard Deviation | ng/mL | Baseline and 12 weeks |
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| Secondary | Change in sCD163 Levels at 12 Weeks | Circulating soluble CD163 levels will be measured. Soluble CD163 is a measure of monocyte/macrophage activation. | The changes in sCD163 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable. | Posted | Mean | Standard Deviation | ng/mL | Baseline and 12 weeks |
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| Secondary | 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. | The changes in CD14+16+ monocyte values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable. | Posted | Mean | Standard Deviation | percentage of total monocytes | Baseline and 12 weeks |
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| Secondary | 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. | The changes in ISI values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
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| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Sleep Education/Hygiene | This arm will receive best practices education on sleep hygiene. Sleep Education/Hygiene: 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. | 0 | 14 | 0 | 14 | 0 | 14 |
Not provided
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |