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HIVの痛みに対する不眠症の影響 (HIPPI)

2026年10月20日 更新者:Burel Goodin、University of Alabama at Birmingham

HIV の痛み、身体機能、および炎症に対する不眠症の影響

The overall objective of this application is to investigate the impact of insomnia on pain, physical functioning, and inflammation in people living with HIV. The two aims of this study to determine 1) whether insomnia promotes increased sensitivity and inflammatory reactivity to pain stimuli, and 2) if weekly fluctuations in insomnia burden drive changes in inflammation, pain severity, and physical functioning in people living with HIV. This research could help confirm insomnia as a therapeutic target for the suppression of pain and inflammation in people living with HIV.

調査の概要

詳細な説明

This study was conducted during the height of the COVID19 pandemic. Recruitment and retention were significantly and negatively affected. The longitudinal time-course was reduced from 8 consecutive weeks of observation down to 3 weeks. We were only able to recruit 171 of an anticipated 200 participants.

Week 1: 171 total participants Week 2: 136 total participants Week 3: 35 participants (insomnia only)

Week 1 Resting Blood Pressure and Body Mass Index will be assessed. Participants who have an HIV negative status will complete the OraQuick Advance Rapid HIV 1/2 Swab test. Study staff will administer the Structured Interview for Sleep Disorders and administer the Rapid Estimation of Adult Literacy Measure-Short Form (REALM-SF) to determine health literacy. The night of Experimental Session 1 participant will be using a Resmed ApneaLink Air device (Resmed, San Diego, CA), to identify apnea and hypopnea and calculate an apnea hypopnea index.

Between Week 1 and Week 2 Sleep assessment: Sleep data will be collected by participants in their own homes using objective and subjective measures of their sleep. Participant instructions for how to collect and record their own sleep data will be provided at the end of study session 1. Participant will be provided with a watch-like device to wear on wrist for 7 consecutive days and nights. This watch measures physical activity and sleep.

Week 2 Resting Blood Pressure and temperature will be assessed. A sample of urine will be taken to test for illicit substances that might affect the study's results. Experimental session 2 will take place in the Center for Clinical and Translational Science (CCTS) Clinical Research Unit (CRU). A clinical Research Unit (CRU) nurse will place an intravenous (IV) cannula (small plastic tube) in the arm using a needle to draw blood at the beginning of the session and then an additional four times across the study for a total of five blood draws. Participants will complete multiple questionnaires to measure health, and experience with insomnia, pain, mood and emotions, experiences with stigma and discrimination, and how participant thinks and feels about things. All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 3-4 hours. Blood will be processed and stored and then used to measure inflammation.

Week 3 Only participants with insomnia (with and without HIV) will complete a battery of ecologically valid movement tasks that include: 1) Performance Battery (SPPB) which includes sitting in a chair, transitioning to a standing position, balancing tests and gait speed, and the Timed Up and Go test (TUG). A clinical Research Unit (CRU) nurse will draw a quick sample of approximately 20 milliliters from the participants arm using a butterfly needle so that CRU nurse can collect blood during the beginning of each visit.

研究の種類

観察的

入学 (実際)

171

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Alabama
      • Birmingham、Alabama、アメリカ、35294
        • UAB

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~85年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

120 individuals with HIV (60 with insomnia & 60 without insomnia) as well as a group of 120 individuals without HIV as Controls (60 with insomnia & 60 without insomnia), for a total sample size of 240 individuals.

説明

Inclusion Criteria:

HIV with Insomnia

  • Confirmed HIV diagnosis
  • currently a patient in the University of Alabama (UAB) 1917 HIV Clinic.
  • must be currently receiving stable antiretroviral therapy (ART).
  • Meets the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for insomnia including sleep difficulty.

HIV Without Insomnia

  • Confirmed HIV diagnosis
  • currently a patient in the University of Alabama (UAB) 1917 HIV Clinic.
  • must be currently receiving stable antiretroviral therapy (ART).
  • Does not meet the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for insomnia including sleep difficulty.

Non HIV with Insomnia

  • Confirmed Non HIV diagnosis and currently not a patient in the UAB 1917 HIV Clinic.
  • Meets DSM-5 diagnostic criteria for insomnia including sleep difficulty.

Non HIV Without Insomnia

  • Confirmed Non HIV diagnosis and currently not a patient in the UAB 1917 HIV Clinic.
  • Does not meets DSM-5 diagnostic criteria for insomnia including sleep difficulty.

Exclusion Criteria:

  • concurrent medical conditions that could confound
  • interpretation of sleep
  • pain
  • inflammatory issues or coexisting diseases
  • Systemic rheumatic disease/condition
  • uncontrolled hypertension (i.e., BP > 150/95)
  • circulatory disorders (e.g., Reynaud's disease)
  • history of heart disease or cardiac events
  • history of cancer
  • asthma AND use of an inhaler
  • history of seizures
  • history of stroke or other neurological disorder
  • pregnancy
  • core body temperature > 100 degrees Fahrenheit as this could indicate acute infection with fever; (k)
  • unwilling to provide blood for this study
  • non-English speaking
  • recent injury or surgical procedure within past 6 months.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:CASE_CONTROL
  • 時間の展望:PROSPECTIVE

コホートと介入

グループ/コホート
介入・治療
HIV and Insomnia

Participants will test positive for HIV and Insomnia.

Structured Clinical Interview For DSM-5 Sleep Disorders-Revised (SCISD-R) - is a semi structured interview for diagnosing sleep disorders according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)

他の名前:
  • DSM-5 睡眠障害の構造化臨床面接 - 改訂版 (SCISD-R)

Home Sleep Test (HST) will measure airflow (i.e., nasal pressure) using a nasal cannula and oxygen saturation to identify apnea and hypopnea and calculate an apnea hypopnea index (AHI; number of apnea and hypopnea per hour).

他の名前:
  • ホームスリープテスト

All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.

Participants who have an HIV positive status will have blood tested for cluster of differentiation 4 (CD4) and Viral load to confirm positive status.

HIV Without Insomnia

Participants will test positive for HIV and test negative for Insomnia.

Structured Clinical Interview For DSM-5 Sleep Disorders-Revised (SCISD-R) - is a semi structured interview for diagnosing sleep disorders according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)

他の名前:
  • DSM-5 睡眠障害の構造化臨床面接 - 改訂版 (SCISD-R)

Home Sleep Test (HST) will measure airflow (i.e., nasal pressure) using a nasal cannula and oxygen saturation to identify apnea and hypopnea and calculate an apnea hypopnea index (AHI; number of apnea and hypopnea per hour).

他の名前:
  • ホームスリープテスト

All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.

Participants who have an HIV positive status will have blood tested for cluster of differentiation 4 (CD4) and Viral load to confirm positive status.

Non HIV with Insomnia

Participants will test negative for HIV and test positive for Insomnia.

Structured Clinical Interview For DSM-5 Sleep Disorders-Revised (SCISD-R) - is a semi structured interview for diagnosing sleep disorders according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)

他の名前:
  • DSM-5 睡眠障害の構造化臨床面接 - 改訂版 (SCISD-R)

Home Sleep Test (HST) will measure airflow (i.e., nasal pressure) using a nasal cannula and oxygen saturation to identify apnea and hypopnea and calculate an apnea hypopnea index (AHI; number of apnea and hypopnea per hour).

他の名前:
  • ホームスリープテスト

All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.

Participants who have an HIV negative status will complete the OraQuick Advance Rapid HIV 1/2 Swab test to confirm negative status.

他の名前:
  • オラクイック
Non HIV Without Insomnia

Participants will test negative for HIV and test negative for Insomnia.

Structured Clinical Interview For DSM-5 Sleep Disorders-Revised (SCISD-R) - is a semi structured interview for diagnosing sleep disorders according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)

他の名前:
  • DSM-5 睡眠障害の構造化臨床面接 - 改訂版 (SCISD-R)

Home Sleep Test (HST) will measure airflow (i.e., nasal pressure) using a nasal cannula and oxygen saturation to identify apnea and hypopnea and calculate an apnea hypopnea index (AHI; number of apnea and hypopnea per hour).

他の名前:
  • ホームスリープテスト

All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.

Participants who have an HIV negative status will complete the OraQuick Advance Rapid HIV 1/2 Swab test to confirm negative status.

他の名前:
  • オラクイック

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Pro-Inflammatory Markers
時間枠:Week 2; 5 blood draws before, during and after quantitative sensory testing; data is average of these 5 samples

TNF-a, IL-6, IL-12, IL-18, C-reactive protein, sCD14/163, D-dimer and IFN-gamma assays will be performed on the blood to identify levels of pro-inflammatory markers.

Week 2; 5 blood draws before, during and after quantitative sensory testing; data is average of these 5 samples
Anti-Inflammatory Markers
時間枠:Week 2; 5 blood draws before, during and after quantitative sensory testing; data is average of these 5 samples

IFN-a, TGF-B, IL4, IL-10 and IL-13 assays will be performed on the blood to identify levels of anti-inflammatory markers.

Week 2; 5 blood draws before, during and after quantitative sensory testing; data is average of these 5 samples
Oxidative Stress Markers
時間枠:Week 2; 5 blood draws before, during and after quantitative sensory testing; data is average of these 5 samples

Mitochondrial DNA damage, Damage associated molecular patterns (DAMPS) and Cortisol assays will be performed on the blood to identify levels of oxidative stress markers.

Week 2; 5 blood draws before, during and after quantitative sensory testing; data is average of these 5 samples
Pain Threshold
時間枠:pain threshold assessed at Week 2; data is average of three assessments

Pain threshold refers to the intensity at which a stimulus is first perceived as painful. Heat stimuli will be delivered using a computer-controlled thermal stimulation system with a 30 millimeter X 30 millimeter probe. From a baseline of 32 degrees Celsius, the probe temperature will increase at a rate of .5 degrees Celsius/second until the participant responds by pressing a button on a handheld device. For heat pain threshold, participants will be instructed to press the button when the sensation "first becomes painful"

pain threshold assessed at Week 2; data is average of three assessments
Pain Tolerance
時間枠:pain tolerance assessed at Week 2; data is average of three assessments

Pain tolerance refers to the maximum amount of pain produced by a stimulus that a person is able/willing to tolerate. Heat stimuli will again be delivered using the computer-controlled thermal stimulation system. From a baseline of 32 degrees Celsius, the probe temperature will increase at a rate of .5 degrees Celsius/second until the participant responds by pressing a button on a handheld device. For heat pain tolerance, participants will be instructed to press the button when they are "no longer willing to tolerate" the painful sensation.

pain tolerance assessed at Week 2; data is average of three assessments
Punctate Stimuli
時間枠:mechanical temporal summation of pain assessed at Week 2; data is average of two test trials

Mechanical temporal summation was assessed using a nylon Von Frey Filament (Stoelting Co., 6.65 g), which is calibrated to bend at 300 g of pressure. The filament was applied to the back of the non-dominant hand for approximately 1 second until the monofilament bent slightly. Participants were instructed to rate their pain level using the 0-100 Numeric Rating Scale (higher numbers represent greater pain). The filament was then applied to the skin for a series of 10 consecutive applications. Participants were instructed to rate the highest level of pain they experienced during the trial. This process was repeated for two trials (2 single trials, 2 series of 10). For each trial, a difference score was calculated between the series of 10 applications and the single presentation, which represented mechanical TS. The difference score was averaged across the two trials.

mechanical temporal summation of pain assessed at Week 2; data is average of two test trials
Temporal Summation of Pain
時間枠:heat temporal summation of pain assessed at Week 2; data presented is the average of 5 heat pulses completed at 44, 46, and 48 degrees in Celsius.

Temporal summation of pain refers to a form of endogenous pain facilitation characterized by the perception of increased pain despite constant or even reduced peripheral afferent input. Temporal summation is presumed to be the psychophysical manifestation of wind-up. Wind-up is a phenomenon where repetitive stimulation of C primary afferents at rates greater than 0.3 Hertz produces a slowly increasing response of second-order neurons in the spinal cord. A series of 5 heat pulses will be repeated every two seconds starting at a baseline temperature of 40 and participants will be asked to rate how painful each peak of the pulse feels to them using a pain rating of 0-100 numeric rating scale. Pain intensity was assessed using a 0-100 numeric rating scale, where 0 indicates no pain and 100 indicates the worst pain imaginable. Participants rated their pain intensity, with higher scores indicating greater pain severity. Temperatures included 44, 46, and 48 degrees in Celsius.

heat temporal summation of pain assessed at Week 2; data presented is the average of 5 heat pulses completed at 44, 46, and 48 degrees in Celsius.
Conditioned Pain Modulation
時間枠:Week 2

A cold-water bath (conditioning stimulus) was set to 10°C prior to the visit. Participants placed their non-dominant hand in the water bath up to their wrist for a maximum of 60 seconds. Immediately after withdrawal of the hand from the cold water, pressure was then applied to the dominant forearm or trapezius muscle using an algometer (testing stimulus). Participants were instructed to press a button when they first felt pain, resulting in termination of the stimuli. This procedure was repeated for a total of 4 trials (2 on each body site) and body site order was randomized (i.e., Forearm, Trapezius, Forearm, Trapezius, Forearm). An average pressure pain threshold score (kiloPascals - kPa of pressure) was generated across the two trials at each site after water immersion. Conditioned pain modulation was calculated as the difference score between baseline pressure pain threshold (kPa) and the average pressure pain threshold after water immersion at each body site

Week 2
Actigraph Sleep Measurement
時間枠:seven consecutive nights of actigraphic sleep monitoring between week 1 and week 2; data reported is average

A light weight and compact watch-like device used for objective measurement of sleep. The device will be worn for 7 consecutive days/nights and will track physical activity, falling asleep and waking events, and includes an integrated light sensor for recording photopic light.

seven consecutive nights of actigraphic sleep monitoring between week 1 and week 2; data reported is average
Weekly Sleep Diaries
時間枠:Baseline up to 8 weeks

A sleep diary including daily questions will be filled out every day for seven days including questions about a participants nightly sleep experiences.

Baseline up to 8 weeks
Weekly Caffeine Diaries
時間枠:Baseline up to 8 weeks

A caffeine dairy including different types of caffeine generally available for the participants to record their daily caffeine consumption of for seven days.

Baseline up to 8 weeks
Actigraph Sleep Measurement
時間枠:seven consecutive nights of actigraphic sleep monitoring between week 1 and week 2; data reported is average

A light weight and compact watch-like device used for objective measurement of sleep. The device will be worn for 7 consecutive days/nights and will track physical activity, falling asleep and waking events, and includes an integrated light sensor for recording photopic light. The primary actigraphic sleep outcome presented here is sleep efficiency. Sleep efficiency will be assessed using wrist-worn actigraphy and calculated as the percentage of time spent asleep relative to the total time spent in bed during the designated sleep period. Sleep efficiency is derived by dividing total sleep time by time in bed and multiplying by 100. The mean scores presented here are percentages. Higher percentages indicate greater sleep efficiency.

seven consecutive nights of actigraphic sleep monitoring between week 1 and week 2; data reported is average

二次結果の測定

結果測定
メジャーの説明
時間枠
Short Physical Performance Battery
時間枠:Completed at Week 3 by people with insomnia only

The Short Physical Performance Battery consists of 3 individual sub-tests - standing balance (participants are asked to stand in 3 easy stances for 10 seconds), 4-meter gait speed (participants are asked to walk a steady pace in a straight line for 4-meters) and 5-repetition sit-to-stand (participants are asked to stand up and sit back down in a stable chair up to 5 times). All 3 are simple and quick to perform in the outpatient setting and require only limited equipment. The total short physical performance battery score ranges from 0-12, with higher scores indicating better physical performance.

Completed at Week 3 by people with insomnia only

その他の成果指標

結果測定
メジャーの説明
時間枠
Timed Up and Go (TUG) Task
時間枠:Completed at Week 3 by people with insomnia only

The Timed Up and Go test (TUG) is a commonly used screening tool to assist clinicians to identify patients at risk of falling. Participants are asked to start in a sitting position in a chair, stand up and walk approximately 3 meters before turning to return to the chair at a steady, straight pace. The outcome will be measured with a stopwatch, then rating difficulty 0-100 (0 no difficulty and 100 being the most difficult imaginable) and pain 0-100 (0 no pain and 100 being the most pain imaginable).

Completed at Week 3 by people with insomnia only
Munich Chrono Type Questionnaires (MCTQ)
時間枠:Baseline

The Munich Chronotype Questionnaire (MCTQ) estimates chronotype primarily from the midpoint of sleep on free days, called MSF (mid-sleep on free days), with MSFsc (sleep-corrected MSF) generally preferred because it adjusts for accumulated weekday sleep debt. The outcome reported in this trial is expressed in minutes - "mid-sleep time on free days, sleep-corrected (minutes). Higher values represent a later/evening chronotype, whereas lower values represent an earlier/morning chronotype.

Baseline
Insomnia Severity Index (ISI)
時間枠:ISI completed Week 1

The Insomnia severity index is a 7 item measure that has each participant subjectively measure their insomnia severity. Each is rated from 0 (none/not at all) to 4 (very severe/very much). The responses are summed to produce a total score that ranges from 0 to 28; higher scores suggest great subjective insomnia severity.

ISI completed Week 1
Demographics (DEMO)
時間枠:Baseline

This questionnaire better helps the investigators understand how each participant's financial, racial, social, etc. background. It ranges from general questions such as age and birthday, to socioeconomic questions such as work status and financial stability.

Baseline
Center for Epidemiological Studies - Depression (CESD)
時間枠:CESD completed Week 1

The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depressive symptoms experienced during the past week, with each item scored 0-3 for a total of 0-60. Commonly used cutoffs are <16 = no significant depressive symptomatology, 16-26 = mild/moderate symptoms, and ≥27 = severe symptoms, although the CES-D is a screening measure rather than a diagnostic instrument. Higher scores indicate greater depressive symptom burden.

CESD completed Week 1
RU Sated
時間枠:RU Sated completed Week 1

Sleep is a key aspect in an individual's everyday life. This questionnaire measures overall sleep quality in six different categories---Regularity, Sleep quality, alertness, timing, efficiency, and duration. This helps investigators understand a person's sleep efficacy.

RU Sated completed Week 1
Physical Health Questionnaire (PHQ-15)
時間枠:Baseline

The PHQ-15 (Patient Health Questionnaire-15) is a 15-item self-report measure of somatic symptom burden, with each symptom scored 0 (not bothered), 1 (bothered a little), or 2 (bothered a lot), producing a total score of 0-30. Commonly used severity categories are 0-4 = minimal, 5-9 = low, 10-14 = medium, and 15-30 = high somatic symptom severity.

Baseline
Difficulties in Emotion Regulation Scale (DERS)
時間枠:Baseline

The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure assessing difficulties with emotion regulation across six domains, with items typically rated 1 (almost never) to 5 (almost always), yielding a total score of 36-180. Higher scores indicate greater emotion-regulation difficulties, and there are no universally accepted clinical cutoff scores; scores are generally interpreted relative to normative samples or as continuous measures of emotion-regulation difficulty.

Baseline
Dysfunctional Beliefs and Attitudes About Sleep (DBAAS)
時間枠:Week 1

The Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) assesses maladaptive beliefs and expectations about sleep; the commonly used DBAS-16 contains 16 items rated on a 0-10 scale, producing a mean score from 0-10. Higher scores indicate stronger dysfunctional sleep beliefs.

Week 1
Pain Interference and Intensity (PI-I)
時間枠:Week 2

This questionnaire seeks to understand how pain has an influence/impacts an individual's everyday life and activities, sleep, and mood in general. Pain intensity and interference in everyday life was assessed using a 0-5 numeric rating scale, where 0 indicates no pain and 5 indicates the worst pain imaginable. Participants rated their pain intensity and interference, with higher scores indicating greater pain severity.

Week 2
Sorge 24 Hour Food Record
時間枠:Food record completed once during Week 2

Dietary intake will be assessed using Sorge 24-hour Food Records. These records will be analyzed with the Nutrition Data System for Research (NDSR), a computer-based dietary assessment software developed by the Nutrition Coordinating Center at the University of Minnesota. Trained interviewers document all foods, beverages, and, when applicable, dietary supplements consumed during the preceding 24 hours. Information regarding food type, portion size, ingredients, preparation methods, and consumption occasions will be collected to improve the completeness and accuracy of dietary reporting. The reported dietary intake will be entered into NDSR and the resulting data may include total energy intake, macronutrients, micronutrients, and other dietary components. NDSR access is proprietary and requires a subscription. We did not have the funds to access NDSR and thus we do not have resulting data to present. The numbers below represent completed 24 hour food records for each group.

Food record completed once during Week 2
Sorge Dietary Habits
時間枠:Sorge dietary habits completed once at Week 2

This questionnaire asks about a person's general diet and intake.

Sorge dietary habits completed once at Week 2
Drug Abuse Screening Test (DAST10)
時間枠:Week 2

The DAST-10 (Drug Abuse Screening Test-10) is a 10-item self-report screening measure of drug-related problems, with each yes/no item scored 0 or 1, producing a total score of 0-10. Common interpretation is 0 = no problems, 1-2 = low level, 3-5 = moderate, 6-8 = substantial, and 9-10 = severe drug-related problems; it is a screening tool rather than a diagnostic measure.

Week 2
State Trait Anxiety Inventory
時間枠:Week 2

The State-Trait Anxiety Inventory-Trait (STAI-T) is a 20-item self-report measure of relatively stable, enduring anxiety proneness, with each item rated 1-4, producing a total score of 20-80. Higher scores indicate greater trait anxiety, but there are no universally accepted clinical severity cutoffs; scores are generally interpreted relative to normative populations, with higher scores reflecting greater anxiety tendency.

Week 2
Penn State Cigarette Dependence Index - Cigarettes
時間枠:Week 2

The Penn State Cigarette Dependence Index (PSCDI) is a brief self-report measure of cigarette dependence, assessing factors such as smoking frequency, time to first cigarette, and difficulty refraining from smoking. The commonly used 9-item version produces a score of 0-9, with higher scores indicating greater nicotine dependence; there are no universally accepted clinical severity cutoffs, so scores are typically interpreted continuously or using study-specific thresholds.

Week 2
Penn State Cigarette Dependence Index - Ecigarettes
時間枠:Week 2

The Penn State Electronic Cigarette Dependence Index (Penn State ECigarette Dependence Index; PS-ECDI) is a brief self-report measure of e-cigarette/vaping dependence, assessing features such as frequency of use, time to first use, and difficulty refraining. The 10-item version is scored from 0-20, with higher scores indicating greater e-cigarette dependence; commonly used categories are 0-3 = no dependence, 4-8 = low, 9-12 = moderate, 13-16 = high, and 17-20 = very high dependence.

Week 2
Alcohol Use Disorders Identification Test - C (AUDIT)
時間枠:Week 2

The AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) is a 3-item screening measure of alcohol consumption, with each item scored 0-4, producing a total score of 0-12. Higher scores indicate greater alcohol consumption and likelihood of hazardous drinking.

Week 2
Alcohol Smoking and Substance Involvement Screening Test (ASSIST)
時間枠:Baseline up to 1 week

This questionnaire detects and measures substance abuse, alcohol, and smoking as well as related problems. It aims to detect the risky behavior related to each.

Baseline up to 1 week
Anger PROMIS
時間枠:Week 2

The 22-item PROMIS Anger scale is a self-report measure of anger and irritability, with each item typically rated from 1 (never) to 5 (always), yielding a raw score of 22-110. Higher raw scores indicate greater anger, but raw scores are not usually interpreted with fixed clinical severity cutoffs.

Week 2
Perceived Stress Scale (PSS)
時間枠:Week 2

The Perceived Stress Scale (PSS) is a 10-item self-report measure assessing how unpredictable, uncontrollable, and overwhelming respondents have found their lives during the past month. Each item is scored 0-4, producing a total raw score of 0-40; higher scores indicate greater perceived stress, but there are no universally accepted clinical severity cutoffs, so scores are generally interpreted continuously.

Week 2
Pain Catastrophizing Scale (PCS)
時間枠:Week 2

The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure assessing three aspects of pain catastrophizing: rumination, magnification, and helplessness. Each item is scored 0-4, producing a total raw score of 0-52; higher scores indicate greater pain catastrophizing, with ≥30 commonly used as a clinically relevant level of catastrophizing.

Week 2
HIV Stigma Mechanisms
時間枠:Week 2

the HIV Stigma Mechanisms Scale (HIV-SMS) assesses three distinct dimensions of HIV-related stigma: enacted (promulgated) stigma, internalized stigma, and anticipated stigma. The original 24-item instrument uses separate five-point response scales for each dimension.

Scoring and interpretation

  • Enacted stigma (9 items): Participants report how frequently they have experienced stigmatizing treatment because of their HIV status, using a five-point scale from 1 (never) to 5 (very often).
  • Internalized stigma (6 items): Participants rate their agreement with statements reflecting negative feelings or beliefs about themselves because of their HIV status, using a five-point scale from 1 (strongly disagree) to 5 (strongly agree).
  • Anticipated stigma (9 items): Participants rate how likely they believe others are to treat them in stigmatizing ways because of their HIV status, using a five-point scale from 1 (very unlikely) to 5 (very likely).
Week 2
Heightened Vigilance Scale (HVS)
時間枠:Week 2

The Heightened Vigilance Scale is a 6-item self-report measure assessing the extent to which individuals feel they must remain alert and cautious because of the possibility of experiencing unfair treatment or discrimination. Each item is typically rated on a 1-6 scale, producing a total score of 6-36, with higher scores indicating greater perceived vigilance.

Week 2
Experience of Discrimination (EOD)
時間枠:Week 2

The 9-item Experiences of Discrimination (EOD) measure assesses lifetime experiences of discrimination across nine settings, including school, employment, housing, health care, and public settings. Each item is scored according to whether the participant reports experiencing discrimination in that setting. For a situation-based total score, responses are coded as 0 (no) or 1 (yes) and summed across the nine items, yielding a total score ranging from 0 to 9. Higher scores indicate experiences of discrimination across a greater number of settings and therefore represent a worse outcome.

Week 2
Adverse Childhood Experiences (ACE)
時間枠:Week 2

The Adverse Childhood Experiences (ACE) Questionnaire is a 10-item retrospective self-report measure assessing exposure to potentially traumatic or stressful experiences before age 18, including abuse, neglect, and household dysfunction. Each experience is typically scored 0 (no) or 1 (yes), producing a total ACE score of 0-10, with higher scores indicating exposure to a greater number of adverse childhood experiences

Week 2
Lee Fatigue Scale (LFS)
時間枠:Week 3

The Lee Fatigue Scale (LFS) is an 18-item self-report measure assessing fatigue severity and energy level, with items rated on a 0-10 scale. Scores are typically averaged across items to produce a 0-10 overall fatigue score, with higher scores indicating greater fatigue

Week 3

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Burel R Goodin, PHd、University of Alabama at Birmingham

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年1月1日

一次修了 (実際)

2025年7月31日

研究の完了 (実際)

2025年7月31日

試験登録日

最初に提出

2020年2月20日

QC基準を満たした最初の提出物

2020年3月3日

最初の投稿 (実際)

2020年3月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月12日

QC基準を満たした最後の更新が送信されました

2026年10月20日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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