Can a phone call help people with HIV sleep better and hurt less?
NCT ID NCT07270406
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This study compares two phone-based programs—Brief Behavioral Treatment for Insomnia and Brief Mindfulness Training—to see which one better improves sleep, reduces chronic pain, and slows biological aging in 200 adults with HIV and ongoing pain. Participants must be 25-65, have HIV, and have insomnia. The goal is to find a simple, accessible way to ease symptoms and improve quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria Each subject must meet all of the following criteria and be confirmed with electronic medical records: 1. Confirmed HIV diagnosis and currently a patient in the WashU Infectious Disease Clinic 2. Age 25-65 years 3. All people with HIV must be currently receiving stable antiretroviral therapy 4. People with HIV with insomnia must report Insomnia Severity Index \>/= 15 at initial screening and meet DSM-5 diagnostic criteria for insomnia including sleep difficulty that occurs at least 3 times per week and has been a problem for at least 3 consecutive months 5. People with HIV must also report the presence of chronic pain on the Brief Chronic Pain Screening Questionnaire and rate their chronic pain as \>/= 3 on a 0-10 scale of intensity. Exclusion Criteria Subjects will not be enrolled if any of the following criteria exist and confirmed with electronic medical records: 1. History of stroke in past 12 months 2. Active cancer with treatment 3. Heart disease 4. Uncontrolled hypertension 5. Epilepsy 6. Active pregnancy 7. Reynaud's disease 8. Traumatic injury or surgical procedure within the last 12 months 9. Acute infection as suggested by thermometry temperature \>100.4 10. Serious psychiatric disorder (bipolar disorder, psychotic disorder) 11. Active suicidal ideation 12. Evidence for severe obstructive sleep apnea (AHI \>30/hr) according to Home Sleep Monitoring or presence of another sleep disorder other than insomnia (i.e., not insomnia) as indicated by SCISD-R
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Washington University School of Medicine
RECRUITINGSt Louis, Missouri, 63110, United States
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