Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain (HIP HOP)

The purpose of this research study is to test whether Brief Behavioral Treatment for Insomnia (BBTI) delivered over the phone or Brief Mindfulness Training (BMT) delivered over the phone is better able to improve the symptoms of insomnia, reduce chronic pain, and slow the pace of biological aging in individuals with HIV and Chronic Pain.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Insomnia; HIV
• Intervention / Treatment: Behavioral: Brief Behavioral Treatment for Insomnia (BBTI); Behavioral: Brief Mindfulness Training (BMT)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dyan White-Gilliam, BS; Phone Number: 314-747-4317; Email: dyanw@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: Dyan White-Gilliam; Phone Number: 314-747-4317; Email: dyanw@wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief Behavioral Treatment for Insomnia (BBTI); BBTI is comprised of four, 30-min weekly sessions, each of which will be administered via telephone. BBTI, utilizes two critical behavioral principles: sleep restriction and stimulus control.	Behavioral: Brief Behavioral Treatment for Insomnia (BBTI); BBTI is comprised of four, 30-min weekly sessions, each of which will be administered via telephone. BBTI, utilizes two critical behavioral principles: sleep restriction and stimulus control.
Experimental: Brief Mindfulness Training (BMT); Brief Mindfulness Training (BMT) is comprised of four, 30-min weekly sessions, each of which will be delivered via telephone. BMT utilizes concepts of being aware of what the body is sensing and feeling in the moment in order to achieve a state of calmness and relaxation.	Behavioral: Brief Mindfulness Training (BMT); Brief Mindfulness Training (BMT) is comprised of four, 30-min weekly sessions, each of which will be delivered via telephone. BMT utilizes concepts of being aware of what the body is sensing and feeling in the moment in order to achieve a state of calmness and relaxation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleep quality as determined by the Insomnia Severity Index (ISI)	Sleep quality as determined by the Insomnia Severity Index (ISI), a brief screening tool for insomnia, seven-item questionnaire that asks respondents to rate the nature and symptoms of their sleep problems using a Likert-type scale. Scoring: Add the scores for all seven items (questions 1 + 2 + 3 + 4 + 5 +6 + 7) = _______ your total score Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)	4 months
pain severity and interference (BPI-SF).	Pain severity and interference as measured by the Brief Pain Inventory - Short Form, (BPI-SF), a self-administered questionnaire designed to assess both the severity of pain and its impact on daily function. Scoring: Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least, average. Higher scores indicate greater pain severity, range 0-10) Pain Interference Score = Mean of items 9A-9G (interference of pain with: general activity, mood, walking, normal work, relations, sleep, enjoyment of life. Higher scores indicate greater pain interference, range 0-10)	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pace of biological aging (DunedinPACE).	DunedinPACE will allow for a measurement of the rate of biological decline.	4 months
Quality of life (SF-36)	Quality of life as measured by the Short Form - 36, (SF-36), a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being. Scoring: The SF-36 has several scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability The sections of the questionnaire will be broken into two groups, Physical and Mental. The physical section will ask about general health, limitations of activities, pain, and physical health problems. The mental section will ask about emotional health problems, social activities, and energy and emotions.	4 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Burel Goodin, PhD, WashU Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): September 16, 2029
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 202508064; R01MD021001 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All de-identified IPD
• IPD Sharing Time Frame: Start date: 12 months following primary outcomes publication End date: No end date
• IPD Sharing Access Criteria: Any qualified investigator will be able to access all de-identified data upon request and approval by Principal Investigator (Goodin)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No