N/A
N=278
Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT03692611 ↗Enrolled (actual)
278
Serious AEs
30.2%
Results posted
Mar 2025
Primary outcome: Primary: Brief Pain Inventory (BPI) Total Score — 4.74; 5.99; 5.13; 5.74 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Skills TO Manage Pain (STOMP) (Behavioral); Comparison group (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Pain Inventory (BPI) Total Score |
4.74; 5.99; 5.13; 5.74 | — |
| SECONDARY Brief Pain Inventory (BPI) Functional Interference Subscore |
4.41; 5.93; 4.92; 5.57 | — |
| SECONDARY Brief Pain Inventory (BPI) Pain Severity Subscore |
5.13; 6.23; 5.25; 6.11 | — |
| SECONDARY The Pain, Enjoyment and General Activity (PEG) Scale |
5.61; 6.94; 5.68; 6.78 | — |
| SECONDARY The Pain Self-Efficacy Questionnaire (PSEQ) |
40.53; 36.44; 40.73; 35.91 | — |
| SECONDARY The Patient Health Questionnaire-8 (PHQ-8) |
6.39; 8.66; 7.25; 7.69 | — |
| SECONDARY The Pain Catastrophizing Scale (PCS) |
34.35; 38.57; 34.24; 35.99 | — |
Summary
Due to its prevalence and impact on quality of life and overall health, the National Academy of Medicine has called chronic pain a "public health crisis." Therefore, this proposal is relevant to public health because it seeks to improve chronic pain treatment in accordance with the approach recommended by the Department of Health and Human Services National Pain Strategy: to develop and test Pain Self-Management interventions tailored to the needs of vulnerable populations, particularly people living with HIV (PLWH). Chronic pain is an important and understudied comorbidity among PLWH; therefore, this proposal is responsive to the NIH's HIV Research Priorities, which identify comorbidities as a high priority research topic.
Eligibility Criteria
Inclusion Criteria
- Enrolled in CNICS
- Age ≥ 18 years
- English-speaking
- Chronic pain (Brief Chronic Pain Screening Questionnaire (BCPQ) = at least moderate pain for at least 3 months)
- Moderately severe and impairing chronic pain (PEG pain questionnaire = average of all three items is 4 or greater)
- Ability and willingness to attend the group sessions at the date/time specified
- No plans for major surgery during the study period that would interfere with study procedures.
Exclusion Criteria
- Do not speak or understand English
- Are planning a new pain treatment like surgery
- Cannot attend the group sessions
- Had previously participated in the pilot study (STOMP)
- Unwilling to provide informed consent
Data sourced from ClinicalTrials.gov (NCT03692611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.