- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03692611
Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV (STOMP)
March 20, 2024 updated by: Jessica Merlin, University of Pittsburgh
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Behavioral interventions for chronic pain among people living with HIV (PLWH) are an understudied area, with great potential to improve pain and function.
Chronic pain is an important comorbidity that affects between 30% and 85% of PLWH and is associated with greater odds of functional impairment, increased emergency room utilization, suboptimal retention in HIV care, and failure to achieve virologic suppression.
What is not known is how to optimally address chronic pain in this population.
Opioids are a commonly used treatment for chronic pain, particularly in PLWH.
Opioid prescribing for chronic pain often does not result in substantial improvement in outcomes and contributes to the growing epidemic of opioid addiction and overdose.
In contrast, behavioral interventions are among the most effective and safest treatments for chronic pain in the general population.
Pain Self-Management (PSM) is a Social Cognitive Theory (SCT)-based behavioral approach that involves pain-related skill acquisition and goal setting.
PSM interventions have been promoted by the 2016 Department of Health and Human Services National Pain Strategy (DHHS NPS) as an effective, scalable approach to chronic pain management.
Especially given the current opioid crisis, the DHHS NPS underscored the urgent need to develop and test PSM interventions tailored to the unique needs of vulnerable populations, particularly PLWH, that can be implemented and disseminated nationwide.
Until an effective and scalable PSM intervention for chronic pain in PLWH is developed, reducing the burden of chronic pain safely and effectively in this population will not be possible.
The overall objective of this proposal is to evaluate a novel theory-based PSM intervention, "Skills TO Manage Pain" (STOMP), developed for and tailored to PLWH.
The investigators will accomplish the overall objective with the following primary specific aim: 1) Evaluate the efficacy of STOMP, a theory-based intervention tailored to improving chronic pain in PLWH.
Given the investigators' rigorous intervention development process and promising pilot trial results, the working hypothesis is that STOMP will decrease pain and improve function in PLWH.
Investigators also propose the following secondary aims: 2) Conduct exploratory analyses of the impact of STOMP on HIV outcomes associated with chronic pain (i.e.
retention in care, virologic suppression), and 3) Investigate proximal outcomes as potential mediators of STOMP's impact on chronic pain.
This approach is innovative because it incorporates novel peer co-led group sessions that were created based on the investigators' formative intervention development work, includes patients with comorbidities (e.g., depressive symptoms, addiction history) common among PLWH but typically excluded from chronic pain studies, and investigates the impact of a chronic pain intervention on disease-specific HIV outcomes in addition to pain and function.
The proposed research will be significant because if successful, it will pave the way for future dissemination and implementation studies that have the potential to dramatically change chronic pain treatment for PLWH.
Study Type
Interventional
Enrollment (Actual)
280
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 352940
- University of Alabama
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Skills to Manage Pain (STOMP)
The intervention group will receive treatment as usual plus the STOMP behavioral intervention.
The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions).
The sessions will be completed over a period of 12-16 weeks from enrollment.
The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention.
The intervention group will utilize a study manual on pain management in which they will use with each session.
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12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
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Active Comparator: comparison group
The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group.
The group will not receive the PSM intervention.
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Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Pain Inventory (BPI) score immediately post intervention
Time Frame: BPI will be conducted at baseline and immediately after the intervention
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the BPI asks 11 questions about pain severity (pain at its worst, least, average, and right now) and the interference of pain in several aspects of patients' lives (activity, mood, walking ability, work, relations with other people, sleep, and enjoyment of life) on a scale of 0 (no pain/does not interfere) to 10 (pain as bad as you imagine/completely interferes).
The BPI-Total score is the average score across all 11 questions.
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BPI will be conducted at baseline and immediately after the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jessica Merlin, MD PhD MBA, Univ of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 14, 2019
Primary Completion (Actual)
January 14, 2024
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
September 7, 2018
First Submitted That Met QC Criteria
September 28, 2018
First Posted (Actual)
October 2, 2018
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY19050051
- 1R01MH115754-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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