Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV



Status:Not yet recruiting
Conditions:Chronic Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 89
Updated:10/4/2018
Start Date:December 2019
End Date:August 2022
Contact:Alissa Eugeni
Email:ale64@pitt.edu
Phone:412-383-0618

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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.

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.

Inclusion Criteria:

1. Enrolled in CNICS

2. Age ≥ 18 years

3. English-speaking

4. Chronic pain (Brief Chronic Pain Screening Questionnaire (BCPQ) = at least moderate
pain for at least 3 months)

5. Moderately severe and impairing chronic pain (PEG pain questionnaire = average of all
three items is 4 or greater)

6. Ability and willingness to attend the group sessions at the date/time specified

7. No plans for major surgery during the study period that would interfere with study
procedures.

Exclusion Criteria:

1. Do not speak or understand English

2. Are planning a new pain treatment like surgery

3. Cannot attend the group sessions

4. Had previously participated in the pilot study (STOMP)

5. Unwilling to provide informed consent
We found this trial at
2
sites
San Diego, California 92103
Principal Investigator: Edward Cachay, MD
Phone: 619-543-6222
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San Diego, CA
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Birmingham, Alabama 35294
Principal Investigator: Michael Mugavero, MD
Phone: 205-975-1274
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Birmingham, AL
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