Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV
NCT ID: NCT03692611
Last Updated: 2025-03-19
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
278 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-08-14
Study Completion Date
2025-01-06
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Chronic Pain
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
This is a randomized controlled trial to discover whether STOMP is an efficacious Pain Self-Management (PSM) intervention, mediated by the hypothesized Social Cognitive Theory (SCT) constructs.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Investigators
Outcome Assessors
Study Groups
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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.
Group Type
EXPERIMENTAL
Skills TO Manage Pain (STOMP)
Intervention Type
BEHAVIORAL
12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
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.
Group Type
ACTIVE_COMPARATOR
Comparison group
Intervention Type
BEHAVIORAL
Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
Interventions
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Skills TO Manage Pain (STOMP)
12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
Intervention Type
BEHAVIORAL
Comparison group
Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
Intervention Type
BEHAVIORAL
Other Intervention Names
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active comparator
Eligibility Criteria
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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.
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
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
Minimum Eligible Age
18 Years
Maximum Eligible Age
89 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Alabama at Birmingham
OTHER
Sponsor Role
collaborator
National Institute of Mental Health (NIMH)
NIH
Sponsor Role
collaborator
University of North Carolina, Chapel Hill
OTHER
Sponsor Role
collaborator
University of Pittsburgh
OTHER
Sponsor Role
lead
Responsible Party
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Jessica Merlin
Visiting Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Jessica Merlin, MD PhD MBA
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Alabama
Birmingham, Alabama, United States
Site Status
University of North Carolina
Chapel Hill, North Carolina, United States
Site Status
Countries
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United States
References
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Merlin JS, Westfall AO, Raper JL, Zinski A, Norton WE, Willig JH, Gross R, Ritchie CS, Saag MS, Mugavero MJ. Pain, mood, and substance abuse in HIV: implications for clinic visit utilization, antiretroviral therapy adherence, and virologic failure. J Acquir Immune Defic Syndr. 2012 Oct 1;61(2):164-70. doi: 10.1097/QAI.0b013e3182662215.
Reference Type
BACKGROUND
Merlin JS, Westfall AO, Johnson MO, Kerns RD, Bair MJ, Kertesz S, Turan JM, Clay OJ, Starrels JL, Kilgore M. Cost-effectiveness of a chronic pain intervention for people living with HIV (PLWH). J Med Econ. 2018 Feb;21(2):122-126. doi: 10.1080/13696998.2017.1377719. Epub 2017 Sep 18.
Reference Type
BACKGROUND
Merlin JS, Westfall AO, Chamot E, Overton ET, Willig JH, Ritchie C, Saag MS, Mugavero MJ. Pain is independently associated with impaired physical function in HIV-infected patients. Pain Med. 2013 Dec;14(12):1985-93. doi: 10.1111/pme.12255. Epub 2013 Oct 9.
Reference Type
BACKGROUND
Robinson-Papp J, Sharma S, Dhadwal N, Simpson DM, Morgello S. Optimizing measures of HIV-associated neuropathy. Muscle Nerve. 2015 Jan;51(1):56-64. doi: 10.1002/mus.24282. Epub 2014 Nov 21.
Reference Type
BACKGROUND
Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559.
Reference Type
BACKGROUND
Liu B, Liu X, Tang SJ. Interactions of Opioids and HIV Infection in the Pathogenesis of Chronic Pain. Front Microbiol. 2016 Feb 10;7:103. doi: 10.3389/fmicb.2016.00103. eCollection 2016.
Reference Type
BACKGROUND
Gandhi RT, McMahon DK, Bosch RJ, Lalama CM, Cyktor JC, Macatangay BJ, Rinaldo CR, Riddler SA, Hogg E, Godfrey C, Collier AC, Eron JJ, Mellors JW; ACTG A5321 Team. Levels of HIV-1 persistence on antiretroviral therapy are not associated with markers of inflammation or activation. PLoS Pathog. 2017 Apr 20;13(4):e1006285. doi: 10.1371/journal.ppat.1006285. eCollection 2017 Apr.
Reference Type
BACKGROUND
Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. 2016 Mar 18;65(1):1-49. doi: 10.15585/mmwr.rr6501e1.
Reference Type
BACKGROUND
Vervest ACM, Schimmel GH. Taxonomy of pain of the IASP. Pain. 1988 Sep;34(3):318-321. doi: 10.1016/0304-3959(88)90129-7. No abstract available.
Reference Type
BACKGROUND
Turk DC, Wilson HD, Cahana A. Treatment of chronic non-cancer pain. Lancet. 2011 Jun 25;377(9784):2226-35. doi: 10.1016/S0140-6736(11)60402-9.
Reference Type
BACKGROUND
Jiao JM, So E, Jebakumar J, George MC, Simpson DM, Robinson-Papp J. Chronic pain disorders in HIV primary care: clinical characteristics and association with healthcare utilization. Pain. 2016 Apr;157(4):931-937. doi: 10.1097/j.pain.0000000000000462.
Reference Type
BACKGROUND
Robinson-Papp J, Morgello S, Vaida F, Fitzsimons C, Simpson DM, Elliott KJ, Al-Lozi M, Gelman BB, Clifford D, Marra CM, McCutchan JA, Atkinson JH, Dworkin RH, Grant I, Ellis R. Association of self-reported painful symptoms with clinical and neurophysiologic signs in HIV-associated sensory neuropathy. Pain. 2010 Dec;151(3):732-736. doi: 10.1016/j.pain.2010.08.045. Epub 2010 Sep 20.
Reference Type
BACKGROUND
Morgello S, Estanislao L, Simpson D, Geraci A, DiRocco A, Gerits P, Ryan E, Yakoushina T, Khan S, Mahboob R, Naseer M, Dorfman D, Sharp V; Manhattan HIV Brain Bank. HIV-associated distal sensory polyneuropathy in the era of highly active antiretroviral therapy: the Manhattan HIV Brain Bank. Arch Neurol. 2004 Apr;61(4):546-51. doi: 10.1001/archneur.61.4.546.
Reference Type
BACKGROUND
Ellis RJ, Rosario D, Clifford DB, McArthur JC, Simpson D, Alexander T, Gelman BB, Vaida F, Collier A, Marra CM, Ances B, Atkinson JH, Dworkin RH, Morgello S, Grant I; CHARTER Study Group. Continued high prevalence and adverse clinical impact of human immunodeficiency virus-associated sensory neuropathy in the era of combination antiretroviral therapy: the CHARTER Study. Arch Neurol. 2010 May;67(5):552-8. doi: 10.1001/archneurol.2010.76.
Reference Type
BACKGROUND
Lehmann HC, Chen W, Borzan J, Mankowski JL, Hoke A. Mitochondrial dysfunction in distal axons contributes to human immunodeficiency virus sensory neuropathy. Ann Neurol. 2011 Jan;69(1):100-10. doi: 10.1002/ana.22150. Epub 2010 Nov 8.
Reference Type
BACKGROUND
Malvar J, Vaida F, Sanders CF, Atkinson JH, Bohannon W, Keltner J, Robinson-Papp J, Simpson DM, Marra CM, Clifford DB, Gelman B, Fan J, Grant I, Ellis RJ; CHARTER Group. Predictors of new-onset distal neuropathic pain in HIV-infected individuals in the era of combination antiretroviral therapy. Pain. 2015 Apr;156(4):731-739. doi: 10.1097/01.j.pain.0000461252.75089.bf.
Reference Type
BACKGROUND
Levy B, Paulozzi L, Mack KA, Jones CM. Trends in Opioid Analgesic-Prescribing Rates by Specialty, U.S., 2007-2012. Am J Prev Med. 2015 Sep;49(3):409-13. doi: 10.1016/j.amepre.2015.02.020. Epub 2015 Apr 18.
Reference Type
BACKGROUND
Silverberg MJ, Ray GT, Saunders K, Rutter CM, Campbell CI, Merrill JO, Sullivan MD, Banta-Green CJ, Von Korff M, Weisner C. Prescription long-term opioid use in HIV-infected patients. Clin J Pain. 2012 Jan;28(1):39-46. doi: 10.1097/AJP.0b013e3182201a0f.
Reference Type
BACKGROUND
Edelman EJ, Gordon K, Becker WC, Goulet JL, Skanderson M, Gaither JR, Brennan Braden J, Gordon AJ, Kerns RD, Justice AC, Fiellin DA. Receipt of opioid analgesics by HIV-infected and uninfected patients. J Gen Intern Med. 2013 Jan;28(1):82-90. doi: 10.1007/s11606-012-2189-z. Epub 2012 Aug 16.
Reference Type
BACKGROUND
Merlin JS, Tamhane A, Starrels JL, Kertesz S, Saag M, Cropsey K. Factors Associated with Prescription of Opioids and Co-prescription of Sedating Medications in Individuals with HIV. AIDS Behav. 2016 Mar;20(3):687-98. doi: 10.1007/s10461-015-1178-8.
Reference Type
BACKGROUND
Frenk SM, Porter KS, Paulozzi LJ. Prescription opioid analgesic use among adults: United States, 1999-2012. NCHS Data Brief. 2015 Feb;(189):1-8.
Reference Type
BACKGROUND
Merlin JS, Long D, Becker WC, Cachay ER, Christopoulos KA, Claborn K, Crane HM, Edelman EJ, Harding R, Kertesz SG, Liebschutz JM, Mathews WC, Mugavero MJ, Napravnik S, C O'Cleirigh C, Saag MS, Starrels JL, Gross R. Brief Report: The Association of Chronic Pain and Long-Term Opioid Therapy With HIV Treatment Outcomes. J Acquir Immune Defic Syndr. 2018 Sep 1;79(1):77-82. doi: 10.1097/QAI.0000000000001741.
Reference Type
BACKGROUND
Noble M, Treadwell JR, Tregear SJ, Coates VH, Wiffen PJ, Akafomo C, Schoelles KM. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD006605. doi: 10.1002/14651858.CD006605.pub2.
Reference Type
BACKGROUND
Koeppe J, Armon C, Lyda K, Nielsen C, Johnson S. Ongoing pain despite aggressive opioid pain management among persons with HIV. Clin J Pain. 2010 Mar-Apr;26(3):190-8. doi: 10.1097/AJP.0b013e3181b91624.
Reference Type
BACKGROUND
Solomon DH, Rassen JA, Glynn RJ, Garneau K, Levin R, Lee J, Schneeweiss S. The comparative safety of opioids for nonmalignant pain in older adults. Arch Intern Med. 2010 Dec 13;170(22):1979-86. doi: 10.1001/archinternmed.2010.450.
Reference Type
BACKGROUND
Li L, Setoguchi S, Cabral H, Jick S. Opioid use for noncancer pain and risk of myocardial infarction amongst adults. J Intern Med. 2013 May;273(5):511-26. doi: 10.1111/joim.12035. Epub 2013 Feb 16.
Reference Type
BACKGROUND
Li L, Setoguchi S, Cabral H, Jick S. Opioid use for noncancer pain and risk of fracture in adults: a nested case-control study using the general practice research database. Am J Epidemiol. 2013 Aug 15;178(4):559-69. doi: 10.1093/aje/kwt013. Epub 2013 May 2.
Reference Type
BACKGROUND
Reddy RG, Aung T, Karavitaki N, Wass JA. Opioid induced hypogonadism. BMJ. 2010 Aug 31;341:c4462. doi: 10.1136/bmj.c4462.
Reference Type
BACKGROUND
Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, Weisner CM, Silverberg MJ, Campbell CI, Psaty BM, Von Korff M. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med. 2010 Jan 19;152(2):85-92. doi: 10.7326/0003-4819-152-2-201001190-00006.
Reference Type
BACKGROUND
Morasco BJ, Dobscha SK. Prescription medication misuse and substance use disorder in VA primary care patients with chronic pain. Gen Hosp Psychiatry. 2008 Mar-Apr;30(2):93-9. doi: 10.1016/j.genhosppsych.2007.12.004.
Reference Type
BACKGROUND
Bohnert AS, Valenstein M, Bair MJ, Ganoczy D, McCarthy JF, Ilgen MA, Blow FC. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA. 2011 Apr 6;305(13):1315-21. doi: 10.1001/jama.2011.370.
Reference Type
BACKGROUND
Gomes T, Mamdani MM, Dhalla IA, Paterson JM, Juurlink DN. Opioid dose and drug-related mortality in patients with nonmalignant pain. Arch Intern Med. 2011 Apr 11;171(7):686-91. doi: 10.1001/archinternmed.2011.117.
Reference Type
BACKGROUND
Paulozzi LJ, Kilbourne EM, Shah NG, Nolte KB, Desai HA, Landen MG, Harvey W, Loring LD. A history of being prescribed controlled substances and risk of drug overdose death. Pain Med. 2012 Jan;13(1):87-95. doi: 10.1111/j.1526-4637.2011.01260.x. Epub 2011 Oct 25.
Reference Type
BACKGROUND
Webster LR, Cochella S, Dasgupta N, Fakata KL, Fine PG, Fishman SM, Grey T, Johnson EM, Lee LK, Passik SD, Peppin J, Porucznik CA, Ray A, Schnoll SH, Stieg RL, Wakeland W. An analysis of the root causes for opioid-related overdose deaths in the United States. Pain Med. 2011 Jun;12 Suppl 2:S26-35. doi: 10.1111/j.1526-4637.2011.01134.x.
Reference Type
BACKGROUND
Weisberg DF, Gordon KS, Barry DT, Becker WC, Crystal S, Edelman EJ, Gaither J, Gordon AJ, Goulet J, Kerns RD, Moore BA, Tate J, Justice AC, Fiellin DA. Long-term Prescription of Opioids and/or Benzodiazepines and Mortality Among HIV-Infected and Uninfected Patients. J Acquir Immune Defic Syndr. 2015 Jun 1;69(2):223-33. doi: 10.1097/QAI.0000000000000591.
Reference Type
BACKGROUND
Merlin JS, Young SR, Starrels JL, Azari S, Edelman EJ, Pomeranz J, Roy P, Saini S, Becker WC, Liebschutz JM. Managing Concerning Behaviors in Patients Prescribed Opioids for Chronic Pain: A Delphi Study. J Gen Intern Med. 2018 Feb;33(2):166-176. doi: 10.1007/s11606-017-4211-y. Epub 2017 Dec 4.
Reference Type
BACKGROUND
Scherrer JF, Svrakic DM, Freedland KE, Chrusciel T, Balasubramanian S, Bucholz KK, Lawler EV, Lustman PJ. Prescription opioid analgesics increase the risk of depression. J Gen Intern Med. 2014 Mar;29(3):491-9. doi: 10.1007/s11606-013-2648-1. Epub 2013 Oct 29.
Reference Type
BACKGROUND
Smallwood N, Politis J, Le B. Prescription opioid use in advanced COPD: benefits, perils and controversies. Eur Respir J. 2017 Jun 22;49(6):1700690. doi: 10.1183/13993003.00690-2017. Print 2017 Jun. No abstract available.
Reference Type
BACKGROUND
El-Hage N, Gurwell JA, Singh IN, Knapp PE, Nath A, Hauser KF. Synergistic increases in intracellular Ca2+, and the release of MCP-1, RANTES, and IL-6 by astrocytes treated with opiates and HIV-1 Tat. Glia. 2005 Apr 15;50(2):91-106. doi: 10.1002/glia.20148.
Reference Type
BACKGROUND
Yu Y, Huang X, Di Y, Qu L, Fan N. Effect of CXCL12/CXCR4 signaling on neuropathic pain after chronic compression of dorsal root ganglion. Sci Rep. 2017 Jul 18;7(1):5707. doi: 10.1038/s41598-017-05954-1.
Reference Type
BACKGROUND
Wilson NM, Jung H, Ripsch MS, Miller RJ, White FA. CXCR4 signaling mediates morphine-induced tactile hyperalgesia. Brain Behav Immun. 2011 Mar;25(3):565-73. doi: 10.1016/j.bbi.2010.12.014. Epub 2010 Dec 28.
Reference Type
BACKGROUND
Davey RT Jr, Bhat N, Yoder C, Chun TW, Metcalf JA, Dewar R, Natarajan V, Lempicki RA, Adelsberger JW, Miller KD, Kovacs JA, Polis MA, Walker RE, Falloon J, Masur H, Gee D, Baseler M, Dimitrov DS, Fauci AS, Lane HC. HIV-1 and T cell dynamics after interruption of highly active antiretroviral therapy (HAART) in patients with a history of sustained viral suppression. Proc Natl Acad Sci U S A. 1999 Dec 21;96(26):15109-14. doi: 10.1073/pnas.96.26.15109.
Reference Type
BACKGROUND
Deeks S. Towards an HIV cure. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19479. doi: 10.7448/IAS.17.4.19479. eCollection 2014.
Reference Type
BACKGROUND
Chun TW, Stuyver L, Mizell SB, Ehler LA, Mican JA, Baseler M, Lloyd AL, Nowak MA, Fauci AS. Presence of an inducible HIV-1 latent reservoir during highly active antiretroviral therapy. Proc Natl Acad Sci U S A. 1997 Nov 25;94(24):13193-7. doi: 10.1073/pnas.94.24.13193.
Reference Type
BACKGROUND
Finzi D, Hermankova M, Pierson T, Carruth LM, Buck C, Chaisson RE, Quinn TC, Chadwick K, Margolick J, Brookmeyer R, Gallant J, Markowitz M, Ho DD, Richman DD, Siliciano RF. Identification of a reservoir for HIV-1 in patients on highly active antiretroviral therapy. Science. 1997 Nov 14;278(5341):1295-300. doi: 10.1126/science.278.5341.1295.
Reference Type
BACKGROUND
Wong JK, Hezareh M, Gunthard HF, Havlir DV, Ignacio CC, Spina CA, Richman DD. Recovery of replication-competent HIV despite prolonged suppression of plasma viremia. Science. 1997 Nov 14;278(5341):1291-5. doi: 10.1126/science.278.5341.1291.
Reference Type
BACKGROUND
Siliciano JM, Siliciano RF. The Remarkable Stability of the Latent Reservoir for HIV-1 in Resting Memory CD4+ T Cells. J Infect Dis. 2015 Nov 1;212(9):1345-7. doi: 10.1093/infdis/jiv219. Epub 2015 Apr 15. No abstract available.
Reference Type
BACKGROUND
Zhang JM, An J. Cytokines, inflammation, and pain. Int Anesthesiol Clin. 2007 Spring;45(2):27-37. doi: 10.1097/AIA.0b013e318034194e.
Reference Type
BACKGROUND
Backonja MM, Attal N, Baron R, Bouhassira D, Drangholt M, Dyck PJ, Edwards RR, Freeman R, Gracely R, Haanpaa MH, Hansson P, Hatem SM, Krumova EK, Jensen TS, Maier C, Mick G, Rice AS, Rolke R, Treede RD, Serra J, Toelle T, Tugnoli V, Walk D, Walalce MS, Ware M, Yarnitsky D, Ziegler D. Value of quantitative sensory testing in neurological and pain disorders: NeuPSIG consensus. Pain. 2013 Sep;154(9):1807-1819. doi: 10.1016/j.pain.2013.05.047. Epub 2013 Jun 3.
Reference Type
BACKGROUND
Cruz-Almeida Y, Fillingim RB. Can quantitative sensory testing move us closer to mechanism-based pain management? Pain Med. 2014 Jan;15(1):61-72. doi: 10.1111/pme.12230. Epub 2013 Sep 6.
Reference Type
BACKGROUND
Goodin BR, Bulls HW, Herbert MS, Schmidt J, King CD, Glover TL, Sotolongo A, Sibille KT, Cruz-Almeida Y, Staud R, Fessler BJ, Redden DT, Bradley LA, Fillingim RB. Temporal summation of pain as a prospective predictor of clinical pain severity in adults aged 45 years and older with knee osteoarthritis: ethnic differences. Psychosom Med. 2014 May;76(4):302-10. doi: 10.1097/PSY.0000000000000058.
Reference Type
BACKGROUND
Stringer EA, Baker KS, Carroll IR, Montoya JG, Chu L, Maecker HT, Younger JW. Daily cytokine fluctuations, driven by leptin, are associated with fatigue severity in chronic fatigue syndrome: evidence of inflammatory pathology. J Transl Med. 2013 Apr 9;11:93. doi: 10.1186/1479-5876-11-93.
Reference Type
BACKGROUND
Parkitny L, Middleton S, Baker K, Younger J. Evidence for abnormal cytokine expression in Gulf War Illness: A preliminary analysis of daily immune monitoring data. BMC Immunol. 2015 Sep 30;16:57. doi: 10.1186/s12865-015-0122-z.
Reference Type
BACKGROUND
Younger J, Kapphahn K, Brennan K, Sullivan SD, Stefanick ML. Association of Leptin with Body Pain in Women. J Womens Health (Larchmt). 2016 Jul;25(7):752-60. doi: 10.1089/jwh.2015.5509. Epub 2016 Mar 30.
Reference Type
BACKGROUND
Merlin JS, Westfall AO, Heath SL, Goodin BR, Stewart JC, Sorge RE, Younger J. Brief Report: IL-1beta Levels Are Associated With Chronic Multisite Pain in People Living With HIV. J Acquir Immune Defic Syndr. 2017 Aug 1;75(4):e99-e103. doi: 10.1097/QAI.0000000000001377.
Reference Type
BACKGROUND
Merlin JS, Westfall AO, Chamot E, Saag M, Walcott M, Ritchie C, Kertesz S. Quantitative Evaluation of an Instrument to Identify Chronic Pain in HIV-Infected Individuals. AIDS Res Hum Retroviruses. 2015 Jun;31(6):623-7. doi: 10.1089/AID.2014.0362. Epub 2015 Mar 12.
Reference Type
BACKGROUND
Goodin BR, Owens MA, Yessick LR, Rainey RL, Okunbor JI, White DM, Mushatt KA, Harmon OA, Heath SL, Merlin JS. Detectable Viral Load May Be Associated with Increased Pain Sensitivity in Persons Living with HIV: Preliminary Findings. Pain Med. 2017 Dec 1;18(12):2289-2295. doi: 10.1093/pm/pnx057.
Reference Type
BACKGROUND
England JD, Gronseth GS, Franklin G, Miller RG, Asbury AK, Carter GT, Cohen JA, Fisher MA, Howard JF, Kinsella LJ, Latov N, Lewis RA, Low PA, Sumner AJ; American Academy of Neurology; American Association of Electrodiagnostic Medicine; American Academy of Physical Medicine and Rehabilitation. Distal symmetric polyneuropathy: a definition for clinical research: report of the American Academy of Neurology, the American Association of Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2005 Jan 25;64(2):199-207. doi: 10.1212/01.WNL.0000149522.32823.EA.
Reference Type
BACKGROUND
Robinson-Papp J, Gonzalez-Duarte A, Simpson DM, Rivera-Mindt M, Morgello S; Manhattan HIV Brain Bank. The roles of ethnicity and antiretrovirals in HIV-associated polyneuropathy: a pilot study. J Acquir Immune Defic Syndr. 2009 Aug 15;51(5):569-73. doi: 10.1097/QAI.0b013e3181adcefa.
Reference Type
BACKGROUND
Robinson-Papp J, Gelman BB, Grant I, Singer E, Gensler G, Morgello S; National NeuroAIDS Tissue Consortium. Substance abuse increases the risk of neuropathy in an HIV-infected cohort. Muscle Nerve. 2012 Apr;45(4):471-6. doi: 10.1002/mus.23231.
Reference Type
BACKGROUND
Simpson DM, Robinson-Papp J, Van J, Stoker M, Jacobs H, Snijder RJ, Schregardus DS, Long SK, Lambourg B, Katz N. Capsaicin 8% Patch in Painful Diabetic Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study. J Pain. 2017 Jan;18(1):42-53. doi: 10.1016/j.jpain.2016.09.008. Epub 2016 Oct 13.
Reference Type
BACKGROUND
Samikkannu T, Rao KV, Arias AY, Kalaichezian A, Sagar V, Yoo C, Nair MP. HIV infection and drugs of abuse: role of acute phase proteins. J Neuroinflammation. 2013 Sep 17;10:113. doi: 10.1186/1742-2094-10-113.
Reference Type
BACKGROUND
Schomberg D, Ahmed M, Miranpuri G, Olson J, Resnick DK. Neuropathic pain: role of inflammation, immune response, and ion channel activity in central injury mechanisms. Ann Neurosci. 2012 Jul;19(3):125-32. doi: 10.5214/ans.0972.7531.190309.
Reference Type
BACKGROUND
Zhao H, Alam A, Chen Q, A Eusman M, Pal A, Eguchi S, Wu L, Ma D. The role of microglia in the pathobiology of neuropathic pain development: what do we know? Br J Anaesth. 2017 Apr 1;118(4):504-516. doi: 10.1093/bja/aex006.
Reference Type
BACKGROUND
Sun C, Zhang J, Chen L, Liu T, Xu G, Li C, Yuan W, Xu H, Su Z. IL-17 contributed to the neuropathic pain following peripheral nerve injury by promoting astrocyte proliferation and secretion of proinflammatory cytokines. Mol Med Rep. 2017 Jan;15(1):89-96. doi: 10.3892/mmr.2016.6018. Epub 2016 Dec 9.
Reference Type
BACKGROUND
Clark AK, Old EA, Malcangio M. Neuropathic pain and cytokines: current perspectives. J Pain Res. 2013 Nov 21;6:803-14. doi: 10.2147/JPR.S53660. eCollection 2013.
Reference Type
BACKGROUND
Zheng L, Bosch RJ, Chan ES, Read S, Kearney M, Margolis DM, Mellors JW, Eron JJ, Gandhi RT; DS Clinical Trials Group (ACTG) A5244 Team. Predictors of residual viraemia in patients on long-term suppressive antiretroviral therapy. Antivir Ther. 2013;18(1):39-43. doi: 10.3851/IMP2323. Epub 2012 Aug 22.
Reference Type
BACKGROUND
Riddler SA, Aga E, Bosch RJ, Bastow B, Bedison M, Vagratian D, Vaida F, Eron JJ, Gandhi RT, Mellors JW; ACTG A5276s Protocol Team. Continued Slow Decay of the Residual Plasma Viremia Level in HIV-1-Infected Adults Receiving Long-term Antiretroviral Therapy. J Infect Dis. 2016 Feb 15;213(4):556-60. doi: 10.1093/infdis/jiv433. Epub 2015 Sep 2.
Reference Type
BACKGROUND
Cillo AR, Vagratian D, Bedison MA, Anderson EM, Kearney MF, Fyne E, Koontz D, Coffin JM, Piatak M Jr, Mellors JW. Improved single-copy assays for quantification of persistent HIV-1 viremia in patients on suppressive antiretroviral therapy. J Clin Microbiol. 2014 Nov;52(11):3944-51. doi: 10.1128/JCM.02060-14. Epub 2014 Sep 3.
Reference Type
BACKGROUND
Cillo AR, Sobolewski MD, Bosch RJ, Fyne E, Piatak M Jr, Coffin JM, Mellors JW. Quantification of HIV-1 latency reversal in resting CD4+ T cells from patients on suppressive antiretroviral therapy. Proc Natl Acad Sci U S A. 2014 May 13;111(19):7078-83. doi: 10.1073/pnas.1402873111. Epub 2014 Mar 31.
Reference Type
BACKGROUND
Palmer S, Wiegand AP, Maldarelli F, Bazmi H, Mican JM, Polis M, Dewar RL, Planta A, Liu S, Metcalf JA, Mellors JW, Coffin JM. New real-time reverse transcriptase-initiated PCR assay with single-copy sensitivity for human immunodeficiency virus type 1 RNA in plasma. J Clin Microbiol. 2003 Oct;41(10):4531-6. doi: 10.1128/JCM.41.10.4531-4536.2003.
Reference Type
BACKGROUND
Ho YC, Shan L, Hosmane NN, Wang J, Laskey SB, Rosenbloom DI, Lai J, Blankson JN, Siliciano JD, Siliciano RF. Replication-competent noninduced proviruses in the latent reservoir increase barrier to HIV-1 cure. Cell. 2013 Oct 24;155(3):540-51. doi: 10.1016/j.cell.2013.09.020. Epub 2013 Oct 24.
Reference Type
BACKGROUND
Pollack RA, Jones RB, Pertea M, Bruner KM, Martin AR, Thomas AS, Capoferri AA, Beg SA, Huang SH, Karandish S, Hao H, Halper-Stromberg E, Yong PC, Kovacs C, Benko E, Siliciano RF, Ho YC. Defective HIV-1 Proviruses Are Expressed and Can Be Recognized by Cytotoxic T Lymphocytes, which Shape the Proviral Landscape. Cell Host Microbe. 2017 Apr 12;21(4):494-506.e4. doi: 10.1016/j.chom.2017.03.008.
Reference Type
BACKGROUND
Bui JK, Mellors JW, Cillo AR. HIV-1 Virion Production from Single Inducible Proviruses following T-Cell Activation Ex Vivo. J Virol. 2015 Nov 11;90(3):1673-6. doi: 10.1128/JVI.02520-15. Print 2016 Feb 1.
Reference Type
BACKGROUND
Hong F, Aga E, Cillo AR, Yates AL, Besson G, Fyne E, Koontz DL, Jennings C, Zheng L, Mellors JW. Novel Assays for Measurement of Total Cell-Associated HIV-1 DNA and RNA. J Clin Microbiol. 2016 Apr;54(4):902-11. doi: 10.1128/JCM.02904-15. Epub 2016 Jan 13.
Reference Type
BACKGROUND
Marchetti G, Tincati C, Silvestri G. Microbial translocation in the pathogenesis of HIV infection and AIDS. Clin Microbiol Rev. 2013 Jan;26(1):2-18. doi: 10.1128/CMR.00050-12.
Reference Type
BACKGROUND
Caradonna L, Amati L, Magrone T, Pellegrino NM, Jirillo E, Caccavo D. Enteric bacteria, lipopolysaccharides and related cytokines in inflammatory bowel disease: biological and clinical significance. J Endotoxin Res. 2000;6(3):205-14.
Reference Type
BACKGROUND
Caliendo AM, St George K, Allega J, Bullotta AC, Gilbane L, Rinaldo CR. Distinguishing cytomegalovirus (CMV) infection and disease with CMV nucleic acid assays. J Clin Microbiol. 2002 May;40(5):1581-6. doi: 10.1128/JCM.40.5.1581-1586.2002.
Reference Type
BACKGROUND
Martin A, Rief W, Klaiberg A, Braehler E. Validity of the Brief Patient Health Questionnaire Mood Scale (PHQ-9) in the general population. Gen Hosp Psychiatry. 2006 Jan-Feb;28(1):71-7. doi: 10.1016/j.genhosppsych.2005.07.003.
Reference Type
BACKGROUND
Newcombe DA, Humeniuk RE, Ali R. Validation of the World Health Organization Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): report of results from the Australian site. Drug Alcohol Rev. 2005 May;24(3):217-26. doi: 10.1080/09595230500170266.
Reference Type
BACKGROUND
Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
Reference Type
BACKGROUND
Tan G, Jensen MP, Thornby JI, Shanti BF. Validation of the Brief Pain Inventory for chronic nonmalignant pain. J Pain. 2004 Mar;5(2):133-7. doi: 10.1016/j.jpain.2003.12.005.
Reference Type
BACKGROUND
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Reference Type
BACKGROUND
Doyle HH, Murphy AZ. Sex differences in innate immunity and its impact on opioid pharmacology. J Neurosci Res. 2017 Jan 2;95(1-2):487-499. doi: 10.1002/jnr.23852.
Reference Type
BACKGROUND
Wegner A, Benson S, Rebernik L, Spreitzer I, Jager M, Schedlowski M, Elsenbruch S, Engler H. Sex differences in the pro-inflammatory cytokine response to endotoxin unfold in vivo but not ex vivo in healthy humans. Innate Immun. 2017 Jul;23(5):432-439. doi: 10.1177/1753425917707026. Epub 2017 Apr 26.
Reference Type
BACKGROUND
Sorge RE, Totsch SK. Sex Differences in Pain. J Neurosci Res. 2017 Jun;95(6):1271-1281. doi: 10.1002/jnr.23841. Epub 2016 Jul 25.
Reference Type
BACKGROUND
Melchior M, Poisbeau P, Gaumond I, Marchand S. Insights into the mechanisms and the emergence of sex-differences in pain. Neuroscience. 2016 Dec 3;338:63-80. doi: 10.1016/j.neuroscience.2016.05.007. Epub 2016 May 12.
Reference Type
BACKGROUND
Frank JW, Lovejoy TI, Becker WC, Morasco BJ, Koenig CJ, Hoffecker L, Dischinger HR, Dobscha SK, Krebs EE. Patient Outcomes in Dose Reduction or Discontinuation of Long-Term Opioid Therapy: A Systematic Review. Ann Intern Med. 2017 Aug 1;167(3):181-191. doi: 10.7326/M17-0598. Epub 2017 Jul 11.
Reference Type
BACKGROUND
McGill LS, Clay OJ, Edwards KA, Jones KF, Long DM, Johnson MO, Bair MJ, Browne LE, Liebschutz JM, Demonte W, Agil D, Burkholder G, Durr AL, Farel CE, Johnson B, Orris SM, Napravnik S, Thomas T, Merlin JS. Trajectories of Pain Impact and Pain Self-Efficacy in People With HIV and Chronic Pain: Extending Findings From the Skills TO Manage Pain Randomized Clinical Trial. J Acquir Immune Defic Syndr. 2025 Dec 1;100(4):347-354. doi: 10.1097/QAI.0000000000003739.
Reference Type
DERIVED
Edwards KA, Long D, Jones KF, Durr AL, Farel CE, Liebschutz JM, Bair MJ, Agil D, Napravnik S, Browne L, Johnson B, Thomas T, Burkholder G, Clay OJ, Demonte W, Orris SM, Johnson MO, Merlin J. The Skills to Manage Pain Randomized Trial: Results of Antiretroviral Therapy Adherence, HIV Primary Care Retention, and Virologic Suppression Outcomes. J Acquir Immune Defic Syndr. 2025 Oct 1;100(2):180-185. doi: 10.1097/QAI.0000000000003706.
Reference Type
DERIVED
Jones KF, Long DM, Bair MJ, Agil D, Browne L, Burkholder G, Clay OJ, Conder K, Durr AL, Farel CE, King K, Johnson B, Liebschutz JM, Demonte W, Leone M, Mullen L, Orris SM, Thomas T, Johnson M, Napravnik S, Merlin JS. Efficacy of a Pain Self-Management Intervention Tailored to People With HIV: A Randomized Clinical Trial. JAMA Intern Med. 2024 Sep 1;184(9):1074-1082. doi: 10.1001/jamainternmed.2024.3071.
Reference Type
DERIVED
Jones KF, Bair MJ, Orris SM, Johnson M, Liebschutz JM, Demonte W, Clay OJ, Durr AL, Farel CE, Agil D, Burkholder G, Johnson B, Conder K, Leone M, Napravnik S, Thomas T, Browne L, King K, Mullen L, Merlin J. Evaluation of the efficacy and mechanisms of a novel intervention for chronic pain tailored to people with HIV: The STOMP protocol. Contemp Clin Trials. 2023 Jun;129:107163. doi: 10.1016/j.cct.2023.107163. Epub 2023 Mar 21.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY19050051
Identifier Type: -
Identifier Source: org_study_id
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