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| ID | Type | Description | Link |
|---|---|---|---|
| K43TW011442 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
| Brigham and Women's Hospital | OTHER |
| University of Adelaide | OTHER |
| University of Michigan |
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This case-control study focuses on pain in HIV, which is common despite antiretroviral therapy and compromises quality of life, mental health and daily functioning. Specifically, it will investigate the relationships between psychosocial distress, inflammation and pain in HIV.
We plan to recruit 100 people and follow them for 6 months, taking repeated measures. Participants who report persistent pain at enrolment will be assessed at 0 (baseline), 2, 4, and 6 months. Participants who report no pain at enrolment will be assessed at 0 (baseline) and 6 months. All participants will also be invited to participate in weekly remote assessment of selected self-reported outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain-free | Report persistent pain at enrolment | ||
| Persistent pain | Report no pain at enrolment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain | Other | As above |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hopkins Symptom Checklist 25-item questionnaire | Psychosocial distress | Baseline |
| Provoked inflammatory response | Multiplex assay | Baseline |
| Brief Pain Inventory | Pain intensity | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary hyperalgesia (surface area) | Induced in a subgroup | Baseline assessment only |
| Brief Pain Inventory | Pain locations | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic in South Africa.
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| Name | Affiliation | Role |
|---|---|---|
| Victoria J Madden, PhD | University of Cape Town | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Health Clinic [name withheld due to risk to participants] | [City Withheld Due to Risk to Participants] | Western Cape | 7784 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40788259 | Derived | Madden VJ, Mqadi L, Arendse G, Bedwell GJ, Msolo N, Lesosky M, Hutchinson MR, Peter JG, Schrepf A, Parker R, Edwards RR, Joska JA. Provoked cytokine response is not associated with distress or induced secondary hyperalgesia in people with suppressed HIV. Pain. 2025 Dec 1;166(12):e830-e843. doi: 10.1097/j.pain.0000000000003748. Epub 2025 Aug 7. | |
| 36691234 | Derived | Madden VJ, Msolo N, Mqadi L, Lesosky M, Bedwell GJ, Hutchinson MR, Peter JG, Parker R, Schrepf A, Edwards RR, Joska JA. Study protocol: an observational study of distress, immune function and persistent pain in HIV. BMJ Open. 2022 Jun 3;12(6):e059723. doi: 10.1136/bmjopen-2021-059723. |
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The final dataset will include demographic, health history, psychological, and physiological data. An important priority when considering sharing of these data is participant confidentiality, particularly considering the stigma and personal social risk associated with HIV+ status in South Africa. If the data can be adequately stripped of identifiers so as to eliminate risk to participants, then the final, de-identified data set will be made available to qualified users through a data sharing platform, and subject to a sharing agreement that includes (1) a commitment to using the data only for research purposes and not to identify any individual participant; and (2) a commitment to securing the data using appropriate computer technology.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D000092862 | Psychological Well-Being |
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
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| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009422 | Nervous System Diseases |