Chronic PainNCT04757987
An Observational Study of Distress, Immune Function, and Pain in HIV.
An observational study of Chronic Pain and HIV, run by University of Cape Town at 1 site in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, HIV, Distress, Emotional
- What is being tested?
- Pain
- How many people
- 107 participants
- Where
- 1 siteSouth Africa
- Study dates
- 11 Feb 2021to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic in South Africa.
Who may be able to join
- HIV-positive with viral suppression
- report either persistent pain or no pain at enrolment
Who cannot join
- pregnancy
- acute psychiatric condition requiring urgent care
- cognitive impairment preventing full participation
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Community Health Clinic [name withheld due to risk to participants]
[City Withheld Due to Risk to Participants], Western Cape, 7784
About this study
Official title: An Observational Study of Shared Variation and Reciprocal Influences: Distress, Immune Function and Pain in HIV.
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.
Read the detailed description
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.
- Conditions
- Chronic Pain, HIV, Distress, Emotional, Immune System and Related Disorders, Central Sensitisation
- Being tested
- Pain
- Keywords
- Chronic pain, HIV, Innate Immune Response, Mental health, Hyperalgesia, secondary
- Medical subject headings
- Chronic Pain, Psychological Well-Being, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PainOther
As above
| Study group | Role | What they receive |
|---|---|---|
| Pain-free | Report persistent pain at enrolment | |
| Persistent pain | Report no pain at enrolment Receives: Other: Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hopkins Symptom Checklist 25-item questionnaire
Psychosocial distress
Measured: Baseline
Provoked inflammatory response
Multiplex assay
Measured: Baseline
Brief Pain Inventory
Pain intensity
Measured: Baseline
Secondary outcomes (2)
Secondary hyperalgesia (surface area)
Induced in a subgroup
Measured: Baseline assessment only
Brief Pain Inventory
Pain locations
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start11 Feb 2021
- Primary completion24 Nov 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Brigham and Women's Hospital, University of Adelaide, University of Michigan
- Responsible party
- Principal investigator, Victoria Madden, University of Cape Town
- Investigators
- Victoria J Madden, PhD, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757987
- Sponsor's protocol ID
- 764/2019
- Other IDs
- K43TW011442
- Status last verified
- Nov 2023
- First submitted
- 9 Feb 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 40788259Madden 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.
PubMed 36691234
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Shared Variation and Reciprocal Influences: Distress, Immune Function and Pain in HIV.
- ClinicalTrials.gov ID
- NCT04757987
- Acronym / sponsor ID
- 764/2019
- Conditions
- Chronic Pain, HIV, Distress, Emotional, Immune System and Related Disorders, Central Sensitisation
- Keywords
- Chronic pain, HIV, Innate Immune Response, Mental health, Hyperalgesia, secondary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Brigham and Women's Hospital, University of Adelaide, University of Michigan
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain-free | – | –Report persistent pain at enrolment |
| Persistent pain | – | Other: PainReport no pain at enrolment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic in South Africa.
Key inclusion criteria (2 listed)
- HIV-positive with viral suppression
- report either persistent pain or no pain at enrolment
Key exclusion criteria (3 listed)
- pregnancy
- acute psychiatric condition requiring urgent care
- cognitive impairment preventing full participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PainAs above | Other | Persistent pain |
Primary outcome
Hopkins Symptom Checklist 25-item questionnaire
Time frame: Baseline
Psychosocial distress
Provoked inflammatory response
Time frame: Baseline
Multiplex assay
Brief Pain Inventory
Time frame: Baseline
Pain intensity
2 secondary outcomes
Secondary hyperalgesia (surface area)
Time frame: Baseline assessment only
Brief Pain Inventory
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 40788259Madden 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.
- Derived from this study: PubMed 36691234Madden 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.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria J Madden, PhD principal investigator
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and HIV, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hopkins Symptom Checklist 25-item questionnaire (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04757987, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.