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The main aim of this pilot trial is to investigate the feasibility of undertaking a randomized controlled trial involving adults living with HIV. Additionally, this trial will explore potential change differences in self-reported quality of life and blood-derived immune markers between a chiropractic care group and no treatment controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chiropractic | Experimental | Participants in this arm will continue their physician-prescribed anti-retroviral therapy (ART) as per standard of care and will receive once per week chiropractic care during the 6-month trial period. |
|
| Controls | No Intervention | Participants in this arm will continue their physician-prescribed anti-retroviral therapy (ART) as per standard of care but will not receive chiropractic care during the 6-month trial period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiropractic Care | Procedure | Full-spine Chiropractic Care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of eligible individuals enrolled | The number of eligible individuals (i.e., people who pass the online screen) who enroll (i.e., sign the consent form), divided by the total number of eligible individuals. This assesses 'Enrollment'. | From online screen submission to enrollment (up to 2 weeks). |
| Proportion of trial participants complying with instructions | The number of trial participants submitting the online assessments within the submission window, divided by the total number of trial participants. This assesses 'Compliance'. | From enrollment to the end of participation (up to 6 months). |
| Proportion of chiropractic participants adhering to the care plan | The number of trial participants randomized to chiropractic care attending at least 90% of their scheduled chiropractic sessions, divided by the total number of trial participants randomized to chiropractic care. This assesses 'Adherence'. | From enrollment to the end of participation (up to 6 months) |
| Proportion of chiropractic participants retained | The number of trial participants randomized to chiropractic care who complete the 3rd and final assessments, divided by the total number of trial participants randomized to chiropractic care. | From enrollment to the end of the 6 month trial period |
| Proportion of control participants retained | The number of trial participants randomized to the control group who complete the 3rd and final assessments, divided by the total number of trial participants randomized to the control group. | From enrollment to the end of the 6 month trial period |
| Measure | Description | Time Frame |
|---|---|---|
| Change difference in the Short Form 12 Health Survey (SF-12) | Change difference in SF-12 scores between the chiropractic and control groups. The SF-12 is a validated, 12-item self-report designed to measure health-related quality of life (HRQoL). The SF-12 uses T-scores with a score of 50 representing the population mean. | Baseline, 12 weeks, 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Programs & Grants Administrator | Contact | 678-331-4527 | angela.seckington@life.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christie Kwon, MS, DC, MPH | Life University | Study Director |
| Mikey Jimenez | Life University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Life University | Recruiting | Marietta | Georgia | 30060 | United States |
Deidentified IPD necessary to reproduce results
(start date): within 1 year of study completion (end date): indefinitely
IPD, metadata & analytic code necessary to reproduce results will be made publicly accessible via a data repository
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Change difference in the General Pain Index (GPI) | Change difference in GPI scores between the chiropractic and control groups. The GPI is a validated, 6-item self-report that asks patients to rate how much pain has interfered with functioning across various aspects of life on a scale of 0 (completely able to function) to 10 (totally unable to function) | Baseline, 12 weeks, 24 weeks |
| Change difference in CD4 count | Change difference in CD4 counts between the chiropractic and control groups. CD4 count is a lab test that measures the number of CD4 T-lymphocytes (also called "helper T-cells") in a cubic millimeter of blood. | Baseline; 12 weeks; 24 weeks |
| Change difference in CD4/CD8 ratio | Change difference in CD4/CD8 ratios between the chiropractic and control groups. CD4/CD8 ratio is calculated by dividing the number of CD4 cells ("helper T-cells") in a cubic millimeter of blood by the number of CD8 cells ("killer T-cells") in a cubic millimeter of blood. | Baseline; 12 weeks; 24 weeks |
| Change difference in C-Reactive Protein (CRP) | Change difference in CRP levels between the chiropractic and control groups. CRP is a marker of inflammation and a measure of the weight of a specific liver-produced protein found in a liter of blood (expressed as mg/L). Its levels rise significantly in the bloodstream in response to IL-6 signaling during infection, tissue injury, or chronic disease. | Baseline; 12 weeks; 24 weeks |
| Change difference in Interleukin-6 (IL-6) | Change difference in IL-6 between chiropractic and control groups. IL-6 is a pro-inflammatory cytokine and a measure of the weight of a specific signaling protein found in a milliliter of blood (expressed as pg/mL). It acts as a primary messenger that triggers the liver to produce CRP and is used as an early marker of systemic immune activation, chronic inflammation, or "cytokine storms." | Baseline; 12 weeks; 24 weeks |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |