Human Immunodeficiency Virus (HIV)
Conditions
Keywords
Human Immunodeficiency Virus, Pilot Projects, Chiropractic, Randomized Controlled Trial
Brief summary
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.
Interventions
PROCEDUREChiropractic Care
Full-spine Chiropractic Care
Sponsors
Tyson Perez, DC, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 or older * Medically confirmed HIV diagnosis * Willing to complete online surveys * Willing to share lab results * Willing to be randomized to either once weekly chiropractic care or a no treatment control condition
Exclusion criteria
* Participating in another clinical/behavioral trial related to HIV * Receiving chiropractic care elsewhere * Involved in litigation related to a physical, health-related injury * Has severe osteoporosis or recent spinal fracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of eligible individuals enrolled | From online screen submission to enrollment (up to 2 weeks). | 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'. |
| Proportion of trial participants complying with instructions | From enrollment to the end of participation (up to 6 months). | The number of trial participants submitting the online assessments within the submission window, divided by the total number of trial participants. This assesses 'Compliance'. |
| Proportion of chiropractic participants adhering to the care plan | From enrollment to the end of participation (up to 6 months) | 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'. |
| Proportion of chiropractic participants retained | From enrollment to the end of the 6 month trial period | 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. |
| Proportion of control participants retained | From enrollment to the end of the 6 month trial period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change difference in the Short Form 12 Health Survey (SF-12) | Baseline, 12 weeks, 24 weeks | 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. |
| Change difference in the General Pain Index (GPI) | Baseline, 12 weeks, 24 weeks | 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) |
| Change difference in CD4 count | Baseline; 12 weeks; 24 weeks | 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. |
| Change difference in CD4/CD8 ratio | Baseline; 12 weeks; 24 weeks | 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. |
| Change difference in C-Reactive Protein (CRP) | Baseline; 12 weeks; 24 weeks | 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. |
| Change difference in Interleukin-6 (IL-6) | Baseline; 12 weeks; 24 weeks | 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." |
Countries
United States
Contacts
CONTACTResearch Programs & Grants Administrator
STUDY_DIRECTORChristie Kwon, MS, DC, MPH
Life University
PRINCIPAL_INVESTIGATORMikey Jimenez
Life University
Outcome results
None listed