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.
Aged 18 or older
Medically confirmed HIV diagnosis
Willing to complete online surveys
Willing to share lab results
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
Parallel
Chiropractic Care
Procedure/SurgeryFull-spine Chiropractic Care
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'.
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'.
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'.
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.
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.
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)
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.
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.
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Tyson Perez, DC, PhD
Lead sponsor
Life University
Sponsor institution
