The Effects of Chiropractic Care on Inflammation and Quality of Life in People Living With HIV (HIV)

May 5, 2026 updated by: Tyson Perez, DC, PhD
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Life University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Tyson Perez, DC, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chiropractic
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.
Procedure: Chiropractic Care
Full-spine Chiropractic Care
No Intervention: Controls
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of eligible individuals enrolled
Time Frame: 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'.
From online screen submission to enrollment (up to 2 weeks).
Proportion of trial participants complying with instructions
Time Frame: 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'.
From enrollment to the end of participation (up to 6 months).
Proportion of chiropractic participants adhering to the care plan
Time Frame: 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'.
From enrollment to the end of participation (up to 6 months)
Proportion of chiropractic participants retained
Time Frame: 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.
From enrollment to the end of the 6 month trial period
Proportion of control participants retained
Time Frame: 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.
From enrollment to the end of the 6 month trial period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change difference in the Short Form 12 Health Survey (SF-12)
Time Frame: 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.
Baseline, 12 weeks, 24 weeks
Change difference in the General Pain Index (GPI)
Time Frame: 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)
Baseline, 12 weeks, 24 weeks
Change difference in CD4 count
Time Frame: 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.
Baseline; 12 weeks; 24 weeks
Change difference in CD4/CD8 ratio
Time Frame: 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.
Baseline; 12 weeks; 24 weeks
Change difference in C-Reactive Protein (CRP)
Time Frame: 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.
Baseline; 12 weeks; 24 weeks
Change difference in Interleukin-6 (IL-6)
Time Frame: 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."
Baseline; 12 weeks; 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tyson Perez, DC, PhD

Investigators

  • Study Director: Christie Kwon, MS, DC, MPH, Life University
  • Principal Investigator: Mikey Jimenez, Life University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FULMJH022526

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified IPD necessary to reproduce results

IPD Sharing Time Frame

(start date): within 1 year of study completion (end date): indefinitely

IPD Sharing Access Criteria

IPD, metadata & analytic code necessary to reproduce results will be made publicly accessible via a data repository

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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