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

August 16, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Life University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tyson Perez, DC, PhD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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