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NCT Number: NCT07466836

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

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.

Recruiting

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Key information

Conditions

Human Immunodeficiency Virus (HIV) Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Life University

Marietta, Georgia, 30060, United States

Location status: Recruiting

Location contact

Angela Research Programs & Grants Administrator

CONTACT

[email protected]

678-331-4527

Christie Kwon, MS, DC, MPH

CONTACT

[email protected]

Tyson Perez, DC, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chiropractic Care

Procedure

Full-spine Chiropractic Care

Primary outcomes

  1. 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'.

  2. 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'.

  3. 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'.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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."

Study contacts

Contact information is provided by the study sponsor or research team.

Research Programs & Grants Administrator

CONTACT

[email protected]

678-331-4527

Sponsors and collaborators

Lead sponsor

Tyson Perez, DC, PhD

Other

Registry information

Acronym: HIV

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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