Human Immunodeficiency Virus (HIV)HIVNCT07466836
The Effects of Chiropractic Care on Inflammation and Quality of Life in People Living With HIV
A study testing Chiropractic Care in people with Human Immunodeficiency Virus (HIV), run by Tyson Perez, DC, PhD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus (HIV)
- What is being tested?
- Chiropractic Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Human Immunodeficiency Virus (HIV)
- Being tested
- Chiropractic Care
- Keywords
- Human Immunodeficiency Virus, Pilot Projects, Chiropractic, Randomized Controlled Trial
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic CareProcedure or surgery
Full-spine Chiropractic Care
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic | Experimental | 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. Receives: Procedure: Chiropractic Care |
| Controls | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: From online screen submission to enrollment (up to 2 weeks).
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'.
Measured: From enrollment to the end of participation (up to 6 months).
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'.
Measured: From enrollment to the end of participation (up to 6 months)
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.
Measured: From enrollment to the end of the 6 month trial period
Proportion of control participants retained
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.
Measured: From enrollment to the end of the 6 month trial period
Secondary outcomes (6)
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.
Measured: Baseline, 12 weeks, 24 weeks
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)
Measured: Baseline, 12 weeks, 24 weeks
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.
Measured: Baseline; 12 weeks; 24 weeks
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.
Measured: Baseline; 12 weeks; 24 weeks
Change difference in C-Reactive Protein (CRP)
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.
Measured: Baseline; 12 weeks; 24 weeks
Change difference in Interleukin-6 (IL-6)
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."
Measured: Baseline; 12 weeks; 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start11 Apr 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tyson Perez, DC, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tyson Perez, DC, PhD, Life University
- Investigators
- Christie Kwon, MS, DC, MPH, Study director, Life UniversityMikey Jimenez, Principal investigator, Life University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466836
- Sponsor's protocol ID
- FULMJH022526
- Acronym
- HIV
- Status last verified
- Aug 2026
- First submitted
- 4 Mar 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified IPD necessary to reproduce results
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Chiropractic Care on Inflammation and Quality of Life in People Living With HIV
- ClinicalTrials.gov ID
- NCT07466836
- Acronym / sponsor ID
- HIV / FULMJH022526
- Conditions
- Human Immunodeficiency Virus (HIV)
- Keywords
- Human Immunodeficiency Virus, Pilot Projects, Chiropractic, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tyson Perez, DC, PhDUniversity, hospital or other
- Study start
- 11 Apr 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chiropractic | Experimental | Procedure: Chiropractic CareParticipants 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. |
| Controls | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chiropractic CareFull-spine Chiropractic Care | Procedure or surgery | Chiropractic |
Primary outcome
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'.
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'.
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'.
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.
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.
6 secondary outcomes
Change difference in the Short Form 12 Health Survey (SF-12)
Time frame: Baseline, 12 weeks, 24 weeks
Change difference in the General Pain Index (GPI)
Time frame: Baseline, 12 weeks, 24 weeks
Change difference in CD4 count
Time frame: Baseline; 12 weeks; 24 weeks
Change difference in CD4/CD8 ratio
Time frame: Baseline; 12 weeks; 24 weeks
Change difference in C-Reactive Protein (CRP)
Time frame: Baseline; 12 weeks; 24 weeks
Change difference in Interleukin-6 (IL-6)
Time frame: Baseline; 12 weeks; 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified IPD necessary to reproduce results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christie Kwon, MS, DC, MPH study director
Life University
Mikey Jimenez principal investigator
Life University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic Care in people with Human Immunodeficiency Virus (HIV), run by Tyson Perez, DC, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible individuals enrolled (time frame: From online screen submission to enrollment (up to 2 weeks).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.