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

NCT07466836 | Recruiting

• 1 other identifier: FULMJH022526
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 treatment controls.

Conditions

Human Immunodeficiency Virus (HIV)

Keywords

Human Immunodeficiency Virus; Pilot Projects; Chiropractic; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (5)

• 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'.

  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'.

  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'.

  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.

  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.

  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)

  Baseline, 12 weeks, 24 weeks

• Change difference in the General Pain Index (GPI)

  Baseline, 12 weeks, 24 weeks

• Change difference in CD4 count

  Baseline; 12 weeks; 24 weeks

• Change difference in CD4/CD8 ratio

  Baseline; 12 weeks; 24 weeks

• Change difference in C-Reactive Protein (CRP)

  Baseline; 12 weeks; 24 weeks

Study Arms (2)

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.

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.

Interventions

Chiropractic Care PROCEDURE

Full-spine Chiropractic Care

Chiropractic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tyson Perez, DC, PhD: lead

Study Sites (1)

Life University

Marietta, Georgia, 30060, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Christie Kwon, MS, DC, MPH

  Life University

  STUDY DIRECTOR

• Mikey Jimenez

  Life University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Programs & Grants Administrator

CONTACT

678-331-4527; angela.seckington@life.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Faculty Sponsor

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 12, 2026
• Study Start: April 11, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: (start date): within 1 year of study completion (end date): indefinitely
• Access Criteria: IPD, metadata \& analytic code necessary to reproduce results will be made publicly accessible via a data repository

Locations

US (1)