NCT04645693

Brief Summary

This is a prospective cohort study designed to investigate the range of metabolic abnormalities observed in patients living with HIV on antiretroviral therapy. This study will also explore the concurrent role of poor oral health in supporting and driving chronic immune activation and inflammation in HIV infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 24, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

October 1, 2020

Last Update Submit

April 28, 2026

Conditions

HIVPeriodontal DiseasesCariesNon-communicable DiseaseXerostomia

Outcome Measures

Primary Outcomes (19)

  • Dental Caries as assessed by DMFS Score

    Decayed, missing and filled surfaces (DMFS) score to assess dental caries. Minimum value is 0 and maximum value is 128 for 28 teeth. Higher scores mean higher levels of dental decay.

    Baseline

  • Dental Caries as assessed by DMFS Score

    Decayed, missing and filled surfaces (DMFS) score to assess dental caries. Minimum value is 0 and maximum value is 128 for 28 teeth. Higher scores mean higher levels of dental decay.

    6 months after baseline visit

  • Dental Caries as assessed by DMFS Score

    Decayed, missing and filled surfaces (DMFS) score to assess dental caries. Minimum value is 0 and maximum value is 128 for 28 teeth. Higher scores mean higher levels of dental decay.

    12 months after baseline visit

  • Dental Caries as assessed by DMFS Score

    Decayed, missing and filled surfaces (DMFS) score to assess dental caries. Minimum value is 0 and maximum value is 128 for 28 teeth. Higher scores mean higher levels of dental decay.

    18 months after baseline visit

  • Dental Caries as assessed by DMFS Score

    Decayed, missing and filled surfaces (DMFS) score to assess dental caries. Minimum value is 0 and maximum value is 128 for 28 teeth. Higher scores mean higher levels of dental decay.

    24 months after baseline visit

  • Periodontal disease

    Incidence of periodontal disease

    Baseline

  • Periodontal disease

    Incidence of periodontal disease

    12 months after baseline visit

  • Periodontal disease

    Incidence of periodontal disease

    24 months after baseline visit

  • Osteopenia as assessed by DXA scan findings

    Incidence of osteopenia

    Baseline

  • Osteopenia as assessed by DXA scan findings

    Incidence of osteopenia

    24 months after baseline visit

  • Quality of life as assessed by the Xerostomia Quality of Life Scale (XeQoLS)

    The XeQoLS consists of 15 questions. The first 14 questions assess how dryness in the mouth impacts the individual's life, with answer options of "not at all," "a little," "somewhat," "quite a bit," and "very much." The final question asks "if you were to spend the rest of your life with your dry mouth/throat dryness just the way it is now, how would you feel about this?" and includes options ranging from "delighted" to "terrible." All 15 questions can be translated to a score of 0-4, with a score of 4 indicating the most dry mouth-related problems and 0 indicating no dry mouth-related problems.

    Baseline

  • Quality of life as assessed by the Xerostomia Quality of Life Scale (XeQoLS)

    The XeQoLS consists of 15 questions. The first 14 questions assess how dryness in the mouth impacts the individual's life, with answer options of "not at all," "a little," "somewhat," "quite a bit," and "very much." The final question asks "if you were to spend the rest of your life with your dry mouth/throat dryness just the way it is now, how would you feel about this?" and includes options ranging from "delighted" to "terrible." All 15 questions can be translated to a score of 0-4, with a score of 4 indicating the most dry mouth-related problems and 0 indicating no dry mouth-related problems.

    12 months after baseline visit

  • Quality of life as assessed by the Xerostomia Quality of Life Scale (XeQoLS)

    The XeQoLS consists of 15 questions. The first 14 questions assess how dryness in the mouth impacts the individual's life, with answer options of "not at all," "a little," "somewhat," "quite a bit," and "very much." The final question asks "if you were to spend the rest of your life with your dry mouth/throat dryness just the way it is now, how would you feel about this?" and includes options ranging from "delighted" to "terrible." All 15 questions can be translated to a score of 0-4, with a score of 4 indicating the most dry mouth-related problems and 0 indicating no dry mouth-related problems.

    24 months after baseline visit

  • Quality of life as assessed by the Oral Health Related Quality of Life (OHRQoL)

    Oral health related quality of life will be assessed using the questionnaire developed for the National Health and Nutrition Examination Survey (NHANES). This questionnaire assesses the topic areas of last visit to dentist or lack of dental care; direct conversation with dental professional about your dental health; dental health perception; oral cancer exam; use of dental floss or dental rinse product; and periodontal disease self-report. Each topic area uses a separate scoring system and may be assessed individually.

    Baseline

  • Quality of life as assessed by the Oral Health Related Quality of Life (OHRQoL)

    Oral health related quality of life will be assessed using the questionnaire developed for the National Health and Nutrition Examination Survey (NHANES). This questionnaire assesses the topic areas of last visit to dentist or lack of dental care; direct conversation with dental professional about your dental health; dental health perception; oral cancer exam; use of dental floss or dental rinse product; and periodontal disease self-report. Each topic area uses a separate scoring system and may be assessed individually.

    12 months after baseline visit

  • Quality of life as assessed by the Oral Health Related Quality of Life (OHRQoL)

    Oral health related quality of life will be assessed using the questionnaire developed for the National Health and Nutrition Examination Survey (NHANES). This questionnaire assesses the topic areas of last visit to dentist or lack of dental care; direct conversation with dental professional about your dental health; dental health perception; oral cancer exam; use of dental floss or dental rinse product; and periodontal disease self-report. Each topic area uses a separate scoring system and may be assessed individually.

    24 months after baseline visit

  • Quality of life as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool

    The TAPS tool screens for substance use (including tobacco, alcohol, prescription medication, and other drugs) and includes a brief assessment of abuse risk for those who screen positive. Individuals who screen positive for use of any of the substances are then scored as 0 (no use in the past 3 months), 1 (problem use), and 2+ (high risk for substance use disorder).

    Baseline

  • Quality of life as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool

    The TAPS tool screens for substance use (including tobacco, alcohol, prescription medication, and other drugs) and includes a brief assessment of abuse risk for those who screen positive. Individuals who screen positive for use of any of the substances are then scored as 0 (no use in the past 3 months), 1 (problem use), and 2+ (high risk for substance use disorder).

    12 months after baseline visit

  • Quality of life as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool

    The TAPS tool screens for substance use (including tobacco, alcohol, prescription medication, and other drugs) and includes a brief assessment of abuse risk for those who screen positive. Individuals who screen positive for use of any of the substances are then scored as 0 (no use in the past 3 months), 1 (problem use), and 2+ (high risk for substance use disorder).

    24 months after baseline visit

Secondary Outcomes (5)

  • Xerostomia as assessed by stimulated saliva secretion rate

    Baseline

  • Xerostomia as assessed by stimulated saliva secretion rate

    6 months after baseline visit

  • Xerostomia as assessed by stimulated saliva secretion rate

    12 months after baseline visit

  • Xerostomia as assessed by stimulated saliva secretion rate

    18 months after baseline visit

  • Xerostomia as assessed by stimulated saliva secretion rate

    24 months after baseline visit

Study Arms (2)

HIV Subjects with Non-Communicable Diseases

Patients living with HIV on Antiretroviral Therapy drugs for at least one year with no diagnosis of non-communicable diseases (diabetes, insulin resistance, hyperlipidemia/dyslipidemia, vascular disease, and/or osteoporosis).

HIV Subjects without Non-Communicable Diseases

Patients living with HIV on Antiretroviral Therapy drugs for at least one year with a diagnosis of one or more systemic non-communicable diseases (diabetes, insulin resistance, hyperlipidemia/dyslipidemia, vascular disease, and/or osteoporosis).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients living with HIV above the age of 18 will be enrolled in this study.

You may qualify if:

  • Age ≥18 years
  • Has been diagnosed with HIV (as documented by a prior laboratory report of positive HIV-1/2 antibody and/or detectable HIV RNA, available for review by the study team)
  • Has received antiretroviral therapy for at least 12 months
  • Able and willing to provide informed consent prior to initiation of study procedures
  • Willing and able to comply with all study procedures, and likely to be available for the duration of the study

You may not qualify if:

  • Has been diagnosed with the following xerostomia-related autoimmune conditions: Sjorgen's and sarcoidosis
  • Has never received radiation therapy to the head or neck (including radioactive iodine therapy)
  • Was taking anti-osteoporotic agents (biphosphonates, denosumab) prior to HIV diagnosis.
  • Women who are pregnant at the time of enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania School of Dental Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Omolehinwa TT, Akintoye SO, Gabinskiy M, Lo Re V 3rd, Mupparapu M, Urbina R, Schaubel DE, Corby PM. Oral health outcomes in an HIV cohort with comorbidities- implementation roadmap for a longitudinal prospective observational study. BMC Oral Health. 2023 Oct 17;23(1):763. doi: 10.1186/s12903-023-03527-5.

    PMID: 37848867DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

saliva, oral swab and blood samples will be collected

MeSH Terms

Conditions

Periodontal DiseasesNoncommunicable DiseasesXerostomia

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSalivary Gland Diseases

Study Officials

  • Temitope Omolehinwa, BDS, DScD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Oral Medicine

Study Record Dates

First Submitted

October 1, 2020

First Posted

November 27, 2020

Study Start

February 24, 2021

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)