NCT06022549

Brief Summary

With improved AIDS treatment leading to extended survival, HIV-infected individuals face a higher metabolic syndrome incidence. This study aims to determine the prevalence of Non-AIDS related Comorbidities (NARC) in HIV-infected individuals. Using purposive and snowball sampling, the cross-sectional survey targets 400 HIV-infected individuals aged 30 and above. Data collection includes demographics, physical activity, nutrition, depression, and physiological measurements. Analyzing the data through statistical tests and structural equation modeling, the study aims to provide precise care recommendations for preventive medicine and healthy aging in this population.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 11, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

1.2 years

First QC Date

August 25, 2023

Last Update Submit

July 26, 2024

Conditions

Keywords

HIV-infected personsMetabolic syndrome

Outcome Measures

Primary Outcomes (3)

  • Mini Nutritional Assessment

    The points of this assessment is from 0 to 30. The points over 23.5 mean normal nutritional status, 17\~23.5 points mean at risk of malnutrition, less 7 points mean malnourished.

    1 year

  • International Physical Activity Questionnaire

    It is a self-administered survey used to assess an individual's physical activity levels. It aims to measure the amount of physical activity a person engages in across various domains of life, including work, transportation, household chores, and leisure time. The IPAQ typically asks participants about the duration and frequency of their physical activities in the past seven days. The MET-minutes per week score is calculated by multiplying the minutes spent in each activity intensity level by the MET value associated with that activity and then summing these values across all activities. The interpretation of MET-minutes per week is as follows: Low activity: Below 600 MET-minutes per week Moderate activity: 600 to 3000 MET-minutes per week High activity: More than 3000 MET-minutes per week

    1 year

  • Patient Health Questionnaire-9

    The Patient Health Questionnaire-9 (PHQ-9) is a self-report assessment tool commonly used to screen and measure the severity of depression symptoms in individuals. It consists of 9 items or questions, each assessing different aspects of depression such as mood, energy level, and concentration. The PHQ-9 scores each item on a scale from 0 (not at all) to 3 (nearly every day), with a maximum total score of 27. Higher scores on the PHQ-9 indicate more severe depressive symptoms, while lower scores suggest milder or no depressive symptoms.

    1 year

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV-infected persons over the age of 30

You may qualify if:

  • HIV-infected persons over the age of 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University, College of Medicine, School of Nursing

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMetabolic Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • PIAO-YI CHIOU, doctoral

    National Taiwan University, College of Medicine, School of Nursing

    STUDY DIRECTOR

Central Study Contacts

PIAO-YI CHIOU, doctoral

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 25, 2023

First Posted

September 5, 2023

Study Start

October 11, 2023

Primary Completion

January 1, 2025

Study Completion

January 31, 2025

Last Updated

July 29, 2024

Record last verified: 2024-07

Locations