Poor Quality of Life Associated With Traditional Chinese Medicine Constitution in HIV-infected Men Who Have Sex With Men

NCT05299775 | Completed DMC

• 1 other identifier: TCHIRB-10707110
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores the pathological constitution as it relates to low quality of life with HIV- infected MSM patients, as a reference for clinical treatment.

Conditions

HIV Infections; Quality of Life

Outcome Measures

Primary Outcomes (2)

• quality of life score

  investigate different quality of life score of HIV infected time in the physical,psychological, social, and environmental domains. Outcome Measure:4 quality of life scores for each constitution ， In the WHOQOL-BREF Taiwan item scores range from 1 (worst condition) to 5 (best condition), except for 3 items (Ph1, Ph2, and Ps6), which have reverse scores. Two scales (0-100 and 4-20, with a higher score indicating better QOL) can be transformed into domain scores for each domain and we used the 4-20 scale in this study,Add the item scores for each domain ,the higher scores indicating better quality of life

  Lasts for 1 year

• TCM constitution

  Investigate TCM constitution composed of HIV-infected in yang deficiency , yin deficiency , qi deficiency , phlegm dampness , damp-heat , blood stasis , special diathesis , qi stagnation , and gentleness constitution . Outcome Measure:Nine kinds TCM constitution-the constitution type must be judged according to the standards. Original score = sum of the scores of items for each constitution, and then the original score is converted into a conversion score \[conversion score = \[(original score-number of answer items) / answer items × 4\] × 100. Judgment of constitutions: gentleness is a normal constitution, and others are pathological constitutions. Gentleness constitution conversion score ≥ 60 points, and other pathological constitution conversion score \<30 points, it is Gentleness constitution; pathological constitution conversion score ≥ 40 is considered pathological constitution, The higher the conversion score is the more obvious the constitution trend

  Lasts for 1 year

Study Arms (2)

HIV infected time

Group are divided by Infected time: 0-2W, 2W-12M, \>1Y

Diagnostic Test: World Health Organization Quality of Life -Brief -Taiwan version (WHOQOL-BREF-Taiwan version)

different constitutions

Group are divided by different constitutions:It includes 9 basic types of constitution, yang deficiency , yin deficiency , qi deficiency , phlegm dampness , damp-heat, blood stasis, special diathesis , qi depression , gentleness constitution .

Interventions

World Health Organization Quality of Life -Brief -Taiwan version (WHOQOL-BREF-Taiwan version) DIAGNOSTIC_TEST

WHOQOL-BREF-Taiwan version is used to measure the quality of life in HIV infected. Wang Qi nine kinds of TCM constitution Questionnaire is used to measure the constitution of HIV infected.

Also known as: Wang Qi nine kinds of TCM constitution Questionnaire

HIV infected time

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We invited all people diagnosed with HIV infected through MSM in the outpatient Department of Infection, Taipei City United Hospital, Linsen Chinese Medicine and Kunming Branch, to participate in this study.

You may qualify if:

• Patients diagnosed with HIV infected.
• Age greater than 20 years old (including) and less than 60 years old.
• Conscious clear and voluntary to attend the project with agreement.
• Willing to fill out the informed consent form.

You may not qualify if:

• conscious unclear
• Patients had histories of severe psychiatric disorders ( ex: schizophrenia) or if they met the criteria of Diagnostic and Statistical Manual of Mental Disorders ( ex: dementia)
• Age \< 20 years old.
• The patient does not want to fill out the informed consent form for any reason.

Sponsors & Collaborators

• Taipei City Hospital: lead

Study Sites (1)

Taipei City Hospital

Taipei, 10845, Taiwan

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Chung-Hua Hsu

  clinical professor

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: March 29, 2022
• Study Start: September 21, 2018
• Primary Completion: February 18, 2019
• Study Completion: July 9, 2019
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

TW (1)