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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Quality of Life
• Intervention / Treatment: Diagnostic test: World Health Organization Quality of Life -Brief -Taiwan version (WHOQOL-BREF-Taiwan version)

Detailed Description

Introduction :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.

Methods :It has a cross-sectional research design using structured questionnaires to collect data,including patient's basic case data, CD4+, CD4+/CD8+ ratio, Wang Qi constitution and WHOQOL-BREF -Taiwan version questionnaires. We consider the association between the constitutions and quality of life for HIV-infected MSM patients.

• Study Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10845
    • Taipei City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.; Other Names: Wang Qi nine kinds of TCM constitution Questionnaire
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taipei City Hospital
• Investigators: Study Director: Chung-Hua Hsu, clinical professor

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 21, 2018
• Primary Completion (ACTUAL): February 18, 2019
• Study Completion (ACTUAL): July 9, 2019

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (ACTUAL): March 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TCHIRB-10707110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No