HIV InfectionsNCT05299775
Poor Quality of Life Associated With Traditional Chinese Medicine Constitution in HIV-infected Men Who Have Sex With Men
An observational study of HIV Infections and Quality of Life, run by Taipei City Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 49 years, men only
- Conditions the study is for
- HIV Infections, Quality of Life
- What is being tested?
- World Health Organization Quality of Life -Brief -Taiwan version (WHOQOL-BREF-Taiwan version)
- How many people
- 203 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Sep 2018to 9 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- Men only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV Infections, Quality of Life
- Being tested
- World Health Organization Quality of Life -Brief -Taiwan version (WHOQOL-BREF-Taiwan version)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
World Health Organization Quality of Life -Brief -Taiwan version (WHOQOL-BREF-Taiwan version)Diagnostic test
Also called Wang Qi nine kinds of TCM constitution Questionnaire
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.
| Study group | Role | What they receive |
|---|---|---|
| HIV infected time | Group are divided by Infected time: 0-2W, 2W-12M, >1Y Receives: 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 . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Lasts for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start21 Sep 2018
- Primary completion18 Feb 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chung-Hua Hsu, Taipei City Hospital
- Investigators
- Chung-Hua Hsu, Study director, clinical professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299775
- Sponsor's protocol ID
- TCHIRB-10707110
- Status last verified
- Mar 2022
- First submitted
- 8 Dec 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Poor Quality of Life Associated With Traditional Chinese Medicine Constitution in HIV-infected Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT05299775
- Acronym / sponsor ID
- TCHIRB-10707110
- Conditions
- HIV Infections, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 18 Feb 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV infected time | – | Diagnostic Test: World Health Organization Quality of Life -Brief -Taiwan version (WHOQOL-BREF-Taiwan version)Group are divided by Infected time: 0-2W, 2W-12M, >1Y |
| 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 . |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| World Health Organization Quality of Life -Brief -Taiwan version (WHOQOL-BREF-Taiwan version)Also: Wang Qi nine kinds of TCM constitution QuestionnaireWHOQOL-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. | Diagnostic test | HIV infected time |
Primary outcome
quality of life score
Time frame: Lasts for 1 year
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
TCM constitution
Time frame: Lasts for 1 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung-Hua Hsu study director
clinical professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Quality of Life, run by Taipei City Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life score (time frame: Lasts for 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.