HIV-1-infectionNCT04063306
Quality of Life of Taiwan People Living With HIV
An observational study of HIV-1-infection, run by Taiwan AIDS Nurse Society at 1 site in Taiwan.
Trial summary
To survey QoL and relevant factors in PLWH Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- none of intervention was given
- How many people
- 550 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Jun 2019to 20 Dec 2020
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult HIV-1 infected patients
Who may be able to join
- adult patient living with HIV, aged >= 18 years old
Who cannot join
- known cognitive dysfunction or attention deficient to complete the survey
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 110
Chung Chin Shih, MS, +886-2-2581-8416, 2irene.s@gamil.com
About this study
Official title: Investigation on Quality of Life and Related Factors of Taiwan People Living With HIV
To survey QoL and relevant factors in PLWH
- Conditions
- HIV-1-infection
- Being tested
- none of intervention was given
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none of intervention was givenOther
this is an observational survey and no intervention is given
What is being measured
The primary outcome is the main question the study is designed to answer.
QoL status of Patient Living with HIV (PLWH) by WHOQOL-HIV Brief questionaire
Measured: in 4 weeks
Medical Outcome of Patient Living with HIV (PLWH) by MOS-HIV questionaire
Measured: in 4 weeks
Stigma Scale of Patient Living with HIV (PLWH) by Berger's HIV Stigma Scale
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start20 Jun 2019
- Primary completion20 Oct 2019 (estimated)
- Study completion20 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies 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
- 550 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Taiwan AIDS Nurse Society
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Chung-Ching Shih, Taiwan AIDS Nurse Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063306
- Sponsor's protocol ID
- TANA-2019-01
- Status last verified
- Aug 2019
- First submitted
- 15 Aug 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Quality of Life and Related Factors of Taiwan People Living With HIV
- ClinicalTrials.gov ID
- NCT04063306
- Acronym / sponsor ID
- TANA-2019-01
- Conditions
- HIV-1-infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Taiwan AIDS Nurse SocietyUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 20 Oct 2019 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 21 Aug 2019 (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.
To survey QoL and relevant factors in PLWH
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult HIV-1 infected patients
Key inclusion criteria (1 listed)
- adult patient living with HIV, aged >= 18 years old
Key exclusion criteria (1 listed)
- known cognitive dysfunction or attention deficient to complete the survey
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 |
|---|---|---|
| none of intervention was giventhis is an observational survey and no intervention is given | Other | – |
Primary outcome
QoL status of Patient Living with HIV (PLWH) by WHOQOL-HIV Brief questionaire
Time frame: in 4 weeks
Medical Outcome of Patient Living with HIV (PLWH) by MOS-HIV questionaire
Time frame: in 4 weeks
Stigma Scale of Patient Living with HIV (PLWH) by Berger's HIV Stigma Scale
Time frame: an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- 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.
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-1-infection, run by Taiwan AIDS Nurse Society 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chung Chin Shih, MS (+886-2-2581-8416, 2Irene.s@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoL status of Patient Living with HIV (PLWH) by WHOQOL-HIV Brief questionaire (time frame: in 4 weeks). The study lists 3 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 21 Aug 2019.