Tuberculin Skin TestISATNCT03835832
Self-Assessment Tuberculin Skin Test
An observational study of Tuberculin Skin Test, run by The HIV Netherlands Australia Thailand Research Collaboration at 2 sites in Thailand.
Trial summary
The research team/investigator/nurse/professional health care workers will teach the participants how to read the results for TST test. The investigator will compare the reading results done by the participants to the results read by the nurses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculin Skin Test
- What is being tested?
- The participants do not receive any intervention for this study
- How many people
- 215 participants
- Where
- 2 sitesThailand
- Study dates
- 4 Jun 2019to 31 May 2020
- 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: HIV-infected adults with documented HIV diagnosis who do not have any signs or symptoms of active TB.
Who may be able to join
- Documented HIV-1 infection
- Aged ≥18 years old
- No sign and symptom of active TB
Who cannot join
- 1. Refuse to read TST by themselves
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, 10330
Taksin Hospital
Bangkok, 10600
About this study
Official title: Innovation of Self-Assessment Tuberculin Skin Test for Latent TB Screening in HIV Patients
The research team/investigator/nurse/professional health care workers will teach the participants how to read the results for TST test. The investigator will compare the reading results done by the participants to the results read by the nurses.
Read the detailed description
This is a cross-sectional study of HIV-infected patients from 2 HIV clinics in Bangkok: HIV-NAT, Thai Red Cross AIDS Research Centre and Taksin Hospital. Research team/investigator/nurse/professional health care workers will assess whether the reading of TST test between the participants and the nurses are the same or not. The investigator and team believe that the readings of the TST tests between the participants and the nurses will be the same. If the investigator and team hypothesis is correct, then this will lessen the workload of the nurses and reduce the number of times the participants have to come to the clinic to see the nurses and the doctors. This is a pilot study to test this innovative method to teach the participants to read the TST results by themselves. If this technique is successful, then the investigator and team can expand the method to other hospitals in Thailand as well as in the region.
- Conditions
- Tuberculin Skin Test
- Being tested
- The participants do not receive any intervention for this study
- Keywords
- Tuberculin skin test, latent TB infection, HIV/TB co-infected participants, Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV)
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The participants do not receive any intervention for this studyOther
The participants do not receive any intervention for this study
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected participants who receive TST test | 0.1 ml of tuberculin purified protein derivative will be intra-dermally inoculated on the forearm of the HIV-infected participants. They will learn how to interpret the results of the TST test. When they return to the clinic, the nurse will also interpret the results of the TST test. The results from the participants will be compared to the nurses' interpretation. We will assess the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the innovative method. Receives: Other: The participants do not receive any intervention for this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-assessment versus nurse reading
this study will assess the sensitivity of this new innovative method for reading TST
Measured: 6 months
self-assessment versus nurse reading
this study will assess the specificity of this new innovative method for reading TST
Measured: 6 months
self-assessment versus nurse reading
this study will assess the positive predictive value (PPV) of this new innovative method for reading TST
Measured: 6 months
self-assessment versus nurse reading
this study will assess the negative predictive value (NPV) of this new innovative method for reading TST
Measured: 6 months
Secondary outcomes (1)
In house questionnaire to assess the patients' satisfaction of reading TST by themselves
Evaluation of patients' satisfaction in self- assessment TST by using questionnaires
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start4 Jun 2019
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculin Skin TestStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Taksin Hospital
- Responsible party
- Sponsor
- Investigators
- Sivaporn Gatechompol, MD, Principal investigator, Thai Red Cross AIDS Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835832
- Sponsor's protocol ID
- HIV-NAT 260
- Acronym
- ISAT
- Status last verified
- Jul 2020
- First submitted
- 7 Feb 2019
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovation of Self-Assessment Tuberculin Skin Test for Latent TB Screening in HIV Patients
- ClinicalTrials.gov ID
- NCT03835832
- Acronym / sponsor ID
- ISAT / HIV-NAT 260
- Conditions
- Tuberculin Skin Test
- Keywords
- Tuberculin skin test, latent TB infection, HIV/TB co-infected participants, Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Taksin Hospital
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 11 Feb 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.
The research team/investigator/nurse/professional health care workers will teach the participants how to read the results for TST test. The investigator will compare the reading results done by the participants to the results read by the nurses.
Detailed description
This is a cross-sectional study of HIV-infected patients from 2 HIV clinics in Bangkok: HIV-NAT, Thai Red Cross AIDS Research Centre and Taksin Hospital. Research team/investigator/nurse/professional health care workers will assess whether the reading of TST test between the participants and the nurses are the same or not. The investigator and team believe that the readings of the TST tests between the participants and the nurses will be the same. If the investigator and team hypothesis is correct, then this will lessen the workload of the nurses and reduce the number of times the participants have to come to the clinic to see the nurses and the doctors. This is a pilot study to test this innovative method to teach the participants to read the TST results by themselves. If this technique is successful, then the investigator and team can expand the method to other hospitals in Thailand as well as in the region.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-infected participants who receive TST test | – | Other: The participants do not receive any intervention for this study0.1 ml of tuberculin purified protein derivative will be intra-dermally inoculated on the forearm of the HIV-infected participants. They will learn how to interpret the results of the TST test. When they return to the clinic, the nurse will also interpret the results of the TST test. The results from the participants will be compared to the nurses' interpretation. We will assess the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the innovative method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected adults with documented HIV diagnosis who do not have any signs or symptoms of active TB.
Key inclusion criteria (3 listed)
- Documented HIV-1 infection
- Aged ≥18 years old
- No sign and symptom of active TB
Key exclusion criteria (1 listed)
- 1. Refuse to read TST by themselves
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 |
|---|---|---|
| The participants do not receive any intervention for this studyThe participants do not receive any intervention for this study | Other | HIV-infected participants who receive TST test |
Primary outcome
self-assessment versus nurse reading
Time frame: 6 months
this study will assess the sensitivity of this new innovative method for reading TST
self-assessment versus nurse reading
Time frame: 6 months
this study will assess the specificity of this new innovative method for reading TST
self-assessment versus nurse reading
Time frame: 6 months
this study will assess the positive predictive value (PPV) of this new innovative method for reading TST
self-assessment versus nurse reading
Time frame: 6 months
this study will assess the negative predictive value (NPV) of this new innovative method for reading TST
1 secondary outcome
In house questionnaire to assess the patients' satisfaction of reading TST by themselves
Time frame: 6 months
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 16 Jul 2020.
Related trials for Tuberculin Skin Test
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Latent Tuberculosis Infection, End Stage Renal Disease (ESRD)
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.
Sivaporn Gatechompol, MD principal investigator
Thai Red Cross AIDS Research Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculin Skin Test, run by The HIV Netherlands Australia Thailand Research Collaboration at 2 sites in Thailand.
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 3 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: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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?
self-assessment versus nurse reading (time frame: 6 months). The study lists 4 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 16 Jul 2020.