Self-Assessment Tuberculin Skin Test
ISAT
Innovation of Self-Assessment Tuberculin Skin Test for Latent TB Screening in HIV Patients
1 other identifier
observational
215
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2019
CompletedFirst Posted
Study publicly available on registry
February 11, 2019
CompletedStudy Start
First participant enrolled
June 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedJuly 16, 2020
July 1, 2020
12 months
February 7, 2019
July 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
self-assessment versus nurse reading
this study will assess the sensitivity of this new innovative method for reading TST
6 months
self-assessment versus nurse reading
this study will assess the specificity of this new innovative method for reading TST
6 months
self-assessment versus nurse reading
this study will assess the positive predictive value (PPV) of this new innovative method for reading TST
6 months
self-assessment versus nurse reading
this study will assess the negative predictive value (NPV) of this new innovative method for reading TST
6 months
Secondary Outcomes (1)
In house questionnaire to assess the patients' satisfaction of reading TST by themselves
6 months
Study Arms (1)
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.
Interventions
The participants do not receive any intervention for this study
Eligibility Criteria
HIV-infected adults with documented HIV diagnosis who do not have any signs or symptoms of active TB.
You may qualify if:
- Documented HIV-1 infection
- Aged ≥18 years old
- No sign and symptom of active TB
You may not qualify if:
- \. Refuse to read TST by themselves
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, 10330, Thailand
Taksin Hospital
Bangkok, 10600, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sivaporn Gatechompol, MD
HIV-NAT, Thai Red Cross - AIDS Research Centre
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2019
First Posted
February 11, 2019
Study Start
June 4, 2019
Primary Completion
May 31, 2020
Study Completion
May 31, 2020
Last Updated
July 16, 2020
Record last verified: 2020-07