Self-Assessment Tuberculin Skin Test

Tuberculin Skin Test Clinical Trial

— ISAT  

Official title:

Innovation of Self-Assessment Tuberculin Skin Test for Latent TB Screening in HIV Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835832
• Other study ID #: HIV-NAT 260
• Status: Completed
• Start date: June 4, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: July 2020
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Documented HIV-1 infection

2. Aged =18 years old

3. No sign and symptom of active TB

Exclusion Criteria:

1. Refuse to read TST by themselves

Related Conditions & MeSH terms

• Tuberculin Skin Test

Intervention

Other:
• The participants do not receive any intervention for this study
The participants do not receive any intervention for this study

Locations

Country	Name	City	State
Thailand	HIV-NAT, Thai Red Cross AIDS Research Centre	Bangkok
Thailand	Taksin Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Taksin Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-assessment versus nurse reading	this study will assess the sensitivity of this new innovative method for reading TST	6 months
Primary	self-assessment versus nurse reading	this study will assess the specificity of this new innovative method for reading TST	6 months
Primary	self-assessment versus nurse reading	this study will assess the positive predictive value (PPV) of this new innovative method for reading TST	6 months
Primary	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	In house questionnaire to assess the patients' satisfaction of reading TST by themselves	Evaluation of patients' satisfaction in self- assessment TST by using questionnaires	6 months