Self-Assessment Tuberculin Skin Test

Study Overview
=================
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.

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.

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

Conditions
-----------------
Tuberculin Skin Test

Intervention / Treatment
-----------------
* Other: The participants do not receive any intervention for this study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented HIV-1 infection Aged ≥18 years old No sign and symptom of active TB Exclusion Criteria: 1. Refuse to read TST by themselves

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-infected participants who receive TST test<br>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. | Other: The participants do not receive any intervention for this study<br>* The participants do not receive any intervention for this study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tuberculin skin test, latent TB infection, HIV/TB co-infected participants, Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV)