Self-Assessment Tuberculin Skin Test (ISAT)

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.

Study Overview

• Status: Completed
• Conditions: Tuberculin Skin Test
• Intervention / Treatment: Other: The participants do not receive any intervention for this study

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 Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • HIV-NAT, Thai Red Cross AIDS Research Centre
  • Bangkok, Thailand, 10600
    • Taksin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV-infected adults with documented HIV diagnosis who do not have any signs or symptoms of active TB.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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

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

Collaborators and Investigators

• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: Taksin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2019
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Sensitivity; Specificity; Tuberculin skin test; latent TB infection; HIV/TB co-infected participants; positive predictive value (PPV); negative predictive value (NPV)
• Other Study ID Numbers: HIV-NAT 260

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No