Self-Assessment Tuberculin Skin Test

Completed

• Conditions: Tuberculin Skin Test
• Interventions: Other: The participants do not receive any intervention for this study

• Registration Number: NCT03835832
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

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.

Study Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-11
• Study Start: 2019-06-04
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

1. Documented HIV-1 infection
2. Aged ≥18 years old
3. No sign and symptom of active TB

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Exclusion Criteria

1. Refuse to read TST by themselves

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV-infected participants who receive TST test	The participants do not receive any intervention for this study	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.

Primary Outcome Measures

Name	Time	Method
self-assessment versus nurse reading	6 months	this study will assess the negative predictive value (NPV) of this new innovative method for reading TST

Secondary Outcome Measures

Name	Time	Method
In house questionnaire to assess the patients' satisfaction of reading TST by themselves	6 months	Evaluation of patients' satisfaction in self- assessment TST by using questionnaires

Trial Locations

Locations (2)

Taksin Hospital; 🇹🇭 Bangkok, Thailand

HIV-NAT, Thai Red Cross AIDS Research Centre; 🇹🇭 Bangkok, Thailand