Self-Assessment Tuberculin Skin Test

NCT ID: NCT03835832

Last Updated: 2020-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-04

Study Completion Date

2020-05-31

Brief Summary

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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

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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.

Conditions

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Tuberculin Skin Test

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

The participants do not receive any intervention for this study

Intervention Type OTHER

The participants do not receive any intervention for this study

Interventions

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The participants do not receive any intervention for this study

The participants do not receive any intervention for this study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taksin Hospital

UNKNOWN

Sponsor Role collaborator

The HIV Netherlands Australia Thailand Research Collaboration

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sivaporn Gatechompol, MD

Role: PRINCIPAL_INVESTIGATOR

HIV-NAT, Thai Red Cross - AIDS Research Centre

Locations

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HIV-NAT, Thai Red Cross AIDS Research Centre

Bangkok, , Thailand

Site Status

Taksin Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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HIV-NAT 260

Identifier Type: -

Identifier Source: org_study_id

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