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Completed

NCT Number: NCT03835832

Self-Assessment Tuberculin Skin Test

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.

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Key information

Conditions

Tuberculin Skin Test Hypersensitivity Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Refuse to read TST by themselves

Treatment and study plan

The participants do not receive any intervention for this study

Other

The participants do not receive any intervention for this study

Primary outcomes

  1. self-assessment versus nurse reading

    Time frame: 6 months

    this study will assess the sensitivity of this new innovative method for reading TST

  2. self-assessment versus nurse reading

    Time frame: 6 months

    this study will assess the specificity of this new innovative method for reading TST

  3. self-assessment versus nurse reading

    Time frame: 6 months

    this study will assess the positive predictive value (PPV) of this new innovative method for reading TST

  4. self-assessment versus nurse reading

    Time frame: 6 months

    this study will assess the negative predictive value (NPV) of this new innovative method for reading TST

Secondary outcomes

  1. In house questionnaire to assess the patients' satisfaction of reading TST by themselves

    Time frame: 6 months

    Evaluation of patients' satisfaction in self- assessment TST by using questionnaires

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • Taksin Hospital

Registry information

Official study title

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

Acronym: ISAT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 11, 2019
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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