PREVAIL VIIIa: Evaluation of Latent Tuberculosis Infection Screening Methods in People Living With Retroviral Infection in Liberia

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04926922
Collaborator
(none)
200
5
24.1
40
1.7

Study Details

Study Description

Brief Summary

Background:

Tuberculosis (TB) is a health threat for people living with human immunodeficiency virus (HIV). People living with HIV are more likely than others to develop active TB. Also, TB makes HIV progress faster. TB is a leading cause of death among people in the West African country of Liberia. Researchers want to find an effective testing method for latent tuberculosis infection (LTBI) to help people living with HIV in Liberia.

Objective:

To compare the interferon-gamma release assay (IGRA) and tuberculin skin test (TST) as LTBI screening tests in people living with HIV in Liberia.

Eligibility:

People ages 18 and older who take part in NIH study #19-I-N014 and are scheduled to have or have had IGRA at a Month 12 HONOR study visit.

Design:

Participants will be screened with a medical history and physical exam. Their medical records and HONOR study records will be reviewed.

Participants will have TST. Purified protein derivative will be placed in the skin of their forearm. They will be observed for adverse reactions for 15 minutes. Between 48 and 72 hours after placement, they will have a second study visit to have the TST read. If they miss this time frame, they can return up to 7 days after placement. If they have a positive test result, they will have a chest x-ray. They will have a third study visit to review the results of the chest x-ray. They will be referred for clinical care if needed. They will take a pregnancy test if needed.

Participation will last from 2 days to 6 weeks.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Study Description:

    This is a prospective study to compare the interferon-gamma release assay (IGRA) and tuberculin skin test (TST) as latent tuberculosis infection (LTBI) screening tests in people living with HIV in Liberia. Participants will be co-enrolled on the ongoing HONOR (A CoHOrt Clinical, Viral, and ImmuNOlogic Monitoring Study of People Living with Retroviral Infection in Liberia) study. A TST will be administered to eligible participants who are being screened by IGRA on HONOR. Since there is no gold standard for diagnosing LTBI, the results of each method will be compared to evaluate whether there is no difference in the probability of testing positive, assess the operational functionality in the clinic and lab, and determine whether one test can be used with greater sensitivity assuming comparable specificity.

    Objectives:

    Primary Objective: Assess the sensitivity of the IGRA and TST as LTBI screening tools in people living with HIV in Liberia.

    Secondary Objective: Assess the operational functionality of the IGRA and TST in Liberia.

    Endpoints:

    Primary Endpoint: Frequency of positive results using the IGRA and TST.

    Secondary Endpoint: Proportion of each test type successfully completed and the result determined.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    PREVAIL VIIIa: Evaluation of Latent Tuberculosis Infection Screening Methods in People Living With Retroviral Infection in Liberia
    Actual Study Start Date :
    Jul 27, 2021
    Anticipated Primary Completion Date :
    Aug 1, 2023
    Anticipated Study Completion Date :
    Aug 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    HONOR participants at Month 12

    Adult participants who agree to participate and meet the study-specific eligibility criteria at their Month 12 HONOR study visit

    Outcome Measures

    Primary Outcome Measures

    1. Frequency of positive results using the IGRA and TST. [48-72 hours after TST placement]

      Assess the sensitivity of the IGRA and TST as LTBI screening tools in people living with HIV in Liberia.

    Secondary Outcome Measures

    1. Proportion of each test type successfully completed and the result determined. [48-72 hours after TST placement]

      Assess the operational functionality of the IGRA and TST.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:

    In order to be eligible to participate in this study, an individual must meet all of the following

    criteria:

    • Be a participant on the PREVAIL VIII/HONOR study.

    • Be at least 18 years of age.

    • Be scheduled to undergo or have undergone IGRA at a Month 12 HONOR study visit.

    • Ability to return to the clinic 48 to 72 hours after TST placement for reading.

    • Ability to provide informed consent.

    EXCLUSION CRITERIA:

    An individual who meets any of the following criteria will be excluded from participation in this

    study:

    • Received BCG vaccine <=10 years prior.

    • Known hypersensitivity or allergy to any component of the PPD product.

    • Previous severe reaction (e.g., necrosis, blistering, ulcerations, or anaphylactic shock) to a TST.

    • Documented active TB or a clear history of treatment for latent infection or active disease.

    • Extensive burns or eczema or other skin conditions on the forearms that could affect placement and reading of the TST.

    • Pregnant or lactating women.

    • Any condition that, in the opinion of the investigator, would compromise the safety of the study participant or staff, or would prevent proper conduct of the study.

    Exclusion of Special Populations (Children, Adults Who Lack Capacity to Consent and

    Pregnant Women):

    We are able to obtain knowledge about TST performance in Liberia without exposing children, adults who lack capacity to consent, and pregnant women to the potential risk of reactions to the TST.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Cinical Center Bethesda Maryland United States 20892
    2 C.H. Rennie Hospital Kakata Liberia
    3 Duport Road Clinic Monrovia Liberia
    4 JFK Medical Center Monrovia Liberia
    5 Redemption Hospital Monrovia Liberia

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Principal Investigator: Stephen A Migueles, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT04926922
    Other Study ID Numbers:
    • 10000231
    • 000231-I
    First Posted:
    Jun 15, 2021
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Jun 24, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 16, 2022