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

NCT04926922 | Completed

• 2 other identifiers: 10000231000231-I
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 5

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. ...

Conditions

Tuberculosis; HIV

Keywords

Interferon-Gamma Release Assay (IGRA); Purified Protein Derivative (PPD); Tuberculin Skin Test (TST); TB; HIV; Natural History

Outcome Measures

Primary Outcomes (1)

• Frequency of positive results using the IGRA and TST.

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

  48-72 hours after TST placement

Secondary Outcomes (1)

• Proportion of each test type successfully completed and the result determined.

  48-72 hours after TST placement

Study Arms (1)

HONOR TB participants with positive IGRA and/or TST during initial phase

Adult participants who who tested positive on IGRA and or TST during initial phase and meet the study-specific eligibility criteria.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants must be enrolled in the main HONOR study of people living with HIV in Liberia who participated in the HONOR TB study at their Month 12 visit and tested positive on IGRA and/or TST.

You may qualify if:

• 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.
• In order to be eligible to participate in the extension phase of the study, an individual must meet all of the following criteria:
• Participated in the PREVAIL VIIIa HONOR TB study.
• Have had a positive TB test result on the TST and/or IGRA performed as part of the PREVAIL VIII HONOR or PREVAIL VIIIa HONOR TB study(ies).
• Ability to provide informed consent.

You may not qualify if:

• 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.
• An individual who meets any of the following criteria will be excluded from participation in the extension phase of this study:
• Pregnant women.
• Contraindication to CT scanning.
• 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.
• 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 or exposure to radiation for research purposes.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (5)

National Institutes of Health Cinical Center

Bethesda, Maryland, 20892, United States

Location

C.H. Rennie Hospital

Kakata, Liberia

Location

Duport Road Clinic

Monrovia, Liberia

Location

JFK Medical Center

Monrovia, Liberia

Location

Redemption Hospital

Monrovia, Liberia

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Stephen A Migueles, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2021
• First Posted: June 15, 2021
• Study Start: July 27, 2021
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-05-19

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Utilized for individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our database but without investigator support.

Locations

US (1); LI (4)