PREVAIL VIIIa: Evaluation of Latent Tuberculosis Infection Screening Methods in People Living With Retroviral Infection in Liberia
Completed
Conditions studied: Tuberculosis, HIV
In brief
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. ...
Key facts
- Study ID
- NCT04926922
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 200
- Starts
- 2021-07-27
- Expected to finish
- 2026-04-30
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
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.
- 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 or exposure to radiation for research purposes.
Where it is running
- National Institutes of Health Cinical Center — Bethesda, Maryland, United States
- C.H. Rennie Hospital — Kakata, Liberia
- Duport Road Clinic — Monrovia, Liberia
- JFK Medical Center — Monrovia, Liberia
- Redemption Hospital — Monrovia, Liberia
Full record on ClinicalTrials.gov
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