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

NCT04926922

CompletedN/A

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions: Tuberculosis, HIV

Countries: United States, Liberia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

* 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.

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.

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.

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.

Locations (5)

Bethesda, Maryland, United States
Kakata, Liberia
Monrovia, Liberia
Monrovia, Liberia
Monrovia, Liberia