NCT04926922Completed
PREVAIL VIIIa: Evaluation of Latent Tuberculosis Infection Screening Methods in People Living With Retroviral Infection in Liberia
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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. ...
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 12 Jun 2021
- Start date
- 27 Jul 2021
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT04926922
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 27 Jul 2021 to the primary completion date, 30 Apr 2026
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received BCG vaccine \<=10 years prior.
- Previous severe reaction (e.g., necrosis, blistering, ulcerations, or anaphylactic shock) to a TST.
Other illness
- Known hypersensitivity or allergy to any component of the PPD product.
- 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.
- 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:
- 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.
Other
- An individual who meets any of the following criteria will be excluded from participation in this
- study:
- Pregnant or lactating women.
- Pregnant women.
- Contraindication to CT scanning.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| C.H. Rennie Hospital Coordinator of this site? Confirm its status | Kakata | Liberia | Unknown status |
| JFK Medical Center Coordinator of this site? Confirm its status | Monrovia | Liberia | Unknown status |
| Redemption Hospital Coordinator of this site? Confirm its status | Monrovia | Liberia | Unknown status |
| Duport Road Clinic Coordinator of this site? Confirm its status | Monrovia | Liberia | Unknown status |
| National Institutes of Health Cinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.