NCT04926922Befejeződött
PREVAIL VIIIa: Evaluation of Latent Tuberculosis Infection Screening Methods in People Living With Retroviral Infection in Liberia
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 5.
Rövid összefoglaló (regiszter, angolul)
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. ...
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 200 (tényleges)
- Első benyújtás
- 2021. jún. 12.
- Kezdés
- 2021. júl. 27.
- Elsődleges befejezés
- 2026. ápr. 30.
- Fő szponzor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Betegségek
- Tuberkulózis, HIV-fertőzés
- NCT-szám
- NCT04926922
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 200
- 2021. júl. 27. és az elsődleges befejezés (2026. ápr. 30.) között
- 5 helyszín, 2 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Received BCG vaccine <=10 years prior.
- Previous severe reaction (e.g., necrosis, blistering, ulcerations, or anaphylactic shock) to a TST.
Más betegség
- 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.
Egyéb
- 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.
A regiszterben nem jelölt feltételek
- 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.
Életkor a regiszterben: 18 év – 99 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (5)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| C.H. Rennie Hospital | Kakata | Libéria | Ismeretlen állapot |
| JFK Medical Center | Monrovia | Libéria | Ismeretlen állapot |
| Redemption Hospital | Monrovia | Libéria | Ismeretlen állapot |
| Duport Road Clinic | Monrovia | Libéria | Ismeretlen állapot |
| National Institutes of Health Cinical Center | Bethesda | Egyesült Államok | Ismeretlen állapot |
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