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PREVAIL VIIIa: 라이베리아에서 레트로바이러스 감염 환자의 잠복결핵감염 선별검사 방법 평가

2026년 11월 4일 업데이트: National Institute of Allergy and Infectious Diseases (NIAID)

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.

...

연구 개요

상태

완전한

정황

상세 설명

Study Description:

This is a prospective study to compare the interferon-gamma release assay (IGRA) and tuberculin skin test (TST) as latent tuberculosis infection (LTBI) screening tests in people living with HIV in Liberia. Participants will be co-enrolled on the ongoing HONOR (A CoHOrt Clinical, Viral, and ImmuNOlogic Monitoring Study of People Living with Retroviral Infection in Liberia) study. A TST will be administered to eligible participants who are being screened by IGRA on HONOR. Since there is no gold standard for diagnosing LTBI, the results of each method will be compared to evaluate whether there is no difference in the probability of testing positive, assess the operational functionality in the clinic and lab, and determine whether one test can be used with greater sensitivity assuming comparable specificity.

In an extension phase, participants who had a positive TST and/or IGRA result will be offered an opportunity to return for an optional assessment by follow-up chest x-ray, non-contrast chest computed tomography (CT) scanning, sputum collection, and phlebotomy. This will involve an additional visit (Visit 4), to occur after completion of the primary phase (Visit 3). The visit may occur in conjunction with (ie, the same day as or within 4 weeks of) a main HONOR study visit, and results of blood tests collected under the main HONOR study will be reviewed. For participants who have already completed the main HONOR study or do not have an upcoming HONOR visit scheduled, a new visit (ie, HONOR TB Visit 4) will be scheduled for this HONOR TB extension study, and a blood draw will also be performed.

Objectives:

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

Secondary Objective: Assess the operational functionality of the IGRA and TST in Liberia.

Exploratory Objective: Investigate testing approaches, including follow-up chest x-ray imaging, high-resolution chest CT imaging, and performance on sputum of the Mycobacterium tuberculosis (MTB) complex/rifampin (RIF) nucleic acid amplification test (NAAT), to improve diagnosis of stage-specific TB infection by examining how classification of TB status is associated with biomarker levels (only for participants with a positive TST and/or IGRA).

Endpoints:

Primary Endpoint: Frequency of positive results using the IGRA and TST.

Secondary Endpoint: Proportion of each test type successfully completed and the result determined.

Exploratory Endpoint: Repeat chest x-ray assessment, non-contrast chest CT assessment, sputum analysis by MTB/RIF NAAT assay, and analysis of serum by a CRISPR-Mtb-cfDNA assay.

연구 유형

관찰

등록 (실제)

200

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

라이베리아
- - Kakata, 라이베리아
    - C.H. Rennie Hospital
  - Monrovia, 라이베리아
    - Redemption Hospital
  - Monrovia, 라이베리아
    - Duport Road Clinic
  - Monrovia, 라이베리아
    - JFK Medical Center
미국
- Maryland
  - Bethesda, Maryland, 미국, 20892
    - National Institutes of Health Cinical Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

관찰 모델: COHORT
시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트 그룹/코호트 생물 의학 또는 건강 결과에 대해 평가되는 관찰 연구의 참가자 그룹 또는 하위 그룹입니다.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Frequency of positive results using the IGRA and TST. 기간: 48-72 hours after TST placement	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

2차 결과 측정

결과 측정	측정값 설명	기간
Proportion of each test type successfully completed and the result determined. 기간: 48-72 hours after TST placement	Assess the operational functionality of the IGRA and TST.	48-72 hours after TST placement

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Institute of Allergy and Infectious Diseases (NIAID)

수사관

수석 연구원: Stephen A Migueles, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 7월 27일

기본 완료 (실제)

2026년 4월 30일

연구 완료 (실제)

2026년 4월 30일

연구 등록 날짜

최초 제출

2021년 6월 12일

QC 기준을 충족하는 최초 제출

2021년 6월 12일

처음 게시됨 (실제)

2021년 6월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 4일

마지막으로 확인됨

2026년 5월 19일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

10000231
000231-I

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Individual participant data that underline the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD 공유 기간

Beginning 9 months and ending 36 months following article publication.

IPD 공유 액세스 기준

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.

IPD 공유 지원 정보 유형

연구_프로토콜

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .