TuberculosisNCT04926922
PREVAIL VIIIa: Evaluation of Latent Tuberculosis Infection Screening Methods in People Living With Retroviral Infection in Liberia
An observational study of Tuberculosis and HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tuberculosis, HIV
- How many people
- 200 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 27 Jul 2021to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Liberia4 sites
C.H. Rennie Hospital
Kakata
Duport Road Clinic
Monrovia
JFK Medical Center
Monrovia
Redemption Hospital
Monrovia
United States1 site
National Institutes of Health Cinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
...
Read the detailed description
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.
- Conditions
- Tuberculosis, HIV
- Keywords
- Interferon-Gamma Release Assay (IGRA), Purified Protein Derivative (PPD), Tuberculin Skin Test (TST), TB, HIV, Natural History
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of positive results using the IGRA and TST.
Assess the sensitivity of the IGRA and TST as LTBI screening tools in people living with HIV in Liberia.
Measured: 48-72 hours after TST placement
Secondary outcomes (1)
Proportion of each test type successfully completed and the result determined.
Assess the operational functionality of the IGRA and TST.
Measured: 48-72 hours after TST placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start27 Jul 2021
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stephen A Migueles, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926922
- Sponsor's protocol ID
- 10000231
- Other IDs
- 000231-I
- Status last verified
- 19 May 2026
- First submitted
- 12 Jun 2021
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underline the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVAIL VIIIa: Evaluation of Latent Tuberculosis Infection Screening Methods in People Living With Retroviral Infection in Liberia
- ClinicalTrials.gov ID
- NCT04926922
- Acronym / sponsor ID
- 10000231
- Conditions
- Tuberculosis, HIV
- Keywords
- Interferon-Gamma Release Assay (IGRA), Purified Protein Derivative (PPD), Tuberculin Skin Test (TST), TB, HIV, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- An individual who meets any of the following criteria will be excluded from participation in this
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of positive results using the IGRA and TST.
Time frame: 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.
1 secondary outcome
Proportion of each test type successfully completed and the result determined.
Time frame: 48-72 hours after TST placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underline the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen A Migueles, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Liberia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of positive results using the IGRA and TST. (time frame: 48-72 hours after TST placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.