An interventional study of patient-centered TB preventive therapy and TB preventive therapy adherence support in Tuberculosis, HIV Coinfection and Tuberculosis Infection, sponsored by Baylor College of Medicine. Completed at 5 sites in 5 countries. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Other
Tuberculosis (TB) is the world's leading infectious cause of mortality and responsible for 1/3 of deaths in people living with human immunodeficiency virus (PLHIV). Children and adolescents living with HIV (CALHIV) are disproportionately affected due to inadequate preventive services, large case detection gaps, treatment and adherence challenges, and knowledge gaps. This project will generate evidence to inform interventions targeting several of these weaknesses in the TB/HIV cascade of care.
Early detection and treatment of TB improve outcomes in people living with HIV (PLHIV). A key challenge in the detection of HIV-associated TB has been the implementation of screening that identifies the correct population for diagnostic testing. Increasing evidence demonstrates the poor performance of recommended symptom screens and diagnostic approaches. Hence, the investigators aim to define a more accurate TB screening and testing strategy among PLHIV (Objective 1 and Objective 2).
TB preventive treatment (TPT) averts HIV-associated TB. Nevertheless, among PLHIV, TPT initiation and completion rates are sub-optimal and effective delivery strategies are not defined. As such, the investigators aim to identify the most effective TPT delivery strategy through shared decision making and by integrating approaches proven to be effective at improving HIV treatment adherence (Objective 3).
Although evidence demonstrates that isoniazid preventive therapy (IPT) is cost-effective in young children living in TB/HIV high burden settings, the cost-effectiveness of newer short-course TPT has primarily been studied in the context of a TB low-burden, high-income setting. The investigators aim to generate evidence to fill this knowledge gap and inform policy for PLHIV living in TB/HIV high burden settings (Objective 4).
This study is supported by the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award totaling an anticipated $5,000,000 over five years with 100 percent funded by CDC/HHS.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's enrollment of 5,733 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
OBJECTIVES 1 and 2:
Inclusion Criteria:
Exclusion Criteria:
OBJECTIVE 3:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention will be administered. Observational data regarding TPT uptake and adherence will be captured on all participants presenting for care
The intervention phase includes i) enrolling participants who have had TB disease excluded and allowing participant selection of a preferred TPT regimen, and ii) randomizing participants to one of two participant adherence support modalities.
Other: patient-centered TB preventive therapy · Other: TB preventive therapy adherence support
The intervention phase includes i) enrolling participants who have had TB disease excluded and allowing participant selection of a preferred TPT regimen, and ii) randomizing participants to one of two participant adherence support modalities.
As part of this study, enhanced adherence support will be provided via bi-directional messaging and/or via clinic phone calls. All participants randomized to enhanced adherence support will receive a weekly text reminder beginning seven days after the initiation. Each message will ask participants if they would like to be contacted to discuss any questions and will prompt participants to ask questions by text if more convenient or preferable. All text-based questions from participants will be answered by a trained nurse with back up from a physician.
TB screening
Sensitivity of C-reactive protein for TB screening compared to the sensitivity of the WHO symptom screening using the McNemar test
Time frame: 24-32 months
TB diagnosis
Sensitivity of Xpert Host Response Cartridge compared with the sensitivity of Xpert Ultra on sputum or on gastric aspirate using the McNemar test
Time frame: 24-32 months
TPT prevention outcomes
Comparing TPT completion rates in participants randomized to bi-directional messaging support vs. standard support
Time frame: 48 months
Cost-effectiveness
Estimating the incremental cost-effectiveness of new shortened TPT regimens measured as cost per DALYS averted for each TPT strategy and the enhanced participant support modality compared with current standard of care
Time frame: 32 months
Proportion of participants selecting 3HP and the proportion selecting 6H when offered a choice within a decentralized model
Time frame: 48 months
Proportion of participants completing 6H and the proportion completing 3HP among participants randomized to standard support vs. bidirectional messaging
Treatment completion will be defined as receipt of at least 80% of doses during a pre-specified period of time and consistent with WHO definitions.
Time frame: 48 months
Proportion of participants initiated on TPT in the control phase vs. the intervention phase
Initiation rates will be estimated by the number of participants initiating TPT divided by the number of instances that TPT was offered
Time frame: 48 months
Description of the number of participants with different TB treatment and TPT outcomes at the completion of respective therapies
At individual study end point or at study closure, participants will be classified as i) retained in care, ii) died, iii) lost to follow-up, or iv) transferred out.
Time frame: 48 months
Number of life years saved through novel TPT approaches
Time frame: 32 months
Number of active TB cases averted through novel TPT approaches
Time frame: 32 months
Measure the association between participant factors and screening and diagnostic positivity rates
Participant factors are inclusive but not limited to TB infection status, immunologic, virologic, demographic, socioeconomic and clinical factors. The screening and diagnosis approaches are: point of care C-reactive protein, chest radiography, Fuji-LAM, Xpert Ultra performed on oral swabs and stool specimens and ultrasound.
Time frame: 24-32 months
Laboratory turnaround time
For all screening and diagnostic tests of the study
Time frame: 24-32 months
Result reporting rate
For all screening and diagnostic tests of the study
Time frame: 24-32 months
Time-to-treatment initiation
For all screening and diagnostic tests of the study
Time frame: 24-32 months
Diagnostic performance of mask sampling with differing forms of quiet and forced expiration (i.e., talking, singing) against standard approaches of sampling
Time frame: 24-32 months
Compare alternative stool processing techniques and molecular diagnostics/tests of MTB resistance against clinical and microbiologic reference standards
Done using de-identified stool collected and bio-banked during the study.
Time frame: 24-32 months
Compare Alere-LAM diagnostic accuracy with that of the SILVAMP-LAM with both spot and early-morning urine samples
Time frame: 24-32 months
Analyze different processing approaches for oral swabs prior to testing by Xpert Ultra vs. other microbiological diagnostic and drug susceptibility tests
Time frame: 24-32 months
Compare clinician read of chest radiograph with point-of-care ultrasound interpretation to determine agreement and additive yield of each method
this outcome will be studied only in Eswatini and Malawi
Time frame: 24-32 months
Prevalence of extrapulmonary TB by means of point of care ultrasound in participants diagnosed with TB
Time frame: 24-32 months
Assess ultrasound inter-reader agreement between hands-on operators
Time frame: 24-32 months
Assess ultrasound inter-reader agreement between hands-on operators AND remote expert reviewers
Time frame: 24-32 months
Compare the proportion of clinician and computer aided detection chest radiograph interpretation with algorithmic approaches against clinical and microbiologic reference standards
Time frame: 24-32 months
Sensitivity of point of care CRP versus the WHO symptom screening
CRP will be performed on whole blood using the FDA approved POC iChroma assay. A CRP of \> 10 mg/L will be considered positive
Time frame: 24-32 months
Specificity of point of care CRP versus the WHO symptom screening
CRP will be performed on whole blood using the FDA approved POC iChroma assay. A CRP of \> 10 mg/L will be considered positive
Time frame: 24-32 months
Area under the receiver operator curve of point of care CRP versus the WHO symptom screening
CRP will be performed on whole blood using the FDA approved POC iChroma assay. A CRP of \> 10 mg/L will be considered positive
Time frame: 24-32 months
Sensitivity of chest radiography versus the WHO symptom screening
Chest radiography will be interpreted as normal or abnormal for the purposes of TB screening and will be evaluated using a standardized interpretation form
Time frame: 24-32 months
Area under the receiver operator curve of chest radiography versus the WHO symptom screening
Chest radiography will be interpreted as normal or abnormal for the purposes of TB screening and will be evaluated using a standardized interpretation form
Time frame: 24-32 months
Specificity of chest radiography versus the WHO symptom screening
Chest radiography will be interpreted as normal or abnormal for the purposes of TB screening and will be evaluated using a standardized interpretation form
Time frame: 24-32 months
Sensitivity of SILVAMP-LAM versus the WHO symptom screening
Time frame: 24-32 months
Area under the curve of SILVAMP-LAM versus the WHO symptom screening
Time frame: 24-32 months
Specificity of SILVAMP-LAM versus the WHO symptom screening
Time frame: 24-32 months
Sensitivity of Xpert Ultra performed on an oral/buccal swab versus Xpert Ultra completed on sputum or gastric aspirate
Time frame: 24-32 months
Specificity of Xpert Ultra performed on an oral/buccal swab versus Xpert Ultra completed on sputum or gastric aspirate
Time frame: 24-32 months
Area under the ROC curve of Xpert Ultra performed on an oral/buccal swab versus Xpert Ultra completed on sputum or gastric aspirate
Time frame: 24-32 months
Sensitivity of Xpert Ultra performed on stool versus Xpert Ultra completed on sputum or gastric aspirate
Time frame: 24-32 months
Specificity of Xpert Ultra performed on stool versus Xpert Ultra completed on sputum or gastric aspirate
Time frame: 24-32 months
Area under the receiver operator curve of Xpert Ultra performed on stool versus Xpert Ultra completed on sputum or gastric aspirate
Time frame: 24-32 months
Sensitivity of LF-LAM versus Xpert Ultra completed on sputum or gastric aspirate
Time frame: 24-32 months
Specificity of LF-LAM versus Xpert Ultra completed on sputum or gastric aspirate
Time frame: 24-32 months
Area under the receiver operator curve of LF-LAM versus Xpert Ultra completed on sputum or gastric aspirate
Time frame: 24-32 months
Sensitivity of Xpert Ultra performed on a gelatin filter removed from a participant's mask versus Xpert Ultra completed on sputum or gastric aspirate
Time frame: 24-32 months
Specificity of Xpert Ultra performed on a gelatin filter removed from a participant's mask versus Xpert Ultra completed on sputum or gastric aspirate
Time frame: 24-32 months
Area under the receiver operator curve of Xpert Ultra performed on a gelatin filter removed from a participant's mask versus Xpert Ultra completed on sputum or gastric aspirate
Time frame: 24-32 months
Sensitivity of point of care ultrasound versus Xpert Ultra completed on sputum or gastric aspirate
Time frame: 24-32 months
Specificity of point of care ultrasound versus Xpert Ultra completed on sputum or gastric aspirate
Time frame: 24-32 months
Area under the receiver operator curve of point of care ultrasound versus Xpert Ultra completed on sputum or gastric aspirate
Time frame: 24-32 months
Sensitivity of Xpert Host Response Cartridge on blood specimen versus Xpert Ultra completed on sputum or gastric aspirate
The blood specimen is collected at the time of positive screening
Time frame: 24-32 months
Specificity of Xpert Host Response Cartridge on blood specimen versus Xpert Ultra completed on sputum or gastric aspirate
The blood specimen is collected at the time of positive screening
Time frame: 24-32 months
Area under the receiver operator curve of Xpert Host Response Cartridge on blood specimen versus Xpert Ultra completed on sputum or gastric aspirate
The blood specimen is collected at the time of positive screening
Time frame: 24-32 months
Sensitivity of chest radiography for TB screening compared to the sensitivity of the WHO symptom screening using the McNemar test
Time frame: 24-32 months
Sensitivity of SILVAMP-LAM for TB screening compared to the sensitivity of the WHO symptom screening using the McNemar test
Time frame: 24-32 months
Ran from Jul 2023 to primary completion in Sep 2026, 38 months.
Of 169 non-industry interventional studies with no phase under Tuberculosis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 41. This study's 38 months is above that.
Counting every sponsor, half of 171 studies reached it within 25 months; a quarter within 14 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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