Closing -TB GAPs - for People Living With HIV: TB Guidance for Adaptable Patient-Centered Service (TB_GAPS)

Baylor College of Medicine

Status: Enrolling

Conditions: Tuberculosis; HIV Coinfection; Tuberculosis Infection

Treatments: Other: patient-centered TB preventive therapy; Other: TB preventive therapy adherence support

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05342064

H-51421

Details and patient eligibility

About

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.

Enrollment: 6,500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

OBJECTIVES 1 and 2:

Inclusion Criteria:

• HIV positive or HIV exposed and presumptively positive while awaiting confirmatory testing in infants

Exclusion Criteria:

• do not provide informed consent or assent as appropriate or are currently being treated for TB

OBJECTIVE 3:

Inclusion Criteria:

• negative TB symptom screen OR for whom TB disease has been ruled out in accordance with WHO Guidelines in adults and according to consensus definitions for child TB

Exclusion Criteria:

• do not provide informed consent or assent as appropriate or are currently being treated for TB

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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6,500 participants in 2 patient groups

Standard of care

No Intervention group

Description:

No intervention will be administered. Observational data regarding TPT uptake and adherence will be captured on all participants presenting for care

TB screening and evaluation followed by TPT via a decentralized delivery system

Experimental group

Description:

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.

Treatment:

Other: TB preventive therapy adherence support

Other: patient-centered TB preventive therapy