Actively Recruiting

Phase Not Applicable
All Genders
NCT05342064

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

Led by Baylor College of Medicine · Updated on 2025-10-21

6500

Participants Needed

5

Research Sites

164 weeks

Total Duration

On this page

Sponsors

B

Baylor College of Medicine

Lead Sponsor

C

Centers for Disease Control and Prevention

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • HIV positive or HIV exposed and presumptively positive while awaiting confirmatory testing in infants
  • Negative TB symptom screen or TB disease ruled out according to WHO guidelines in adults and consensus definitions for child TB
Not Eligible

You will not qualify if you...

  • Do not provide informed consent or assent as appropriate
  • Currently being treated for tuberculosis (TB)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 5 locations

1

Baylor College of Medicine Children's Foundation

Mbabane, Eswatini

Actively Recruiting

2

Baylor College of Medicine Children's Foundation

Maseru, Lesotho

Actively Recruiting

3

Baylor College of Medicine Children's Foundation

Lilongwe, Malawi

Actively Recruiting

4

Baylor College of Medicine Children's Foundation

Mbeya, Tanzania

Actively Recruiting

5

Baylor College of Medicine Children's Foundation

Kampala, Uganda

Actively Recruiting

Loading map...

Research Team

A

Anna Mandalakas, MD, PhD

CONTACT

A

Alexander Kay, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

OTHER

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Closing -TB GAPs - for People Living With HIV: TB Guidance for Adaptable Patient-Centered Service | DecenTrialz