Actively Recruiting
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
Eligibility Criteria
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
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
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
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