Improving TB prevention and care for people living with HIV
Closing -TB GAPs - for People Living With HIV: TB Guidance for Adaptable Patient-Centered Service
This study is testing new ways to improve tuberculosis screening and treatment for children and teens living with HIV to help them stay healthier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6500 (estimated) |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 5 sites (Mbabane and 4 other locations) |
| Trial ID | NCT05342064 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance tuberculosis (TB) screening and preventive therapy for individuals living with HIV, particularly children and adolescents. It addresses significant gaps in TB detection and treatment adherence among this vulnerable population. The study will generate evidence to inform better screening strategies and patient-centered interventions to improve outcomes for those affected by TB/HIV co-infection.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who are HIV positive or presumptively positive and are at risk for TB infection.
Not a fit: Patients currently being treated for TB or those who cannot provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved TB prevention and treatment outcomes for people living with HIV, particularly in pediatric populations.
How similar studies have performed: Other studies have shown success in improving TB screening and treatment strategies for HIV-positive populations, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Mbabane and 4 other locations
- Baylor College of Medicine Children's Foundation — Mbabane, Eswatini (Recruiting)
- Baylor College of Medicine Children's Foundation — Maseru, Lesotho (Recruiting)
- Baylor College of Medicine Children's Foundation — Lilongwe, Malawi (Recruiting)
- Baylor College of Medicine Children's Foundation — Mbeya, Tanzania (Recruiting)
- Baylor College of Medicine Children's Foundation — Kampala, Uganda (Recruiting)
Study contacts
- Study coordinator: Anna Mandalakas, MD, PhD
- Email: anna.mandalakas@bcm.edu
- Phone: 832-822-6730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.