Targeted TB testing and preventive therapy for people living with HIV in South Africa
TUTT-PT: Targeted Universal TB Testing With Simultaneous TPT Prescribing Among People Living With HIV in South Africa
This study is testing a new way to give TB tests and preventive treatment to adults living with HIV in South Africa who are starting or restarting their HIV medication, to see if it helps them avoid getting TB.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Soweto, Gauteng) |
| Trial ID | NCT06739915 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new approach called targeted universal TB testing (TUTT) combined with simultaneous tuberculosis preventive therapy (TPT) for adults living with HIV who are starting or restarting antiretroviral therapy (ART) in South Africa. The aim is to address the conflicting guidelines on when to initiate TPT, which can lead to delays in treatment and increased risk of TB. By providing TPT at the time of TB testing, the study seeks to improve the rates of TPT initiation and reduce the incidence of TB among this high-risk population. Participants will be monitored through follow-up calls or home visits by the study team.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are newly initiating or re-initiating ART and living with HIV.
Not a fit: Patients who are stable on ART and not experiencing any new treatment initiation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of tuberculosis among people living with HIV in South Africa.
How similar studies have performed: Other studies have shown success with similar approaches to TB testing and preventive therapy, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 18 years and older * Person living with HIV newly initiating or re-initiating ART at a participating site. * Residing within the catchment area of the clinic and willing to be followed up at telephonically or via a home visit by a study team tracer. * Willing and able to provide written informed consent. Exclusion Criteria: * Person living with HIV stable on ART. * Not speaking any of the languages spoken by the study team
Where this trial is running
Soweto, Gauteng
- Perinatal HIV Research Unit — Soweto, Gauteng, South Africa (Recruiting)
Study contacts
- Principal investigator: Christopher Hoffmann, MD, MPH — Johns Hopkins University
- Study coordinator: Christopher Hoffmann, MD, MPH
- Email: choffmann@jhmi.edu
- Phone: 410-614-4257
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.