Status:
COMPLETED
ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Human Sciences Research Council
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Tuberculosis
HIV I Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will compare community-delivered, multi-month dispensing of tuberculosis preventive therapy (TPT) to standard-of-care clinic-based TPT delivery in a population of South African adults who a...
Detailed Description
The research objective is to understand and overcome key barriers to tuberculosis preventive therapy (TPT) delivery and completion in South Africa in the setting of 3HP scale-up. (3HP: short-course TP...
Eligibility Criteria
Inclusion
- ≥18 years of age
- Living in the study catchment area
- Eligible for TPT according to South African National guidelines(5), i.e. are a) living with HIV or b) are a close contact of a person with TB disease (defined by a person that resides in the same house as a person with TB), c) and in either case
- Have screened negative for TB disease in the last 6 months, through TB TRIAGE+ Trial, other household contact tracing, or other community TB screening
- Negative TB screening at enrolment (if TB TRIAGE+ screening was more than 3 months ago)
- Willing and able to provide written or verbal consent
- Participants whom have not received TPT in the last 12 months; this was confirmed verbally with participants during the enrolment process.
Exclusion
- Less than 18 years of age.
- Pregnant or planning on pregnancy within next three months
- Planning on moving or relocating from the area within the next three months
- Positive for active TB
- Currently on TB treatment
Key Trial Info
Start Date :
February 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2025
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT06214910
Start Date
February 20 2024
End Date
August 4 2025
Last Update
January 2 2026
Active Locations (1)
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1
Human Sciences Research Council
Sweetwaters, KwaZulu-Natal, South Africa