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ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa

NCT06214910 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2026-01-02

No results posted yet for this study

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 are recommended to receive TB preventive therapy.

We hypothesize that persons receiving multi-month dispensing of TPT in the community will have a higher rate of TPT completion at 3 months than persons receiving TPT via standard of care with monthly clinic-based refills.

Conditions

Interventions

OTHER

Community-delivered TB preventive therapy (TPT) - 3 months weekly isoniazid plus rifapentine (3HP)

Participants randomized to this arm will receive the entire supply of TB preventive therapy (TPT) at enrollment.

OTHER

Clinic-link TPT

Participants receive 2-week supply of TPT at initiation, then continue to receive remainder of TPT course at clinic (including refills).

Sponsors & Collaborators

  • Human Sciences Research Council

    collaborator OTHER_GOV

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Adrienne E Shapiro, MD, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2025-05-30
Completion
2025-08-04

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06214910 on ClinicalTrials.gov