Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial)

NACompletedINTERVENTIONAL
Enrollment

1,656

Participants

Timeline

Start Date

July 13, 2020

Primary Completion Date

September 29, 2022

Study Completion Date

January 13, 2025

Conditions
TuberculosisLatent TuberculosisHIV/AIDS
Interventions
OTHER

Streamlined weekly DOT visits

Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects

OTHER

Weekly DOT visit reminders

Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits

OTHER

Cost reimbursement DOT

Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12)

OTHER

99DOTS

99DOTS-based digital adherence technology to monitor and promote adherence

OTHER

Weekly SAT dosing reminders/check-ins

Weekly SMS or IVR phone call dosing reminder/check-in for side effects

OTHER

Cost reimbursement SAT

Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12)

Trial Locations (1)

Unknown

Mulago Immune Suppression Syndrome (ISS) Clinic, Kampala

All Listed Sponsors
collaborator

Makerere University

OTHER

collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

collaborator

University of Colorado, Denver

OTHER

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

University of California, San Francisco

OTHER

NCT03934931 - Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial) | Biotech Hunter | Biotech Hunter