At a glance
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Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention: the 3HP Options Implementation Trial
In Brief
A clinical study evaluating Streamlined weekly DOT visits, Weekly DOT visit reminders, and 4 other interventions for Tuberculosis and 2 related conditions. Completed, enrolled 1,656 participants across 1 site.
Detailed Summary
The Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial) study will be a three-arm, open-label, parallel, randomized trial. This hybrid effectiveness-implementation trial will be conducted among people living with HIV infection (PLHIV) enrolled in HIV/AIDS care at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. The overall objective of this study is to identify a patient-centered delivery strategy that will facilitate acceptance and completion of a three-month (12-dose) regimen of weekly rifapentine (RPT) and isoniazid (INH) by PLHIV enrolled in routine HIV/AIDS care in a high HIV/TB burden country. The primary outcome will be acceptance and completion of 3HP. Additional objectives will be to evaluate the implementation and cost-effectiveness of each delivery strategy.
Study Details
Timeline
Interventions
Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects
Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits
Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12)
99DOTS-based digital adherence technology to monitor and promote adherence
Weekly SMS or IVR phone call dosing reminder/check-in for side effects
Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12)