1 to 3 HP

Protocol Title: A Randomized Trial Comparing Treatment Completion of Daily Rifapentine & Isoniazid for One Month (1HP) to Weekly Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in HIV-negative Household Contacts of Recently Diagnosed Tuberculosis Patients, The “One To Three” Trial

OBJECTIVES:

Primary Objectives

To compare treatment success (completion of treatment with >90% adherence) of 1HP compared with 3HP in adolescents and adults who are living with HIV or are HIV-negative household contacts of an adult with confirmed pulmonary TB.

To compare the safety of 1HP vs 3HP in adolescents and adults who are living with HIV or are HIV-negative household contacts of an adult with confirmed pulmonary TB.

Secondary Objective­
 To compare the cost-effectiveness of 1HP and 3HP using a societal approach, modelling the incremental cost-effectiveness of 1HP vs 3HP, 6H, and no treatment.

OUTCOMES:

Primary Outcomes

(1)  Successful completion of TPT with >90% adherence documented by self-report, pill count, and EMD reporting.

(2)  Safety of treatment regimens, defined as occurrence of Grade 2 or higher targeted safety events and discontinuation of study medications because of side effects.

Targeted safety events are hypersensitivity syndrome, rash, seizure, peripheral neuropathy, hepatotoxicity, nausea and vomiting, and drug-related fever.

Secondary Outcome:

(1) Incremental cost-effectiveness of 1HP and 3HP (compared to each other, 6H, and no treatment) using a societal perspective.