Increasing Market and Public Health Outcomes Through Scaling Up Affordable Access Models of Short Course Preventive Therapy for TB (IMPAACT4TB)

Primary Objective:

This study is being conducted in Brazil, Cambodia, China, Ethiopia, Ghana, Haiti, India, Indonesia, Kenya, Malawi, Mozambique, South Africa, Tanzania, and Zimbabwe. The overall goal is to reduce TB incidence among (1) people living with HIV who are on antiretroviral therapy, and (2) child contacts (under five years of age) of adult TB patients, by contributing to the sustainable scale up of 3HP preventive therapy (a short-course regimen of isoniazid and rifapentine taken weekly for three months).

Secondary Objectives:

1. To assess the feasibility of providing 3HP under program settings.
2. To describe the adverse drug events of the 3HP under programmatic conditions.
3. To determine the proportion of individuals on once-weekly Rifapentine and Isoniazid (3HP) regimen with incidence of TB and proportion of individuals with mortality over a 12 month period.