Study name and trial number	Sponsors	Country / Sample size	Criteria	Phase	Study arms Intervention                              Control		Duration / Primary outcome
Community level trials in settings with a high HIV prevalence
The Zambia, South Africa, Tuberculosis and Acquired Immune Deficiency Syndrome‐reduction Trial (ZAMSTAR). ISRCTN36729271	CREATE, Bill and Melinda Gates Foundation	Zambia South Africa	Those with symptoms and families with a member with TB 1	Community randomised, factorial design	* Improved TB case finding *  Integrated TB/HIV care delivered through the household: including TB preventive therapy (INH for 6 months)	Standard TB control	Prevalence of culture‐positive TB, measured after 3 years of the interventions
Effect of community‐wide isoniazid preventive therapy on tuberculosis among South African gold miners (Thibela TB). ISRCTN63327174	CREATE, Bill and Melinda Gates Foundation	South Africa	Employees at intervention clusters Age: ?18 years No active TB	Cluster randomized non‐blinded controlled trial	* Standard TB control + INH for 9 months to all eligible employees  (N˜38000) regardless of HIV and silicosis status	Standard TB control N˜30000	Start June 2006 End June 2010 Each arm followed for 2 yrs   TB incidence in second year of follow up
Impact of TB Preventive Therapy for HIV/TB Co‐Infected Patients With Access to Highly Active Antiretroviral Therapy in Rio De Janeiro, Brazil. NCT00107887	CREATE, Bill and Melinda Gates Foundation	Brazil N˜15000 (Enrolling)	Age?16yrs HIV+ Attending a participating HIV clinic	A Phased Implementation Trial.	ARVs and implementation of IPT policy	ARVs alone	4 yr duration Incidence of active TB  before and following implementation of IPT policy
Nation wide TB preventive therapy program	Botswana Government CDC	Botswana N>30000	HIV+ No active TB	Routine implementation	INH for 6 months	NA	TB incidence