TB (Tuberculosis) Preventive Therapy for HIV Patients With Access to HAART (Highly Active Antiretroviral Therapy)

Study Overview
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Brief Summary
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The purpose of this study is to determine if implementing a policy of widespread INH (Isoniazid) prophylaxis therapy in HIV-infected patients with access to antiretroviral therapy reduces the incidence of active TB disease in the HIV clinic population.

Detailed Description
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Tuberculosis remains a major public health problem in Brazil. Approximately 35% of HIV-infected adults in Rio de Janeiro are co-infected with latent TB. The Brazilian policies for the provision of treatment to HIV-infected people are among the most progressive in the world. Brazil provides combination antiretroviral therapy free of charge to all patients who meet clinical criteria and maintains an extensive clinic and laboratory system for the appropriate prescription and monitoring of therapy. The use of IPT, however, has been very limited in Brazil and TB remains a prominent disease in AIDS patients. A clustered randomized trial (CRT) will determine if the routine detection of latent TB in HIV-infected patients identified at HIV clinics in Rio de Janeiro, followed by treatment with isoniazid, will reduce TB incidence in this population. The CRT will take a phased-implementation approach to ensure that all clinics will eventually have full coverage. This study will determine if implementing a policy of widespread IPT use in HIV-infected patients with access to ARV therapy reduces the incidence of active TB disease in the HIV clinic population. The study population will be comprised of HIV-infected individuals who attend any of the 29 government HIV clinics in Rio de Janeiro, Brazil. We expect that IPT use in addition to ARVs will result in a 40-60% reduction in TB incidence, and that approximately 50% of the prevented TB cases will be in patients not yet eligible for HAART.

Official Title
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Impact of TB Preventive Therapy for HIV/TB Co-infected Patients With Access to Highly Active Antiretroviral Therapy in Rio de Janeiro, Brazil: A Phased Implementation Trial

Conditions
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Tuberculosis, HIV Infections

Intervention / Treatment
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* Drug: INH preventive therapy
* Drug: TST (tuberculin skin test)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Attending 1 of 29 participating HIV clinics Confirmed HIV infection Age > 15 years Exclusion Criteria: Current active TB disease TB infection within 2 years Hepatitis

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Subjects in clinics that have not received the intervention | |
| Experimental: 2<br>Subjects at clinics that have received the intervention | Drug: INH preventive therapy<br>* Clinics will receive training regarding the use of IPT for prevention of Tuberculosis<br>Drug: TST (tuberculin skin test)<br>* Clinics will be trained in the use of TST for assessing exposure to TB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measured incidence of active TB in HIV clinic population before and following implementation of IPT policy |  | 6 Years | 
| Comparative impact of IPT (Isoniazid Preventive Therapy) and ARVs (antiretrovirals) on TB incidence in the HIV clinic population |  | 6 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of TST+ vs. TST+ HIV-infected patients |  | 6 Years | 
| Clinical, demographic and laboratory predictors of developing active TB |  | 6 Years | 
| Lessons learned related to training and implementation |  | 6 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TST, isoniazid, HAART, Brazil, HIV