A Randomized Trial of DOTS Versus Enhanced DOTS for Community Control of Tuberculosis
This study will test the effectiveness of two different tuberculosis (TB) prevention strategies, DOTS or DOTS-A. DOTS is the current prevention strategy for TB. DOTS-A is an enhanced prevention strategy that will screen household members of individuals diagnosed with active TB and will provide enhanced treatment as needed. The study will be conducted in 8 communities located in Rio de Janeiro. Study participants will include 6400 males and females of all ages, including active TB patients and their household contacts. Patients with TB identified for treatment at the Health Clinics of 8 urban communities will be eligible. The communities will be assigned to 1 of the 2 prevention strategies, DOTS or DOTS-A. After 4 years, the information gathered during the study will be used to determine the incidence of TB in these communities to see which prevention strategy was more effective in decreasing TB.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Trial of DOTS Versus Enhanced DOTS for Community Control of Tuberculosis|
|Study Start Date:||December 2004|
|Estimated Study Completion Date:||June 2005|
This will be a single site, prospective, community-randomized trial to study the effectiveness for two TB prevention strategies on the community incidence of TB: DOTS versus Enhanced DOTS (DOTS-Ampliado, or DOTS-A). DOTS-A will add intensive screening of household contacts of active TB cases and the provision of TB treatment or prophylaxis as needed to the standard DOTS regimen. Adult contacts in the DOTS-A communities will be offered enrollment into a randomized clinical trial comparing rifapentine/isoniazid preventive therapy to rifampin/pyrazinamide. Subjects will be recruited from TB cases identified for treatment at the Health Clinics of eight urban communities. These communities will be matched and randomly assigned to receive either DOTS or DOTS-A strategy. The change in the incidence of TB in the two groups of communities will be measured after a 4-year period to determine whether DOTS-A strategy significantly reduces the incidence of TB compared to DOTS alone.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317330
|Municipal Health Department|
|Rio de Janeiro, Brazil, 21945|