None listed
Conditions
Brief summary
This study is a pilot study for a proposed community-based cluster-randomised controlled trial of universal testing and treatment for latent TB infection, together with active case finding for TB disease, to reduce the prevalence of TB. The aim of this pilot study is to develop the detailed procedures for implementing the universal testing for, and treatment of, LTBI infection and to demonstrate the feasibility, safety and acceptability in preparation for the RCT. The study will be conducted in three Aps (sub-communes) in South Vietnam. All community members will be screened for LTBI infection and those who have evidence of LTBI will be offered drug treatment. The primary outcome will be the proportion of eligible participants with LTBI who completed at least 80% of the scheduled doses of drug treatment. Secondary outcomes include indices of participation and acceptability of the intervention.
Interventions
The initial treatment regimen will be 4RIF as this is currently approved and available. When 3HP is approved and available, we will switch to that regimen.
RIF regimen: 18 weeks of oral treatment with rifampicin (600mg/day for > 50 kg or 400mg/day < 50 kg body weight) as a single daily dose dispensed weekly at the participants home by a study team member.
If during the pilot study we receive approval for the use of a new treatment regimen we will commence new participants on this regimen.
3HP
The initial treatment regimen will be 4RIF as this is currently approved and available. When 3HP is approved and available, we will switch to that regimen. RIF regimen: 18 weeks of oral treatment with rifampicin (600mg/day for > 50 kg or 400mg/day < 50 kg body weight) as a single daily dose dispensed weekly at the participants home by a study team member. If during the pilot study we receive approval for the use of a new treatment regimen we will commence new participants on this regimen. 3HP regimen: 12 weeks of oral treatment administered once a week with isoniazid (15mg/kg, with 900mg maximum dose) and rifapentine (900mg if greater than or equal to 50Kg, otherwise 15mg/kg if aged > 12 years) Screening for LTBI will be performed as the part if the study. Screening involves implementation of an tuberculin skin test (TST) using the Mantoux technique. The TST is performed by injecting a small amount of tuberculin under the skin on the participants forearm. 48-72 hours after injection the test site is checked and the size of any lump will determine whether the test is positive or negative. Participants who do not have a positive TST will not be offered any LTBI treatment. However, if they have symptoms of TB, they will be screened for TB disease. TEST phase Screening for LTBI infection TREAT phase Treatment of LTBI in those who screen positive for LTBI.
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Resident in any of three selected Aps in Ca Mau Province, Vietnam
Exclusion criteria
Exclusion criteria for the TEST phase; No exclusion criteria for the test phase. Exclusion criteria for the TREAT phase; * Pregnant women or women planning and attempting to fall pregnant * Active TB
Outcome results
None listed