DRug Use & Infections in ViEtnam: TuBerculosis Control

Vietnam has a strong National TB Program (NTP), but it belongs to the 20 countries with the highest TB burden in the world. A TB prevalence study among people who inject drugs (PWID) was conducted as part of the Drug use \& Infections in ViEtnam (DRIVE) program, in collaboration with a local screening initiative (Zero TB Vietnam, national TB program - NTP) in 2018 in Hai Phong. While the annual TB rate in the general population of Vietnam is 0.13%, this study found an alarming prevalence of confirmed TB cases from 1.8% to 5.6% among PWID. Some populations, such as people who inject drugs (PWID), combine a very high risk of TB and low access to TB care. Based on the investigators experience in operational research among PWID and their expertise in TB, they designed an intervention to end TB among a highly vulnerable population such as PWID, through significant community involvement.

They hypothesize that a targeted, multi-component community-based intervention among PWID in Hai Phong will decrease TB prevalence among this very high-risk population.

The DRIVE-TB intervention will use four repeated large-scale randomized driven sampling surveys (RDSS) to identify TB-infected PWID in the community. During RDSS 1 and 4 all participants will undergo a questionnaire on TB symptoms, and have CRP, chest X-ray, and sputum collection for Xpert MTB-RIF®. In RDSS 2 and 3, participants will be screened through the best screening algorithm (elaborated in RDSS1). Participants from all RDSS will also be screened for LTBI through Tuberculin Skin Test (TST). Moreover the 3HP ancillary study, a therapeutic cohort will assess the acceptability, safety, adherence, and cost of a 12-dose once-weekly regimen of isoniazid/rifapentine (3HP) to prevent TB disease among RDSS 2 participants with a positive QuantiFERON test result will be assessed.

• Assess TB awareness [Time frame: 2 years]
• The feasibility and efficacy of the TB mass screening [Time frame: Through study completion, an average of 2 years]
• Proportion of confirmed TB cases who have initiated TB treatment among those who have attended the referral TB center for confirmation in RDSS 1, 2, 3. [Time frame: Up to one year]
• Prevalence of active TB and LTBI among PWID contacts [Time frame: 1 year]
• The incidence of active TB and LTBI among PWID contacts at 6 and 12 months. [Time frame: 2 years]
• The proportion of PWID contacts actually screened for TB at the community study site. [Time frame: 1 year]
• The incidence of TB infection (LTBI and active TB) among PWID in Hai Phong [Time frame: 2 years]
• HIV viremia prevalence at RDSS1 [Time frame: At baseline]
• Incremental cost-effectiveness ratio (ICER) and cost per DALY averted. [Time frame: At baseline]
• Acceptability of the 3HP regimen, [Time frame: 3 months after inclusion in RDSS2]
• Safety of the 3HP regimen, [Time frame: 3 months after inclusion in RDSS2]
• Proportion of participants who have completed a 12-dose once-weekly regimen of isoniazid/rifapentine (3HP) among those who have initiated 3HP. [Time frame: 3 months after inclusion in RDSS2]