DRug Use & Infections in ViEtnam: TuBerculosis Control

Study Overview
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Brief Summary
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The overarching purpose of the proposed research is to demonstrate that a targeted, multi-component community-based intervention among PWID in Hai Phong will decrease TB prevalence among this very high-risk population.

Detailed Description
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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.

Official Title
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DRug Use & Infections in ViEtnam: TuBerculosis Control Towards Tuberculosis Elimination Among People Who Inject Drugs: Evaluation of a Community-based Intervention in Vietnam

Conditions
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Tuberculosis

Intervention / Treatment
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* Other: Community based TB intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Self-declaring injecting heroin or any other drug Positive urine test for heroin or methamphetamine Presence of recent injection site marks Exclusion Criteria: Unable to understand or refused to sign informed consent Patients currently under treatment for active TB Any condition which might, in the investigator's opinion, compromise the safety of the patient by participating in the study, including very severe clinical condition Person deprived of freedom by a judicial or administrative decision

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: community-based TB intervention<br> | Other: Community based TB intervention<br>* 3 bi-annual RDSS (RDSS1, 2 and 3), for TB screening A PWID-specific Information and communication (I&C) TB module to improve PWID awareness about TB, Peer group support to facilitate TB treatment initiation and retention, Implementation of a peer support contact tracing and screening for active TB in contacts.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of confirmed TB cases at RDSS 1 and RDSS 4 |  | 2 years between RDSS 1 and 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess TB awareness | Appropriate answers to a set of questions on the knowledge of TB encompassing 3 domains (symptoms, mode of transmission, treatment), at RDSS1 and RDSS4. | 2 years | 
| The feasibility and efficacy of the TB mass screening | will be evaluated by the proportion of eligible RDSS participants (i.e. meeting the inclusion criteria) who consent to participate after information. The efficacy of the mass screening, defined by the proportion of those actually tested among the RDSS participants. | 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. |  | Up to one year | 
| Prevalence of active TB and LTBI among PWID contacts |  | 1 year | 
| The incidence of active TB and LTBI among PWID contacts at 6 and 12 months. |  | 2 years | 
| The proportion of PWID contacts actually screened for TB at the community study site. |  | 1 year | 
| The incidence of TB infection (LTBI and active TB) among PWID in Hai Phong |  | 2 years | 
| HIV viremia prevalence at RDSS1 | defined by the ratio of PWID with HIV viral load >1000 copies/mL among all PWID, whatever their HIV status | At baseline | 
| Incremental cost-effectiveness ratio (ICER) and cost per DALY averted. |  | At baseline | 
| Acceptability of the 3HP regimen, | Defined by both the proportion of RDSS2 participants who accept to participate in the LTBI study after information, and by those who initiated a isoniazid/rifapentine (3HP) among those eligible (i.e. with a positive QuantiFERON test result). | 3 months after inclusion in RDSS2 | 
| Safety of the 3HP regimen, | Defined by the rate of patients with grade ≥2 adverse events, potentially related to the 3HP regimen, including craving symptoms. | 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. |  | 3 months after inclusion in RDSS2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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people who inject drug, screening