DRug Use & Infections in ViEtnam: TuBerculosis Control

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

4000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2025-11-30

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.

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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.

Conditions

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Tuberculosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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community-based TB intervention

Group Type OTHER

Community based TB intervention

Intervention Type OTHER

* 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.

Interventions

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Community based TB intervention

* 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.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes