DRug Use & Infections in ViEtnam: TuBerculosis Control

NCT05655702 | Recruiting DMC

• 1 other identifier: ANRS 0092s DRIVE-TB
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Tuberculosis

Keywords

people who inject drug; screening

Outcome Measures

Primary Outcomes (1)

• Prevalence of confirmed TB cases at RDSS 1 and RDSS 4

  2 years between RDSS 1 and 4

Secondary Outcomes (12)

• Assess TB awareness

  2 years

• The feasibility and efficacy of the TB mass screening

  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

Study Arms (1)

community-based TB intervention

OTHER

Other: Community based TB intervention

Interventions

Community based TB intervention 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.

community-based TB intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Haiphong University of Medicine and Pharmacy: collaborator
• Expertise France: collaborator
• Université Montpellier: collaborator
• New York University: collaborator
• CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES: collaborator

Study Sites (2)

Hai Phong University of Medecine and Pharmacy

Haiphong, Vietnam

RECRUITING

Viettiep 2 Hospital

Haiphong, Vietnam

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Nicolas NAGOT

  PCCI UMR 1058 - INSERM, Univ Montpellier, EFS, Montpellier, Franc

  PRINCIPAL INVESTIGATOR

• Huong DUONG THI

  Hai Phong University of Medicine and Pharmacy, Vietnam

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion BONNETON

CONTACT

+84344755013; marion.bonneton@inserm.fr

Hai NGUYEN THANH

CONTACT

+84 9 13 51 36 54; nthanhhai@hpmu.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: December 19, 2022
• Study Start: October 2, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)