DRug Use & Infections in ViEtnam: TuBerculosis Control (DRIVE-TB)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tuberculosis
• Intervention / Treatment: Other: Community based TB intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 4000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion BONNETON; Phone Number: +84344755013; Email: marion.bonneton@inserm.fr
• Study Contact Backup: Name: Hai NGUYEN THANH; Phone Number: +84 9 13 51 36 54; Email: nthanhhai@hpmu.edu.vn

Study Locations

• Vietnam
  • Hải Phòng, Vietnam
    • Recruiting
    • Hai Phong University of Medecine and Pharmacy
    • Contact: Huong DUONG THI; Email: dthuong@hpmu.edu.vn
  • Hải Phòng, Vietnam
    • Recruiting
    • Viettiep 2 Hospital
    • Contact: Vinh VU HAI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: community-based TB intervention	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Collaborators: New York University; Université Montpellier; Expertise France; Haiphong University of Medicine and Pharmacy; CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES
• Investigators: Principal Investigator: Nicolas NAGOT, PCCI UMR 1058 - INSERM, Univ Montpellier, EFS, Montpellier, Franc; Principal Investigator: Huong DUONG THI, Hai Phong University of Medicine and Pharmacy, Vietnam

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: screening; people who inject drug
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: ANRS 0092s DRIVE-TB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No