Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05655702

DRug Use & Infections in ViEtnam: TuBerculosis Control

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hai Phong University of Medecine and Pharmacy, Haiphong, Vietnam

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 2 years between RDSS 1 and 4

Secondary outcomes

  1. Assess TB awareness

    Time frame: 2 years

    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. The feasibility and efficacy of the TB mass screening

    Time frame: Through study completion, an average of 2 years

    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.

  3. 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

  4. Prevalence of active TB and LTBI among PWID contacts

    Time frame: 1 year

  5. The incidence of active TB and LTBI among PWID contacts at 6 and 12 months.

    Time frame: 2 years

  6. The proportion of PWID contacts actually screened for TB at the community study site.

    Time frame: 1 year

  7. The incidence of TB infection (LTBI and active TB) among PWID in Hai Phong

    Time frame: 2 years

  8. HIV viremia prevalence at RDSS1

    Time frame: At baseline

    defined by the ratio of PWID with HIV viral load >1000 copies/mL among all PWID, whatever their HIV status

  9. Incremental cost-effectiveness ratio (ICER) and cost per DALY averted.

    Time frame: At baseline

  10. Acceptability of the 3HP regimen,

    Time frame: 3 months after inclusion in RDSS2

    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).

  11. Safety of the 3HP regimen,

    Time frame: 3 months after inclusion in RDSS2

    Defined by the rate of patients with grade ≥2 adverse events, potentially related to the 3HP regimen, including craving symptoms.

  12. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hai NGUYEN THANH

CONTACT

[email protected]

+84 9 13 51 36 54

Marion BONNETON

CONTACT

[email protected]

+84344755013

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES
  • Expertise France
  • Haiphong University of Medicine and Pharmacy
  • New York University
  • Université Montpellier

Registry information

Official study title

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

Acronym: DRIVE-TB

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2022
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.