DRug Use & Infections in ViEtnam: TuBerculosis Control

Tuberculosis Clinical Trial

— DRIVE-TB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05655702
• Other study ID #: ANRS 0092s DRIVE-TB
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: ANRS, Emerging Infectious Diseases
• Contact: Marion BONNETON
• Phone: +84344755013
• Email: marion.bonneton[@]inserm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

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.

Locations

Country	Name	City	State
Vietnam	Hai Phong University of Medecine and Pharmacy	H?i Phòng
Vietnam	Viettiep 2 Hospital	H?i Phòng

Sponsors (6)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases	CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES, Expertise France, Haiphong University of Medicine and Pharmacy, New York University, Université Montpellier

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of confirmed TB cases at RDSS 1 and RDSS 4		2 years between RDSS 1 and 4
Secondary	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
Secondary	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
Secondary	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
Secondary	Prevalence of active TB and LTBI among PWID contacts		1 year
Secondary	The incidence of active TB and LTBI among PWID contacts at 6 and 12 months.		2 years
Secondary	The proportion of PWID contacts actually screened for TB at the community study site.		1 year
Secondary	The incidence of TB infection (LTBI and active TB) among PWID in Hai Phong		2 years
Secondary	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
Secondary	Incremental cost-effectiveness ratio (ICER) and cost per DALY averted.		At baseline
Secondary	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
Secondary	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
Secondary	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