Clinical trial NCT05655702: DRug Use & Infections in ViEtnam: TuBerculosis Control
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tuberculosis
Keywords: people who inject drug
screening
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Haiphong University of Medicine and Pharmacy
name: Expertise France
name: Université Montpellier
name: New York University
name: CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES
First posted: 2022-12-19
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of confirmed TB cases at RDSS 1 and RDSS 4
timeFrame: 2 years between RDSS 1 and 4
Secondary outcomes:
measure: Assess TB awareness
timeFrame: 2 years
measure: The feasibility and efficacy of the TB mass screening
timeFrame: Through study completion, an average of 2 years
measure: 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.
timeFrame: Up to one year
measure: Prevalence of active TB and LTBI among PWID contacts
timeFrame: 1 year
measure: The incidence of active TB and LTBI among PWID contacts at 6 and 12 months.
timeFrame: 2 years
measure: The proportion of PWID contacts actually screened for TB at the community study site.
timeFrame: 1 year
measure: The incidence of TB infection (LTBI and active TB) among PWID in Hai Phong
timeFrame: 2 years
measure: HIV viremia prevalence at RDSS1
timeFrame: At baseline
measure: Incremental cost-effectiveness ratio (ICER) and cost per DALY averted.
timeFrame: At baseline
measure: Acceptability of the 3HP regimen,
timeFrame: 3 months after inclusion in RDSS2
measure: Safety of the 3HP regimen,
timeFrame: 3 months after inclusion in RDSS2
measure: Proportion of participants who have completed a 12-dose once-weekly regimen of isoniazid/rifapentine (3HP) among those who have initiated 3HP.
timeFrame: 3 months after inclusion in RDSS2
Other outcomes:
Locations:
city: Hải Phòng
country: Vietnam
facility: Hai Phong University of Medecine and Pharmacy
city: Hải Phòng
country: Vietnam
facility: Viettiep 2 Hospital
Study officials:
affiliation: PCCI UMR 1058 - INSERM, Univ Montpellier, EFS, Montpellier, Franc
name: Nicolas NAGOT
role: PRINCIPAL_INVESTIGATOR
affiliation: Hai Phong University of Medicine and Pharmacy, Vietnam
name: Huong DUONG THI
role: PRINCIPAL_INVESTIGATOR
References: