TuberculosisDRIVE-TBNCT05655702
DRug Use & Infections in ViEtnam: TuBerculosis Control
A study testing Community based TB intervention in people with Tuberculosis, run by ANRS, Emerging Infectious Diseases at 2 sites in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Community based TB intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 2 sitesVietnam
- Study dates
- 2 Oct 2023to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam2 sites, 2 recruiting
- Recruiting
Hai Phong University of Medecine and Pharmacy
Haiphong
Huong DUONG THI, dthuong@hpmu.edu.vn
- Recruiting
Viettiep 2 Hospital
Haiphong
Vinh VU HAI
About this study
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
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.
Read the 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.
- Conditions
- Tuberculosis
- Being tested
- Community based TB intervention
- Keywords
- people who inject drug, screening
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community based TB interventionOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| community-based TB intervention | Other | Not described Receives: Other: Community based TB intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of confirmed TB cases at RDSS 1 and RDSS 4
Measured: 2 years between RDSS 1 and 4
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: Up to one year
Prevalence of active TB and LTBI among PWID contacts
Measured: 1 year
The incidence of active TB and LTBI among PWID contacts at 6 and 12 months.
Measured: 2 years
The proportion of PWID contacts actually screened for TB at the community study site.
Measured: 1 year
The incidence of TB infection (LTBI and active TB) among PWID in Hai Phong
Measured: 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
Measured: At baseline
Incremental cost-effectiveness ratio (ICER) and cost per DALY averted.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 3 months after inclusion in RDSS2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start2 Oct 2023
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Haiphong University of Medicine and Pharmacy, Expertise France, Université Montpellier, New York University, CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES
- Responsible party
- Sponsor
- Investigators
- Nicolas NAGOT, Principal investigator, PCCI UMR 1058 - INSERM, Univ Montpellier, EFS, Montpellier, FrancHuong DUONG THI, Principal investigator, Hai Phong University of Medicine and Pharmacy, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655702
- Sponsor's protocol ID
- ANRS 0092s DRIVE-TB
- Acronym
- DRIVE-TB
- Status last verified
- Jan 2025
- First submitted
- 2 Nov 2022
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05655702
- Acronym / sponsor ID
- DRIVE-TB / ANRS 0092s DRIVE-TB
- Conditions
- Tuberculosis
- Keywords
- people who inject drug, screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Haiphong University of Medicine and Pharmacy, Expertise France, Université Montpellier, New York University, CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| community-based TB intervention | Other | Other: Community based TB intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | community-based TB intervention |
Primary outcome
Prevalence of confirmed TB cases at RDSS 1 and RDSS 4
Time frame: 2 years between RDSS 1 and 4
12 secondary outcomes
Assess TB awareness
Time frame: 2 years
The feasibility and efficacy of the TB mass screening
Time frame: 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.
Time frame: Up to one year
Prevalence of active TB and LTBI among PWID contacts
Time frame: 1 year
The incidence of active TB and LTBI among PWID contacts at 6 and 12 months.
Time frame: 2 years
The proportion of PWID contacts actually screened for TB at the community study site.
Time frame: 1 year
The incidence of TB infection (LTBI and active TB) among PWID in Hai Phong
Time frame: 2 years
HIV viremia prevalence at RDSS1
Time frame: At baseline
Incremental cost-effectiveness ratio (ICER) and cost per DALY averted.
Time frame: At baseline
Acceptability of the 3HP regimen,
Time frame: 3 months after inclusion in RDSS2
Safety of the 3HP regimen,
Time frame: 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.
Time frame: 3 months after inclusion in RDSS2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas NAGOT principal investigator
PCCI UMR 1058 - INSERM, Univ Montpellier, EFS, Montpellier, Franc
Huong DUONG THI principal investigator
Hai Phong University of Medicine and Pharmacy, Vietnam
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community based TB intervention in people with Tuberculosis, run by ANRS, Emerging Infectious Diseases at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion BONNETON (+84344755013, marion.bonneton@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of confirmed TB cases at RDSS 1 and RDSS 4 (time frame: 2 years between RDSS 1 and 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.