Tuberculosis Clinical Trial
— DRIVE-TBOfficial 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.
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 |
Country | Name | City | State |
---|---|---|---|
Vietnam | Hai Phong University of Medecine and Pharmacy | H?i Phòng | |
Vietnam | Viettiep 2 Hospital | H?i Phòng |
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 |
Vietnam,
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 |
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