Tuberculosis
Conditions
Keywords
people who inject drug, 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.
Interventions
OTHERCommunity 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.
Sponsors
Haiphong University of Medicine and Pharmacy
Expertise France
Université Montpellier
New York University
CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES
ANRS, Emerging Infectious Diseases
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of confirmed TB cases at RDSS 1 and RDSS 4 | 2 years between RDSS 1 and 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV viremia prevalence at RDSS1 | At baseline | defined by the ratio of PWID with HIV viral load \>1000 copies/mL among all PWID, whatever their HIV status |
| Assess TB awareness | 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. |
| The feasibility and efficacy of the TB mass screening | 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. |
| 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 | — |
| Prevalence of active TB and LTBI among PWID contacts | 1 year | — |
| Incremental cost-effectiveness ratio (ICER) and cost per DALY averted. | At baseline | — |
| The proportion of PWID contacts actually screened for TB at the community study site. | 1 year | — |
| The incidence of TB infection (LTBI and active TB) among PWID in Hai Phong | 2 years | — |
| Acceptability of the 3HP regimen, | 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). |
| Safety of the 3HP regimen, | 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. |
| 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 | — |
| The incidence of active TB and LTBI among PWID contacts at 6 and 12 months. | 2 years | — |
Countries
Vietnam
Contacts
Primary ContactMarion BONNETON
Backup ContactHai NGUYEN THANH
Outcome results
None listed