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DRug Use and Infections in Hai Phong ViEtnam Among Persons Who Inject Drugs

DRIVE (DRug Use and Infections in ViEtnam) Project : Ending the HIV Epidemic Among Persons Who Inject Drugs in Hai Phong, Viet Nam

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03526939
Acronym
DRIVE
Enrollment
5546
Registered
2018-05-16
Start date
2016-10-17
Completion date
2020-01-10
Last updated
2021-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, HIV, Mental Health

Keywords

Persons who inject drugs, HIV, Hepatitis C, Vietnam, Behavioral Intervention

Brief summary

The overarching purpose of the proposed research is to demonstrate that high coverage implementation of combined prevention and care using an innovative approach will end the HIV epidemic among PWID in Haiphong, Viet Nam.

Detailed description

Injection drug use is driving HIV epidemics in low/middle-income countries in Eastern Europe, Central Asia and Southeast Asia. Combined prevention and care, including needle/syringe programs (NSP), medication-assisted treatment for opiate dependence, and antiretroviral treatment, has greatly reduced HIV incidence among persons who inject drugs (PWID) in many high-income areas, to where the HIV epidemics among PWID have ended. There is now the need for a convincing demonstration that an HIV epidemic can be ended in a low/middle income setting. The overarching purpose of the proposed research is to demonstrate that high coverage implementation of combined prevention and care using an innovative approach will end the HIV epidemic among PWID in Haiphong, Viet Nam. The researchers define ending the epidemic as reducing HIV incidence to 0.5/100 person-years at risk. Data collection will include recruitment using repeated community based respondent driven sampling (RDS) surveys, once per year among PWID in Hai Phong. Participants will be given a quantitative questionnaire and tested for HIV and Hepatitis C (HCV). Peer support groups will be mobilized to help recruit PWID and assist in educations on the benefits of early ART, access to methadone, antiretroviral treatment and psychiatric services, and ways to prevent HIV and HCV transmission through safe injection practices and safe sex. Additionally, the investigators will develop large cohorts of HIV positive and HIV negative PWID to closely document behaviors trends, HIV incidence, and the obstacles of the access and retention in HIV care and methadone. It has been shown that it is possible to end HIV epidemics among PWID in several high income countries. This study will build upon the knowledge and results gained in high income settings to achieve viral suppression among HIV positive PWID and reduce HIV/HCV incidence in order to end the HIV epidemic among persons who inject drugs in Haiphong.

Interventions

None listed

Sponsors

Hai Phong Medical University
CollaboratorOTHER
Université Montpellier
CollaboratorOTHER
Centre for Supporting Community Development Initiatives (SCDI)
CollaboratorUNKNOWN
New York University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* age 18 or older * capable of giving informed consent and participating in study activities * history of drug injection (confirmed by visual inspection or subject knowledge of injecting procedures) * currently using an injectable drug (heroin or methamphetamine * confirmed by urine test), not on MMT at initial recruitment * willingness to participate in follow up studies, and expecting to remain in Haiphong for 2 years

Exclusion criteria

* less than 18 years of age * on MMT at initial recruitment * refusal to participate in follow-up studies * no history of drug injection * not currently using injectable drug (heroin or methamphetamine) * not capable of giving informed consent * those not expecting to remain in Haiphong for at least 2 years

Design outcomes

Primary

MeasureTime frameDescription
Incidence of HIV in the PWID populationup to 48 monthsIncidence of HIV in the PWID population to be calculated in person-years

Secondary

MeasureTime frameDescription
Number of participants with unsuppressed viral loadup to 48 monthsThe number of HIV+ PWID with unsuppressed viral load in the strategic subpopulation
Cost-Effectiveness ratio as compared to baselinebaseline, 3 years, 7 years, 10 years, and 20 yearsC1 and C0 denote the total (discounted) costs of HIV prevention and treatment for PWID. H1 and H0 denote the total number of incident HIV infections. If T denotes the average lifetime cost of treating someone with HIV and D denotes the average number of disability-adjusted life years (DALYs) lost due to HIV infection, then the cost per DALY saved by the proposed interventions is the cost-effectiveness ratio, R = (∆C - ∆H\*T)/(∆H\*D).
Incremental costs avertedup to 20 yearsEstimated incremental costs per HIV infection averted
Lifetime medical costsup to 20 yearsEstimated lifetime medical costs for treating HIV infection

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026