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

March 2, 2021 updated by: New York University

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

5546

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hải Phòng, Vietnam
        • Haiphong Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Residents of Haiphong Vietnam who currently are injecting drugs (heroin or methamphetamine) and at least 18 years of age

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
HIV negative from RDS round 1
HIV negative PWID subjects from RDS round 1
HIV negative from RDS round 2
HIV negative PWID subjects from RDS round 2
HIV negative from RDS round 3
HIV negative PWID subjects from RDS round 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of HIV in the PWID population
Time Frame: up to 48 months
Incidence of HIV in the PWID population to be calculated in person-years
up to 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with unsuppressed viral load
Time Frame: up to 48 months
The number of HIV+ PWID with unsuppressed viral load in the strategic subpopulation
up to 48 months
Cost-Effectiveness ratio as compared to baseline
Time Frame: baseline, 3 years, 7 years, 10 years, and 20 years
C1 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).
baseline, 3 years, 7 years, 10 years, and 20 years
Incremental costs averted
Time Frame: up to 20 years
Estimated incremental costs per HIV infection averted
up to 20 years
Lifetime medical costs
Time Frame: up to 20 years
Estimated lifetime medical costs for treating HIV infection
up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York University

Collaborators

Université Montpellier
Hai Phong Medical University
Centre for Supporting Community Development Initiatives (SCDI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2016

Primary Completion (Actual)

January 10, 2020

Study Completion (Actual)

January 10, 2020

Study Registration Dates

First Submitted

May 4, 2018

First Submitted That Met QC Criteria

May 4, 2018

First Posted (Actual)

May 16, 2018

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 15-1533

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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