Feasibility of Interventions on People Who Inject Drugs in Vietnam (DRIVE-IN)

August 20, 2018 updated by: ANRS, Emerging Infectious Diseases

Feasibility of an Interventional Project to Reduce HIV Incidence Among People Who Inject Drugs in Haiphong, Viet Nam

This study aims at assessing the feasibility of implementing an interventional cohort of people who inject drugs in Haiphong, Viet Nam.

For this purpose, the investigators will conduct a RDS survey to i) assess the current situation of drug use behaviour, HIV and Hepatitis C Virus (HCV) infection in the study population and ii) recruit participants for the longitudinal phase. The latter will consist of enroling the most difficult to reach People Who Inject Drugs (PWID) (those not followed by health centers), including early injectors, Men who have Sex with Men (MSM) and female sex workers (FSW) and following them up for 6 months in order to estimate the follow-up rate and preliminary estimates of HIV and HCV incidence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives:

The primary objective of the DRIVE-IN project is to evaluate the feasibility of implementing an interventional cohort of PWID in Haiphong. Such a cohort (DRIVE) will be instrumental in demonstrating the efficacy of a community-involved intervention integrating prevention and care in order to reduce HIV and HCV transmission among PWID in Haiphong.

The main expected result of DRIVE-IN is to demonstrate that enrolment and follow-up of various hard-to-reach subgroups of PWID is feasible in the local context. These feasibility objectives will be evaluated using a set of relevant indicators.

Design:

The research will first include a respondent-driven sampling (RDS) survey, including a maximum of 600 PWID. Then 250 RDS participants (i.e about a quarter of the future DRIVE cohort) will be selected for a longitudinal study, with an enrolment and 3 follow-up visits at week 4, 12 and 24. In parallel, four qualitative studies will be implemented: one study to explore how to reach the hardest-to-reach and most-at-risk PWID, one feed-back study on PWID feeling about their participation in the research, one study investigating the reasons of drop-outs, and a final study on the research process itself.

Endpoints:

The RDS will describe the target population and the patterns of drug use. The feasibility of implementing an interventional cohort will be evaluated on several indicators:

  • International multi-disciplinary research network is operational
  • Completion of recruitment within the time frame
  • Follow-up rate >80% at 24 weeks
  • Implementation and increased access to peer-led interventions
  • Establishment of a data management center
  • Improved laboratory capacities for research
  • Documented support of local and national authorities

Study population RDS survey Inclusion criteria Age > 18 years Self-reported drug injector confirmed by a positive urinary test and either skin marks of injection or knowledge of injecting procedures Signed informed consent Non-inclusion criteria Unable of understanding informed consent and answering questionnaires

Longitudinal study Inclusion criteria Having participated to the RDS survey Signed informed consent specific to the longitudinal study Non-inclusion criteria Ongoing Methadone Maintenance Therapy (MMT) Ongoing antiretroviral therapy Health status not compatible with study follow-up Have a plan to move out of Haiphong over the next two years. Have been sentenced recently to a prison term

Follow-up and study visits contents:

Participants of the longitudinal phase will be followed at week 4, 12 and 24 (final visit). During the RDS, face-to-face questionnaires will be applied on drug use, sexual health, and referral to care and repeated at each follow-up visit, along with the record of medical events. In addition, a urinary test will be collected at the RDS to assess the range of recent drugs used, and repeated at the final follow-up visit (week 24). Finally, at the RDS and final visit, HIV, HCV, Hepatitis B Virus (HBV) serology will be done along with appropriate counselling.

Sample size:

  • 603 PWID will be enrolled in the RDS survey
  • 250 RDS participants will be enroled in the longitudinal phase, including:
  • 140 PWID for > 2 years, including females
  • 50 recent injectors (< 2 years from first injection)
  • 30 FSW who inject drugs
  • 30 MSM who inject drugs

Study Type

Observational

Enrollment (Actual)

603

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
      • Hai Phong, Vietnam
        • Hai Phong 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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People who inject drugs living in Haiphong, Vietnam. The longitudinal phase will be restricted to those not followed by health care services, i.e. not taking methadone nor antiretroviral therapy

Description

  • Inclusion criteria

    • Being more than 18 years of age
    • Being drug injector confirmed by a positive urine drug test with knowledge of injecting procedures
    • Having signed the informed consent form
    • For the Longitudinal study - having participated in the RDS survey

  • Exclusion criteria

    • Unable to understand informed consent and how to answer a questionnaire
    • For the longitudinal study - being under methadone maintenance therapy and antiretroviral treatment
    • Having a health condition not compatible with study follow-up
    • Plan to move away from Haiphong in the next 2 years
    • Serving a sentence in prison

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Cohort Participants Attending the Last Follow-up Visit at W52
Time Frame: 52 weeks
Number of participants who were followed up and not lost to follow-up after enrolment into cohort.
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCV Seroconversion
Time Frame: 52 weeks
Number of new HCV infection among HCV negative (at RDS) cohort participants over 1 year period
52 weeks
HIV Seroconversion
Time Frame: 52 weeks
Number of new HIV infection among HIV negative (at RDS) cohort participants over 1 year period.
52 weeks
Incidence of HCV Infection
Time Frame: 52 weeks
The HCV incidence was calculated by 100person/year
52 weeks
HIV Incidence
Time Frame: 52 weeks
HIV incidence was calculated by 100person/year. With zero conversion, we choose 2.5% unilateral confidence interval.
52 weeks

Collaborators and Investigators

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

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Nicolas Nagot, MD,PhD, INSERM U1058 & University of Montpellier, France
  • Principal Investigator: Oanh Khuat Thi, MD, MSc, Supporting Community Development Initiatives (SCDI)
  • Principal Investigator: Don DesJarlais, PhD, Mount Sinai Beth Israel

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

September 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS12299 DRIVE IN
  • P30DA011041 (U.S. NIH Grant/Contract)

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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