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Trial record 1 of 1 for:    NCT02573948
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Feasibility of Interventions on People Who Inject Drugs in Vietnam (DRIVE-IN)

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ClinicalTrials.gov Identifier: NCT02573948
Recruitment Status : Completed
First Posted : October 12, 2015
Results First Posted : August 8, 2018
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Brief Summary:

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.


Condition or disease Intervention/treatment
HIV Hepatitis Virus Substance Abuse Other: no intervention is assessed

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 603 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility of an Interventional Project to Reduce HIV Incidence Among People Who Inject Drugs in Haiphong, Viet Nam
Study Start Date : September 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. HCV Seroconversion [ Time Frame: 52 weeks ]
    Number of new HCV infection among HCV negative (at RDS) cohort participants over 1 year period

  2. HIV Seroconversion [ Time Frame: 52 weeks ]
    Number of new HIV infection among HIV negative (at RDS) cohort participants over 1 year period.

  3. Incidence of HCV Infection [ Time Frame: 52 weeks ]
    The HCV incidence was calculated by 100person/year

  4. HIV Incidence [ Time Frame: 52 weeks ]
    HIV incidence was calculated by 100person/year. With zero conversion, we choose 2.5% unilateral confidence interval.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573948


Locations
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Vietnam
Hai Phong Medical University
Hai Phong, Vietnam
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
National Institute on Drug Abuse (NIDA)
Investigators
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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 of Results:

Other Publications:
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Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT02573948     History of Changes
Other Study ID Numbers: ANRS12299 DRIVE IN
P30DA011041 ( U.S. NIH Grant/Contract )
First Posted: October 12, 2015    Key Record Dates
Results First Posted: August 8, 2018
Last Update Posted: September 18, 2018
Last Verified: August 2018
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
People who inject drugs
Vietnam
Community support groups
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders