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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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)

Tracking Information
First Submitted Date September 22, 2015
First Posted Date October 12, 2015
Results First Submitted Date March 20, 2017
Results First Posted Date August 8, 2018
Last Update Posted Date September 18, 2018
Study Start Date September 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 12, 2018)
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.
Original Primary Outcome Measures
 (submitted: October 9, 2015)
Proportion of participants followed up and not lost to follow-up after enrolment. [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures
 (submitted: July 12, 2018)
  • HCV Seroconversion [ Time Frame: 52 weeks ]
    Number of new HCV infection among HCV negative (at RDS) cohort participants over 1 year period
  • HIV Seroconversion [ Time Frame: 52 weeks ]
    Number of new HIV infection among HIV negative (at RDS) cohort participants over 1 year period.
  • Incidence of HCV Infection [ Time Frame: 52 weeks ]
    The HCV incidence was calculated by 100person/year
  • HIV Incidence [ Time Frame: 52 weeks ]
    HIV incidence was calculated by 100person/year. With zero conversion, we choose 2.5% unilateral confidence interval.
Original Secondary Outcome Measures
 (submitted: October 9, 2015)
  • Proportion of individuals who are newly HCV infected of the total number of participants in the 6 month period [ Time Frame: 6 months ]
  • Proportion of individuals who are newly HIV infected of the total number of participants in the 6 month period [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Feasibility of Interventions on People Who Inject Drugs in Vietnam
Official Title Feasibility of an Interventional Project to Reduce HIV Incidence Among People Who Inject Drugs in Haiphong, Viet Nam
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • HIV
  • Hepatitis Virus
  • Substance Abuse
Intervention Other: no intervention is assessed
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 12, 2018)
603
Original Estimated Enrollment
 (submitted: October 9, 2015)
600
Actual Study Completion Date June 2016
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number NCT02573948
Other Study ID Numbers ANRS12299 DRIVE IN
P30DA011041 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Study Sponsor French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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
PRS Account French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Verification Date August 2018