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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)

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions HIV
Hepatitis Virus
Substance Abuse
Intervention Other: no intervention is assessed
Enrollment 603
Recruitment Details People Who Injected Drugs (PWID), age > 18 years, with history of injecting drug use confirmed by a positive urine test and visual inspection of injection marks
Pre-assignment Details  
Arm/Group Title People Who Injected Drugs (PWID) Respondent Driven Sample (RDS
Hide Arm/Group Description 603 participants recruited through Respondent Driven Sample survey
Period Title: RDS
Started 603
Completed 603
Not Completed 0
Period Title: Longitudinal Cohort
Started [1] 250 [2]
Completed 194
Not Completed 56
Reason Not Completed
Death             9
Lost to Follow-up             22
Incarcerated             25
[1]
Among 603 RDS participants, 250 PWID were selected for the longitudinal follow-up.
[2]
Not on ART a/o MMT. MSM and FSW were prioritized for enrolling,
Arm/Group Title PWID RDS
Hide Arm/Group Description 603 participants
Overall Number of Baseline Participants 603
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 603 participants
36.5  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 603 participants
Female
61
  10.1%
Male
542
  89.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Vietnam Number Analyzed 603 participants
603
Medical Insurance  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 603 participants
105
  17.4%
Duration of Injection use  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 603 participants
8
(4 to 13)
Number of drug injection (typical day)  
Mean (Standard Deviation)
Unit of measure:  Injection per day
Number Analyzed 603 participants
2.7  (1)
Injecting drug: heroin alone  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 603 participants
602
  99.8%
Injection with syringe already used by someone else (last 3 months)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 603 participants
33
   5.5%
HIV positive  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 603 participants
152
  25.2%
Currently under Methadone Maintenance Therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 603 participants
36
   6.0%
HCV positive  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 603 participants
398
  66.0%
1.Primary Outcome
Title Number of Cohort Participants Attending the Last Follow-up Visit at W52
Hide Description Number of participants who were followed up and not lost to follow-up after enrolment into cohort.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were invited to follow-up visits at W4, W12, W24 and W52
Arm/Group Title PWID Cohort
Hide Arm/Group Description:
250 participants selected among 603 RDS participants
Overall Number of Participants Analyzed 250
Measure Type: Count of Participants
Unit of Measure: Participants
194
  77.6%
2.Secondary Outcome
Title HCV Seroconversion
Hide Description Number of new HCV infection among HCV negative (at RDS) cohort participants over 1 year period
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
HCV negative cohort participants with HCV test result available at W24 and/or W52.
Arm/Group Title HCV Negative Cohort Participants
Hide Arm/Group Description:
Cohort participants, HCV negative at RDS
Overall Number of Participants Analyzed 92
Measure Type: Count of Participants
Unit of Measure: Participants
18
  19.6%
3.Secondary Outcome
Title HIV Seroconversion
Hide Description Number of new HIV infection among HIV negative (at RDS) cohort participants over 1 year period.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
HIV negative cohort participants with HIV test result available at W24 and/or W52.
Arm/Group Title HIV Negative Cohort Participants
Hide Arm/Group Description:
Cohort participants, HIV negative at RDS.
Overall Number of Participants Analyzed 180
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Secondary Outcome
Title Incidence of HCV Infection
Hide Description The HCV incidence was calculated by 100person/year
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
HCV negative cohort participants with HCV test result available at W24 a/or W52
Arm/Group Title HCV Negative Cohort Participants
Hide Arm/Group Description:
HCV negative (at RDS) participants
Overall Number of Participants Analyzed 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: infections per 100 person-years
19.4
(11.5 to 30.7)
5.Secondary Outcome
Title HIV Incidence
Hide Description HIV incidence was calculated by 100person/year. With zero conversion, we choose 2.5% unilateral confidence interval.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
HIV negative cohort participants with HCV test result available at W24 a/or W52
Arm/Group Title HIV Negative Cohort Participants
Hide Arm/Group Description:
Cohort participants, HIV negative at RDS.
Overall Number of Participants Analyzed 180
Measure Type: Number
Number (2.5% Confidence Interval)
Unit of Measure: infections per 100 person-years
0
(0 to 1.8)
Time Frame 52 weeks
Adverse Event Reporting Description Adverse events reported for cohort participants (n=250)
 
Arm/Group Title PWID Cohort
Hide Arm/Group Description 250 participants
All-Cause Mortality
PWID Cohort
Affected / at Risk (%)
Total   9/250 (3.60%)    
Hide Serious Adverse Events
PWID Cohort
Affected / at Risk (%) # Events
Total   9/250 (3.60%)    
General disorders   
Overdose *  2/250 (0.80%)  2
Immune system disorders   
AIDS *  5/250 (2.00%)  5
Psychiatric disorders   
Suicide *  2/250 (0.80%)  2
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PWID Cohort
Affected / at Risk (%) # Events
Total   0/250 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: NAGOT NICOLAS
Organization: UMR 1058 (Inserm/University of Montpellier/EFS)
Phone: +33 4 34 35 91 09
EMail: n-nagot@chu-montpellier.fr
Publications of Results:
Layout table for additonal information
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    
Other Study ID Numbers: ANRS12299 DRIVE IN
P30DA011041 ( U.S. NIH Grant/Contract )
First Submitted: September 22, 2015
First Posted: October 12, 2015
Results First Submitted: March 20, 2017
Results First Posted: August 8, 2018
Last Update Posted: September 18, 2018