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
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|
|Study Type :||Observational|
|Actual Enrollment :||603 participants|
|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|
- 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.
- 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.
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
|Hai Phong Medical University|
|Hai Phong, Vietnam|
|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|