Feasibility of Interventions on People Who Inject Drugs in Vietnam

Completed

• Conditions: Substance Abuse; Hepatitis Virus; HIV

• Registration Number: NCT02573948
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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 Timeline

• Study Start: 2014-09
• Primary Completion: 2015-06
• Study First Submitted: 2015-09-22
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-12
• Study Completion: 2016-06
• Results First Submitted: 2017-03-20
• Results First Submitted QC: 2018-07-12
• Status Verified: 2018-08
• Results First Posted: 2018-08-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 603

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hai Phong Medical University; 🇻🇳 Hai Phong, Vietnam