Clinical trial NCT02573948: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Hepatitis Virus
Substance Abuse
Keywords: People who inject drugs
Vietnam
Community support groups
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-10-12
Enrollment: 603
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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

Primary outcomes:
measure: Number of Cohort Participants Attending the Last Follow-up Visit at W52
timeFrame: 52 weeks
Secondary outcomes:
measure: HCV Seroconversion
timeFrame: 52 weeks
measure: HIV Seroconversion
timeFrame: 52 weeks
measure: Incidence of HCV Infection
timeFrame: 52 weeks
measure: HIV Incidence
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Hai Phong
country: Vietnam
facility: Hai Phong Medical University
Study officials:
affiliation: INSERM U1058 & University of Montpellier, France
name: Nicolas Nagot, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Supporting Community Development Initiatives (SCDI)
name: Oanh Khuat Thi, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Beth Israel
name: Don DesJarlais, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elliott JC, Hasin DS, Stohl M, Des Jarlais DC. HIV, Hepatitis C, and Abstinence from Alcohol Among Injection and Non-injection Drug Users. AIDS Behav. 2016 Mar;20(3):548-54. doi: 10.1007/s10461-015-1113-z.
citation: Perlman DC, Des Jarlais DC, Feelemyer J. Can HIV and Hepatitis C Virus Infection be Eliminated Among Persons Who Inject Drugs? J Addict Dis. 2015;34(2-3):198-205. doi: 10.1080/10550887.2015.1059111.
citation: Perlman DC, Jordan AE, Uuskula A, Huong DT, Masson CL, Schackman BR, Des Jarlais DC. An international perspective on using opioid substitution treatment to improve hepatitis C prevention and care for people who inject drugs: Structural barriers and public health potential. Int J Drug Policy. 2015 Nov;26(11):1056-63. doi: 10.1016/j.drugpo.2015.04.015. Epub 2015 Apr 27.
citation: Hatzakis A, Sypsa V, Paraskevis D, Nikolopoulos G, Tsiara C, Micha K, Panopoulos A, Malliori M, Psichogiou M, Pharris A, Wiessing L, van de Laar M, Donoghoe M, Heckathorn DD, Friedman SR, Des Jarlais DC. Design and baseline findings of a large-scale rapid response to an HIV outbreak in people who inject drugs in Athens, Greece: the ARISTOTLE programme. Addiction. 2015 Sep;110(9):1453-67. doi: 10.1111/add.12999. Epub 2015 Jul 14.
citation: Des Jarlais DC. AIDS, people who use drugs, and altruism: reflection on a personal image. Subst Use Misuse. 2015 Mar;50(4):532-3. doi: 10.3109/10826084.2015.978185. Epub 2014 Dec 26. No abstract available.
citation: Michel L, Des Jarlais DC, Duong Thi H, Khuat Thi Hai O, Pham Minh K, Peries M, Vallo R, Nham Thi Tuyet T, Hoang Thi G, Le Sao M, Feelemyer J, Vu Hai V, Moles JP, Laureillard D, Nagot N; DRIVE Study Team. Intravenous heroin use in Haiphong, Vietnam: Need for comprehensive care including methamphetamine use-related interventions. Drug Alcohol Depend. 2017 Oct 1;179:198-204. doi: 10.1016/j.drugalcdep.2017.07.004. Epub 2017 Aug 2.
citation: Des Jarlais D, Duong HT, Pham Minh K, Khuat OH, Nham TT, Arasteh K, Feelemyer J, Heckathorn DD, Peries M, Moles JP, Laureillard D, Nagot N; (The Drive Study Team). Integrated respondent-driven sampling and peer support for persons who inject drugs in Haiphong, Vietnam: a case study with implications for interventions. AIDS Care. 2016 Oct;28(10):1312-5. doi: 10.1080/09540121.2016.1178698. Epub 2016 May 13.
citation: Des Jarlais DC, Thi Huong D, Thi Hai Oanh K, Khue Pham M, Thi Giang H, Thi Tuyet Thanh N, Arasteh K, Feelemyer J, Hammett T, Peries M, Michel L, Vu Hai V, Roustide MJ, Moles JP, Laureillard D, Nagot N; DRIVE Study Team. Prospects for ending the HIV epidemic among persons who inject drugs in Haiphong, Vietnam. Int J Drug Policy. 2016 Jun;32:50-6. doi: 10.1016/j.drugpo.2016.02.021. Epub 2016 Feb 27.
citation: Duong HT, Jarlais DD, Khuat OHT, Arasteh K, Feelemyer J, Khue PM, Giang HT, Laureillard D, Hai VV, Vallo R, Michel L, Moles JP, Nagot N; Drive Study Group. Risk Behaviors for HIV and HCV Infection Among People Who Inject Drugs in Hai Phong, Viet Nam, 2014. AIDS Behav. 2018 Jul;22(7):2161-2171. doi: 10.1007/s10461-017-1814-6.