HIVDRIVE-INNCT02573948
Feasibility of Interventions on People Who Inject Drugs in Vietnam
An observational study of HIV and Hepatitis Virus, run by ANRS, Emerging Infectious Diseases at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Hepatitis Virus, Substance Abuse
- How many people
- 603 participants
- Where
- 1 siteVietnam
- Study dates
- Sep 2014to Jun 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of an Interventional Project to Reduce HIV Incidence Among People Who Inject Drugs in Haiphong, Viet Nam
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.
Read the 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
- Conditions
- HIV, Hepatitis Virus, Substance Abuse
- Being tested
- no intervention is assessed
- Keywords
- People who inject drugs, Vietnam, Community support groups
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention is assessedOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cohort Participants Attending the Last Follow-up Visit at W52
Number of participants who were followed up and not lost to follow-up after enrolment into cohort.
Measured: 52 weeks
Secondary outcomes (4)
HCV Seroconversion
Number of new HCV infection among HCV negative (at RDS) cohort participants over 1 year period
Measured: 52 weeks
HIV Seroconversion
Number of new HIV infection among HIV negative (at RDS) cohort participants over 1 year period.
Measured: 52 weeks
Incidence of HCV Infection
The HCV incidence was calculated by 100person/year
Measured: 52 weeks
HIV Incidence
HIV incidence was calculated by 100person/year. With zero conversion, we choose 2.5% unilateral confidence interval.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Nicolas Nagot, MD,PhD, Principal investigator, INSERM U1058 & University of Montpellier, FranceOanh Khuat Thi, MD, MSc, Principal investigator, Supporting Community Development Initiatives (SCDI)Don DesJarlais, PhD, Principal investigator, Mount Sinai Beth Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573948
- Sponsor's protocol ID
- ANRS12299 DRIVE IN
- Other IDs
- P30DA011041
- Acronym
- DRIVE-IN
- Status last verified
- Aug 2018
- First submitted
- 22 Sep 2015
- Last updated
- 18 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26080690Perlman 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.
PubMed 26075647Perlman 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.
PubMed 26050614Hatzakis 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.
PubMed 26032121Des 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.
PubMed 25540950Michel 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.
PubMed 28800503Des 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.
PubMed 27178119Des 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.
PubMed 27006257Duong 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.
PubMed 28612212
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Interventional Project to Reduce HIV Incidence Among People Who Inject Drugs in Haiphong, Viet Nam
- ClinicalTrials.gov ID
- NCT02573948
- Acronym / sponsor ID
- DRIVE-IN / ANRS12299 DRIVE IN
- Conditions
- HIV, Hepatitis Virus, Substance Abuse
- Keywords
- People who inject drugs, Vietnam, Community support groups
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Posted 8 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention is assessed | Other | – |
Primary outcome
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.
4 secondary outcomes
HCV Seroconversion
Time frame: 52 weeks
HIV Seroconversion
Time frame: 52 weeks
Incidence of HCV Infection
Time frame: 52 weeks
HIV Incidence
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26080690Elliott 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.
- Background: PubMed 26075647Perlman 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.
- Background: PubMed 26050614Perlman 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.
- Background: PubMed 26032121Hatzakis 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.
- Background: PubMed 25540950Des 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.
- Results publication: PubMed 28800503Michel 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.
- Results publication: PubMed 27178119Des 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.
- Results publication: PubMed 27006257Des 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.
- Results publication: PubMed 28612212Duong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Nagot, MD,PhD principal investigator
INSERM U1058 & University of Montpellier, France
Oanh Khuat Thi, MD, MSc principal investigator
Supporting Community Development Initiatives (SCDI)
Don DesJarlais, PhD principal investigator
Mount Sinai Beth Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Hepatitis Virus, run by ANRS, Emerging Infectious Diseases at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Cohort Participants Attending the Last Follow-up Visit at W52 (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02573948, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.