HIVDRIVENCT03526939
DRug Use and Infections in Hai Phong ViEtnam Among Persons Who Inject Drugs
An observational study of HIV and Hepatitis C, run by New York University at 1 site in Vietnam.
Trial summary
The overarching purpose of the proposed research is to demonstrate that high coverage implementation of combined prevention and care using an innovative approach will end the HIV epidemic among PWID in Haiphong, Viet Nam. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Hepatitis C, Mental Health
- How many people
- 5,546 participants
- Where
- 1 siteVietnam
- Study dates
- 17 Oct 2016to 10 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Residents of Haiphong Vietnam who currently are injecting drugs (heroin or methamphetamine) and at least 18 years of age
Who may be able to join
- age 18 or older
- capable of giving informed consent and participating in study activities
- history of drug injection (confirmed by visual inspection or subject knowledge of injecting procedures)
- currently using an injectable drug (heroin or methamphetamine
- confirmed by urine test), not on MMT at initial recruitment
- willingness to participate in follow up studies, and expecting to remain in Haiphong for 2 years
Who cannot join
- less than 18 years of age
- on MMT at initial recruitment
- refusal to participate in follow-up studies
- no history of drug injection
- not currently using injectable drug (heroin or methamphetamine)
- not capable of giving informed consent
- those not expecting to remain in Haiphong for at least 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DRIVE (DRug Use and Infections in ViEtnam) Project : Ending the HIV Epidemic Among Persons Who Inject Drugs in Hai Phong, Viet Nam
The overarching purpose of the proposed research is to demonstrate that high coverage implementation of combined prevention and care using an innovative approach will end the HIV epidemic among PWID in Haiphong, Viet Nam.
Read the detailed description
Injection drug use is driving HIV epidemics in low/middle-income countries in Eastern Europe, Central Asia and Southeast Asia. "Combined prevention and care", including needle/syringe programs (NSP), medication-assisted treatment for opiate dependence, and antiretroviral treatment, has greatly reduced HIV incidence among persons who inject drugs (PWID) in many high-income areas, to where the "HIV epidemics" among PWID have "ended." There is now the need for a convincing demonstration that an HIV epidemic can be ended in a low/middle income setting. The overarching purpose of the proposed research is to demonstrate that high coverage implementation of combined prevention and care using an innovative approach will end the HIV epidemic among PWID in Haiphong, Viet Nam. The researchers define "ending the epidemic" as reducing HIV incidence to 0.5/100 person-years at risk.
Data collection will include recruitment using repeated community based respondent driven sampling (RDS) surveys, once per year among PWID in Hai Phong. Participants will be given a quantitative questionnaire and tested for HIV and Hepatitis C (HCV). Peer support groups will be mobilized to help recruit PWID and assist in educations on the benefits of early ART, access to methadone, antiretroviral treatment and psychiatric services, and ways to prevent HIV and HCV transmission through safe injection practices and safe sex. Additionally, the investigators will develop large cohorts of HIV positive and HIV negative PWID to closely document behaviors trends, HIV incidence, and the obstacles of the access and retention in HIV care and methadone. It has been shown that it is possible to end HIV epidemics among PWID in several high income countries. This study will build upon the knowledge and results gained in high income settings to achieve viral suppression among HIV positive PWID and reduce HIV/HCV incidence in order to "end the HIV epidemic" among persons who inject drugs in Haiphong.
- Conditions
- HIV, Hepatitis C, Mental Health
- Keywords
- Persons who inject drugs, HIV, Hepatitis C, Vietnam, Behavioral Intervention
- Medical subject headings
- Hepatitis C, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV negative from RDS round 1 | HIV negative PWID subjects from RDS round 1 | |
| HIV negative from RDS round 2 | HIV negative PWID subjects from RDS round 2 | |
| HIV negative from RDS round 3 | HIV negative PWID subjects from RDS round 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HIV in the PWID population
Incidence of HIV in the PWID population to be calculated in person-years
Measured: up to 48 months
Secondary outcomes (4)
Number of participants with unsuppressed viral load
The number of HIV+ PWID with unsuppressed viral load in the strategic subpopulation
Measured: up to 48 months
Cost-Effectiveness ratio as compared to baseline
C1 and C0 denote the total (discounted) costs of HIV prevention and treatment for PWID. H1 and H0 denote the total number of incident HIV infections. If T denotes the average lifetime cost of treating someone with HIV and D denotes the average number of disability-adjusted life years (DALYs) lost due to HIV infection, then the cost per DALY saved by the proposed interventions is the "cost-effectiveness ratio," R = (∆C - ∆H*T)/(∆H*D).
Measured: baseline, 3 years, 7 years, 10 years, and 20 years
Incremental costs averted
Estimated incremental costs per HIV infection averted
Measured: up to 20 years
Lifetime medical costs
Estimated lifetime medical costs for treating HIV infection
Measured: up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start17 Oct 2016
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by New York UniversityThe 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
- 5,546 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- Hai Phong Medical University, Université Montpellier, Centre for Supporting Community Development Initiatives (SCDI)
- Responsible party
- Sponsor
- Investigators
- Don Des Jarlais, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526939
- Sponsor's protocol ID
- GCO 15-1533
- Acronym
- DRIVE
- Status last verified
- Mar 2021
- First submitted
- 4 May 2018
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Des Jarlais D, Khue PM, Feelemyer J, Arasteh K, Thi Huong D, Thi Hai Oanh K, Thi Giang H, Thi Tuyet Thanh N, Vinh VH, Heckathorn DD, Moles JP, Vallo R, Quillet C, Rapoud D, Michel L, Laureillard D, Hammett T, Nagot N. Using dual capture/recapture studies to estimate the population size of persons who inject drugs (PWID) in the city of Hai Phong, Vietnam. Drug Alcohol Depend. 2018 Apr 1;185:106-111. doi: 10.1016/j.drugalcdep.2017.11.033. Epub 2018 Feb 2.
PubMed 29432973Michel 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 28800503Duong 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 28612212Des 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 27006257Hammett TM, Trang NT, Oanh KTH, Huong NT, Giang LM, Huong DT, Nagot N, Des Jarlais DC. The relationship between health policy and public health interventions: a case study of the DRIVE project to "end" the HIV epidemic among people who inject drugs in Haiphong, Vietnam. J Public Health Policy. 2018 May;39(2):217-230. doi: 10.1057/s41271-017-0115-7.
PubMed 29531303Gay L, Rapenne C, Desquiret-Dumas V, Vallo R, Bach Thi Nhu Q, Le Thi Thuy L, Thi Duong H, Nguyen Thanh B, Quillet C, Thi Tran H, Nham Thi Tuyet T, Khuat Thi Hai O, Vu Hai V, Pham Minh K, Nagot N, Laureillard D, Reynier P, Moles J-P. Low-level of mitochondrial DNA alterations during direct-acting antiviral treatment in leukocytes of people who inject drugs living with HCV. Microbiol Spectr. 2026 Oct 9:e0194626. doi: 10.1128/spectrum.01946-26. Online ahead of print.
PubMed 42852927
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DRIVE (DRug Use and Infections in ViEtnam) Project : Ending the HIV Epidemic Among Persons Who Inject Drugs in Hai Phong, Viet Nam
- ClinicalTrials.gov ID
- NCT03526939
- Acronym / sponsor ID
- DRIVE / GCO 15-1533
- Conditions
- HIV, Hepatitis C, Mental Health
- Keywords
- Persons who inject drugs, HIV, Hepatitis C, Vietnam, Behavioral Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,546 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- Hai Phong Medical University, Université Montpellier, Centre for Supporting Community Development Initiatives (SCDI)
- Study start
- 17 Oct 2016 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching purpose of the proposed research is to demonstrate that high coverage implementation of combined prevention and care using an innovative approach will end the HIV epidemic among PWID in Haiphong, Viet Nam.
Detailed description
Injection drug use is driving HIV epidemics in low/middle-income countries in Eastern Europe, Central Asia and Southeast Asia. "Combined prevention and care", including needle/syringe programs (NSP), medication-assisted treatment for opiate dependence, and antiretroviral treatment, has greatly reduced HIV incidence among persons who inject drugs (PWID) in many high-income areas, to where the "HIV epidemics" among PWID have "ended." There is now the need for a convincing demonstration that an HIV epidemic can be ended in a low/middle income setting. The overarching purpose of the proposed research is to demonstrate that high coverage implementation of combined prevention and care using an innovative approach will end the HIV epidemic among PWID in Haiphong, Viet Nam. The researchers define "ending the epidemic" as reducing HIV incidence to 0.5/100 person-years at risk.
Data collection will include recruitment using repeated community based respondent driven sampling (RDS) surveys, once per year among PWID in Hai Phong. Participants will be given a quantitative questionnaire and tested for HIV and Hepatitis C (HCV). Peer support groups will be mobilized to help recruit PWID and assist in educations on the benefits of early ART, access to methadone, antiretroviral treatment and psychiatric services, and ways to prevent HIV and HCV transmission through safe injection practices and safe sex. Additionally, the investigators will develop large cohorts of HIV positive and HIV negative PWID to closely document behaviors trends, HIV incidence, and the obstacles of the access and retention in HIV care and methadone. It has been shown that it is possible to end HIV epidemics among PWID in several high income countries. This study will build upon the knowledge and results gained in high income settings to achieve viral suppression among HIV positive PWID and reduce HIV/HCV incidence in order to "end the HIV epidemic" among persons who inject drugs in Haiphong.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV negative from RDS round 1 | – | –HIV negative PWID subjects from RDS round 1 |
| HIV negative from RDS round 2 | – | –HIV negative PWID subjects from RDS round 2 |
| HIV negative from RDS round 3 | – | –HIV negative PWID subjects from RDS round 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Residents of Haiphong Vietnam who currently are injecting drugs (heroin or methamphetamine) and at least 18 years of age
Key inclusion criteria (6 listed)
- age 18 or older
- capable of giving informed consent and participating in study activities
- history of drug injection (confirmed by visual inspection or subject knowledge of injecting procedures)
- currently using an injectable drug (heroin or methamphetamine
- confirmed by urine test), not on MMT at initial recruitment
Key exclusion criteria (7 listed)
- less than 18 years of age
- on MMT at initial recruitment
- refusal to participate in follow-up studies
- no history of drug injection
- not currently using injectable drug (heroin or methamphetamine)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of HIV in the PWID population
Time frame: up to 48 months
Incidence of HIV in the PWID population to be calculated in person-years
4 secondary outcomes
Number of participants with unsuppressed viral load
Time frame: up to 48 months
Cost-Effectiveness ratio as compared to baseline
Time frame: baseline, 3 years, 7 years, 10 years, and 20 years
Incremental costs averted
Time frame: up to 20 years
Lifetime medical costs
Time frame: up to 20 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Background: PubMed 29432973Des Jarlais D, Khue PM, Feelemyer J, Arasteh K, Thi Huong D, Thi Hai Oanh K, Thi Giang H, Thi Tuyet Thanh N, Vinh VH, Heckathorn DD, Moles JP, Vallo R, Quillet C, Rapoud D, Michel L, Laureillard D, Hammett T, Nagot N. Using dual capture/recapture studies to estimate the population size of persons who inject drugs (PWID) in the city of Hai Phong, Vietnam. Drug Alcohol Depend. 2018 Apr 1;185:106-111. doi: 10.1016/j.drugalcdep.2017.11.033. Epub 2018 Feb 2.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: PubMed 29531303Hammett TM, Trang NT, Oanh KTH, Huong NT, Giang LM, Huong DT, Nagot N, Des Jarlais DC. The relationship between health policy and public health interventions: a case study of the DRIVE project to "end" the HIV epidemic among people who inject drugs in Haiphong, Vietnam. J Public Health Policy. 2018 May;39(2):217-230. doi: 10.1057/s41271-017-0115-7.
- Derived from this study: PubMed 42852927Gay L, Rapenne C, Desquiret-Dumas V, Vallo R, Bach Thi Nhu Q, Le Thi Thuy L, Thi Duong H, Nguyen Thanh B, Quillet C, Thi Tran H, Nham Thi Tuyet T, Khuat Thi Hai O, Vu Hai V, Pham Minh K, Nagot N, Laureillard D, Reynier P, Moles J-P. Low-level of mitochondrial DNA alterations during direct-acting antiviral treatment in leukocytes of people who inject drugs living with HCV. Microbiol Spectr. 2026 Oct 9:e0194626. doi: 10.1128/spectrum.01946-26. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Don Des Jarlais, PhD principal investigator
New York University
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 C, run by New York University 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 6 inclusion and 7 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 4 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of HIV in the PWID population (time frame: up to 48 months). 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 NCT03526939, which also lists 7 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 4 Mar 2021.