DRug Use and Infections in Hai Phong ViEtnam Among Persons Who Inject Drugs

NCT ID: NCT03526939

Last Updated: 2021-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

5546 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-17

Study Completion Date

2020-01-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Hepatitis C Mental Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HIV negative from RDS round 1

HIV negative PWID subjects from RDS round 1

No interventions assigned to this group

HIV negative from RDS round 2

HIV negative PWID subjects from RDS round 2

No interventions assigned to this group

HIV negative from RDS round 3

HIV negative PWID subjects from RDS round 3

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hai Phong Medical University

OTHER

Sponsor Role collaborator

Université Montpellier

OTHER

Sponsor Role collaborator

Centre for Supporting Community Development Initiatives (SCDI)

UNKNOWN

Sponsor Role collaborator

New York University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Don Des Jarlais, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Haiphong Medical University

Haiphong, , Vietnam

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Vietnam

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29432973 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28800503 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28612212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27178119 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27006257 (View on PubMed)

Hammett 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.

Reference Type BACKGROUND
PMID: 29531303 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GCO 15-1533

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Integrated HIV Prevention and HCV Care for PWID
NCT03981445 ACTIVE_NOT_RECRUITING NA
PrEP Affect Regulation Treatment Innovation
NCT04899024 ACTIVE_NOT_RECRUITING NA
Tele-Harm Reduction
NCT05208697 ACTIVE_NOT_RECRUITING NA