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

HIV Clinical Trial

— DRIVE  

Official title:

DRIVE (DRug Use and Infections in ViEtnam) Project : Ending the HIV Epidemic Among Persons Who Inject Drugs in Hai Phong, Viet Nam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526939
• Other study ID #: GCO 15-1533
• Status: Completed
• Start date: October 17, 2016
• Est. completion date: January 10, 2020

Study information

• Verified date: March 2021
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5546
• Est. completion date: January 10, 2020
• Est. primary completion date: January 10, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• HIV
• Mental Health

Locations

Country	Name	City	State
Vietnam	Haiphong Medical University	H?i Phòng

Sponsors (4)

Lead Sponsor	Collaborator
New York University	Centre for Supporting Community Development Initiatives (SCDI), Hai Phong Medical University, Université Montpellier

Country where clinical trial is conducted

Vietnam, 

References & Publications (6)

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. — View Citation

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. — View Citation

Des Jarlais DC, Thi Huong D, Thi Hai Oanh K, Khuê 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. — View 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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of HIV in the PWID population	Incidence of HIV in the PWID population to be calculated in person-years	up to 48 months
Secondary	Number of participants with unsuppressed viral load	The number of HIV+ PWID with unsuppressed viral load in the strategic subpopulation	up to 48 months
Secondary	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).	baseline, 3 years, 7 years, 10 years, and 20 years
Secondary	Incremental costs averted	Estimated incremental costs per HIV infection averted	up to 20 years
Secondary	Lifetime medical costs	Estimated lifetime medical costs for treating HIV infection	up to 20 years