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

NCT03526939 | Completed

• 1 other identifier: GCO 15-1533
• Study Type: observational
• Target: 5,546
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV; Hepatitis C; Mental Health

Keywords

Persons who inject drugs; HIV; Hepatitis C; Vietnam; Behavioral Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of participants with unsuppressed viral load

  up to 48 months

• Cost-Effectiveness ratio as compared to baseline

  baseline, 3 years, 7 years, 10 years, and 20 years

• Incremental costs averted

  up to 20 years

• Lifetime medical costs

  up to 20 years

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Residents of Haiphong Vietnam who currently are injecting drugs (heroin or methamphetamine) and at least 18 years of age

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York University: lead
• Hai Phong Medical University: collaborator
• Université Montpellier: collaborator
• Centre for Supporting Community Development Initiatives (SCDI): collaborator

Study Sites (1)

Haiphong Medical University

Haiphong, Vietnam

Location

Related Publications (6)

• 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.

  PMID: 29432973 BACKGROUND

• 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.

  PMID: 28800503 BACKGROUND

• 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.

  PMID: 28612212 BACKGROUND

• 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.

  PMID: 27178119 BACKGROUND

• 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.

  PMID: 27006257 BACKGROUND

• 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.

  PMID: 29531303 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

serum and plasma aliquots and dried blood spots

MeSH Terms

Conditions

Hepatitis C; Psychological Well-Being

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Personal Satisfaction; Behavior

Study Officials

• Don Des Jarlais, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: May 16, 2018
• Study Start: October 17, 2016
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)