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

Completed

• Conditions: HIV; Mental Health; Hepatitis C

• Registration Number: NCT03526939
• Lead Sponsor: New York University

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.

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 Timeline

• Study Start: 2016-10-17
• Study First Submitted: 2018-05-04
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-16
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-10
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5546

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of HIV in the PWID population	up to 48 months	Incidence of HIV in the PWID population to be calculated in person-years

Secondary Outcome Measures

Name	Time	Method
Number of participants with unsuppressed viral load	up to 48 months	The number of HIV+ PWID with unsuppressed viral load in the strategic subpopulation
Cost-Effectiveness ratio as compared to baseline	baseline, 3 years, 7 years, 10 years, and 20 years	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).
Incremental costs averted	up to 20 years	Estimated incremental costs per HIV infection averted
Lifetime medical costs	up to 20 years	Estimated lifetime medical costs for treating HIV infection

Trial Locations

Locations (1)

Haiphong Medical University; 🇻🇳 Hải Phòng, Vietnam