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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV, Hepatitis C, Mental Health

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV negative from RDS round 1<br>HIV negative PWID subjects from RDS round 1 | |
| HIV negative from RDS round 2<br>HIV negative PWID subjects from RDS round 2 | |
| HIV negative from RDS round 3<br>HIV negative PWID subjects from RDS round 3 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with unsuppressed viral load | The number of HIV+ PWID with unsuppressed viral load in the strategic subpopulation | 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). | baseline, 3 years, 7 years, 10 years, and 20 years | 
| Incremental costs averted | Estimated incremental costs per HIV infection averted | up to 20 years | 
| Lifetime medical costs | Estimated lifetime medical costs for treating HIV infection | up to 20 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persons who inject drugs, HIV, Hepatitis C, Vietnam, Behavioral Intervention