Seek, Test, Treat Strategies for Vietnamese Drug Users: A Randomized Controlled Trial

Study Overview
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Brief Summary
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This research examines the effectiveness of an intervention that employs seek, test, and treat strategies for Vietnamese injection drug users (IDU) and their network members, by ensuring that high risk individuals are sought for HIV testing and promptly referred to and maintained on antiretroviral therapy (ART). HIV prevention interventions are provided to IDUs who test HIV-negative, as well as those who test HIV-positive. HIV-positive IDUs will be referred to HIV care through a two-arm randomized controlled trial to compare the effects of different levels of engagement in care on ART uptake, ART adherence, and treatment outcome.

Detailed Description
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Opioid injection and HIV infection are major public health problems in Vietnam. Injection drug users (IDUs) have a high burden of HIV infection (20% HIV prevalence, nationally; 6% mortality per year) and the high rate of HIV transmission continues (HIV incidence, 5% per year). The investigators propose an intervention that employs the seek, test, and treat strategies for the IDU population and their network members, by ensuring that high risk individuals are sought for HIV testing, promptly referred to and maintained on ART, while HIV prevention interventions provided to the many who test HIV-negative, as well as those who test HIV-positive. The intervention will seek and test IDUs and their network members in the community, particularly those who are recently released from drug treatment centers. HIV-positive IDUs will be referred to HIV care through a two arm randomized controlled trial to compare the effects of different levels of engagement in care on ART uptake, antiretroviral adherence, and treatment outcome.

Official Title
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Seek, Test, Treat Strategies for Vietnamese Drug Users: A Randomized Controlled Trial

Conditions
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HIV, Addiction

Intervention / Treatment
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* Other: Integrated methadone and antiretroviral therapy (iMART) clinic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older; Recently released from drug treatment centers; Positive HIV serology; Male; Meet criteria for ART initiation according to Vietnam's national guidelines; Provide informed consent for the study; and Reside in study area and do not plan to move away in the next 18 months. Exclusion Criteria: Currently on ART; Co-enrollment in other HIV interventional research study; Unwilling to provide locator information.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants who are assigned to intervention arm will receive ART and methadone maintenance at an integrated methadone and antiretroviral therapy (iMART) clinic and ART adherence support through the use of mobile phone technologies. | Other: Integrated methadone and antiretroviral therapy (iMART) clinic<br> <br> * Other names: ART adherence support through mobile phone technologies;|
| No Intervention: Standard of Care<br>Participants will be referred to standard HIV outpatient clinics and methadone maintenance clinics. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from randomization to the initiation of antiretroviral therapy (ART) |  | At month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4+ counts |  | At months 6, 12, and 18 | 
| HIV-1 RNA levels |  | At months 6 and 12 |