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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01841320
Acronym
VISTA
Enrollment
378
Registered
2013-04-26
Start date
2011-10-31
Completion date
2016-08-31
Last updated
2016-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Addiction, HIV

Brief summary

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

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.

Interventions

OTHERIntegrated methadone and antiretroviral therapy (iMART) clinic

Sponsors

Hanoi Center for HIV/AIDS Prevention and Control
CollaboratorUNKNOWN
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age 18 years or older; 2. Recently released from drug treatment centers; 3. Positive HIV serology; 4. Male; 5. Meet criteria for ART initiation according to Vietnam's national guidelines; 6. Provide informed consent for the study; and 7. Reside in study area and do not plan to move away in the next 18 months.

Exclusion criteria

1. Currently on ART; 2. Co-enrollment in other HIV interventional research study; 3. Unwilling to provide locator information.

Design outcomes

Primary

MeasureTime frame
Time from randomization to the initiation of antiretroviral therapy (ART)At month 3

Secondary

MeasureTime frame
CD4+ countsAt months 6, 12, and 18
HIV-1 RNA levelsAt months 6 and 12

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026