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

October 4, 2016 updated by: Vu Minh Quan, Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

378

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • Tu Liem Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
Other Names:
  • ART access support
  • ART adherence support through mobile phone technologies
No Intervention: Standard of Care
Participants will be referred to standard HIV outpatient clinics and methadone maintenance clinics.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Hanoi Center for HIV/AIDS Prevention and Control

Investigators

  • Principal Investigator: Quan M Vu, M.D, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

April 25, 2013

First Posted (Estimate)

April 26, 2013

Study Record Updates

Last Update Posted (Estimate)

October 6, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DA030776 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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