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Completed

NCT Number: NCT01841320

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tu Liem Medical Center

Hanoi, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Integrated methadone and antiretroviral therapy (iMART) clinic

Other

Other names: ART access support, ART adherence support through mobile phone technologies

Primary outcomes

  1. Time from randomization to the initiation of antiretroviral therapy (ART)

    Time frame: At month 3

Secondary outcomes

  1. CD4+ counts

    Time frame: At months 6, 12, and 18

  2. HIV-1 RNA levels

    Time frame: At months 6 and 12

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Hanoi Center for HIV/AIDS Prevention and Control

Registry information

Acronym: VISTA

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Apr 26, 2013
Registry last updated
Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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