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

This study is currently recruiting participants.
Verified April 2013 by Johns Hopkins University
Sponsor:
Collaborator:
Hanoi Center for HIV/AIDS Prevention and Control
Information provided by (Responsible Party):
Vu Minh Quan, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01841320
First received: April 24, 2013
Last updated: April 25, 2013
Last verified: April 2013

April 24, 2013
April 25, 2013
October 2011
June 2016   (final data collection date for primary outcome measure)
Time from randomization to the initiation of antiretroviral therapy (ART) [ Time Frame: At month 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01841320 on ClinicalTrials.gov Archive Site
  • CD4+ counts [ Time Frame: At months 6, 12, and 18 ] [ Designated as safety issue: No ]
  • HIV-1 RNA levels [ Time Frame: At months 6 and 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Seek, Test, Treat Strategies for Vietnamese Drug Users: A Randomized Controlled Trial
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • HIV
  • Addiction
Other: Integrated methadone and antiretroviral therapy (iMART) clinic
Other Names:
  • ART access support
  • ART adherence support through mobile phone technologies
  • 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.
    Intervention: Other: Integrated methadone and antiretroviral therapy (iMART) clinic
  • No Intervention: Standard of Care
    Participants will be referred to standard HIV outpatient clinics and methadone maintenance clinics.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
June 2016
June 2016   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Not Provided
Vietnam
 
NCT01841320
R01DA030776
Yes
Vu Minh Quan, Johns Hopkins University
Johns Hopkins University
Hanoi Center for HIV/AIDS Prevention and Control
Principal Investigator: Quan M Vu, M.D Johns Hopkins University
Johns Hopkins University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP