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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
HIV
Addiction
Other: Integrated methadone and antiretroviral therapy (iMART) clinic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Seek, Test, Treat Strategies for Vietnamese Drug Users: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Time from randomization to the initiation of antiretroviral therapy (ART) [ Time Frame: At month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
Study Start Date: October 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841320

Locations
Vietnam
Tu Liem Medical Center Recruiting
Hanoi, Vietnam
Contact: Phi V Nguyen, MD    84 4 3768 0924    nguyenvanphi.nvp@gmail.com   
Contact: Trang T Nguyen, MD    84 98 365 1270    trangthu1900@gmail.com   
Principal Investigator: Tuan N Le, MD         
Sponsors and Collaborators
Johns Hopkins University
Hanoi Center for HIV/AIDS Prevention and Control
Investigators
Principal Investigator: Quan M Vu, M.D Johns Hopkins University
  More Information

No publications provided

Responsible Party: Vu Minh Quan, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01841320     History of Changes
Other Study ID Numbers: R01DA030776
Study First Received: April 24, 2013
Last Updated: April 25, 2013
Health Authority: United States: Institutional Review Board
Vietnam: Ministry of Health

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on July 20, 2014