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Clinical Trials/NCT01841320
NCT01841320
Completed
Not Applicable

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

Johns Hopkins University1 site in 1 country378 target enrollmentOctober 2011
ConditionsHIVAddiction

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
Johns Hopkins University
Enrollment
378
Locations
1
Primary Endpoint
Time from randomization to the initiation of antiretroviral therapy (ART)
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
August 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vu Minh Quan

Assistant Professor

Johns Hopkins University

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or older;
  • Recently released from drug treatment centers;
  • Positive HIV serology;
  • 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.

Outcomes

Primary Outcomes

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

Time Frame: At month 3

Secondary Outcomes

  • HIV-1 RNA levels(At months 6 and 12)
  • CD4+ counts(At months 6, 12, and 18)

Study Sites (1)

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