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

HIV Clinical Trial

— VISTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841320
• Other study ID #: R01DA030776
• Status: Completed
• Phase: N/A
• First received: April 24, 2013
• Last updated: October 4, 2016
• Start date: October 2011
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardVietnam: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Addiction
• HIV

Intervention

Other:
• Integrated methadone and antiretroviral therapy (iMART) clinic

Locations

Country	Name	City	State
Vietnam	Tu Liem Medical Center	Hanoi

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Hanoi Center for HIV/AIDS Prevention and Control

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from randomization to the initiation of antiretroviral therapy (ART)		At month 3	No
Secondary	CD4+ counts		At months 6, 12, and 18	No
Secondary	HIV-1 RNA levels		At months 6 and 12	No