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

Not Applicable

Completed

• Conditions: Addiction; HIV
• Interventions: Other: Integrated methadone and antiretroviral therapy (iMART) clinic

• Registration Number: NCT01841320
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-04-25
• Study First Posted: 2013-04-26
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 378

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Integrated methadone and antiretroviral therapy (iMART) clinic	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.

Primary Outcome Measures

Name	Time	Method
Time from randomization to the initiation of antiretroviral therapy (ART)	At month 3

Secondary Outcome Measures

Name	Time	Method
HIV-1 RNA levels	At months 6 and 12
CD4+ counts	At months 6, 12, and 18

Trial Locations

Locations (1)

Tu Liem Medical Center; 🇻🇳 Hanoi, Vietnam