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

NCT ID: NCT01841320

Last Updated: 2016-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 378 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2016-08-31

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.

Conditions

HIV; Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Integrated methadone and antiretroviral therapy (iMART) clinic

Intervention Type: OTHER

Standard of Care

Participants will be referred to standard HIV outpatient clinics and methadone maintenance clinics.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Integrated methadone and antiretroviral therapy (iMART) clinic

Intervention Type: OTHER

Other Intervention Names

ART access support; ART adherence support through mobile phone technologies

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hanoi Center for HIV/AIDS Prevention and Control

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Vu Minh Quan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Quan M Vu, M.D

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Tu Liem Medical Center

Hanoi, , Vietnam

Countries

Vietnam

Other Identifiers

R01DA030776

Identifier Type: NIH

Identifier Source: org_study_id

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