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

Johns Hopkins University

Status: Completed

Conditions: Addiction; HIV

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01841320

R01DA030776

Details and patient eligibility

About

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.

Full 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.

Enrollment: 378 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

378 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Other: Integrated methadone and antiretroviral therapy (iMART) clinic

Standard of Care

No Intervention group

Description:

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