Clinical trial NCT01841320: Seek, Test, Treat Strategies for Vietnamese Drug Users: A Randomized Controlled Trial
Official title: Seek, Test, Treat Strategies for Vietnamese Drug Users: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Addiction
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Hanoi Center for HIV/AIDS Prevention and Control
First posted: 2013-04-26
Enrollment: 378
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Primary outcomes:
measure: Time from randomization to the initiation of antiretroviral therapy (ART)
timeFrame: At month 3
Secondary outcomes:
measure: CD4+ counts
timeFrame: At months 6, 12, and 18
measure: HIV-1 RNA levels
timeFrame: At months 6 and 12
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Tu Liem Medical Center
Study officials:
affiliation: Johns Hopkins University
name: Quan M Vu, M.D
role: PRINCIPAL_INVESTIGATOR
References: