Seek, Test, Treat Strategies for Vietnamese Drug Users: A... | NCT01841320

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

NCT01841320

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

Oct 6, 2016Estimated

Enrollment

378Actual

Phase

Not Applicable

Conditions

HIV
Addiction

Interventions

Integrated methadone and antiretroviral therapy (iMART) clinic

Countries

Vietnam

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Apr 24, 2013

First Submission Date that Met QC Criteria

Apr 25, 2013

First Posted Date

Apr 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2016

Last Update Posted Date

Oct 6, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vu Minh Quan, Assistant Professor, Johns Hopkins UniversityPrincipal Investigator

Lead Sponsor

Johns Hopkins UniversityOTHER

Collaborators

Name	Class
Hanoi Center for HIV/AIDS Prevention and Control	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

378Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	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.	Other: Integrated methadone and antiretroviral therapy (iMART) clinic
Standard of Care	No Intervention	Participants will be referred to standard HIV outpatient clinics and methadone maintenance clinics.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Integrated methadone and antiretroviral therapy (iMART) clinic	Other		Intervention	ART access support ART adherence support through mobile phone technologies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time from randomization to the initiation of antiretroviral therapy (ART)		At month 3

Secondary Outcomes

Measure	Description	Time Frame
CD4+ counts		At months 6, 12, and 18
HIV-1 RNA levels		At months 6 and 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older;
Recently released from drug treatment centers;
Positive HIV serology;
Male;
Meet criteria for ART initiation according to Vietnam's national guidelines;
Provide informed consent for the study; and
Reside in study area and do not plan to move away in the next 18 months.

Exclusion Criteria:

Currently on ART;
Co-enrollment in other HIV interventional research study;
Unwilling to provide locator information.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Quan M Vu, M.D	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tu Liem Medical Center		Hanoi			Vietnam

Condition Browse Module

MeSH Terms

ID	Term
D016739	Behavior, Addictive

Ancestor Terms

ID	Term
D003192	Compulsive Behavior
D007175	Impulsive Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000554	Ambulatory Care Facilities

Ancestor Terms

ID	Term
D006268	Health Facilities
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided