Use of Incentives to Engage Drug Users in HIV Therapy (Incentives-1)

December 18, 2012 updated by: University of British Columbia

A Randomized Clinical Trial Evaluating the Role of Contingent Reinforcement in the Engagement of and Retention of Drug Users in HAART Programs - Part 1

Highly active antiretroviral therapy (HAART), the current standard of care for treatment of HIV infection, is highly effective when taken appropriately. Before starting this treatment, a person must be aware of their HIV status and present to a clinic for medical care. They then undergo screening procedures (medical assessment and laboratory tests) to determine whether they are eligible to receive HAART, i.e. whether HIV treatment is necessary and safe for them.

In many urban centres including Vancouver's Downtown Eastside, there is a high rate of HIV infection among users of illicit drugs. However, HIV-infected drug users often do not present to the medical system and complete the process necessary to start HAART. Given the known benefits of HAART, new strategies are required to increase rates of HAART initiation in this group. Contingency management (CM) is a strategy to affect behaviour by providing a reward (e.g. money) to reinforce the desired behaviour. CM has been used with success in other areas of medicine (e.g. smoking cessation, weight loss) and in the drug using population, but has not been established as a means to improve HAART uptake.

The proposed research primarily seeks to assess the effectiveness of monetary-based CM in engaging HIV-infected drug users in HAART programs. Drug users identified through outreach will be randomized in a 1:1 ratio to one of two arms; participants in one arm will be offered a monetary-based reinforcer to participate (n=150) and participants in the second arm will be offered no reinforcer (n=150). Participation involves reporting to the study site for formal study of eligibility screening, consisting of clinical evaluation, medical history and laboratory testing required to determine eligibility to receive HAART. Participants randomized to the reinforcer arm will receive gift cards at the completion of screening procedures.

Our hypothesis is that drug users offered a monetary-based reinforcer will be significantly more likely to complete HAART eligibility screening than those not offered a reinforcer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

HAART eligibility screening entails presenting to the study site within 2 weeks of pre-screening, undergoing laboratory testing and providing a medical history, and returning for results within the subsequent four weeks. Any potential subjects who appear to be acutely intoxicated will be asked to return the next day or at a later date or time of their choosing. All participants will be asked to return for their results within four weeks after screening. Subjects will have 70 mL of whole blood collected by venipuncture by a trained study nurse. Laboratory tests will include HIV confirmatory testing (antibody and Western blot), CD4 cell count and plasma HIV-1-RNA level (plasma viral load; pVL), Hepatitis A, B and C serology, pregnancy test for women of child-bearing potential, complete blood count (CBC) with differential and platelet count, chemistry profile (creatinine, urea and electrolytes), and transaminase levels (ALT, AST). All participants will also have a medical history taken and undergo a physical examination. Recorded data will include subject gender, age, ethnicity, race, area of residence and living arrangement (categorized as homeless/on the street, unstable [defined as living primarily in a single room occupancy hotel, boarding room, or transition house] or stable). Additional features which will be recorded will include nature and frequency of illicit substance use, and participation in other cohort studies or methadone maintenance programs. All clinical past medical history and co-morbidities and laboratory data will be recorded for assessment of subject HAART eligibility.

All subjects who return for the results, whether HAART-eligible or not, will have their laboratory results explained to them and will be counseled as to a recommended course of clinical care by the study nurse. Those eligible for HAART will be offered enrollment into Part II of the study. Those not eligible for HAART will be invited to re-evaluate their eligibility for antiretroviral therapy at yearly intervals through the study site. Once 150 subjects have been randomized to each of the two study arms (total n=300), recruitment will be temporarily halted and statistical analysis will determine whether the reinforcer resulted in a significant and clinically relevant increase in the proportion of subjects who complete HAART eligibility screening.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
301

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • St. Paul's Hospital, VIDUS study office site, 342 East Hastings

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 19 years or older
  2. Self-reports as having used illicit drugs within last 3 months
  3. Self-reports known or at-risk for HIV infection.

Exclusion Criteria:

  1. Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
  2. Has lived in the greater Vancouver area for three months or less (as a means to enhance participant retention)
  3. Pregnancy
  4. Receipt of antiretroviral therapy within the last 12 months
  5. Known history of gambling addiction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: monetary reinforcer
Other: monetary reinforcer
Participants randomized to the reinforcer arm will receive gift cards at the completion of screening procedures.
Other Names:
  • contingency management
No Intervention: no reinforcer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the proportion of drug users undertaking clinical and laboratory screening to determine eligibility for highly active antiretroviral therapy (HAART).
Time Frame: 6 weeks
HAART eligibility screening entails presenting to the study site within 2 weeks of pre-screening, undergoing laboratory testing and providing a medical history, and returning for results within the subsequent four weeks.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H11-00592 (Other Identifier: UBC/Providence Health Care REB)
  • 1R01DA031043-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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