HIV InfectionIncentives-1NCT01526421
Use of Incentives to Engage Drug Users in HIV Therapy
A study testing monetary reinforcer in people with HIV Infection, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- monetary reinforcer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 years or older
- Self-reports as having used illicit drugs within last 3 months
- Self-reports known or at-risk for HIV infection.
Who cannot join
- Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
- Has lived in the greater Vancouver area for three months or less (as a means to enhance participant retention)
- Pregnancy
- Receipt of antiretroviral therapy within the last 12 months
- Known history of gambling addiction.
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Paul's Hospital, VIDUS study office site, 342 East Hastings
Vancouver, British Columbia
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- HIV Infection
- Being tested
- monetary reinforcer
- Keywords
- HIV, Antiretroviral therapy, highly active
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monetary reinforcerOther
Also called contingency management
Participants randomized to the reinforcer arm will receive gift cards at the completion of screening procedures.
| Study group | Role | What they receive |
|---|---|---|
| monetary reinforcer | Experimental | Not described Receives: Other: monetary reinforcer |
| no reinforcer | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of drug users undertaking clinical and laboratory screening to determine eligibility for highly active antiretroviral therapy (HAART).
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Mark Hull, MD, Principal investigator, University of British ColumbiaJulio SG Montaner, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526421
- Sponsor's protocol ID
- H11-00592
- Other IDs
- H11-00592, 1R01DA031043-01
- Acronym
- Incentives-1
- Status last verified
- Dec 2012
- First submitted
- 1 Feb 2012
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Evaluating the Role of Contingent Reinforcement in the Engagement of and Retention of Drug Users in HAART Programs - Part 1
- ClinicalTrials.gov ID
- NCT01526421
- Acronym / sponsor ID
- Incentives-1 / H11-00592
- Conditions
- HIV Infection
- Keywords
- HIV, Antiretroviral therapy, highly active
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| monetary reinforcer | Experimental | Other: monetary reinforcer |
| no reinforcer | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 19 years or older
- Self-reports as having used illicit drugs within last 3 months
- Self-reports known or at-risk for HIV infection.
Key exclusion criteria (5 listed)
- Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
- Has lived in the greater Vancouver area for three months or less (as a means to enhance participant retention)
- Pregnancy
- Receipt of antiretroviral therapy within the last 12 months
- Known history of gambling addiction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| monetary reinforcerAlso: contingency managementParticipants randomized to the reinforcer arm will receive gift cards at the completion of screening procedures. | Other | monetary reinforcer |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Hull, MD principal investigator
University of British Columbia
Julio SG Montaner, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing monetary reinforcer in people with HIV Infection, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of drug users undertaking clinical and laboratory screening to determine eligibility for highly active antiretroviral therapy (HAART). (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2012.