HIVProject FIRSTNCT01376570
Project FIRST - Financial Incentives to Reduce Substance Use and Improve Treatment
A study testing Abstinence-reinforcing contingency management intervention and Performance Feedback intervention in people with HIV and Opiate Dependence, run by Albert Einstein College of Medicine at 3 sites in United States.
Trial summary
This study will test whether contingency management (monetary vouchers contingent on abstinence from drugs) that reinforces one behavior (achieving abstinence from drugs) leads to improved outcomes in other related behaviors (achieving HIV viral load suppression). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Opiate Dependence
- What is being tested?
- Abstinence-reinforcing contingency management intervention and Performance Feedback intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2012to 10 Aug 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old
- English or Spanish fluency
- HIV-infected
- Currently taking highly active antiretroviral therapy
- a) opioid use disorder and receiving opioid agonist treatment with methadone or buprenorphine, or b) cocaine use disorder
- urine toxicology positive for cocaine, oxycodone, or opioids during the run-in period
- detectable viral load while prescribed highly active antiretroviral therapy in the prior 6 months
- self-reported adherence to HAART <100%
Who cannot join
- inability to give informed consent
- inability to follow the research protocol (e.g., visits twice weekly)
- frequent hospitalizations (>2) in the prior 6 months
- currently with a chronic pain condition in which the participant has been prescribed opioid analgesics for longer than the past month
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Montefiore's Community Clinics (Montefiore Medical Group)
The Bronx, New York, 10451
Albert Einstein College of Medicine Division of Substance Abuse clinics
The Bronx, New York, 10461
Montefiore Infectious Disease Clinic
The Bronx, New York, 10467
About this study
Official title: A Randomized Trial of an Abstinence-reinforcing Contingency Management Intervention to Suppress HIV Viral Load
This study will test whether contingency management (monetary vouchers contingent on abstinence from drugs) that reinforces one behavior (achieving abstinence from drugs) leads to improved outcomes in other related behaviors (achieving HIV viral load suppression). In a randomized controlled trial, the investigators propose to test whether an abstinence-reinforcing contingency management intervention improves viral load suppression in HIV-infected drug users.
Read the detailed description
Using a randomized controlled study design, the investigators will test the efficacy of an abstinence-reinforcing contingency management intervention compared with a control condition (Performance Feedback) on HIV viral load suppression. The investigators will enroll 202 opioid-dependent HIV-infected individuals who are receiving opioid agonist treatment with buprenorphine or methadone, who continue to use opiates, oxycodone or cocaine (drugs that are consistently associated with poor HIV treatment outcomes), and who are prescribed antiretroviral medication, but with suboptimal viral load suppression. The contingency management group will have the potential to receive compensation in vouchers over the 16-week intervention based on drug-free urine. Participants will be followed for 28 weeks, with research visits occurring twice weekly during the Baseline Period (weeks 1-4) and Intervention Period (weeks 5-20), then every two weeks during the Post-Intervention Period (weeks 21-28). Data sources will include blood tests (viral load and CD4 count), urine toxicology tests, questionnaires, pill counts, and medical records. The primary outcome will be change in HIV viral load, and secondary outcomes will include CD4 count, antiretroviral adherence, and abstinence.
- Conditions
- HIV, Opiate Dependence
- Being tested
- Abstinence-reinforcing contingency management intervention, Performance Feedback intervention
- Keywords
- HIV, Opiate dependence, Opiate replacement therapy, Cocaine-related disorders, Risk Reduction Behavior, Medication Adherence, Motivation
- Medical subject headings
- Opioid-Related Disorders, Cocaine-Related Disorders, Risk Reduction Behavior, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abstinence-reinforcing contingency management interventionBehavioural
The contingency management intervention consists of participants receiving vouchers exchangeable for goods and services contingent on achieving abstinence. When participants are abstinent (urine is free of cocaine, oxycodone and opiates), they will receive a voucher. If participants are not abstinent (cocaine or oxycodone or opiates are in the urine), they will not receive a voucher. The value of vouchers increases with continued evidence of abstinence. When participants have urines with opiates or cocaine, the value of the voucher is reset. The vouchers are part of the intervention, they are not participant compensation.
Performance Feedback interventionBehavioural
Participants will receive performance feedback about their drug use. The research team will provide informational slips of paper indicating results of urine tests and will congratulate participants when urines are drug-free or encourage participants to stop using cocaine and/or opiates when urines are not drug-free.
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management arm | Experimental | The Contingency Management arm will receive the abstinence-reinforcing contingency management intervention. Receives: Behavioral: Abstinence-reinforcing contingency management intervention |
| Control arm | Active comparator | The Control arm will receive the performance feedback intervention. Receives: Behavioral: Performance Feedback intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV viral load
Every 4 weeks participants will undergo phlebotomy to measure HIV viral load. Viral load will be analyzed as a continuous measure (log10 copies/ml). In secondary analyses, viral load will be analyzed dichotomously, as undetectable (<45 copies/ml) or not.
Measured: Viral load will be measured every 4 weeks over the 28-week follow-up period.
Secondary outcomes (3)
CD4 count
At weeks 0, 4, 20, and 28, participants will undergo phlebotomy and CD4 count will be measured. CD4 count will be analyzed as a continuous measure and an increase of 50 cells/mm3 will be considered a clinically significant improvement.
Measured: CD4 count will be measured at weeks 0, 4, 20, and 28.
Abstinence from opiates, oxycodone, and cocaine
Participants will provide urine samples twice weekly during weeks 0-20, and every two weeks during weeks 21-28. Abstinence will be defined as having drug-free urine (no cocaine, oxycodone and opiates). Abstinence will be examined two different ways-as the proportion of drug-free urines and the number of consecutive drug-free urines. Although urine toxicology tests will be our primary data source for measuring abstinence, we will also measure addiction severity using the Addiction Severity Index.
Measured: Abstinence will be measured twice weekly during weeks 0-20, then every two weeks during weeks 21-28.
Antiretroviral adherence
Antiretroviral adherence will be measured using pill counts. Adherence will be analyzed as a continuous measure, defined as the proportion of pills taken (# pills taken / # pills prescribed). Mean adherence over each 4-week period will be examined. In addition, we will also analyze adherence as a dichotomous measure (e.g., perfect [100%] adherence or not during each 4-week period).
Measured: Antiretroviral adherence will be measured every 4 weeks during the 28-week follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startJun 2012
- Primary completion10 Aug 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Chinazo Cunningham, Albert Einstein College of Medicine
- Investigators
- Chinazo Cunningham, MD,MS, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376570
- Sponsor's protocol ID
- 2010-553
- Other IDs
- R01DA032110
- Acronym
- Project FIRST
- Status last verified
- Dec 2020
- First submitted
- 16 Jun 2011
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of an Abstinence-reinforcing Contingency Management Intervention to Suppress HIV Viral Load
- ClinicalTrials.gov ID
- NCT01376570
- Acronym / sponsor ID
- Project FIRST / 2010-553
- Conditions
- HIV, Opiate Dependence
- Keywords
- HIV, Opiate dependence, Opiate replacement therapy, Cocaine-related disorders, Risk Reduction Behavior, Medication Adherence, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2012
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 20 Jun 2011 (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.
This study will test whether contingency management (monetary vouchers contingent on abstinence from drugs) that reinforces one behavior (achieving abstinence from drugs) leads to improved outcomes in other related behaviors (achieving HIV viral load suppression). In a randomized controlled trial, the investigators propose to test whether an abstinence-reinforcing contingency management intervention improves viral load suppression in HIV-infected drug users.
Detailed description
Using a randomized controlled study design, the investigators will test the efficacy of an abstinence-reinforcing contingency management intervention compared with a control condition (Performance Feedback) on HIV viral load suppression. The investigators will enroll 202 opioid-dependent HIV-infected individuals who are receiving opioid agonist treatment with buprenorphine or methadone, who continue to use opiates, oxycodone or cocaine (drugs that are consistently associated with poor HIV treatment outcomes), and who are prescribed antiretroviral medication, but with suboptimal viral load suppression. The contingency management group will have the potential to receive compensation in vouchers over the 16-week intervention based on drug-free urine. Participants will be followed for 28 weeks, with research visits occurring twice weekly during the Baseline Period (weeks 1-4) and Intervention Period (weeks 5-20), then every two weeks during the Post-Intervention Period (weeks 21-28). Data sources will include blood tests (viral load and CD4 count), urine toxicology tests, questionnaires, pill counts, and medical records. The primary outcome will be change in HIV viral load, and secondary outcomes will include CD4 count, antiretroviral adherence, and abstinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management arm | Experimental | Behavioral: Abstinence-reinforcing contingency management interventionThe Contingency Management arm will receive the abstinence-reinforcing contingency management intervention. |
| Control arm | Active comparator | Behavioral: Performance Feedback interventionThe Control arm will receive the performance feedback intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- at least 18 years old
- English or Spanish fluency
- HIV-infected
- Currently taking highly active antiretroviral therapy
- a) opioid use disorder and receiving opioid agonist treatment with methadone or buprenorphine, or b) cocaine use disorder
Key exclusion criteria (4 listed)
- inability to give informed consent
- inability to follow the research protocol (e.g., visits twice weekly)
- frequent hospitalizations (>2) in the prior 6 months
- currently with a chronic pain condition in which the participant has been prescribed opioid analgesics for longer than the past month
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 |
|---|---|---|
| Abstinence-reinforcing contingency management interventionThe contingency management intervention consists of participants receiving vouchers exchangeable for goods and services contingent on achieving abstinence. When participants are abstinent (urine is free of cocaine, oxycodone and opiates), they will receive a voucher. If participants are not abstinent (cocaine or oxycodone or opiates are in the urine), they will not receive a voucher. The value of vouchers increases with continued evidence of abstinence. When participants have urines with opiates or cocaine, the value of the voucher is reset. The vouchers are part of the intervention, they are not participant compensation. | Behavioural | Contingency Management arm |
| Performance Feedback interventionParticipants will receive performance feedback about their drug use. The research team will provide informational slips of paper indicating results of urine tests and will congratulate participants when urines are drug-free or encourage participants to stop using cocaine and/or opiates when urines are not drug-free. | Behavioural | Control arm |
Primary outcome
HIV viral load
Time frame: Viral load will be measured every 4 weeks over the 28-week follow-up period.
Every 4 weeks participants will undergo phlebotomy to measure HIV viral load. Viral load will be analyzed as a continuous measure (log10 copies/ml). In secondary analyses, viral load will be analyzed dichotomously, as undetectable (<45 copies/ml) or not.
3 secondary outcomes
CD4 count
Time frame: CD4 count will be measured at weeks 0, 4, 20, and 28.
Abstinence from opiates, oxycodone, and cocaine
Time frame: Abstinence will be measured twice weekly during weeks 0-20, then every two weeks during weeks 21-28.
Antiretroviral adherence
Time frame: Antiretroviral adherence will be measured every 4 weeks during the 28-week follow-up period
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 3 Dec 2020.
- Abstinence-reinforcing contingency management improves HIV viral load suppression among HIV-infected people who use drugs: A randomized controlled trialLink provided by the sponsor.
- Characteristics of methadone maintenance treatment patients prescribed opioid analgesicsLink provided by the sponsor.
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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.
Chinazo Cunningham, MD,MS principal investigator
Albert Einstein College of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abstinence-reinforcing contingency management intervention and Performance Feedback intervention in people with HIV and Opiate Dependence, run by Albert Einstein College of Medicine at 3 sites in United States.
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 8 inclusion and 4 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 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
HIV viral load (time frame: Viral load will be measured every 4 weeks over the 28-week follow-up period.). 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 3 Dec 2020.