Substance AbusePhase 1NCT01481428
Reducing High Risk Behavior in Treatment Court
A Phase 1 study testing Computer-facilitated HIV intervention in people with Substance Abuse and HIV, run by Treatment Research Institute at 1 site in United States.
Trial summary
This study will be the first to examine the efficacy of using a brief, computerized HIV risk reduction intervention in treatment courts. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, HIV
- What is being tested?
- Computer-facilitated HIV intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2016
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be at least 18 years of age;
- be charged with a non-violent felony offense
- have no more than two prior non-violent convictions or diversionary opportunities
- be willing to participate in the treatment court program for at least 12 months
- be in need of treatment for substance abuse or dependence as assessed by case management.
Who cannot join
- Elderly subjects and those with medical problems will be included in the research as long as they do not have any physical or psychiatric condition that would impede their ability to give competent consent to research participation or to understand the research instruments.
- Those individuals who are intoxicated, cognitively impaired, or psychiatrically unstable when approached will not be included; however, such individuals may subsequently be included if the disqualifying condition subsides.
- Spanish speaking only individuals.
- Client remanded to jail or residential treatment facilities at the time of Treatment Court enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia Treatment Court
Philadelphia, Pennsylvania, 19107
About this study
Official title: Delivering HIV Risk Reduction Services in Treatment Court
This study will be the first to examine the efficacy of using a brief, computerized HIV risk reduction intervention in treatment courts.
Read the detailed description
Four hundred consenting treatment drug court participants will be randomly assigned to either an HIV intervention group (n = 200) or an attention control group. All clients will attend their regularly scheduled status hearings which are scheduled approximately every six weeks. Clients in the HIV intervention group will receive a brief computerized, self-administered HIV risk reduction intervention following each of their first three status hearings. Clients in the attention control condition will view a series of educational life-skill videos of matched length following each of their first three status hearings. The primary outcome will be engagement in high risk behaviors as measured by the Risk Assessment Battery (RAB). Secondary HIV-related outcomes will include: (1) rate of HIV testing, (2) condom procurement, and (3) self-reported condom use. Tertiary outcomes related to treatment court compliance will include: (1) drug court graduation, (2) urinalysis-confirmed drug abstinence, (3) case management attendance, and (4) satisfaction with case management. In addition, we will conduct preliminary cost and cost-effectiveness analyses on the delivery of the brief computerized HIV intervention. Assessments will be conducted at baseline and 9- and 15-months post admission.
- Conditions
- Substance Abuse, HIV
- Being tested
- Computer-facilitated HIV intervention, Attention Control
- Keywords
- High risk behavior, Drug court clients, Substance abuse, HIV intervention, Treatment Court Clients
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-facilitated HIV interventionBehavioural
Individuals assigned to the experimental condition will complete the self-directed CARE HIV intervention during each of their first three sessions. The 20 minute intervention sessions involve several components including a brief risk assessment, review of identified risks, structured skill building videos, and the development of a risk prevention action plan. Because of the adaptive nature of the CARE program, the content of each session will be tailored to address the current risks of the participant. While the main focus of the intervention is on risk, individuals who report being HIV infected will receive a referral to treatment if they are not currently receiving medical care and their session will address, among other things, adherence to HIV care.
Attention ControlBehavioural
Life skills training DVDs that match the duration of the anticipated experimental condition. The DVDs address topics such as positive listening skills, anger management, and stress reduction.
| Study group | Role | What they receive |
|---|---|---|
| Attention Control | Active comparator | Not described Receives: Behavioral: Attention Control |
| Computer-facilitated HIV intervention | Experimental | Not described Receives: Behavioral: Computer-facilitated HIV intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in high risk behaviors
Measured by the Risk Assessment Battery (RAB)
Measured: 15 month follow-up
Secondary outcomes (3)
Rate of HIV testing
Measured: 15 month follow-up
Condom Procurement
Measured: 15 month follow-up
Self-reported Condom Use
Measured: 15 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startSep 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Treatment Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- David S Festinger, Ph.D., Principal investigator, Treatment Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481428
- Sponsor's protocol ID
- #1002
- Other IDs
- R01DA030257
- Status last verified
- Mar 2023
- First submitted
- 18 Nov 2011
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering HIV Risk Reduction Services in Treatment Court
- ClinicalTrials.gov ID
- NCT01481428
- Acronym / sponsor ID
- #1002
- Conditions
- Substance Abuse, HIV
- Keywords
- High risk behavior, Drug court clients, Substance abuse, HIV intervention, Treatment Court Clients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Treatment Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Nov 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 be the first to examine the efficacy of using a brief, computerized HIV risk reduction intervention in treatment courts.
Detailed description
Four hundred consenting treatment drug court participants will be randomly assigned to either an HIV intervention group (n = 200) or an attention control group. All clients will attend their regularly scheduled status hearings which are scheduled approximately every six weeks. Clients in the HIV intervention group will receive a brief computerized, self-administered HIV risk reduction intervention following each of their first three status hearings. Clients in the attention control condition will view a series of educational life-skill videos of matched length following each of their first three status hearings. The primary outcome will be engagement in high risk behaviors as measured by the Risk Assessment Battery (RAB). Secondary HIV-related outcomes will include: (1) rate of HIV testing, (2) condom procurement, and (3) self-reported condom use. Tertiary outcomes related to treatment court compliance will include: (1) drug court graduation, (2) urinalysis-confirmed drug abstinence, (3) case management attendance, and (4) satisfaction with case management. In addition, we will conduct preliminary cost and cost-effectiveness analyses on the delivery of the brief computerized HIV intervention. Assessments will be conducted at baseline and 9- and 15-months post admission.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Control | Active comparator | Behavioral: Attention Control |
| Computer-facilitated HIV intervention | Experimental | Behavioral: Computer-facilitated HIV intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- be at least 18 years of age;
- be charged with a non-violent felony offense
- have no more than two prior non-violent convictions or diversionary opportunities
- be willing to participate in the treatment court program for at least 12 months
- be in need of treatment for substance abuse or dependence as assessed by case management.
Key exclusion criteria (4 listed)
- Elderly subjects and those with medical problems will be included in the research as long as they do not have any physical or psychiatric condition that would impede their ability to give competent consent to research participation or to understand the research instruments.
- Those individuals who are intoxicated, cognitively impaired, or psychiatrically unstable when approached will not be included; however, such individuals may subsequently be included if the disqualifying condition subsides.
- Spanish speaking only individuals.
- Client remanded to jail or residential treatment facilities at the time of Treatment Court enrollment.
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 |
|---|---|---|
| Computer-facilitated HIV interventionIndividuals assigned to the experimental condition will complete the self-directed CARE HIV intervention during each of their first three sessions. The 20 minute intervention sessions involve several components including a brief risk assessment, review of identified risks, structured skill building videos, and the development of a risk prevention action plan. Because of the adaptive nature of the CARE program, the content of each session will be tailored to address the current risks of the participant. While the main focus of the intervention is on risk, individuals who report being HIV infected will receive a referral to treatment if they are not currently receiving medical care and their session will address, among other things, adherence to HIV care. | Behavioural | Computer-facilitated HIV intervention |
| Attention ControlLife skills training DVDs that match the duration of the anticipated experimental condition. The DVDs address topics such as positive listening skills, anger management, and stress reduction. | Behavioural | Attention Control |
Primary outcome
Engagement in high risk behaviors
Time frame: 15 month follow-up
Measured by the Risk Assessment Battery (RAB)
3 secondary outcomes
Rate of HIV testing
Time frame: 15 month follow-up
Condom Procurement
Time frame: 15 month follow-up
Self-reported Condom Use
Time frame: 15 month follow-up
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 28 Mar 2023.
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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.
David S Festinger, Ph.D. principal investigator
Treatment Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computer-facilitated HIV intervention in people with Substance Abuse and HIV, run by Treatment Research Institute at 1 site 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 5 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 28 Mar 2023. 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Engagement in high risk behaviors (time frame: 15 month follow-up). 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 28 Mar 2023.