HIV InfectionsPhase 1NCT00748800
An Affect Management Intervention for Juvenile Offenders
A Phase 1 study testing Affect Management and General Health Promotion in people with HIV Infections, run by Rhode Island Hospital at 1 site in United States.
Trial summary
Adolescents are at risk for HIV because of sexual and drug behavior initiated during this developmental period. Adolescents in the juvenile justice system are at increased risk for HIV due to higher rates of substance use and psychopathology than their non-offending peers. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Affect Management and General Health Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Oct 2007
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents enrolled in the juvenile drug court program
Who cannot join
- Adolescent is HIV positive
- Adolescent is pregnant
- Adolescent is developmentally delayed
- Adolescent has history of sexual crime
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Adolescents are at risk for HIV because of sexual and drug behavior initiated during this developmental period. Adolescents in the juvenile justice system are at increased risk for HIV due to higher rates of substance use and psychopathology than their non-offending peers. Juvenile justice youth may therefore also be less likely to benefit from frequently used skills based interventions. It appears that emotional lability, frequently found in this population, disrupts skills learned. This project will implement and evaluate an affect management HIV prevention intervention for adolescents in a juvenile drug court program. Affect management and general health promotion interventions will be compared to determine which intervention best reduces risk behavior among adolescents in the drug court.
- Conditions
- HIV Infections
- Being tested
- Affect Management, General Health Promotion
- Keywords
- HIV prevention, HIV seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affect ManagementBehavioural
5 session group intervention that focused on teaching affect management skills and included HIV prevention and sexual health training
General Health PromotionBehavioural
5 session group focused on delivering general health promotion information in didactic format
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Affect Management |
| 2 | Active comparator | Not described Receives: Behavioral: General Health Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent-reported sexual activity and condom use
Measured: 3 month post-intervention
Secondary outcomes (1)
Adolescent substance use (self-report and urine toxicology screen results)
Measured: 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startSep 2004
- Primary completionMay 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Larry K Brown, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748800
- Sponsor's protocol ID
- R21DA019245
- Status last verified
- Feb 2009
- First submitted
- 5 Sep 2008
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Affect Management Intervention for Juvenile Offenders
- ClinicalTrials.gov ID
- NCT00748800
- Acronym / sponsor ID
- R21DA019245
- Conditions
- HIV Infections
- Keywords
- HIV prevention, HIV seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- May 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 9 Sep 2008 (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.
Adolescents are at risk for HIV because of sexual and drug behavior initiated during this developmental period. Adolescents in the juvenile justice system are at increased risk for HIV due to higher rates of substance use and psychopathology than their non-offending peers. Juvenile justice youth may therefore also be less likely to benefit from frequently used skills based interventions. It appears that emotional lability, frequently found in this population, disrupts skills learned. This project will implement and evaluate an affect management HIV prevention intervention for adolescents in a juvenile drug court program. Affect management and general health promotion interventions will be compared to determine which intervention best reduces risk behavior among adolescents in the drug court.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Affect Management |
| 2 | Active comparator | Behavioral: General Health Promotion |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescents enrolled in the juvenile drug court program
Key exclusion criteria (4 listed)
- Adolescent is HIV positive
- Adolescent is pregnant
- Adolescent is developmentally delayed
- Adolescent has history of sexual crime
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 |
|---|---|---|
| Affect Management5 session group intervention that focused on teaching affect management skills and included HIV prevention and sexual health training | Behavioural | 1 |
| General Health Promotion5 session group focused on delivering general health promotion information in didactic format | Behavioural | 2 |
Primary outcome
Adolescent-reported sexual activity and condom use
Time frame: 3 month post-intervention
1 secondary outcome
Adolescent substance use (self-report and urine toxicology screen results)
Time frame: 3 months post-intervention
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 6 Feb 2009.
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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.
Larry K Brown, MD principal investigator
Rhode Island Hospital
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 Affect Management and General Health Promotion in people with HIV Infections, run by Rhode Island Hospital 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 1 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 6 Feb 2009. 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?
Adolescent-reported sexual activity and condom use (time frame: 3 month post-intervention). 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 6 Feb 2009.