HIV InfectionsPhase 1NCT00680719
Preventing HIV/Aids in Drug Abusing Youth
A Phase 1 study testing IBFT /HIV prevention and IBFT in people with HIV Infections, run by Oregon Research Institute at 1 site in United States.
Trial summary
This project involves two studies focusing on the engagement and treatment of adolescents diagnosed with substance use disorders. Study 1 will evaluate a promising parent-based engagement intervention, Community Reinforcement Training, designed to facilitate the entry of resistant drug-abusing adolescents in… Read more about this study
- Who is it for?
- Ages 15 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- IBFT /HIV prevention and IBFT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jun 2013
- 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 15 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Parents have an adolescent in the ages of 15-20 years.
- Have had contact with the adolescent on at least 40% of the past 90 days.
- Have some knowledge or evidence that the adolescent would meet DSM-IV diagnostic criteria for a substance abuse disorder.
- Adolescent has explicitly refused to attend any intake or therapy sessions.
- All parents' efforts to enter adolescent into treatment have failed, despite therapist's assistance.
- Residence in Portland vicinity.
- Sufficient residential stability to permit probable contact at follow-up. (e.g. not homeless at time of intake)
Who cannot join
- Evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures.
- Adolescent has received residential drug treatment longer than a 2-week period in the past 90 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Research Institute Center for Family and Adolescent Research
Portland, Oregon, 97205
About this study
Official title: Preventing HIV/Aids in Tx-Resistant Drug-Abusing Youth
This project involves two studies focusing on the engagement and treatment of adolescents diagnosed with substance use disorders. Study 1 will evaluate a promising parent-based engagement intervention, Community Reinforcement Training, designed to facilitate the entry of resistant drug-abusing adolescents in treatment. The approach will be compared with an Engagement As Usual intervention condition. Study 2 involves a controlled clinical trial evaluating the efficacy of an HIV/AIDS prevention intervention embedded in family-based drug abuse treatment for reducing HIV/AIDS risk behaviors and substance use. Adolescents who are successfully engaged in treatment through Study 1 will be randomly assigned to receive either family therapy alone or family therapy with the integrated HIV/AIDS prevention intervention. Both studies are being conducted in Portland, Oregon.
- Conditions
- HIV Infections
- Being tested
- IBFT /HIV prevention, IBFT
- Keywords
- substance abuse, HIV risk, Behavior and Mental Disorders, HIV Seronegativity
- Medical subject headings
- HIV Infections, Substance-Related Disorders, Behavior, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBFT /HIV preventionBehavioural
Integrated Behavioral and Family Therapy (IBGT) with HIV prevention.
IBFTBehavioural
Integrated Behavioral and Family Therapy (IBFT).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Family Therapy plus HIV prevention Receives: Behavioral: IBFT /HIV prevention |
| 2 | Active comparator | Family Therapy only. Receives: Behavioral: IBFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in adolescent's substance use.
Measured: 12 months
Secondary outcomes (1)
Changes in HIV risk behaviors.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startJun 2004
- Primary completionJun 2013
- Study completionJun 2013
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Holly B Waldron, Ph.D., Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680719
- Sponsor's protocol ID
- DA17023
- Status last verified
- Aug 2014
- First submitted
- 16 May 2008
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing HIV/Aids in Tx-Resistant Drug-Abusing Youth
- ClinicalTrials.gov ID
- NCT00680719
- Acronym / sponsor ID
- DA17023
- Conditions
- HIV Infections
- Keywords
- substance abuse, HIV risk, Behavior and Mental Disorders, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2004
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 May 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.
This project involves two studies focusing on the engagement and treatment of adolescents diagnosed with substance use disorders. Study 1 will evaluate a promising parent-based engagement intervention, Community Reinforcement Training, designed to facilitate the entry of resistant drug-abusing adolescents in treatment. The approach will be compared with an Engagement As Usual intervention condition. Study 2 involves a controlled clinical trial evaluating the efficacy of an HIV/AIDS prevention intervention embedded in family-based drug abuse treatment for reducing HIV/AIDS risk behaviors and substance use. Adolescents who are successfully engaged in treatment through Study 1 will be randomly assigned to receive either family therapy alone or family therapy with the integrated HIV/AIDS prevention intervention. Both studies are being conducted in Portland, Oregon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: IBFT /HIV preventionFamily Therapy plus HIV prevention |
| 2 | Active comparator | Behavioral: IBFTFamily Therapy only. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Parents have an adolescent in the ages of 15-20 years.
- Have had contact with the adolescent on at least 40% of the past 90 days.
- Have some knowledge or evidence that the adolescent would meet DSM-IV diagnostic criteria for a substance abuse disorder.
- Adolescent has explicitly refused to attend any intake or therapy sessions.
- All parents' efforts to enter adolescent into treatment have failed, despite therapist's assistance.
Key exclusion criteria (2 listed)
- Evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures.
- Adolescent has received residential drug treatment longer than a 2-week period in the past 90 days.
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 |
|---|---|---|
| IBFT /HIV preventionIntegrated Behavioral and Family Therapy (IBGT) with HIV prevention. | Behavioural | 1 |
| IBFTIntegrated Behavioral and Family Therapy (IBFT). | Behavioural | 2 |
Primary outcome
Changes in adolescent's substance use.
Time frame: 12 months
1 secondary outcome
Changes in HIV risk behaviors.
Time frame: 12 months
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 5 Aug 2014.
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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.
Holly B Waldron, Ph.D. principal investigator
Oregon 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 IBFT /HIV prevention and IBFT in people with HIV Infections, run by Oregon 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 7 inclusion and 2 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 5 Aug 2014. 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?
Changes in adolescent's substance use. (time frame: 12 months). 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 5 Aug 2014.