HIVNCT00182585
Computer-Assisted HIV Prevention for Young Drug Users
A study testing computer-based HIV, STD & Hepatitis Education and educator-delivered HIV, STD and Hepatitis education in people with HIV, run by National Development and Research Institutes, Inc. at 2 sites in United States.
Trial summary
In this study, the investigators are developing and evaluating an interactive, computer-assisted HIV, STD and disease prevention program for young substance abusers that incorporates effective components of both prevention science and educational technologies. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- HIV
- What is being tested?
- computer-based HIV, STD & Hepatitis Education and educator-delivered HIV, STD and Hepatitis education
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2004to not given
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aadolescents in outpatients substance abuse treatment
- Ages 13 - 18 years
- Within first month of treatment entry
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Daytop
Brooklyn, New York, 11217
St. Luke's-Hospital, CAPA Program
New York, New York, 10025
About this study
In this study, the investigators are developing and evaluating an interactive, computer-assisted HIV, STD and disease prevention program for young substance abusers that incorporates effective components of both prevention science and educational technologies.
Read the detailed description
Adolescents and young adults who use drugs are at high risk for infection with HIV, STDs and other diseases with similar transmission dynamics. Although several age-appropriate and effective HIV, STD and disease prevention efforts have been identified for young substance abusers, most interventions have been narrow in focus and are generally not structured to readily address changing patterns of drug use among adolescents that place them at risk for infection with these diseases. In this study, we are developing and evaluating an interactive, computer-assisted HIV, STD and disease prevention program for young substance abusers that incorporates effective components of both prevention science and educational technologies. We plan to develop this program with the input from the target population of adolescents and young adults. We also plan to conduct a randomized, controlled trial to evaluate the benefit of including this program in HIV and disease prevention efforts with youth in substance abuse treatment. In so doing, we will evaluate the ability of the program to promote accurate knowledge about HIV and other diseases, promote self-efficacy to reduce risk behavior and change actual rates of risk behavior among young substance abusers. This computer-based program will be designed to promote the increased adoption of effective HIV and disease prevention science for this population. New information about changing patterns of drug use and HIV risk behaviors can be readily incorporated into the program as it becomes available. The program can be easily exported and able to be applied with fidelity. Importantly, the program will be structured such that a therapist or educator may customize the program content for use by various sub-populations of substance-abusing adolescents and young adults. Thus, the program will be able to address risk factors specific to each young drug user. This program may address many of the challenges associated with the current delivery of evidence-based HIV prevention programs to this population.
- Conditions
- HIV
- Being tested
- computer-based HIV, STD & Hepatitis Education, educator-delivered HIV, STD and Hepatitis education
- Keywords
- HIV, hepatitis, STDs, adolescents, addiction, treatment, prevention, HIV and related risk behavior among youth in drug treatment
- Medical subject headings
- Hepatitis, Sexually Transmitted Diseases, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer-based HIV, STD & Hepatitis EducationProcedure or surgery
educator-delivered HIV, STD and Hepatitis educationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV risk behavior
Secondary outcomes (4)
knowledge related to HIV, Hepatitis, STDs
behavioral intentions
attitudes toward risk-reduction behavior
feedback on intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startAug 2004
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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Development and Research Institutes, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Daytop (adolescent treament program), St. Luke's-Roosevelt Hospital Center
- Investigators
- Lisa Marsch, PhD, Principal investigator, National Development and Research Institutes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182585
- Sponsor's protocol ID
- R01DA015964
- Status last verified
- Aug 2008
- First submitted
- 10 Sep 2005
- Last updated
- 13 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Assisted HIV Prevention for Young Drug Users
- ClinicalTrials.gov ID
- NCT00182585
- Acronym / sponsor ID
- R01DA015964
- Conditions
- HIV
- Keywords
- HIV, hepatitis, STDs, adolescents, addiction, treatment, prevention, HIV and related risk behavior among youth in drug treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- National Development and Research Institutes, Inc.University, hospital or other
- Collaborators
- Daytop (adolescent treament program), St. Luke's-Roosevelt Hospital Center
- Study start
- Aug 2004
- First posted
- 16 Sep 2005 (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.
In this study, the investigators are developing and evaluating an interactive, computer-assisted HIV, STD and disease prevention program for young substance abusers that incorporates effective components of both prevention science and educational technologies.
Detailed description
Adolescents and young adults who use drugs are at high risk for infection with HIV, STDs and other diseases with similar transmission dynamics. Although several age-appropriate and effective HIV, STD and disease prevention efforts have been identified for young substance abusers, most interventions have been narrow in focus and are generally not structured to readily address changing patterns of drug use among adolescents that place them at risk for infection with these diseases. In this study, we are developing and evaluating an interactive, computer-assisted HIV, STD and disease prevention program for young substance abusers that incorporates effective components of both prevention science and educational technologies. We plan to develop this program with the input from the target population of adolescents and young adults. We also plan to conduct a randomized, controlled trial to evaluate the benefit of including this program in HIV and disease prevention efforts with youth in substance abuse treatment. In so doing, we will evaluate the ability of the program to promote accurate knowledge about HIV and other diseases, promote self-efficacy to reduce risk behavior and change actual rates of risk behavior among young substance abusers. This computer-based program will be designed to promote the increased adoption of effective HIV and disease prevention science for this population. New information about changing patterns of drug use and HIV risk behaviors can be readily incorporated into the program as it becomes available. The program can be easily exported and able to be applied with fidelity. Importantly, the program will be structured such that a therapist or educator may customize the program content for use by various sub-populations of substance-abusing adolescents and young adults. Thus, the program will be able to address risk factors specific to each young drug user. This program may address many of the challenges associated with the current delivery of evidence-based HIV prevention programs to this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aadolescents in outpatients substance abuse treatment
- Ages 13 - 18 years
- Within first month of treatment entry
Key exclusion criteria (0 listed)
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-based HIV, STD & Hepatitis Education | Procedure or surgery | – |
| educator-delivered HIV, STD and Hepatitis education | Procedure or surgery | – |
Primary outcome
HIV risk behavior
4 secondary outcomes
knowledge related to HIV, Hepatitis, STDs
behavioral intentions
attitudes toward risk-reduction behavior
feedback on intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2008.
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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.
Lisa Marsch, PhD principal investigator
National Development and Research Institutes, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computer-based HIV, STD & Hepatitis Education and educator-delivered HIV, STD and Hepatitis education in people with HIV, run by National Development and Research Institutes, Inc. at 2 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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 13 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
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 risk behavior. 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 13 Aug 2008.