- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01142882
Comparative Effectiveness of Web-based Versus Traditional Adolescent HIV Prevention
Comparative Effectiveness of Web-based vs. Traditional Adolescent HIV Prevention
Study Overview
Status
Intervention / Treatment
Detailed Description
This trial will examine the comparative effectiveness and cost-effectiveness of a web-based HIV, hepatitis and STI prevention intervention when offered to youth in outpatient, community-based substance abuse treatment as directly compared to a traditional HIV (and infectious disease) prevention intervention. We will assess the comparative effectiveness and cost-effectiveness of these interventions by primarily examining changes from pre- to post-intervention in accurate HIV/disease prevention knowledge, intentions to engage in safer sex and HIV risk behavior. Additionally, we will examine the extent to which the interventions impact relevant skills acquisition (e.g., communication skills, negotiation skills and condom use skills), attitudes toward safer sex and self-reported substance use, as well as the acceptability of each intervention. We also plan to evaluate youth at both 1 and 3 month post-intervention to examine the durability of effects (including any differential durability of effects across intervention conditions). The web-delivered prevention intervention to be evaluated in this study has the potential to allow for a complex intervention to be delivered at a low cost, without increasing demands on staff time or training needs, and may thereby expand the reach of evidence-based prevention for youth in substance-abuse treatment.
This study will be conducted at three collaborating, community-based adolescent substance abuse treatment programs all of which are housed within the Daytop Village network of services and are located in New York City: (1) Daytop Village's Brooklyn Outreach Center; (2) Daytop Village's Bronx Outreach Center; and (3) Daytop Village's Queens Outreach Center. We expect to recruit approximately one third of the total number of participants from each site.
A total of up to 160 (no fewer than 120) adolescent participants will be enrolled in this study. Participants will be randomly assigned to one of the two study conditions in an intent-to-treat design (n=60-80 per group): (1) computer-delivered intervention or (2) traditional (person-delivered intervention). Participants in the traditional prevention intervention condition will complete two sessions (of approx. one hour in duration) across the course of a week, conducted by a trained HIV (and infectious disease) prevention educator; these sessions will typically be conducted in small groups of 2-4 participants but may be offered individually. Participants in the computer-delivered intervention condition will complete an interactive, web-based HIV, hepatitis and STI prevention program instead of the traditional, person-delivered prevention intervention. Youth will be asked to complete a customized plan of approximately 2-4 hours in length using the web-based tool; participants will complete two 60-minute sessions per week until they complete their customized plan. Participants will access this intervention using dedicated computer stations set up at their substance abuse treatment program.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Honoria M. Guarino, Ph.D.
- Phone Number: 212-845-4540
- Email: guarino@ndri.org
Study Locations
-
-
New York
-
Bronx, New York, United States, 10461
- Recruiting
- Daytop Village, Bronx Outreach Center
-
Contact:
- Cassandra Melnikow, MA
- Phone Number: 2112 718-518-9007
- Email: melnikow@ndri.org
-
Brooklyn, New York, United States, 11217
- Recruiting
- Daytop Village, Brooklyn Outreach Center
-
Contact:
- Elaine Dillingham, B.A.
- Phone Number: 2811 718-625-1388
- Email: dillingham@ndri.org
-
Jamaica, New York, United States, 11435
- Recruiting
- Daytop Village, Queens Outreach Center
-
Contact:
- Cassandra Melnikow, M.A.
- Phone Number: 2252 718-523-4242
- Email: melnikow@ndri.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Enrolled in collaborating adolescent substance abuse treatment program (i.e., Daytop's Brooklyn Outreach Center, Bronx Outreach Center or Queens Outreach Center)
- 12-18 years of age
- Within first 30 days of substance abuse treatment (current treatment episode)
- Not yet received formal HIV prevention intervention during current treatment episode
Exclusion Criteria:
- Plans to move out of the area within the next 5 months
- Insufficient ability to understand and provide informed consent/assent to participate
- Insufficient ability to use English to participate in the consent process, the interventions and/or assessments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Traditional Prevention
educator-delivered, small-group HIV & disease prevention education
|
Participants in the traditional prevention intervention condition will complete two sessions (of approx.
one hour in duration) across the course of a week, conducted by a trained HIV (and infectious disease) prevention educator; these sessions will typically be conducted in small groups of 2-4 participants but may be offered individually.
|
Experimental: Web-based Prevention
self-directed, interactive & customized web-based HIV & disease prevention education
|
Participants in the web-based intervention condition will complete an interactive, web-based HIV, hepatitis and STI prevention program.
Youth will be asked to complete a customized plan of approximately 2-4 hours in length using the web-based tool; participants will complete two 60-minute sessions per week until they complete their customized plan.
Participants can choose to access this intervention using dedicated computer stations set up at their substance abuse treatment setting or can complete these sessions at their own home via the web.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV/disease prevention knowledge
Time Frame: 3 months
|
3 months
|
|
behavioral intentions
Time Frame: 3 months
|
intentions to engage in safer sex
|
3 months
|
HIV risk behavior
Time Frame: 3 months
|
sexual risk behavior
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
skills acquisition
Time Frame: 3 months
|
communication skills; negotiaion skills & condom use skills
|
3 months
|
self-reported substance use
Time Frame: 3 months
|
as measured via Timeline Follow-back
|
3 months
|
intervention acceptability
Time Frame: post-intervention
|
post-intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lisa A. Marsch, Ph.D., National Development and Research Institutes, Inc.
- Study Director: Honoria M. Guarino, Ph.D., National Development and Research Institutes, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIVPrev613
- 1RC1DA028415 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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