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Comparative Effectiveness of Web-based Versus Traditional Adolescent HIV Prevention

Primary Purpose

HIV Infections, Hepatitis, Sexually Transmitted Infections

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional Prevention
Web-based Prevention
Sponsored by
National Development and Research Institutes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring adolescent HIV prevention, web-based interventions, adolescent substance abuse treatment, comparative effectiveness research, HIV prevention, hepatitis prevention, STI prevention

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Daytop Village, Bronx Outreach CenterRecruiting
  • Daytop Village, Brooklyn Outreach CenterRecruiting
  • Daytop Village, Queens Outreach CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional Prevention

Web-based Prevention

Arm Description

educator-delivered, small-group HIV & disease prevention education

self-directed, interactive & customized web-based HIV & disease prevention education

Outcomes

Primary Outcome Measures

HIV/disease prevention knowledge
behavioral intentions
intentions to engage in safer sex
HIV risk behavior
sexual risk behavior

Secondary Outcome Measures

skills acquisition
communication skills; negotiaion skills & condom use skills
self-reported substance use
as measured via Timeline Follow-back
intervention acceptability

Full Information

First Posted
June 9, 2010
Last Updated
July 19, 2011
Sponsor
National Development and Research Institutes, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01142882
Brief Title
Comparative Effectiveness of Web-based Versus Traditional Adolescent HIV Prevention
Official Title
Comparative Effectiveness of Web-based vs. Traditional Adolescent HIV Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Development and Research Institutes, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the comparative effectiveness and cost-effectiveness of a customized, interactive web-based HIV, sexually transmitted infections (STI) and hepatitis prevention intervention as compared to a traditional, educator-delivered prevention intervention. Both interventions will be offered to youth enrolled in outpatient, community-based substance abuse treatment at our collaborating treatment facilities. Outcomes to be measured include accurate HIV/disease prevention knowledge, intentions to engage in safer sex, actual HIV risk behavior, attitudes toward safer sex and self-reported substance use. The web-delivered intervention under evaluation has the potential to deliver evidence-based content at low cost without increasing demands on treatment staff time or training needs.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hepatitis, Sexually Transmitted Infections
Keywords
adolescent HIV prevention, web-based interventions, adolescent substance abuse treatment, comparative effectiveness research, HIV prevention, hepatitis prevention, STI prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional Prevention
Arm Type
Active Comparator
Arm Description
educator-delivered, small-group HIV & disease prevention education
Arm Title
Web-based Prevention
Arm Type
Experimental
Arm Description
self-directed, interactive & customized web-based HIV & disease prevention education
Intervention Type
Behavioral
Intervention Name(s)
Traditional Prevention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Web-based Prevention
Intervention Description
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.
Primary Outcome Measure Information:
Title
HIV/disease prevention knowledge
Time Frame
3 months
Title
behavioral intentions
Description
intentions to engage in safer sex
Time Frame
3 months
Title
HIV risk behavior
Description
sexual risk behavior
Time Frame
3 months
Secondary Outcome Measure Information:
Title
skills acquisition
Description
communication skills; negotiaion skills & condom use skills
Time Frame
3 months
Title
self-reported substance use
Description
as measured via Timeline Follow-back
Time Frame
3 months
Title
intervention acceptability
Time Frame
post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Honoria M. Guarino, Ph.D.
Phone
212-845-4540
Email
guarino@ndri.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa A. Marsch, Ph.D.
Organizational Affiliation
National Development and Research Institutes, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Honoria M. Guarino, Ph.D.
Organizational Affiliation
National Development and Research Institutes, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Daytop Village, Bronx Outreach Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassandra Melnikow, MA
Phone
718-518-9007
Ext
2112
Email
melnikow@ndri.org
Facility Name
Daytop Village, Brooklyn Outreach Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11217
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine Dillingham, B.A.
Phone
718-625-1388
Ext
2811
Email
dillingham@ndri.org
Facility Name
Daytop Village, Queens Outreach Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11435
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassandra Melnikow, M.A.
Phone
718-523-4242
Ext
2252
Email
melnikow@ndri.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
26293644
Citation
Marsch LA, Guarino H, Grabinski MJ, Syckes C, Dillingham ET, Xie H, Crosier BS. Comparative Effectiveness of Web-Based vs. Educator-Delivered HIV Prevention for Adolescent Substance Users: A Randomized, Controlled Trial. J Subst Abuse Treat. 2015 Dec;59:30-7. doi: 10.1016/j.jsat.2015.07.003. Epub 2015 Jul 15.
Results Reference
derived

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Comparative Effectiveness of Web-based Versus Traditional Adolescent HIV Prevention

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