CClinicalTrials.gg
Status unknownNCT01142882Updated Jul 20, 2011

Comparative Effectiveness of Web-based Versus Traditional Adolescent HIV Prevention

An interventional study of Traditional Prevention and Web-based Prevention in HIV Infections, Hepatitis and Sexually Transmitted Infections, sponsored by National Development and Research Institutes, Inc.. Status unknown at 3 sites in United States. Open to participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-20.

Sponsored by National Development and Research Institutes, Inc. · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 120 is close to the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

National Development and Research Institutes, Inc. is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Traditional Prevention

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

    Behavioral: Traditional Prevention

  • Experimental
    Web-based Prevention

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

    Behavioral: Web-based Prevention

Interventions

  • BehavioralTraditional Prevention

    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.

  • BehavioralWeb-based Prevention

    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.

06

What researchers measure

Primary outcomes

  1. HIV/disease prevention knowledge

    Time frame: 3 months

  2. behavioral intentions

    intentions to engage in safer sex

    Time frame: 3 months

  3. HIV risk behavior

    sexual risk behavior

    Time frame: 3 months

Secondary outcomes

  1. skills acquisition

    communication skills; negotiaion skills \& condom use skills

    Time frame: 3 months

  2. self-reported substance use

    as measured via Timeline Follow-back

    Time frame: 3 months

  3. intervention acceptability

    Time frame: post-intervention

07

Study locations

3 of 3 sites recruiting
  • Daytop Village, Bronx Outreach Center
    Bronx, New York 10461, United States
    Recruiting
  • Daytop Village, Brooklyn Outreach Center
    Brooklyn, New York 11217, United States
    Recruiting
  • Daytop Village, Queens Outreach Center
    Jamaica, New York 11435, United States
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26293644 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01142882
Lead sponsor
National Development and Research Institutes, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
First posted
Jun 11, 2010
Start date
Feb 2010
Primary completion
Aug 2011 (estimated)
Completion
Aug 2011 (estimated)
Last update
Jul 20, 2011

Study contacts

Honoria M. Guarino, Ph.D.
Contact
guarino@ndri.org
212-845-4540
Lisa A. Marsch, Ph.D.
principal investigator · National Development and Research Institutes, Inc.
Honoria M. Guarino, Ph.D.
study director · National Development and Research Institutes, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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