NCT01142882

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

1.5 years

First QC Date

June 9, 2010

Last Update Submit

July 19, 2011

Conditions

Keywords

adolescent HIV preventionweb-based interventionsadolescent substance abuse treatmentcomparative effectiveness researchHIV preventionhepatitis preventionSTI prevention

Outcome Measures

Primary Outcomes (3)

  • HIV/disease prevention knowledge

    3 months

  • behavioral intentions

    intentions to engage in safer sex

    3 months

  • HIV risk behavior

    sexual risk behavior

    3 months

Secondary Outcomes (3)

  • skills acquisition

    3 months

  • self-reported substance use

    3 months

  • intervention acceptability

    post-intervention

Study Arms (2)

Traditional Prevention

ACTIVE COMPARATOR

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

Behavioral: Traditional Prevention

Web-based Prevention

EXPERIMENTAL

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

Behavioral: Web-based Prevention

Interventions

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.

Traditional 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.

Web-based Prevention

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Enrolled in collaborating adolescent substance abuse treatment program (i.e., Daytop's Brooklyn Outreach Center, Bronx Outreach Center or Queens Outreach Center)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Daytop Village, Brooklyn Outreach Center

Brooklyn, New York, 11217, United States

RECRUITING

Daytop Village, Queens Outreach Center

Jamaica, New York, 11435, United States

RECRUITING

Daytop Village, Bronx Outreach Center

The Bronx, New York, 10461, United States

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

HIV InfectionsHepatitisSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesLiver DiseasesDigestive System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lisa A. Marsch, Ph.D.

    National Development and Research Institutes, Inc.

    PRINCIPAL INVESTIGATOR
  • Honoria M. Guarino, Ph.D.

    National Development and Research Institutes, Inc.

    STUDY DIRECTOR

Central Study Contacts

Honoria M. Guarino, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 11, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations