Recruiting

Web-based & Traditional

Sponsor:

National Development and Research Institutes, Inc.

Code:

NCT01142882

Conditions

HIV Infections

Hepatitis

Sexually Transmitted Infections

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

Interventions

Traditional Prevention

Web-based Prevention

Study Details

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.

Conditions

HIV Infections

Hepatitis

Sexually Transmitted Infections

Study ID

NCT01142882

Start date

Feb, 2010

Status verified date

Jul, 2011

Completion date

Aug, 2011

Anticipated

Primary completion date

Aug, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Traditional Prevention

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

experimental: Web-based Prevention

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

Interventions

Traditional 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.

Web-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.

Primary outcome measure

  • HIV/disease prevention knowledge [ Time Frame: 3 months ]
  • behavioral intentions [ Time Frame: 3 months ]
  • HIV risk behavior [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Honoria M. Guarino, Ph.D.

212-845-4540guarino@ndri.org

Locations

Daytop Village, Bronx Outreach Center

Recruiting

Bronx, New York, United States, 10461

Contacts

Cassandra Melnikow, MA

718-518-9007melnikow@ndri.org

Daytop Village, Brooklyn Outreach Center

Recruiting

Brooklyn, New York, United States, 11217

Contacts

Elaine Dillingham, B.A.

718-625-1388dillingham@ndri.org

Daytop Village, Queens Outreach Center

Recruiting

Jamaica, New York, United States, 11435

Contacts

Cassandra Melnikow, M.A.

718-523-4242melnikow@ndri.org

More Information

Sponsor

National Development and Research Institutes, Inc.

Last update posted

Jul 20, 2011

Last verified

Jul, 2011

Keywords

  • adolescent HIV prevention
  • web-based interventions
  • adolescent substance abuse treatment
  • comparative effectiveness research
  • HIV prevention
  • hepatitis prevention
  • STI prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Development and Research Institutes, Inc. on 2011-07-20.