Comparative Effectiveness of Web-based Versus Traditional Adolescent HIV Prevention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01142882|
Recruitment Status : Unknown
Verified July 2011 by National Development and Research Institutes, Inc..
Recruitment status was: Recruiting
First Posted : June 11, 2010
Last Update Posted : July 20, 2011
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Hepatitis Sexually Transmitted Infections||Behavioral: Traditional Prevention Behavioral: Web-based Prevention||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Effectiveness of Web-based vs. Traditional Adolescent HIV Prevention|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||August 2011|
Active Comparator: Traditional Prevention
educator-delivered, small-group HIV & disease prevention education
Behavioral: 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.
Experimental: Web-based Prevention
self-directed, interactive & customized web-based HIV & disease prevention education
Behavioral: 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.
- HIV/disease prevention knowledge [ Time Frame: 3 months ]
- behavioral intentions [ Time Frame: 3 months ]intentions to engage in safer sex
- HIV risk behavior [ Time Frame: 3 months ]sexual risk behavior
- skills acquisition [ Time Frame: 3 months ]communication skills; negotiaion skills & condom use skills
- self-reported substance use [ Time Frame: 3 months ]as measured via Timeline Follow-back
- intervention acceptability [ Time Frame: post-intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142882
|Contact: Honoria M. Guarino, Ph.D.||firstname.lastname@example.org|
|United States, New York|
|Daytop Village, Bronx Outreach Center||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Cassandra Melnikow, MA 718-518-9007 ext 2112 email@example.com|
|Daytop Village, Brooklyn Outreach Center||Recruiting|
|Brooklyn, New York, United States, 11217|
|Contact: Elaine Dillingham, B.A. 718-625-1388 ext 2811 firstname.lastname@example.org|
|Daytop Village, Queens Outreach Center||Recruiting|
|Jamaica, New York, United States, 11435|
|Contact: Cassandra Melnikow, M.A. 718-523-4242 ext 2252 email@example.com|
|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.|