HIV Infections Clinical Trial
Official title:
Comparative Effectiveness of Web-based vs. Traditional Adolescent HIV Prevention
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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