- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01142882
Comparative Effectiveness of Web-based Versus Traditional Adolescent HIV Prevention
Comparative Effectiveness of Web-based vs. Traditional Adolescent HIV Prevention
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
New York
-
Bronx, New York, Spojené státy, 10461
- Nábor
- Daytop Village, Bronx Outreach Center
-
Kontakt:
- Cassandra Melnikow, MA
- Telefonní číslo: 2112 718-518-9007
- E-mail: melnikow@ndri.org
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Brooklyn, New York, Spojené státy, 11217
- Nábor
- Daytop Village, Brooklyn Outreach Center
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Kontakt:
- Elaine Dillingham, B.A.
- Telefonní číslo: 2811 718-625-1388
- E-mail: dillingham@ndri.org
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Jamaica, New York, Spojené státy, 11435
- Nábor
- Daytop Village, Queens Outreach Center
-
Kontakt:
- Cassandra Melnikow, M.A.
- Telefonní číslo: 2252 718-523-4242
- E-mail: melnikow@ndri.org
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Traditional Prevention
educator-delivered, small-group HIV & disease prevention education
|
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.
|
|
Experimentální: Web-based Prevention
self-directed, interactive & customized web-based HIV & disease prevention education
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
HIV/disease prevention knowledge
Časové okno: 3 months
|
3 months
|
|
|
behavioral intentions
Časové okno: 3 months
|
intentions to engage in safer sex
|
3 months
|
|
HIV risk behavior
Časové okno: 3 months
|
sexual risk behavior
|
3 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
skills acquisition
Časové okno: 3 months
|
communication skills; negotiaion skills & condom use skills
|
3 months
|
|
self-reported substance use
Časové okno: 3 months
|
as measured via Timeline Follow-back
|
3 months
|
|
intervention acceptability
Časové okno: post-intervention
|
post-intervention
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Lisa A. Marsch, Ph.D., National Development and Research Institutes, Inc.
- Ředitel studie: Honoria M. Guarino, Ph.D., National Development and Research Institutes, Inc.
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HIVPrev613
- 1RC1DA028415 (Grant/smlouva NIH USA)
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