- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01142882
Comparative Effectiveness of Web-based Versus Traditional Adolescent HIV Prevention
Comparative Effectiveness of Web-based vs. Traditional Adolescent HIV Prevention
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
New York
-
Bronx, New York, Estados Unidos, 10461
- Recrutamento
- Daytop Village, Bronx Outreach Center
-
Contato:
- Cassandra Melnikow, MA
- Número de telefone: 2112 718-518-9007
- E-mail: melnikow@ndri.org
-
Brooklyn, New York, Estados Unidos, 11217
- Recrutamento
- Daytop Village, Brooklyn Outreach Center
-
Contato:
- Elaine Dillingham, B.A.
- Número de telefone: 2811 718-625-1388
- E-mail: dillingham@ndri.org
-
Jamaica, New York, Estados Unidos, 11435
- Recrutamento
- Daytop Village, Queens Outreach Center
-
Contato:
- Cassandra Melnikow, M.A.
- Número de telefone: 2252 718-523-4242
- E-mail: melnikow@ndri.org
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
|
Experimental: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
HIV/disease prevention knowledge
Prazo: 3 months
|
3 months
|
|
|
behavioral intentions
Prazo: 3 months
|
intentions to engage in safer sex
|
3 months
|
|
HIV risk behavior
Prazo: 3 months
|
sexual risk behavior
|
3 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
skills acquisition
Prazo: 3 months
|
communication skills; negotiaion skills & condom use skills
|
3 months
|
|
self-reported substance use
Prazo: 3 months
|
as measured via Timeline Follow-back
|
3 months
|
|
intervention acceptability
Prazo: post-intervention
|
post-intervention
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lisa A. Marsch, Ph.D., National Development and Research Institutes, Inc.
- Diretor de estudo: Honoria M. Guarino, Ph.D., National Development and Research Institutes, Inc.
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HIVPrev613
- 1RC1DA028415 (Concessão/Contrato do NIH dos EUA)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .