- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00906178
CyberSenga: Internet-based HIV Prevention in Uganda
CyberSenga: Harnessing the Power of the Internet to Prevent HIV in Ugandan Youth
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
HIV/AIDS is a major contributor to morbidity and mortality in Uganda. Despite aggressive advances in HIV prevention efforts, recent data suggest that HIV prevalence is increasing generally, and HIV knowledge, a direct contributor to behavior, is on the decline among young people specifically as compared to a decade ago.
The Internet is a promising mode of intervention delivery in resource poor-settings because the costs associated with scaling up are minimal; dissemination online is the same if one person or 100,000 people use the program. Just as important, it provides access to important health information in a stigma-free, anonymous atmosphere. Our recent data indicate that 45% of adolescents in Mbarara, Uganda have used the Internet, 78% of whom went online at least once in the previous week. Eighty-one percent of respondents in the same survey indicated they would go to an HIV prevention web site if it existed. Based upon these data, we propose to develop a culturally appropriate, Internet-based HIV prevention program designed specifically for Ugandan adolescents between the ages of 12 and 18 years. Our specific aims are as follows:
Specific Aim 1: Design a 6-hour, Internet-based HIV prevention program for adolescents. Content will be culturally tailored to the HIV preventive information, motivation, and behavioral skills needs of Ugandan adolescents.
Specific Aim 2: Test the intervention in a randomized controlled trial (n=500) among adolescents attending grades Secondary 1-4 (similar to US high school grades 8th - 11th) at day schools in Mbarara.
This project has the potential to develop low-cost and salable interventions to HIV transmission risk behaviors among adolescents in Uganda.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Mbarara, Uganda
- Internet Solutions for Kids Uganda, Limited
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Enrollment in grades Secondary 1 through 4 at a partner secondary school
- Having used a computer or the Internet at least once in the past year
- Not having been part of the intervention development activities
- Caregiver informed permission and adolescent informed assent
Exclusion Criteria:
- none
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 |
|---|---|
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Experimental: CyberSenga
6-module HIV prevention program tailored for adolescents in Uganda
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Internet-based HIV prevention program
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Sem intervenção: Control
"treatment as usual" - the sexual health education adolescents currently receive in secondary school
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sex Without a Condom as Assessed by Self-report
Prazo: 6-months post-intervention
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Unprotected sex (i.e., vaginal or anal sex without a condom) in the past three months
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6-months post-intervention
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Sexual Abstinence
Prazo: 6-months post-intervention
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Not having had vaginal or anal sex in the past three months
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6-months post-intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Abstinence at Three-month Follow-up
Prazo: 3 months post-intervention
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Sexual abstinence (i.e., not having vaginal or anal sex) in the past 90 days
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3 months post-intervention
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Unprotected Sex at Three-month Follow-up
Prazo: 3 months post-intervention
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Ever had vaginal or anal sex without a condom in the past 90 days
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3 months post-intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michele Ybarra, MPH PhD, Center for Innovative Public Health
Publicações e links úteis
Publicações Gerais
- Mitchell KJ, Bull S, Kiwanuka J, Ybarra ML. Cell phone usage among adolescents in Uganda: acceptability for relaying health information. Health Educ Res. 2011 Oct;26(5):770-81. doi: 10.1093/her/cyr022. Epub 2011 May 2.
- Bull S, Nabembezi D, Birungi R, Kiwanuka J, Ybarra M. Cyber-Senga: Ugandan youth preferences for content in an internet-delivered comprehensive sexuality education programme. East Afr J Public Health. 2010 Mar;7(1):58-63.
- Ybarra ML, Biringi R, Prescott T, Bull SS. Usability and navigability of an HIV/AIDS internet intervention for adolescents in a resource-limited setting. Comput Inform Nurs. 2012 Nov;30(11):587-95; quiz 596-7. doi: 10.1097/NXN.0b013e318266cb0e.
- Hampanda K, Ybarra M, Bull S. Perceptions of health care services and HIV-related health-seeking behavior among Uganda adolescents. AIDS Care. 2014;26(10):1209-17. doi: 10.1080/09540121.2014.894612. Epub 2014 Mar 13.
- Ybarra ML, Korchmaros J, Kiwanuka J, Bangsberg DR, Bull S. Examining the applicability of the IMB model in predicting condom use among sexually active secondary school students in Mbarara, Uganda. AIDS Behav. 2013 Mar;17(3):1116-28. doi: 10.1007/s10461-012-0137-x.
- Katz IT, Ybarra ML, Wyatt MA, Kiwanuka JP, Bangsberg DR, Ware NC. Socio-cultural and economic antecedents of adolescent sexual decision-making and HIV-risk in rural Uganda. AIDS Care. 2013;25(2):258-64. doi: 10.1080/09540121.2012.701718. Epub 2012 Jul 27.
- Ybarra ML, Bull SS, Kiwanuka J, Bangsberg DR, Korchmaros J. Prevalence rates of sexual coercion victimization and perpetration among Uganda adolescents. AIDS Care. 2012;24(11):1392-400. doi: 10.1080/09540121.2011.648604. Epub 2012 Feb 2.
- Birungi R, Nabembezi D, Kiwanuka J, Ybarra M, Bull S. Adolescents' perceptions of sexual coercion in Uganda. Afr J AIDS Res. 2011 Dec;10(4):487-94. doi: 10.2989/16085906.2011.646664.
- Ybarra ML, Emenyonu N, Nansera D, Kiwanuka J, Bangsberg DR. Health information seeking among Mbararan adolescents: results from the Uganda Media and You survey. Health Educ Res. 2008 Apr;23(2):249-58. doi: 10.1093/her/cym026. Epub 2007 Jul 16.
- Ybarra ML, Korchmaros JD, Prescott TL, Birungi R. A Randomized Controlled Trial to Increase HIV Preventive Information, Motivation, and Behavioral Skills in Ugandan Adolescents. Ann Behav Med. 2015 Jun;49(3):473-85. doi: 10.1007/s12160-014-9673-0.
- Ybarra ML, Bull SS, Prescott TL, Birungi R. Acceptability and feasibility of CyberSenga: an Internet-based HIV-prevention program for adolescents in Mbarara, Uganda. AIDS Care. 2014 Apr;26(4):441-7. doi: 10.1080/09540121.2013.841837. Epub 2013 Oct 4.
- Ybarra ML, Bull SS, Prescott TL, Korchmaros JD, Bangsberg DR, Kiwanuka JP. Adolescent abstinence and unprotected sex in CyberSenga, an Internet-based HIV prevention program: randomized clinical trial of efficacy. PLoS One. 2013 Aug 14;8(8):e70083. doi: 10.1371/journal.pone.0070083. eCollection 2013.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Outros números de identificação do estudo
- ISK-NIH-MH080662
- 5R01MH080662 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Dados/documentos do estudo
- Intervention website
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Formulário de Consentimento Informado
Comentários informativos: All study documents (consent form, surveys, etc) are available for free download at the study site
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 .