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Effectiveness of a Community-level HIV/STD Prevention Intervention in Promoting Safer Sexual Behaviors in High-risk Populations

1 de novembro de 2013 atualizado por: RTI International

NIMH Collaborative HIV/STD Prevention Trial

This study will evaluate the effectiveness of a community-level HIV prevention program in promoting safer sexual behaviors and reducing the transmission of HIV/sexually transmitted diseases among at-risk populations in China, India, Peru, Russia, and Zimbabwe.

Visão geral do estudo

Descrição detalhada

The HIV/AIDS epidemic remains largely out of control in many areas of the world, with an estimated 2.5 million new HIV infections worldwide in 2007. Developing countries with few economic resources and world regions undergoing difficult social transitions have been particularly impacted by large increases in HIV and sexually transmitted disease (STD) infections. To date, effective individual prevention approaches have not been rapid enough to avert the epidemic in these areas and may be too resource intensive to maintain. Behavioral HIV prevention interventions on the community level seek to reduce the prevalence of high-risk sexual behaviors by reaching large numbers of vulnerable people in a cost-effective and feasible manner, even in areas with limited resources. The Community Popular Opinion Leader (C-POL) program is an HIV prevention intervention that recruits and trains trusted opinion leaders in the community to promote safe sex behaviors through risk-reduction conversations with peers. Implementing the C-POL program in world regions facing significant HIV/AIDS epidemics may be the most effective means of encouraging behavior change among members of at-risk populations and strengthening social norms to maintain these changes. This study will evaluate the effectiveness of the C-POL program in promoting safer sexual behaviors and reducing the transmission of HIV/STDs among at-risk populations in China, India, Peru, Russia, and Zimbabwe.

Participation in this study will last 2 years. Initially, an ethnographic study will be conducted to determine the HIV/STD knowledge, attitudes, and behaviors among the population living in the target communities. Information collected via observation, focus groups, and interviews will be used to determine the social risk groups operating within the community and to identify and recruit the opinion leaders who are influential in these groups. Also, an epidemiological study will be conducted to collect information on sexual behaviors and HIV/STD rates.

A cohort of members from participating communities will first undergo baseline assessments that will include a survey about general health and knowledge of HIV/STDs and a biological sampling for HIV/STD testing. Participating communities will then be assigned randomly to receive the C-POL intervention and HIV/STD educational materials or HIV/STD educational materials alone. In communities receiving the C-POL intervention, the previously recruited opinion leaders will be taught skills for sharing HIV risk-reduction messages in daily conversation with peers. This training will occur over four to five weekly sessions. At least 15% of the community population will be trained as opinion leaders. After the initial training, opinion leaders will attend six to nine booster sessions over the next 2 years to reinforce and support continued conversation efforts. Communities assigned to receive the HIV/STD educational materials will receive informational materials on HIV/STDs to provide to community members and will provide treatment or treatment referral for people with nonviral STDs.

All participants in the baseline cohort will be asked to repeat the baseline testing 1 and 2 years later. Participants who are not able to visit a clinic for testing will be contacted by phone to complete the baseline survey. After the 2-year assessments, the C-POL intervention will be conducted in the communities that received educational materials only.

Tipo de estudo

Intervencional

Inscrição (Real)

18147

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Fuzhou, China, 350003
        • Fujian Institute of Health Education
      • St. Petersburg, Federação Russa, 197110
        • Biomedical Center
      • Lima, Peru
        • Universidad Peruana Cayetano Heredia
      • Harare, Zimbábue
        • Zimbabwe Community Health Intervention Research (ZiCHIRe) - University of Zimbabwe
      • Chennai, Índia, 600 113
        • YRG Centre for AIDS Research and Education (YRGCARE)

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 49 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Either lives, works, or socializes in the selected venues
  • Plans to remain in the venue for at least 1 year after study entry

Exclusion Criteria:

  • Permanent disability that hinders participation (e.g. deaf, mental retardation)
  • Reports no sex in the 6 months before study entry (China, Peru)
  • No STDs present at study entry (China)
  • Enrolled in final year of school at time of recruitment (Russia)
  • Has lived in venue for less than 2 years (Zimbabwe)
  • Lives in venue for less than 9 months out of a year (Zimbabwe)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 1
Participating communities will receive the Community Popular Opinion Leader intervention and HIV/STD educational materials.
The C-POL intervention will teach identified opinion leaders to share personalized HIV prevention messages in conversations with peers in an effort to change community norms. Opinion leaders will be taught skills for sharing HIV risk-reduction messages during four to five weekly training sessions. At least 15% of the community population will be trained as opinion leaders. After the initial training, opinion leaders will attend six to nine booster sessions over the next 2 years to reinforce and support continued conversation efforts.
Outros nomes:
  • Popular Opinion Leader (POL)
  • Diffusion of Innovations
Communities will receive HIV/STD educational materials and treatment referral information to distribute to community members.
Comparador Ativo: 2
Participating communities will receive HIV/STD educational materials only.
Communities will receive HIV/STD educational materials and treatment referral information to distribute to community members.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Frequency of unprotected sexual acts with nonspousal partners
Prazo: Measured at baseline and Years 1 and 2
Measured at baseline and Years 1 and 2
Overall observed incidence of sexually transmitted diseases (STDs) (e.g., chlamydia, gonorrhea, syphilis, trichomonas, HIV, or herpes simplex virus-2), as detected by biological specimens
Prazo: Measured at baseline and Years 1 and 2
Measured at baseline and Years 1 and 2

Medidas de resultados secundários

Medida de resultado
Prazo
Increased exposure to HIV prevention messages, more STD treatment seeking, lower stigma regarding HIV and STDs, and lower substance abuse associated with sexual behavior in intervention group as compared to control group
Prazo: Measured at Year 2
Measured at Year 2

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Carlos F. Caceres, PhD, Cayetano Heredia University, Lima, Peru
  • Investigador principal: David D. Celentano, ScD, The Johns Hopkins University, Baltimore, Maryland (India)
  • Investigador principal: Thomas J. Coates, PhD, University of California at Los Angeles, Los Angeles, California (Peru)
  • Investigador principal: Tyler D. Hartwell, PhD, RTI International, Research Triangle Park, North Carolina (DCC)
  • Investigador principal: Danuta Kasprzyk, PhD, Battelle Center for Public Health Research and Evaluation, Seattle, Washington (Zimbabwe)
  • Investigador principal: Jeffrey A. Kelly, PhD, Medical College of Wisconsin, Milwaukee, Wisconsin (Russia)
  • Investigador principal: Andrei P. Kozlov, PhD, Biomedical Center, St. Petersburg State University, St. Petersburg, Russia
  • Investigador principal: Willo Pequegnat, PhD, National Institute of Mental Health, Bethesda, Maryland
  • Investigador principal: Mary Jane Rotheram-Borus, PhD, University of California at Los Angeles, Los Angeles, California (China)
  • Investigador principal: Suniti Solomon, MD, YRG Centre for AIDS Research and Education, Chennai, India
  • Investigador principal: Godfrey B. Woelk, PhD, University of Zimbabwe Medical School, Harare, Zimbabwe
  • Investigador principal: Zunyou Wu, MD, PhD, Chinese Center for Disease Control and Prevention, Beijing, P.R. China

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de setembro de 2002

Conclusão Primária (Real)

1 de agosto de 2007

Conclusão do estudo (Real)

1 de agosto de 2007

Datas de inscrição no estudo

Enviado pela primeira vez

30 de junho de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de junho de 2008

Primeira postagem (Estimativa)

3 de julho de 2008

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

3 de novembro de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de novembro de 2013

Última verificação

1 de julho de 2008

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • U10MH061537 (Concessão/Contrato do NIH dos EUA)
  • DAHBR 9A-ASGT
  • U10MH061499 (Concessão/Contrato do NIH dos EUA)
  • U10MH061513 (Concessão/Contrato do NIH dos EUA)
  • U10MH061536 (Concessão/Contrato do NIH dos EUA)
  • U10MH061543 (Concessão/Contrato do NIH dos EUA)
  • U10MH061544 (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 .

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