- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00130273
Managed Problem Solving to Increase Treatment Adherence in Individuals With HIV (MAPS)
Managed Problem Solving: An HIV Adherence Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
HAART is considered to be the most effective treatment for HIV. However, sustained and consistent adherence to HAART is necessary for long-term success. Issues such as memory problems, lack of social support, medication side effects, depression, and substance abuse can significantly reduce patient adherence to HAART. This study will evaluate the effectiveness of a managed problem solving strategy to increase HAART adherence in patients with HIV. Both treatment-naive and treatment-experienced participants will be recruited for this study.
The treatment part of this study will last 12 months. Participants will be randomly assigned to receive the managed problem solving intervention or standard of care for 12 months. Participants in the managed problem solving group will have 4 study visits and will receive 3 phone calls for the first 3 months of the study, and 1 phone call every month for the following 9 months. At each study visit, participants will identify barriers to adherence. During the phone calls, participants will be asked about any steps they have taken to improve their adherence. A medication event monitoring system (MEMS) will be used to assess participants' treatment adherence. MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings. Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes. Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count. Follow-up phone interviews will be conducted every year for 3 years after the end of treatment.
Study hypothesis: Managed problem solving will result in better adherence to highly active antiretroviral therapy (HAART) and better virologic control and immunological outcomes at the end of 1 year compared with a control group receiving standard or care.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania School of Medicine
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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 for All Participants:
- HIV infected
- Infection likely to be susceptible to a specific treatment regimen
- Have access to a telephone
- Willing and able to comply with all study requirements
Exclusion Criteria for All Participants:
- Live in a care facility that provides medications on schedule
Inclusion Criteria for Treatment-Experienced Participants:
- Restarting HAART after a treatment interruption of at least 3 months OR after virologic failure with a viral load greater than 1,000 copies/ml
- On a treatment regimen for less than 2 weeks prior to study entry
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 1
Participants will receive managed problem solving for 12 months
|
Participants in the managed problem solving group will have four study visits and will receive three phone calls for the first 3 months of the study, and one phone call every month for the following 9 months.
At each study visit, participants will identify barriers to adherence.
During the phone calls, participants will be asked about any steps they have taken to improve their adherence.
A medication event monitoring system (MEMS) will be used to assess participants' treatment adherence.
MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings.
Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes.
Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count.
|
|
Comparador Ativo: 2
Participants will receive standard of care for 12 months
|
Participants will receive standard of care for 12 months.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Improved adherence
Prazo: Measured at Year 4
|
Measured at Year 4
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Decrease in viral load
Prazo: Measured at Year 4
|
Measured at Year 4
|
|
Increase in CD4 count
Prazo: Measured at Year 4
|
Measured at Year 4
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Robert Gross, MD, MSCE, University of Pennsylvania
Publicações e 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
Termos MeSH relevantes adicionais
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções transmitidas pelo sangue
- Doenças Transmissíveis
- Doenças Sexualmente Transmissíveis, Virais
- Doenças Sexualmente Transmissíveis
- Infecções por Lentivírus
- Infecções por Retroviridae
- Síndromes de Deficiência Imunológica
- Doenças do sistema imunológico
- Infecções por HIV
Outros números de identificação do estudo
- R01MH067498 (Concessão/Contrato do NIH dos EUA)
- DAHBR 9A-ASPG (National Institute of Mental Health (NIMH-DAHBR))
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 .