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- Ensaio Clínico NCT00137670
Video-based Intervention Study to Prevent HIV/Sexually Transmitted Diseases (STDs) Among STD Clinic Patients
Effectiveness of a Video-based Educational Intervention to Prevent Human Immunodeficiency Virus (HIV) and Sexually Transmitted Diseases (STDs) Among Patients Attending STD Clinics
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Approximately 15 million incident cases of sexually transmitted diseases (STDs) occur annually. As a result, primary prevention of HIV/STDs among persons who have chosen to be sexually active remains a high public health priority. A number of effective interventions to prevent HIV/STDs have been developed, however many require considerable time and resource investments from both service providers and participants. These programs are often difficult to implement and sustain over time. As a result, simple practical interventions that can reduce transmission or acquisition of HIV/STDs among STD clinic patients while being both easily implemented and sustainable are urgently needed, and will ultimately enhance the menu of effective programs that are currently available to the STD clinic population.
The intervention trial was designed to develop and evaluate a video-based HIV/STD prevention intervention for STD clinic clients. The primary goals of this study are to assess whether a brief video-based educational waiting room intervention can reduce STD incidence (STD incidence outcome study) and high risk behavior (behavioral outcome study) among male and female patients attending STD clinics, when compared with patients who receive standard clinic services. This study is being conducted as a multi-site trial in 3 urban STD clinics.
The intervention condition consists of a 23-minute educational video focused on preventing STD and HIV infection shown on a large television in the waiting room. Health promotion posters supplement the video. The control condition consists of the current standard waiting room experience in each city's STD clinic.
In the STD incidence outcome study, groups of patients attending the participating STD clinics are randomly assigned to blocks of clinic weeks to either the intervention or control condition. A waiver of informed consent was obtained whereby no subjects are actively enrolled for this phase of the study. Through a retrospective review of existing medical records and STD surveillance registry data, we will determine and compare the incidence of new STDs over a 12-month period (on average) by assigned waiting room conditions.
In the behavioral outcome study, investigators administer computer-based survey instruments to a random sample of ~1600 male and female patients (800 per arm) both at enrollment and at 3 months following their initial clinic visit. The primary objective of the behavioral study is to assess the effectiveness of the video intervention by comparing levels of high-risk behavior between waiting room conditions at 3 months' follow-up.
Tipo de estudo
Inscrição
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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Long Beach, California, Estados Unidos, 90815
- California State University, Long Beach
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San Francisco, California, Estados Unidos, 94103
- San Francisco Department of Public Health
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Colorado
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Denver, Colorado, Estados Unidos, 80204
- Denver public Health
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Massachusetts
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Newton, Massachusetts, Estados Unidos, 02458
- Education Development Center, Inc.
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
STD Incidence Outcome Study:
- All medical records for STD clinic patients visiting participating STD clinics during the study period.
Behavioral Outcome Study:
STD clinic patients:
- Not returning for a follow-up visit related to a previously diagnosed problem.
- 18 years of age or older.
- Not known to be HIV-infected by self-report.
- Able to understand and speak English fluently.
- Have not been previously seen as a patient in the clinic during an intervention block when the video was being played.
- Have never received a diagnosis of a condition that necessitates frequent return visits (e.g., genital warts) by self-report.
- Have not previously enrolled in the study.
- Reported being in the clinic waiting room at least 20 minutes.
- Do not plan to move outside the clinic's catchment area during the next 6 months.
- Are willing to provide informed consent for review of their medical record and STD surveillance registry information by study staff.
- Are not known to be pregnant according to self-report (women only).
- Are not known by clinicians or counselors to be seriously ill (e.g. new HIV diagnosis or severe pelvic inflammatory disease [PID]).
- Engaged in intercourse in the last three months.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Solteiro
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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STD Incidence Outcome Study: Compare STD incidence in groups by intervention and control conditions at 3, 6, and 12 months follow-up
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Behavioral Outcome Study: Compare the incidence of risk behavior during the 3 month follow-up period among intervention and control conditions
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Medidas de resultados secundários
Medida de resultado |
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STD Incidence Outcome Study: Compare incidence of STD syndromes, and first episode of genital herpes or genital warts in intervention/control conditions
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Behavioral Outcome Study: Compare additional measures of risk between intervention and control conditions at three months follow-up including potential mediators of risk and clinic utilization
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jeff D Klausner, MD, MPH, San Francisco Department of Public Health/ STD Prevention and Control Services
- Investigador principal: Cornelis A Rietmeijer, MD, PhD, Denver public Health
- Investigador principal: Kevin Malotte, DrPH, California State University, Long Beach
- Investigador principal: Lydia N O'Donnell, Ed.D., Education Development Center, Inc.
Publicações e links úteis
Publicações Gerais
- Gallo MF, Margolis AD, Malotte CK, Rietmeijer CA, Klausner JD, O'Donnell L, Warner L; Safe in the City Study Group. Sexual abstinence and other behaviours immediately following a new STI diagnosis among STI clinic patients: Findings from the Safe in the City trial. Sex Transm Infect. 2016 May;92(3):206-10. doi: 10.1136/sextrans-2014-051982. Epub 2015 Dec 15.
- Warner L, Klausner JD, Rietmeijer CA, Malotte CK, O'Donnell L, Margolis AD, Greenwood GL, Richardson D, Vrungos S, O'Donnell CR, Borkowf CB; Safe in the City Study Group. Effect of a brief video intervention on incident infection among patients attending sexually transmitted disease clinics. PLoS Med. 2008 Jun 24;5(6):e135. doi: 10.1371/journal.pmed.0050135.
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
Outros números de identificação do estudo
- CDC-NCHSTP-3500
- R18/CCR921007
- R18/CCR121005
- R18/CCR821004
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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