- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00841360
ID and Testing Via Friendship Networks
A Pilot Study to Identify Undiagnosed Asymptomatic HIV Infections in Adolescent and Young Adult Women
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The proposed pilot study will utilize a cross-sectional research design to recruit Hispanic/Latina and African American young women to undergo HIV screening. The research design will consist of a friendship-based, female network recruitment approach that incorporates a dual method of incentives for index recruiters and network members as a strategy for identifying new HIV infections in the target population. Among sexually experienced young women (many of whom who reside in communities with a high prevalence of STIs and HIV), 50 who self-identify as HIV positive, 50 who self-identify as HIV negative (based on receiving a negative HIV test within 12 months prior to study consent), and 50 whose HIV status is self-reported as unknown (who have no history of prior HIV testing or who had HIV screening more than 12 months prior to date of study consent) will be recruited. These women will serve as index recruiters to recruit two or more (on average four) female friendship network members to undergo HIV screening. The index recruiters will be recruited through three participating ATN sites utilizing the existing infrastructure within the AMTUs and their community and clinical partnerships. Index participants that agree to take part in this research will be asked to self-disclose their HIV status, to complete a risk assessment and indicate their willingness to recruit their close female friends to undergo HIV screening. In addition, index recruiters who self-identify as HIV negative and those who do not know their HIV status will be invited to undergo HIV screening.
Index recruiters will be given up to four months to recruit members of their friendship network. At the end of this recruitment period or after successful recruitment of two or more friendship network members, whichever comes first, all index recruiters will be asked to complete a brief questionnaire that describes factors that both facilitated and hindered their ability to recruit the friendship network members. Sexually experienced friendship network members who agree to participate in the study will also complete a risk assessment regardless of whether or not they agree to undergo HIV screening. Participation in this study will be strictly on a voluntary basis.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Florida
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Miami, Florida, Estados Unidos, 33101
- University of Miami School of Medicine
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Stroger Hospital of Cook County
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New York
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Bronx, New York, Estados Unidos, 10467
- Montefiore Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Index recruiters will consist of sexually experienced females between the ages of 13 and 24 years old and of African American race, Hispanic/Latina ethnicity, or mixed-race/ethnicity, which must include African American race and/or Hispanic/Latina ethnicity.
Friendship network members will also consist of sexually experienced females, aged 13 years and older. Although most members are expected to be of African American race and/or Hispanic/Latina ethnicity, all races and ethnicities will be included.
Descrição
Inclusion Criteria for INDEX RECRUITERS:
- Born female;
- Aged 13-24 years at the time of consent;
- African American or Hispanic/Latina ethnicity or mixed-race/ethnicity, which must include African American race and/or Hispanic/Latina ethnicity;
- A history of sexual intercourse with at least one male sexual partner;
- Any HIV status as follows: (1) HIV positive; (2) HIV negative defined as receiving a negative HIV test result < 12 months prior to the date of study consent); or (3) HIV status unknown defined as either no history of HIV testing or receipt of negative HIV test results more than 12 months prior to the date of study consent);
- History of vaginal and/or anal sexual intercourse with a male;
- Willing to complete a HIV risk assessment; and
- Willing to recruit two or more friendship network members to discuss and eventually undergo HIV screening;
- Ability to understand written and spoken English; and
- Willing to provide written informed consent/assent.
Inclusion Criteria for FRIENDSHIP NETWORK MEMBERS:
- Born female;
- Aged > 13 years at the time of consent;
- A history of sexual intercourse with at least one male sexual partner;
- Willing to complete an HIV risk assessment;
- Willing to discuss and consider HIV screening;
- Self-report that the most recent HIV test result was negative, or has no prior history of HIV testing;
- Ability to understand written and spoken English; and
- Willing to provide written informed consent/assent.
Exclusion Criteria for INDEX RECRUITERS:
- Psychiatric disorder (untreated) associated with thought disorder, hallucinations, acute substance use withdrawal. Stabilized patients receiving appropriate psychiatric care will not be excluded if informed consent can be reasonably assumed;
- Visibly distraught and/or visibly emotionally unstable (e.g., depressive mood; exhibiting manic, suicidal, or violent behavior);
- Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with ability to give true informed consent and to adhere to the study requirements; and
- Acutely ill at the time of enrollment.
Exclusion Criteria for FRIENDSHIP NETWORK MEMBERS:
- Self-report an HIV positive test result;
- Psychiatric disorder (untreated) associated with thought disorder, hallucinations, acute substance use withdrawal. Stabilized patients receiving appropriate psychiatric care will not be excluded if informed consent can be reasonably assumed;
- Visibly distraught and/or visibly emotionally unstable (e.g., depressive mood; exhibiting manic, suicidal, or violent behavior);
- Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with ability to give true informed consent and to adhere to the study requirements;
- Acutely ill at the time of enrollment.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
HIV Positive
Participant self-discloses as HIV positive. Sexually experienced females between the ages of 13 and 24 years old and of African American race, Hispanic/Latina ethnicity, or mixed-race/ethnicity, which must include African American race and/or Hispanic/Latina ethnicity. |
Participants agree to recruit at least two female friends from their friendship network to undergo HIV screening.
|
HIV Negative
Participant self-discloses as HIV negative (based on receiving a negative HIV test within 12 months prior to study consent). Sexually experienced females between the ages of 13 and 24 years old and of African American race, Hispanic/Latina ethnicity, or mixed-race/ethnicity, which must include African American race and/or Hispanic/Latina ethnicity. |
Participants agree to recruit at least two female friends from their friendship network to undergo HIV screening.
|
HIV Status Unknown
Participant self-discloses as HIV negative (no history of prior HIV testing, or HIV screening more than 12 months prior to date of study consent). Sexually experienced females between the ages of 13 and 24 years old and of African American race, Hispanic/Latina ethnicity, or mixed-race/ethnicity, which must include African American race and/or Hispanic/Latina ethnicity. |
Participants agree to recruit at least two female friends from their friendship network to undergo HIV screening.
|
Friendship Network Members
Friendship network members will also consist of sexually experienced females, aged 13 years and older.
Although most members are expected to be of African American race and/or Hispanic/Latina ethnicity, all races and ethnicities will be included.
|
Participants are recruited by Index Recruiters to enroll in study and receive HIV screening and complete a questionnaire either on Facilitators of HIV Screening or Barriers to HIV Screening.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Number of young women (HIV status positive, negative, or unknown) who are identified and recruited to serve as index recruiters divided by the number of young women screened.
Prazo: 2
|
2
|
Proportion of index recruiters who recruit two or more of their female, friendship network members to undergo HIV screening.
Prazo: 2 years
|
2 years
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A description of factors that facilitate and hinder index recruiters in recruiting female friendship network members.
Prazo: 2 years
|
2 years
|
A description of factors that facilitate and hinder HIV screening among female friendship network members.
Prazo: 2 years
|
2 years
|
A preliminary estimate of HIV infection prevalence among the friendship networks of all index recruiters and separately in the friendship networks of each group of index recruiters.
Prazo: 2 years
|
2 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Cherrie B Boyer, PhD, University of California, San Francisco; ATN
Publicações e links úteis
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 (Real)
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 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
- Doenças de Vírus Lento
- Infecções por HIV
- Infecções
- Síndrome da Imunodeficiência Adquirida
Outros números de identificação do estudo
- ATN 067
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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