HIV Prevention Toolkit for HIV-negative Male Couples (MCAP)
28 de março de 2019 atualizado por: Daniel J Feaster, University of Miami
Development of a HIV Prevention Toolkit for At-risk HIV-negative Male Couples
Though technology is integrated into the lives of our target population, use of any particular technology will depend on the content delivered, aesthetic appeal, and overall design.
Based on the completion and analysis of data from Phase 1, the investigators were able to obtain feedback on HIV-negative male couples' attitudes toward the original content in the prevention toolkit modules.
The research team, along with the web-developers, used this feedback to specifically tailor the content of the modules to fit the unique needs of the intervention's target population: at risk HIV-negative male couples.
For Phase 2, the investigators conducted focus groups at each site to help identify strengths and potential areas for improvement of the prevention toolkit, which will be incorporated before piloting it in the intervention for Phase 3 of this project.
After assessing the acceptability of the prevention toolkit, including the content of modules, aesthetic appeal, and overall design with HIV-negative male couples target population, the research team will pilot test whether the RCT with the prevention toolkit will help reduce HIV risk through formation and adherence to a sexual agreement, reduction in occurrences of condomless anal sex with casual sex partners, and increase testing behaviors among at-risk HIV-negative male couples.
The interactive website, herein referred to as the "HIV prevention toolkit" will contain unique modules about sexual agreements and effective HIV prevention strategies.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
298
Estágio
- Não aplicável
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
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Florida
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Miami, Florida, Estados Unidos, 33136
- Clinical Research Building
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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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Macho
Descrição
Inclusion Criteria:
Eligible male couples:
- are identified as two men (i.e., main partners) who had been in a sexual relationship together for > 6 months;
- are at least 18 years of age;
- are self-reported as being HIV-negative;
- had been practicing CAS in their relationship for > 6 months;
- report no recent history (< 1 year) of intimate partner violence (IPV) or coercion;
- have had no current sexual agreement; and
- own a smartphone and have an alternate method to access the Internet (e.g., computer).
Exclusion Criteria:
- Interested participants, including both men of a male couple, who did not meet the inclusion criteria above will be excluded from participating in Phase 3 of this study.
- Individuals who participated in Phase 1 or 2 will be were excluded from participating in Phase 3 of this study.
- Adults who are unable to consent;
- Individuals who are not yet adults;
- Pregnant and non-pregnant women, and prisoners.
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: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de Placebo: Control group
Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
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Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center.
As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
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Comparador Ativo: Intervention group
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center.
As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
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Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center.
As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Formation of a Sexual Agreement at 6 Months
Prazo: 6 month
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Self-reports of yes/no to forming a sexual agreement via electronic survey
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6 month
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Adherence to a Sexual Agreement at 6 Months
Prazo: 6 month
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Self-report of yes/no of adhering to a sexual agreement
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6 month
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Formation of a Sexual Agreement at 3 Months
Prazo: 3 month
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Self-reports of yes/no to forming a sexual agreement via electronic survey
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3 month
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Adherence to a Sexual Agreement
Prazo: 3 month
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Self-reports of yes/no to adhering to a sexual agreement via electronic survey
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3 month
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Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3
Prazo: 3 month
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Self-reports of yes/no of any anal sex with casual male sex partner between months and month 3 via electronic survey
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3 month
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Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6
Prazo: month 6
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Self-reports of yes/no any anal sex with casual male sex partner, measured at month 6 via electronic survey (about the previous 3 months, i.e., timeframe between months 3-6).
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month 6
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Test for HIV During Past 3 Months (Months 0-3)
Prazo: 3 month
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Self-reports of yes/no via electronic survey taken at 3 month.
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3 month
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Test for HIV During the Last 3 Months (Months 3-6)
Prazo: month 6
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Self-reports of yes/no any test for HIV at month 6 assessment, collected via electronic survey for timeframe between months 3 and 6.
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month 6
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jason W Mitchell, PhD, University of Miami
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
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 outubro de 2015
Conclusão Primária (Real)
1 de setembro de 2016
Conclusão do estudo (Real)
1 de setembro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
7 de julho de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de julho de 2015
Primeira postagem (Estimativa)
10 de julho de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de abril de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de março de 2019
Última verificação
1 de março de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 20140561
- R34MH102098 (Concessão/Contrato do NIH dos EUA)
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