- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03435497
Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda
27 de maio de 2020 atualizado por: RAND
Game Changers: Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda
This randomized controlled pilot study of the "Game Changers" program will:
- Assess the feasibility and acceptability of implementing an HIV prevention advocacy intervention with people living with HIV who are in HIV care, and who will be trained to be advocates of HIV protective behaviors within their social networks.
- Assess preliminary intervention effects on a) protective behavior of the HIV-positive clients (condom use, partner concurrency/number of partners, engagement in HIV care, ART adherence); and b) diffusion of prevention messages across the network, as assessed by the content and extent of communication with network members about protective behaviors (condom use, partner concurrency/number of partners, HIV testing, engagement in HIV care, circumcision), HIV disclosure, and HIV stigma.
- Explore characteristics of HIV-positive clients who more effectively engage in prevention advocacy (in terms of socio-demographics, network characteristics, and network position and type of alters receiving advocacy).
Visão geral do estudo
Descrição detalhada
People living with HIV (PLWH) have a critical role to play in HIV prevention, not only in the context of Prevention for Positives and Treatment as Prevention, but as powerful change agents for HIV protective behaviors among others.
Our research suggests that as PLWH receive HIV treatment and restore their health and functioning, many are motivated to protect their loved ones and engage in prevention advocacy (i.e., to encourage friends and family to seek HIV testing and treatment, and to reduce risk behavior); however, the quality of this advocacy is hampered by challenges related to message content, style and timing of delivery, and selection of advocacy recipients.
With effective advocacy training, mobilizing PLWH to be change agents within their social networks has the potential to be a "game changer" for HIV prevention, particularly in high prevalence settings such as Uganda, where virtually every family is touched by someone living with HIV.
Drawing upon theoretical frameworks for network-based interventions, such as theories of social diffusion, cognitive consistency, and social influence, the proposed study will develop and pilot test "Game Changers"-- an intervention that aims to empower and mobilize PLWH to be agents for HIV prevention and behavioral change in their social networks.
In Phase 1, separate focus groups of PLWH and members of their social networks (family and friends) were conducted to explore barriers to and facilitators of mobilizing clients to advocate for HIV prevention, perceptions on how advocacy could be most effective in motivating behavior change, and how to best structure the intervention and its content.
In Phase 2 findings from Phase 1 and network-based intervention models were used to develop the structure and content of an intervention designed to help clients cope with stigma, manage their disease, live positively, and develop motivation and skills for HIV disclosure and prevention advocacy.
In Phase 3 a pilot group intervention will be conducted in a controlled trial of 96 clients, with 48 randomly assigned to receive the intervention and 48 to the wait-list control.
Assessments will be administered to all participants at baseline, 5 months later, and again 8 months after baseline, after which the control group will receive the intervention (but not the interviews).
PLWH interviews and social network assessments will examine intervention effects on protective behaviors of the participant (condom use, HIV treatment adherence), and diffusion of prevention messages across the network, as assessed by the content and extent of communication with network members about protective behaviors (condom use, partner concurrency/number of partners, HIV testing, engagement in HIV care, circumcision), HIV disclosure, and HIV stigma.
At the end of the intervention period a focus group with program participants will be conducted to get feedback on the intervention.
To help understand how participation in the program might affect health, date of HIV diagnosis, last two CD4 counts and HIV viral loads, and prescribed HIV medications will be obtained from PLWH participant medical charts.
Participants (about 15/arm) will be asked to recruit up to 3 alters each, who know the participant's serostatus, to be interviewed to assess their HIV protective behaviors (e.g., condom use) and receipt of prevention advocacy from the intervention participant.
Tipo de estudo
Intervencional
Inscrição (Real)
99
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
-
-
-
Kampala, Uganda
- Infectious Diseases Institute
-
-
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
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria (People living with HIV):
- 18+ years old
- In HIV care for > 1 year
- Having disclosed serostatus to at least one person
Inclusion Criteria (Social network members):
- 18+ years old
- Referred by a patient participant because they are family members, friends, or other people in patients' social network
- knows patient participant's serostatus
Exclusion Criteria:
- Individuals who meet the inclusion criteria above will be eligible to participate, and no other exclusion criteria apply.
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Game Changers Intervention
Game Changers is an intervention that aims to empower and mobilize people living with HIV to be agents for HIV prevention and behavioral change in their social networks.
|
Game Changers is an intervention that aims to empower and mobilize PLHA to be agents for HIV prevention and behavioral change in their social networks.
|
|
Sem intervenção: Control
The control group will receive standard of care during the intervention assessment period.
All control participants will be offered the Game Changers program once all assessments for the primary study outcomes have been completed.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Engagement HIV Prevention Advocacy
Prazo: Past 3 months, measured at baseline and 5 and 8 months post-baseline
|
Self-reported communication with social network members about protective behaviors.
This is a composite of 14 survey items rated on a scale of 1 (low level of communication) to 5 (high level of communication).
|
Past 3 months, measured at baseline and 5 and 8 months post-baseline
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Sexual Risk Behavior Among Alters
Prazo: Measured at baseline and 5 and 8 months post-baseline
|
Increased percentage of self-reported condom use with main partner in past 3 months
|
Measured at baseline and 5 and 8 months post-baseline
|
|
Change in HIV Treatment Adherence
Prazo: Measured at baseline and 5 and 8 months post-baseline
|
Increased antiretroviral treatment adherence (self-reported % doses taken in past month)
|
Measured at baseline and 5 and 8 months post-baseline
|
|
Change in Internalized HIV Stigma
Prazo: Measured at baseline and 5 and 8 months post-baseline
|
Decreased rates of internalized HIV-related stigma on Internalized AIDS Stigma Scale (range=1-5, higher values = high stigma)
|
Measured at baseline and 5 and 8 months post-baseline
|
|
Number of Participants Who Have Reported Their HIV Status to Their Main Partner
Prazo: Measured at baseline and 5 and 8 months post-baseline
|
Increased self-reported rates of HIV status disclosure: Participants were asked if they had disclosed their HIV-serostatus to their main partner or spouse (yes/no).
|
Measured at baseline and 5 and 8 months post-baseline
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
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 (Real)
16 de abril de 2018
Conclusão Primária (Real)
31 de julho de 2019
Conclusão do estudo (Real)
31 de julho de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
8 de fevereiro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de fevereiro de 2018
Primeira postagem (Real)
19 de fevereiro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de junho de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de maio de 2020
Última verificação
1 de maio de 2020
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- R34MH111460 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .
Ensaios clínicos em HIV
-
Duke UniversityGilead SciencesRecrutamentoPrevenção do HIV | Profilaxia pré-exposição ao HIV | Programa de Prevenção do HIV | Prevenção e cuidados com o HIV | Uso de profilaxia pré-exposição ao HIVEstados Unidos
-
Federal University of São PauloGilead SciencesConcluído
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRecrutamentoHIV | Teste de HIV | Ligação do HIV ao Cuidado | Tratamento de HIVEstados Unidos
-
University of Alabama at BirminghamNational Institute of Mental Health (NIMH)RecrutamentoPreparação | HIV | Prevenção do HIV | Absorção de PrEPEstados Unidos
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH)RecrutamentoViabilidade | Prevenção do HIV | Absorção de PrEP | Aceitabilidade | Autoteste de HIV | Parceiros masculinos de mulheres pós-parto HIV negativasÁfrica do Sul
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement e outros colaboradoresDesconhecidoHIV | Crianças não infectadas pelo HIV | Crianças expostas ao HIVCamarões
-
University of MinnesotaRetiradoInfecções por HIV | HIV/AIDS | HIV | AUXILIA | Aids/problema de HIV | AIDS e InfecçõesEstados Unidos
-
University of PennsylvaniaNational Institute of Mental Health (NIMH); University of BotswanaRecrutamentoGravidez | HIV | Pós-parto | Adesão à terapia antirretroviral (TARV) para HIVBotsuana
-
National Institute of Allergy and Infectious Diseases...Duke University; Department of Health and Human Services (HHS)Ainda não está recrutando
-
Jecho Biopharmaceuticals Co., Ltd.Ainda não está recrutando
Ensaios clínicos em Game Changers
-
Babes-Bolyai UniversityThe Executive Agency for Higher Education, Research, Development and Innovation...ConcluídoRegulação da EmoçãoRomênia
-
Université Blaise Pascal, Clermont-FerrandRetiradoVideogames passivos (PVG) | Jogos de vídeo ativos (AVG) | Exercício (EX)França
-
Federico II UniversityDesconhecidoTranstorno do Espectro AutistaItália
-
Centre Hospitalier Universitaire de NiceConcluídoCuidador Familiar de Paciente com Doença de AlzheimerFrança
-
University of Applied Sciences and Arts of Southern...Concluído
-
Indonesia UniversityConcluídoJogos sérios | Processos de educação odontológica e ensino de ensino | Educação DentáriaIndonésia
-
Encore Research Inc.CoolSystems, Inc.Concluído
-
University of MiamiNational Institute of Nursing Research (NINR)RescindidoComportamento adolescenteEstados Unidos
-
Chang Gung University of Science and TechnologyNational Science and Technology Council, TaiwanConcluídoPromoção de saúde | Fragilidade em adultos mais velhosTaiwan
-
Dana-Farber Cancer InstituteConcluído