- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03076359
Traditional Healers as Adherence Partners for Persons Living With HIV in Rural Mozambique (PLHIV)
Traditional Healers as Adherence Partners for PLHIV in Rural Mozambique
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Incorporating healers as anti-retroviral therapy adherence counselors can help reduce the crisis of HIV treatment abandonment. Healers are often accused of encouraging patients to abandon HIV care, but they can also serve as strong advocates for patient health. When healers were engaged as tuberculosis adherence counselors in South Africa, their patients were as successful as those supported by non-healer counselors. An innovative solution would be to engage trained healers as treatment partners to support medication and appointment adherence for people living with HIV.
Healers are well positioned to address reported patient concerns, including: (1) keeping a patients HIV status a secret while providing support; (2) assisting with partner disclosure and initiating community/clinical systems of assistance if gender base violence is threatened/occurs; and (3) advocating for patients during clinical visits to ensure quality care is provided. Other programs in sub-Saharan Africa have shown that incorporating healers into an allopathic health system as adherence supporters for TB treatment is feasible, but healer use in HIV treatment is not well-documented. This novel intervention would provide patients newly initiated on ART a choice to nominate a specially trained healer as a treatment partner, and assess acceptability, feasibility, and patient outcomes using an interrupted time series quasi-experimental design. Community-based treatment partners can improve pharmacy adherence and loss to follow up , while decreasing stigma and isolation.
Engaging healers to conduct counseling sessions in a community setting to improve ART adherence necessitates technical clinical and psycho-social training. The ART Adherence Support Worker Training program will be adapted and used to train healers to be quality treatment partners and advocates. The training will ensure healers have the knowledge and skills to effectively: (1) Educate people living with HIV about treatment and HIV care; (2) Assess serious medication side effects or HIV co-infections; (3) Counsel patients about safer strategies for partner disclosure (with assistance if needed); (4) Accompany the patient for each clinical appointment; and (5) Advocate for quality health care delivery when assisting each patient. The training team will conduct training of the healers. All patients initiating treatment will be screened for interest in having a healer treatment partner. Control and intervention patients will be followed for one year, allowing the investigators to compare outcomes at 12-months to study the effectiveness of healers as adherence partners.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Zambezia
-
Namacurra, Zambezia, Moçambique
- Namacurra Sede Health Facility
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patients: Individuals 18 years of age or older, HIV-infected, and newly enrolled in ART and treatment services at Namacurra Sede.
- Traditional Healers: Healers will be eligible to participate if the healer lives within 10 km of the Namacurra Sede, received previous training from FGH, is 18 years of age or older, speak Portuguese, and see at least one patient per month
Exclusion Criteria:
- Patients: Individuals that are currently pregnant, HIV-uninfected, and/or not yet enrolled in HIV care. Individuals who cannot give consent due to mental limitations or intoxication.
- Traditional Healers: Healers who believe they can effectively treat or cure HIV or other associated conditions will be excluded from the project.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Standard of Care
Intervention: This group will receive only standard of care HIV treatment, including ART medications (First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.
|
First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.
Outros nomes:
|
|
Experimental: Traditional Healer Support Program
This group will receive standard of care as described above. In addition, the investigators will assess an intervention partnership with traditional healer including: community and clinic based support from a trained traditional healer. The intervention includes: (1) healer visits to the patient at home, healer support for couples counseling, healer provision of nutritional advice, and healer counsel about the importance of adherence. If anything is amiss, the healer will accompany the patient to the health facility for additional clinical services. In addition, the healer will accompany the patient on all regularly scheduled clinical visits. |
First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.
Outros nomes:
Traditional Healers will provide the "traditional healer support program" assistance, as previously described, to all newly diagnosed patients.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Retention in Care
Prazo: Retention in care over 12 months
|
We accessed the percentage of days where participants have medication.
For example, if a participant picked up a 30 day supply of medication on August 1st but did not collect their next medication until October 1st, the patient would only be considered retained for 50% of the time.
|
Retention in care over 12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Viral Load
Prazo: 12 months post-enrollment
|
Patient viral load at 12 months to assess the impact of the intervention on HIV viral suppression.
HIV viral load tests are reported as the number of HIV copies in a milliliter (copies/mL) of blood using a reverse-transcriptase polymerase chain reaction (RT-PCR) test.
If the viral load measurement is high, it generally indicates that HIV is present and replicating.
Initial, untreated, and uncontrolled HIV viral loads can range as high as one million or more copies/mL.
Viral loads that are consistently less than 200 copies/mL indicate that the virus is adequately suppressed and that the risk of disease progression is low.
Viral load results below zero indicate that no virus was detected (this is how the outputs are recorded using the PRC test in the region.
We did not assess change in values over time.
|
12 months post-enrollment
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Carolyn Audet, PhD, Vanderbilt University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
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
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
- Doenças de Vírus Lento
- Infecções por HIV
- Síndrome da Imunodeficiência Adquirida
Outros números de identificação do estudo
- 150217
- K01MH107255-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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/AIDS
-
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 Standard of Care
-
Case Comprehensive Cancer CenterFlorida Department of Health (Casey DeSantis Florida Cancer Innovation Fund)Recrutamento
-
Compedica IncProfessional Education and Research InstituteConcluídoÚlcera do pé diabéticoEstados Unidos, Canadá
-
University Hospital, ToursRecrutamentoInsuficiência Respiratória Hipoxêmica Aguda | Oxigenoterapia nasal de alto fluxoFrança
-
Integra LifeSciences CorporationIntegriumRescindidoÚlceras do Pé DiabéticoEstados Unidos, Porto Rico, Canadá, África do Sul
-
Mayo ClinicAtivo, não recrutandoFibromialgiaEstados Unidos
-
LuminopiaRecrutamentoAmbliopiaEstados Unidos
-
ULURU Inc.Navy Advanced Medical Development (NAMD) CommandRecrutamentoFerimentos e LesõesEstados Unidos
-
Washington University School of MedicineAinda não está recrutandoCâncer de intestinoEstados Unidos
-
Vanderbilt University Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)ConcluídoDispepsia Funcional | Doença do Refluxo Gastroesofágico (DRGE) | Esofagite Eosinofílica (EoE)Estados Unidos
-
Intergroupe Francophone de Cancerologie ThoraciqueRecrutamento