Supporting Treatment Adherence Readiness Through Training (START) (START)
5 de outubro de 2020 atualizado por: RAND
Controlled Evaluation of the Adherence Readiness Program for ART Adherence
Multi-site, randomized controlled trial of the Adherence Readiness Program (ARP) adherence intervention for HIV clients starting or restarting antiretroviral therapy (ART) for the purpose of achieving and sustaining optimal levels of ART adherence and virologic suppression.
Eligible participants will be randomized to receive either the ARP intervention or usual care (no intervention) and followed for 24 months.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This study will evaluate the effects of the Adherence Readiness Program (ARP) intervention on the primary outcomes of dose-taking HIV antiretroviral (ART) adherence and undetectable HIV viral load in a multi-site randomized controlled trial.
The ARP is based on the Information Motivation Behavioral skills (IMB) model of behavior change and includes (1) brief pill taking practice trials for enhancing pre-treatment adherence counseling and providing a behavioral criterion for determining adherence readiness and the start of treatment, and (2) a performance driven dose regulation mechanism to tailor the amount of counseling (from pre-treatment through the full course of treatment) to the individual needs of the patient and conserve limited resources.
Participants will be randomized to receive either the ARP (adherence counseling sessions) or usual care.
Primary assessments will be administered at screening and every 6 months after ART initiation over a 24-month follow-up, making it one of the few studies to examine intervention effects longer than one year.
Secondary outcomes include dose-timing adherence and CD4 count.
If effective, the ARP will provide clinicians with an intervention that (1) informs providers and patients when the patient is ready to adhere well and start treatment, (2) enhances adherence readiness from the outset of treatment through the full course of therapy, and (3) tailors the amount of adherence support based on individual patient need and performance, thus more efficiently using clinic resources, fostering better acceptance from providers and patients, and increasing the likelihood of successful program adoption and dissemination.
This emphasis on efficient use of resources will be complemented by a cost-effectiveness analysis to further inform policy decisions regarding the transportability of the intervention and its potential for more wide scale use and sustainability if effective.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
240
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
-
-
California
-
Long Beach, California, Estados Unidos
- CaRe Clinic
-
Los Angeles, California, Estados Unidos
- T.H.E. Clinic
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Los Angeles, California, Estados Unidos
- UCLA CARE Center
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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
Tudo
Descrição
Inclusion Criteria:
The patient's provider views the patient as medically appropriate to begin (ART naïve) or restart ART (has been off ART for at least 2 months), and either
- plans to start the patient on ART
- would like to start the patient on ART but the provider or patient is uncertain about the patient's readiness to adhere well.
Patients who are currently on ART are also eligible if they meet the following criteria, which are specific only to this type of patient:
i) the patient has 2 or more HIV viral load tests in the past year > 1000 copies/ml ii) the patient has had no HIV viral load tests that were undetectable in the past year iii) the patient has a genotype in the past year that does not show resistance as a reason for virologic failure (detectable viral load) iv) primary care provider views the patient as a good candidate for the study, with the understanding that the patient will interrupt ART if assigned to the intervention.
Criteria i to iii are intended to define a subgroup of nonadherent patients who are taking very little of their ART medications, as evidenced by the combination of consistently high viral load and no drug resistance. If the patient was taking at least a moderate level of drug and still had consistently high viral load, than they would have evidence of drug resistance. Providers are generally comfortable with this type of patient stopping their medication in order to facilitate the pre-treatment, adherence readiness assessment and training phase of the intervention prior to restarting the patient on treatment.
- The patient's health status is stable. There is no current acute OI or medical condition that calls for immediate ART, as determined by the patient's provider.
- Most recent HIV viral load is detectable.
- If CD4 < 200, the patient is on or will be prescribed prophylactic medication
- Patient is 18 or older.
- Patient is able and willing to give informed consent.
- English speaking.
Exclusion Criteria:
1. Patient just tested HIV+ and their provider suspects the patient may be acutely or recently infected (within past 6 months).
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: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: ARP intervention
Adherence counseling intervention
|
The ARP consists of pre-treatment (including practice trials to determine readiness for and timing of ART initiation), early-treatment, and ongoing maintenance training (using a performance-based, dose regulation mechanism to tailor the amount and intensity) phases
|
|
Sem intervenção: usual care
no intervention, standard care practices regarding adherence support
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
HIV virologic suppression
Prazo: Month 24
|
undetectable HIV viral load at time of assessment
|
Month 24
|
|
log change in HIV viral load (log change in HIV RNA levels)
Prazo: Month 24
|
log change in HIV RNA levels from baseline to Month 24.
|
Month 24
|
|
optimal dose-taking adherence (whether at least 85% of prescribed doses were taken)
Prazo: Month 24
|
binary variable representing whether at least 85% of prescribed doses were taken between baseline and Month 24
|
Month 24
|
|
percent dose-taking adherence
Prazo: Month 24
|
percent of prescribed doses taken between baseline and Month 24
|
Month 24
|
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HIV virologic suppression
Prazo: Month 6
|
undetectable HIV viral load at time of assessment
|
Month 6
|
|
log change in HIV viral load (log change in HIV RNA levels)
Prazo: Month 6
|
log change in HIV RNA levels from baseline to Month 6
|
Month 6
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optimal dose-taking adherence (whether at least 85% of prescribed doses were taken)
Prazo: month 6
|
binary variable representing whether at least 85% of prescribed doses were taken between baseline and Month 6
|
month 6
|
|
percent dose-taking adherence
Prazo: month 6
|
percent of prescribed doses taken between baseline and Month 6
|
month 6
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
dose-timing adherence
Prazo: Month 24
|
percent of prescribed doses taken within correct time-window between baseline and Month 24
|
Month 24
|
|
dose-timing adherence
Prazo: Month 6
|
percent of prescribed doses taken within correct time-window between baseline and Month 6
|
Month 6
|
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optimal dose-timing adherence
Prazo: Month 24
|
binary variable representing whether at least 85% of prescribed doses were taken within correct time-window between baseline and Month 24
|
Month 24
|
|
optimal dose-timing adherence
Prazo: Month 6
|
binary variable representing whether at least 85% of prescribed doses were taken within correct time-window between baseline and Month 6
|
Month 6
|
|
change in CD4 count
Prazo: Month 24
|
change in CD4 count from baseline to Month 24
|
Month 24
|
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change in CD4 count
Prazo: Month 6
|
change in CD4 count from baseline to Month 6
|
Month 6
|
|
clinic attendance (number of missed clinic appointments)
Prazo: Month 24
|
number of missed clinic appointments between baseline and Month 24
|
Month 24
|
|
clinic attendance (number of missed clinic appointments)
Prazo: Month 6
|
number of missed clinic appointments between baseline and Month 6
|
Month 6
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Glenn Wagner, PhD, RAND
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.
Publicações Gerais
- Wagner GJ, Seelam R, Hoffman R, Ghosh-Dastidar B. Mediators and moderators of ART adherence effects of supporting treatment adherence readiness through training (START): evidence that START helps vulnerable clients achieve better adherence. AIDS Care. 2022 Oct;34(10):1249-1256. doi: 10.1080/09540121.2021.2006133. Epub 2021 Nov 21.
- Wagner GJ, Hoffman R, Linnemayr S, Schneider S, Ramirez D, Gordon K, Seelam R, Ghosh-Dastidar B. START (Supporting Treatment Adherence Readiness through Training) Improves Both HIV Antiretroviral Adherence and Viral Reduction, and is Cost Effective: Results of a Multi-site Randomized Controlled Trial. AIDS Behav. 2021 Oct;25(10):3159-3171. doi: 10.1007/s10461-021-03188-x. Epub 2021 Apr 2.
- Wagner GJ, Linnemayr S, Ghosh-Dastidar B, Currier JS, Hoffman R, Schneider S. Supporting Treatment Adherence Readiness through Training (START) for patients with HIV on antiretroviral therapy: study protocol for a randomized controlled trial. Trials. 2016 Mar 24;17:162. doi: 10.1186/s13063-016-1287-3.
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)
1 de fevereiro de 2015
Conclusão Primária (Real)
30 de março de 2020
Conclusão do estudo (Real)
30 de março de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
22 de dezembro de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
31 de dezembro de 2014
Primeira postagem (Estimativa)
1 de janeiro de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de outubro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de outubro de 2020
Última verificação
1 de outubro de 2020
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- MH104086
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Não
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