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Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa

16 de maio de 2022 atualizado por: Jessica Magidson, University of Maryland, College Park

Hybrid Effectiveness-Implementation Trial for ART Adherence and Substance Use in HIV Care in South Africa

The purpose of this study is to test the effectiveness and implementation of a brief, integrated behavioral intervention for HIV medication adherence and substance use in the HIV care setting in South Africa. The intervention is specifically designed to be implemented by non-specialist counselors using a task sharing model in local HIV clinics. The behavioral intervention will be compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) on study endpoints (as described in study endpoint section below).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

The HIV epidemic in South Africa (SA) is among the highest in the world. SA has a large antiretroviral therapy (ART) program, but some individuals exhibit poor ART adherence, which increases the likelihood of developing drug resistance and failing the only available first and second line ART regimens in SA. ART nonadherence contributes to greater morbidity, mortality, and higher likelihood of sexual HIV transmission when virus is detectable. At the same time, alcohol and other drug use is prevalent among HIV-infected individuals in SA and associated with worse ART adherence, lower rates of viral suppression, and HIV transmission risk behavior. Yet, despite the impact of untreated substance use on poor HIV treatment outcomes and continued HIV transmission, there is little if any integration of substance use and HIV care services in SA, which creates a fragmented and incomplete system of care. This study had three phases, first being formative, qualitative work which led to a systematic treatment adaptation phase. This third phase, the clinical trial, is based on this formative work and other empirical support using behavioral interventions to improve ART adherence and reduce substance use in resource-limited settings, including SA. This study is a Type 1 hybrid effectiveness-implementation trial of a lay counselor-delivered behavioral intervention for adherence and substance use integrated into the HIV primary care setting in SA. To ensure that those who need this intervention most will receive it, participants will be patients with HIV who are struggling with adherence (as defined in the investigator's inclusion criteria) and who have an elevated substance use risk.

Tipo de estudo

Intervencional

Inscrição (Real)

66

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

  • Estados Unidos
    • Maryland
      • College Park, Maryland, Estados Unidos, 20742
        • University of Maryland
  • África do Sul
      • Cape Town, África do Sul, 7700
        • University of Cape Town

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 a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • HIV positive and on ART
  • 18-65 years of age
  • Elevated substance use risk (ASSIST score greater than or equal to 4 for drugs or greater than or equal to 11 for alcohol)

  • Have at least one of the following:

    1. Not attained viral suppression from first line ART (VL>400 copies/mL)
    2. On second-line ART treatment
    3. Reinitiated first-line treatment within the past three months
    4. Had a pharmacy non-refill at least once in the past 3 months

Exclusion Criteria:

  • Inability to provide informed consent or complete procedures in English or isiXhosa
  • Severe risk/likely dependence for opiates (ASSIST score >26) because opiate substitution therapy may not be available
  • Severe alcohol dependence symptoms that may warrant medical management of potential withdrawal symptoms
  • Active, untreated, major mental illness (with untreated psychosis or mania) that would interfere with the paraprofessional adapted intervention

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: Project Khanya
Those assigned to Project Khanya (the behavioral intervention for substance use and adherence condition) will have approximately 6 sessions (including Life-Steps, behavioral activation, and relapse prevention) delivered by a peer interventionist plus standard of care, which is typically referral to a local outpatient substance use treatment clinic. They will also receive a Wisepill, a wireless, real-time adherence monitoring device.
Comportamental: Project Khanya
This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
Sem intervenção: ESOC
Those assigned to the ESOC (enhanced standard of care) condition will receive the standard of care, which is referral to a local substance use treatment clinic. The substance use clinics in the location that this study occurs follow the Matrix, and evidence-based 16-week outpatient program to treat substance use. We will enhance patients' normal referral to Matrix for ESOC participants by promoting facilitating and following up on the referral. Additionally, those in the control group will also receive a Wisepill, a wireless adherence monitoring device.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Changes in HIV Medication Adherence Throughout Intervention Phase
Prazo: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Percentage of prescribed antiviral therapy agent (medications) taken as measured by real time wireless motoring device
Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Biological Measure of Substance Use
Prazo: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Substance use measured with urinalysis.
Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Biological Measure of Substance Use
Prazo: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Substance use measured with phosphatidylethanol (PEth) concentration, which is an objective biomarker of alcohol use that can detect blood collected up to 21 days after alcohol consumption. Minimum detection value is 8 ng/mL. Higher PEth values indicate greater concentration of alcohol. Values of ≥ 50 ng/mL indicate unhealthy drinking.
Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Changes in Self-reported Substance Use
Prazo: Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO-ASSIST). It is a measure used to assess substance use risk for alcohol, cannabis, cocaine, opiates, and amphetamines, hallucinogens, and other drugs. Standardized cutoff scores are used to categorize risk levels: low risk (0-3 for illicit drugs/0-10 for alcohol), moderate risk (4-26 for illicit drugs/11-26 for alcohol), or high risk (> 26) for substance use-related problems.
Assessed between baseline assessment and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Biological Measure of Substance Use
Prazo: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Substance use measured with urinalysis.
Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Biological Measure of Substance Use
Prazo: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Substance use measured with phosphatidylethanol (PEth) concentration, which is an objective biomarker of alcohol use that can detect blood collected up to 21 days after alcohol consumption. Minimum detection value is 8 ng/mL. Higher PEth values indicate greater concentration of alcohol. Values of ≥ 50 ng/mL indicate unhealthy drinking.
Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Changes in Self-reported Substance Use
Prazo: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO-ASSIST). It is a measure used to assess substance use risk for alcohol, cannabis, cocaine, opiates, and amphetamines, hallucinogens, and other drugs. Standardized cutoff scores are used to categorize risk levels: low risk (0-3 for illicit drugs/0-10 for alcohol), moderate risk (4-26 for illicit drugs/11-26 for alcohol), or high risk (> 26) for substance use-related problems.
Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Intervention Acceptability
Prazo: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)

15-item acceptability subscale of a pragmatic, quantitative assessment based on RE-AIM developed by the Applied Mental Health Research group (AMHR) at Johns Hopkins University. Total scores are averaged across all items and range from 0 to 3. Higher scores indicate greater acceptability.

Qualitative interviews will also be conducted with intervention participants at the end of the study to assess acceptability guided by RE-AIM and the Proctor model.
Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Intervention Feasibility
Prazo: Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)

14-item feasibility subscale of a pragmatic, quantitative assessment based on RE-AIM developed by the Applied Mental Health Research group (AMHR) at Johns Hopkins University. Total scores are averaged across all items and range from 0 to 3. Higher scores indicate greater feasibility.

Qualitative interviews will also be conducted with intervention participants at the end of the study to assess feasibility guided by RE-AIM and the Proctor model.
Assessed at the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Intervention Fidelity
Prazo: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Independent fidelity ratings of a randomly selected subset (20%) of intervention sessions using a fidelity assessment developed for each session that includes 15-19 items that map onto each core intervention component, and factors unique to the peer delivery implementation strategy (i.e., appropriate self-disclosure, stigmatizing behaviors, common factors including warmth and non-judgment).
Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Intervention Uptake
Prazo: Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)
Intervention participant attendance and retention (i.e., the mean number of intervention sessions attended by intervention participants)
Assessed between randomization and the acute outcome (approximately 12-weeks post-randomization/ post-intervention assessment)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
HIV Viral Load
Prazo: Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Percentage of patients with a suppressed viral load (<400 copies/ml)
Assessed at follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Changes in Self-reported Substance Use
Prazo: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Changes in percent days used any substance measured by timeline follow-back
Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Changes in Self-reported Substance Use
Prazo: Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)
Changes in number of drinks measured by timeline follow-back
Assessed between baseline assessment and follow-up (approximately 24-weeks post-randomization/ 6-month follow-up assessment)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Maryland, College Park

Colaboradores

National Institute on Drug Abuse (NIDA)
University of Cape Town

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

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)

30 de julho de 2018

Conclusão Primária (Real)

12 de fevereiro de 2020

Conclusão do estudo (Real)

7 de abril de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

7 de maio de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de maio de 2018

Primeira postagem (Real)

18 de maio de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de maio de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de maio de 2022

Última verificação

1 de maio de 2022

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 187/2018
  • K23DA041901 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Sim

Descrição do plano IPD

After all primary analyses are complete, de-identified data will be available per request of outside individual.

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 .

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