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Partners Demonstration Project of PrEP and ART

7 de dezembro de 2017 atualizado por: Jared Baeten, University of Washington

An Open Label, Pilot Demonstration and Evaluation Project of Antiretroviral-based HIV-1 Prevention Among High-risk Serodiscordant African Couples

The purpose of this protocol is to determine user preferences for antiretroviral therapy (ART) for HIV-1 infected partners and pre-exposure prophylaxis (PrEP) HIV-1 un-infected partners and to optimize targeted delivery and sustained use of these interventions.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

An open-label, prospective cohort study of higher-risk HIV-1 serodiscordant couples in order to determine barriers and facilitators to uptake and sustained adherence to ART for HIV-1 infected partners and daily oral PrEP for HIV-1 uninfected partners. The investigators developed a risk score tool to identify couples at highest risk for HIV-1 transmission. PrEP was offered as a 'bridge' to ART in the partnership - i.e., until ART initiation by the HIV-infected partner and for the first 6 months after ART is started; ART was recommended following national ART guidelines. A subset (up to 80 couples per site) was invited to participate in qualitative in-depth interview and focus group discussions.

Tipo de estudo

Intervencional

Inscrição (Real)

1013

Estágio

  • Fase 4

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

  • Quênia
      • Kisumu, Quênia
        • Kemri-Ucsf
      • Thika, Quênia
        • Partners in Prevention-Thika
  • Uganda
      • Bushenyi, Uganda
        • Kabwohe Clinical Research Center
      • Kampala, Uganda
        • Partners in Prevention-Infectious Diseases Institute LTD

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:

For couples

  • Risk score defining higher HIV-1 risk (≥6)
  • Sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months)
  • Willing to enter the study as a couple and intending to remain as a couple for the next 12 months
  • Did not participate in the Partners PrEP Study

For HIV-1 uninfected members of the couple (partner participants)

  • Age ≥18
  • Able and willing to provide written informed consent
  • HIV-1 uninfected based on negative HIV-1 rapid tests, both at study screening and at the enrollment visit
  • Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance >60 mL/min
  • Not infected with hepatitis B virus, as determined by a negative hepatitis B surface antigen test
  • Not currently pregnant or breastfeeding
  • Not currently enrolled in an HIV-1 prevention clinical trial
  • Not currently using PrEP
  • Enrollment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator

For HIV-1 infected members of the couple (index participants)

  • Age ≥18
  • Able and willing to provide written informed consent
  • HIV-1 infected based on positive rapid HIV-1 tests, according to national algorithm
  • No history of WHO stage III or IV conditions
  • Not currently using ART
  • Not currently enrolled in an HIV-1 treatment study
  • Note: current pregnancy and breastfeeding are permitted for HIV-1 infected partners

Exclusion Criteria:

  • Otherwise not eligible based on the above inclusion criteria

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: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: PrEP as a bridge to ART
FTC-TDF PrEP for HIV uninfected partners and ART for HIV infected partners
Medicamento: FTC-TDF PrEP
FTC-TDF PrEP for HIV-1 uninfected partners
Medicamento: ART
ART for HIV-1 infected partners

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Ability to recruit high-risk HIV-1 serodiscordant couples: Screen-to-eligible ratio.
Prazo: 24 months
High-risk couples defined by a validated risk scoring tool. Ability to recruit high-risk HIV-1 serodiscordant couples will be measured as screen-to-eligible ratio of HIV-1 serodiscordant couples.
24 months
Ability to recruit high-risk HIV-1 serodiscordant couples: Eligible couples who decide to enroll in the cohort.
Prazo: 24 months
High-risk couples defined by a validated risk scoring tool. We will measure the proportion of eligible couples who decide to enroll in the cohort.
24 months
Ability to recruit high-risk HIV-1 serodiscordant couples: Costs of screening and targeting high-risk couples decide to enroll in the cohort.
Prazo: 24 months
High-risk couples were defined by a validated risk scoring tool. The cost-effectiveness analysis will follow World Health Organization (WHO) guidelines and report summary estimates for the PrEP intervention which allow comparison to other strategies to decrease HIV-1 transmission among serodiscordant couples. Costs of offering and delivering PrEP as a bridging strategy to ART, including recruitment costs for targeting higher-risk couples and PrEP delivery and monitoring costs will be collected. The incremental cost-effectiveness ratio (ICER) per HIV related infection, death and Disability-Adjusted Life Year (DALY) averted will be estimated. Results will be reported as the ICER of PrEP compared to current practice per incident HIV-1 case, HIV related death and DALY averted.
24 months
User preferences for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners: preferred ART-based HIV prevention method.
Prazo: 24 months
Measure the number of couples choosing to use PrEP or ART for HIV-1 prevention or both.
24 months
User preferences for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners: reasons for choice and concerns about both methods.
Prazo: 24 months
Quantitative questionnaire will be used to elicit reasons for the choice and concerns about both methods. Reasons for or concerns about both methods measured as proportion of participants reporting a particular reason for or concerns about both methods
24 months
PrEP initiation by HIV uninfected partners.
Prazo: 24 months

Measure the number of HIV-1 uninfected partners initiating PrEP.

Proportion of samples with detectable and quantifiable PrEP levels
24 months
PrEP adherence: Self-reported missed doses of PrEP.
Prazo: 24 months
Measure the proportion of visits when HIV-uninfected partner reported missing 1) any dose of PrEP in the prior quarter 2) 2 or more consecutive doses of PrEP.
24 months
PrEP adherence: Detectable and quantifiable PrEP levels in plasma.
Prazo: 24 months
Measure the proportion of plasma samples of HIV-1 uninfected partners with detectable and quantifiable PrEP levels.
24 months
PrEP adherence: PrEP hold.
Prazo: 24 months
Measure the total number of HIV-1 uninfected partners with PrEP hold designated as a safety issue.
24 months
ART initiation.
Prazo: 24 months
Measure the number of HIV-1 infected partners initiating ART.
24 months
ART Adherence.
Prazo: 24 months
Measure the number of HIV-1 infected partners with suppressed plasma HIV-1 RNA levels.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Sexual frequency.
Prazo: 24 months
Proportion of visits when participants report having sex.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Condom use frequency.
Prazo: 24 months
Proportion of visits when participants report having condomless sex.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Outside partners for HIV-1 uninfected partners.
Prazo: 24 months
Proportion of visits when HIV-1 uninfected partners report outside partners.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Gender of the HIV-1 uninfected partner.
Prazo: 24 months
Proportion of couples in which the HIV-1 uninfected partner is female.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Fertility intentions.
Prazo: 24 months
Proportion of couples with desire to conceive a child.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Relationship dissolution.
Prazo: 24 months
Number of couples continuing their relationship during follow up.
24 months
Correlates of preferences, uptake, and adherence to ART and PrEP: Depression and substance use.
Prazo: 24 months
Annual interviewer-administered questionnaire to collect depression and substance use indicators. Measure proportion of participants with depression and substance use.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: ART initiation by HIV-1 infected partner.
Prazo: 24 months
Proportion of HIV-1 infected partners initiating ART.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: Number of children.
Prazo: 24 months
Proportion of partnership reporting to have children at baseline.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: CD4 count.
Prazo: 24 months
Proportion of HIV infected partners with CD4 count >200, >350, >500.
24 months
Correlates of preferences, uptake and adherence to ART and PrEP: WHO stage of HIV-1 infected partner.
Prazo: 24 months
Proportion HIV-1 infected partners with WHO HIV-1 stage 1, 2, 3, or 4.
24 months
Feasibility to PrEP discontinuation in couples when the HIV-1 infected partner initiates ART.
Prazo: 24 months
We will conduct in-depth interviews and focus group discussions. Qualitative analyses will identify and describe key themes and explore variation within themes of participants' attitudes and understanding of PrEP discontinuation.
24 months
PrEP use and pregnancy: HIV-1 infection.
Prazo: 24 months
Number of HIV-1 infections among women who continue PrEP in pregnancy.
24 months
PrEP use and pregnancy: Congenital abnormalities among infants born to female Participants taking PrEP.
Prazo: 24 months
Infant outcomes measured as the number of live-born infants born to female participants taking PrEP that had any congenital anomalie.
24 months
PrEP use and pregnancy: Any serious adverse event.
Prazo: 24 months
Number of women who continue PrEP in pregnancy with any serious adverse event.
24 months
Infant growth for women who continue PrEP in pregnancy: Length.
Prazo: 24 months
Length of infants born to female Participants taking PrEP. The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month.
24 months
Infant growth for women who continue PrEP in pregnancy: Weight.
Prazo: 24 months
The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month.
24 months
Infant growth for women who continue PrEP in pregnancy: Head circumference.
Prazo: 24 months
The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant will be measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, will be calculated using all available z-scores over study duration and regressing against study month.
24 months

Colaboradores e Investigadores

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

Patrocinador

University of Washington

Colaboradores

National Institute of Mental Health (NIMH)
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation

Publicações e links úteis

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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

1 de novembro de 2012

Conclusão Primária (Real)

1 de junho de 2016

Conclusão do estudo (Real)

1 de junho de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

10 de maio de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de maio de 2016

Primeira postagem (Estimativa)

18 de maio de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de dezembro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de dezembro de 2017

Última verificação

1 de dezembro de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • STUDY00001674
  • R01MH095507 (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

Data from the Partners Demonstration Project are available by contacting the International Clinical Research Center at the University of Washington (icrc@uw.edu).

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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