Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Rudi Kundini, Pamoja Kundini: Fase I (RKPK: Phase I)

26 de agosto de 2026 atualizado por: University of California, Berkeley

Fortalecendo a continuidade dos cuidados de HIV na Tanzânia com apoio econômico: Fase I

This protocol describes a 2-arm cluster, randomized controlled trial designed to test the effectiveness of a conditional cash transfer on viral suppression at 6 months among people living with HIV infection (PLHIV) in Tanzania who have disengaged from HIV care. Randomization will take place at the clinic level (HIV primary care clinics). The comparison group receives standard of care standard of care HIV tracing services according to Tanzania's National Guidelines for the Management of HIV and the Ministry of Health to locate potential participants, including home based care (HBC) tracing of PLHIV who have disengaged from primary care, the provision of counseling to return to HIV care, and the offer to schedule an HIV primary care appointment on the spot. Eligible adult PLHIV disengaged from HIV care and living in an intervention facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time cash transfer incentive, conditional upon confirmed completion of a clinical visit if within 90 days of study enrollment. The primary endpoint is viral suppression (<1000 copies/ml) at 6 months after study enrollment.

Visão geral do estudo

Status

Concluído

Descrição detalhada

The overall objective of this study is to evaluate the effectiveness of a home visit plus one-time financial incentive on the proportion of out of care PLHIV with viral load suppression (<1000 copies/ml) at 6 months after study enrollment. We will use a cluster, randomized controlled trial design with a sample size of 20 PLHIV in each of the 32 health facility catchment areas (N=640 PLHIV total) to examine the effect of a home visit plus one-time financial incentive on the primary outcome of viral suppression at 6 months. The study will take place across Geita and Kagera Regions (Lake Zone) in Tanzania.

This study will follow standard of care HIV tracing services according to Tanzania's National Guidelines for the Management of HIV and the Ministry of Health to locate potential participants, including home based care (HBC) tracing of PLHIV who have disengaged from primary care, the provision of counseling to return to HIV care, and the offer to schedule an HIV primary care appointment on the spot. Eligible and consenting participants living in an intervention health facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time incentive of 22,500 TSH (~$10 USD), with half (11,250 TSH) delivered upon enrollment in the study and half delivered after confirmation of the completion of a clinical visit if within 90 days of study enrollment.

Primary Endpoint:

1. Viral suppression (<1000 copies/ml) at 6 months after enrollment

Secondary Endpoints:

  1. Viral suppression at 12 months after enrollment
  2. Durable viral suppression at 12 months after enrollment
  3. Appointment attendance
  4. Time to re-linkage to care
  5. Mortality at 12 months after enrollment
  6. Re-linkage to care at 12 months after enrollment
  7. Retention at 6 and 12 months, defined as the proportion of PLHIV on antiretroviral therapy (ART) at 6 months after enrollment and 12 months after enrollment, respectively

Tipo de estudo

Intervencional

Inscrição (Real)

567

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

      • Geita, Tanzânia
        • Geita Region
      • Kagera, Tanzânia
        • Kagera Region

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:

  1. PLHIV living in the catchment area of a study health facility;
  2. Age 18 years or older;
  3. Phone ownership OR phone consistent phone access;
  4. Classified as lost to follow up (LTFU) from HIV care (not attended a clinic appointment for ≥28 days since last scheduled appointment);
  5. Has had a clinic appointment within the last 24 months, and
  6. Provides written informed consent for participation

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: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Conditional Cash Transfer

Eligible and consenting participants living in an intervention health facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time incentive of 22,500 Tanzanian Shillings (TSH) (~$10), with half (11,250 TSH) delivered upon enrollment in the study and half delivered after confirmation of the completion of a clinical visit if within 90 days of study enrollment.

The intervention is a one-time cash transfer of 22,500 Tanzanian Shillings (~$10), with half (11,250 TSH) delivered upon enrollment in the study and half delivered after confirmation of the completion of a clinical visit if within 90 days of study enrollment.

Sem intervenção: Control

Eligible and consenting participants living in a control health facility catchment area will receive the standard of care HIV tracing and clinical services.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With 6-month Viral Suppression
Prazo: 6 months

The proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 6 months following study enrollment. The primary outcome is expressed as a binary variable, defined as PLHIV who are on ART and with sufficient HIV viral suppression (<1000 copies/ml, WHO's threshold for virologic failure in LMICs) versus not on ART or viral failure (≥1000 copies/ml).

6 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With 12-month Viral Suppression
Prazo: 12 months

The proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 12 months following study enrollment. The primary outcome is expressed as a binary variable, defined as PLHIV who are on ART and with sufficient HIV viral suppression (<1000 copies/ml, the World Health Organization (WHO) threshold for virologic failure in low- and middle-income countries (LMIC)) versus not on ART or viral failure (≥1000 copies/ml).

12 months
Number of Participants With 12-month Durable Viral Suppression
Prazo: 12 months

The proportion of people living with HIV (PLHIV) with durable HIV viral suppression at 12 months after study enrollment months (either: 1) ≥2 assessments of viral load, taken from up to 6 months prior to study enrollment and up to and including 12 months following study enrollment (the recommended timing of immunologic monitoring for stable PLHIV on ART with viral suppression), or 2) ≥3 assessments if baseline viral load is >1000 copies/ml (the recommended timing of immunologic monitoring mandates an additional follow-up assessment 3 months and again at 12 months)

12 months
Total Number of Attended Visits Across All Scheduled Visits Between 0 to 6 Months
Prazo: 6 months

Number of scheduled visits that were completed during the 0-6 month period

6 months
Total Number of Attended Visits Across All Scheduled Visits Between 0 to 12 Months
Prazo: 12 months

Number of scheduled visits attended between 0 and 12 months

12 months
Incidence of Mortality at 12-month
Prazo: 12 months

The cumulative incidence of all-cause mortality at 12 months after study enrollment

12 months
Proportion of Participants Virally Suppressed Within 12-months
Prazo: 12 months

Proportion of PLHIV with viral suppression in the 0-12-month follow-up period

12 months
Number of Participants at 12-months Re-linked to HIV Care
Prazo: 12 months

Number of participants re-linked to to HIV care over 0 to 12 months, after study enrollment

12 months
Time to Re-linkage to HIV Care
Prazo: 12 months

Time for patients to re-link back to HIV care

12 months
Number of Participants at 6-months Retained in Care
Prazo: 6 months

The number of people living with HIV (PLHIV) on ART at 6 months after study enrollment (PEPFAR considers those not retained on ART to include those who died, disengaged from care, stopped ART, or had no evidence of care for ≥28 days after a missed visit. Participants not found after exhaustive tracing efforts to rule out silent transfers will be classified as not retained on ART)

6 months
Number of Participants at 12-months Retained in Care
Prazo: 12 months

The proportion of people living with HIV (PLHIV) on ART at 12 months after study enrollment (PEPFAR considers those not retained on ART to include those who died, disengaged from care, stopped ART, or had no evidence of care for ≥28 days after a missed visit. Participants not found after exhaustive tracing efforts to rule out silent transfers will be classified as not retained on ART)

12 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Jingshen Wang, PhD, University of California, Berkeley
  • Investigador principal: Amon Sabasaba, MD, Health for a Prosperous Nation

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.

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)

13 de julho de 2022

Conclusão Primária (Real)

12 de julho de 2024

Conclusão do estudo (Real)

3 de dezembro de 2024

Datas de inscrição no estudo

Enviado pela primeira vez

9 de fevereiro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de fevereiro de 2022

Primeira postagem (Real)

21 de fevereiro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de agosto de 2026

Última verificação

1 de setembro de 2025

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Provided upon request

Critérios de acesso de compartilhamento IPD

Provided upon request

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • ANALYTIC_CODE

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 .

Se inscrever