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临床试验/NCT04417127
NCT04417127已完成不适用

Harambee: Integrated Community-based HIV/NCD Care & Microfinance Groups in Kenya

Brown University1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2020年11月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,200
试验地点
1
主要终点
HIV-1 RNA Viral Load Suppression at 18-months

研究概览

简要总结

The objective of this project is to demonstrate the effectiveness and longer-term sustainability of a differentiated care delivery model for improving HIV treatment outcomes. The central hypothesis is that the integration of community-based HIV and NCD care with group microfinance will improve retention in care and rates of viral suppression (VS) among people living with HIV (PLHIV) in Kenya via two mechanisms: improved household economic status and easier access to care.

The specific aims are as follows:

  1. To evaluate the extent to which integrated community-based HIV care with group microfinance affects retention in care and viral suppression among n=900 PLHIV in rural western Kenya using a cluster randomized intervention design of at least n=40 existing (fully HIV+) microfinance groups to receive either: (A) integrated community-based HIV and NCD care or (B) usual facility-based care. Data from the two trial arms will be augmented with a matched contemporaneous control group of n=300 patients receiving usual facility-based care and not involved in microfinance (group C), comparing outcomes in groups A, B and C. The hypothesize is that A > B > C in terms of viral suppression and retention in care.
  2. To identify specific mechanisms through which microfinance and integrated community-based care impact viral suppression. Using a mixed methods approach, the study will characterize the mechanisms of effect on patient outcomes. Investigators will conduct quantitative mediation analysis to examine two main mediating pathways (household economic conditions and easier access to care), as well as exploratory mechanisms (food security, social support, HIV- related stigma). Investigators will also use qualitative methods and multi-stakeholder panels to contextualize implementation of the intervention.
  3. To assess the cost-effectiveness of microfinance and integrated community-based care delivery to maximize future policy and practice relevance of this promising intervention strategy. The working hypothesis is that the differentiated model will be cost-effective in terms of cost per HIV suppressed person-time, cost per patient retained in care, and cost per disability-adjusted life year saved.

The main expected outcomes will be rigorous evidence of effectiveness, mechanisms and cost-effectiveness of a differentiated model for achieving the last key step in the HIV care continuum. These results are expected to have an important positive impact in terms of improved, high-quality services that address known individual and structural barriers to care and promote long-term sustainability of care for PLHIV in rural settings with high HIV prevalence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older at study baseline
  • HIV-positive
  • Have received any care through AMPATH since 2010
  • Initiated ART at least 6 months prior to study baseline
  • Have participated in at least one microfinance group meeting in the prior 12 months at study baseline (for Study Arms A & B)
  • Willing and able to provide informed consent.

排除标准

  • Currently participating in the BIGPIC study
  • Unable to provide informed consent for participation

结局指标

主要结局

HIV-1 RNA Viral Load Suppression at 18-months

时间窗: 18 months

Participants whose 18-month viral load assessment occurred before January 1, 2023 were considered suppressed if their viral load was \<400 copies/mL. Following changes to Kenya's national HIV monitoring cutoffs that occurred during the trial, patients whose 18- month viral load assessment was on or after January 1, 2023 were considered suppressed if their viral load was \<200 copies/mL.

次要结局

  • Change in Systolic Blood Pressure (SBP)(Between baseline and 18 months)
  • Retention in Care Each Quarter During 18-months of Follow-up(Between baseline and 18 months)
  • Change in Systolic Blood Pressure (SBP)(Between baseline and 18 months)
  • Change in Random Blood Sugar (mmol/L)(Between baseline and 18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Galarraga, PhD

ASSOCIATE PROFESSOR

Brown University

研究点 (1)

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