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临床试验/NCT02337504
NCT02337504Unknown不适用

Developing and Assessing a Community Based Model of Antiretroviral Care

Moi University0 个研究点目标入组 360 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
360
主要终点
ART durability

研究概览

简要总结

Tremendous efforts and resources have been expended by the global community to ensure that antiretroviral therapy (ART) is available and accessible to all that need it. Despite these, less than a half of Human Immunodeficiency Virus (HIV)-infected patients requiring ART in sub-Saharan Africa (SSA) are receiving it. Some of the most significant barriers to attaining universal access to ART in this region include large distances that patients have to travel to clinic, time spent in accessing care and a significant shortage of human resources. In order to address these challenges the World Health Organization (WHO) advocates alternative care models especially those that incorporate task-shifting to lower cadre health care workers and lay persons. Unfortunately, few such alternative care models have been identified and very little data exist on their long-term outcomes.

With this project we will develop and assess an alternative care model that is established on the platform of a HIV-infected peer-group (ART Co-op) and facilitated by community health workers (CHW's). This model of care is intended to decentralize ART services and bring them closer to the patients. Specifically, we will:

  1. Develop an acceptable and sustainable model for extending HIV care and treatment into the community.
  2. Perform a pilot study comparing the outcomes of patients enrolled in the ART Co-ops program to those receiving standard of care.
  3. Determine the cost savings and cost effectiveness of ART Co-ops.

详细描述

Universal Access to ART: Since 2003 there has been a concerted international effort to increase access to ART for HIV-infected individuals living in low and middle income countries.[1-6] Despite the substantial increase in the number of people receiving ART in SSA, by the end of 2010 only 49% of the 10,400,000 persons in need of ART were receiving treatment.[7-8] This is far short of the universal ART access goal of ≥80% of those in need of treatment.[2] Given that SSA commands only 3% of the world's health care providers and contributes to only 1% of the global health care expenditures, a significant barrier to meeting this goal is the profound shortage of infrastructure resources, most specifically, trained medical personnel.[9-10] With regard to Kenya, WHO estimates that the country will only be able to provide 25% of the 240,000 physicians needed to serve the country's population by 2015.[11] New initiatives under consideration such as "Test and Treat", Option B+ (ART for all pregnant women with lifelong maintenance) and treatment of index partners within HIV-discordant relationships will further tax the already strained health care work force.[12-22] As such, unless new care models can be developed that require fewer health care provider resources while maintaining optimal patient outcomes, the goal of universal access is unachievable.

Retention in Care: The high program attrition rates in SSA make achieving universal access even more complex. A meta-analysis of HIV-care programs in resource-constrained settings estimated one and two-year attrition rates (defined as death or lost to follow up (LTFU)) to be 22.6% (range 7-45%) and 25% (11-32%), respectively.[23] Of these approximately 41% were confirmed dead and 59% were LTFU. Patients LTFU represent heterogeneous outcomes including death, in care elsewhere, and disengaged from care.[24] Patients disengaged from care are at high risk of morbidity, mortality and transmitting HIV.[25-29] Despite the desirability of providing outreach to all patients LTFU, the cost of such programs frequently comes at the expense of expanding ART access. Geographic accessibility (distance to clinic and transportation costs) and shortages in health care personnel (excessive clinic waiting times) are documented barriers to retention.[24-25,30-35] As such, the optimal ART care model in resource constrained settings should minimize LTFU through reductions in transport time and costs as well as reducing clinic waiting time.

Task Shifting: In response to the severe shortage of health care workers in SSA, WHO and other organizations have advocated task shifting to lower cadre health care workers and lay individuals, including persons living with HIV (PLWHIV), in order to maximize patients' access to ART.[36-39] Such strategies decrease physician resource requirements, allow for decentralized ART delivery, and improve patient retention.[26,40-50] Médecins Sans Frontières (MSF) has developed a model of care which allows PLWHIV to become active participants in their own care and the care of other community members.[49]They successfully formed Community ART Groups (CAGs) to facilitate ART distribution, promote adherence, provide social support and monitor clinical status. During monthly group meetings a CAG member was chosen to represent each group at the clinic where each member's status was discussed and the group's monthly ART supply was picked up. Retention was exceptionally high with 97.5% patients remaining in care for a median follow-up period of 12.9 months (range 8.5-14 months).

Cost Effectiveness: Site-level cost studies of HIV care services have shown that human resource costs are a major determination of treatment scale-up costs and, as such, support the recommendations for task-shifting.[51-53] Despite this, only a few cost and cost-effectiveness studies have assessed alternative ART-delivery models.[54-59]

Justification for study:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • HIV-infected
  • ≥18 years old
  • Have a current cluster of differentiation 4 (CD4)count ≥200cells/µl
  • Have an undetectable VL
  • Are clinically stable on ART for ≥ 6 months
  • A resident of a sub-location within the AMPATH Kitale clinic catchment area
  • Are willing to consent to participate

排除标准

  • Active opportunistic infection (OI)
  • Unable to consent for study participation due to physical or mental incapacity

结局指标

主要结局

ART durability

时间窗: 48 weeks

Durability of ART regimen (ART failure). This is defined as the need to change ART regimens based on clinical (new or recurrent WHO 3 or 4 event), immunologic (CD4 count\< pre-ART; ≥50% CD4 decrease from peak; persistent CD4\<100) or virologic failure (VL\>10,000 copies/mL). Durability of the patient's ART regimen (requiring no change to second line for failure) will remain equivalent to those seen in clinic regularly.

次要结局

  • Retention in care(48 weeks)
  • Quality of life(48 weeks)
  • stigma(48 weeks)
  • HIV VL (copies/mL)(48 weeks)

研究者

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

ABRAHAM M. SIIKA, MBChB, MMed, MS

Professor

Moi University

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