Cobbing Saul, Hanass-Hancock Jill, Myezwa Hellen
Department of Physiotherapy, University of KwaZulu-Natal, Private Bag X 54001, Durban, 4000, South Africa.
Health Economics and HIV/AIDS Research Division (HEARD), University of KwaZulu-Natal, Durban, South Africa.
Trials. 2015 Nov 2;16:491. doi: 10.1186/s13063-015-1025-2.
In the era of highly active antiretroviral therapy HIV is now viewed as a chronic disease. Although people living with HIV are living longer lives, they are prone to a number of disabilities. Home-based rehabilitation has been shown to be an effective means of improving quality of life and function for people with a wide range of chronic diseases. There is a dearth of evidence, however, related to home-based rehabilitation interventions for people living with HIV, particularly in sub-Saharan Africa - the region with the highest global prevalence of HIV.
A randomised controlled trial design will be employed. Adults living with HIV who have been on antiretroviral therapy for at least six months and with defined limited mobility will be randomly allocated to either an intervention group or the control group. Pre and post-intervention testing will be conducted at a public hospital in KwaZulu-Natal, South Africa in order to assess the participants' quality of life, perceived level of disability, functional ability and endurance. Individuals randomly allocated to the intervention group will participate in a four-month home-based rehabilitation programme, conducted once a week in their homes. This programme will be implemented by community workers who will be trained and supervised by a qualified physiotherapist. The participants in the control group will continue with the standard clinic management offered to them. On completion of the intervention, all participants will be re-assessed using the same outcome measures. Analysis of results will be carried out on intention-to-treat basis in order to identify any changes between intervention and control groups.
The researchers aim to employ a novel task shifting approach to implement a needs-based home-based rehabilitation programme for people living with HIV in order to improve their quality of life and functional ability. It is hoped that this study will provide rehabilitation professionals and researchers with evidence that can be utilised to improve existing rehabilitation interventions for people living with HIV.
South African National Clinical Trials Register: NHREC#4094 (Date of registration: 21 July 2015).
在高效抗逆转录病毒治疗时代，现在将艾滋病毒视为一种慢性病。尽管艾滋病毒感染者的寿命延长，但他们容易出现多种残疾。家庭康复已被证明是改善各种慢性病患者生活质量和功能的有效手段。然而，缺乏关于艾滋病毒感染者家庭康复干预措施的证据，特别是在撒哈拉以南非洲地区——全球艾滋病毒感染率最高的地区。
将采用随机对照试验设计。接受抗逆转录病毒治疗至少六个月且有明确行动不便的成年艾滋病毒感染者将被随机分配到干预组或对照组。在南非夸祖鲁 - 纳塔尔省的一家公立医院进行干预前后测试，以评估参与者的生活质量、残疾感知水平、功能能力和耐力。随机分配到干预组的个体将参加为期四个月的家庭康复计划，每周在其家中进行一次。该计划将由社区工作者实施，他们将由一名合格的物理治疗师进行培训和监督。对照组的参与者将继续接受提供给他们的标准门诊管理。干预完成后，所有参与者将使用相同的结果指标进行重新评估。将在意向性治疗基础上进行结果分析，以确定干预组和对照组之间的任何变化。
研究人员旨在采用一种新颖的任务转移方法，为艾滋病毒感染者实施基于需求的家庭康复计划，以提高他们的生活质量和功能能力。希望这项研究将为康复专业人员和研究人员提供可用于改善现有艾滋病毒感染者康复干预措施的证据。
南非国家临床试验注册：NHREC#4094（注册日期：2015年7月21日）。
