Improving Outcomes in HIV Patients Using Mobile Phone Based Interactive Software Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Determine effect of Call for Life tool on physical quality of life of HIV patients receiving care at the 2 study sites
研究概览
简要总结
Current estimates point towards a huge increase in the number of people that are eligible to start ART in Uganda and globally. As many of the newly eligible patients are largely asymptomatic, there are concerns about adherence and retention of these individuals and especially those starting ART with a higher CD4 counts. Urgent information is required to plan for implementation of most recent WHO and National guidelines in the most cost effective manner as well as maximizing retention of HIV positive individuals in care and achieving virological suppression.
The investigators plan to undertake research designed to see if investigators can optimize adherence, virological outcomes and HIV knowledge, in order to give an overall increased quality of life in vulnerable populations starting or established on ART in Kampala, Uganda. The investigators will test implementation of an open source software-based tool to send text messages and to give access to an interactive voice response system using patients' mobile phones.
The investigators' aim to undertake an open labelled randomised trial at two sites: the IDI which is an urban centre of excellence in HIV care, and Kasangati Health Centre, which is a peri-urban public health care facility. The project aims to enrol HIV positive patients starting ART, already established on first line ART or switching to second line ART, including special populations (pregnant women, discordant couples and young people). The estimated length of the project is 30 months. The technology to be evaluated in this study is based on CONNECT FOR LIFETM m-health technology (CFL2015.01 or higher), which provides text messages or Interactive Voice Response (IVR) functionalities, and allows a computer to interact with humans through the use of voice and tones input via keypad and offers pill reminders, clinic visit reminders, health tips and support symptom reporting.
Primary Objective is to determine the effect of the CFL2015.01 tool on quality of life of HIV patients receiving care at IDI and Kasangati HCIV. At the start of the intervention, all patients will undergo quality of life assessment, which will be repeated at months 6, 12, 18 and 24 months. The scores will be compared to assess the effect of the tool on quality of life. The Secondary Objectives are virological outcomes baseline, 6, 12,18 and 24 months, retention in care, aversion of early treatment failure, disease knowledge, clinic attendance and cost analysis.
详细描述
CALL FOR LIFE UGANDATM Janssen Global Public Health Research and Development, in close collaboration with the Infectious Disease Institute Kampala (IDI), has developed Call for Life Uganda tailored to the needs of PLHIV in Uganda. Call for Life UgandaTM is based on the CONNECT FOR LIFETM technology (CFL2015.01 or higher version) and the MOTECH platform, an open source platform developed by Grameen Foundation and the University of Southern Maine with financial support from the Bill and Melinda Gates Foundation, and was released under the terms of the MOTECH open source license agreement.
All patients consenting will; At enrolment receive detailed information from a nurse/counsellor on the Call for Life UgandaTM system and how it operates Receive calls or text messages from Call for Life UgandaTM will include recording of self-reported adherence (soliciting active feedback via keypad) and symptom management triggering alerts for the clinic.
STUDY PROCEDURES Screening The subjects will be screened and enrolled over a period of 6 months These are the screening procedures oAll consecutive eligible patients will be approached for participation in the study.
oFor patients interested in participating the inclusion and exclusion criteria will be ascertained.
oThe patients will receive information about the study by the study nurse or counselor Patients who agree to participate in the study will sign the informed Follow-up Visit The participants will come to the clinic monthly or 2 monthly to pick up their ART and concomitant medications (non-study visits).
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 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- •Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Patients having the ability to use basic cell phone functions (e.g., being able to make and receive phone calls).
- •Patients with access to a mobile phone (need to be able to answer the phone at a predetermined time slot and to be able to call the clinic if they are sick)
- •Patients who are able to understand Luganda or Runyankole or English (as these are the languages of the overwhelming majority of patients at IDI and Kasangati and so will be used for the trial. If any other language has more than 30 patients who require it, the tool will be adapted to include this new language before the roll out of the tool to the entire clinic population
排除标准
- •Patient whose clinical condition interferes with appropriate use of cell phone (e.g., deafness, severe cognitive impairment)
- •Patients < 15 years unless emancipated minors as defined by Ugandan National Research Ethics Committee guidelines.
- •Patients who are enrolled in an interventional study at IDI
- •Patients who are not receiving standard first and second line treatment
- •Patients who are critically ill.
结局指标
主要结局
Determine effect of Call for Life tool on physical quality of life of HIV patients receiving care at the 2 study sites
时间窗: Month 06, Month 12, 18 and 24 MONTHS
Change in physical health score by 5-point in those accessing Call for Life Uganda between baseline, 6 , 12, 18 and 24 months of Call for Life Uganda use, and comparison to those with no access to Call for Life UgandaTM at 6 and 12 months
次要结局
- Determine effect of Call for life Uganda, on retention in care at the 2 sites(24 months)
- Determine effect of Call for Life tool on virological outcome and aversion of early treatment failure(Baseline, Month 6, 12, 18 and 24)
- Determine effect of Call for life Uganda on attendance on scheduled appointment days +/- 2 working days(Month 06, 12, 18 and 24)
- Determine effect of Call for Life tool on mental quality of life of HIV patients receiving care at the 2 study sites(Month 06, Month 12 , 18 and month 24)