A Pilot Randomized Controlled Trial and an Interview Study to Evaluate a Chatbot for People Living With HIV in Nigeria
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 314
- 试验地点
- 6
- 主要终点
- Participant's HIV knowledge
研究概览
简要总结
This study will investigate the use of a HIV chatbot that acts as an informational coach.
The main question the study aims to answer is:
Does the chatbot improve HIV knowledge in adults (older than 18-years) newly diagnosed with HIV in Nigeria - compared to a control group?
Moreover, the study will also determine potential effects of the chatbot use on patients' resilience, psychological well-being. The study will explore patients' use and perceptions of the chatbot, as well as potential gender differences.
The control group will receive Standard of Care only. Patients in the chatbot intervention group will interact with the chatbot in addition to receiving Standard of Care. They will be able to:
- Use a chatbot via WhatsApp
- Receive information on relevant HIV topics
- Get automated responses to their HIV-related questions
- Be reminded of medical appointments and medication schedules
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Diagnosed with HIV
- •ART enrollment: at the day of recruitment or in the subsequent 7 days. But no longer than 30 months prior to enrolment in the study..
- •Age ≥ 18 years
- •Have a personal internet-enabled smartphone with WhatsApp installed
- •Carry the phone with them at the time of recruitment
- •Able to understand, read, and write in English (the official language in Nigeria)
- •Able to understand the information about the study
- •Provide written informed consent.
排除标准
- •Known pregnancy or ≤3 months postpartum
- •Persons with suicidal ideation and/or severe mental distress
研究组 & 干预措施
Chatbot Intervention
In addition to the Standard of Care described, participants in the intervention group will be able to use a chatbot system. The chatbot was designed especially with the goal to support people newly diagnosed with HIV at the beginning of their antiretroviral therapy (ART).
干预措施: Chatbot as an informational coach (Other)
Control Group
Study participants in the control group will receive the Standard of Care only, offered by the clinics:
- st visit in the clinic: Testing and ART enrolment: When patients in the clinic have a positive HIV test, various health assessments are carried out, including TB testing. The patient has a session with an adherence counsellor. A medical consultation takes place where a doctor addresses health issues and prescribes ART medication. First-time patients receive a 3-month prescription.
- nd visit in the clinic in the first three months: Patients return to the clinic within the first 3 months. They are given the results of the tests carried out during their first visit, undergo health checks (vital signs) and receive health information. The patient is also seen by a doctor who prescribes ART for the next 3 months.
- rd visit to the clinic at 6 months: The procedure is the same as for the 3-month visit, except that a viral load test is performed.
结局指标
主要结局
Participant's HIV knowledge
时间窗: Baseline to 50-day follow-up
The primary endpoint is the change of HIV knowledge from baseline to the 50-day follow-up assessed using the Patient's HIV Knowledge Questionnaire (PHKQ). The questionnaire consists of 15 items and includes the components (subscales) Transmission and Misconceptions, Causes and Treatment Outcomes, and Diet and Immunity (Jackson, Okonta, \& Ukwe, 2020). Participants are required to evaluate statements such as "HIV infection is caused by evil spirits" using a three-point scale: "Yes," "No," and "I don't know." The correct answer is awarded one point, while incorrect responses or the option "I don't know" are each awarded zero points.
次要结局
- Participants' extended HIV knowledge(at 50 day follow up)
- Participants' Resilience (PLHIV Scale)(At 50 day follow up)
- Participants' psychological well-being (SRQ-20)(at 50 day follow up)
- Users' perception of the chatbot: trust and parasocial relationships(at 25 day follow up)
- Participants' Resilience (PLHIV Scale)(At 50 day follow up)
- Participants' extended HIV knowledge(at 50 day follow up)
- Participants' psychological well-being (SRQ-20)(at 50 day follow up)
- Users' perception of the chatbot: trust and parasocial relationships(at 25 day follow up)
研究者
Christoph Pimmer
PhD
Swiss Tropical & Public Health Institute