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临床试验/NCT03808597
NCT03808597已完成不适用

Free Digital Health Education for Diseases of Public Health Importance (HIV, Tuberculosis and Taenia Solium Cysticercosis/Taeniosis) in Iringa, Tanzania

University of Oslo6 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2019年4月1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
600
试验地点
6
主要终点
Change from Baseline Health knowledge score at 3 months

研究概览

简要总结

Increased health education has the potential to facilitate better use of health care services and to promote early treatment, thus it can strengthen the health care system, and ultimately reduce morbidity and mortality. In this study, we will develop and test the effect of digital health messages related to HIV, Tuberculosis (TB) and Taenia solium cysticercosis/taeniosis (TSCT) (the intervention diseases) in Migoli and Izazi (the intervention villages), in Iringa, Tanzania (TZ).

The intervention is planned as follows: A digital platform, providing the intervention villages with digital health messages related to the above-mentioned diseases, will be implemented in TZ in 2019. The platform will be accessible free of charge, through own devices and tablets based in the local Wi-Fi spots in the villages.

In the first part of this project, the doctoral research fellow will participate in developing the digital health messages, together with experts from the medical and teaching environments in Tanzania, Norway, Germany and USA.

The second part of the PhD-project consists of a cluster non-randomised controlled trial and semi-structured interviews in Tanzania. The digital health messages will be physically shown to the participants in the intervention group. The study is planned to investigate the knowledge related to the intervention diseases, before the intervention, immediately after exposure to the intervention, and at follow-up points throughout one year, after the intervention has been implemented. Semi-structured interviews with clients (users of the intervention) from each of the intervention villages are included, to explore the perception and reception of the intervention.

The baseline study and the immediate after survey will take place in Tanzania in Q1 2019, while the other follow-up studies and interviews (3, 6 and 12 months after baseline) will be undertaken throughout one year.

详细描述

Introduction This protocol is registered in Helseforsk, University of Oslo, and the project has been assessed by Norwegian Centre for Research Data (NSD), ref. number 59643. Ethical approval from the National Institute for Medical Research (NIMR), Tanzania, has been granted with the reference number NIMR/HQ/R.8a/Vol IX/2947.

The PhD-project consist of three work packages (WPs): WP1: A systematic review and meta-analysis, WP2: A cluster non-randomised controlled trial and WP3: Semi-structured interviews with clients in the intervention group. Only WP2 and WP3 are elaborated upon in this protocol.

The planned research project will be included as a health-research component in the Norwegian Government- and Norwegian Research Council- funded innovation project "Non-discriminating access for Digital Inclusion" (DigI). The project runs from January 2017 to September 2020. Altogether 11 partners from eight countries are collaborating on the project. Professor Josef Noll from the Dept. of Technology Systems (ITS), University of Oslo (UiO), is the project owner, and the doctoral research fellow's co- supervisor. Responsible for the health-research component and main supervisor of the doctoral research fellow, is Professor Dr. Andrea Winkler at the Institute of Health and Society, UiO. Head in TZ, is Dr. Bernard Ngowi (HIV/AIDS and TB specialist) from NIMR and Associate professor Helena Ngowi (TSCT specialist) from Sokoine University of Agriculture (SUA). Associate professor Maurice Isabwe from Dept. of Information and Communication Technology at University of Agder is head of developing the digital health messages. This study is thus multicentre with several institutions responsible for research.

In Tanzania, DigI will facilitate a digital health education platform, where digital health messages related to HIV / AIDS, Tuberculosis (TB) and Taenia solium cysticercosis/taeniosis (TSCT) will be transferred to the community; hereby called clients, defined by the World Health Organization (2017) as "members of the public that are potential or current users of health services, including promotion activities" .

The digital health messages will be accessible at a Wi-Fi spot in the local village close to the local health post. The digital health messages will also be shown face-to-face to each of the participants in the intervention group, by enumerators in the research team from SUA and the doctoral research fellow. The intervention will be available for all clients in the intervention villages, not only for the participants in the study described in this protocol.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Living in the selected household (15-70 years), at least for the past six months, and at least planning to not move the next 12 months.
  • Must be capable and willing to sign written informed consent and thumb-print for illiterate participants

排除标准

  • Planning to be out of the village for more than 6 weeks in the next 12 months
  • Those above 71 or under 15
  • Not capable of signing consent letter (very sick)

结局指标

主要结局

Change from Baseline Health knowledge score at 3 months

时间窗: Up to 3 months

Score calculated from the questionnaire with questions related to HIV, TB and TSCT. Comparison between baseline score and post intervention (3 months) score. The score is calculated on the number of correct answers. The questionnaire contains 42 questions. If each question is correctly answered, the total score will be 225 (5 point for each question - weighted equally). Higher values represent a better outcome.

Baseline Health knowledge score

时间窗: One day

Score calculated from the questionnaire with questions related to HIV, TB and TSCT. The score is calculated on the number of correct answers. The questionnaire contains 42 questions. If each question is correctly answered, the total score will be 225 (5 point for each question - weighted equally). Higher values represent a better outcome.

Change from Baseline Health knowledge score, immediately after exposure

时间窗: One day

Score calculated from the questionnaire with questions related to HIV, TB and TSCT. Comparison between baseline score and immediate post intervention score. The score is calculated on the number of correct answers. The questionnaire contains 42 questions. If each question is correctly answered, the total score will be 225 (5 point for each question - weighted equally). Higher values represent a better outcome.

Change from Baseline Health knowledge score at 6 months

时间窗: Up to 6 months

Score calculated from the questionnaire with questions related to HIV, TB and TSCT. Comparison between baseline score and post intervention (6 months) score. The score is calculated on the number of correct answers. The questionnaire contains 42 questions. If each question is correctly answered, the total score will be 225 (5 point for each question - weighted equally). Higher values represent a better outcome.

Change from Baseline Health knowledge score at 12 months

时间窗: Up to 12 months

Score calculated from the questionnaire with questions related to HIV, TB and TSCT. Comparison between baseline score and post intervention (12 months) score. The score is calculated on the number of correct answers. The questionnaire contains 42 questions. If each question is correctly answered, the total score will be 225 (5 point for each question - weighted equally). Higher values represent a better outcome.

次要结局

  • Participants own perspectives on the intervention (qualitative)(One hour)

研究者

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

Christine Holst

Doctoral Research Fellow

University of Oslo

研究点 (6)

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