NCT03808597

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

January 2, 2019

Last Update Submit

November 3, 2020

Conditions

Keywords

digital healthdigital health promotionhealth promotiondisease preventionHIVTuberculosisCysticercosis

Outcome Measures

Primary Outcomes (5)

  • Baseline Health knowledge score

    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.

    One day

  • Change from Baseline Health knowledge score, immediately after exposure

    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.

    One day

  • Change from Baseline Health knowledge score at 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.

    Up to 3 months

  • Change from Baseline Health knowledge score at 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.

    Up to 6 months

  • Change from Baseline Health knowledge score at 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.

    Up to 12 months

Secondary Outcomes (1)

  • Participants own perspectives on the intervention (qualitative)

    One hour

Study Arms (2)

Intervention group

EXPERIMENTAL

The participants in this group will be exposed to digital health promotion. Please note that the participants are not randomly chosen, but stratified after the project villages. The participants in this group belong to the villages: Izazi and Migoli.

Other: Digital health promotion intervention

Control group

NO INTERVENTION

The participants in this group will be not be exposed to digital health promotion, but the villages will receive the intervention after one year. Please note that the participants are not randomly chosen, but stratified after the project villages. The participants in this group belong to the villages: Kimande and Idodi.

Interventions

Digital health promition related to HIV, Tuberculosis and TSCT in a digital format.

Intervention group

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

National Institute for Medical Research / Muhimbili University

Dar es Salaam, Dar, Tanzania

Location

Idodi

Iringa, Tanzania

Location

Izazi

Iringa, Tanzania

Location

Kimande

Iringa, Tanzania

Location

Migoli

Iringa, Tanzania

Location

Sokoine University of Agriculture

Morogoro, Tanzania

Location

Related Publications (2)

  • Holst C, Stelzle D, Diep LM, Sukums F, Ngowi B, Noll J, Winkler AS. Improving Health Knowledge Through Provision of Free Digital Health Education to Rural Communities in Iringa, Tanzania: Nonrandomized Intervention Study. J Med Internet Res. 2022 Jul 28;24(7):e37666. doi: 10.2196/37666.

  • Holst C, Sukums F, Ngowi B, Diep LM, Kebede TA, Noll J, Winkler AS. Digital Health Intervention to Increase Health Knowledge Related to Diseases of High Public Health Concern in Iringa, Tanzania: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2021 Apr 22;10(4):e25128. doi: 10.2196/25128.

Related Links

MeSH Terms

Conditions

HIV InfectionsTuberculosisCysticercosisTaeniasis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesCestode InfectionsHelminthiasisParasitic Diseases

Study Officials

  • Andrea S Winkler, M, PhdD

    University of Oslo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Research Fellow

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 17, 2019

Study Start

April 1, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share
Shared Documents
ANALYTIC CODE
Time Frame
2020

Locations