Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202111889589868 Date of Approval: 10/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Mobile Health Framework for Public-Private Mix in Tuberculosis Prevention and Care in Uganda
Official scientific title A Mobile Health Framework for Public-Private Mix in Tuberculosis Prevention and Care in Uganda
Brief summary describing the background and objectives of the trial Lack of mechanisms to track TB patients referred from private to public health facilities has led to increased delayed diagnosis and treatment initiation and lost follow-up and contact after referral. This has consequently resulted in increased disease severity, prolonged duration of infectivity and transmission at the household level, increased household expenditure in managing the disease, increases the risk of drug resistance (Law et al 2017), worsens the patients’ health conditions, and eventually leads to death in the Long run (Wood et al, 2010). Despite the referrals, patients often delay going to the referral units due to the reluctance to transfer from private to public facilities. Most patients from private facilities end up getting lost to contact on a referral since it is usually difficult to know whether the referred patients reach the peripheral health units and initiated on TB treatment or not (Choun et al 2017 and O’hanlon et al 2016). Mhealth-based tools like smartphone apps have been recommended by the World Health Organization for TB control efforts such as case identification and management, and patient support (Iribarren et al 2016, Musiimenta et al 2019). However, their feasibility, acceptability, and impact in enhancing Public Private Mix (PPM) for TB prevention and care remain unknown. The following are the objectives for this trial. 1) To explore the barriers and motivators to private hospitals’ engagement in TB care. 2) To develop a mobile health framework for enhancing the tracking of TB patients referred from private to public hospitals and assess its initial acceptability and feasibility 3) To assess the preliminary impact of the developed framework on TB patients’ adherence to referrals for TB diagnosis and treatment in public hospitals
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MOHE
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Supportive care
Anticipated trial start date 15/11/2021
Actual trial start date
Anticipated date of last follow up 30/04/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
HS963ES Uganda National Council of Science and Technology
32 03 20 Mbarara University Research Ethics Committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tuuka app Arm Health care workers at the private health care facilities will use Tuuka App to notify the identified presumptive TB case to the healthcare workers at the public health facility. Six months Health care workers from the private hospital facilities will receive Tuuka mobile application installed on their smartphones which they will use for tracking suspected TB patients referred to a public health facility. They will use the app to enter the patients' details and the app will automatically send an SMS notification to the patient about the referral and will also send an SMS notification to a healthcare worker at the public health facility about the referred presumptive TB patient. Health Care workers from the Public Hospital facility will receive Tuuka mobile application that will be installed on their smartphones. Upon receiving an SMS notification and the patient arriving at the Public facility, the healthcare worker will use the Tuuka app to notify the healthcare worker at the private healthcare worker that the patient has been received. Patients allocated to this arm will receive an SMS on their mobile phones upon about the name and the details of the public hospital where they have been referred and how important it is for them to adhere to that referral. In case they fail to turn up at the place of referral, they will receive an SMS reminder after 12 hours to go to the hospital where they have been referred. 40
Control Group Routine care arm For patients allocated to this arm, Health care workers at the private health care facilities will use the routine standard of care (referral notes) to refer the identified presumptive TB cases to the healthcare workers at the public health facility. Six Months In this group, participants will receive routine standards of care from the private hospitals, No SMS reminders will be sent to them. they will receive the referral notes from the private hospitals and the researcher will assess hospital records to ascertain their adherence to referrals. 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For HealthCare workers at private hospitals •Employed in a private hospital setting •Willing and able to give consent •Aged 18 and above •Involved in Screening for TB For Health care workers at Public hospitals •Employed in a public hospital setting •Willing and able to give consent •Aged 18 and above •Involved in TB case management For Patients •Referred from the private hospital (study sites) to the public health facility (Mbarara Regional Referral Hospital) •Possess a mobile phone and able to read SMS texts •Willing and able to give consent •Aged 18 and above For HealthCare workers at private hospitals •Not willing and unable to give consent •Not involved in the screening and diagnosing for TB disease For Health care workers at Public hospitals •Not willing and unable to give consent •Not involved in TB case management For Patients •Does not possess a mobile phone and is unable to read SMS texts •Not willing and unable to give consent 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 120 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/06/2020 Mbarara University Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Plot 18, Kabale Road Mbarara 1410 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/05/2020 Uganda National Council of Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road Ntinda, Kampala Uganda Kampala 1410 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence to referrals to the public hospital. Data on adherence to referral will be electronically captured by the Tuuka App specifically about the time spent to reach the referral. We hypothesize that at six months, adherence to referral as ascertained by Tuuka mobile app, will be higher in the intervention arm compared to the control arm. Potential influencing and mediating socio-behavioral factors will also be explored. Six Months
Primary Outcome The feasibility of the Tuuka app in following up the referred patients from private to public hospitals. We will verify the technical functionality of the intervention with the following statistics at the end of six months for feasibility. 1) Using the intervention to notify presumptive TB case, 2) number and type of technical problems encountered. The intervention will be considered feasible if >70% of the participants 1) notify TB cases, 2) Healthcare workers at the public facility use the application to inform the patient that the patients have been received, 3) patients receive SMS reminders about the referral. Six Months
Secondary Outcome The Tuuka mobile app intervention will be considered acceptable if >70% participants rate 70% (7/10) items on the SU scale as very good or higher at the end of six months. Qualitative interviews will delve deeply into each of the four domains of the UTAUT model to provide in-depth feedback on the intervention. Six Months
Primary Outcome TB treatment Initiation. Medical records will be reviewed to obtain information about the treatment initiation rate at the end of six months. Comparisons will be made between study arms (Intervention and Control) to ascertain the level of impact of the intervention among the participants. Six Months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Divine Mercy Hospital Father bash Foundation Kamukuzi Division, 200 metres Off Mbarara-Bushenyi Road Mbarara Uganda
Homely Medical Centre opposite Uganda Martyrs Church Mbarara Uganda
Mayanja Memorial Hospital neighborhood of Nyamityobora, in Kakoba Division Mbarara Uganda
Mbarara Regional Referral Hospital Mbarara Mbarara Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Plot 6 Mbarara Kabale Road Mbarara Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mbarara University of Science and Technology Plot 9 Mbarara Kabale Road Mbarara 1410 Uganda University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wilson Tumuhimbise twilson@must.ac.ug +256772068858 Plot 6, Mbarara Kabale Road
City Postal code Country Position/Affiliation
Mbarara Uganda PhD Student
Role Name Email Phone Street address
Public Enquiries Angella Musiimenta amusiimenta@must.ac.ug +256705317463 Plot 6, Mbarara Kabale Road
City Postal code Country Position/Affiliation
Mbarara Uganda Senior Lecturer Faculty of Computing and Informatics
Role Name Email Phone Street address
Scientific Enquiries Daniel Atwine daniel.atwine@must.ac.ug 0759542376 Plot 6, Mbarara Kabale Road
City Postal code Country Position/Affiliation
Mbarara Uganda Lecturer
Role Name Email Phone Street address
Public Enquiries Fred Kaggwa kaggwa_fred@must.ac.ug +256701930825 Plot 6, Mbarara Kabale Road
City Postal code Country Position/Affiliation
Mbarara Uganda Lecturer Faculty of Computing and Informatics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Individual participant Data (IPD) including data dictionaries, all indivudual particiipant's data collected during the trial and after de-identification will be made available immediately following the publication with any one who wishes to access the data for any research related purposes and this data will be made available upon request to the PI and they will be required to sign a data access agreement to ensure individual participant's data integrity. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately after the publication This will be upon request to the Principal Investigator at twilson@must.ac.ug
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information