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.: PACTR201908770159765 Date of Approval: 21/08/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Tuberculosis among Women: Mobile Phones to the Rescue?
Official scientific title Using Mobile Technology for Monitoring Tuberculosis Treatment among Women with Tuberculosis and Tuberculosis HIV Co-Infection in the Greater Accra Region, Ghana
Brief summary describing the background and objectives of the trial Tuberculosis has for years been a public health menace despite several attempts to contain the situation. The number of deaths and disabilities resulting from TB has made it a global public health concern.TB prevalence is mostly higher among men than women. However, the devastating effect of TB on women and their children make the subject of utmost importance among women. Several attempts have been made by global, regional and national bodies to fight the disease. The use of the directly observed treatment (DOT) is the standard of care recommended for member countries of the World Health Organization (WHO). Despite these efforts and the fact that TB is curable, poor treatment adherence among diagnosed TB patients has resulted in the emergence of new strains of TB; drug resistant TB. The dearth of information on context specific interventions to control TB necessitated this study. Mobile technology is widely in use across the globe including Ghana for several health interventions. However, its use is limited for TB treatment especially among women, who are most affected. This study, therefore will apply the concept of mobile technology to monitor TB treatment adherence among women of reproductive age in the Greater Accra region. Quasi-experimental design was employed to determine the feasibility of this intervention. Patients receiving TB treatment in one group will receive daily SMS reminders to take their TB drugs, another group will use an app to video themselves taking their TB drugs and submit to the DOT nurse via internet. The third group of patients will be on the current standard treatment for TB without any of these two interventions. A standard tool will be used to measure adherence among these three groups during recruitment and at the end of their treatment and compared. Also, various factors influencing treatment adherence will be explored in this study.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Using Mobile Phones for Monitoring TB Treatment
Anticipated trial start date 15/09/2019
Actual trial start date
Anticipated date of last follow up 15/02/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
GHSERC0051118 Ghana Health Service Ethics Review Board
Not applicable Not Applicable
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
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Direct Observed Treatment Daily Six (6) Months Patient is given TB drugs and monitored by either a health worker or a monitor to take drugs daily 120 Active-Treatment of Control Group
Experimental Group Daily SMS reminders Daily 6 Months Patients will receive daily SMS reminders to take their TB drugs 70
Experimental Group Video Direct Observed Treatment Daily 6 Months Patients will video themselves taking their TB drugs using an app and submit via internet to researcher 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women 15 years and above within 6 weeks of receiving treatment for TB in the selected DOT units. Patients completing treatment in the selected facility Patients with non smart phones for SMS intervention Patients with smart phones for VDOT intervention Women within 6 weeks of treatment but severely ill Patients on referral to other facilities 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) 15 Year(s) 120 Year(s) Female
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 16/01/2019 Ghana Health Service Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Adabraka-Accra Accra 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Treatment Adherence On completion of TB treatment
Secondary Outcome Treatment Outcome On completion of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tema General Hospital Ghana Tema Accra 00233 Ghana
Ashaiman Polyclinic Ashaiman Accra 00233 Ghana
Madina Polyclinic Kekele Madina Accra 00233 Ghana
Accra Regional Hospital Ridge Accra 00233 Ghana
Maamobi General Hospital Maamobi Accra 00233 Ghana
Kaneshie Polyclinic Kaneshie Accra 00233 Ghana
Ga South Municipal Hospital Weija Accra 00233 Ghana
Ga West Municipal Hospital Amasaman Accra 00233 Ghana
Achimota Hospital Achimota Accra 00233 Ghana
La General Hospital Labadi Accra 00233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
NIH Fogarty International Centre National Institutes of Health Building 31 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 USA Bethesda 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of GhanaUniversity of Florida Partnership for TB and HIV Research in Ghana College of Health Sciences, University of Ghana, Legon Accra 00233 Ghana University
COLLABORATORS
Name Street address City Postal code Country
Caroline Dinam Badzi School of Public Health, College of Health Sciences, University of Ghana, Legon Accra 00233 Ghana
University of Ghana University of Florida Partnership for TB and HIV Research in Ghana. College of Health Sciences, University of Ghana, Legon Accra 00233 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Caroline Badzi cdinama@yahoo.com +233243217664 School of Public Health, College of Health Sciences, Box LG 13, Legon
City Postal code Country Position/Affiliation
Accra 00233 Ghana Student
Role Name Email Phone Street address
Public Enquiries Caroline Badzi cdinama@yahoo.com +233243217664 School of Public Health, College of Health Sciences, Box LG 13, Legon
City Postal code Country Position/Affiliation
Accra 00233 Ghana Student
Role Name Email Phone Street address
Scientific Enquiries Richard Adanu rmadanu@yahoo.com +233244238556 School of Public Health, College of Health Sciences, Box LG 13, Legon
City Postal code Country Position/Affiliation
Accra Ghana Professor
Role Name Email Phone Street address
Scientific Enquiries Kwasi Torpey ktorpey@hotmail.com +233244563322 School of Public Health, College of Health Sciences, P. O Box LG 13, Legon
City Postal code Country Position/Affiliation
Accra 00233 Ghana Professor
Role Name Email Phone Street address
Scientific Enquiries Kotoh Agnes nyamikye@yahoo.co.uk +233246397590 School of Public Health, College of Health Sciences, Box LG 13, Legon
City Postal code Country Position/Affiliation
Accra 00233 Ghana Lecturer
Role Name Email Phone Street address
Scientific Enquiries Awewura Kwara awewura.kwara@medicine.ufl.edu +13522739501 Emerging Pathogen Institute, University of Florida P.O. Box 100009 2055 Mowry Road Gainesville, FL 32610
City Postal code Country Position/Affiliation
Gainesvile 32610 United States of America Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results Clinical Study Report A maximum of six months after data collection Be a collaborator A journal accepting findings for publication For communicating to the scientific community
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