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.: PACTR201909858930669 Date of Registration: 20/09/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Feasibility and Efficacy of Test-Messaging to Promote Care Among Trauma Patients Screened for HIV at the Emergency Medicine Department of Muhimbili National Hospital
Official scientific title The Feasibility and Efficacy of Test-Messaging to Promote Care Among Trauma Patients Screened for HIV at the Emergency Medicine Department of Muhimbili National Hospital
Brief summary describing the background and objectives of the trial HIV continues to be a major global public health problem, and in Tanzania 1.4 million people are living with HIV/AIDS. Tanzanian National Guideline for Management of HIV and AIDS recommend routine HIV testing in all health facilities, however a recent study of cohort of trauma patients tested for HIV in the emergency medicine department found that only half of those who tested positive attended HIV clinic for follow-up. Automated telecommunication systems, (such as text short messaging services) has been shown to be effective increasing compliance to care in different disease in in Africa; however, there is paucity of data on feasibility and efficacy of using such services to increase linkage to HIV following provided initiated testing and counseling at the emergency medicine department. The objective of this study is to determine the feasibility and efficacy of using text-messaging to promote care among trauma patients receiving provided initiated testing and counseling (PITC) at the Emergency Medicine Department of Muhimbili National Hospital.:
Type of trial RCT
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 HIV/AIDS
Purpose of the trial Automated Test Message
Anticipated trial start date 16/09/2019
Actual trial start date 23/09/2019
Anticipated date of last follow up 30/04/2020
Actual Last follow-up date 31/05/2020
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 240
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Automated Text message Once One month in HIV reactive patients ( to remind them on CTC visits), three months on HIV non rective patient to (remind them on repeat screening) Then after collecting the data, we will use extrateq bulk SMS service to send the automated text to the patients depending on the criteria the patient falls into. Message received will be used to guide whether the patient got the message or not. Extrateq bulk SMS portal allows to create a flow which may be guided depending on the criteria specified in the flow itself and the SMS can be scheduled to run at a certain time of interval and when a certain condition set is met. SMS content: “Dear EMD client, this is a reminder that’s is important for your health that you visit the nearest hospital to you, thank you in advance and have a good day.’ 120
Control Group standard care once during testing once Pre-testing and post-testing counselling will be done by an Emergency medicine nurse that has been trained in HIV testing and counselling. 120 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adult patients of trauma attending Emergency Department of Muhimbili National Hospital. All below 18yrs Unconscious patient and those with GCS of below 15 Known HIV cases with evidence of either treatment card or others Clinically unstable patient doesn’t own a cell phone or phones not capable of receiving an SMS. 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) 80 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 14/08/2019 Muhimbili University of Health and Allied Science
Ethics Committee Address
Street address City Postal code Country
Kalenga Street Dar Es Salaam 65000 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of patient who follows up after SMS notification. End of study
Secondary Outcome The proportion of positive result Proportional of those who accepted PITC The proportion of those who accepted automated SMS The proportion who have had initial CTC visit Proportional of those who had repeat testing at 3 months throughout the study
Secondary Outcome proportion of participants attending their follow-up visit between those patients receiving text reminders versus those receiving standard care only End of trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Emergency Department of Muhimbili National Hospital Kalenga Street Dar Es Salaam United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Muhimbili University of Health and Allied Sciences Kalenga street Dar es Salaam 65001 Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amina Karuma Mazengo Street Dar es Salaam 13404 United Republic of Tanzania Individual
COLLABORATORS
Name Street address City Postal code Country
Hendry Sawe Kalenga Road Dar es salaam 65001 United Republic of Tanzania
Muhimbili University of Healthy And Allied Sciences Kalenga Street Dar Es Salaam 65001 United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gimbo Hyuha ghyuha@gmail.com +255784379770 Mazengo Road
City Postal code Country Position/Affiliation
Dar Es Salaam 13404 United Republic of Tanzania self
Role Name Email Phone Street address
Public Enquiries Gimbo Hyuha ghyuha@gmail.com +255784379770 Mazengo Road
City Postal code Country Position/Affiliation
Dar Es Salaam 13404 Tanzania Self
Role Name Email Phone Street address
Scientific Enquiries Hendry Sawe hendry_sawe@yahoo.com +255754885658 Kalenga street
City Postal code Country Position/Affiliation
Dar Es Salaam 65000 United Republic of Tanzania Senior lecture
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All de-identified IPD including data dictionary collected during the trial will be available ( 3months after publication and ending 36 months after publication) to researchers whose proposed use of the data has been approved by independent review committee, to achieve aims of the approved proposal. Clinical Study Report,Study Protocol 3 months after publication and ending 36 months after publication All researchers whose proposed use of the data has been approved by independent review committee
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