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.: PACTR202003823226570 Date of Approval: 04/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluating the role of mobile Health platform and peer to peer mentoring in improving adherence to HIv pre-exposure prophylaxis among high risk population in Tanzania
Official scientific title Pragmatic Trial for HIV Pre-Exposure Prophylaxis Roll-Out in Tanzania
Brief summary describing the background and objectives of the trial Pre-exposure prophylaxis (PrEP) is effectrive in preventing new HIV infection among at risk population such as men who have sex with men and female sex workers but uptake and adherence to medication (Truvada) pose a challenge to its effectiveness. We will work with these populations to develop, test and implement an interactive mobile application platfom to address uptake and adhrenece to PrEP. A phased approach will be employed and this will include a formative phase to provide baseline information to be used in the development of the mobile platform in the subsequent phase. Phase two will include assessment of uptake, experience and opinion about the intervention. The last phase will involve a rigorous experimental approach to test the effectivenss of the intervention in increasing uptake and adherence to PrEP and pomotion of safer behaviours. Both qualitative and quantitative methodologies will be used in this project while working with and for the population at risk.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) PREPTA
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 01/04/2020
Actual trial start date
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 2500
Actual target sample size (number of participants)
Recruitment status Not yet 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
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group standard of care All eligible population in the intervention region will receive the pre-exposure prophylaxis medication only -standard of care 2 years no intervention 1100 Active-Treatment of Control Group
Experimental Group Jichunge mobile application All participants in the intervention regionm shall receive a mobile Application in their mobile phones 2 years The "Jichunge" mobile Application shall have the flowing functionalities. 1. will send daily reminder Message to all participants to remind them to take their daily medication at the time of their Choices 2. will provide medication-truvada, education and other HIV related health promotion information 3. will provide direct access to a medical doctor for advices on medication and other HIV treatment and prevention information 4. will provide direct access to a peer educators for health education and other psychosocial support 5. will provide a discussion forum with peers giving an opportunity to share experiences and encouragement on medication 6. will provide gamification opportunities to encourage participants to access and use the mobile application system 1100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. men who have sex with men 2. female sex workers 3. age 18 years and above 4. resident of the participating region 5. HIV negative 6. Able to offer informed consent 7. having an internet enabled mobile phone 1. pregnant women 2. participants with serum Creatinine clearance < 60 ml/min 3. Not willing to take daily medication 4. Allergy or contraindications to any medication within the PrEP regime Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 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 12/02/2020 Regional Commitee for Medical and Health Sciences Research
Ethics Committee Address
Street address City Postal code Country
Gullhaugveien 1-3, 0484 Oslo Oslo 0047 Norway
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 22/11/2019 Muhimbili University of Health and Allied Sciences Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
9 United Nations Road Dar es Salaam 00255 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence Baseline and monthly
Secondary Outcome Reduced HIV infection rates baseline and 12 monthly
Secondary Outcome Increased reported condom use baseline and 6 monthly
Secondary Outcome Reduced reported number of sexual partners baseline and 6 monthly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dar es salaam regions 9 United Nations Road, Dar es Salaam 00255 United Republic of Tanzania
Tanga region Ngamiani Tanga 00255 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Norwegian Research Council Drammensveien 288 Oslo 0047 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oslo Kirkeveien 166 Oslo 0047 Norway University
Primary Sponsor Muhimbili University of Health and Allied Sciences 9 United Nations Road Dar es Salaam 00255 United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
University of Oslo Kirkeveien 166 Oslo 0047 Norway
Muhimbili University of Health and Allied Sciences 9 United Nations Road Dar es Salaam 00255 United Republic of Tanzania
National AIDS Control Program Dodoma Dodoma 00255 United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elia John Mmbaga ejmmbaga@medisin.uio.no 004747728384 Kirkeveien 166
City Postal code Country Position/Affiliation
Oslo 0047 Norway Professor
Role Name Email Phone Street address
Public Enquiries Kare Moen kare.moen@medisin.uio.no 004790923780 Kirkeveien 166
City Postal code Country Position/Affiliation
Oslo 0047 Norway Professor
Role Name Email Phone Street address
Scientific Enquiries Melkizedeck Leshabari mleshabari@muhas.ac.tz 00255783287062 9 United Nations Road
City Postal code Country Position/Affiliation
Dar es Salaam 00255 United Republic of Tanzania Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participants data that underlie results reportyed in any of the publication emanating from this trial after deidentification Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. Anyone who submit a reasonable request to Access and use the data can submit such request to the Principal investigator or correponsing Author of any of the publication emanating from the trial.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
to be added later 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