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.: PACTR202303867267716 Date of Approval: 23/03/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Remind Adolescents and Young Adults; REMIND-AYA
Official scientific title The effectiveness of a customised digital adherence tool on HIV treatment outcomes in adolescents and young adults living with HIV in Blantyre, Malawi
Brief summary describing the background and objectives of the trial INTRODUCTION People living with HIV (PLHIV) have to take lifelong treatment, which is often challenging. Young people living with HIV (YPLHIV) have the lowest viral load suppression rates in Malawi and globally mostly due to poor treatment adherence. This is a result of complex interactions of multiple factors that are unique to this demographic. The use of digital health interventions, such as real time medication monitor (RTMM) based digital adherence tools (DATS), could improve ART adherence in YPLHIV and subsequently improve viral load suppression which in turn could lead to improved HIV associated morbidity and mortality. BROAD OBJECTIVE To determine the effectiveness of a customized DAT: RTMMs coupled with reminder SMSs and customised adherence feedback, in HIV disease management of YPLHIV in Blantyre, Malawi. SPECIFIC OBJECTIVES 1. The primary objective is to determine the effectiveness of the customised DAT compared to the standard of care in improving ART adherence in YPLHIV. 2. The secondary objective is to determine the effectiveness of the customised DAT compared to the standard of care in improving viral load suppression in YPLHIV. METHODOLOGY This will be a parallel open label randomized control 2-arm trial in which non-adherent YPLHIV in selected ART facilities in Blantyre will be randomised in a 1:1 ratio to a customised DAT and standard care arms and followed up for 9 months. The primary outcome is proportion adherent at 9 months (>= 95% by pill count) and the secondary outcome is proportion viral load suppressed at 9 months (<200 copies/ml). CONCLUSION There is a paucity of good quality evidence on effective digital health to improve ART adherence and viral load suppression in YPLHIV globally and in HIV high burden settings like Malawi. This study will provide good quality evidence on the effectiveness of the customised DAT in improving ART adherence and viral load suppression in this important demographic.
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 Supportive care
Anticipated trial start date 01/06/2023
Actual trial start date
Anticipated date of last follow up 02/06/2025
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
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 Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Intensive Adherence Counselling Participants that are not adherent to treatment or are at risk of virological failure undergo counselling as per the discretion of the psychosocial counsellor. However, they are required to undergo a minimum of three months of intensive adherence counselling. Minimum of 3 months Participants undergo intensive adherence counselling once every three months for a minimum of 3 months. Once adherence is optimal for a mimimum of 3 months, a targeted viral load testing is conducted. If the participant is suppressed, they are discharged and attend regular ART clinics. However, if the participant is unsuppressed, further investigations are undertaken to determine if the cause is non-adherence or drug resistance. 120 Active-Treatment of Control Group
Experimental Group Customised Digital Adherence Tool The intervention is adaptive to participant behaviour and is supplemental to the standard of care. 9 months The intervention will consist of the followig: a real time medication monitor (RTMM); triggered SMS reminder based on data from the RTMM; customised adherence feedback based on data from the RTMM; and all standard of care procedures. 120
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants must be on first line ART regimen (Tenofovir/Lamuvidine/Dolutegravir) or (Tenofovir/Lamuvidine/Efavirenz) Participants must have had full disclosure of their HIV status Participants must be able to read and understand Chichewa or English Participants must be competent in the use of mobile devices. Hospitalisation at the time of study entry Prior participation in digital adherence health research Enrolment in other HIV-related studies Treatment for a comorbidity that significantly increases the participants’ pill burden. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 Year(s) 24 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 27/02/2023 College of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mahatma Ghandi Road Blantyre 360 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion adherent 0, 1, 2, 3, 6, and 9 months
Secondary Outcome Proportion virologically suppressed 0, and 9 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ndirande Health Center Blantyre Urban Blantyre Malawi
Limbe Health Centre Blantyre Urban Blantyre Malawi
Bangwe Health Centre Blantyre Urban Blantyre Malawi
Chilomoni Health Centre Blantyre Urban Blantyre Urban Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trials Partnership Tygerberg 7505 Cape Town 19070 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kilimanjaro Clinical Research Institute Moshi Moshi 2236 United Republic of Tanzania Charities/Societies/Foundation
Secondary Sponsor Helse Nord Tuberculosis Initiative Mahatma Ghandi Road Blantyre Malawi Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Takondwa Msosa takondwamsosa@gmail.com +265992303978 Mahatma Ghandi Road
City Postal code Country Position/Affiliation
Blantyre 360 Malawi Research Fellow
Role Name Email Phone Street address
Public Enquiries Mary Chimwaza mchimwaza@kuhes.ac.mw +265994739950 Mahatma Ghandi Road
City Postal code Country Position/Affiliation
Blantyre 360 Malawi Administrator
Role Name Email Phone Street address
Scientific Enquiries Marriott Nliwasa mnliwasa@gmail.com +265888681948 Mahatma Ghandi Road
City Postal code Country Position/Affiliation
Blantyre 360 Malawi Senior Scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Analytic Code,Clinical Study Report,Statistical Analysis Plan,Study Protocol 1 year after completion of the trial, all documents will be made available Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose. Types of analysis allowed will be as stated in the approved proposal. The proposals should be submitted to takondwamsosa@outlook.com, and to gain access, a data sharing agreement will have to be signed
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