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.: PACTR202307473009904 Date of Approval: 17/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Young People, ART and Adherence (YPAA) Trial
Official scientific title Young People, ART and Adherence
Brief summary describing the background and objectives of the trial Adherence to antiretroviral therapy (ART) among young people living with HIV (YPLWH) is lower than other age-groups, which leads to viral non-suppression, increased morbidity and an overall poor quality of life. Nonadherence to ART is the strongest known predictor of viral non-suppression, emergence of drug resistance, increased risk of HIV transmission, disease progression, and death. Identifying patterns of treatment adherence is a crucial initial step to developing effective intervention strategies targeting adherence in young people. Electronic monitoring devices (EMDs) combine objective data collection with detailed day-to-day information about medication intake and can be used for early identification of those at risk of treatment failure. EMD monitoring with feedback can be used as motivation for patients to improve their adherence behaviour and has been used in research settings in children (10 years and younger) and adults. However, its use has been very limited in YPLWH in both research and in clinical practice. The aim of this project is to investigate the effect of EMD-informed text message reminders with adherence feedback for 6 months on ART adherence in YPLWH aged 16-24 years, at risk of HIV virologic failure. 200 YPLWH, taking ART for at least 6 months will be recruited from 3 HIV outpatient clinics in Harare, Zimbabwe. Participants will be randomised 1:1 using block randomisation of variable lengths to use an EMD with text message reminders and focused adherence feedback or standard of care for 6 months.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) YPAA
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Intervention to improve ART adherence using an electronic pill box
Anticipated trial start date 01/08/2023
Actual trial start date 04/09/2023
Anticipated date of last follow up 16/01/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group EMD Participants randomised to the intervention arm will use the EMD called Wisepill RT2000 dispenser to keep and take their ARVs from daily. 6 months. Participants randomised to the intervention arm will receive the EMD to keep and take their ARVs from daily for 6 months. A text message linked to non-opening of the EMD 30 minutes after scheduled ART intake time will be sent to the participant’s mobile phone to remind them to take their ART drugs. A text message will also be sent every fortnight as positive reinforcement to those participants with on-schedule EMD opening events. The positive reinforcement text messages will be sent on different days every fortnight to avoid monotony. In addition, participants will receive monthly focused adherence feedback based on EMD-recorded adherence data as seen on the web server. 100
Control Group Standard of care Three time points 6 months Participants randomised to the standard of care(SoC) group will receive EAC from their respective HIV clinic as per the Zimbabwe HIV treatment and monitoring guidelines. SoC participants will have 3 study visits only: at baseline, 6 and 9 months where they will be seen by the research staff. At these visits no feedback on ART adherence will be discussed with the participants. 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age 16-24 years. 2. Taking ART for at least 6 months 3. Custodian of a mobile phone to prevent inadvertent HIV disclosure and able to receive text messages on the mobile phone 4. VL result >200 copies/ml taken within the last six months. If no recent viral load done within the last six months a viral load sample will be collected as part of screening. 5. A firm home address in Greater Harare accessible for visiting and intending to remain there for 9 months 6. Positive HIV status known by participant 7. Consenting to participate in the study and to give blood samples 1. Any condition (except HIV) that may prove fatal during the study period (e.g. malignancy, end-stage HIV disease or other conditions deemed likely fatal by the principal investigator). 2. Conditions likely to lead to lack of understanding of study procedures or to uncooperative behaviour e.g. neurocognitive disease, developmental delay, psychiatric illness or any other illness that may result in failure to understand study procedures (based on clinical assessment). 3. Living in the same household as a trial participant (to avoid inadvertent mix-up of intervention components) 4. Concurrent participation in other interventional studies addressing adherence Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 16 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 28/04/2023 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
20 Cambridge Road Harare 0000 Zimbabwe
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 30/05/2023 London School of Hygiene and Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Keppel St, Bloomsbury London WC1E7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of participants with suppressed viral load (<50 copies/ml) 6 months
Secondary Outcome Proportion of participants with viral load <50 copies/ml 9 months
Secondary Outcome Proportion of virally suppressed participants at 6 months with viral load rebound (>200 copies/ml) at 9 months 9 months
Secondary Outcome Change in proportion of participants with GRT mutations Baseline and 6 months
Secondary Outcome Number of antiretroviral therapy regimen switches 6 and 9 months
Secondary Outcome Mean adherence to ART as measured by the EMD - intervention participants only 6 and 9 months
Secondary Outcome Adherence behaviour patterns using machine learning techniques 6 months
Secondary Outcome Mean adherence to ART as measured by pill count, self-report and pharmacy refill 6 and 9 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Parirenyatwa HIV Centre of Excellence Mazowe Street Harare 0000 Zimbabwe
Sally Mugabe Central Hospital Southerton Harare 0000 Zimbabwe
Chitungwiza Central Hospital Zengeza Harare 0000 Zimbabwe
Wilkins Infectious Diseases Hospital Princess Road Harare 0000 Zimbabwe
Beatrice Road Infectious Diseases Hospital Simon Mazorodze Road, Mbare Harare 0000 Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP funded VITALITY Trial P.O Box 93015 The Hague 2509 AA Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene and Tropical Medicine Keppel st, Bloomsbury London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
University of Zimbabwe College Road, Mt Pleasant Harare 0000 Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nyasha Dzavakwa nyasha.dzavakwa@lshtm.ac.uk +263773659363 10 Seagrave Road, Avondale
City Postal code Country Position/Affiliation
Harare 0000 Zimbabwe PhD Candidate
Role Name Email Phone Street address
Public Enquiries Mufaro Makuni mufaronashe@gmail.com +263774153146 10 Seagrave Road, Avondale
City Postal code Country Position/Affiliation
Harare 0000 Zimbabwe Communications and public engagement officer
Role Name Email Phone Street address
Scientific Enquiries Nyasha Dzavakwa nyasha.dzavakwa@lshtm.ac.uk +263773659363 10 Seagrave Road
City Postal code Country Position/Affiliation
Harare 0000 Zimbabwe PhD candidate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Cleaned and locked datasets will have additional anonymization (e.g. removal of exact birthdate), and be archived with a codebook in a curated repository accessible via catalogue search. This protocol, CRFs, the analytical plan and metadata will also be deposited. Data will be primarily shared with scientific collaborators, but we will as far as possible facilitate data sharing with any group requesting access to individual patient records, using anonymised data. Where appropriate, and with the proper safeguards, data will be made freely available through LSHTM repository. Beside the original data, anonymised databases will be created and stored with all relevant data to facilitate any data transfer requests that are made subsequently. Priority will be given to local investigators and publicly funded international investigators with data management and sharing policies in line with those of the regulations of the ethical agencies in Zimbabwe as well as LSHTM. The governance of data and materials generated by the programme, and the monitoring of their use either locally or abroad, is an area that is currently under detailed review by ourselves. Ethical clearance will be sought before data are transferred to other groups for secondary analysis. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Protocol and informed consent forms will be available for sharing once recruitment begins. Clinical study report will be made available a year after the study has completed recruitment (December 2024). Data collection is scheduled to end in August 2024 so we anticipate the data will be deposited in December 2024. Additional precautions will be taken to maintain anonymity, such as the removal of birthdates. All documentation will be freely available for download by third parties. Requests for access to the dataset will be made via DataCompass. A committee consisting of PhD supervisors will review requests within 30 days of application. Any scientifically valid request will be granted access to the dataset.
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