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.: PACTR202303729957231 Date of Approval: 03/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Patterns of use and benefits of an online health portal among young people living with HIV in Kiambu and Kirinyaga counties of Kenya
Official scientific title Exploring usability and outcomes among young people living with HIV in Kiambu and Kirinyaga counties of Kenya using an online health portal
Brief summary describing the background and objectives of the trial Background: Globally, whereas new HIV infections are declining for other age groups, they are increasing among adolescents and young people, who also contribute disproportionately to AIDS related deaths. Being early adopters and avid users of technology, this age-group may benefit from an online patient portal designed to create awareness, build capabilities, and motivate users to achieve patient activation, defined as, “willingness and ability to take independent actions to manage their health and care.” Despite this potential, it is still unclear how patient portals can influence patient activation and outcomes amongst young persons living with HIV in Kenya. Objectives: 1. To document the process of developing and implementing a patient health portal, 2. To describe portal use over the study period 3. To explore the effect of an online patient health portal on patient activation measure, self-reported medication adherence, viral load suppression, and social engagement among adolescents and young persons living with HIV. Methods: Design – Stepped wedge cluster randomised trial. Study population - individuals living with HIV aged between 15-24 years old receiving anti-retroviral therapy at selected study sites in Kenya between May 2022 and May 2023, and with ready access to smartphones. Data collection: manual paper-based tools and online portal-based capture. Statistical analysis of primary and secondary endpoints will be conducted using generalized linear mixed models. Study Outcomes: i) Portal functionality, fidelity, stability, and quality ii) Portal use patterns iii) Patient activation measure, iv) Monthly self-reported medication adherence, v) Viral load suppression vi) social engagement
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 Mobile-phone based digital health intervention incorporating a behavioural change model based on enhancing capabilities, opportunities and motivation for self efficacy resulting into patient activation
Anticipated trial start date 01/09/2022
Actual trial start date 01/09/2022
Anticipated date of last follow up 31/08/2023
Actual Last follow-up date 31/12/2023
Anticipated target sample size (number of participants) 480
Actual target sample size (number of participants) 575
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
Crossover: all participants receive all interventions in different sequence during study 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard care N/A 3-6 months Patient activation and outcomes on standard care prior to use of a mobile based online patient portal 288 Placebo
Experimental Group Patient health portal N/A Between 6 and 12 months Patient activation and outcomes while using a patient health portal 287
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Cluster level 1) Facilities with EMR 2) Close geographical proximity to each other Individual level 1) Persons living with HIV aged between 15-24 years old receiving ART at study sites: where care is primarily provided by a caregiver, they will be allowed to continue their agency role in the study 2) Must have ready access to a smartphone 3) Must consent to download and use the portal Participants likely to migrate from the study location during the study period, as self-reported during enrolment screening. Adolescent: 13 Year-18 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 23/06/2022 AMREF ethics and scientific review committee
Ethics Committee Address
Street address City Postal code Country
Amref Health Africa in Kenya. P.O. Box 30125 - 00100, Wilson Airport Nairobi Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be change in patient activation measure (PAM) 0, 6, 9 months
Secondary Outcome self-reported adherence to Antiretroviral therapy 3, 6 and 9 months
Secondary Outcome Viral load suppression 0,3,6 and 9 months
Secondary Outcome Mobile health application usability score End of study - month 12
Secondary Outcome Mobile health application acceptability score End of study - month 12
Secondary Outcome Portal incorporated health tools - TB screening, contraceptive need assessment, substance use disorder screening, PHQ-9 depression score Continous
Secondary Outcome Portal functionality assessment metrics - stability and fidelity from system reports Continous
Secondary Outcome Cost analysis Endline - month 12
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Juja subcounty Thika road Nairobi Kenya
Kiambaa subcounty Kiambu road Kiambu Kenya
Kirinyaga central Kerugoya Kerugoya Kenya
Kabete Wangige Kiambu Kenya
Kirinyaga South Nairobi-Embu highway Mwea Kenya
Ruiru Thika superhighway Ruiru Kenya
Gatundu South Gatundu Gatundu Kenya
Gatundu North Gachororo Gatundu Kenya
Limuru Nairobi-Naivasha highway Limuru Kenya
Lari Nairobi-Naivasha highway Kiambu Kenya
Kirinyaga East Kianyaga Kianyaga Kenya
Thika Level 5 Thika Thika Kenya
Githunguri Githunguri Githunguri Kenya
Thika town Thika Thika Kenya
Kiambu township Kiambu Kiambu Kenya
Kirinyaga west Nairobi-Nyeri highway Sagana Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Johnson and Johnson Foundation Scotland 5 Atholl crescent, EH3, 8EJ Edinburgh EH3, 8EJ United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Nairobi cenrre for health quality and innovation Church road, westlands Nairobi 00202 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Savannah informatics LTD One padmore place, george padmore road Nairobi 00202 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eric Mugambi ericmugambi@gmail.com +254722758767 Royal park estate Langata road 259, P.O. Box 29774
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Programs Director
Role Name Email Phone Street address
Public Enquiries Elizabeth Kubo elizabeth.kubo@gmail.com +254727547649 NATIL House, Church road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Study Coordinator
Role Name Email Phone Street address
Scientific Enquiries Jared Mecha jomecha@gmail.com +254786842741 NATIL House, Church road P.O. Box 19676
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Director of centre
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Study Protocol 9 - 36 months following publication Controlled access as granted by centre director and PIs
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