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.: PACTR202209900806595 Date of Approval: 23/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Assessing the effectiveness of a mobile phone short messaging to enhance youth peer navigation system (m-care) for ART adherence and retention promotion among adolescents in Suba Sub – County, Kenya.
Official scientific title Assessing the effectiveness of a mobile phone short messaging to enhance youth peer navigation system (m-care) for ART adherence and retention promotion among adolescents in Suba Sub – County, Kenya.
Brief summary describing the background and objectives of the trial Adolescents and young adults (AYA) aged 15 – 24 years with HIV in Africa experience substantially higher rates of viral failure and HIV-related mortality as compared to adults. Poor ART adherence has been associated with many challenges that young people undergo. For example, stigma, long waits in line at the clinics, health care provider attitude, poverty, long distance treks to health facilities. Psychological distress is one of the commonest difficulties faced by adolescents living with HIV around the world, and has been associated with non-adherence to antiretroviral treatment (ART), leading to poor virology suppression, drug resistance, and increased morbidity and mortality (Enane et al., 2020). There is need for public health interventions that are tailored for and tested in this age group. The World Health Organization’s (WHO) HIV-Testing and treatment guidelines for adolescents recommends the use of technology and community – based approaches for strengthening antiretroviral treatment adherence and retention in care. We propose a text messaging system that will be navigated by adolescent peer navigators. Main Objective To assess the feasibility and acceptability of implementing a peer navigated mobile based SMS tailored care platform (M-CARE) into rural healthcare system to promote ART adherence and retention among adolescents and young adults for a 9-month pilot period. Specific objectives • To evaluate the feasibility and acceptability of implementing a peer navigated mobile based short messaging to promote adherence and retention among adolescents and young adults. • To evaluate the effectiveness of the peer navigated mobile based short messaging intervention adolescents and young adults ART adherence and retention. • To collect information on intervention delivery approaches to inform future scale up.
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 Treatment: Other
Anticipated trial start date 19/11/2021
Actual trial start date 18/12/2021
Anticipated date of last follow up 16/09/2022
Actual Last follow-up date 30/09/2022
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 150
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NON KEMRI 722 Kenya Medical Research Institute - Scientific Ethics Review Unit
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Not applicable Not applicable 6-9 months We propose a pilot research project targeting young people aged 15 to 24 years enrolled for ART in Suba Sub County hospital, Homabay County to send them weekly messages and reminders using a software/system with an aim of promoting ART adherence and retention to HIV care and treatment. This software which shall be used is a SMS tailored platform which will be operated by youth peer navigators. They will send the adolescents reminders and educational messages, handle the adolescents concerns individually by either sending messages or making direct calls and receive feedback from adolescents so as to promote daily uptake of drugs, ART adherence and retention among HIV positive adolescents. The adolescent will be enrolled into the project and randomized into either the intervention (SMS) group and the control (no SMS) group Participants in the control arm will not be exposed to the text messages. However, they will benefit from the routine health services obtained at the clinics. Data will be collected from them at the same time and on the same variables as those in the intervention. 75 Uncontrolled
Experimental Group Not applicable Not applicable 6-9 months We propose a pilot research project targeting young people aged 15 to 24 years enrolled for ART in Suba Sub County hospital, Homabay County to send them weekly messages and reminders using a software/system with an aim of promoting ART adherence and retention to HIV care and treatment. This software which shall be used is a SMS tailored platform which will be operated by youth peer navigators. They will send the adolescents reminders and educational messages, handle the adolescents concerns individually by either sending messages or making direct calls and receive feedback from adolescents so as to promote daily uptake of drugs, ART adherence and retention among HIV positive adolescents. The adolescent will be enrolled into the project and randomized into either the intervention (SMS) group and the control (no SMS) group Participants in the intervention arm will recieve text messages through the M-CARE system . 75
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a) Enrolled for ART care at the Suba Sub County hospital for at least six months. b) Owns or has access to a mobile phone c) Should have a routine ART care at the facility for the entire 9-month study period. d) Aged between 15-24 years a) Not enrolled for ART care at the Sub county hospital for at least 6 months b) Does not have or able to access a mobile phone c) Not available for 9-month study period d) Aged below 15 years and above 24 years 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 23/05/2022 Kenya Medical Research Institute Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Off Raila Odinga Way. Nairobi, Kenya. Nairobi 00200 Kenya
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 07/06/2021 Kenya Medical Research Institute Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Off Raila Odinga Way. Nairobi, Kenya. Nairobi 00200 Kenya
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 06/09/2021 National Commission for Science Technology and Innovation
Ethics Committee Address
Street address City Postal code Country
Waiyaki Way, Nairobi Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Improved viral load of ≤ 500 copies 2. Improved pill uptake Baseline at month 1 and monthly for 6-9 months
Secondary Outcome 1. Uptake of the interventions among those eligible for the study. Assessed by measuring the proportion of eligible adolescents who agree to join and remain in the study. 2. Documented barriers to and facilitators of intervention delivery among participants in the intervention arm. This will be achieved by reviewing the barriers and facilitators listed by the intervention implementers, and proportion of those enrolled in intervention arm. Acceptability will be measured at baseline month 1 and Feasibility will be measured at baseline endline month 9
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suba Sub County Hospital Kisii Isbania Road, Sindo Homa Bay County,. Homabay County 30408 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation Seattle, WA98102, USA Seattle United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Impact Research and Development Organization Tuungane Hospital, Tom Mboya Estate Mito Jura Road, off Kisumu-Kakamega Highway Kisumu 40141 Kenya Grants management
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joseph Ouko were.joseph7@gmail.com +254718355136 104 - 40305 Mbita
City Postal code Country Position/Affiliation
Homabay 40305 Kenya County Youth and Adolescent Network
Role Name Email Phone Street address
Public Enquiries Kawango Agot kawango@impact-rdo.org +254736505046 Tuungane Hospital, Tom Mboya Estate Mito Jura Road, off Kisumu-Kakamega Highway
City Postal code Country Position/Affiliation
Kisumu 40141 Kenya Impact Research and Development Organization
Role Name Email Phone Street address
Scientific Enquiries Charles Obonyo cobonyo@kemri.go.ke +254724993118 Off Raila Odinga Way. Nairobi, Kenya.
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Kenya Medical Research Institute
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We are committed to public dissemination of results of the study to participants, local stakeholders in Kenya, the global scientific community and global policymakers. Dissemination of study results will follow principles of good participatory practice. Study results will be disseminated through presentations to the relevant stakeholders, starting with the study participants, participating health facilities as well as the Ministry of Health officials in Suba Sub-County, Homabay County. Results will be published in conference abstracts and peer-reviewed journals. Statistical Analysis Plan,Study Protocol One Year Upon completion of study analysis, the final dataset will be striped of identifiers prior to release for sharing. We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Results from research conducted under this project will be shared in several ways. • Manuscripts will be submitted for publication in high-quality peer-reviewed journals • The MPI and Co-Investigator will also disseminate results from this research through presentations at public lectures, scientific institutions and meetings, as well as to the community in which the research took place as detailed in the enclosed.
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