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.: PACTR202209650999226 Date of Approval: 19/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Using a mobile phone app and sms to increase uptake of information on HIV/AIDS and improve HIV testing among adolescents and youth.
Official scientific title Using a mobile phone app and sms to increase uptake of information on HIV/AIDS and improve HIV testing among adolescents and youth.
Brief summary describing the background and objectives of the trial The spread of HIV/AIDS among young adults is a major public health concern in the world. The ages between 15 and 24 years represent a high-risk group for the infection of the virus. Approximately 2 million adolescents were living with HIV worldwide, and 25% of this figure was found in South Africa, Nigeria, and Kenya in 2014. Sub-Saharan Africa is one of the most affected regions. It has a high rate of HIV infection among adolescents and youths.Countries in Africa with a high HIV burden had a low HIV prevalence in early childhood for both males and females, which changed when they reached adolescence due to factors like late disclosure and rebellion . Low levels of knowledge were also observed among adolescents on PREP uptake and information on HIV. Youth who were fond of using social media and mass media demonstrated an improved knowledge on HIV and PrEP. A study showed that there was a strong relationship between adequate knowledge of HIV and the sexual behaviors that the adolescents’ and youths exhibited This project aims to show how the development of a simple app will increase uptake of information on HIV, testing and retention to care among adolescents and the youth. Specific objectives • Develop/customise available and validated information sources on HIV among adolescent and youth into a mobile app and SMS • Pilot the adolescent and youth HIV information through a mobile app and SMS and evaluate knowledge and awareness • To determine the acceptability of using a mobile app and SMS in improving uptake of HIV testing and retention to care among adolescents and youth • To determine feasibility of using a mobile app and SMS to improve uptake of HIV testing and retention to care among adolescents and youth with an aim 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 Prevention
Anticipated trial start date 01/03/2022
Actual trial start date 01/04/2022
Anticipated date of last follow up 24/11/2022
Actual Last follow-up date 15/12/2022
Anticipated target sample size (number of participants) 192
Actual target sample size (number of participants) 192
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NON KEMRI 734 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 months This project aims to use a mobile phone application and SMS to help spread awareness on HIV, modes of prevention and HIV testing and linkage to care for those found positive after testing. Participants will be selected from the adolescents and youth enrolled in MWENDO project in Budalangi Theatre CBO. Budalangi theatre CBO is a community based organization in Bunyala West Ward, Busia County that serves children, adolescents and youth aged 5 to 24 years in the Making Well informed efforts to nurture disadvantaged OVCs (MWENDO)project. This is a HIV prevention intervention and approximately 5000 young people are enrolled in this project. The Budalangi theatre staff will explain to the adolescents enrolled in the MWENDO project about the study and those who are interested to be engaged in the study shall be referred by the Budalangi theatre staff to our study staff. They shall be screened for eligibility and consented to participate in the study. The adolescents and youth will first be screened using the screening assessment tool to assess phone ownership, duration of stay in Bunyala, literacy level etc. At least 192 participants will be enrolled into the study. Participant with smart phones, therefore able to use the app, will be randomized to either intervention (App) group composed of 48 participants or control group composed of 48 participants. Those with basic phones, therefore able to receive SMS, will also be randomized to either intervention (SMS) group composed of 48 participants or control group composed of 48 participants. The control arm will have no intervention but data will be collected from them at the same time and on the same variables as the intervention. 96 Uncontrolled
Experimental Group Not applicable Not applicable 6 months This project aims to use a mobile phone application and SMS to help spread awareness on HIV, modes of prevention and HIV testing and linkage to care for those found positive after testing. Participants will be selected from the adolescents and youth enrolled in MWENDO project in Budalangi Theatre CBO. Budalangi theatre CBO is a community based organization in Bunyala West Ward, Busia County that serves children, adolescents and youth aged 5 to 24 years in the Making Well informed efforts to nurture disadvantaged OVCs (MWENDO)project. This is a HIV prevention intervention and approximately 5000 young people are enrolled in this project. The Budalangi theatre staff will explain to the adolescents enrolled in the MWENDO project about the study and those who are interested to be engaged in the study shall be referred by the Budalangi theatre staff to our study staff. They shall be screened for eligibility and consented to participate in the study. The adolescents and youth will first be screened using the screening assessment tool to assess phone ownership, duration of stay in Bunyala, literacy level etc. At least 192 participants will be enrolled into the study. Participant with smart phones, therefore able to use the app, will be randomized to either intervention (App) group composed of 48 participants or control group composed of 48 participants. Those with basic phones, therefore able to receive SMS, will also be randomized to either intervention (SMS) group composed of 48 participants or control group composed of 48 participants. Participants both in the app group and the SMS group will receive information on HIV and the facilities where HIV testing, care and treatment services are offered. They will receive this information for 6 months. 96
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i) Adolescents and youth between the ages of 15-24 ii) Enrolled in Budalangi theatre community-based organization iii) Planning to remain in Bunyala for the duration of study (9 months) iv) Adolescents and youth who own/have access to a phone v) Verified literacy in reading and understanding English/Kiswahili languages, to be able to read SMS or information on the App i) Adolescents and youth below the age of 15 and above the age of 24 ii) Adolescent not enrolled in Budalangi theatre community-based organization iii) Planning to move out of Bunyala within the next 9 months. iv) Adolescents and youth without a phone or access to a phone v) Those unable to read and understand English/Kiswahili languages 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 31/05/2022 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 26/08/2021 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. Developed/customised available and validated information sources on HIV among adolescent and youth in a mobile app and SMS. 2. Uptake of HIV testing and retention to care among adolescents and youth using a mobile phone application and SMS. At month1, 6 months prior to the intervention compared to 6 months during the intervention
Secondary Outcome 1. Uptake of the interventions among those eligible for the study. Assessed by measuring the proportion of eligible FSWs who agree to join and remain in the study. 2. Documented barriers to and facilitators of WhatsApp and SMS delivery among young FSW, and participation in WhatsApp discussions. This will be achieved by reviewing the barriers and facilitators listed by the intervention implementers, and proportion of those enrolled in WhatsApp who participate in the discussions Acceptability will be measured at baseline month 1 and Feasibility will be measured at baseline endline month 6
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bunyala Sub county Budalangi Constituency Busia County Busia County 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 Anne Omuke annomuke@gmail.com +254702201037 Nairobi
City Postal code Country Position/Affiliation
Nairobi 00100. Kenya Penda Health
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 Bunyala Sub county, Budalangi Constituency, Busia 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