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.: PACTR202209833111359 Date of Approval: 22/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Assessing the use of mobile phone based messaging in improving PrEP retention and adherence among AGYW enrolled in DREAMS Program in Siaya County Kenya.
Official scientific title Assessing the use of mobile phone based messaging in improving PrEP retention and adherence among AGYW enrolled in DREAMS Program in Siaya County Kenya.
Brief summary describing the background and objectives of the trial HIV Pre-exposure prophylaxis (PrEP) is an oral antiretroviral containing pill that has been proven safe and effective in reducing the risk of acquiring HIV in individuals at risk (5-7). It is recommended by the World Health Organization and has been adopted into the HIV treatment and prevention guidelines in different countries including Kenya. Oral PrEP is effective if consistently taken daily and adhered to. HIV PrEP programs report that over half of those who initiate PrEP drop out within the first three months of initiation. In the DREAMS program in Siaya County in Western Kenya, 3,862 AGYW have been enrolled in PrEP since 2017 to date, and 64.7% (2,499) have dropped out. The DREAMS program is using adolescent girls and young women (AGYW) using PrEP as PrEP champions to support their peers on PrEP through addressing the challenges they face while taking PrEP, providing education to them on importance of adhering to PrEP, following up those who miss their refill visits to understand their reasons, address the reasons and support them where possible. Most of these tasks are done manually making them time and resource-consuming. We are proposing to assess the use of mobile phone based messaging in improving PrEP retention and adherence among adolescent girls and young women (AGYW) enrolled in DREAMS Program in Siaya County Kenya. Objectives 1. To determine the acceptability of using mobile phone-based messaging services to enhance the retention and adherence to PrEP among AGYW in DREAMS program in Siaya County. 2. To assess the efficacy of using mobile phone-based messaging to enhance PrEP retention and adherence rates of AGYW in DREAMS program in Siaya County. 3. To assess the association of mobile phone-based messaging counseling with PrEP retention and adherence among AGYW in the DREAMS program in Siaya County. 4. To determine the feasibility of using phone based texting messages to improve retention and adherence to PrEP among AGYW in the DREAMS progam
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 02/05/2022
Actual trial start date 06/06/2022
Anticipated date of last follow up 29/11/2022
Actual Last follow-up date 15/12/2022
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NON KEMRI 720 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 Approximately 200 AGYW who are enrolled in the DREAMS project in Siaya County, having phones and are currently using PrEP or have used PrEP within the last 12 months shall be enrolled into the study. Those with smart phones, therefore able to join WhatsApp, will be randomized to either intervention (WhatsApp) group composed of 50 AGYW or control group composed of 50 AGYW. Those with basic phones, therefore able to receive SMS, will also be randomized to either intervention (SMS) group composed of 50 AGYW or control group composed of 50 AGYW. 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. No one will be in more than one group. In case a participant loses their access or gains access to either of the two platforms, they will not be moved to the other group. 100 Uncontrolled
Experimental Group Not applicable Not applicable 6 months The intervention arm will be composed of the WhatsApp and SMS groups. AGYW in both the WhatsApp group and (SMS) group will receive weekly WhatsApp or SMS messages from the study investigators seeking challenges they are experiencing with PrEP adherence and going for refill. We will create a list of these challenges, send them to the WhatsApp group for those with WhatsApp and to individual phones for those with access to SMS. The study team will then initiate an investigator led discussion of the challenges and generate solutions on WhatsApp group for those with WhatsApp and a group call for those with access to SMS. In addition to this, a tool recommended by World Health Organisation (World Health Organisation implementation tool for Pre-exposure prophylaxis (PrEP) of HIV infection.) shall be used to guide topical discussions in the two groups; the link to the tool is https://www.who.int/hiv/pub/prep/prep-implementation-tool/en/. These are the discussion topics that will be handled: basic information on PrEP, importance of retention and adherence, challenges of retention and adherence and how they can be addressed, sharing of success stories by participants, other topics suggested by participants, and weekly reminders to honor appointments. 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Aged 18-24 years enrolled in DREAMS in Siaya county for at least 1 month • Who have ever been on PrEP or currently on PrEP • Able and willing to give informed consent for study participation • Owns a personal mobile phone • Willing to be contacted via WhatsApp or SMS • Willing to join a counselling WhatsApp group or group call • Willing to undergo study follow up for 6 - 9 months. • AGYW who are not enrolled in Siaya county DREAMS project • AGYW who have never used PrEP • AGYW below 18 years and above 24 years • AGYW who do not have personal mobile phones • AGYW who will not be able to undergo the study follow up for 6 - 9 months. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 24 Year(s) Female
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 21/09/2021 National Commission for Science Technology and Innovation
Ethics Committee Address
Street address City Postal code Country
Waiyaki Way, Nairobi Nairobi 00100 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 08/06/2022 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
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Enhanced PrEP retention and adherence to among AGYW in DREAMS Program . Evaluated by measuring the Proportion of AGYW who remain on and adhere to PrEP, assessed by a two-way comparison of data at participating health facilities: i) testing rate 3-6 months before the intervention and 3-6 months during the intervention, and ii) comparing PrEP retention and adherence between participants in the intervention and control arms. At 6 months pre- intervention, monthly for 6 months during the intervention and at endline in month 6
Secondary Outcome 1. Reception of the intervention by the targeted population. Assessed by measuring the number of particpants reached and screened in the targeted population against those who are enrolled in the study. 2. Identification of the barriers and facilitators of implementing the intervention. Assessed by evaluating feedback collected from study participants reached with the intervention. Acceptability of the intervention at baseline month 1 and Feasibility of the intervention at endline month 6.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
DREAM safe space in Siaya County Not applicable Siaya County N/A 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 Ruth Rapando ruturapando@gmail.com +254719189353 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
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 DREAMS safe spaces and as well as the Ministry of Health officials in Siaya County. Study will address critical aspects of adherence and retention of AGYW in PrEP and the results can be used to spark off discussions with stakeholders about additional ways to support AGYW to remain adherent thereby informing future scale up of the study. 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