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.: PACTR202301844164954 Date of Approval: 27/01/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of a customized digital adherence tool on retention in care among breastfeeding women living with HIV and adherence to antiretroviral treatment among children and adolescents living with HIV in Northern zone Tanzania.
Official scientific title Effect of a customized digital adherence tool on retention in care among breastfeeding women living with HIV and adherence to antiretroviral treatment among children and adolescents living with HIV in Northern zone Tanzania.
Brief summary describing the background and objectives of the trial Background Children and adolescents continue to be vulnerable group among population living with HIV. There has been increased number of children and adolescents infected and dead due to HIV/AIDS. The United National AIDS programme (UNAIDS) through its “start free, stay free and AIDS free” initiative aims to achieve a generation of children and adolescents free from AIDS. Poor adherence to antiretroviral treatment (ART) is a challenge hampering to achieve this target. Interventions are therefore warranted to address challenges on adherence among children and adolescents. The use of digital health tools on adherence has proven success in different settings. Aim & Objectives The objective of REMIND-KID trial is to test the effectiveness of the customized DAT on retention in care and adherence to antiretroviral treatment through three randomized controlled clinical trials. Methodology This study is the second phase of REMIND KID project. The design of the study will be three parallel randomized controlled clinical trials, each with two arms: the intervention and control arm. Participants in the intervention arm will use the customized DAT developed in the first phase whereas the control group will use the standard care. We will test the effect of a customized digital health intervention on retention into care among breastfeeding women and adherence to treatment among, children and adolescents living with HIV in Kilimanjaro region.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) REMIND KID
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: Devices
Anticipated trial start date 15/02/2023
Actual trial start date
Anticipated date of last follow up 16/09/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 540
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL www.remindstudies.net
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 Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Digital Adherence Device To be used daily Children and adolescents will use it for 12 months, Breastfeeding women will use it for 18 months The intervention contains a digital adherence tool that comprises the Wisepill box, an internet enabled medication dispenser, with customized SMS messages consisting of reminder cues, education, and motivation. The basis for the intervention is our developed DAT consisting of either Wisepill with customized SMS. The Wisepill device (RT2000 dispenser) is a pocket-sized dispenser designed by the Wisepill Company. It contains a global SIM card which communicates through cellular networks to automatically synchronize with the Wisepill Cloud service each time the device is opened. The signal provides real-time medication information about the time that the device is opened, identification number of the device, and technical information about the battery and strength of the signal. User’s intake time is required to be registered on the Wisepill Web Server by the study team. If a participant forgets to take medication at the prescribed time, a reminder SMS is sent to their mobile phones. The health care workers can monitor medication adherence with access provided to online adherence reports and graphs. Customized SMS will be randomly selected from SMS scheme and sent on a daily basis to remind taking medication half an hour before usual time of intake. In addition, if the box was not opened on time, a second customized reminder SMS will be sent one hour after usual time of intake. In addition, we will send tailored clinic reminders one day before clinic visit and other weekly- customized educational information (depending on the needs as established in our formative study) through SMS. 270
Control Group Standard Care Will still use their medication daily without reminder SMS or use of wisepill box 12 months for children and adolescents, 18 months for breastfeeding women Participants at control group will continue with normal standard of care. That is they will continue taking their medications daily without reminder SMS and wisepill box 270 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Mother/child/adolescent being HIV-positive 2. The infant of the mother being HIV exposed and aged less than 2 weeks 3. Attending Care and Treatment Centres (CTC) or postnatal clinics in Kilimanjaro and Arusha 4. Age of mother between 15-49 years, age of children living with HIV 0-14 years and adolescents living with HIV 15-19 years 5. Mother, caregiver/parents, and adolescents willing to use RTMM and/or receive SMS (participant will be provided with a phone if needed) 6. Mother, caregiver/parent, and adolescents able to read and understand SMS 7. Mother, caregiver/parent, and adolescents aged 18-19 able to understand and willing to sign informed consent 8. Adolescents aged 15-17 able and willing to sign informed assent. 1. Admission to hospital at study-entry 2. Participation in other trials related to adherence and retention into care 3. Previous participation in digital health research 4. Participation in the formative stage Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 2 Week(s) 49 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 01/11/2022 National Health Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive, 11101 Dar es Salaam Dar es Salaam 9653 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Proportion of breastfeeding women retained in care at 18 months. 2. Proportion of children and adolescents with adherence of 95% over 12 months of follow up. After 12 months of follow up for children and adolescents and after 18 months for breastfeeding women
Secondary Outcome 1. Breastfeeding women a) Percentage of infants found to be HIV positive in 24 months post-partum between those whose mothers use DAT and those in standard care b) Percentage of participants found to be virologically suppressed at month 12 and 24 between those who use DAT and those in standard care 2. Children and adolescents a) Percentage of participants found to be virologically suppressed at month 12 between those who use DAT and those in standard care 3. All groups a) Quality of life between those use DAT and those in standard care b) To investigate whether standardized questionnaires for stigmatization, depression, social support and quality of life are context-specific c) Feasibility and acceptability of the digital adherence tool d) Cost effectiveness of the digital adherence tool compare to the standard of care After 12 months of follow up for children and adolescents and after 18 months for breastfeeding women
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kilimanjaro Clinical Research Institute will use health facilities that provide CTC servises in Kilimanjaro and Arusha region 2236 Moshi United Republic of Tanzania
Mawenzi Regional Hospital Kilima street Moshi 0000 United Republic of Tanzania
Pasua health centre Bomambuzi, Moshi District Moshi United Republic of Tanzania
Majengo health centre Majengo Moshi United Republic of Tanzania
Kibosho Distric hospital Moshi rural district Moshi 866 United Republic of Tanzania
Kilema Hospital Vunjo Moshi rural Moshi 1080 United Republic of Tanzania
Hai distric hoapital Bomagombe Moshi 1750 United Republic of Tanzania
Himo OPD health centre Himo Moshi United Republic of Tanzania
Mount Meru Regional hospital Naura Arusha 3092 United Republic of Tanzania
Kaloleni health centre Kaloleni mashariki Arusha Arusha United Republic of Tanzania
Levolosi Kisumayo street Arusha Arusha United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP 2509 AA The Hague Hague 93015 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor KILIMANJARO CLINICAL RESEARCH INSTITUTE KCRI 2236 Moshi United Republic of Tanzania Hospital
COLLABORATORS
Name Street address City Postal code Country
Univerisity of Amsterdam Meibergdreef 115 Amsterdam Netherlands
Radboud University Geert Grooteplein 21 Nijmegen Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marion Sumari de Boer m.sumari@kcri.ac +255754331948 2236
City Postal code Country Position/Affiliation
Moshi United Republic of Tanzania Seniour Researcher at KCRI
Role Name Email Phone Street address
Public Enquiries Kennedy Ngowi k.ngowi@kcri.ac.tz +255758048649 2236
City Postal code Country Position/Affiliation
Moshi United Republic of Tanzania Researcher at KCRI
Role Name Email Phone Street address
Scientific Enquiries Iraseni Ufoo Swai i.swai@kcri.ac.tz +255767149306 2236
City Postal code Country Position/Affiliation
Moshi United Republic of Tanzania Trial Coordinator
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, will be available after de-identification Study Protocol Beginning 12 months following the last article publication Investigators whose proposed use of the data has been approved by an independent review committee
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