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.: PACTR202107638293593 Date of Approval: 20/07/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title mHealth intervention in improving adherence to and retention in HIV care
Official scientific title Mobile phone text messaging to improve adherence to and retention in HIV care among adolescents living with HIV in Ethiopia: a randomized controlled trial
Brief summary describing the background and objectives of the trial Introduction Over a quarter of the world’s population consists of young people, including adolescents aged 10 to 19 years. Important health problems and risk factors for adult disease emerge during these years (1). However, the health problems of this age group are often neglected because of the perception that this age group, in general, represents a healthy population with few problems. However, according to the UNAIDS and WHO’s report, globally, there were approximately 37.9 million people across the globe with HIV/AIDS in 2018. Of these, 36.2 million were adults and 1.7 million were children (<15 years old), 1.6 million were adolescent between the ages of 10-19, and 58% of these were girls. The WHO African region remains most severely affected, with nearly 1 in every 25 adults (3.9%) living with HIV and accounting for more than two-thirds of the people living with HIV worldwide. About 1.5 million (85 percent) of the HIV-infected adolescents were living in sub-Saharan Africa (2, 3, 4). Sub-Saharan Africa remains the most affected region accounting for 90% of the world’s HIV related deaths among adolescents. Here one of every six deaths among adolescents is due to HIV, making up approximately 16% of all adolescent deaths in the region (5). Many adolescents acquire HIV sexually but with the improved availability of antiretroviral therapy (ART), an increasing number of vertically infected children are also growing to adolescence and adulthood. These large numbers of HIV infected adolescents have poorer outcomes in many aspects than HIV-infected adults and younger children; for example, they have poorer retention in care, poorer rates of viral suppression, and a delay in ART initiation. Recent data show an increase in AIDS-related deaths among this population, making AIDS the leading cause of death among adolescents in SSA and the second leading cause of death among adolescents globally (6,7). In addition to this, patient suffering from HIV become more susceptible
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 Sending reminder text message on patients mobile phone
Anticipated trial start date 03/01/2022
Actual trial start date
Anticipated date of last follow up 03/01/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 333
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
B83E614F0B7D402DB2E4 Swedish Ethical Review Authority
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sending reminder text message on patients mobile phone twice per a day 24 months A simple mobile phone will be given to each of the participant. In the SMS arm, participants received SMS texts on daily bases. SMS text message to remind patients to take their medication will be send thirty minutes before the usual time of ART intake. Another SMS text message will be send with the question “Did you take your medication? One hour after the usual time of intake. The participant will be asked to reply 1 for Yes, I took it, 2 for No, I did not take it, or 3 for not yet. These responses will help to display automatically on graphs for tailored feedback during consultation with a study nurse. 166
Control Group Routine care 24 months According to the Guidelines for Pediatric HIV/AIDS Care and Treatment in Ethiopia, routine care involves monthly follow-ups to collect medication and assess adherence and a clinical examination and toxicity assessment every three months. 166 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be eligible in the study, adolescents, aged 10-19, living with HIV and currently enrolled in ART care. They also stay in selected facility for 24 months following study enrollment. Each participant or care giver must provide written informed consent confirming his or her participation in the study. The informed consent includes signed permission to retrieve their medical records over the duration of the study. Patient outside of the specified age and adolescents, who are in-patient department and adolescents who cannot read Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year 10 Year(s) 19 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 02/09/2019 Swedish Ethical Review Authority
Ethics Committee Address
Street address City Postal code Country
750 02 Uppsala Uppsala Box 2110 Sweden
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome adherence to ART, and retention in care At base line, before every new sequence, and final assessment
Secondary Outcome Disease progression, message fatigue, Anxiety, Depression, self-esteem, social capital, mental health, preference for intervention, and other opportunistic infections At baseline, before every new sequence, and final assessment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Arba Minch University Arba Minch, South Ethiopia Arba Minch 21 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Swedish Research Council for FORTE Lund Lund Sweden
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Swedish Research Council Stockholm Stockholm Box 38084 Sweden Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Arba Minch University Arba Minch, South Ethiopia Arba Minch 21 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abayneh Tunje Tanga abayneh_tunje.tanga@med.lu.se +251920011972 Arba Minch,South Ethiopia
City Postal code Country Position/Affiliation
Arba Minch 21 Ethiopia PhD student
Role Name Email Phone Street address
Scientific Enquiries Degu Jerene Dare degu.jerene.7501@med.lu.se +25111546407 Hague, Netherlands
City Postal code Country Position/Affiliation
Hague 146 Netherlands Senior Epidemiologist at KNCV Tuberculosis Foundation
Role Name Email Phone Street address
Public Enquiries Inger Hallstrom inger.kristensson_hallstrom@med.lu.se 46730391920 Lund
City Postal code Country Position/Affiliation
Lund Sweden Head of department at Department Office of Health Sciences
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share summary results within the trial registration record and after completion of implementation Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol we will share within 12 months of the study completion date Adolescent, mobile phones; mHealth; ART adherence, retention in HIV care, stepped-wedge-RCT, Ethiopia
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