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.: PACTR201712002844286 Date of Approval: 07/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title REMIND
Official scientific title Effect of reminder cues and tailored feedback on adherence to antiretroviral drug treatment among people living with HIV in the Kilimanjaro region, Tanzania
Brief summary describing the background and objectives of the trial People living with HIV (PLHIV) have to take lifelong treatment, which is often challenging. With this study, we aim to introduce an innovative, accessible and affordable means of improving adherence to antiretroviral treatment that exploits the large use of mobile phones in Tanzania and Sub-Saharan Africa and involves patients in their own care. The objective is to investigate the effect of short message service (SMS) and real time medication monitoring (RTMM), which both generate reminder cues and adherence performance reports for tailored feedback, on adherence to treatment among PLHIV in Kilimanjaro region, Tanzania.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) REMIND
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 01/01/2017
Actual trial start date 11/12/2017
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date 28/02/2020
Anticipated target sample size (number of participants) 264
Actual target sample size (number of participants) 265
Recruitment status Completed
Publication URL https://journals.lww.com/jaids/Fulltext/2021/08150/Effect_of_Digital_Adherence_Tools_on_Adherence_to.4.aspx
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 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Real Time Medication Monitoring (RTMM) Daily use One year Participants will use the RTMM pillbox (Wisepill) to store and take medication. If medication is not taken on time, the participant will receive a reminder SMS asking to take medication. In addition, printed reports from the medication intakes will be used to give tailored feedback to the participant during consultation with a health care worker 88
Experimental Group Short Message Service (SMS) Three random days a week 1 year Participants will receive a reminder SMS to take medication on three random days a week half an hour before usual intake of medication. One hour after usual intake of medication they will receive another SMS asking whether they took medication. To this last SMS, the participant will have to reply with 'yes' or 'no' or 'not yet'. In case of 'not yet', one hour later, the question will be repeated 88
Control Group Standard care Two-monthly consultation 1 year Participants will be exposed to standard care only 88
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿HIV positive ¿Attending a CTC at Kilimanjaro Christian Medical Centre (KCMC), Mawenzi Hospital, Pasua Health Centre or Majengo Health Centre ¿Treatment-experienced (i.e. on cART for at least six months) ¿Adherence below 100% as judged by nurses: patients who self-reported to be suboptimal adherent, who missed at least one medication refill visit or who had leftover medication ¿Age between 18 and 65 ¿Living in Kilimanjaro Region ¿Willing to use the RTMM-device ¿Willing to come to the clinic monthly ¿Able to read and understand SMS ¿Able to understand and willing to sign the informed consent document ¿Admitted to hospital ¿Participating in other trials ¿Previously participated in studies with Electronic Monitoring Devices 18 Year(s) 65 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 11/09/2017 National Institute of Medical Research
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam 11101 Tanzania
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 17/10/2017 Kilimanjaro Christian Medical College and Duke
Ethics Committee Address
Street address City Postal code Country
Sokoine Road Moshi 0000 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence to treatment Baseline (enrollment) Month 2 Month 4 Month 6 Month 8 Month 10 Month 12
Secondary Outcome Viroal load Baseline Month 12
Secondary Outcome Factors influencing adherence Baseline (enrollment) Month 12
Secondary Outcome Costs of interventions Month 12
Secondary Outcome Acceptability and feasibility of the interventions Month 13
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kilimanjaro Christian Medical Center Sokoine Road Moshi Tanzania
Majengo Health Centre Lucy Lameck Road Moshi Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP The Hague Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kilimanjaro Clinical Research Institute Sokoine Road Moshi Tanzania Hospital
COLLABORATORS
Name Street address City Postal code Country
Radboud University - Rob Aarnoutse Geert Grooteplein Zuid 10 Nijmegen 6525 GA Netherlands
University of Amsterdam - Pythia Nieuwkerk Meibergdreef 9 Amsterdam 1105 AZ Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marion Sumari-de Boer m.sumari@kcri.ac.tz +255754331948 PO Box 2236
City Postal code Country Position/Affiliation
Moshi Tanzania Post Doc Researcher
Role Name Email Phone Street address
Public Enquiries Tupokigwe Jana t.jana@kcri.ac.tz +255272754201 PO Box 2236
City Postal code Country Position/Affiliation
Moshi Tanzania Research administrator
Role Name Email Phone Street address
Scientific Enquiries Kennedy Ngowi k.ngowi@kcri.ac.tz +255758048649 PO Box 2236
City Postal code Country Position/Affiliation
Moshi Tanzania PhD candidate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Trial was registered earlier Study Protocol NA NA
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