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.: PACTR201105000299318 Date of Approval: 16/05/2011
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Using mobile-phone based text messages to improve retention of patients initiating antiretroviral therapy in South Africa
Official scientific title Using mobile-phone based text messages to improve retention of patients initiating antiretroviral therapy in South Africa
Brief summary describing the background and objectives of the trial Long-term retention of patients in antiretroviral therapy (ART) programmes is essential for achieving optimal adherence and successful treatment of HIV infection. The risk of treatment interruptions and missed scheduled clinic appointments were observed to be the highest in the first six months following initiation of ART. South African mobile connections have recently reached 50 million, of which 72-76% are individual subscriptions. Studies on the impact of mobile technology for healthcare report strong evidence to support text messages as a tool for behaviour change in disease prevention and management. In this trial we aim to assess whether mobile phone based text messages can be used to improve retention of patients initiating ART.
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 Treatment: Devices
Anticipated trial start date 01/06/2011
Actual trial start date
Anticipated date of last follow up 14/09/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 1200
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
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 randomisation Allocation will be determined by software package - system allocated patients to intervention arm Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SMSs Daily 12 months Participants randomized to the intervention arm will receive the routine standard of care, in addition to the daily delivery of text messages on their mobile-phones. Text messages will include ARV medication pickup reminders (in advance of scheduled appointments and following missed scheduled appointments) and positive living messages. 600
Control Group Standard Care None None Participants randomized to the control arm will receive the routine standard of care provided at the clinic. 600 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients who are 18 years of age or older. Patients who are initiating ART. Patients who own or have access to a mobile phone with functional text message features. Patients who can receive text messages. Patients who can read text messages. Patients who agree to continue their ART at the site at which they were initiated for 12 months. In other words, the patient will not be down referred to a local community clinic during the study. Patients who reside in an area where there is no mobile network reception. Patients who plan to relocate away from the area or transfer to another antiretroviral treatment facility during the next 12 months. Patients who are enrolled in other concurrent research studies designed to investigate the effect of mobile-phone based text message reminders to improve retention in treatment. Patients who belong to a household within which another individual has already enrolled for the study. 18 Year(s) 100 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
No 04/03/2011 3. WITS Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of the Witwatersrand Suite 189 Private Bag x2600 Houghton 2041 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Retention Retention rates will be compared between the intervention and control arms at 12 months. Retention is defined in this study as the number of patients receiving ART beyond the 12 month follow-up period.
Primary Outcome Treatment Interruptions The number of treatment interruptions will be compared between the intervention and control arms over the 12 month duration of the intervention. Treatment interruption is defined in this study as the sustained discontinuation of ART for more than 14 days.
Secondary Outcome Clinical outcome: HIV-1 RNA viral load and CD4 T-lymphocyte count To demonstrate improved clinical outcomes of patients at 6 months and 12 months following initiation of antiretroviral therapy.
Secondary Outcome patient medication self-efficacy compared at baseline and at 12 months of follow up
Secondary Outcome commitment to treatment compared at baseline and at 12 months of follow up
Secondary Outcome perceived social support compared at baseline and at 12 months of follow up
Secondary Outcome disclosure of HIV status compared at baseline and at 12 months of follow up
Secondary Outcome interpersonal relationships compared at baseline and at 12 months of follow up
Secondary Outcome experienced stigma and depression compared at baseline and at 12 months of follow up
Secondary Outcome optimistic self-beliefs about health benefits of ART compared at baseline and at 12 months of follow up
Secondary Outcome awareness of possible adverse effects and toxicity compared at baseline and at 12 months of follow up
Secondary Outcome knowledge of difficulties experienced during ART initiation compared at baseline and at 12 months of follow up
Secondary Outcome lifestyle changes for improved health outcomes compared at baseline and at 12 months of follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KwaMashu Community Health Centre G1400 Bhejane Road KwaMashu, Durban 4360 South Africa
Charles James Hospital 6 Sompukane Road Amanzimtoti, Durban 4125 South Africa
Cato Manor Community Health Centre 25 Kalenden Road Mayville, Durban 4000 South Africa
R.K. Khan Hospital R.K. Khan Circle Chatsworth, Durban 4030 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Canadian International Development Agency (CIDA) 200 Promenade du Portage Gatineau, Quebec K1A 0G4 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Canadian International Development Agency (CIDA) 200 Promenade du Portage Gatineau, Quebec K1A 0G4 Canada Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Catherine Searle, MA University of the Witwatersrand 155 Juniper Road Durban 4091 South Africa
Catherine Searle, MA University of the Witwatersrand 155 Juniper Road Durban 4091 South Africa
Leya Hassanally, MSc Cell-Life 1st Floor CPUT BARC Building Cnr Brandweer/Waterloo St Cape Town 8001 South Africa
Sarah Brown, MSc Cell-Life 1st Floor CPUT BARC Building Cnr Brandweer/Waterloo St Cape Town 8001 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Catherine Searle csearle@match.org.za 27 31 275 1540 University of the Witwatersrand 155 Juniper Road
City Postal code Country Position/Affiliation
Durban 4091 South Africa Operations and Development Director and Co-principal Investigator
Role Name Email Phone Street address
Principal Investigator Leya Hassanally Leya@cell-life.org 27 (0)21 469-1111 1st Floor CPUT BARC Building Cnr Brandweer/Waterloo St
City Postal code Country Position/Affiliation
Cape Town 8001 South Africa Lead Researcher and Co-Principal Investigator
Role Name Email Phone Street address
Principal Investigator Sarah Brown Sarah@cell-life.org 27 (0)21 469-1111 1st Floor CPUT BARC Building Cnr Brandweer/Waterloo St
City Postal code Country Position/Affiliation
Cape Town 8001 South Africa Project Manager and Co-Principal Investigator
Role Name Email Phone Street address
Public Enquiries Sarah Brown Sarah@cell-life.org 27 (0)21 469-1111 1st Floor CPUT BARC Building Cnr Brandweer/Waterloo St
City Postal code Country Position/Affiliation
Cape Town 8001 South Africa Project Manager and Co-Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Leya Hassanally Leya@cell-life.org 27 (0)21 469-1111 1st Floor CPUT BARC Building Cnr Brandweer/Waterloo St
City Postal code Country Position/Affiliation
Cape Town 8001 South Africa Lead Researcher and Co-Principal Investigator
REPORTING
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