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.: PACTR201611001858240 Date of Approval: 10/11/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Kadoma Cellphone Study
Official scientific title Does a Weekly Short Message Service Reminder Improve Adherence to Antiretroviral Therapy? A Randomized Control Trial Among HIV Clients Seeking Care at Rimuka Integrated HIV and TB Clinic Kadoma (Zimbabwe).
Brief summary describing the background and objectives of the trial A study on anti retroviral therapy adherence among HIV infected in Kadoma City by Muringazuva et. al. (2015) reported an adherence rate of 87%. This was based on self-reports. Based on pill counts at the health center, among a subset of respondents, the adherence rate was 65%. This is a cause of concern since ART adherence should be above 95% to have virological or public health impacts . It is against this background that we set out to find novel methods to improve adherence among HIV positive clients on ART so that the benefits of ART treatment are maximized. The specific objectives are: - i. To compare the effectiveness of cell phone-supported SMS messaging plus HIV standard care and HIV standard care alone on adherence among clients seeking HIV care at Rimuka Integrated TB/ HIV care Clinic (Kadoma). ii. To identify factors associated with adherence to medication among clients seeking HIV care at Rimuka Integrated TB/ HIV care Clinic (Kadoma). iii. To investigate the impact of SMS on immunological outcomes among clients seeking HIV care at Rimuka Integrated TB/ HIV care Clinic (Kadoma). iv. To assesse the acceptability of SMS reminders among among clients seeking HIV care at Rimuka Integrated TB/ HIV care Clinic (Kadoma).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) KAMPS
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: Other
Anticipated trial start date 03/10/2016
Actual trial start date 10/10/2016
Anticipated date of last follow up 10/11/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 316
Actual target sample size (number of participants) 500
Recruitment status Closed to recruitment,follow-up continuing
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 Simple Random numberd using randomisation table created by a computer software Used sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cellphone Group Weekly cephone reminder to take ART medicine 52 weeks The intervention will be a weekly SMs send to participants reminding them to take their medicines and usual ART services 250
Control Group Non Intervention Usual HIV care at 3 months interval. 12 months Non intervention group 250 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Any person, registered on the Rimuka ART clinic register. Has been on ART for at least 4 weeks, owns a cellphone. Willing to receive SMS reminders for adherence Does not plan to move out of Kadoma in the next 12 months, Gives written informed consent to participate in the study Aged below 18 years or above 60, Severely sick, Non-residents in Kadoma Does not consent to participate Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 02/01/2017 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Cnr Josiah Tongogara / Mazowe St. Harare 263 Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure will be adherence rates measured as self-reported adherence,Visual Anologue Scale, pill identification tests and by pill counts. Base line, 6 months and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rimuka Integrated TB and HIV Centre Rimuka Round About Kadoma 263 Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Kadoma City Health Council Fitt Square Kadoma 263 Zimbabwe
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kadoma City Health 3780 Mushumavale Kadoma Zimbabwe Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof T. Mduluza University of Zimbabwe Harare Zimbabwe
Dr. Pamela Magande University of Zimbabwe Harare 263 Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Daniel Chirundu dchirundu@me.com 263773235595 Fitt Square
City Postal code Country Position/Affiliation
Kadoma Zimbabwe Director of Health
Role Name Email Phone Street address
Public Enquiries Scholtz Gift gscholtz@gmail.com 263772942199 City Health Fitt square
City Postal code Country Position/Affiliation
Kadoma Zimbabwe Manager HIV/TB Collaborative Centre
Role Name Email Phone Street address
Scientific Enquiries Daniel Chirundu dchirundu@me.com +263773235595 Kadoma City Health Fitt Square
City Postal code Country Position/Affiliation
Kadoma Zimbabwe Director of Health Kadoma City Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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