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.: PACTR201302000427144 Date of Registration: 04/10/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title m-Assist
Official scientific title The use of a package of information, self-assessment and support as an alternative to follow-up visits after medical abortion and to strengthen family planning messages
Brief summary describing the background and objectives of the trial The current medical abortion (MA) protocol requires a follow-up visit, which presents challenges for MA rollout. Studies have shown that the second appointment can be replaced by a telephonic assessment. South Africa has relatively low access to landlines, but high mobile phone penetration. The study aimed to assess whether mobile phones can be used to provide an alternative to follow-up visits after MA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied medical abortion,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Education /Training
Anticipated trial start date 26/07/2011
Actual trial start date 03/10/2011
Anticipated date of last follow up 16/04/2012
Actual Last follow-up date 13/07/2012
Anticipated target sample size (number of participants) 460
Actual target sample size (number of participants) 469
Recruitment status Completed
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 Computer-generated random permuted blocks of varying size from 8-20 Sequentially numbered, opaque,sealed envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group package of information, self-assessment and support via mobile phone 21-25 days 3 mobile phone components: SMSs sent to participants; participants asked to do a self-assessment questionnaire on day10, to assess abortion completion; participants given access to family planning information via SMS, mobisite and MXit 234
Control Group control group 235 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women had to be: Already signed up to undergo MA at the clinic. Over 18 years old. Willing to comply with visit schedules. Be accessible by phone for at least 1.5 months following enrolment in the study. Had to own a mobile phone or have daily access to one on which they could receive MA-related messaging. Women undergoing surgical abortion 18 Year(s) 100 Year(s) Female
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 14/01/2011 WHO Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
20 Avenue Appia Geneva CH-1211 Switzerland
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 22/11/2010 UCT Faculty of Health Science Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room E52-24, Groote Schuur Hospital Old Main Building, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Effectiveness of the text based intervention in reducing the need for a follow up visit. Follow-up clinic visit interview. Telephonic interview 4-6 weeks after follow-up clinic visit.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nolungile youth clinic Site B, Sulani Drive, Khayelitsha Cape Town 7784 South Africa
Marie Stopes clinic, Cape Town CBD 91 Bree St Cape Town 8001 South Africa
Marie Stopes clinic, Wynberg 1st Floor, Royal Square building, Station Rd Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
World Health Organisation Avenue Appia 20 1211 Geneva 27 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor World Health Organisation Avenue Appia 20 1211 Geneva 27 Switzerland Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Deborah Constant Falmouth Building Medical Campus, Observatory Cape Town 7925 South Africa
Katherine de Tolly 1st Floor CPUT BARC Building Cnr Brandweer/Waterloo St Gardens Cape Town 8001 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Deborah Constant Deborah.Constant@uct.ac.za 021 4066722 Falmouth Building, Medical Campus
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Senior Researcher
Role Name Email Phone Street address
Principal Investigator Katherine de Tolly kmdetolly@gmail.com 021 469 1111
City Postal code Country Position/Affiliation
South Africa mHealth Project Manager, Senior Researcher
Role Name Email Phone Street address
Public Enquiries Deborah Constant Deborah.Constant@uct.ac.za 021 4066722
City Postal code Country Position/Affiliation
Role Name Email Phone Street address
Scientific Enquiries Deborah Constant Deborah.Constant@uct.ac.za 021 4066722
City Postal code Country Position/Affiliation
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