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.: PACTR201912734889796 Date of Approval: 04/12/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Teen MomConnect Pilot Study
Official scientific title A Pilot Study of Improving Outcomes in Teenage Pregnancy Using a Combined Tailored M- Health Program and Motivational Interviewing Intervention
Brief summary describing the background and objectives of the trial Mortality amongst pregnant teenagers in South Africa (SA) is very high: institutional Maternal Mortality Ratio (iMMR) of 67.1 deaths per 100,000 live births in teenagers; with 71.7% of deaths resulting from four causes: hypertension (22.8%); non pregnancy-related infections (21.1%) (HIV/AIDS-related, such as TB or pneumonia); obstetric haemorrhage (14.2%); and medical and surgical disorders (13.6%). Risk factors for these four leading causes of death include poor antenatal clinic (ANC) attendance, lack of adherence to antiretroviral therapy, poor compliance with treatment for tuberculosis, inadequate management of preeclampsia, and slow referral of high risk pregnancies to secondary and tertiary centres. Changing the health-related behaviour of pregnant teenagers, using an m-health intervention could reduce the prevalence of these risk factors, thereby reducing mortality. This pilot study to be conducted in the Western Cape province of SA will test the feasibility, user acceptability and preliminary efficacy of an enhanced version of MomConnect, called Teen MomConnect – an m-Health programme. The proposed enhancements to MomConnect include adding tailored content to the SMS messaging platform. The Objectives are to: - Design and integrate the Teen-MomConnect messages into the MomConnect platform. - Pilot the enhanced MomConnect programme amongst 200 pregnant SA teenagers - Evaluate if the Teen Momconnect intervention has an impact on pregnant teenagers’ ANC attendance and their risk behaviours during pregnancy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 31/05/2018
Actual trial start date
Anticipated date of last follow up 30/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
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 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 Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group MomConnect standard care Participants receive messages every week From recruitment into the study (at <25 weeks pregnant) up to the end of their pregnancy, that is 3-8 months. MomConnect uses cell phones to register pregnancies on a central database and to send health education SMSs to pregnant women designed to encourage ANC attendance and better care seeking. 100 Placebo
Experimental Group Teen MomConnect Participants receive messages every week From recruitment into study (up to 24 weeks pregnant) up to the end of pregnancy, that is 3-8 months. MomConnect uses cell phones to register pregnancies on a central database and to send health education SMSs to pregnant women designed to encourage ANC attendance and better care seeking. Teen Momconnect is an adapted version of MomConnect, where the messages are designed to be tailored to young women and girls. The Teen Momconnect platform allows 2-way messaging. SMS content includes motivational and behavioural messages relating to appointment keeping and risk behaviours such as smoking and alcohol use. 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant females aged 13 – 20 years old <=24 weeks pregnant Did not have access to a cellphone Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 13 Year(s) 20 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 18/01/2018 Human Sciences Research Council Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
134 Pretorius Street Pretoria 0001 South Africa
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 18/03/2019 Human Sciences Research Council Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
134 Pretorius Street Pretoria 0001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of antenatal appointments attended at end of pregnancy
Secondary Outcome Number of HIV tests, Smoking status, alcohol use At end of pregnancy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mitchells Plain Community Health Centre 1st Avenue, Eastridge, Mitchells Plain, Cape Town, South Africa Cape Town South Africa
Guguletu Community Health Clinic and MOU NY3, Gugulethu Cape Town South Africa
Elsies River Community Health Clinic and Midwife Obstetrics Unit 29th Avenue, Elsiesriver Cape Town South Africa
Bishop Lavis Community Health Centre and MOU C/o Kasteelberg Road and Lavis Drive, Bishop Lavis Cape Town South Africa
Khayelitsha Site B Midwife Obstetrics Unit Lwandle Road, Site B Khayelitsha Cape Town South Africa
Kraaifontein Community Health Clinic and MOU 303 6th Avenue, Kraaifontein Cape Town South Africa
Macassar Community Health Clinic and MOU C/o Hospital and Musica Streets, Macassar Cape Town South Africa
Chestnut Community Health Clinic 103 Chestnut Way, Belhar Cape Town South Africa
Delft Community Health Clinic Corner of Main and Leiden Road, Delft Cape Town South Africa
Bellville South Community Daycare Centre Kasselsvlei Road, Bellville South Cape Town South Africa
Sarepta Clinic Rietvlei Road, Sarepta, Kuilsriver Cape Town South Africa
Durbanville Clinic De Villiers Street, Durbanville Cape Town South Africa
Wallacedene Clinic Youth Centre, Eoan Street, Scottsdene Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
UKRI MRC North Star Avenue Swindon 7505 United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Human Sciences Research Council 118 Buitengraght Street Cape Town 8000 South Africa Research Organisation
COLLABORATORS
Name Street address City Postal code Country
Ken Resnicow 1415 Washington Heights Ann Arbor Michigan 48109202 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sasiragha Priscilla Reddy preddy@hsrc.ac.za +27214667870 118 Buitengraght Street
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa Deputy Executive Director Social Aspects of Public Health
Role Name Email Phone Street address
Scientific Enquiries Natisha Dukhi ndukhi@hsrc.ac.za +27214667870 118 Buitengraght Street
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa Research Specialist
Role Name Email Phone Street address
Public Enquiries Benelton Jumath bjumath@hsrc.ac.za +27214667871 118 Buitengraght Street, Cape Town
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa Programme Officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Deidentified individual participant data, including data dictionaries, that underlie the results in the main publication/s will be shared. Informed Consent Form,Study Protocol Beginning 18 months and ending 5 years following article publication. Data will be made available via controlled access to researchers or investigators for the purposes of individual participant meta-analyses. Investigators will be required to submit a brief proposal detailing their analysis plans. An independent committee will review the requests and approve access to methodologically sound proposals.
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