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.: PACTR202203673222680 Date of Approval: 14/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Amandla Mama
Official scientific title Optimizing behavioral intention and knowledge of women and their partners in the perinatal period: a randomized control trial in the Tshwane District, Gauteng Province, South Africa
Brief summary describing the background and objectives of the trial In 2018, Stanford University and global health researchers at Heidelberg University began experimenting the use of simple, animated, story-based health communication tools for the promotion of basic health literacy in the general public. This study will advance the work of the researchers in the development and deployment of mHealth communication support tools. The study aims to address an existing knowledge gap in women attending public sector services. To achieve this aim the barriers to practicing priority perinatal health behaviours will be explored by engaging with stakeholders in maternal-child health decision-making (mothers, partners, health professionals, and community health care workers) and by sharing key messages that are relevant to key perinatal topics with the identified stakeholders.
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 07/03/2022
Actual trial start date
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 280
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Amandla Mama videos Each participant will receive 10 Amandla Mama videos once at recruitment. Participants will receive Amandla Mama videos at recruitment, and will be requested to watch them at their own time and space. Each participant will be followed up 3 months after the date of receiving the videos. Participants allocated to the intervention arm will receive narrative, video-based m-Health series of 10 “micro-messages” (short messages designed to impact behavior change) called Amandla Mama Videos. The 10 videos will be iteratively developed through - scripting, storyboard development, and refining the developed storyboards by incorporating formative qualitative feedback from participant during the first phase of the study. 140
Control Group Treatment as usual Participants will receive information leaflet once at recruitment Participant will be followed up 3 months after the date of recruitment. Participants in the control arm will not receive Amandla Mama videos however they will be given maternal and neonatal health educational information leaflets. 140 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women and their partners who are 18 years and older. Women presenting for their ANC visit at one of the two facilities selected for the study. Participants who provided informed consent to participate in the study. No specific exclusion criteria beyond the inclusion criteria Adult: 19 Year-44 Year 19 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
Yes 24/01/2022 Pharma ethics
Ethics Committee Address
Street address City Postal code Country
123 Amkor Road, Lyttelton Manor Ext 3 Centurion 0157 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in participants knowledge. Outcome will be measured 3 months after administration of intervention.
Secondary Outcome Change in behavioral intentions Outcome will be measured 3 months after participants receives the videos.
Secondary Outcome User satisfaction Outcome will be measured 3 months after participants receives the videos.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FF Ribbeiro clinic Corner Sisulu and Madiba Street Pretoria 0002 South Africa
Kgabo community health centre 1526 Kgabo Street, Mabopane Pretoria 0190 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Grant Challenges Africa P.O. Box 24916-00502 Nairobi Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Not applicable Not applicable Not applicable South Africa Not applicable
COLLABORATORS
Name Street address City Postal code Country
Stanford University 450 Jane Stanford Way Stanford United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yogan Pillay ypillay@clintonhealthaccess.org +27123426911 1166 Frances Baard
City Postal code Country Position/Affiliation
Pretoria 0087 South Africa Country Director
Role Name Email Phone Street address
Public Enquiries Zwannda Kwinda zkwinda@clintonhealthaccess.org 0762131636 1166 Frances Baard, Hatfield
City Postal code Country Position/Affiliation
Pretoria 0083 South Africa Clinton Health Access Initiative
Role Name Email Phone Street address
Scientific Enquiries Elizabeth Leonard eleonard@clintonhealthaccess.org +27123426911 1166 Frances Baard, Hatfield
City Postal code Country Position/Affiliation
Pretoria 0083 South Africa Clinton Health Access Initiative
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data collected during the study will be stored on an encrypted and secure server which will be password protected and only the research team and study sponsors will have access to. The data analysts will only have access to the participants’ anonymized ID and no other personal or confidential information. The summary of results will be published and presented in a respectful manner and no information which could enable anyone to identify the participants will be reported. The anonymized data, study protocol and data collection tools will be made available to researchers who will request to access them. Clinical Study Report,Informed Consent Form,Study Protocol The data will be deleted two years after the study has been completed. Researchers may request access to the data through the gate-keeper for use in an ethical approved secondary analysis research study.
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