Systematic Investigation of Blacks With Stroke - GENOMICS (SIBS-GENOMICS)
Phase: NA
Conditions: Hypertension, Adult, Dyslipidemias, Physical Inactivity, Diabetes, Alcohol Consumption
Sponsor: University College Hospital, Ibadan

 
 
SYSTEMATIC INVESTIGATION OF BLACKS WITH STROKE- GENOMICS  
(SIBS-GENOMICS) STUDY 
 
 
 
 
 
 
 
 
 
SEPTEMBER 5TH, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
PILOT TRIAL 
Specific Aim. To determine the effectiveness of the Afrocentric stroke riskometer mobile phone 
application combined with the motivation stroke educational video and educational modules for 
improvement of individual awareness and reduction of the total quantitative risk of stroke through a 
randomized controlled trial among stroke-free adults in Nigeria and Ghana. 
Study design: A feasibility pilot study involving stroke-free adults with at least 2 vascular risk factors for 
stroke assigned to an educational intervention for 2 months comprising of a stroke video and riskometer 
App aimed at improving stroke risk factor awareness and health seeking behavioural modification to control 
vascular risk (n=50) compared with a control group (n=50) who are offered one time counselling. 
Study Sites: 3 sites across Nigeria and Ghana 
Study Participants: Study participants will be CONSECUTIVELY selected from the existing pool of 
stroke-free controls in SIREN and SIBS Genomics studies across the 3 study sites (60 from Ibadan, 20 
from Kumasi and 20 from Zaria). The vascular risk factor profile of these control participants has already 
been assessed. Stroke free status at enrollment will be reconfirmed using the locally validated version of 
the QVSFS. 
Eligibility criteria: Inclusion criteria: (i) male or female (sex is a biologic variable of interest), (ii) age ≥ 
18 years, (iii) with at least 2 stroke risk factors based on the list of 11 topmost modifiable risk factors 
identified in the SIREN study (including hypertension, diabetes mellitus, dyslipidemia, smoking, 
overweight, physical inactivity, or unbalanced/poor diet). (iv) ownership or access to smartphone in 
consenting stroke-free adults.  Exclusion criteria: prior history of vascular disease (e.g., stroke, transient 
ischemic attack, angina, myocardial infarction, peripheral vascular disease, and atrial fibrillation), or 
cognitive impairment; not comfortable reading and writing, depression or other psychiatric disorders 
(through personal declaration) likely to affect the interventions; participation in another RCT; other 
conditions  rendering the individual unsuitable to participate in this research as judged by treating 
physicians, 
Justification for Eligibility Criteria: Individuals with existing high modifiable risk are more likely to be 
motivated to engage in behavioral change activities more so than those without. 
Recruitment: Research coordinators (RCs) will obtain informed consent, schedule baseline assessment 
& alert statistician of a new participant to be randomized via REDCap. Randomization will be performed 
within 24 hours & baseline assessments within one week at the respective SIREN facility/community. 
Baseline assessment will include screening of all participants for stroke risk factors by trained RCs. Risk 
factor screening will include measurement of blood pressure, blood glucose and lipid profile, psychosocial 
assessment for stress, dietary recall to assess salt intake and vegetable consumption, waist circumference 
and body mass index. 
Intervention: The app will not be installed on the smartphones during the pilot study to limit potential future 
exposure contamination. RCs will complete baseline screening assessment with participants and capture 
a screenshot of the individual’s current global stroke risk score as a percentage, which will then be given 
to the participant via their smartphone (i.e., screenshot of the score produced by the app). Participants 
will be shown their risk scores and the specific risk factors identified through the screening. They will be 
asked to visit their doctors /primary care clinicians to facilitate management their risk factors through 
therapeutic lifestyle changes or pharmacotherapy, for example antihypertensives for hypertension, statins 
for dyslipidemia, or oral hypoglycemics for diabetes. This will be part of health seeking behaviour the app 
should promote, which will be assessed as part of process measure. Participants will receive monthly 
reminders on compliance/adherence to any clinician prescribed treatment or lifestyle modifications, as 
applicable, and to follow-up with primary provider if they haven’t already and especially if their risks include 
hypertension, diabetes, or dyslipidemia. Participants will be asked to show their current global stroke risk 
to their clinician/doctor. As part of process measure, we will assess clinician acceptability and readiness 
to use the app to monitor their patients overall progress with total risk factor control. The records will be 
stored on our server, such that if they lose the score risk, the RC will be able to provide another copy 
(paper or digital) so their clinicians will still be able to access risk scores when shown by participants. In 

addition, participants will be encouraged to watch the stroke video at least once monthly that will be shared 
via their smartphone, although they will be asked not to share it with others to minimize exposure beyond 
enrolled intervention participants. 
Control group will be screened at baseline and be informed about their risk factors. They will be 
encouraged to seek medical therapy for a doctor after assessment of their baseline risk factors, should 
they have hypertension, diabetes, or dyslipidemia, but this advice will not be reinforced by either exposed 
to the app or the stroke video. They will complete a post-study questionnaire to assess any contamination 
with the intervention. 
Randomization: will be at individual level, per site as the app is meant to be developed at individual level 
eventually.  
Concealment of allocation: Blinding of participants is not possible given the nature of the intervention. 
However, the adjudicator and the study statistician will not be aware of the allocation status of study 
participants during outcome data collection and analysis respectively. Outcome assessors will not be 
involved in delivering the intervention. To ensure blindness, trial participants will be told not to divulge 
details of their treatment to the assessors. The randomization scheme which will be used to allocate 
patients to groups will be developed & maintained by the lead study biostatistician. Randomization 
database will be independent & will not be accessible to outcome assessors or other personnel. Whereas 
the research coordinators (RCs) will be aware of the randomization assignment, they will not have any 
role in the delivery of the intervention or outcome adjudication. 
Outcome measures: 
1. Feasibility measures: Proportion approached, proportion refused, proportion ineligible (reasons 
for ineligibility), proportion enrolled, proportion completing follow-up, & proportion visiting their 
doctors will be compared between the two groups. 
2. Satisfaction and acceptability measures: (i) autonomous self-regulation was assessed using the 
15-item Treatment Self-regulation questionnaire,14 (ii) patient satisfaction using the telemedicine 
satisfaction and usefulness questionnaire, (iii) reported side effects of medications, (iv) 
hypertension and stroke knowledge using a 14 item questionnaire & (v) adherence measures to 
medications prescribed for primary prevention and lifestyle advice (physical activity, dietary 
patterns, alcohol and cigarette use); and participant preferences, insights, and challenges in using 
the app and efforts toward adopting behavioral change collected through and end of study key 
informant interview.  
3. Signal of Efficacy measures:1.) Change in total stroke risk score at month 2 calculated as 
difference between baseline score and month 2 score. 2) Change in stroke risk factor awareness 
score. 3) differences in number of encounters with healthcare provider during the period of the trial 
in those who have either hypertension, dyslipidemia or diabetes. 
Statistical Analysis: For this pilot trial, our sample size focused on precision of estimates for a future 
study design rather than power of statistical tests. We will compare medians and means for continuous 
variables using either the Mann-Whitney’s U-test or Student’s t-test (paired) while categorical variables will 
be compared using the Chi-squared tests. A p<0.05 was considered significant difference between the 2 
groups. Unadjusted odds ratios were calculated for primary outcome measures. 
Qualitative Interviews: We will conduct key informant interviews (KIIs) with intervention participants to 
explore personal perspectives on acceptability of the app and video, including barriers and facilitators of 
its use, behavioral change efforts made to reduce stroke risk, and recommendations for revision and 
educational module content. Educational module content via a wireframe of app content will be shared 
with participants to ascertain their perceptions and recommendations for content refinement. Additionally, 
factors related to the social determinants of health (SDOH) will be included to better understand influence 
on lifestyle modification, stroke risk, and access to care and adoption of recommended health behaviors. 
Clinician KIIs will be completed to explore their acceptance and readiness to use the app, input of current 
treatment practices, recommendations for educational module content, behavioral modification strategies, 
clinical team educational needs, and barriers and facilitators toward intervention implementation. 
Interviews will be audio-recorded, transcribed and translated to English when necessary, and thematically 
analyzed using inductive and deductive approaches. 
 

SIBS-GENOMICS INFORMATION SHEET AND CONSENT FORM - CASE 
Title of Research: Systemic Investigation of Blacks with Stroke-Genomics (SIBS-Genomics)  
IRB Research approval number: 
 
Principal Investigators:             Prof. Mayowa O. Owolabi MBBS, MSc, DrM, MWACP, FMCP, FAAN, FAS 
                                                  Professor & Dean, Faculty of Clinical Sciences, 
                                                  University of Ibadan 
                                                   Prof. Bruce Ovbiagele MD, MSc, MAS, FAAN 
                                                   Professor and Associate Dean, University of Califonia, San Francisco 
                                                   Chief of Staff, San Francisco Veterans Healthcare System 
Funded by:                                 National Institutes of Health (NIH) USA in collaboration with 
                                                   University College Hospital, Ibadan 
You are being invited to participate in SIBS-Genomics, a project designed to discover, validate and 
functionally characterize novel genetic variants associated with ischemic stroke in people of African 
ancestry. We hope that you will find this information helpful. 
The University of Ibadan in collaboration with a network of other Universities and research centres in 
Nigeria, Ghana, South Africa, UK and US is conducting a research (SIBS-Genomics) on black populations 
of West Africa and the US, to find out more about how lifestyle, medical conditions (eg. blood pressure 
and cholesterol) and genes act together to influence the development of stroke in people of black African 
origin. We are asking everyone who comes to this hospital/clinic with acute Ischemic stroke (within two 
weeks) to participate in this study. Approximately. 2,100 patients with stroke and 2,100 people without 
stroke in Nigeria and Ghana will take part in this study. 
Why is SIBS-Genomics being done? 
As you may know, stroke is the major cause of death and disability worldwide. We know that a person's 
chance of getting a stroke is related to lifestyles such as eating habits, level of exercise as well as exposure 
to tobacco smoke, blood pressure and diabetes. Scientists have also found that many genes may be linked 
to stroke and we expect they will find many more in the future. Ischemic stroke is defined as "a 
spontaneous, non-traumatic, abrupt onset of global and/or focal neurologic deficit associated with brain 
infarction seen on neuroimaging and is not due to haemorrhage or non-vascular causes. 
The purpose of SIBS-Genomics is to discover, validate and functionally characterize novel genetic variants 
associated with ischemic stroke (IS) in people of African ancestry. This will substantially facilitate the 
understanding of the molecular mechanisms of ischemic stroke thereby enabling the emergence of a new 
array of targeted diagnostic/prognostic tools and interventions to reduce the burden of stroke globally and 
especially in African Americans in whom the burden remains disproportionately high. Please ask us 
questions about anything you do not understand or if you would like more information, we are happy to 
explain this to you more than once. 
How long will this research last and how much of your time will be involved? 
To meet up with our target sample size of 100 participants, the study will run for 3 months but your 
involvement will only last while you are admitted on the ward and for at least 1 month after the stroke 
episode. You may be contacted for follow-up afterwards if you wish to continue participate. 
What is involved in participating in SIBS-Genomics? 
We will help you to fill out a questionnaire about your health, diet, exercise, and your use of tobacco, 
alcohol, stress, previous medical problems, medications and your level of knowledge about stroke, hospital 
anxiety and depression Scale and other aspects of your health. The tests and analysis required of you are 
part of the harmless routine procedures needed for treating your disease condition and they include: 
evaluation of your blood pressure, heart rate, height, we waist and hip circumference, Carotid 
ultrasonography, brain scan (MRI), ECG, Echocardiography and duplex ultrasound of the vessels 
supplying your brain. In addition, we will need to withdraw about 30ml of blood (this is not up 3 tablespoons) 
which will be used to test for lipids, sugar level and genetic analysis while the other will be stored for future 
analyses. We will also collect abo 20ml of your urine for further analysis. 

We will need less than 5 minutes to take the blood sample from a vein in your arm. They will be involved 
in an interview which will take about 20 minutes of their time. There will be no medicines to take and no 
experimental treatments to undergo in SIBS-Genomics. Nothing else is required. The only genetic testing 
on your blood sample will be for conditions associated with stroke. 
 
How will information about me be kept private? 
To protect your privacy, we will replace your name with a code (numbers, letters or both). We will separate 
your name and any other information that points to you from your blood sample and your data. We will 
keep files that link your name to the code number in a locked cabinet. Only permitted members of the 
research team will have access to these files. No one who reads or hears a report about SIBS-Genomics 
will be able to identify you because, before any facts are given out we combine your facts with those of 
other people in the study. Your name or other facts that might point to you will not appear when we present 
this study or publish its results. 
A goal of H3Africa is to create a way for researchers to share and learn from each other especially within 
Africa. One of the best ways to do this is for scientists to share research data. We like your permission to 
share your health history, laboratory test results and your go information. When we share this information, 
people will not know your name. Other investigator who want to use your data (without your name) will 
need to first ask for permission from the central repository. They will need to agree only to use the data for 
a specific scientific research. There is a small chance that your data together with the data of many other 
people could be to develop new treatments which might be beneficial to you or other people. If this 
happens, it is unlikely that the proceeds will be shared with you. 
What will happen to the samples? 
Your blood samples will be processed in our laboratory and the result of the fasting blood sugar and lipid 
profile will be given during follow-up. 
Voluntary nature of participation and right to withdrawal 
It is a personal decision whether you take part in the study. You can say "Yes" and join the study or you 
can also say "No" you don't want to join. If you participate in the study, you can change your mind later 
and decide that you don't want to participate anymore and you do not want your blood to be used in this 
study. Please let us know and we will destroy the sample. If your sample has already been tested at the 
time you change your mind, your results and other data may have already been shared with investigators. 
In that case we will not be able to destroy this data. Your data can be removed from the central repository, 
however, that means that no additional researchers get your data. 
Whether you decide to join or not to join the study, the way we look after you in this clinic will be the same. 
It is your decision whether to be in the study or not. 
 
Potential Risks associated with the research 
We want to tell you of the possible risk associated with this study. Most of the time when we take blood it 
is safe, but sometimes when we take the blood sample, people feel a bit faint or very rarely get an infection. 
You may also get a slight bruise where we took the blood, if it does happen you will be treated immediately 
without extra costs. 
Potential benefits associated with the research 
This study may not directly help you (or your children) to get better but we hope it will benefit others in the 
future. What we are trying to do is very complex and could take a long time. Whether you decide to 
Potential benefits join this study or not will not affect your treatment in the clinic. Your decision to join is of 
your own free will. 
 How will I find out the results of the study? 
We plan to share some of the results of tests conducted during this project (e.g duplex ultrasound, blood 
sugar) that may contribute to your medical care with you. We will attempt to input relevant results into your 
medical records. 
This study will take a while before it is concluded and when it is finished, observations and discoveries will 
be shared with other health professional through publications. However, if you have any questions, you 
could ask your doctor. 
Are any costs or payments involved?  
It does not cost you anything to provide a blood sample for SIBS-Genomics and you will not be charged 
for any tests required specifically for this research only. Although, you will not receive any monetary 

gratification for participating in this study, you will enjoy excellent clinical care and have access to 
communicate issues about your health with the clinicians working with the team of investigators. We will 
do everything possible to avoid any degree or form or injury while undergoing clinical assessment or giving 
a blood sample, nonetheless we will provide adequate treatment in the very unlikely event that this occurs. 
SIBS-GENOMICS CONSENT FORM-Case 
Principal Investigators:          Prof. Mayowa O. Owolabi MBBS, MS, DM, MWACP, FMCP, FAAN, FAS 
                                               Professor & Dean, Faculty of Clinical Sciences,                                                   
                                               University of Ibadan 
                                                Prof. Bruce Ovbiagele MD, MSc, MAS, FAAN  
                                                Professor and Associate Dean, University of Califonia, San Francisco 
                                                Chief of Staff, San Francisco Veterans Healthcare System 
                                                                
Funded by:                              National Institutes of Health (N.L.H) USA in collaboration with 
                                                University College Hospital, Ibadan                                                                             
This research which is part of the Human Heredity and Health in Africa ("H3Africa") project has been 
approved by the University of Ibadan/University College Hospital Ethics Committee, Ibadan and the 
Chairman of this Committee can be contacted at IMRAT, UCH, Ibadan, Nigeria. 
Email: academic uichhric@yahoo.com 
In addition, if you have any question about your participation in this research, you can contact the overall 
principal investigator Prof. Mayowa O. Owolabi, Professor & Dean, Faculty of Clinical Sciences, University 
of Ibadan, Nigeria. 
Consents and Signature 
I agree to participate in SIBS-Genomics. I understand that I will fill out a brief survey about my health, 
lifestyle, food habits, medications and knowledge about stroke. I will have about 30ml of one blood sample 
drawn and about 20ml of urine collected. The tests to be carried out on my samples will include cholesterol, 
glucose and genetic factors. I will also have my blood pressure and heart rate taken, my height, weight, 
waist and hip circumference measured. My medical record will be assessed for my medical and treatment 
information. My only discomfort will be related to the needle prick for drawing the blood, and the most 
common adverse effect is bruising around the vein from where the blood sample is drawn 
I understand that my participation in the study is voluntary. All information gathered for this study strictly 
confidential and will not be used to create financial profit. I will not be identified in any published report. 
am free to refuse to participate or withdraw from the study at any time without jeopardizing my future care. 
I have been given a chance to ask questions and feel that all of my questions have been answered. 
I know that giving a blood sample for this study is my choice. I understand that my individual results will 
not be given to me. I will receive a signed copy of this form. I have read the part of the formation Sheet 
about storing my blood sample for future research. My choice about having my blood sample stored and 
used for research under the conditions described is: (please check ONE box) 
o I agree to participate in SIBS-Genomics but do not want my sample to be shared with other 
Investigators outside SIBS-Genomics. I agree to participate in SIBS-Genomics and my sample can 
be shared with other investigators within H3 Africa only for research in a related field (e.g. 
cardiovascular research) 
o I agree to participate in SIBS-Genomics and my sample can be shared with other investigators in 
any other research field 
________________________________________ 
Name of Participant 
________________________________________                                             
Name of Authorized Representative (if applicable)                                                       
___________________________________________                                             _________________ 

Signature of Participant Authorized Representative                                                              Date                               
Consent form administered and explained in person by: 
_____________________________________________ 
                      Name and title 
_____________________________________________                                           ________________ 
                    Signature                                                                                                               Date 
In my judgement, the participant is voluntarily and knowingly giving informed consent and possesses the 
legal capacity to give informed consent to participate in this research study. 
___________________________________________________________________________________
__ 
Name of Investigator 
____________________________________                                  _______________________________ 
Signature of Investigator                                                                                       Date                                                
PLEASE KEEP A COPY OF THE SIGNED INFORMED CONSENT.