Community-Based Communication Approaches for Blood Donation in Ghana
Phase: NA
Conditions: Blood Donors
Sponsor: University of Minnesota

 
 
 
 
Community-based communication interventions for increasing the blood donor 
pool in Ghana: a pilot randomized controlled trial 
 
NCT04783077 
 
Protocol 
Version: 1.0 
Date: 26 April 2021 
 
 
Statistical analysis plan: pages 28-29 
Participant information sheet:  Appendix 4 
Signature page of consent:  Appendix 5 

Protocol Title 
Community-based communication interventions for increasing the blood donor pool in 
Ghana: a pilot randomized controlled trial 
 
Short Title: 
Community-based communication approaches for blood donation in Ghana – Pilot Study 
 
Version: 1.0 
Date: 26 April 2021 
 
Name of PI 
Dr Lucy Asamoah- Akuoko 
Institution of PI 
National Blood Service Ghana 
 
Name of MPI 
Dr Yvonne Dei- Adomakoh 
Institution of MPI 
University of Ghana Medical School 
 
Grant Number 
1UG3HL151599-01 
 
Funded by the National Heart, Lung, and Blood Institute (NHLBI), 
National Institutes of Health (NIH) 
 

i 
 
 
Table of Contents 
List of Abbreviations .............................................................................................................................. iv 
General Information .............................................................................................................................. vi 
Project Summary ................................................................................................................................... ix 
Rationale & Background Information .................................................................................................... 1 
Background ....................................................................................................................................... 3 
Study Location .................................................................................................................................. 4 
Study Goals and Objectives .................................................................................................................... 7 
Primary Objectives .......................................................................................................................... 7 
Secondary Objectives ....................................................................................................................... 7 
Study Design ........................................................................................................................................... 8 
PRECEDE-PROCEED Framework ............................................................................................... 8 
Randomization ............................................................................................................................... 13 
Blinding ........................................................................................................................................... 14 
Methodology ........................................................................................................................................ 15 
Study Interventions ........................................................................................................................ 15 
Study Population ............................................................................................................................ 17 
Inclusion Criteria .......................................................................................................................... 17 
Exclusion Criteria .......................................................................................................................... 18 
Outcome measures ......................................................................................................................... 18 
Primary Outcome ......................................................................................................................... 18 
Secondary Outcomes ................................................................................................................... 18 
Sample Size Assumptions .............................................................................................................. 19 
Schedule of Assessments: Follow-Up ................................................................................................... 22 
6 months .......................................................................................................................................... 23 
6–12 months .................................................................................................................................... 24 
Risk/Benefit Assessment ...................................................................................................................... 25 
Known Potential Risks ................................................................................................................... 25 
Known Potential Benefits .............................................................................................................. 25 
Safety Assessment ........................................................................................................................... 25 
Definitions .................................................................................................................................... 25 
Data Analysis ........................................................................................................................................ 27 
Qualitative Data Analysis .............................................................................................................. 27 

ii 
 
Quantitative Data Analysis ............................................................................................................ 28 
Analysis pilot trial: ........................................................................................................................ 28 
Quality Assurance ................................................................................................................................ 29 
Expected Outcomes of the Study ......................................................................................................... 30 
Dissemination of Results and Publication Policy .................................................................................. 30 
Problems Anticipated and Unanticipated ............................................................................................ 31 
Unanticipated Problems ................................................................................................................ 31 
Project Management ........................................................................................................................... 32 
Protection of Human Subjects and Other Ethical Considerations ........................................................ 35 
Participating Clinical Sites and Local Review of Protocol and Informed Consent .................. 35 
Ethical Conduct of the Study ........................................................................................................ 35 
Informed Consent of Study Participants ...................................................................................... 35 
Known Potential Risks ................................................................................................................... 36 
Known Potential Benefits .............................................................................................................. 36 
Compensation ................................................................................................................................. 36 
Funding information ...................................................................................................................... 36 
Declaration of Conflict of Interest ................................................................................................ 37 
COVID-19 Social Protocols ........................................................................................................... 37 
Confidentiality of Study Participants ........................................................................................... 37 
Regulatory Oversight ..................................................................................................................... 37 
Appendices ........................................................................................................................................... 39 
I Budget ........................................................................................................................................... 39 
II Timeline ...................................................................................................................................... 40 
References ........................................................................................................................................... 41 
Participant Information and Consent Forms ............................................................................................  
1. Participant Information Sheet for Key Informant Interviews ...................................................  
2. Participant Information Sheet for Docu-drama Test Run ..........................................................  
3. Participant Information Sheet for the Docu-Drama Design Workshop ....................................  
4. Participant Information Sheet for the Pilot Randomized Controlled Trials of WhatsApp 
and Control .........................................................................................................................................  
5. Consent Form for Focus Group Discussions, Key Informant Interviews, Docu-Drama 
Design Workshop, Docu-Drama Test-run, and the Pilot Randomized Control Trial of 
WhatsApp and Control. .....................................................................................................................  
Study Tools ...............................................................................................................................................  

iii 
 
1. Key Informant Interview Guide for Intervention Development (WhatsApp and Docu-
Drama) ................................................................................................................................................  
2. Docu-Drama Design Workshop Discussion Guide ......................................................................  
3. Focus Group Discussion Guide for Test-Run Docu-Drama Intervention and for Assessing 
Acceptability, Feasibility and Cultural Appropriateness ...............................................................  
4. Participant Observation Guide for Docu-Drama Viewing and Focus Group Discussion ........  
5. Focus Group Discussion Guide for Assessing Acceptability, Feasibility and Cultural 
Appropriateness at End of 6-month WhatsApp Pilot RCT ............................................................  
6. Case Report Form for participants attending baseline visit .......................................................  
7. Case Report Form for participants enrolled in the RCT of the study after randomization ....  
8. Case Report Form for participants attending docu-drama prior to viewing ............................  
9. Case Report Form for reporting participant death .....................................................................  
10. Case Report Form for participants enrolled in the RCT of the study attending the Month 
6 visit ...................................................................................................................................................  
11. Case Report Form for participants attending docu-drama after viewing ...............................  
12. Participant Contact Information Form ......................................................................................  
13. Protocol Deviation Form .............................................................................................................  
14. Serious Events (SAEs) Report Form ..........................................................................................  
15. Study Volunteers Screening Form ..............................................................................................  
16. Participation Withdrawal Form .................................................................................................  
17. SOP: Randomizing participants into study groups for the pilot RCT of WhatsApp and 
control .................................................................................................................................................  
18. Phone Interview Guide ................................................................................................................  
 

iv 
 
List of Abbreviations 
“PRECEDE”  
Predisposing, Reinforcing and Enabling Constructs in Educational 
Diagnosis and Evaluation.  
“PROCEED”  
Policy, Regulatory, and Organizational Constructs in Educational and 
Environmental Development 
AE  
Adverse Event 
BCI  
 
 
Blood Collection Index 
Co-I 
 
 
Co-Investigator 
CRFs  
 
Case Report Forms 
DCC   
 
Data Coordinating Center.  
DSMB  
 
Data Safety Monitoring Board 
EU 
 
 
European Union  
FRD   
 
Family/Replacement Blood Donors 
GCP  
 
 
Good Clinical Practice  
ICF  
 
 
Informed Consent Form 
ICH   
 
International Council for Harmonization 
IRB 
 
 
Institutional Review Board 
LMICs  
 
Low- and Middle-Income Countries  
MICE   
 
Multiple Imputation Via Chained Equations 
NBSG  
 
National Blood Service Ghana 
NIH 
 
 
National Institutes of Health 
NHLBI  
 
National Heart, Lung, and Blood Institute 
OHRP   
 
US Office for Human Research Protections 
PI 
 
 
Principal Investigator 
QSR   
 
Qualitative Software and Research 
R 
 
 
R Project for Statistical Computing  
RCT   
 
Randomized Controlled Trial 
SAE   
 
Serious Adverse Event 

v 
 
SOP 
 
 
Standard Operation Procedure 
SSA   
 
Sub-Saharan Africa 
SU  
 
 
Syracuse University  
SZBC   
 
Southern Zonal Blood Centre  
TAM   
 
Technology Acceptance Model  
TPB   
 
theory of planned behaviour 
UG3  
 
Exploratory/Developmental Cooperative Agreement Phase I 
UH3   
 
Exploratory/Developmental Cooperative Agreement Phase II 
UP  
 
 
Unanticipated Problem 
US 
 
 
United States of America  
VNRBD  
 
Voluntary Non-Remunerated Blood Donors 
WHO  
 
World Health Organisation  
 
 

vi 
 
General Information 
Study title: Community-based communication interventions for increasing the blood donor 
pool in Ghana: a pilot randomized controlled trial 
 
Funder:  The National Heart, Lung, and Blood Institute (NHLBI), United States 
Address of Funder: 6701 Rockledge Drive, Building II, Suite 10118, Bethesda, MD 20892  
Project Investigators/Co-Investigators 
 
Investigator 
Role 
Responsibilities 
Contact Information 
Dr. Lucy 
Asamoah-
Akuoko 
Principal 
Investigator 
Study oversight, liaising with 
funder and lead awardee 
institution, overall 
responsibility for protocol 
development and 
implementation, design of data 
collection tools, input into all 
data collection (training, tools) 
and analysis, overall design of 
larger study, support to staff, 
liaising with key stakeholders, 
leading write-up of findings, 
facilitate National Blood 
Service Ghana support to 
project implementation 
National Blood Service Ghana 
Head, Research and 
Development  
National Blood Service Ghana  
Korle-Bu, Accra 
Tel: +233 206 301006 
Ext: 339 
Email: 
lucyasamoah@yahoo.com 
Dr. Yvonne 
Dei-
Adomakoh 
Co-
Investigator 
Lead institution PI, contribute 
to administrative leadership 
and will also contribute to 
protocol writing, data analysis 
and publication, facilitate 
University of Ghana support to 
the project. 
Department of Hematology  
College of Health Sciences  
Korle-Bu, Accra  
Tel: +233243550980  
Email: yadei-
adomakoh@ug.edu.gh 
Dr. Bernard 
Appiah 
Co-
investigator 
Protocol development, design, 
implementation and evaluation 
of interventions to promote 
recruitment and retention of 
blood donors. Facilitating 
training workshops to build 
local capacity. Dissemination 
of findings to key audiences 
Department of Public Health 
Falk College, Syracuse 
University  
435A White Hall Syracuse, 
NY 13244 
Tel: +1-315443152 
email: beappiah@syr.edu 

vii 
 
including policymakers, media 
professionals and researchers 
Dr. Tara 
Tancred 
Co-
Investigator 
Contribute to design, 
implementation and evaluation 
of study, development of study 
manuals, manuscripts, 
abstracts, presentations.  
Facilitate training workshops 
with local research staff to 
build local capacity in 
implementation research.  
The Centre for Capacity 
Research 
Liverpool School of Tropical 
Medicine Pembroke Place, 
Liverpool, United Kingdom 
Tel: +44(0)7597640371 
email: 
tara.tancred@lstmed.ac.uk  
Prof. Philip 
Adongo 
Co-
investigator 
Provide research and 
implementation support, 
particularly in the area of 
qualitative research. 
Department of Social & 
Behavioural Sciences 
School of Public Health 
University of Ghana 
Tel: +233244806015 
Email: 
adongophilip@yahoo.com  
 
Dr. Seth Adu-
Afarwuah 
Co-
Investigator 
Contribute to protocol 
development, provide support 
for study design and statistical 
analysis, contribute to 
development of manuals of 
operation. 
The Centre for Capacity 
Research 
Liverpool School of Tropical 
Medicine Pembroke Place, 
Liverpool, United Kingdom 
Tel: +44(0)7597640371 
email: 
tara.tancred@lstmed.ac.uk  
Prof. Alfred 
Yawson 
Co-
investigator 
Technical research support to 
data collection. 
Project Monitoring and Data 
Management. 
Department of Community 
Health, College of Health 
Sciences, Korle-Bu, Accra 
Tel: +233244662711 
email: aeyawson@yahoo.com  
Prof. 
Edeghonghon 
Olayemi 
Co-
Investigator 
Contribute to development of 
manuals of operation, review 
of protocol, reports and 
manuscripts. 
Department of Hematology 
College of Health Sciences, 
Korle-Bu, Accra 
Tel: +233246968211 
email: eolayemi@ug.edu.gh  
Dr. Michael 
Acquah 
Co-
Investigator 
Review of developed protocol 
and manuals of operation.  
National Blood Service, Korle- 
Bu, Accra 
Tel: +233206301106 

viii 
 
Email: 
michael.e.acquah@gmail.com  
 
Dr. Amma 
Benneh - 
Akwasi Kuma 
Co-
Investigator 
Contribute towards finalization 
of standard operation 
procedures (SOPs) and case 
report forms (CRFs).  
Contribute to analysis, 
interpretation and write-up of 
research findings. 
Department of Hematology  
College of Health Sciences, 
Korle-Bu, Accra  
Tel: +233208305555 
email: 
animabenneh@yahoo.com  
Dr. Catherine 
Segbefia 
Co-
Investigator 
Review of SOPs and study 
protocol. 
Department of Child Health,  
College of Health Sciences, 
Korle Bu, Accra.  
Tel: +233302 665406/+23320 
888 7888  
email: csegbefia@chs.edu.gh  
Prof. Cavan 
Reilly 
Co-
Investigator 
Provide advice on study 
implementation. Generation of 
randomization schedules. 
Oversee data management. 
Coordinating Centers for 
Biometric Research 
Division of Biostatistics 
University of Minnesota, Twin 
Cities 
Tel: +1 612-624-9644 
Email:  cavanr@ccbr.umn.edu  
Prof. Haitao 
Chu 
Co-
investigator 
Statistical collaborator 
including statistical design and 
data analysis, reporting and 
manuscript drafting and 
editing. 
Department of Biostatistics 
School of Public Health 
University of Minnesota Twin 
Cities 
Tel: +1 612-219-7180 
Email: chux0051@umn.edu  
Susan Telke 
Co-
investigator 
Masters level statistical 
collaborator on study design, 
reports to support 
implementation, analysis and 
manuscript preparation.  
Generation of reports for 
DSMB review.   
Coordinating Centers for 
Biometric Research 
Division of Biostatistics 
University of Minnesota, Twin 
Cities 
Tel: +1 612-626-8887 
Email:  telke001@umn.edu  
 
 
 
Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical 
department(s) and/or institutions involved in the research: None 
 

ix 
 
Project Summary 
This pilot study utilizes a mixed-methods approach to develop a novel docu-drama 
communication strategy, design WhatsApp intervention, evaluate the feasibility of a larger 
pragmatic randomized controlled trial (RCT) of the two communication strategies and assess 
acceptability of the communication strategies aimed to increase blood donation among first-
time blood donors within the catchment areas of the Southern Zonal Blood Centre (SZBC) in 
Ghana.  
The pilot study has four components: 1) a qualitative component (a workshop) will be used to 
design a docu-drama (to be incorporated into the larger study), 2) key informant interviews to 
guide intervention development, 3) a simultaneous randomized pilot trial will evaluate the 
feasibility of the larger trial design of  communication interventions using WhatsApp compared 
to control, and 4) a final mixed-methods (quantitative survey and focus groups) assessment of 
participant views of acceptability, effectiveness, feasibility and cultural appropriateness of the 
two proposed communication interventions  
The three objectives of this pilot study are the careful design of a novel docu-drama 
communication intervention and WhatsApp intervention, evaluation of the feasibility of a 
larger randomised controlled trial (RCT) of communication strategies, and assessment of 
participant views of the two proposed communication interventions (i.e., docu-drama, 
WhatsApp) and control among first time blood donors within the catchment areas of the SZBC.  
The design of the docu-drama will engage designers and hold a drama design workshop for 2 
days. To later assess acceptability among blood donors in Southern Zonal Blood Center 
(SZBC) of the National Blood Service Ghana (NBSG), the resulting proposed docu-drama 
design will be followed by a small-scale test-run with blood donors. The pilot RCT with 
WhatsApp and control has a duration of 12 months with a maximum of 6 months to achieve 
enrollment goals to allow for 6 months of communication intervention with follow-up for the 
last individual enrolled.  
 
 

1 
 
Rationale & Background Information 
Culturally appropriate interventions are urgently needed to increase blood donation in Ghana 
and other countries in Sub-Saharan Africa (SSA) given the region’s low blood donation rates. 
Such interventions need to be evidence-based. However, the lack of implementation research 
for promoting adequate blood supply has been identified as a challenge in SSA (Custer et al., 
2018). For example, a review of the interventions to promote blood donation globally did not 
identify a single study from SSA (Godin et al., 2012). The review identified mobile phone-
based interventions including the use of mobile phone calls and text messages for promoting 
blood donation. A subsequent but related review globally focusing on the retention of first-
time blood donors, did not identify a single study in Sub-Saharan Africa (Bagot et al., 2016). 
Several health services interventions in SSA have included the use of drama (Joronen et al., 
2008), mobile phones (Aranda-Jan et al., 2014) and community groups to promote health 
behaviours with promising findings. However, scientific research on the effectiveness of such 
interventions aimed to promote blood donation is lacking. 
This project aims to use social media (WhatsApp) and audio-visual docu-drama interventions 
to increase awareness of the need, advantages, and opportunities for voluntary blood donations 
as a collective resource to significantly increase the retention of first-time blood donors in 
Ghana. A docu-drama is a form of a communication programming that has drama of 
actual events re-enacted in addition to a brief documentary to explain those events. Docu-
dramas tend to have the entertainment appeal of drama while also having factual 
information often created in documentaries. As participants watch and listen to docu-
dramas, they are likely to be engaged in blood donation issues in an entertaining manner, 
with factual data that could have the potential to make them to become repeat blood 
donors. 
Our scientific premise for the use of community-based interventions for promoting the 
availability of safe blood donation in Ghana is based on the PRECEDE-PROCEED framework 
(Figure 3). The acronym “PRECEDE” stands for Predisposing, Reinforcing and Enabling 
Constructs in Educational Diagnosis and Evaluation. “PROCEED” stands for Policy, 
Regulatory, and Organizational Constructs in Educational and Environmental Development. 
Predisposing factors exist at the cognitive level and include factors such as attitudes, and beliefs 
that influence behaviours (Green & Kreuter, 1999). Reinforcing factors relate to actions that 

2 
 
help to maintain a behaviour. Such factors include providing rewards and praising individuals 
for maintaining particular behaviours (Green & Kreuter, 1999). Enabling factors represent the 
suitable conditions that must exist for a given behaviour to occur. For example, in blood 
donation, this could include attitudes of blood donation staff or the availability of mobile blood 
donation drives (Appiah, 2013). Policy, regulatory, and organizational constructs in 
educational and environmental development describe factors that could influence the 
implementation and process, impact and outcome evaluations of interventions (Green & 
Kreuter, 1999). 
The study also uses the technology acceptance model (TAM) and the theory of planned 
behaviour (TPB) to help explain factors that serve us mediators for aiding blood donation. Our 
choice of integrating these models is to help us identify socio-behavioural, environmental, and 
societal barriers to safe blood donation in communities and to assess the extent to which new 
mobile health communicating strategy involving WhatsApp and other communication 
strategies could be useful for promoting blood donation in Ghana. According to the TAM, the 
actual use of technology is influence by the intention to use, which is also influenced by 
perceived usefulness and perceived ease of use of the technology (Venkatesh & Bala, 2008). 
The theory of planned behaviour indicates that factors such as attitude, subject norms, and 
perceived behavioural control influence an individual's behavioural intentions and behaviours 
and has been examined in first-time blood donors (Masser et al., 2012). 
The PRECEDE-PROCEED model can be used as a planning tool for health programs (Green 
& Kreuter, 1999), including blood donation. Despite the utility of the PRECEDE-PROCEED 
model, it has largely not been used for community-based blood donation studies in SSA. One 
study that did apply this model to community-focused studies on blood donation in SSA found 
it to be helpful for identifying deterrents to and motivators for blood donation in the region 
(Appiah, 2013). However, the study did not specifically target its use for testing the efficacy 
of interventions for promoting blood donation. 
Moreover, there is a lack of evidence for using interventions such as audio-visual docu-dramas 
in community settings (Godin et al., 2012) and WhatsApp applications for attracting and 
retaining blood donors in SSA. For example, a WhatsApp intervention in Brazil was “not 
effective at increasing the blood donors’ return rates” (Rodrigues Lucena et al., 2020). 
However, the intervention used WhatsApp as a text messaging platform and did not assess the 
utility of WhatsApp as a social networking–based relatedness intervention among blood 

3 
 
donors. There is a critical need for an evidence-based determination of how to establish the use 
of culturally appropriate communication interventions, including the use of WhatsApp and 
audio-visual docu-dramas to attract and retain new blood donors, especially in SSA. 
This project aims to test if social media interaction (WhatsApp) and audio-visual docu-drama 
interventions aimed to increase awareness of the need, advantages, and opportunities for 
voluntary blood donations as a collective resource will successfully retain both first-time 
voluntary non-remunerated blood donors (VNRBD) and family/replacement blood donors 
(FRD) as repeat donors. The implementation research endpoints of acceptability, feasibility, 
and cultural appropriateness of these interventions will also be evaluated. 
Background 
Blood mobilization and collection agencies worldwide are increasingly challenged with blood 
donor recruitment and retention. Despite having about 84% of the world’s population, LMICs 
contribute only about 60% of the 118.5 million donations of blood collected annually 
worldwide (WHO, 2020). This translates into a gap between national blood needs and supply, 
which is largest in low- and middle-income countries (LMICs) (Roberts et al., 2019). 
In many SSA countries, blood donation is mainly from two types of donors: voluntary non-
remunerated blood donors (VNRBD) and family/replacement donors (FRDs). Family 
replacement donations serve as either an alternative for or a supplement to insufficient numbers 
of VNRBDs in many SSA countries. FRDs, who donate blood only in response to the need of 
their own family or acquaintances fill the gap between demand and supply. However, the FRD 
system places an undue burden on patients because the family of the patient bears the 
responsibility of recruiting blood donors. The transfusion of patients or their discharge from 
wards may also be delayed until friends and/or family can be mobilized to ‘donate’ equivalent 
numbers of units required or transfused. Because of the time lag in organizing family of friends 
to donate blood when the need arises, reliance on replacement donations accounts for 
inadequate blood for emergencies such as obstetric hemorrhage and severe anemia in children 
due to malaria. 
In Ghana, there is about a 40% deficit in blood requirements annually. Based on the estimated 
population of Ghana, the estimated minimum annual blood requirement for Ghana for 2019 
was 300,000 units and the Blood Collection Index (BCI) was about 6. The percentage of blood 
collected from voluntary blood donors was about 34% in 2019 (NBS Ghana, 2020). Studies on 

4 
 
blood donor motivation have identified several global and locally relevant factors that influence 
blood donation. Such factors include prosocial motivation, including altruism (donating blood 
to help others), collectivism (donating blood for family and/or friends), reciprocity (donating 
blood in response to or in anticipation of a kind act); education, and educational talks on blood 
donation; incentives, and awareness of the need for blood (Asamoah-Akuoko, 2018; Asenso-
Mensah, 2014). These findings are in agreement with studies in other SSA countries (Duboz et 
al 2010; Muthivhi et al., 2015). The studies also identified that interventions that are likely to 
increase repeat blood donation among first-time donors include those with a focus on 
education, information, addressing fears, and regular communication with blood donors 
(Asamoah-Akuoko et al., 2020; Asenso-Mensah et al., 2014). 
In a study in Ghana, only 3.1% (Asamoah-Akuoko, 2018) of first-time donors (voluntary non-
remunerated and family replacement donors) returned to donate blood. In SSA, several factors 
including negative perceptions and beliefs deter people from donating blood (Asamoah-
Akuoko et al., 2017). Factors such as fear, attitudes and misperceptions contribute to low blood 
donation rates (Asamoah-Akuoko et al., 2017). Thus, socio-behavioural interventions are 
urgently needed to retain first-time donors. 
Study Location 
Ghana 
Ghana is situated on the south-central coast of West Africa and covers an area of about 238,537 
square kilometers. The country is bound north by Burkina Faso, east by Togo, west by Cote 
d’Ivoire, and south by the Atlantic Ocean. Administratively, Ghana is divided into 16 regions 
and 216 districts. Ghana had a population of 24.6 million in the 2010 census (Ghana Statistical 
Service, 2012), a figure projected to be about 30 million in 2019 (Ghana Statistical Service, 
2019.). 
The agency of the Ministry of Health responsible for the provision of blood services in Ghana 
is the NBSG. The NBSG coordinates the activities of one stand-alone blood center, the SZBC, 
which is located in Accra in the southern zone of Ghana, and another 153 hospital-based blood 
collection sites (NBS Ghana, 2011). The hospital-based blood collection sites are located in 
teaching, regional and district hospitals, and operate their respective hospital-based transfusion 
facilities. The SZBC is responsible for procuring and supplying blood and blood components 
to hospitals and clinics that transfuse blood in the five southern administrative regions of Ghana 
with a total population of about 16.5 million but is only able to provide blood mainly for three 

5 
 
of the regions. Since the SZBC is not able to meet the blood requirements of all health facilities, 
some health facilities in the catchment area collect and test blood for use, to supplement the 
blood supplied by the SZBC. 
The Southern Zonal Blood Centre 
The study will take place in the catchment area of the SZBC of NBSG. Currently, the SZBC 
(Figure 1) provides services for health facilities in the Greater Accra Region, and parts of the 
Eastern and Central Regions with a total population of about 10.7 million (Ghana Statistical 
Services, 2019), and collected about 33,000 (NBS Ghana, 2020) units of blood in 2019. About 
70.5% of the total blood collected was from first-time donations, and 47% was from voluntary 
non-remunerated blood donors. The estimated minimum blood requirement for the three 
regions is about 100,000 units per annum based on the World Health Organisation (WHO) 
formula of 1% of the population. 
Data collection will occur at blood donation sessions conducted by the SZBC. The Centre 
has six fixed blood collection sites. Five of these are located in various health facilities: Korle-
Bu Blood Bank, Korle-Bu Maternity Site, Pentecost Hospital, LEKMA Hospital, and the 
Maamobi Polyclinic. Blood collection at these sites is predominantly from family replacement 
donors (FRDs). The sixth site is located at the Accra Shopping Mall, and blood collection is 
from voluntary non-remunerated blood donors (VNRBDs). Mobile blood collection sessions 
are scheduled on a weekly basis and are planned to be easily accessible to groups of individuals 
or organizations such as churches and mosques, schools, corporate organizations, social and 
community groups. Such sites could be located in the city or in the peri-urban parts of the 
catchment area. Four blood collection teams collect blood from mobile blood collection sites 
and the fixed sites.  

6 
 
 
Figure 1: Catchments areas of Zonal Centers of the National Blood Service Ghana 
 
 

7 
 
Study Goals and Objectives 
The study has a main goal of creating and testing the feasibility of using communication 
interventions to make first-time blood donors become repeat donors.   
Primary Objectives 
The three objectives of this pilot study are the careful design of a novel docu-drama 
communication intervention and WhatsApp intervention, evaluation of the feasibility of a 
larger RCT of communication strategies, and assessment of participant views of the two 
proposed communication interventions (i.e., docu-drama, WhatsApp) and control) among first 
time blood donors within the catchment areas of the Southern Zonal Blood Centre: 
1. Development of the Docu-drama will involve a drama workshop with blood donors and 
non-blood donors who are > 18 years with the aid of drama and communication 
professionals. Key informant interviews will guide the development of WhatsApp 
intervention. 
2. Feasibility of recruitment, enrollment, retention and adherence with a two-arm pilot 
RCT (WhatsApp and control).  A target retention rate of at least 90% completing the 
pilot trial is sought. Retention will be measured by the proportion of participants who 
will remain in the study by the end of the follow-up period. If we are unable to achieve 
this target, alternative strategies will be considered for the UH3 phase. One of the 
primary objectives is to estimate the proportion of successful return blood donation for 
planning the programmatic randomized clinical trial in the UH3 phase. 
3. Acceptability will be assessed with quantitative surveys and participant focus groups to 
understand the opinions and perspectives of acceptability, effectiveness, feasibility and 
cultural appropriateness of the docu-drama, WhatsApp and control communication 
interventions. 
Secondary Objectives 
To design culturally appropriate communication interventions: docu-drama and WhatsApp 
groups for retaining first-time blood donors using the PRECEDE-PROCEED framework. 
To examine intervention-specific increases in knowledge, attitudes, beliefs, motivations, 
intention, and relatedness as potential mediators of intention to donate among first-time blood 
donors. Evaluate the reliability of new or modified outcome measurement instruments. 

8 
 
Study Design  
The pilot study utilizes a mixed-methods approach to develop a novel docu-drama 
communication strategy, evaluate the feasibility of a larger pragmatic randomized controlled 
trial (RCT) of a WhatsApp based communication strategy and assess acceptability of the 
communication strategy aimed to increase blood donation among first time blood donors within 
the catchment areas of the SZBC. 
There are two communication interventions: docu-drama and WhatsApp. However, because 
the development of the docu-drama takes more time, it will not be feasible to include the docu-
drama intervention in the pilot RCT, recruit 100% participants, follow up for 6-months for the 
primary outcome and evaluate the secondary outcomes, considering the duration the UG3 
phase. Therefore, only the WhatsApp intervention will be piloted in the RCT. The docu-drama 
intervention will be designed and test-run in preparation for an RCT in the UH3 phase. 
In sequence, this pilot study and larger RCT are grounded in the PRECEDE-PROCEED 
implementation science framework.  This study has four components 1) a qualitative 
component (workshop) will be used to design a docu-drama (to be incorporated into the larger 
study), 2) Key informant interviews to guide intervention development 3) a simultaneous pilot 
RCT will evaluate the feasibility and the proportion of successful return blood donation for 
planning the larger trial design of the communication interventions using WhatsApp and 
control, and 4) a final mixed-methods (quantitative survey and focus groups) assessment of 
participant views of acceptability, effectiveness, feasibility and cultural appropriateness of all 
of the proposed communication interventions intended for the larger UH3 RCT to be 
administered after completion of the pilot trial prior to the UH3 phase. 
The PRECEDE-PROCEED framework planning tool will be used to develop and evaluate the 
three strategies (Figure 3) and will incorporate the Theory of Planned Behaviour (Figure 4) and 
Technology Acceptance Model (Figure 5). 
PRECEDE-PROCEED Framework 
PRECEDE provides a planning approach to help create our interventions whereas PROCEED, 
aids the implementation and evaluation of the interventions to be designed in the PRECEDE 
part of the model. 

9 
 
 
Figure 2: PRECEDE-PROCEED Model that guides the study 
Planning Model Component: Five Phases 
We will use the following PRECEDE strategies during the UG3 phase: 
First, we will conduct a systematic literature review of the effectiveness of social behavioural 
interventions including the use of drama for aiding blood donation in low-and middle-income 
countries. Second, we will conduct key informant interviews with four key stakeholders, with 
a minimum analysis sample of 24, comprising of: a) Blood Donors (n=6), b) Non-blood Donors 
(n=6), c) Blood Donation Staff (n=6) and d) community leaders (n=6) in the Greater Accra 
area of Ghana to seek their perspectives on how to encourage repeat blood donation. The 
sample size, as recommended for qualitative studies, will be increased if saturation is not 
reached (Saunders et al., 2018). Blood donors usually donate in groups in the community - such 
as social clubs, community youth clubs, religious groups etc. Blood donors will be selected 

10 
 
from a list provided by the Blood Donor Recruitment Officers or volunteers (Blood Donor 
Recruitment Officers are on the staff of the NBSG who work with donors; volunteers are liaison 
persons between the community groups and the blood center. Both groups recruit blood donors 
and can advise on non-donors within their groups). Non-donors will be selected purposively 
from communities within which blood donation sessions are held, to ensure that the non-donors 
have been exposed to blood donation education just as the donor. The non-donor is a person 
who is qualified to donate but has never donated and does not intend to donate on the day of 
the interview. 
Third, we will organize a drama design workshop with at least 20 key stakeholders including 
blood donors, drama actors and drama production experts. 
All qualitative data collection will be conducted by trained researchers with social science and 
qualitative research background. A training manual will be developed for the training which 
will be conducted prior to data collection. 
The activities will help the team to identify barriers, opportunities and recommendations that 
will inform the development and guidelines for implementation of the docu-drama and 
WhatsApp weekly messages to promote blood donation in Ghana. Specifically, the five 
PRECEDE phases will be addressed as follows: 
Phase 1: Social Assessment 
We will use the proposed systematic review, in-depth interviews and drama design workshop 
to explore and understand the need for creating socio-behavioural interventions to aid blood 
donation in Ghana. 
Phase 2: Epidemiological assessment 
We will use the findings of the systematic review and other data collected in Phase 1 to identify 
the evidence around repeat donations among first-time blood donors. This will include 
assessing current information on the proportion of first-time donors who become repeat donors. 
Information will be obtained from National Blood Service Ghana records and published 
literature in Ghana and elsewhere in sub-Saharan Africa. 
 
 

11 
 
Phase 3: Behavioural and Environmental Assessment 
We will use both primary data (key informant interviews) and secondary data (for example, 
the findings from the systematic review) to identify donor factors and service factors, that affect 
the subsequent blood donation efforts of first-time blood donors. 
Phase 4: Educational and Ecological Assessment. 
We will consider factors that must be in place to initiate and sustain first time blood donors’ 
attempts at returning to donate blood. These are called predisposing, enabling and reinforcing 
factors. We will identify these factors through analysis of primary and secondary data, and put 
them into categories, and rank their importance. 
Predisposing factors, which explain first-time blood donors’ behaviour regarding subsequent 
donation efforts, include knowledge, attitudes, cultural beliefs, and readiness to change. 
Enabling factors, which enable first-time blood donors to act on their beliefs, attitudes, and 
knowledge, include the availability of policies, assistance, or resources. 
Reinforcing factors, which become prominent after a behaviour has been started, promote 
repetition or persistence of behaviour through the provision of continuing rewards or incentives 
such as praise or reassurance. 
These factors will be identified from previous data on first-time blood donors in Ghana, and 
the key informant interviews with participants will be drawn from the NBSG staff, community-
based blood donation volunteers, blood donors and non-blood donors. 
Phase 5: Administrative and Policy Assessment 
Identify the administrative and policy factors that influence what can be implemented. The 
team will evaluate how organizational factors such as policies, procedures, culture and the 
availability of resources influence what can be implemented by using two approaches to 
evaluate implementation research outcomes of the interventions. These are the creation of 
WhatsApp and docu-drama interventions and test-running the interventions. 
WhatsApp pilot RCT 
A WhatsApp group will be formed for the pilot RCT. There will be one study team member, 
who will be the content mediator (research assistant), and who will be responsible for sending 

12 
 
weekly messages and clarifications on blood donation for six months. The participants in the 
WhatsApp group, after the pilot RCT will have a focus group discussion on what worked well 
and what did not, and provide information on feasibility, acceptability and cultural 
appropriateness of the intervention. Prior to, and after exposure to the WhatsApp intervention, 
a pre-, and post-test survey on the theory of planned behaviour constructs and implementation 
research measures will be conducted. 
Docu-drama test-run 
A docu-drama group of purposively selected 10 first-time donors will be formed. They will 
attend one meeting to watch two docu-dramas, each lasting 15 minutes, followed by a one-hour 
focus group discussion on the content of the drama, and feasibility, acceptability and cultural 
appropriateness of the intervention. Prior to, and after the viewing and discussion, a pre-, and 
post-test survey on the theory of planned behaviour constructs and implementation research 
measures will be conducted. Two study team members will facilitate the discussions. The docu-
drama test-run will include an attendance list at the scheduled meeting. Those who attended, 
watch the 2 episodes, and stayed for the discussion will be considered as having adhered to the 
intervention. 
The PROCEED Component will be addressed during the four years of the UH3 phase. 
The PROCEED component involves exposing the interventions to participants and evaluating 
their outcomes. The UG3 pilot RCT will address the feasibility and inform the design of the 
PROCEED component. 
The Theory of Planned Behaviour 
As shown in Figure 4, according to the theory of planned behaviour, behavioural intention to 
return to donate in 6 months is influenced by factors such as attitude, subject norms, and 
perceived behavioural control, and has been examined in first-time blood donors (Masser et 
al., 2012). The theory of planned behaviour model will be used to evaluate the effect of 
intervention-specific changes in attitude, subject norms, and perceived behavioural control on 
intention to return to donate blood, and on actual return donation attempt. 

13 
 
 
Figure 3: Theory of planned behaviour 
The Technology Acceptance Model 
As shown in Figure 5, according to the technology acceptance model, intention to use 
technology (in this case, WhatsApp) is influenced by perceived usefulness and perceived ease 
of use of the technology (Venkatesh & Bala, 2008). 
 
Figure 4: Technology Acceptance Model 
Randomization 
The docu-drama design and test-run will not employ randomization.  The participants enrolled 
in the pilot RCT will be randomized immediately following the baseline assessment with a 1:1 
allocation ratio to WhatsApp or control using blocked randomization (with randomly mixed 

14 
 
and varying block sizes) stratified by blood donor type. Computer-generated random 
intervention assignments will be generated by an independent study statistician and conveyed 
electronically through a web-based app at the time of enrollment to preserve allocation 
concealment. The upcoming intervention assignment will be concealed from the study staff 
prior to the randomization outcome. Details on randomization are outlined in the randomization 
Standard Operating Procedure under “Study tools”. 
Blinding  
This study uses behavioural interventions. Participants and most study staff are not blinded to 
the intervention assignment. However, both baseline and post-intervention questionnaire 
administration will be conducted by research assistants who will not be made aware of the 
treatment assignment of participants. 
 
 

15 
 
Methodology  
Study Interventions 
Docu-drama pilot test-run: Participants assigned to this group meet once during the 
intervention. Participants will be asked to watch, in the group setting, a two-episode drama, 
each lasting 15 minutes. The docu-drama on blood donation will address their concerns for 
donating blood again and address common donor fears. This will be followed by a one- hour 
discussion. The meeting will also address common donor fears. The meeting will be facilitated 
by two project team members who will moderate discussions, record attendance, and make 
notes on discussions and outcomes. Participants also receive standard National Blood Service 
Ghana (NBSG) communications for first-time donors (see below). The docu-drama design is 
subject to change in response to objective 1. 
WhatsApp: Participants assigned to the WhatsApp group will receive weekly messages 
developed by communication specialists aimed to motivate blood donation, be encouraged to 
discuss their blood donation experiences, and share their own motivations for donating blood 
in a moderated, closed group over a six-month duration. The moderator will provide guidelines 
on acceptable use of WhatsApp, including images they can or cannot share.  Participants also 
receive standard NBSG communications for first-time donors (see below). WhatsApp 
functions both online and offline. When a participant's WhatsApp is offline (i.e. not connected 
to the internet), the participant can access posted messages received earlier, respond to these 
posts and post new comments. However, the participant can only receive newly posted 
messages only when the WhatsApp is connected to the internet (online). Similarly, the 
participant's posted messages will only be sent when the participant's WhatsApp is back online. 

16 
 
Control: Participants in this group will receive the standard NBSG communications for first-
time donors 1) a “thank you” phone call and 2) and a reminder phone call two-weeks prior to 
the second blood donation eligibility. The second blood donation eligibility is four months after 
the first donation. 
Avoiding intervention contamination: For the docu-drama intervention, only those 
invited to receive the intervention will be allowed to view the docu-drama in and be part 
of the discussions to avoid intervention contamination. In addition, the docu-drama 
viewing will be conducted face-to-face, which will make it impossible for those who are 
not present to share the content. For the WhatsApp intervention, only those randomly 
selected to be part of the WhatsApp intervention group would receive the messages and 
be part of the discussion. Participants will be advised against sharing the contents of the 
WhatsApp intervention with those who are not in the group to avoid contamination. 
As shown in Figure 2, the two interventions, WhatsApp and docu-drama, are expected to lead 
to sharing of positive experiences, leading to repeat blood donors. However, for these to occur, 
the project has several assumptions as indicated in black triangles. 
Figure 5: The Theory of Change: Community-Based Communication Approaches for Blood 
Donation in Ghana 
A major assumption is that there will be high fidelity of the interventions. We will assess 
adherence to the interventions as a key element of fidelity (Carroll et al., 2007). Adherence will 
include subcategories of content, frequency, duration and dose (Carroll et al., 2007). The extent 
to which the intended content or frequency of WhatsApp and docu-drama are implemented will 

17 
 
represent the degree of implementation fidelity achieved for the two interventions (Carroll et 
al., 2007; Song et al., 2010). 
Study Population 
Inclusion Criteria 
Docu-drama design 
Design workshop participants will be drawn from blood donors, non-blood donors, drama 
experts, drama actors, and communication professionals. All must be at least 18 years old, 
consent to participate and understand English. 
WhatsApp intervention design 
Key informants will be drawn from the NBSG staff, community-based blood donation 
volunteers, blood donors, and non-blood donors. All must be at least 18 years old, consent to 
participate, and understand one of English, Twi, or Ga. 
Pilot RCT  
• At least 18 years-old 
• First-time whole blood donor with the SZBC of the NBSG 
• Eligible to donate again 
• Consent to participate 
• Understands one of English, Twi, or Ga 
• Have a smart phone 
• Have, or be willing to sign up for an active WhatsApp account 
Docu-drama test-run 
• At least 18 years-old 
• First-time whole blood donor with the SZBC of the NBSG 
• Eligible to donate again 
• Consent to participate 
• Understands one of English, Twi, or Ga 
 
 

18 
 
Exclusion Criteria 
Docu-drama design 
Do not meet the above inclusion criteria 
WhatsApp intervention design 
Do not meet the above inclusion criteria 
Pilot RCT 
History of more than one lifetime whole blood donation (with any blood centre) 
Docu-drama test-run 
History of more than one lifetime whole blood donation (with any blood centre) 
Outcome measures   
Primary Outcome 
The primary outcome for the pilot RCT is to estimate the proportion of return blood donation 
attempts within six months of enrollment for each arm. 
Secondary Outcomes 
The secondary outcomes are the following measures. 
WhatsApp and control 
• Blood donation attitudes,  
• subjective norms,  
• perceived behavioural control,  
•  intention, 
•  ease of use of WhatsApp, 
•  perceived usefulness of WhatsApp. 
Docu-drama, WhatsApp and control 
• Intention of using the intervention 

19 
 
• Acceptability of the intervention 
• Feasibility of the intervention 
• Cultural appropriateness of the intervention 
• Intervention relatedness 
Several measures are new or adapted: cultural appropriateness, acceptability, feasibility, 
perceived usefulness and perceived ease of use. These measures will be assessed for reliability. 
The secondary outcomes will be determined through the use of questionnaires.  
Sample Size Assumptions 
Docu-drama design sample size 
The planning of the docu-drama will involve participants who will take part in the drama design 
workshop discussion (n=20). In addition, we will recruit n=10 first-time donors to test-run and 
provide feedback on the newly designed docu-drama intervention.  
WhatsApp intervention sample size 
Key informant interviews (n=24) will help the team to identify how the WhatsApp platform 
will be used, and the WhatsApp intervention. 
Pilot RCT sample size 
The targeted sample size is 64 first time blood donors per treatment arm. 
One of the primary objectives is to estimate the proportion of return blood donation for 
planning the randomized clinical trial in the UH3 phase. As the donor return rates are unknown 
given the Covid-19 pandemic, we focused on obtaining an acceptable precision of event rates 
for the sample size and power calculation for the UG3 phase. Figure 6 presents the sample size 
needed to achieve 80% confidence interval length equal to 0.15, 0.20, and 0.25 using the Exact 
(Clopper-Pearson) method, assuming the return rate ranging from 5% to 30% (Fleiss et al., 
2003, Newcombe et al., 1998). A sample size of 59 produces a two-sided 80% confidence 
interval with a width equal to 0.149 when the sample proportion is 20%, which is the targeted 
donor return rate in the WhatsApp group. Considering 10% lost-to-follow-up, we would need 
a sample size of 64 for each treatment arm. 
 

20 
 
Alternatively, Figure 7 presents the minimum donor return rate in the WhatsApp group that 
can be significantly detected under various effective sample sizes and event rates in the control 
group. For example, if the donor return rate in the control group is 3%, an effective sample size 
of 59 in each group achieve 80% power to detect a minimum difference of 17.21% (i.e. the 
donor return rate in the WhatsApp group = 20.21%) when using the two-sided Fisher's exact 
test, with a 2-sided Type I error rate of 5%. 
 
 
Figure 6: Sample size calculation based on precision 
 
 

21 
 
 
Figure 7: Alternative sample size calculation 
 
 
 
 
 
 
 
 
 
 
 

22 
 
Schedule of Assessments: Follow-Up 
The participants will be invited to participate in screening after blood donation at SZBC sites. 
Table 1: Schedule of assessments for pilot RCT 
Assessment 
Screening 
(At first-time 
donation) 
 
Baseline A 
pre-
randomization 
(Day 0) 
Baseline B 
post- 
randomization 
(Day 0) 
6-month 
follow-up 
(Days 176-
190)1 
6-12 
months 
follow-up 
Informed Consent Form   
X 
 
 
 
 
Demographics  
X 
 
 
 
 
Blood donation attitudes, 
subjective norms, perceived 
behavioural control, and 
intention 
 
X 
 
X 
 
Randomization 
 
 
X 
 
 
Intention of using the 
intervention   
 
 
X 
 
 
Acceptability of the 
intervention 
 
 
X 
X 
 
Feasibility of the intervention 
 
 
X 
X 
 
Cultural appropriateness of 
the intervention 
 
 
X 
X 
 
Perceived usefulness of the 
intervention 
 
 
X 
X 
 
Perceived ease of use of the 
intervention   
 
 
X 
X 
 
Intervention relatedness 
 
 
X 
X 
 
Return blood donation 
attempts2   
 
 
 
X 
 
Focus groups of participant 
views of acceptability, 
effectiveness, feasibility, and 
cultural appropriateness 
 
 
 
 
X 
Note:  The participants involved in the test-run of the docu-drama will be surveyed prior-to and after the 
docu-drama with all instruments (except blood donation attempts) and participate in facilitator-led focus 
groups. 
1 6-months with a 2-week window. 
2 Donor return will be assessed via telephone calls and cross-checked with SZBC donor records. 
 
 
 
 

23 
 
 
Follow-up assessments for the pilot RCT 
There will be two follow-up assessments. 
6 months 
The 6-month assessment for the pilot RCT will occur over the phone with a 2-week window 
of the 6-month pilot. Donor return will be assessed via telephone calls and cross-checked with 
SZBC donor records. The six-month follow-up will repeat baseline post-randomization 
questionnaires and include the intention of using the intervention, acceptability of the 
intervention, feasibility of the intervention, cultural appropriateness of the intervention, 
perceived ease of use of the intervention, perceived usefulness of the intervention, and 
intervention relatedness. In line with definitions of acceptability, appropriateness and 
feasibility given by Weiner et al. (2017), we defined these characteristics as follows: 
Acceptability is the perception among first-time blood donors that an intervention is agreeable 
or satisfactory for promoting blood donation. Thus, acceptability will be measured with a five-
item questionnaire. 
Cultural appropriateness is the perceived fit, relevance, or compatibility of an intervention; 
and/or perceived fit of these interventions for promoting blood donation among first-time blood 
donors (Weiner et al., 2017). Cultural appropriateness will be measured with a five-item 
questionnaire. 
Feasibility is defined as the extent to which an intervention, can be successfully used by the 
NBSG to promote blood donation among first-time blood donors. Feasibility will be measured 
with a six-item questionnaire by integrating appropriateness measures (Weiner et al.,2017) and 
the role of culture as it pertains to health communication (Kreuter & McClure, 2004). 
The extent to which respondents participated in the activities will also be documented for the 
WhatsApp intervention and includes not leaving the WhatsApp group during the intervention; 
evidence of having read a post, an indicator that can be used in closed WhatsApp groups such 
as the one to be implemented in the study, and posting at least once a month. Those not reading 
50% of the weekly post by the moderator and not posting at least three times during the 
intervention will be considered as non-adherent. The WhatsApp group moderator will obtain 
participation data by checking the read status and post by participants.  

24 
 
6–12 months 
The second follow-up will involve facilitator-led participant focus group (8 participants per 
group) discussions of views on acceptability, effectiveness, feasibility, and cultural 
appropriateness. 
The participants involved in the test-run of the docu-drama will be surveyed after the docu-
drama with all follow-up instruments (except blood donation attempts) and participate in 
facilitator-led focus-groups similar to participants in the pilot RCT. 
All the constructs will be constructed using a 5-point Likert scale ranging from “completely 
disagree” to “completely agree”. Focus group discussions will also be held with 6–8 
participants from each group to assess all the above implementation research outcomes of 
interventions. 
 
 
 

25 
 
Risk/Benefit Assessment 
Known Potential Risks 
Potential risks may include breach of confidentiality and any discomfort that may result from 
discussions of the docu-drama or issues about blood donation. However, these risks are 
minimal and are not more than those encountered in everyday life. 
Those assigned to the docu-drama may be at risk of contracting COVID-19 if safety 
protocols are not adhered to during group meetings. To mitigate this risk, the viewing of the 
docu-drama will be held in a spacious environment where social distancing can be observed 
and participants will be seated six feet apart. All participants to be required to wear study 
provided face masks, adhere to socially distanced seating markers and walking directions, 
and other COVID-19 safety protocols. 
There is also the potential of participants assigned to the WhatsApp group posting comments 
or images that may be upsetting to others. Participants will be given guidelines to follow to 
mitigate these risks. Participants will have access to each other’s personal information (names 
and phone numbers). They may also share other personal details or experiences, all of which 
should be kept strictly confidential. This may lead to a breach of confidentiality for participants. 
From the outset, participants will sign a confidentiality agreement, in which privacy and 
confidentiality (and how they can be breached) will be explained, and participants will agree 
to uphold confidentiality and privacy throughout. 
Known Potential Benefits 
This study is expected to lead to increased motivation to repeat blood donation. Learning about 
the challenges around blood donation will help us to address these in the future. This could 
have a very important impact on patients who require blood transfusion as part of their medical 
treatment and will hopefully save many lives. 
Safety Assessment 
Definitions 
Adverse Event (AE) 
This is a socio-behavioural study, and thus clinical adverse events are unlikely. 

26 
 
Potential risks may include breach of confidentiality, and any discomfort that may result from 
WhatsApp group participation, discussions of the docu-drama group meetings, or issues about 
blood donation. In other words, while we will make every effort to de-identify any information 
participants share with the team, it may not be possible to keep their identity completely 
anonymous from those who may know their role closely. However, these risks are minimal and 
are not more than those encountered in everyday life. 
There is also the potential of participants assigned to the WhatsApp group posting comments 
or images that may be upsetting to others. Participants will be given guidelines to follow to 
mitigate these risks, and a moderator will monitor the group interactions. 
Serious Adverse Event (SAE) 
Serious adverse events (SAEs) are defined as the following: 
• Death 
• Life-threatening (i.e., an immediate threat to life) 
• Hospitalization or prolongation of hospitalization 
• Persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions 
• Congenital abnormalities/birth defects 
Other important medical events that may jeopardize the participant and/or may require 
intervention to prevent one of the outcomes listed above. 
This study does not anticipate any serious adverse events. 
 
 
 
 
 
 
 

27 
 
Data Analysis 
Qualitative Data Analysis 
All qualitative data collection will proceed simultaneously with data analysis. 
Focus group discussions and key informant interviews will be audio recorded with consent 
from the participants. The recorded interviews and focus group discussions will be tracked and 
uploaded to the DCC secure server. The recorded information will be transcribed verbatim and 
will be translated where appropriate. 
The framework method will be used for data analysis. This is in part because of the multi-
disciplinary team involved in the research (Gale et al., 2013) and use of a-priori themes 
(Srivastava & Thomson, 2009). The framework analysis will have five steps (Srivastava & 
Thomson, 2009). 
1. Familiarization: Researchers will read the transcripts thoroughly to gain an understanding of 
the qualitative data collected. 
2. Identifying a thematic framework: Researchers will identify key themes from the transcripts. 
The themes will be determined a-priori, but other themes that emerge will be identified. The 
themes will include barriers to becoming a repeat donor and motivations for being a repeat 
donor. These themes will be used to guide intervention development, and to assess secondary 
outcomes. 
3. Indexing: Researchers will identify portions or sections of the data that match particular 
themes. 
. Charting: This will involve arranging specific pieces of data that were indexed in the previous 
stage into charts. This means that the data will be lifted and placed in charts that consist of the 
headings and subheadings that were drawn during the thematic framework, or from a priori 
research inquiries or in the manner that is perceived to be the best way to report the research. 
5. Mapping and interpretation: The research team will analyse key characteristics as laid out in 
the charts and generate a schematic diagram of the key themes. This will include creating 
typologies, finding associations, providing explanations, and developing strategies. 
Data will be coded and analyzed for themes using the Qualitative Software and Research (QSR) 
Nvivo Release 1.0 (Released March 18, 2020). 

28 
 
Information from the different qualitative methods will be linked to the focus of the study as 
follows: 
1. Key informant interviews: These will be used to get information that will help the 
research team to identify challenges and motivations for first-time blood donors to 
repeat donation among respondents. The information will help in creating the study 
interventions. 
2. Design workshop: Information from the design workshop will be used to create a 
design document to guide the scriptwriter to produce a script that truly captures the 
focus of the drama intervention. 
3. Focus group discussions: Information from the focus groups will be used to identify 
what worked and what did not work well for the interventions, and to assess the 
acceptability, feasibility and cultural appropriateness of the interventions. 
Quantitative Data Analysis 
Statistical analysis will be completed using SAS or R. 
Analysis pilot trial: 
The analysis for the pilot study is to inform the planned larger UH3 randomized controlled trial 
and will follow the same anticipated primary analysis (see below) with acknowledgment of 
low power to evaluate effectiveness. 
The feasibility of the larger study will be assessed with descriptive statistics for enrollment 
rates, retention, and adherence.  Key blood donation measures needed to inform the design of 
the larger UH3 randomized controlled study will be analyzed and include the proportion of 
participants who return to the blood centre to donate blood. 
Primary analysis (anticipated) for the larger UH3 randomized controlled trial: 
Baseline characteristics and outcome variables of each group will be summarized by 
proportions for categorical variables and means with standard deviations for continuous 
variables as appropriate. The primary analysis will be performed as ‘intent-to-treat’ with all 
enrolled subjects included in the analysis as randomly allocated regardless of actual 
compliance. All analyses will account for stratification by blood donor type. The primary 
analysis will use logistic regression with a two-sided type I error of 5% using robust standard 

29 
 
errors.  Secondary analyses are not adjusted for known multiplicities (e.g., multiple secondary 
endpoint assessment).  As such, all secondary analyses will intentionally not focus on 
conclusions around the statistical significance, but rather on practical or clinical benefit. Each 
additional outcome measure will be analyzed separately by appropriate generalized linear 
regression models (e.g., logistic regression models for binary outcomes and linear models for 
continuous outcomes) in a similar way to the primary analysis using robust standard errors. 
Subgroup analyses for the primary endpoint and major secondary outcomes will be performed 
to determine whether the intervention differs qualitatively across various baseline-defined 
subgroups. Subgroup analyses will be performed by age, gender, blood donation group, and 
blood donation type (e.g., voluntary non-remunerated, family/replacement blood donors). An 
overall test of heterogeneity will provide evidence of whether the magnitude of the estimates 
varies across these baseline subgroups. 
If necessary, missing data will be handled by multiple imputation via chained equations 
(MICE), as implemented in SAS PROC MI procedure (White et al., 2011). 
Quality Assurance 
A Data Safety Monitoring Board (DSMB) will provide independent monitoring of this pilot 
study in accordance with the BLOODSAFE DSMB charter. The DSMB will have an 
opportunity to review the protocol and informed consent and provide feedback prior to study 
initiation. An open report will be prepared by a DCC statistician, and a closed report will be 
generated by statisticians from the DCC. Interim data summaries will be prepared by the DCC 
statisticians and reviewed at regular intervals by the DSMB (at least twice a year). The DSMB 
is an oversight committee assigned by the National Institutes of Health (NIH) to oversee 
the conduct of the study. 
The DSMB will review the quality and completeness of study data and enrollment data at each 
meeting to ensure proper trial conduct. Study personnel should provide any new literature 
particularly pertinent to the trial, along with their recommendation as to whether it affects the 
trial conduct or design. The DSMB will review the consent periodically and/or as needed and 
consider whether the consent form requires revision in light of any new findings or 
amendments. 
 
 

30 
 
Expected Outcomes of the Study 
This study will contribute to the literature the use of communication interventions for 
promoting repeat blood donation in Ghana. The findings could influence the design of socio-
behavioral interventions to positively influence blood donation in Ghana. Increased blood 
donation will lead to improved health outcomes.    
Dissemination of Results and Publication Policy 
At the end of the study, we will disseminate the results through 
• Report to the Ghana Health Service 
• Report to the National Blood Service, Ghana  
• Report to our funder  
• Publications in peer-reviewed journals 
• Conference presentations 
• Mass media  
 
 

31 
 
Problems Anticipated and Unanticipated  
We anticipate that some respondents may not be willing to take part in the study.  
Unanticipated Problems 
An Unanticipated Problem (UP) is any incident, experience, or outcome that is: 
1. 
Unexpected in terms of nature, severity, or frequency in relation to: 
a. the research risks that are described in the IRB-approved research 
protocol and informed consent document; or other study documents; and 
b. the characteristics of the population being studied; and 
2. 
Possibly, probably, or definitely related to participation in the research; and 
3. 
Places study participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously 
known or recognized. 
 
Furthermore, an UP could be an expected event that occurs at a greater frequency than would 
be expected based on current knowledge of the disease and treatment under study. The DSMB 
providing oversight to the study may make such an assessment based on an aggregate analysis 
of events. 
Participants who attend the viewing of the docu-drama will be seated six feet apart, with all 
participants being required to wear face masks (individual or study provided), observe social 
distancing, handwashing, use of study provided hand sanitizers, and adhere to any new 
COVID-19 safety protocols. 
The national responses to COVID-19 to minimize spread, including social distancing, ban on 
gatherings, and closure of institutions and lockdown, have resulted in the cancellation of 
scheduled mobile blood donation sessions, closure of institutions that are the major groups that 
donate blood (schools, churches, mosques, corporate organizations). There is also reduced 
blood donations at fixed sites due to reduced numbers of FRDs on account of cancellation of 
elective surgeries, fear of visiting hospital-based collection sites, and reduced prioritization of 
blood donation due to public anxiety and economic stress. 
These problems, if they remain, could have an impact on the recruitment of participants for the 
randomized control trial and the pre-trial activities. 

32 
 
Those assigned to interventions requiring meetings may be at risk of contracting COVID-19 if 
safety protocols are not adhered to during group meetings. 
Project Management 
This protocol is one of two being supported by the National Heart, Lung and Blood Institutes 
of the US-based National Institutes of Health.  
The study will have the following organizational components:   
One active Coordinating site at the Department of Hematology, Korle-Bu Teaching 
Hospital/College of Health Sciences  
• 
NIH Steering Committee for BLOODSAFE Consortia  
• 
Executive Committee  
• 
Advisory committee  
• 
Operations committee  
• 
Implementation Science Committee,   
• 
Data and Safety Monitoring Committee   
 
 Committee 
Type:   
Participants:   
Responsibilities  
NIH Steering 
Committee for  
BLOODSAFE  
Consortia  
NIH SC Chair  
NIH/NHLBI Staff  
Data Coordinating Center (DCC)  
Dr Yvonne Dei-Adomakoh (PI)  
Dr. Lucy Asamoah-Akuoko (PI)   
Dr. Bernard Appiah (SU PI)  
Kenya Site PIs  
Uganda Site PIs  
  
§ 
Serve as the main governing board and 
monitor progress  
§ 
Facilitate coordination and synergy for 
the entire program  
§ 
Develop recommendations for uniform 
procedures and policies  
§ 
Identify issues that have broad 
applicability across the program  
§ 
Determine research collaborations 
such as methodology, data, and core 
measures and assessment available  
§ 
Review the protocols developed by the 
Research Teams  
§ 
Subcommittees  
§ 
e.g. Publications Committee  
  

33 
 
Executive 
Committee   
Dr Yvonne Dei-Adomakoh (PI) 
(Chair)  
Dr. Lucy Asamoah-Akuoko (PI)   
Dr. Bernard Appiah (SU PI)  
Project Admin(s)  
   
Meetings of the Executive Committee shall 
be called by the chair.  
• 
Staff recruitment  
• 
Review progress and timelines, 
enrollment  
• 
Review conduct of the protocol  
• 
Discuss regulatory issues  
• 
Review responsibilities and 
performance of staff and other 
investigators  
• 
Discuss feasibility scientific merit of 
proposed studies or publications, and 
issues raised by the various sites.   
Advisory 
Committee  
Prof. Imelda Bates   
Prof. Solomon Ofori-Acquah  
Dr. Justina Ansah  
• 
Provides non-binding strategic advice 
to the Executive Committee.  
• 
The Advisory Committee members 
bring valuable expertise, knowledge, 
and appreciation of matters within 
their areas of expertise, and are asked 
for input into strategy, policy and the 
future direction of the project.  
Operations 
Committee   
Dr. Yvonne Dei-Adomakoh (PI)   
Dr. Lucy Asamoah-Akuoko (PI)  
Dr. Bernard Appiah (SU PI)   
All Co-Investigators   
Project Admin(s)  
Research Officers  
• 
Update on progress of implementation 
on tasks and protocol  
• 
Discuss day to day implementation 
issues  
• 
Knowledge sharing   
Implementation  
Science  
Committee  
Dr. Yvonne Dei-Adomakoh (PI)  
Dr. Lucy Asamoah-Akuoko (PI)  
Dr. Bernard Appiah (SU PI)  
Prof. Philip Adongo (Co-I)  
Dr. Tara Tancred (Co-I)  
Dr. Seth Adu-Afarwuah (Co-I)  
• 
Make input into, and review the 
implementation science aspects of the 
project  

34 
 
Data Safety and  
Monitoring  
Committee  
Dr. Yvonne Dei-Adomakoh (PI)  
Dr. Lucy Asamoah-Akuoko (PI)  
Dr. Bernard Appiah (SU PI)  
Prof. Alfred Yawson  
Dr. Seth Adu-Afarwuah  
Data Quality Officer  
  
• 
Periodically review and evaluate the 
accumulated study data for participant 
safety study conduct and progress, and, 
when appropriate, efficacy  
• 
Make recommendations concerning the  
continuation, 
modification, 
or 
termination of the trial  
 
 

35 
 
Protection of Human Subjects and Other Ethical Considerations 
Participating Clinical Sites and Local Review of Protocol and Informed Consent 
Participating sites include fixed and mobile blood donation sites of the Southern Zonal Blood 
Center National Blood Service Ghana. Ethical approval will be sought from the Ghana Health 
Service Research Ethics Committee.  Approval will also be sought from the Institutional 
Review Board of the College of Health Sciences, University of Ghana. and the University of 
Minnesota. Written approvals obtained will be from these institutions prior to the 
commencement of the study. 
Ethical Conduct of the Study 
The study will be conducted according to the Declaration of Helsinki in its current version; the 
requirements of Good Clinical Practice (GCP) as defined in Guidelines, EU Clinical Trials 
Directive (2001/20/EC), and EU GCP Directive (2005/28/EC); International Council for 
Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) 
Guidelines; Human Subject Protection and Data Protection Acts; the US Office for Human 
Research Protections (OHRP); or with the local law and regulation, whichever affords greater 
protection of human subjects. 
Informed Consent of Study Participants 
Eligible participants will be informed about the project in English or their preferred local 
language by a senior project staff member trained in obtaining informed consent. Information 
provided for participants will include a description of the project, potential benefits and risks 
to themselves, and the expected outcomes and impact of the project. They will be assured of 
the anonymity of their data and that if they choose not to participate, it will not affect their 
normal donor care. They will be allowed time to ask questions and consider whether or not 
they want to participate before being asked to sign (or thumbprint if they cannot write) the 
consent form. For a participant who is not able to read and write, the purpose and contents of 
the participant information sheet (Appendices I, J, L, and M) will be read and explained 
satisfactorily to him/her in the local language he/she understands. All questions and 
clarifications raised by the participant and responses from the investigator will also be 
translated. The participant will be given a copy of the signed form, and the original will be 
stored in a locked cabinet, which is only accessible to the project team. 

36 
 
Known Potential Risks 
Potential risks may include breach of confidentiality and any discomfort that may 
result from discussions of the docu-drama or issues about blood donation. However, 
these risks are minimal and are not more than those encountered in everyday life. 
There is also the potential of participants assigned to the WhatsApp group posting 
comments or images that may be upsetting to others. Participants will be given guidelines 
to follow to mitigate these risks. Participants will have access to each other’s personal 
information (names and phone numbers). They may also share other personal details or 
experiences, all of which should be kept strictly confidential. This may lead to a breach 
of confidentiality for participants. From the outset, participants will sign a confidentiality 
agreement, in which privacy and confidentiality (and how they can be breached) will be 
explained, and participants will agree to uphold confidentiality and privacy throughout. 
Known Potential Benefits 
This study is expected to lead to increased motivation to repeat blood donation. Learning 
about the challenges around blood donation will help us to address these in the future. 
This could have a very important impact on patients who require blood transfusion as 
part of their medical treatment and will hopefully save many lives. 
Compensation 
Other than participant’s time and the cost of data for participating in WhatsApp groups, and 
online interviews/discussions, participants will not incur any costs for participating in this 
study. Participants will not be paid for participating in this study. Focus group and docu-drama 
workshop participants will be reimbursed with the Ghana Cedi equivalent of 10 US Dollars for 
direct transport cost and internet data respectively, and refreshments will be offered during 
focus group discussion meetings. All participants in the WhatsApp intervention pilot 
Randomized Controlled Trial will be given internet data worth the Ghana Cedi equivalent of 
3.5 US Dollars per month for the period of the intervention. 
Funding information 
This study is funded by the National Heart, Lung, and Blood Institute (NHLBI), National 
Institutes of Health (NIH) of the United States. Grant Number 1UG3HL151599-01. 

37 
 
Declaration of Conflict of Interest 
None declared. 
COVID-19 Social Protocols 
Those assigned to the docu-drama may be at risk of contracting COVID-19 if safety 
protocols are not adhered to during group meetings. To mitigate this risk, the viewing of the 
docu-drama will be held in a spacious environment where social distancing can be observed 
and participants will be seated six feet apart. In addition, focus group discussion participants 
will be required to observe all COVID-19 protocols. All participants will be required to wear 
study provided face masks, adhere to socially distanced seating markers and walking 
directions, and other COVID-19 safety protocols. Where possible, data collection (surveys 
and docu-drama design workshop) have been planned to be conducted via phone or online 
to reduce the risk of COVID-19 transmission. 
Confidentiality of Study Participants 
The confidentiality of the data provided will be assured at all stages of the project. Data 
collectors will take every precaution possible to ensure risks to participants are minimized, and 
information is kept confidential. This will include holding interviews in a private setting where 
they will not be overheard by anyone else. Confidentiality of all individuals who provide data 
through focus group discussions will be upheld by asking participants to agree to keep any 
responses heard confidential. All completed questionnaires will be numerically coded to ensure 
anonymity. Electronic files will be stored in an encrypted and password-protected database on 
a secure server by the Data Coordinating Center (DCC). Only research team members who 
contact the subjects will have access to information linked to subject identifiers. All the data 
that are interview and focus group tapes, transcripts, electronic data, and completed 
questionnaires will be available only to the research team and will be kept locked up in a metal 
cabinet in the PI’s office for 5 years and then destroyed. 
Regulatory Oversight 
Approvals will be sought from the BLOODSAFE Steering Committee, and NHLBI protocol 
review teams, the Ghana Health Service Ethics Review Committee, and IRBs of collaborating 
Institutions (College of Health Sciences of the University of Ghana, Syracuse University, and 
Liverpool School of Tropical Medicine) for the trial protocol, written informed consent form 

38 
 
(ICF), consent form updates, participant recruitment procedures and any other written 
information to be provided to study participants. Prior to the start of the study, all of the 
instructions and procedures found in this protocol will be read and accepted by the study team. 
An inspection of the clinical site (site initiation visit) will be done by NHLBI (or a designated 
representative) before the start of the study. 
Monitoring will occur in coordination with the data coordinating centre (DCC), the principal 
investigator (PI), and an independent data safety and monitoring board (DSMB).  Regulatory 
requirements and site-level interim monitoring will be tracked by the DCC. The PI will ensure 
the required documentation is available to the DCC and site monitoring personnel. The 
National Heart, Lung, and Blood Institute (NHLBI) will be responsible for providing program 
oversight through an independent DSMB. 

 
 
II Timeline 
The timeline of the project is as shown below.  
 
 
 
 
J
A S
O N D J
F
M A M J
J
A S
O N D J
F
M A M J
J
A S
O N D J
F
M
1 Study Protocol Development and Approvals
Protocol Version 0.1
Steering Committee Review 1
Protocol Version 0.2
Steering Committee Review 2
Protocol Version 0.2
DSMB/OSMB Review
Local IRB Reviews and Approvals (Version 1)
2 Development and evaluation of Interventions (WhatApp/Drama)
KII/Design Workshop/Qualitative data analysis
Development of  WhatsApp Intervention
Developmemt  of Drama
Test Run of Docu-Drama (Viewing, Survey, FGD)
Pilot 2-Arm RCT (WhatsApp+Control) 
Baseline
25% Enrollment
50% Enrollment
75% Enrollment
100% Enrollment
Pilot 2-Arm RCT  (WhatsApp+Control) Follow-
Data Collection (Survey + FGDs)
FGD FGD FGD FGD4
Data Analysis (Survey + FGDs)
Reports/Manuscripts
UH3 Protocols
2023
YEAR 2
UG3
ACTIVITY
YEAR 1
2020
2021
2022
                                                               BLOOSAFE Ghana Site Project - UG3 Timelines: Aim 1
YEAR 3

 
 
References  
Appiah, B. (2013). Promoting blood donation in Sub-Saharan Africa: Role of culture and 
interventions (Doctoral dissertation). 
Aranda-Jan, C. B., Mohutsiwa-Dibe, N., & Loukanova, S. (2014). Systematic review on what 
works, what does not work and why of implementation of mobile health (mHealth) projects in 
Africa. BMC public health, 14(1), 188. 
Asamoah-Akuoko, L. (2018). Evolving strategies to encourage repeat donations among first time 
voluntary and replacement blood donors in southern Ghana (Doctoral dissertation, University of 
Liverpool). https://livrepository.liverpool.ac.uk/3028674/. 
Asamoah-Akuoko, L., Hassall, O. W., Bates, I., & Ullum, H. (2017). Blood donors' perceptions, 
motivators and deterrents in Sub-Saharan Africa – a scoping review of evidence. British Journal 
of Haematology, 177(6), 864-877. 
Asamoah‐Akuoko, L., Ullum, H., Appiah, B., Hassall, O. W., Ndanu, T., Adongo, P., & Bates, I. 
(2020). Determinants of intention to return to donate blood among first‐time blood donors in 
Ghana. Vox Sanguinis.  https://doi.org/10.1111/vox.13026 
Asenso-Mensah, K., Achina, G., Appiah, R., Owusu-Ofori, S., & Allain, J. P. (2014). Can family 
or replacement blood donors become regular volunteer donors? Transfusion, 54(3pt2), 797-804. 
Bagot, K. L., Murray, A. L., & Masser, B. M. (2016). How can we improve retention of the first-
time donor? A systematic review of the current evidence. Transfusion medicine reviews, 30(2), 
81-91. 
Carroll, C., Patterson, M., Wood, S., Booth, A., Rick, J., & Balain, S. (2007). A conceptual 
framework for implementation fidelity. Implementation science, 2(1), 40.  
Creswell, J. W. (2002). Research design: Qualitative, quantitative, and mixed methods 
approaches. Sage publications. 
Custer, B., Zou, S., Glynn, S. A., Makani, J., Tayou Tagny, C., El Ekiaby, M., ... & Peprah, E. 
(2018). Addressing gaps in international blood availability and transfusion safety in low‐and 
middle‐income countries: a NHLBI workshop. Transfusion, 58(5), 1307-1317. 
Duboz, P., Macia, E., & Cunéo, B. (2010). Sociodemographic and attitudinal factors to blood 
donation in the urban population of Dakar, Senegal. Transfusion, 50(12), 2713-2720. 
Fleiss, J. L., Levin, B., & Paik, M. C. (2003). Statistical methods for rates and proportions. John 
Wiley & Sons: Hoboken, New Jersey. 

 
 
Gale, N. K., Heath, G., Cameron, E., Rashid, S., & Redwood, S. (2013). Using the framework 
method for the analysis of qualitative data in multi-disciplinary health research. BMC medical 
research methodology, 13(1), 1-8. 
Ghana Statistical Service. (2012). 2010 Population & Housing Census: Summary report of final 
results. Accra. Retrieved from 
http://www.statsghana.gov.gh/docfiles/2010phc/Census2010_Summary_report_of_final_results.
pdf 
Ghana Statistical Services. (2019). Population by Regions, 2019. Retrieved August 18, 2020, 
from https://statsghana.gov.gh/regionalpopulation.php?population 
Godin, G., Vézina-Im, L. A., Bélanger-Gravel, A., & Amireault, S. (2012). Efficacy of 
interventions promoting blood donation: a systematic review. Transfusion medicine reviews, 
26(3), 224-237. 
Green, L., & Kreuter, M. (1999). The precede–proceed model. Health promotion planning: an 
educational approach. 3rd ed. Mountain View (CA): Mayfield Publishing Company, 32-43. 
Guest G, Namey E, McKenna K. How Many Focus Groups Are Enough? Building an Evidence 
Base for Nonprobability Sample Sizes. Field Methods. 2017;29(1):3-22. 
Joronen, K., Rankin, S. H., & Åstedt-Kurki, P. (2008). School‐based drama interventions in 
health promotion for children and adolescents: systematic review. Journal of advanced nursing, 
63(2), 116-131. 
Kreuter, M. W., & McClure, S. M. (2004). The role of culture in health communication. Annu. 
Rev. Public Health, 25, 439-455. 
Masser, B. M., Bednall, T. C., White, K. M., & Terry, D. (2012). Predicting the retention of first-
time donors using an extended Theory of Planned Behaviour. Transfusion, 52(6), 1303-1310.  
Muthivhi, T. N., Olmsted, M. G., Park, H., Sha, M., Raju, V., Mokoena, T., ... & Reddy, R. 
(2015). Motivators and deterrents to blood donation among Black South Africans: a qualitative 
analysis of focus group data. Transfusion Medicine, 25(4), 249-258. 
NBS Ghana. (2011). Request for Task Order Proposal (RFTOP) blood safety contract, Ghana. 
NBS Ghana. (2020). National Blood Service Ghana: 2019 Annual Performance Review (Annual 
Report). Accra. 
Newcombe, R. G. (1998). Two-sided confidence intervals for the single proportion: comparison 
of seven methods. Statistics in medicine, 17(8), 857-872. 

 
 
Roberts, N., James, S., Delaney, M., & Fitzmaurice, C. (2019). The global need and availability 
of blood products: a modelling study. The Lancet Haematology, 6(12), e606-e615. 
Rodrigues Lucena, T. F., Queiroz Negri, L., Marcon, D., & Yamaguchi, M. U. (2020). Is 
WhatsApp Effective at Increasing the Return Rate of Blood Donors? Telemedicine and e-Health, 
26(3), 304-309. 
 
 

1 
 
Participant Information and Consent Forms 
1. Participant Information Sheet for Key Informant Interviews 
Title: Community-based communication interventions for increasing the blood donor pool 
in Ghana: a pilot randomized controlled trial 
Introduction: 
Hello. My name is ________________________________________, I am working with the 
BLOODSAFE Ghana team, conducting a research study with the National Blood Service Ghana 
on approaches to increase blood donation in Ghana.  
Background and purpose of research: Based on the population of Ghana, about 300,000 units 
of blood are required per year to ensure that people who need blood transfusion as part of their 
medical treatment receive enough blood in a timely manner. However, we know that for a number 
of reasons, all across the country just over half of the required number of units are donated per 
year. We would like to learn more about these problems so that we can design a bigger piece of 
research that will allow us to develop approaches to improve blood donation so that patients who 
require blood transfusion receive it, when they need it.  
Nature of research: Alongside colleagues from the National Blood Service Ghana, University of 
Ghana, Syracuse University and the Liverpool School of Tropical Medicine, we are carrying out 
a study that is trying to uncover why people do not donate blood regularly and what approaches 
can be used to improve blood donation. This study will involve speaking with people in 
communities and staff from blood centres about blood donation. We will only be collecting data 
from people in the Greater Accra, Eastern and Central Regions where the Southern Zonal Blood 
Centre of the National Blood Service collects blood.  
Reason for your participation: You have been selected be in this study because you are either 
a staff of the National Blood Service Ghana, a community-based blood donation volunteer, 
a blood donor, or a non-blood donor, who can provide information relevant to study.  
Participant involvement: 
• Duration /what is involved: This information and consent process is being conducted 
face-to-face, but the actual interview will occur via phone or online, depending on 
your preference. You will be participating in a key informant interview, which will last 
for a maximum of 60 minutes. The key informant interview will be arranged for a time 
when it is most convenient for you and will occur via a phone call or online. You will be 
asked questions about issues such as blood donation barriers and enablers, and the 
challenges and opportunities for using WhatsApp and docu-drama for promoting blood 
donation. The key informant interview will be audio recorded.  

2 
 
• Potential Risks and mitigation: There are very few risks from participating in this study. 
Potential risks may include breach of confidentiality and any discomfort that may result 
from some discussions about blood donation. In other words, while we will make every 
effort to anonymise any information you share with us, it may not be possible to keep your 
identity completely anonymous from those who may know your role closely. Also, while 
we put in every effort to maintain the confidentiality of the discussion among study 
participants, there is a risk that this confidentiality may be breached. 
However, these risks are minimal and are not more than those encountered in everyday 
life. Another possible risk is the risk of contracting COVID-19 during discussions if safety 
protocols are not adhered to during the information and consent process. The information 
and consent process will be conducted in a spacious environment to facilitate physical 
distancing. Face masks (study-provided masks where required by interviewee) will be 
worn by both the interviewer and interviewee, and study-provided hand sanitizers will be 
made available for use. The interview will also be conducted by phone to minimize the risk 
of contracting COVID-19. 
• Benefits: There is no direct benefit to the you as a participant. Learning about the 
challenges around blood donation will help us to address these in the future. This could 
have a very important impact on patients who require blood transfusion as part of their 
medical treatment and will hopefully save many lives.   
• Costs: Other than your time and the cost of internet data for online key informant interview 
participants, you will not incur any other costs for participating in this study.  
• Compensation: You will not be paid for participating in this study. Online key informant 
interview participants will be reimbursed 3.5 USD for internet data. 
• Confidentiality: In addition to the interviews taking place in a private space where your 
responses will not be heard by others, your name and any identifying information you 
provide will never be linked to your responses to questions. Instead, you will be assigned 
a unique number that will be used instead of your name. In addition, transcripts (a record 
of what was said in the focus group discussion/interview) will have all identifying 
information removed.   
• Voluntary participation/withdrawal: Participation is voluntary, and participants have 
the right to decline to participate and also withdraw from the study at any time without 
penalty and without having to give any reasons.   
• Outcome and feedback: Once data have been collected for this study; we will discuss 
key summarised findings with some stakeholders so that they can help us design a bigger 
study that will enable us to tackle some of these key problem areas.  
• Feedback to participant: If you wish, we will take additional contact information from 
you so that we can share summarised key findings with you as well.  

3 
 
• Funding information: This work is funded by the National Heart Lung and Blood 
Institute (NHLBI), National Institutes of Health (NIH) of the United States and carried out 
by BLOODSAFE Ghana.  
• Sharing of participants Information/Data: All data from this study will be stored and 
used by the BLOODSAFE Ghana team and by the National Blood Service Ghana. It will 
only be shared upon reasonable request in a in totally anonymised form with no participant 
information provided. It will be stored in a secured place for five years before being 
destroyed.  
You will be given a copy of this information sheet as well as your signed informed consent 
form to keep.  
Who to Contact for Further Clarification/Questions:  
Key study contacts: 
Dr Lucy Asamoah-Akuoko 
(Principal Investigator) 
Head, Research and 
Development 
National Blood Service 
Tel: +233 302 663701 Ext 339  
+233 206 301006 
lucyasamoah@yahoo.com 
Dr. Yvonne Dei-Adomakoh 
(Co-Investigator) 
Department of Haematology,  
Korle-Bu Teaching Hospital 
Tel: +233 243 550980  
Email: deiadom@yahoo.com 
yadei-adomakoh@ug.edu.gh 
Mr. Emmanuel Nene Dei 
(Study Manager) 
Research and Development 
National Blood Service  
Tel: +233 243 442126  
Email: nenedei@yahoo.com 
For further clarification on ethical issues and rights of participants, contact:  
Administrator 
Ghana Health Service Ethics Review Committee  
Tel: +233 503539896  
Ethics.research@ghsmail.org 
 
 

4 
 
2. Participant Information Sheet for Docu-drama Test Run  
Title: Community-based communication interventions for increasing the blood donor pool 
in Ghana: a pilot randomized controlled trial 
Introduction: 
Hello. My name is ________________________________________, I am working with the 
BLOODSAFE Ghana team, conducting a research study with the National Blood Service 
Ghana on approaches to increase blood donation in Ghana.  
Background and purpose of research: Based on the population of Ghana, about 300,000 units 
of blood are required per year to ensure that people who need blood transfusion as part of 
their medical treatment receive enough blood in a timely manner. However, we know that 
for a number of reasons, all across the country just over half of the required number of units 
are donated per year. We would like to learn more about these problems so that we can 
design a bigger piece of research that will allow us to develop approaches to improve blood 
donation so that patients who require blood transfusion receive it, when they need it.  
Nature of research: Alongside colleagues from the National Blood Service Ghana, University 
of Ghana, Syracuse University and the Liverpool School of Tropical Medicine, we are 
carrying out a study that is trying to uncover why people do not donate blood regularly and 
what approaches can be used to improve blood donation. This study will involve speaking 
with people in communities and staff from blood centres about blood donation. We will only 
be collecting data from people in the Greater Accra, Eastern and Central Regions where the 
Southern Zonal Blood Centre of the National Blood Service collects blood.  
Reason for your participation: You have been selected be in this study because you are a 
first-time whole blood donor with the SZBC of the NBSG, who can provide information 
relevant to study.  
Participant involvement: 
• Duration /what is involved: You will be participating in four activities: 
a) You will be asked to complete a first survey over the phone, which will last a 
maximum of 30 minutes. You will be asked questions about blood donation issues 
including blood donation knowledge, barriers, motivations and use of 
communication interventions for promoting blood donation  
b) You will be asked to be in a group to watch two episodes of 15-minute video 
documentary/drama on blood donation, each lasting 15 minutes.  
c) You will be asked to participate in a focus group discussion, which will last a 
maximum of 90 minutes. The focus group discussion will be about the docu-
drama, including its feasibility and cultural appropriateness in Ghana.  The focus 

5 
 
group discussion will be arranged in a convenient location in this community. The 
focus group discussion will be audio recorded.  
d) You will also be asked to participate in a second survey to be completed over the 
phone, which will last a maximum of 30 minutes. The second survey will also be 
about blood donation.  
• Potential Risks and mitigation: There are very few risks from participating in this 
study. Potential risks may include breach of confidentiality and any discomfort that 
may result from some discussions about blood donation. In other words, while we 
will make every effort to anonymise any information you share with us, it may not be 
possible to keep your identity completely anonymous from those who may know your 
role closely. Also, while we put in every effort to maintain the confidentiality of the 
discussion among study participants, there is a risk that this confidentiality may be 
breached. 
However, these risks are minimal and are not more than those encountered in 
everyday life. Another possible risk is the risk of contracting COVID-19 during 
discussions if safety protocols are not adhered to during group meetings. Group 
discussions will be held in a spacious environment with markings of spaces, where 
social distancing protocols can be observed. Face masks (study-provided masks where 
required by participants) will be worn by all study team members and participants, 
and study-provided hand sanitizers/hand washing facilities will be used by all 
participants. 
• Benefits: There is no direct benefit to the you as a participant. Learning about the 
challenges around blood donation will help us to address these in the future. This 
could have a very important impact on patients who require blood transfusion as part 
of their medical treatment and will hopefully save many lives.   
• Costs: Other than your time, and the cost of transportation for focus group 
discussion, you will not incur any other costs for participating in this study.  
• Compensation: You will not be paid for participating in this study. Focus group 
discussion participants will be reimbursed with Ghana Cedi equivalent of 10 US 
Dollars for direct transport cost, and refreshments will be offered during the focus 
group discussion.  
• Confidentiality: In addition to the focus group discussions/interviews taking place in 
a private space where your responses will not be heard by others, your name and any 
identifying information you provide will never be linked to your responses to 
questions. Instead, you will be assigned a unique number that will be used instead of 
your name. In addition, transcripts (a record of what was said in the focus group 
discussion/interview) will have all identifying information removed.   

6 
 
• Voluntary participation/withdrawal: Participation is voluntary, and participants 
have the right to decline to participate and also withdraw from the study at any time 
without penalty and without having to give any reasons.   
• Outcome and feedback: Once data have been collected for this study; we will discuss 
key summarised findings with some stakeholders so that they can help us design a 
bigger study that will enable us to tackle some of these key problem areas.  
• Feedback to participant: If you wish, we will take additional contact information 
from you so that we can share summarised key findings with you as well.  
• Funding information: This work is funded by the National Heart Lung and Blood 
Institute (NHLBI), National Institutes of Health (NIH) of the United States and 
carried out by BLOODSAFE Ghana.  
• Sharing of participants Information/Data: All data from this study will be stored and 
used by the BLOODSAFE Ghana team and by the National Blood Service Ghana. It 
will only be shared upon reasonable request in a in totally anonymised form with no 
participant information provided. It will be stored in a secured place for five years 
before being destroyed.  
You will be given a copy of this information sheet as well as your signed informed consent 
form to keep.  
Who to Contact for Further Clarification/Questions:  
Key study contacts: 
Dr Lucy Asamoah-Akuoko 
(Principal Investigator) 
Head, Research and 
Development 
National Blood Service 
Tel: +233 302 663701 Ext 339  
+233 206 301006 
lucyasamoah@yahoo.com 
Dr. Yvonne Dei-Adomakoh 
(Co-Investigator) 
Department of Haematology,  
Korle-Bu Teaching Hospital 
Tel: +233 243 550980  
Email: deiadom@yahoo.com 
yadei-adomakoh@ug.edu.gh 
Mr. Emmanuel Nene Dei 
(Study Manager) 
Research and Development 
National Blood Service 
Tel: +233 243 442126  
Email: nenedei@yahoo.com 
For further clarification on ethical issues and rights of participants, contact:  
Administrator 
Ghana Health Service Ethics Review Committee  
Tel: +233 503539896  
Ethics.research@ghsmail.org 
 

7 
 
3. Participant Information Sheet for the Docu-Drama Design Workshop 
Title: Community-based communication interventions for increasing the blood donor pool 
in Ghana: a pilot randomized controlled trial 
Introduction: 
Hello. My name is ________________________________________, I am working with the  
BLOODSAFE Ghana team, conducting a research study with the National Blood Service Ghana 
on approaches to increase blood donation in Ghana. 
Background and purpose of research: Based on the population of Ghana, about 300,000 units 
of blood are required per year to ensure that people who need a blood transfusion as part of their 
medical treatment receive enough blood in a timely manner. However, we know that for a number 
of reasons, all across the country, just over half of the required number of units are donated per 
year. We would like to learn more about these problems so that we can design a bigger piece of 
research that will allow us to develop approaches to improve blood donation so that patients who 
require blood transfusion receive it when they need it. 
Nature of research: Alongside colleagues from the National Blood Service Ghana, University of 
Ghana, Syracuse University and the Liverpool School of Tropical Medicine, we are carrying out 
a study that is trying to uncover why people do not donate blood regularly and what approaches 
can be used to improve blood donation. This study will involve speaking with people in 
communities and staff from blood centres about blood donation. We will only be collecting data 
from people in the Greater Accra, Eastern and Central Regions where the Southern Zonal Blood 
Centre of the National Blood Service collects blood. 
Reason for your participation: You have been selected be in this study because you are a 
blood donor, non-blood donor, drama expert, drama actor, or communication professional 
who can provide information relevant to the study.  
Participant involvement: 
• Duration /what is involved: You will be participating in a docu-drama design workshop, 
which will take place over two days and last for 2-3 hours each day. The docu-drama 
design workshop will be held online. The workshop will discuss issues such as key themes 
for encouraging blood donation, and what the script to be written for the docu-drama 
should have. The workshop discussions will be audio recorded. 
• Potential Risks and mitigation: There are very few risks from participating in this study. 
Potential risks may include breach of confidentiality and any discomfort that may result 
from some discussions about blood donation. The docu-drama design workshop will lead 
to a design document that will have the names and affiliations of all participants. However, 
the names will not be linked to the discussions. In other words, while we will make every 

8 
 
effort to anonymise any information you share with us by not linking your name to the 
discussions, it may not be possible to keep your identity completely anonymous from those 
who may know your role closely. Also, while we put in every effort to maintain the 
confidentiality of the discussion among study participants, there is a risk that this 
confidentiality may be breached. 
However, these risks are minimal and are not more than those encountered in everyday 
life. The docu-drama design workshop will be held online to avoid the risk of participants 
and study staff contracting COVID-19. 
• Benefits: There is no direct benefit to the you as a participant. Learning about the 
challenges around blood donation will help us to address these in the future. This could 
have a very important impact on patients who require blood transfusion as part of their 
medical treatment and will hopefully save many lives. 
• Costs: Other than your time and the cost of internet data, you will not incur any other costs 
for participating in this study.  
• Compensation: You will not be paid for participating in this study. Docu-drama design 
workshop participants will be reimbursed with Ghana Cedi equivalent of 10 US Dollars of 
internet data. 
• Confidentiality: Other than your expertise, your name and any identifying information 
you provide will never be linked to your responses to questions. In addition, transcripts (a 
record of what was said in the docu-drama discussion) will have all identifying information 
removed other than your expertise. However, the docu-drama design workshop will lead 
to a design document that will have the names and affiliations of all participants.  
• Voluntary participation/withdrawal: Participation is voluntary, and participants have 
the right to decline to participate and also withdraw from the study at any time without 
penalty and without having to give any reasons. 
• Outcome and feedback: Once data have been collected for this study; we will discuss 
key summarised findings with some stakeholders so that they can help us design a bigger 
study that will enable us to tackle some of these key problem areas. 
• Feedback to participant: If you wish, we will take additional contact information from 
you so that we can share summarised key findings with you as well. 
• Funding information: This work is funded by the National Heart Lung and Blood 
Institute (NHLBI), National Institutes of Health (NIH) of the United States and carried out 
by BLOODSAFE Ghana. 
• Sharing of participants Information/Data: All data from this study will be stored and 
used by the BLOODSAFE Ghana team and by the National Blood Service Ghana. It will 
only be shared upon reasonable request in a totally anonymised form with no participant 
information provided. It will be stored in a secured place for five years before being 
destroyed. 

9 
 
You will be given a copy of this information sheet as well as your signed informed consent 
form to keep. 
Who to Contact for Further Clarification/Questions: 
Key study contacts: 
Dr Lucy Asamoah-Akuoko 
(Principal Investigator) 
Head, Research and 
Development 
National Blood Service 
Tel: +233 302 663701 Ext 339  
+233 206 301006 
lucyasamoah@yahoo.com 
Dr. Yvonne Dei-Adomakoh 
(Co-Investigator) 
Department of Haematology,  
Korle-Bu Teaching Hospital 
Tel: +233 243 550980  
Email: deiadom@yahoo.com 
yadei-adomakoh@ug.edu.gh 
Mr. Emmanuel Nene Dei 
(Study Manager) 
Research and Development 
National Blood Service 
Tel: +233 243 442126  
Email: nenedei@yahoo.com 
For further clarification on ethical issues and rights of participants, contact:  
Administrator 
Ghana Health Service Ethics Review Committee  
Tel: +233 503539896  
Ethics.research@ghsmail.org

1 
 
4. Participant Information Sheet for the Pilot Randomized Controlled Trials of WhatsApp 
and Control 
Title: Community-based and donor care interventions for increasing the blood donor pool 
in Ghana: a pilot randomized controlled trial 
Introduction: 
Hello. My name is ________________________________________, I am working with the 
BLOODSAFE Ghana team, conducting a research study with the National Blood Service Ghana 
on approaches to increase blood donation in Ghana.  
Background and purpose of research: Based on the population of Ghana, about 300,000 units 
of blood are required per year to ensure that people who need a blood transfusion as part of their 
medical treatment receive enough blood in a timely manner. However, we know that for a number 
of reasons, all across the country, just over half of the required number of units are donated per 
year. We would like to learn more about these problems so that we can design a bigger piece of 
research that will allow us to develop approaches to improve blood donation so that patients who 
require blood transfusion receive it when they need it.  
Nature of research: Alongside colleagues from the National Blood Service Ghana, University of 
Ghana, Syracuse University and the Liverpool School of Tropical Medicine, we are carrying out 
a study that is trying to uncover why people do not donate blood regularly and what approaches 
can be used to improve blood donation. This study will involve speaking with people in 
communities and staff from blood centres about blood donation. We will only be collecting data 
from people in the Greater Accra, Eastern and Central Regions where the Southern Zonal Blood 
Centre of the National Blood Service Ghana collects blood.  
Reason for your participation: You have been selected be in this study because you are a 
first-time whole blood donor with the SZBC of the NBSG, who can provide information 
relevant to study. 
Participant involvement: 
• Duration /what is involved: You will be participating in this study for about 6 months 
and will be asked some questions as part of a survey relating to blood donation issues such 
as knowledge, attitudes and feasibility of using communication interventions for 
promoting blood donation twice: at the beginning and at the end, each survey lasting a 
maximum of 30 minutes.  In this study, you will be “randomized” into a WhatsApp group 
or a control group. “Randomized” means that you are put into a group by chance, like 
flipping a coin. You will have an equal chance of being placed into the WhatsApp or 
control group.  If you are placed in the control group, your participation will be limited to 

2 
 
only completing the two surveys. If you are asked to be in a control group, you will not be 
exposed to the WhatsApp intervention. If you are asked to be in a WhatsApp group, you 
will be expected to read and or comment on posts related to blood donation. You will also 
be expected to share your blood donation experience with others in the group. Individuals 
in the WhatsApp group will also be participating in a focus group discussion, which will 
last a maximum of 90 minutes. This focus group discussion will focus on your experiences 
during the WhatsApp intervention. If you are participating in a focus group discussion, it 
will be arranged in a convenient location in this community. Focus group discussions will 
be audio recorded. 
• Potential Risks and mitigation: Potential risks may include breach of confidentiality and 
any discomfort that may result from the WhatsApp group discussions or issues about blood 
donation. In other words, while we will make every effort to anonymise any information 
you share with us, it may not be possible to keep your identity completely anonymous.  
However, these risks are minimal and are not more than those encountered in everyday 
life.  
Those assigned to interventions requiring meetings may be at risk of contracting COVID-
19 if safety protocols are not adhered to during group meetings. Group discussions will be 
held in a spacious environment with markings of spaces, where social distancing protocols 
can be observed. Participants will be seated six feet apart for the focus group discussion. 
All participants to be required to wear face masks (study-provided masks where required 
by participants) and adhere to other COVID-19 safety protocols such as using study-
provided hand sanitizers/hand washing facilities. Six-month survey data collection will be 
done via phone.  
There is also the potential of participants assigned to the WhatsApp group posting 
comments or images that may be upsetting to others. Participants will be given guidelines 
to follow to mitigate these risks.  
• Benefits: There is no direct benefit to the you as a participant. Learning about the 
challenges around blood donation will help us to address these in the future. This could 
have a very important impact on patients who require blood transfusion as part of their 
medical treatment and will hopefully save many lives.   
• Costs: Other than your time and cost of data for participating in WhatsApp groups, you 
will not incur any costs for participating in this study.  
• Compensation: You will not be paid for participating in this study. Focus group 
participants will be reimbursed with the Ghana Cedi equivalent of 10 US Dollars for direct 
transport cost, and refreshments will be offered during focus group discussion meetings. 
All participants in the WhatsApp intervention will be given internet data worth the Ghana 
Cedi equivalent of 3.5 US Dollars per month for the period of the intervention. 

3 
 
• Confidentiality: In addition to confidentiality guidelines within the group, your name and 
any identifying information you provide will never be linked to your responses to 
questions. Instead, you will be assigned a unique number that will be used instead of your 
name. In addition, all your responses to questions will have all identifying information 
removed.   
• Voluntary participation/withdrawal: Participation is voluntary, and participants have 
the right to decline to participate and also withdraw from the study at any time without 
penalty and without having to give any reasons.  
• Outcome and feedback: Once data have been collected for this study, we will discuss 
key summarised findings with some stakeholders so that they can help us design a bigger 
study that will enable us to tackle some of these key problem areas.  
• Feedback to participant: If you wish, we will take additional contact information from 
you so that we can share summarised key findings with you as well.  
• Funding information: This work is funded by the National Heart Lung and Blood 
Institute (NHLBI), National Institutes of Health (NIH) of the United States and carried out 
by BLOODSAFE Ghana.  
• Sharing of participants Information/Data: All data from this study will be stored and 
used by the BLOODSAFE Ghana and by the National Blood Service Ghana. It will only 
be shared upon reasonable request in a totally anonymised forms with no participant 
information provided. It will be stored in a secured place for five years before being 
destroyed.  
You will be given a copy of this information sheet as well as your signed informed consent 
form to keep.  
Who to Contact for Further Clarification/Questions:  
Key study contacts: 
Dr Lucy Asamoah-Akuoko 
(Principal Investigator) 
Head, Research and 
Development 
National Blood Service 
Tel: +233 302 663701 Ext 339  
+233 206 301006 
lucyasamoah@yahoo.com 
Dr. Yvonne Dei-Adomakoh 
(Co-Investigator) 
Department of Haematology,  
Korle-Bu Teaching Hospital 
Tel: +233 243 550980  
Email: deiadom@yahoo.com 
yadei-adomakoh@ug.edu.gh 
Mr. Emmanuel Nene Dei 
(Study Manager) 
Research and Development 
National Blood Service 
Tel: +233 243 442126  
Email: nenedei@yahoo.com 
 
 
 

4 
 
For further clarification on ethical issues and rights of participants, contact:  
Administrator, Ghana Health Service Ethics Review Committee  
Tel: +233 503539896  
Ethics.research@ghsmail.org 

1 
 
5. Consent Form for Focus Group Discussions, Key Informant Interviews, Docu-Drama 
Design Workshop, Docu-Drama Test-run, and the Pilot Randomized Control Trial of 
WhatsApp and Control. 
Title: Community-based communication interventions for increasing the blood donor pool 
in Ghana: a pilot randomized controlled trial  
PARTICIPANTS’ STATEMENT 
I acknowledge that I have read or have had the purpose and contents of the Participants’ 
Information Sheet read and all questions have been satisfactorily explained to me in a language 
(English/Twi) I understand. I fully understand the contents and any potential implications, as well 
as my right to change my mind (i.e. withdraw from the research) even after I have signed this form.  
 
Initials (all that apply) 
I voluntarily agree to be part of this research 
 
I agree to be assigned to a group 
 
I agree to anonymised quotations being used for analysis and reporting 
purposes  
 
 I agree to be audio recorded 
 
 
Name of Participant  
 
 
 
 
 
 
 
 
 
 
 
Participants’ Signature  
 
 
 
 
 
OR Thumb Print 
 
 
Date:  
 
 
 
 
STATEMENT OF INTERPRETER 
I certify that the statement and questions have been satisfactorily translated in a local language to 
the participant. All questions and clarifications raised by the participant and responses from the 
investigator have also been translated.  
Translator’s name 
 
 
 
 
 
 
 
 
 
 
 
 
Signature  
 
 
 
 
 
 
 
 
Date 
 
 
 
 
 
 

2 
 
STATEMENT OF WITNESS 
I was present when the purpose and contents of the Participant Information Sheet were read and 
explained satisfactorily to the participant in the local language he/she understood. 
I confirm that he/she was given the opportunity to ask questions/seek clarifications, and the same 
were duly answered to his/her satisfaction before voluntarily agreeing to be part of the research. 
 
Name:  
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
 
 
 
 
Date:  
 
 
 
 
 
 
INVESTIGATOR STATEMENT AND SIGNATURE 
I certify that the participant has been given ample time to read and/or learn about the study 
All questions and clarifications raised by the participant have been addressed.  
 
Researcher’s name 
 
 
 
 
 
 
 
 
 
 
 
Signature  
 
 
 
 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 

1 
 
MODULE 3 
Study Tools 
1. Key Informant Interview Guide for Intervention Development (WhatsApp and Docu-
Drama) 
Title: Community-based communication interventions for increasing the blood donor pool 
in Ghana: a pilot randomized controlled trial 
Interview number: 
 
 
 
 
Brief introduction: This is an interview with a (participant identifiers other than name) on 
designing interventions to promote blood donation (replace with an appropriate category of 
audience). 
Start time: 
Introduction 
Good morning/afternoon. My name is _______________ 
 
 
 and I will be your 
interviewer. I work for the ________________ 
 
based in  
 
 
 
 
I am a trained interviewer and I would like to hear your honest opinions about the topics we will 
discuss today. There is no right or wrong answer to the questions I’m going to ask. Please just 
relax and enjoy the interview. 
Please keep in mind that your participation is completely voluntary. If for any reason you wish to 
leave the discussion, you may do so. 
We are doing this as part of a project to develop interventions for promoting blood donation. 
Kindly state whether it is okay to continue with the interview. 
RULES OR GUIDELINES 
1. You have been invited here to offer your views and opinions. 
2. Again, there are no right or wrong answers and its okay to be critical. I want to hear your 
views and opinions about whether you like or dislike something you see or hear. 
3. You may excuse yourself from the conversation at any time for any reason. 
4. Although this session will be audio taped, it will remain confidential and will ONLY be 
used to capture everything that is being said today, for the purpose of listening to it again 
to get the message well. Please feel free to say exactly what is on your mind as nothing 
will be attributed to any particular person in our report. 
 

2 
 
A. WhatsApp Intervention 
Demographics 
• 
What is your name? 
• 
How old are you?  
Knowledge 
• 
What is the potential of using WhatsApp for promoting blood donation? 
• 
What do you consider as advantages of using WhatsApp to encourage blood donation? 
• 
What do you consider as disadvantages of using WhatsApp to encourage blood donation? 
Beliefs 
• 
Do you believe that WhatsApp can be used to promote blood donation? If yes, why? If 
no, why not? 
Attitudes 
• 
How will you feel if your friends, relatives or others you respect found out that you are in 
a WhatsApp group that promotes blood donation? 
If positive, explain why 
If negative, explain why 
Challenges, opportunities and recommendations 
We will be designing WhatsApp intervention for promoting blood donation. Group 
participants will be expected to share information on their blood donation experiences to 
encourage others to donate blood. A moderator will also post   relevant items periodically. 
• Have you used WhatsApp for health promotion activities? If so, was it positive or 
negative and explain why?  
• What do you foresee as potential challenges in the design of WhatsApp intervention for 
promoting blood donation? 
• How can we address these challenges?  
• What suggestions do you have for making such an intervention successful? 
• How many times should a moderator post an item in a week and why?  
• What further comments do you have on the intervention?  
 
 

3 
 
 
 
B. Docu-drama intervention 
Demographics 
• 
What is your name? 
• 
How old are you? 
Knowledge 
• 
What is the potential of using video documentary with drama (docu-drama) for promoting 
blood donation? 
• 
What do you consider as advantages of using docu-drama to encourage blood donation? 
• 
What do you consider as disadvantages of using docu-drama to encourage blood 
donation? 
Beliefs 
• 
Do you believe that docu-drama can be used to promote blood donation? If yes, why? If 
no, why not? 
Attitudes 
• 
How will you feel if your friends, relatives or others you respect found out that you are in 
a docu-drama group that promotes blood donation? 
If positive, explain why? 
If negative, explain why? 
Challenges, opportunities and recommendations: 
We will be designing docu-drama intervention for promoting blood donation.  
We plan to produce two episodes, each lasting 15 minutes. Each episode will be discussed 
for about 1 hour. 
• Have you used drama for health promotion activities? If so, was it positive or negative 
and explain why? 
• What do you foresee as potential challenges in the design of such an intervention for 
promoting blood donation? 
• How can we address these challenges? 
• What suggestions do you have for making such an intervention successful? 
• What comments do you have on the duration of the discussion of the docu-drama? 
• What comments do you have on what should be discussed after showing the drama? 
• What further comments do you have on the intervention? 
Thank you 
End time: 
 
 

1 
 
2. Docu-Drama Design Workshop Discussion Guide 
Title: Community-based communication interventions for increasing the blood donor pool 
in Ghana: a pilot randomized controlled trial 
Goal: The goal of the docu-drama design workshop is to help create a document a scriptwriter can 
use to write the script. 
Duration: Two days (Zoom meeting); 2-3 hours each day; include Zoom breakout groups. 
Questions for discussion (add probes where necessary): 
a. Identify name of the docu-drama 
b. Identify overall tone of the docu-drama   
c. Describe overall objectives of the drama 
d. Identify key messaging for the docu-drama  
e. Describe specific objectives of each drama episode or topic  
Discuss the order of the 2 docu-drama episodes 
 
 

1 
 
3. Focus Group Discussion Guide for Test-Run Docu-Drama Intervention and for 
Assessing Acceptability, Feasibility and Cultural Appropriateness 
Title: Community-based communication interventions for increasing the blood donor pool 
in Ghana: a pilot randomized controlled trial 
Good morning/afternoon. My name is _______________ 
 
 
 and I will be your 
moderator for this focus group discussion. I work for the ________________based in  
 
 
If asked (explain about your organization and its objectives): I am a trained focus group moderator 
and I would like to hear your honest opinions about the topics we will discuss today. There is no 
right or wrong answer to the questions I’m going to ask. Please just relax and enjoy the discussion. 
Please keep in mind that your participation is completely voluntary. If for any reason you wish to 
leave the discussion, you may do so. 
We are doing this as part of a project to develop interventions for promoting blood donation. I am 
accompanied by__________________ who will be responsible for note taking. Other project staff 
from _________________ will also be in the room observing the focus group discussion. Kindly 
state whether it is okay to continue with the discussion. 
RULES OR GUIDELINES 
a. You have been invited here to offer your views and opinions. 
b. Again, there are no right or wrong answers and its okay to be critical. I want to hear your 
views and opinions about whether you like or dislike something you see or hear. 
c. There will be observers. 
d. You may excuse yourself from the conversation at any time for any reason. 
e. Although this session will be audio taped, it will remain confidential and will ONLY be 
used to capture everything that is being said today, for the purpose of listening to it again 
to get the message well. Please feel free to say exactly what is on your mind as nothing 
will be attributed to any particular person in our report. 
f. Lastly, please turn off the ringers on your cell phones. 
ADDITIONAL GUIDELINES 
a. Everyone’s participation is important. 
b. Please speak one at a time and avoid side conversations. 
c. Please use any of your names that you are comfortable with only during the discussion. 
d. Respect each other’s opinions. 
 
 

2 
 
Demographics 
• 
What is your name? 
• 
How old are you?  
 
Docu-drama 
Play the docu-drama and let the respondent(s) watch/listen: 
a. Ask the respondent(s) what message was being transmitted by the docu-drama 
b. Ask the respondent(s) for any words in the message whose meaning they did not 
understand. If there are unclear words, identify the words and ask the respondents what 
they think the words mean. (If necessary, tell the respondent what was meant by the words 
and ask for what words they suggest should be used as a better substitute that will be 
generally understood). 
c. Ask the respondent if there is anything in the message that they or other people in would 
say differently (If yes, ask for the phrase or wording). 
d. Ask the respondent if there is anything in the message which they think is not true (probe 
to get details if the response is yes). 
e. Ask the respondent if they feel the message said anything that might upset or offend people 
(if the answer is yes, probe to get what is offensive or upsetting). 
f. Ask the respondents what they think this message is asking them to do (probe their 
willingness to follow the message). 
g. Ask the respondent(s) what they liked most about the message. 
h. Ask the respondent(s) what would encourage them to follow the message they have just 
heard (probe if there is something that would discourage them). 
i. Ask the respondents to whom they think this message is directed? 
j. Ask if docu-drama says or suggests that they must do something? If yes, what? 
k. Ask if they would be willing to follow the advice given? Why/Why not? 
l. Ask the respondent(s) if the message is appropriate for blood donors  
m. Ask the respondent(s) if there is anything in the message which they would say differently 
(ask them to say it if applicable). 
n. How would you gauge the quality of the docu-drama program in terms of sound (volume) 
and words spoken? 
o. Ask the respondent(s) whether the sound level (volume) acceptable 
p. Ask the respondent(s) how they would rate the duration of the docu-drama (probe if too 
long, too short or just right). 

3 
 
q. Ask respondents questions that could be asked of the audience to spark discussions and 
why 
r. Ask the respondents if they have any further questions/observations. 
 
Docu-drama – acceptability, feasibility, cultural appropriateness 
 
You watched docu-drama on blood donation and participated in the discussion. We would like to 
seek your feedback on it. 
a. To what extent was the use of docu-drama and its discussion for sharing your experience 
with blood donation acceptable to you? 
 
b. To what extent was the use of docu-drama and its discussion for sharing your experience 
with blood donation culturally appropriate (for example, language for the drama and 
discussion, religious beliefs or differences, concept in line with your personal experiences), 
for you? 
 
c. To what extent was the use of docu-drama and its discussion for sharing your experience 
with blood donation effective? 
 
d. How did the use of docu-drama influence your knowledge about blood donation? 
e. How did the use of docu-drama influence your beliefs about blood donation? 
f. How did the use of docu-drama influence your intention to return to give blood? 
g. Indicate the elements of the docu-drama intervention you preferred and why 
i 
Watching the docu-drama 
ii Discussion of the docu-drama 
iii Share moments of blood donation 
iv Sharing positive experiences with other blood donors 
v Sharing negative experiences with other blood donors 
vi Sharing motivational messages with other blood donors 
vii Organization of the docu-drama meetings 
viii Facilitation of the docu-drama meetings 
h. What prevented you from participating actively watching the docu-drama and participating 
in the discussions? 
i. How can these barriers be resolved? 
j. What should be done to be make the docu-drama on blood donation more feasible for 
positively influencing first-time blood donor’s attempt to give blood again? 
Any other comments?

1 
 
4. Participant Observation Guide for Docu-Drama Viewing and Focus Group Discussion 
Title: Community-based communication interventions for increasing the blood donor pool 
in Ghana: a pilot randomized controlled trial 
1. What are the first-time blood donors doing?  
a. Asking questions? 
b. Sharing their experiences? 
c. Remain quiet? 
 
2. What are they trying to accomplish? 
a. Motivating others? 
b. Demotivating others? 
 
3. How exactly do they do these?  
 
4. How do people characterise and understand what is going on?  
 
5. What do I see going on here?  
 
6. What did I learn?

1 
 
5. Focus Group Discussion Guide for Assessing Acceptability, Feasibility and Cultural 
Appropriateness at End of 6-month WhatsApp Pilot RCT  
Title: Community-based communication interventions for increasing the blood donor pool 
in Ghana: a randomized controlled trial 
 
1. Docu-drama group  
 
Good morning/afternoon. My name is _______________ and I will be your moderator for this 
focus group discussion. I work for the ________________based in  
If asked (explain about your organization and its objectives): I am a trained focus group moderator 
and I would like to hear your honest opinions about the topics we will discuss today. There is no 
right or wrong answer to the questions I’m going to ask. Please just relax and enjoy the discussion. 
Please keep in mind that your participation is completely voluntary. If for any reason you wish to 
leave the discussion, you may do so. 
We are doing this as part of a project to develop interventions for promoting blood donation. I am 
accompanied by__________________ who will be responsible for note taking. Other project staff 
from _________________ will also be in the room observing the focus group discussion. Kindly 
state whether it is okay to continue with the discussion.  
RULES OR GUIDELINES 
a. You have been invited here to offer your views and opinions. 
b. Again, there are no right or wrong answers and its okay to be critical. I want to hear your 
views and opinions about whether you like or dislike something you see or hear. 
c. There will be observers. 
d. You may excuse yourself from the conversation at any time for any reason. 
e. Although this session will be audio taped, it will remain confidential and will ONLY be 
used to capture everything that is being said today, for the purpose of listening to it again 
to get the message well. Please feel free to say exactly what is on your mind as nothing 
will be attributed to any particular person in our report. 
f. Lastly, please turn off the ringers on your cell phones. 
ADDITIONAL GUIDELINES  
a. Everyone’s participation is important. 
b. Please speak one at a time and avoid side conversations. 
c. Please use any of your names that you are comfortable with only during the discussion. 
d. Respect each other’s opinions. 

2 
 
Demographics:  
• 
What is your name? 
• 
How old are you?  
WhatsApp  
You have been in this WhatsApp group for the past six months. We will like seek your feedback 
in terms of the acceptability and feasibility of using WhatsApp to encourage blood donation. 
a. To what extent was the use of WhatsApp for sharing your experience with blood donation 
acceptable to you? 
 
b. To what extent was the use of WhatsApp for sharing your experience with blood donation 
culturally appropriate (for example, language for the drama and discussion, religious 
beliefs or differences, concept in line with your personal experiences) for you? 
 
c. To what extent was the use of WhatsApp for sharing your experience with blood donation 
effective? 
 
d. How did the use of WhatsApp influence your knowledge about blood donation? 
e. How did the use of WhatsApp influence your beliefs about blood donation? 
f. How did the use of WhatsApp influence your intention to return to give blood? 
g. Indicate the elements of the WhatsApp intervention you preferred and why 
i 
Share moments of blood donation 
ii Send blood donation images or videos 
iii Send blood donation audio notes 
iv Send blood donation motivational messages  
v Comment on other posts 
vi Send positive experiences with blood donation 
vii Send negative experiences with blood donation? 
h. How frequently did you read messages or other information posted to the WhatsApp group 
and why?  
i. What prevented you from participating actively in the WhatsApp group on blood donation? 
j. How can these barriers be resolved? 
k. What should be done to be make the WhatsApp group on blood donation more acceptable 
to you?  
l. What should be done to be make the WhatsApp group on blood donation more feasible for 
positively influencing first-time blood donor’s attempt to give blood again?  
 
 

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6. Case Report Form for participants attending baseline visit 
  

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7. Case Report Form for participants enrolled in the RCT of the study after randomization 
 

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8. Case Report Form for participants attending docu-drama prior to viewing  
 

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9. Case Report Form for reporting participant death 

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10. Case Report Form for participants enrolled in the RCT of the study attending the 
Month 6 visit 
 
 

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11. Case Report Form for participants attending docu-drama after viewing 
 

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12. Participant Contact Information Form 
 

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13. Protocol Deviation Form 
 

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14. Serious Events (SAEs) Report Form  
 

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15. Study Volunteers Screening Form  
 

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16. Participation Withdrawal Form 

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17. SOP: Randomizing participants into study groups for the pilot RCT of WhatsApp and 
control 
 

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18. Phone Interview Guide 
 Title: Community-based communication interventions for increasing the blood donor pool 
in Ghana: a randomized controlled trial 
Phone Interview Guide 
Introduction should be brief, clearly identifying the caller, caller’s institution and referring to the 
invitation to participation. In asking to speak with the intended participant, the actual nature of the 
call should not be disclosed to a third party. For instance, it is enough to say “I would like to speak 
with… in relation to having scheduled a phone interview earlier about blood donation”.   
A. STRATEGIES FOR INCREASING PHONE INTERVIEW PARTICIPATION  
Hangs up before hearing reason for survey. Call back! 
1. “I want to make sure you understand that I’m not selling or promoting anything. I’m calling in 
regard to the earlier request to interview you on blood donation. I was wondering if this would 
be a good time to go through the survey with you. It only takes about 30 minutes.” 
2. “I’m sorry, I realize I’ve called at a bad time, but we are conducting a very important study 
that will have a direct impact on blood donation as we informed you the last time,  and I’d like 
to have a chance to get your opinions. When would be the best time to call you back?” (Be 
sure to use assertive language such as, “When can I call you back?” instead of “Can I call you 
back?”) 
I don’t have time now. 
“As explained to you the last time, the survey only takes about 30 minutes and I can assure you 
that your responses will have a direct impact on blood donation in Ghana. If now is not a good 
time, when would be the best time to call you back?” 
I agree with the rest of the questions. 
“We’re very interested in your opinions on the rest of the questions because your opinion on all 
the questions is very important for the study.” 
I can no longer continue with the interview: 
“We’re very interested in your opinions. When can I call you?”  
 
 

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B. CONDUCTING THE PHONE INTERVIEW 
1. Each interview will last about 30 minutes. Ask interviewer at 5 minutes intervals if they 
are still willing to proceed with the interview. 
 
2. The participant must be informed about the next set of questions and whether they are 
willing to continue with the interview or where the subject matter changes during the 
interview.

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