Iron Supplementation and Nutritional Counseling Interventions to Improve Availability and Safety of Blood in Ghana
Phase: NA
Conditions: Iron-deficiency Anemia, Iron-deficiency
Sponsor: University of Minnesota

 
 
BloodSafe Ghana 
 
 
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PROTOCOL TITLE:  
Iron Supplementation and Nutritional Counseling Interventions to 
Improve 
Availability and Safety of Blood in Ghana 
SHORT TITLE: Bloodsafe Ghana- Iron and Nutritional Counseling 
Strategy Pilot Study (BLIS)  
Amended Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
Grant Number: 1UG3HL151599-01 
 
 
Funded by the National Heart, Lung, and Blood Institute (NHLBI), 
National Institutes of Health (NIH), USA 

 
 
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DECLARATION 
We the undersigned declare that the contents of this proposal is original. 
 
 
 
 
 
 
                         
 
  Sign: ……………………………………………  
Date: 28th May, 2021 
 
Dr. Yvonne Dei-Adomakoh (PI) 
 
 
 
 
 
                      
 
Sign: …………………………………………… 
 
Date: 28th May, 2021 
 
Dr. Lucy Asamoah-Akuoko (MPI) 
 
 
 

 
 
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INFORMATION ON CO- INVESTIGATORS AND THEIR 
COLLABORATING INSTITUTIONS 
UNIVERSITY OF GHANA 
Prof. Edeghonghon Olayemi 
Haematologist / Co-Investigator 
ADDRESS: 
Department 
of 
Haematology, University of Ghana 
Medical School 
TELEPHONE: +233246968211 
EMAIL: eolayemi@ug.edu.gh 
Dr. Amma Benneh - Akwasi Kuma 
Haematologist / Co-Investigator 
ADDRESS: Department of Haematology, 
University of Ghana Medical School 
TELEPHONE: +233208305555 
EMAIL: animabenneh@yahoo.com 
Dr. Catherine Segbefia 
Pediatric 
Haematologist 
/Co-
Investigator 
ADDRESS: 
Department 
of 
Child 
Health, University of Ghana Medical 
School 
TELEPHONE: +23320 888 7888 
EMAIL: csegbefia@chs.edu.gh 
 
Prof Alfred Yawson 
Consultant Public Health Physician/ Co-
Investigator 
ADDRESS: Department of Community 
Health, University of Ghana Medical 
School 
TELEPHONE: +233244662711 
EMAIL: aeyawson@ug.edu.gh 
Dr. Seth Adu-Afarwuah 
Nutritionist / Co-Investigator 
Department of Nutrition and Food 
Science, University of Ghana 
Tel: +233249149385 
EMAIL : ct3665@gmail.com  
Prof Philip Adongo 
Associate Professor/Co-investigator 
Department of Social & Behavioural 
Sciences 
School of Public Health, University of 
Ghana 
Tel: +233244806015 
EMAIL : adongophilip@yahoo.com 
NATIONAL 
BLOOD 
SERVICE 
GHANA 
SYRACUSE UNIVERSITY 
Dr. Michael Ebo Acquah 
Haematologist / Co-Investigator 
ADDRESS: National Blood Service, 
Korle- Bu, Accra 
TELEPHONE: +233206301106 
EMAIL: bondze@gmail.com 
Dr. Bernard Appiah 
Assistant Professor/Co-investigator with 
expertise in medication adherence, health 
communication and socio-behavioural 
health 
Department of Public Health, Falk 
College, Syracuse University, 435A 
White Hall Syracuse, NY 13244,  
Tel: +1-9795715170 
EMAIL: beappiah@syr.edu 
Liverpool 
School 
of 
Tropical 
Medicine 
 
Dr. Tara Tancred 
Senior Research Associate / Co-Investigator  
International Public Health Department 
Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, United 
Kingdom 
EMAIL: tara.tancred@lstmed.ac.uk 
 
 

 
 
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University of Minnesota 
Prof Haitao Chu 
Professor/Co-investigator 
Division of Biostatistics 
School of Public Health 
University of Minnesota Twin Cities 
Tel: +1 612-219-7180 
Email: chux0051@umn.edu 
 
Susan Telke, MS 
Biostatistician/DCC Coordinator 
Coordinating 
Centers 
for 
Biometric 
Research 
Division of Biostatistics, University of 
Minnesota, Twin Cities.  
Tel: +1 612-626-8887 
Email: telke001@umn.edu  
 
Prof. Cavan Reilly 
DCC Principal Investigator 
Coordinating Centers for Biometric 
Research 
Division of Biostatistics  
University of Minnesota, Twin Cities 
Tel-+1612-219-9644 
Email: cavanr@ccbr.umn.edu 
 
 
CONSULTANTS 
Prof Solomon Ofori-Acquah 
Dean 
School of Biomedical & Allied 
Health Sciences 
College of Health Sciences, 
Korle Bu, Accra 
Tel: +233272369030 
EMAIL: sofori-
acquah@ug.edu.gh 
Prof. Imelda Bates 
Professor in Clinical Tropical Haematology 
The Centre for Capacity Research, 
Liverpool School of Tropical Medicine, Pembroke 
Place, Liverpool, United Kingdom. 
Tel: +44 151 705 3115 
EMAIL: imelda.bates@lstmed.ac.uk 
Dr. Justina Ansah 
Director 
National Blood Service,  
Korle Bu, Accra, Ghana 
Tel: +233208162812 
EMAIL: 
kordaiansah@yahoo.com 
 
 
 
 
 
 
 
 
 
 

 
 
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STATEMENT TO COMPLY WITH ETHICAL PRINCIPLES  
 
 
I, Dr. Yvonne Dei-Adomakoh, the Principal Investigator (PI) of this study titled “Iron 
Supplementation and Nutritional Counseling Interventions to Improve Availability and 
Safety of Blood in Ghana” and on behalf of my research team state that we will comply 
strictly to all ethical principles, which includes the principles of beneficence and non-
maleficence i.e. promoting the interest and wellbeing of others, not doing harm and 
respect for the right of others. The above ethical principles will be adhered to 
throughout the study, by ensuring that the research is based on full informed consent 
and that the participants’ right to confidentiality is maintained. Data collected will be 
used solely for the purpose of this research. 
 
Dr. Lucy Asamoah-Akuoko, Co-Principal Investigator 
 
 
 
 
Dr. Yvonne Dei-Adomakoh, Principal Investigator  
 
Dr. Bernard Appiah, Co-investigator  
 
 
 
 
 
 
Dr. Tara Tancred, Co-Investigator 
 
 
 
 
 
 
 
Prof. Philip Adongo, Co-investigator  
 
 
 
 
 
 
Dr. Seth Adu-Afarwuah, Co-Investigator 
 
 
 
 
 
 
Prof. Alfred Yawson, Co-investigator 
 
 
 
 
 
 
Prof. Edeghonghon Olayemi, Co-Investigator 
 
 
 
 
 

 
 
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Dr. Michael Acquah, Co-Investigator 
 
 
 
 
 
 
Dr. Catherine Segbefia, Co-Investigator 
 
 
 
Dr. Amma Benneh - Akwasi Kuma, Co-Investigator 
 
Prof. Cavan Reilly, Co-Investigator  
 
 
 
 
 
 
Prof. Haitao Chu, Co-investigator 
 
 
 
 
 
 
 
Susan Telke, Co-investigator  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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TABLE OF CONTENTS 
 
DECLARATION ............................................................................................................... ii 
INFORMATION ON CO- INVESTIGATORS AND THEIR 
COLLABORATING INSTITUTIONS .................................................................... iii 
ABSTRACT ................................................................................................................ x 
Background ...................................................................................................... x 
Methods ............................................................................................................. x 
Expected Outcomes ....................................................................................... x 
INTRODUCTION ........................................................................................................ 1 
Problem Statement ......................................................................................... 1 
Aim 2 
Objectives ......................................................................................................... 2 
Justification ...................................................................................................... 4 
LITERATURE REVIEW ............................................................................................ 6 
METHODOLOGY ....................................................................................................... 8 
Design ................................................................................................................ 8 
Duration ........................................................................................................... 10 
Sample Size .................................................................................................... 11 
Study site and Population .......................................................................... 15 
Stratification and Sampling ........................................................................ 16 
Regimen .......................................................................................................... 16 
Inclusion Criteria ........................................................................................... 17 
Exclusion Criteria ......................................................................................... 18 
Approach to Inter-current Therapies and Clinical Trial Co-
enrolment: ...................................................................................................... 18 
Costs to Participants ................................................................................... 19 
Study Products, Procedures and Assessments ................................... 19 
Schedule of Assessments (Table 5) ........................................................ 22 
Enrolment ....................................................................................................... 23 
Follow Up Assessments ............................................................................. 23 
Adherence Strategies .................................................................................. 25 

 
 
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Follow-Up for AEs ......................................................................................... 29 
Expectedness ................................................................................................ 32 
Data Analysis ................................................................................................. 34 
Data Monitoring Guidelines for an Independent DSMB ...................... 39 
DISSEMINATION OF RESULTS ........................................................................... 39 
ETHICAL ISSUES ................................................................................................... 40 
REFERENCES .......................................................................................................... 45 
APPENDICES .......................................................................................................... 48 
APPENDIX 1 –Data Collection Instruments ................................................ 48 
APPENDIX 2 ................................................................................................... 55 
APPENDIX 4: Study Design Flowchart .................................................... 82 
APPENDIX 5: Study Timelines ...................................................................... 83 
 
 
          
 
 
 
 
 
 
 
 

 
 
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LIST OF ACRONYMS 
 
ABC         Area Blood Centre 
DCC 
Data Coordinating Centre  
DSMB 
Data and Safety Monitoring Board  
eCRF 
Electronic Case Report Forms 
FBC  
Full Blood Count  
FRD  
Family replacement donor  
GCP 
Good Clinical Practice 
Hb  
Haemoglobin 
HBV  
Hepatitis B virus 
HCV  
Hepatitis C virus 
HIV  
Human immunodeficiency virus  
HSP 
Human Subjects Protection  
ICF 
Informed consent form 
ICH 
International Conference for Harmonization 
ID  
Iron Deficiency 
IDA  
Iron Deficiency Anaemia  
IRB 
Institutional Review Board  
MCV  
Mean Corpuscular Volume 
NBSG  
National Blood Service Ghana  
NHLBI 
National Heart, Lung, and Blood Institute 
OSMB 
Observational Study Monitoring Board  
QSR 
Qualitative Software and Research  
SSA  
Sub-Saharan Africa 
SZBC  
Southern Zonal Blood Centre  
TTI  
Transfusion Transmissible Infections  
UMN 
University of Minnesota 
WHO  
World Health Organisation 
 

 
 
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ABSTRACT 
 Background  
The major challenge for blood transfusion services in Sub-Saharan Africa 
(SSA) is the juxtaposition of an increasing clinical demand for blood and a 
historically insufficient supply of safe blood in the region. The system of blood 
donation in Ghana, has been identified as the major barrier to providing 
adequate and regular blood to meet the transfusion needs of the country. This 
study is therefore planned as a feasibility and acceptability pilot trial of iron 
supplementation to increase blood donation among blood donors deferred for 
low levels of haemoglobin within the catchment areas of the Southern Zonal 
Blood Centre (SZBC).  
Methods 
This pilot study has 2 components: 1) a cross-sectional assessment designed 
to estimate the prevalence of anaemia leading to donor deferral, the prevalence 
of iron deficiency (ID) and iron deficiency anaemia (IDA) among first-time 
donors, and 2) a longitudinal 2-arm parallel groups trial among first-time 
voluntary donors that compares haemoglobin levels at 4 months among those 
with ID or IDA who receive iron supplementation to those without ID or IDA who 
do not receive iron supplementation. A structured questionnaire will be used to 
extract demographic characteristics. Participants will be followed for a total of 6 
months with study visits at 2, 4 and 6 months after the baseline assessments. 
Blood draws for full blood count (FBC), peripheral film comment, malaria rapid 
diagnostic tests (RDT) and ferritin assessment will occur at baseline and all 
follow-up visits. In addition, we will use a qualitative approach to identify barriers 
and facilitators of blood donation and the use of dietary and iron 
supplementation strategies to address iron deficiency and/or anaemia. This will 
involve conducting focus group discussions during the last month of the 
intervention and key informant interviews. 
Expected Outcomes 
The expected outcomes of the study have been grouped into two, primary and 
secondary. Primary Outcome will be haemoglobin level after 4 months. 
Secondary Outcomes are A. Change in haemoglobin levels B. Diagnosis of ID 
or IDA at 4 months C. Serum ferritin concentration after 4 months of intervention 

 
 
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D. Acceptability of iron supplementation among participants and stakeholders 
E. Incidence of gastrointestinal adverse events F. Incidence of suspected 
malaria or bacterial infections G. Incidence of ID and IDA H. Successful return 
(non-deferred) to the blood donor pool after intervention within 6 months of 
enrolment I. Key barriers and facilitators of intervention implementation. 
. 

 
 
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INTRODUCTION 
The major challenge for blood transfusion services in sub-Saharan Africa is the 
juxtaposition of an increasing clinical demand for blood and a historically 
insufficient supply of safe blood in the region 1,2. We have identified the system of 
blood donation in Ghana as the major barrier to providing adequate and regular 
blood to meet the transfusion needs of the country. Currently, over 66% of blood 
collection in Ghana is obtained through a Family Replacement Donor (FRD) 
system, which is associated with insufficient, unsustainable and relatively unsafe 
supply of blood particularly for emergencies3,4. 
Iron balance in donors is also an important safety issue. Iron deficiency is initially 
without anaemia, manifesting as reduced iron stores (iron depletion) and iron 
deficient erythropoiesis, and without intervention is complicated by overt anaemia5. 
Major causes of iron deficiency are inadequate dietary iron, malabsorption and loss 
of iron6. One complete whole blood donation (400-500 ml) leads to the loss of 
almost 250mg of iron7. In adolescents and adult females, the iron stores are about 
300mg 5. The female blood donor therefore loses a significant amount of her total 
body iron, and risks becoming iron depleted after one donation of whole blood.  
Problem Statement  
With continuous loss of iron from repeat whole blood donations and inadequate 
replacement, blood donors inevitably develop ID and, later, IDA. From 2015 to 
2018, between 33 and 53% of deferred voluntary blood donors attending National 
Blood Service blood drives in southern Ghana were deferred for low haemoglobin. 
Although these individuals are motivated to donate blood for reasons other than 
replacement for family and friends, iron deficiency anaemia emerges as a 
significant challenge to increasing the limited voluntary blood donor population in 
Ghana. Only 39% of voluntary donors registered at the SZBC donate blood at least 
twice in a year. An unpublished prospective study looking at characterization of 
anaemia in 150 blood donors showed a prevalence of anaemia in potentially 
healthy blood donors to be 48% with IDA accounting for 63.9% and ID 86.1%. 

 
 
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Another unpublished prospective study on iron status of blood donors at the SZBC 
estimated the overall prevalence of ID to be 68.8%.  
The WHO advocates the use of repeat voluntary blood donations since these are 
associated with both blood safety and availability. However, in the absence of 
adequate interventions to prevent anaemia, repeat attempts by previously iron 
deficient blood donors leads to IDA and deferment at subsequent donations. The 
prevalence of anaemia among men globally is 12.7% whilst that of women in 
reproductive age is 30.2%6. The prevalence of anaemia in Ghana is higher than 
the global average, estimated at 42.4% in women of reproductive age7 and 18.8% 
among peri-urban men8.  
This high prevalence of anaemia in the general population may contribute to an 
increased rate of deferrals due to anaemia in potential blood donors in Ghana. This 
results in a loss of valuable members of the donor pool who could have been 
retained if they had been identified, counseled, and treated appropriately for iron 
deficiency and iron deficiency anaemia.  
Aim 
To determine the potential for iron supplementation and nutritional counseling 
strategy to increase blood donations in Ghana.  
HYPOTHESIS: Haemoglobin levels among deferred blood donors with anaemia 
will improve to near normal after iron supplementation compared to those who 
were not deferred with normal haemoglobin.   
Objectives 
Primary Objectives  
The primary objective of this study is to determine the potential for an iron 
supplementation strategy to increase blood donations in Ghana. To determine this 
potential, the study will investigate the feasibility and acceptability of this 
intervention along with key return blood donation measures among first-time blood 
donors deferred for low haemoglobin or found to have IDA or be ID within the 

 
 
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catchment areas of the SZBC. These aspects of the potential for this intervention 
will be operationalized as follows:  
• 
Feasibility of recruitment, enrolment, retention, and adherence will be 
evaluated with a target retention rate > 90% of all participants recruited 
completing the trial. If we are unable to achieve this target, alternative 
strategies will be considered for the UH3 phase. 
• 
Acceptability will involve establishing the safety profile of 3 times weekly 
low dose ferrous sulphate (65mg elemental iron) supplements among 
deferred prospective blood donors with ID and IDA. This safety profile will 
be established by comparison to a similar group of participants who do not 
receive iron supplementation. Participant and key informant views and 
perspectives 
of 
barriers 
and 
recommendations 
for 
using 
iron 
supplementation and nutritional counseling to increase the blood donor pool 
will also be investigated with participant questionnaires.  In addition, focus 
group discussions and key informant interviews will provide critical insights 
into the acceptability of this intervention.  
• 
Key blood donation measures include haemoglobin levels at 4 months, 
the change in haemoglobin concentration, ferritin levels at 4 months, the 
proportion of participants with corrected ID, the proportion of participants 
who return to the blood centre to donate blood and the proportion of 
returners who are able to successfully donate (not deferred). In addition, the 
incidence of ID and IDA among blood donors will be determined using a 
group of participants who were not deferred, were not ID and did not have 
IDA at baseline.  
To achieve this objective, a pilot study will be conducted for one year. This allows 
for enrolment over a maximum of 6 months and 6 months of follow-up for the last 
individual enrolled. The follow-up period incorporates 4 months of the iron 
supplementation intervention. 
 

 
 
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Secondary Objectives  
• 
To determine changes in haemoglobin in blood donors over a 6-month 
period. 
• 
To determine the impact of iron supplementation on the change in 
haemoglobin. 
• 
To estimate the prevalence of iron deficiency and iron deficiency 
anaemia in prospective first-time blood donors.  
• 
To determine the factors associated with iron deficiency and iron 
deficiency anaemia among prospective blood donors. 
• 
To determine the prevalence of malaria or adverse events among the 
prospective first-time blood donors. 
• 
To identify the barriers and facilitators of repeat donation and the use of 
dietary and iron supplementation interventions to address iron 
deficiency and/or anaemia among blood doors.   
• 
To determine feasibility of the intervention, through documenting 
implementation fidelity, intervention adaptation, and intervention 
strengths and weaknesses. 
• 
To understand participant and key informant acceptance of the 
intervention. 
• 
Develop and implement key strategies aimed at increasing the blood 
donor pool.  
• 
To compare Hb levels as determined by copper sulphate versus 
automated haematology analyzer.  
 
Justification 
The system of blood donation in Ghana has been identified as the major barrier to 
providing adequate and regular blood to meet the transfusion needs of the country. 
Currently, over 66% of blood collection in Ghana is obtained through a Family 
Replacement Donor (FRD) system. In countries with a 100% voluntary blood donor 
base, the average blood donation rate is 31 units per 1000 population. In contrast, 
the blood donation rate in Ghana saw little increase from 5.8 to 6.0 units per 1000 

 
 
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population between 2016 and 2018, with the proportion of voluntary unpaid donors 
stagnant at less than 35% over that period3. As a direct result, the blood supply is 
characterized by chronic inadequacy with frequent critical shortages and 
represents a major developmental challenge. In addition, deferrals among 
potential blood donors in Ghana is high9,10. Anaemia accounted for 33-53% of 
voluntary donor deferrals at the Southern Zonal Blood Centre between 2015 and 
2018 and is, therefore, a major focus of the current study.  
 
 

 
 
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LITERATURE REVIEW  
The reduction in iron stores in regular blood donors has become a recognized 
safety issue, because multiple donations are associated with increasing frequency 
of ID. In Enugu, Southern Nigeria, 11% of donors who had donated blood once 
within four years were observed to be iron deficient11. However, the prevalence of 
ID in voluntary blood donors can be as high as 40% and 50% in persons donating 
6 and 7 times in two years, respectively12. In the REDS-II Donor Iron Status 
Evaluation study in the USA, 15% of donors had absent iron stores (serum ferritin 
<12ng/ml) and 41.7% iron deficient erythropoiesis (log TfR/ferritin 2.07 )13. 
Increasing the inter-donation interval14, iron supplementation 15 or regular iron 
status monitoring 16 are some measures used to reduce the risk of iron deficiency 
from repeated blood donations. 
At the SZBC of the NBSG, blood donors are routinely advised to eat iron-rich diet. 
However, unlike a typical Western diet which provides about 10 to 15 mg of iron 
daily in the form of heme proteins found in meat, with good intestinal absorption5, 
the Ghanaian diet is mainly cereal and plant-based with low iron and a high phytate 
content that further reduces iron bioavailability17. Iron absorption from non-heme 
sources of iron such as cereals and legumes has been noted to be between 1% to 
22% 18 and even less bioavailable in a cereal porridge-based diet with absorption 
of 2-3%19. Dietary measures for restoring a blood donor’s low haemoglobin levels 
from depleted iron stores requires about 24 weeks of adequate dietary modification 
in the absence of iron supplementation 15. 
Currently, over 66% of blood collection in Ghana is obtained through a Family 
Replacement Donor (FRD) system, which is associated with insufficient, 
unsustainable and relatively unsafe supply of blood particularly for emergencies3,4. 
In countries with a 100% voluntary blood donor base, the average blood donation 
rate is 31 units per 1000 population. In contrast, the blood donation rate in Ghana 
saw little increase from 5.8 to 6.0 units per 1000 population between 2016 and 
2018, with the proportion of voluntary unpaid donors stagnant at less than 35% 
over that period3. As a direct result, the blood supply is characterized by chronic 

 
 
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inadequacy with frequent critical shortages and represents a major developmental 
challenge. In addition, deferrals among potential blood donors in Ghana is high 
9’10.This project is directed towards transforming the blood donor pool in Ghana 
from FRDs to sustainable voluntary collections, in support of Ghana’s national 
blood policy that aims at a 100% voluntary blood donation pool to secure and 
sustain an adequate and safe blood supply.  
The effect of replacement blood collections in health service delivery: (1) The 
FRD system places undue burden on patients because the transfusion of patients 
or their discharge from wards is delayed until friends and/or family can be mobilized 
to ‘donate’ equivalent numbers of units transfused. As a result, eligible donors 
refrain from voluntary donations in case they are called on to replace blood for 
relatives. (2) Because of the lag time in organizing FRDs, reliance on replacement 
donations accounts for inadequate blood for emergencies such as obstetric 
haemorrhage and severe malaria in children. Haemorrhage remains the leading 
cause of maternal mortality in Ghana as a direct consequence. (3) FRD collections 
are generally less safe compared to voluntary donations, with higher prevalence 
of seropositivity to markers for Hepatitis B and C and HIV. Paid donors, and less 
often FRDs, have a vested interest in providing false information during the pre-
donation assessment designed to exclude those potential donors at high risk for 
transfusion transmissible infections. Paid donors have higher rates of transfusion-
transmitted infections (TTI) 20. Although the Ghana national blood policy proscribes 
paid blood donations, the FRD system provides cover for these donors, who pose 
as relatives of patients.  
Importance of pre-emptive correction of inevitable iron loss to sustain 
regular voluntary donations: The project will address ID and IDA as a 
preventable cause of donor deferrals and to promote blood donor safety. While the 
national blood policy encourages repeat donations among the small voluntary 
unpaid blood donor pool in Ghana, iron depletion from regular scheduled 
venesections has not been addressed. Deferral of donors on account of anaemia 
contributes to the slow growth of the voluntary donor pool, in spite of recruitment 

 
 
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campaigns. The prevention of ID through nutritional education and iron 
supplementation programs is an important intervention where repeat voluntary 
donations are well established15. This ID and IDA prevention arm of the project will 
inform workable strategies to protect and maintain the improved pool of blood 
donors to sustain improved collection rates. 
METHODOLOGY 
Design 
This pilot study has 2 components: 1) a cross-sectional assessment designed to 
estimate the prevalence of anaemia leading to donor deferral, the prevalence of ID 
and the prevalence of IDA among first-time donors, and 2) a longitudinal 2-arm 
parallel groups trial among first-time voluntary donors that compares haemoglobin 
levels at 4 months among those with ID or IDA who receive iron supplementation 
to those without ID or IDA who do not receive iron supplementation. The primary 
outcome will be haemoglobin levels at 4 months. Participants will be followed for a 
total of 6 months with study visits at 2, 4 and 6 months after the baseline 
assessment. Blood draws for FBC, peripheral film comment, Malaria rapid test and 
ferritin assessment and the administration of a structured questionnaire will occur 
at all follow-up visits. 
The parallel group’s component is designed as a non-inferiority trial for 
haemoglobin levels at 4 months. At baseline, the 2 groups will be determined 
based on the need for iron supplementation: all individuals with ID or IDA, who 
satisfy our eligibility criteria regardless of deferral status, will receive iron 
supplements while all others will not. While a high prevalence of ID and IDA is 
expected, enrolment will be staggered so that an equal number of participants from 
each group are enrolled from each site with at least 1 participant who is found to 
be ID or have IDA. If there are more potential participants in one group at some 
site, randomization will be used to select the individuals to enroll in the trial to 
maintain balance over time. The extent of adherence is a central question for this 
study, and it is also unclear if the haemoglobin deficiency can be improved above 
what is seen in the control group, hence it is not hypothesized that those receiving 

 
 
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iron supplementation will have higher levels of haemoglobin at 4 months. The 
hypothesis about iron supplementation intervention is that it will improve 
haemoglobin levels to near that seen among those who were not deferred. If 
haemoglobin levels are higher in those receiving iron supplementation the 
intervention would also be deemed a success. Hence a non-inferiority trial is most 
appropriate for this hypothesis.  
Selection of the margin is a critical component of a non-inferiority trial. Here, we 
specify a margin of 1 g/dL for haemoglobin levels at 4 months. Under a collection 
of reasonable assumptions, this margin will ensure that the majority of those with 
low haemoglobin at baseline will have haemoglobin levels at 4 months above the 
threshold for anaemia and should therefore qualify as donors. To see this, assume 
that half of donors are anaemic at baseline (using the thresholds for anaemia of 
13 g/dL for men and 11.5 g/dL for women). A simple calculation finds that if we 
assume haemoglobin levels are normally distributed (which is a reasonable 
assumption based on observed distributions for haemoglobin in healthy 
individuals) and the standard deviation of baseline haemoglobin levels is 1.89 g/dL 
(this estimate will be described below) then the mean haemoglobin level among 
men who are deferred is 11.5 g/dL and the mean haemoglobin level among men 
who are not deferred is 14.5 g/dL (these values for women are 10.0 g/dL and 13.0 
g/dL). If we assume that the haemoglobin level among those who are not deferred 
is the same 4 months later then a margin of 1 g/dL implies a mean haemoglobin 
level among those with anaemia at baseline of at least 13.5 g/dL for men and 12.0 
g/dL for women. Thus, the mean haemoglobin level after 4 months of iron 
supplementation among those who should have been deferred will exceed the 
threshold for anaemia and consequently, if the distribution of haemoglobin levels 
is symmetric, the majority of those who were anaemic at baseline would qualify as 
donors (in fact at least 60.4% would pass the threshold for both sexes if this 
distribution is normal).  Note that the threshold for the copper sulphate test used 
for women is 12 g/dL, not 11.5 g/dL, so under these assumptions 50% of women 
would pass the copper sulphate test. Nonetheless, since well over 50% of donors 
are men the majority of deferred donors would pass the copper sulphate test. It is 

 
 
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likely that fewer than half of all donors will be anaemic at baseline. In this case the 
difference in the means between those with anaemia and those without anaemia 
will be larger, the gain in haemoglobin levels in the anaemic group will be larger 
and the proportion of donors who would be deferred at baseline but would not be 
deferred after 4 months of iron supplementation will be even larger.   It is possible 
that the difference between the 2 groups is smaller than the margin at baseline. 
This seems unlikely since the 2 groups are defined by a threshold for haemoglobin 
levels, but if the standard deviation of haemoglobin levels is 0.62 then the 
difference between the groups among men would be less than the margin under 
the assumptions of the previous paragraph (this standard deviation is less than 
one third of the standard deviation used for design). To address this, when 
enrolment reaches 50% of the total planned sample size, the statisticians 
supporting the trial at the data coordinating center (DCC) will compute the standard 
deviation of haemoglobin levels at baseline and revisit the margin calculation and 
the sample size. If the standard deviation is low enough so that the difference 
between the groups is less than the margin, then the study will be overpowered for 
the current margin and a smaller margin will be selected so that the trial is still 
testing for differences at 4 months that exceed the baseline difference. Any 
changes to the study design based on these analyses will be discussed with the 
DSMB.      
In addition, we will use a qualitative approach to identify barriers and facilitators of 
blood donation and the use of dietary and iron supplementation strategies to 
address iron deficiency and/or anaemia. This will involve conducting focus group 
discussions during the last month of the intervention. The interviews will focus on 
issues including culture concerning food selection and consumption, cost of 
micronutrient-rich foods as well as other potential issues that might contribute to 
the success or otherwise of the dietary and iron supplementation interventions. 
Duration 
The duration of this UG3 phase (Pilot trial) is 1 year 

 
 
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Sample Size 
Qualitative study:  In all, ten focus groups of 8-10 participants purposively 
selected with one group from each blood donation group category (i) religious 
organisations, (ii) educational institutions, (iii) corporate institutions, (iv) organised 
community groups, and (v) walk-in blood donors. The aim of the focus groups is to 
identify barriers and recommendations for using iron supplementation and 
nutritional counselling to increase the blood donor pool. These will be gender-
sensitive such that there will be two groups of each blood donation category by 
gender (e.g., 8-10 females, 8-10 males). The female and male focus groups will 
meet in separate spaces so only one gender will be interviewed at a time.  Thus, 
there is one male and one female group for each donation category. 
Quantitative method: Cross-sectional study to determine the prevalence of 
anaemia among prospective blood donors: There are 2 distinct components of the 
cross-sectional study: estimation of the proportion of potential donors deferred due 
to low haemoglobin and the proportion of first-time potential donors who are ID and 
IDA. The determination of deferral due to low haemoglobin is routinely collected 
by the NBSG and does not require consent of potential donors in this study. The 
proportion deferred will be determined using the same donation sites as the other 
components of the study with an estimated sample size of 600 and resulting margin 
of error less than 0.04. Consequently, the 95% confidence intervals for deferment 
prevalence will have a total width of less than 0.08 giving a more precise estimate 
than the year-to-year variation in the total percentage deferred. Participant consent 
is needed to draw blood for determination of ID and IDA.  We anticipate that 292 
participants will consent and be enrolled with resulting margin of error less than 
0.057 and total confidence interval width of less than 0.11 for likely values of the 
prevalence of ID and IDA among first-time potential donors. Thus the ID and IDA 
prevalence estimates will have comparable precision to the estimated proportion 
of deferred using all potential donors at recruitment sites. 
Parallel groups’ trial to assess the acceptability of iron supplementation: Using a 
non-inferiority design with a non-inferiority margin of 1 g/dL for haemoglobin levels 

 
 
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12 
at 4 months, a 1-sided alpha level of 0.025, at least 85% power and under the 
assumption that the true difference in the means is 0.3 requires 262 participants 
(131 per arm). This number has been increased to allow up to 10% loss to follow-
up or iron supplementation for those initially not requiring supplements (such 
individuals will be excluded from the primary analysis: see Section 12 for further 
details), thus the sample size is 292. For efficiency, participants will be enrolled 
into both parts of the quantitative study.   
For efficiency, participants will be enrolled into both parts of the quantitative study.   
Sample size justification 
Cross-sectional study: Since all potential donors will contribute to the estimate 
of the proportion of potential donors who are deferred due to low haemoglobin, the 
estimate of this proportion will be sufficiently accurate to allow for comparisons 
against yearly rates. As stated above, the annual proportion of deferrals from 2015-
2018 ranged from 33-53%. If we assume that 5 blood donors attempt to donate 
each business day, then there should be about 600 donation attempts over the 6-
month enrolment period. Table 1 shows values for the prevalence of low 
haemoglobin, the corresponding margin of error and the corresponding 95% 
confidence interval. For example, if the prevalence of low haemoglobin leading to 
deferral is 50% then a 95% confidence interval would be (46%, 53%) which allows 
for determination of the prevalence in a range that is smaller than the range of 
yearly estimates. Note: these estimates were obtained using the usual normal 
approximation to the sampling distribution of a proportion without a continuity 
correction. 
Table 1: Precision of prevalence estimates for low haemoglobin leading to 
deferral. 
Prevalence 
Margin of error 
95% confidence 
interval 
0.2 
0.032 
0.17, 0.23 

 
 
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0.3 
0.037 
0.26, 0.34 
0.4 
0.039 
0.36, 0.44 
0.5 
0.040 
0.46, 0.54 
0.6 
0.039 
0.56, 0.64 
   
Since not all participants will consent to participate in the study and only a subset 
of donors are first-time donors, the precision of estimates of the prevalence of ID 
and IDA will be lower. Based on the unpublished estimates of the prevalence of ID 
and IDA provided above (i.e., 63.9% of those with anaemia had IDA and 86.1% of 
those with anaemia had ID, so 30.7% of the total had IDA and 41.3% had ID), 
estimates of the prevalence of these conditions cover almost the same range as 
our estimates of the prevalence of low haemoglobin. Since enrolment for this 
component of the study entails enrolment in the longitudinal study, the sample size 
was determined by the requirements for the longitudinal study which is 292 
participants. Since some participants in the cross-sectional study of ID and IDA 
may be found to have Hb<10g/dl and will therefore be excluded from the 
longitudinal study, the sample size for the cross-sectional study may exceed 292. 
This will require that, on average, almost 2.5 participants per day consent to the 
study to get to about 300 over the 6-month enrolment period. Table 2 shows values 
for the prevalence of ID/IDA, the corresponding margin of error and the 
corresponding 95% confidence interval. For example, if the prevalence of IDA is 
30% then a 95% confidence interval would be (25%, 35%) which has a total width 
comparable to the confidence intervals obtained using all potential donors. 
 
Table 2: Precision of prevalence estimates for ID and IDA. 
Prevalence 
Margin of error 
95% confidence 
interval 

 
 
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0.2 
0.046 
0.15, 0.25 
0.3 
0.053 
0.25, 0.35 
0.4 
0.056 
0.34, 0.46 
0.5 
0.057 
0.44, 0.56 
  
Parallel groups study: The primary outcome for this portion of the study is 
haemoglobin levels at 4 months. Formally the null hypothesis for this outcome is 
inferiority of treatment of low haemoglobin with iron supplementation among those 
with low haemoglobin at baseline to no treatment among those without low 
haemoglobin at baseline. The non-inferiority margin is fixed at a value of 1.0 g/dL. 
Based on recent work in west Africa, the DCC has access to haemoglobin 
measurements from 1548 individuals between the ages of 17 and 60 who weigh 
at least 50 kg. Among these individuals the standard deviation of haemoglobin was 
1.89 g/dL (the mean was 13.4 g/dL). These individuals did not pass the strict 
screening criteria used by the NBSG, so this estimate might be slightly inflated and 
so our power calculations may be somewhat conservative. We specify an alpha 
level of 0.025 and require power of at least 85%. With these values we can 
determine the number of participants per arm if we assume a value for the true 
difference between the groups (the absolute value of this difference must be less 
than our margin and will generally be negative when the margin is positive to be 
consistent with the lack of superiority of iron supplementation). Table 3 presents 
the number of participants per arm under these assumptions for a selection of 
values for the true difference. We assume that the true difference is -0.3 g/dL and 
obtain a sample size of 131 participants per arm. If the true difference is larger 
than -0.3 g/dL (e.g., if there is no difference) then the power will exceed 85%. To 
allow for loss to follow-up and some participants requiring iron supplementation 
due to incident ID or IDA the sample size has been increased to 292.  
Table 3: Number of participants per arm for 1-sided alpha of 0.025 and power of 
at least 85%. 

 
 
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Mean Hb treated-mean Hb 
control (i.e., true treatment 
difference) 
Sample size (per group) 
0 
65 
-0.1 
80 
-0.2 
101 
-0.3 
131 
-0.4 
179 
 
Study site and Population 
The National Blood Service, Ghana (NBSG) SZBC located in the capital Accra 
annually collects voluntary blood donations from 200-300 blood donor groups that 
are categorised as (i) religious organisations, (ii) educational institutions, (iii) 
corporate institutions, (iv) organised community groups, (v) walk-in blood donors 
and (vi) mass/media events. Data for the prevalence of deferral assessment will 
be collected from all prospective voluntary blood donors within the catchment 
areas of the SZBC.  The prevalence study of ID and IDA as well as the parallel 
groups’ trial will be restricted to first-time donors. Generally, prospective voluntary 
blood donors are healthy, unlikely to be severely anaemic and are more likely to 
be male.  
The study population will be all adults between the ages of 17 and 60 years who 
visit blood donation sites at the time of recruitment. The lower limit takes into 
account the lawful requirements of a country for giving consent, the intensified 
threat of vasovagal reactions in younger donors, and the augmented iron needs of 
adolescents and young females 21,22. The upper age limit is so set because of an 
increase in various medical conditions with age especially cardiovascular diseases 
making donations more hazardous23. A stringent screening and selection process 
is performed to evaluate the suitability of prospective donors. This is essential to 

 
 
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guarantee the safety and adequacy of the blood supply; protecting the wellbeing 
of the recipients of transfusion as well as the fitness of the donors while ensuring 
that qualified donors are not deferred needlessly.  
Stratification and Sampling 
The SZBC contributes to the blood service needs of the Western, Central, Greater 
Accra, Eastern and the Volta Regions of Ghana. In 2018 and 2019, the SZBC 
attended to an average of 550 prospective voluntary blood donors a week, 
including 80 walk-in donors. Out of this number, the study will recruit all participants 
(who fall within the inclusion criteria) reporting per day for up to 6 months until the 
sample size is attained. Eligible participants will form the sampling frame for the 
study.  
Out of the sampling frame, participants will be purposively sampled for Focus 
Group Discussions (FGDs). In all there will be ten FGDs i.e. two groups (male-only 
and female-only) randomly selected to represent each of the five NBSG voluntary 
blood donation categories (excluding mass/media event donors), and with each 
group composed of both first-time and repeat donors. In-depth interviews will also 
be conducted with blood donation staff and medical officers responsible for blood 
donation. 
Regimen 
The prevalence study will be conducted over the first 6 months of the study period. 
For the cross-sectional deferral assessment, all donation attempts and deferrals 
from sites where recruitment for the parallel groups study will take place will be 
recorded. The number of deferrals among first-time donors will also be determined. 
Potential first-time donors will be asked if they are interested in participating in a 
study of the prevalence of ID and IDA and the impact of iron supplementation on 
haemoglobin levels and repeat donation. Those who express interest and consent 
to the study will be asked to return in approximately 2 weeks. During this 2-week 
period a full blood count (FBC) and plasma ferritin measurement will be 
determined, and participants will be classified as ID, IDA or otherwise (which we 
refer to as controls in this protocol). Those found to be ID or IDA will receive oral 

 
 
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iron supplementation and nutritional counseling. Controls will not be given iron 
supplementation but will receive the standard practice of nutritional counseling for 
blood donors. Additional baseline data will be collected at the 2-week return visit. 
The duration of the intervention period is 4 months with two interim visits 
(approximately 2 months apart) and a final visit at 6 months. A blood draw will be 
conducted for a FBC, peripheral film comment, malaria rapid test and ferritin 
measurement at both interim visits and the final visit. Participants will receive bi-
weekly follow-up phone calls for adherence and monitoring for adverse events. 
Qualitative assessment of acceptability of oral iron supplementation among donors 
previously deferred will be performed during the final month of the pilot study. 
Inclusion Criteria 
There are 3 components of the quantitative study (observational study of deferral, 
observational study of the prevalence of ID and IDA, and the clinical trial of 
supplementation) with slightly different inclusion and exclusion criteria, hence we 
indicate which criteria apply to which component of the study below. 
Items 1-3 are required for the observational study of deferral, items 1-4 are 
required for the observational study of the prevalence of ID and IDA and items 1-
5 are required for the clinical trial. Only participants who meet ALL the following 
inclusion criteria will be eligible for the clinical trial: 
1. Males or females aged between 17 and 60 years who weigh at least 
50kg. 
2. Pass pre-donation screening using the NBSG standardised donor 
screening questionnaire for medical conditions and lifestyle risks for 
transfusion transmissible infections (Appendix 5). 
3. Vital signs must meet the NBSG requirement for blood donation: 
systolic and diastolic blood pressures between 90-140 mmHg and 60-
90 mmHg, respectively; pulse rate between 50-100 bpm; non-contact 
forehead temperature not exceeding 37.5°C; meeting acceptable 
requirements for skin lesions, needle marks and physical appearance.  
4. Must be willing and able to give study consent or assent. 

 
 
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5. Intend to remain in the study location/site during the entire length of 
the study. 
Exclusion Criteria 
There are no additional exclusion criteria for the observational study of 
deferral, items 1-2 are required for the observational study of the prevalence 
of ID and IDA, and items 1-5 pertain to the clinical trial. All persons who meet 
ANY of the following exclusion criteria will be excluded from participating in 
the clinical trial. 
1. Persons who have used iron supplementation within the past one 
month. 
2. Participant reports having previously donated blood.  
3. Evidence for a TTI at baseline among those who successfully donated. 
4. Evidence of Malaria and helminthic infections at baseline 
5. Participants who have Hb <10g/dl at screening  
Potential donors who are found to have Hb < 10g/dl at screening will be referred 
for further evaluation and care by a haematologist. Any clinical trial participant 
found to have Hb < 10g/dl at any follow-up visit will be referred for evaluation by 
a haematologist.  
Approach to Inter-current Therapies and Clinical Trial Co-enrolment:  
Nutritional counselling for all study subjects will be provided by the study nutritionist 
and trained counsellors at each visit. The counselling will cover nutritional advice 
and drug interactions. Participants will be advised to eat a meal before taking the 
assigned capsule or tablet each time to minimize the possibility of gastrointestinal 
effects. Participants will also be counselled on minimizing potential adverse iron-
food interactions and on the danger of consumption of large quantities of iron 
supplements. The supplements will be administered in child-safe containers. A 
consumer-friendly brochure on benefits of adhering to iron, and safe use of 
medicines including food interactions and medicine interactions involving iron will 
be provided to participants. (Appendix 3) 

 
 
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Costs to Participants 
Travel costs for study visits will be reimbursed to the participants. Study 
participants are not compensated for other costs to avoid participation based on 
remuneration. During the course of this study all laboratory tests, visits and 
interventions will be free of charge for study participants. Participants who during 
the course of the study are found to have malaria or helminthic infection will be 
treated free of charge by study physicians.   
Study Products, Procedures and Assessments 
Description of Product 
Oral iron supplements specifically ferrous sulphate 200mg (65mg Elemental iron).  
Handling of Study Product 
The iron supplements are already available at the Korle-Bu Teaching Hospital 
Pharmacy. The study principal investigators and study pharmacist will ensure the 
medicine is stored properly and dispensed only when needed for study 
participants. The following will be monitored and completed on a continuous basis 
to ensure the medicine is within study guidelines, pharmaceutical compliance, and 
manufacturer guidelines:  
• 
Drug Accountability Record  
• 
Iron supplement Safety and Handling Sheet  
Study Procedures and Assessments 
Evaluation of Factors leading to ID and IDA 
• 
Systematic Literature Review 
We will systematically review the literature on factors contributing to iron deficiency 
in prospective blood donors. 
• 
Community Engagement 
We will carry out community engagement meetings with stakeholders in our blood 
donor communities to introduce the project to them. 

 
 
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Screening /Baseline Assessments 
• Donor Eligibility Screening by NBSG 
Individuals in blood donor groups will proceed with routine assessment by blood 
donation staff for eligibility for whole blood donation as defined by the NBSG. As 
part of this assessment, these potential blood donors will undergo routine semi-
quantitative haemoglobin assessment using the copper sulphate (CuSO4) 
gravimetric method with a cut- off Hb concentration value of <13.0 g/dL for males 
and <12.0 g/dL for females. Prospective blood donors who consent and meet the 
eligibility criteria will be eligible for the study. The site will log potential blood donors 
who are approached to participate in the study and document whether the 
participant elects or declines involvement with the study. 
• Consenting Procedure 
Prospective blood donors who pass all pre-donation assessments, and those who 
are deferred specifically on account of failed CuSO4 will be approached and 
informed about the study by trained research assistants. All eligible participants 
will provide written informed consent and, in the case of minors, additional assent. 
Eligible enrolled minors who turn 18 during the course of the study will need to be 
re-consented as adults.  
 
 
• Rescreening 
Rescreening will be allowed for previously excluded participants after four months. 
In this case a new study identification number will be assigned to the participant 
and the participant will be identified with this new number for the rest of his/her 
participation in the study. If participant has been enrolled, re-screening is not 
allowed. In case rescreening occurs, all evaluations re-assessed should meet the 
eligibility criteria. A new informed consent form (ICF) must be signed only if there 
is an interruption in the participant’s eligibility evaluation and the investigator 
chooses to re-screen the participant following screen failure. If a new ICF is signed, 

 
 
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AEs and medical history will be assessed relative to the new informed consent 
date.  
• Blood Sampling:  
Participants who consent/assent to participate will have 5ml of whole blood 
sampled into an EDTA tube for full blood count, peripheral film comment, malaria 
rapid test and plasma ferritin analysis. This blood draw will take place prior to 
donation for those participants who can donate to prevent a classification of ID due 
to sampling immediately after a donation. 
• Estimation of Iron Deficiency and Iron Deficiency Anaemia 
Anaemia is a state in which the amount of red blood cells (RBCs) is insufficient to 
meet the body’s physiologic needs 24. Mild anaemia is defined as Hb ranging from 
11-12.9 g/dL in adult males and 11-11.9 g/dL in adult females. Moderate anaemia 
is defined as Hb level of 8-10.9 g/dL and severe anaemia is defined as Hb level of 
less than 8 g/dl for all the age groups 25,26. 
Following FBC and plasma ferritin estimation, screened participants will be 
classified by the WHO criteria as shown in Table 4: 
 
 
 
 
Table 4: Definition of Iron Status Criteria 
Haemoglobin  
concentration, g/dL 
Plasma ferritin concentration
µg/L 
Interpretation 
[Male] 
>13.0  
[Female] >11.5  
< 15 
Iron deficiency without 
anaemia 
[Male] 
≥8.0-13.0  
[Female] ≥8.0-11.5  
< 15 
Iron 
deficiency 
with  
mild 
to 
moderate 
anaemia 

 
 
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[All] 
<8.0 
< 15 
Iron 
deficiency 
with 
severe anaemia 
Schedule of Assessments (Table 5) 
Assessment 
Screening 
(Day -14 to 
0) 
Enrolment 
(Day 0) 
Biweekly 
(Throughou
Interim Visit 
1 
(Week 8-10) 
Interim Visit 
2 
(Week 16-
Final Visit 
(Week 24) 
NBSG Pre-Donation 
Assessment 
X 
 
 
 
 
X 
Informed Consent 
X 
 
 
 
 
 
Inclusion and Exclusion 
Criteria 
X 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
Full Blood Count and 
peripheral blood comment 
X 
 
 
 
X 
 
X 
 
X 
 
Plasma Ferritin 
X 
 
 
X 
X 
X 
Malaria Parasites Testing 
(RDT) 
X 
X 
 
X 
X 
X 
Nutritional Counselling 
 
X 
 
X 
X 
 
Qualitative Assessment 
 
 
 
 
 
X 
Follow-Up Calls 
 
 
X 
 
 
 
Return Blood Donation Status 
 
 
 
X 
X 
X 
Assessment for Adverse 
Events 
 
X 
X 
X 
X 
X 
Adherence Assessment (for 
those receiving supplemental 
iron) 
 
 
X 
X 
X 
X 
RDT – Rapid Diagnostic Test 
 

 
 
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Enrolment 
Participants will be re-assessed with their laboratory results at the Day 0 visit.  
• Eligibility Check 
The investigator will be responsible to ensure only participants who meet all 
inclusion and none of the exclusion criteria are included in this study. Following 
registration for screening, participant eligibility will be checked once all screening 
procedures are completed.  
• 
Screening failures 
Participants who sign an ICF and are subsequently found to be ineligible prior to 
enrolment will be considered a screen failure. The reason for screen failure should 
be recorded on the appropriate eCRF. The demographic information, informed 
consent, and Inclusion/Exclusion pages must also be completed for screen failure 
participants. No other data will be entered into the clinical database for participants 
who are screen failures, unless the participant experienced a SAE during the 
screening phase (see SAE section for reporting details). Prospective donors who 
are found after baseline screening to have haemoglobin values less than 10g/dl will 
be referred to the haematology outpatient clinic or community clinic for further 
investigations and management. This includes participants who are found to have 
haemoglobin values less than 10g/dl at a follow-up visit. These participants will 
continue to be followed for the duration of follow-up. If use of iron supplementation 
is consistent with recommended medical care, the study will provide iron 
supplements to these participants and this will be captured in the study database. 
Follow Up Assessments 
The assessment schedule lists all of the assessments and indicates with an “X” 
(table 5), the visits when they are performed. All data obtained from these 
assessments will be entered into a database.  
Study participants will be seen for all visits/assessments as outlined in the 
assessment schedule or as close to the designated day/time as possible. 
Participants who have not previously been provided with iron supplementation and 

 
 
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are found to have ferritin <15g/dl or low haemoglobin by the sex-based thresholds 
during study visits will be offered iron supplementation. This will be recorded in the 
study database and these participants will be followed for the duration of follow-
up. Participants will be instructed to report missed doses to the study team and 
this will be documented. They will be instructed to wait till the next dosing day and 
not to double their dose. Missed or rescheduled visits will not lead to automatic 
discontinuation.  
Participants will be followed up every 2 months and will be interviewed by members 
of the research team and appropriate CRFs completed by study staff. Adherence 
to iron supplementation and nutritional counseling will be assessed biweekly by 
phone and at each visit. 
Participants with suspected adverse events of iron supplementation will be 
appropriately managed. Participants with suspected bacterial infections will be 
assessed with blood cultures (if indicated) and tested for malaria parasites during 
study visits. Malaria preventive measures will be discussed with all study 
participants on enrolment, and they will be encouraged to use these preventive 
measures throughout the study. A history of medical events and selected potential 
adverse events will be obtained at each scheduled visit and during biweekly follow 
up phone calls. Participants will also be given identification cards to carry with them 
at all times providing instructions directed to any health care provider who sees 
them for an unscheduled medical care visit. 
• 
Treatment  
The planned duration of treatment is 4 months. Participants with a low plasma 
ferritin <15µg/L, with or without anaemia, will be given oral iron supplementation 
and nutritional counseling. Treatment will continue for 16 weeks or until the end of 
follow-up, during which participants will be followed up for adherence counseling 
at each visit. Clear written instructions for use 3 times a week will be discussed 
with them. Research staff will contact participants every 2 weeks by phone for 
adherence and feedback, and to remind participants to keep their scheduled study 
visits. 

 
 
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Testing of plasma ferritin and FBC after 4 months of supplementation will allow us 
to assess for response to study treatment with regards to iron stores. After 
correction of iron depletion or IDA, FBC and plasma ferritin will be monitored at 4 
months from baseline. Participants after the end of the intervention phase still 
found to be iron deficient or anaemic will continue management and further 
evaluation at the haematology clinic.  
• 
Discontinuation 
If discontinuation of study treatment occurs, the investigator should make a 
reasonable effort to understand the primary reason for the participant’s premature 
discontinuation of study treatment and record this information. 
Participants who discontinue study treatment or who decide they do not wish to 
participate in study assessments are not considered withdrawn from the study 
UNLESS the participant withdraws their consent. When possible, participants are 
encouraged to return for the follow up visits. If they fail to return for the follow up 
visit for unknown reasons, every effort (e.g., telephone calls) should be made to 
contact the subject/pre-designated contact. This contact should preferably be done 
according to the study visit schedule. 
The investigator may discontinue study treatment for a given subject if he/she 
believes that continuation would be detrimental to the subject’s well-being. 
Adherence Strategies 
The study team will perform adherence improvement techniques by phone 
biweekly and at each study visit. All study participants will have nutritional 
counseling, dietary advice, and for those receiving iron, the need for iron therapy 
to be used consistently 3 days a week. The study team will call each participant 
biweekly and ask about the number of days during the past 2 weeks he/she 
consumed or did not consume the iron supplement and dietary recall. At each 
scheduled visit, they will be encouraged to bring back the bottle he/she received 
so any remaining amount can be counted. If participants demonstrate verbal non-

 
 
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adherence, they will be provided pillboxes and called up by phone weekly for 
adherence counseling.  
• 
Adherence Assessment 
To evaluate the various methods for adherence, several strategies to be employed 
will include pill counting and administering adherence questionnaires. Adherence 
will also be calculated as the percent of follow-up days/expected pill consumption 
days, participant did consume the pill. We will also use a validated simplified self-
report medication adherence measure with six items 27. 
Retention Strategies 
The use of simple, clear, detailed written and verbal instructions regarding therapy, 
possible side effects of iron supplementation and tests required for the study 
increases comprehension of the purpose and importance of the study and yields 
better adherence to the trial. Study research assistants are to regularly 
communicate with donors in the study and provide feedback to them using a 
structured guideline. Reminders will be sent to donors for their study visits by the 
research assistants. A consumer-friendly brochure on safe use of medicines 
including food interactions and medicine interactions involving iron is to be 
provided to participants. 
The key to the success of retention and follow-up will be attention to detail, 
consistency of the research team and trust among the potential blood donors and 
staff. The staff will contact potential blood donors immediately and reschedule 
appointments when missed. Close monitoring of participants’ visits and need for 
return appointments with follow-up telephone calls are key elements for monitoring 
attendance and prevention of study participants’ being lost to follow-up. 
Every attempt will be made by the study team to contact participants prior to their 
scheduled visit based on the allotted schedule for participants on both arms of the 
study. Identification of a stable contact person (such as a neighbor or a friend) who 
does not live with the study participant’s family, but always knows his or her 

 
 
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whereabouts will assist in tracking study participants and will decrease the number 
lost to follow up.  
Safety Assessment 
Definitions 
• 
Adverse Event (AE) 
An AE is any untoward or unfavourable medical occurrence in a study participant, 
including any abnormal sign (e.g., abnormal physical exam or laboratory finding), 
symptom, or disease, temporally associated with their participation in research.  
Only AEs potentially related to iron supplementation will be recorded as AEs.  
At each follow-up visit all participants will be asked if they have experienced each 
item from a list of common side effects of iron supplementation. Furthermore, the 
occurrence of additional AEs will be sought by non-directive questioning of the 
study participant at each visit during the study. AEs also may be detected when 
they are volunteered by the study participants during or between visits or through 
physical examination findings, laboratory test findings, or other assessments. 
Adverse events will be recorded in the Adverse Events eCRF under the signs, 
symptoms, or diagnosis associated with them, accompanied by the following 
information (as far as possible): 
• 
AEs will be assessed.  
• 
Its relationship to the study treatment.  
• 
Its duration (start and end dates) or if the event is ongoing, an outcome of not 
recovered/not resolved must be reported. 
• 
The grade of the AE. 
• 
Whether it constitutes a SAE. 
• 
Action taken regarding with study treatment. 
All AEs will be treated appropriately. Treatment may include one or more of the 
following: 

 
 
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• 
Dose not changed 
• 
Dose Reduced/increased  
• 
Drug interrupted/withdrawn. 
• 
Its outcome (i.e., recovery status or whether it was fatal). 
If the event worsens the event will be reported a second time in the eCRF noting 
the start date when the event worsens. For Grade 3 and 4 AEs only, if improvement 
to a lower grade is determined a new entry for this event will be reported in the 
eCRF noting the start date when the event improved from having been Grade 3 or 
Grade 4. 
Adverse events (including lab abnormalities that constitute AEs) will be described 
using a diagnosis whenever possible, rather than individual underlying signs and 
symptoms. 
Once an AE is detected, it will be followed until its resolution or the end of follow-
up and an assessment will be made at each visit (or more frequently, if necessary) 
of any changes in severity, the suspected relationship to the interventions required 
to treat it, and the outcome. If an AE has not resolved by the end of follow-up for a 
participant, the outcome of the AE will be recorded as unknown. 
Common adverse events associated with iron supplementation are minor and 
include:  
• 
Unpleasant taste, 
• 
Constipation 
• 
Dark stools  
• 
Nausea  
• 
Vomiting 
• 
Abdominal pain  
• 
Diarrhoea.  

 
 
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Abnormal laboratory values or test results constitute AEs only if they fulfil at least 
one of the following criteria: 
• 
they induce clinical signs or symptoms 
• 
they are considered clinically significant 
• 
they require therapy. 
Clinically significant abnormal laboratory values or test results will be identified 
through a review of values outside of normal ranges/clinically notable ranges, 
clinically significant changes from baseline or the previous visit. 
Follow-Up for AEs 
Study Subjects who experience any AEs will be followed up at least once a week 
(or more frequently if required by institutional practices, or if clinically indicated) for 
4 weeks, or until resolution or stabilization of the event, whichever comes first. 
Appropriate clinical experts will be consulted as deemed necessary.  
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.  
Information about all SAEs will be collected and recorded on the electronic Serious 
Adverse Event Report Form; all applicable sections of the form will be completed 

 
 
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in order to provide a clinically thorough report. The investigator will assess and 
record the relationship of each SAE to the study intervention, complete the SAE 
Report Form in English, and submit the completed form within 24 hours to the 
College of Health Sciences IRB. 
All follow-up information for the SAE including information on complications, 
progression of the initial SAE and recurrent episodes will be reported as follow-up 
to the original episode within 24 hours of the investigator receiving the follow-up 
information. An SAE occurring at a different time interval or otherwise considered 
completely unrelated to a previously reported one will be reported separately as a 
new event. 
Follow-up information will be submitted in the same way as the original SAE Report 
and will describe whether the event has resolved or continues, if and how it was 
treated, and whether the study participant continued or withdrew from study 
participation. 
We do not anticipate any SAEs directly related to iron supplementation in this 
study. However, accidental ingestion of a large amount of oral iron preparation 
may result in acute iron poisoning which can manifest as severe diarrhoea, 
acidosis, shock, and death. Study participants will be educated and strict 
instructions on iron supplementation given and the need to store them away from 
children. Study pills will be distributed in child-safe containers. The pills will be 
taken three times weekly, specifically Mondays, Wednesdays and Fridays. 
• 
Unanticipated Problems 
An Unanticipated Problem (UP) is any incident, experience or outcome that is: 
• 
Unexpected in terms of nature, severity, or frequency in relation to: 
• 
the research risks that are described in the IRB-approved research 
protocol and informed consent document; Investigator’s Brochure 
(IB) or other study documents; and 
• 
the characteristics of the population being studied; and 

 
 
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• 
Possibly, probably, or definitely related to participation in the 
research; and 
• 
Places study participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was 
previously known or recognized per the IB.  
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. 
• 
Severity 
The investigator will evaluate all AEs related to iron supplementation with respect 
to both seriousness (results in outcomes as above) and severity (intensity or 
grade).  
The following generic scale will be used: 
Grade 1 
Symptoms causing no or minimal interference with usual social and 
functional activities 
Grade 2 
Symptoms causing greater than minimal interference with usual 
social and functional activities 
Grade 3 
Symptoms causing inability to perform usual social and functional 
activities 
Grade 4 
Symptoms causing inability to perform basic self-care functions, or 
medical or operative intervention indicated to prevent permanent 
impairment, persistent disability, or death 
Grade 5 
Events resulting in death 
 
• 
Causality 

 
 
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Causality refers to the likelihood that the event is related to the study intervention. 
It will be assessed for SAEs and UPs.  
The causality assessment is based on available information at the time of the 
assessment of the event. The investigator may revise these assessments as 
additional information becomes available. 
Expectedness 
Expectedness will be assessed for SAEs using the Reference Safety Information 
section of the IBs for the investigational agent and any study-provided background 
therapy. 
The expectedness assessment is based on available information at the time of the 
assessment of the event. The investigator may revise these assessments as 
additional information becomes available. 
Schedule for Data Collection and Reporting of Specific Events  
Safety assessments will consist of monitoring and recording all AEs related to iron 
supplementation. It will also include regular monitoring of laboratory assessments 
including FBC and plasma ferritin.  
Steps to limit adverse events due to iron supplementation: 
All study participants will be evaluated at each visit as well as during an acute 
event. Malaria preventive measures will be discussed with all study participants on 
enrolment, and they will be encouraged to use these preventive measures 
throughout the study. A history of medical events and potential adverse events will 
be obtained at each visit. Participants will also be given a card to carry with them 
at all times providing instructions directed (including contact number of PIs) to any 
health care provider who sees them for an unscheduled medical care visit. 
Treatment will be given to those with signs and symptoms suggestive of an 
adverse event. They will be monitored with a FBC, cultures will be done if bacterial 
infection suspected and tests for malaria parasites will be done.  

 
 
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Iron supplementation with nutritional counseling for potential blood donors will be 
given for 4 months (16 weeks). Nutritional counseling for all study subjects 
receiving iron supplementation will be done at each visit including the need for 
participants to eat before taking study treatment to help minimize gastrointestinal 
effects. Participants will also be counseled on potential iron-food interactions and 
how to minimize that from occurring. A consumer-friendly brochure on safe use of 
medicines including food interactions and medicine interactions involving iron will 
be provided to participants. 
However, it is anticipated that AEs will occur infrequently in this population. There 
is no predefined type or frequency of AEs or SAEs for a stopping rule in this study. 
Review of SAEs and deaths on study will be performed routinely by the DSMB. If 
a safety concern arises that warrants review for possible study termination, the 
DSMB (or party identifying such concern) will notify the NHLBI immediately. 
Enrolment in the study may be temporarily halted for further review of safety data. 
This further assessment of safety data will include review by the DSMB, which may 
include a recommendation to terminate the study early. Termination of the clinical 
study may also occur due to a regulatory authority decision or if the sponsor or 
regulatory authority decides that subject safety may be compromised by continuing 
in the study. If the study is halted temporarily or prematurely terminated, a written 
statement fully documenting the reasons for study halt or termination will be 
provided to the Institutional Review Board (IRB)/ Independent Ethics Committee 
(IEC) and NHLBI. 
Covid-19 Mitigation Strategies 
Staff contact with participants for follow-up biweekly by phone for adherence and 
feedback. During study visits staff and participants will practice social distancing 
when possible and wear face masks that cover the mouth and nose. The study will 
provide facilities for frequent hand washing and alcohol-based sanitizers.   
Halting Enrolment for Safety Reasons 
The study may be discontinued at any time by the IRB, OSMD/DSMB or NHLBI as 
part of their duties to ensure that research participants are protected. 

 
 
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Data Analysis 
 
• 
Qualitative Data Analysis 
Qualitative data collection and analysis will proceed simultaneously. In all, ten 
focus groups of 8-10 participants purposively selected with one group from each 
blood donation group categories (i) religious organizations, (ii) educational 
institutions, (iii) corporate institutions, (iv) organized community groups, and (v) 
walk-in blood donors. The aim of the focus groups is to identify barriers and 
recommendations for using iron supplementation and nutritional counseling to 
increase the blood donor pool. These will be gender-sensitive such that each focus 
group is equality split by gender (e.g., 4-5 females, 4-5 males). The female and 
male focus groups will meet in separate spaces so only one gender will be present.  
Thus, there is one male and one female group for each donation category.  
Focus Group Discussions will be audio recorded with consent from the 
participants. Information obtained will be transcribed verbatim and translated when 
appropriate. The qualitative analysis protocol will include: (1) preliminary 
exploration of the data by reading through the transcripts and writing memos; (2) 
coding the data by segmenting and labelling the text; (3) using codes to develop 
themes by aggregating similar codes together; (4) connecting and interrelating 
themes; (5) constructing a narrative. Data will be coded and analysed for themes 
using the Qualitative Software and Research (QSR) Nvivo 1.0 (March 18, 2020).  
The qualitative study that will precede the trial will be used to guide implementation 
and evaluation of the larger study at the UH3 Phase, including identifying barriers 
and recommendations for using iron supplementation and nutritional counseling to 
increase the blood donor pool. Moreover, qualitative findings resulting from focus 
groups to be conducted at the end of the trial at the UG3 phase and key informant 
interviews will be used to guide the planning, implementation, and evaluation of 
the UH3 phase.  
• 
Quantitative Data Analysis 

 
 
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Prior to database lock a detailed statistical analysis plan will be written and shared 
with the DSMB. Here, a summary of the proposed approach is provided. 
As data collection proceeds, descriptive statistics will be provided on reports 
posted to the study website to summarize donor characteristics such as age in 
years, sex, and first-time donation status. These summaries will be presented in 
the form of counts and percentages for binary and categorical variables, and 
medians (with first and third quartiles) for continuous variables. Percentages, 
means, medians and quartiles will be rounded to one significant digit. The 
frequency and percent of missing or unknown data will also be presented for each 
characteristic. 
Analytical approaches to the analysis of data from the prevalence study will focus 
on univariate summaries but will also investigate risk factors for deferral, ID, and 
IDA. Exact confidence intervals for the probability of deferral, the probability of ID 
and the probability of IDA will be computed using the method first described by 
Clopper and Pearson. Logistic regression will be used to assess risk factors for 
these outcomes. For deferral, these risk factors will include age and sex but likely 
little else as the data we can obtain for these individuals is limited. For ID and IDA, 
the role of demographics will be investigated as well as other factors including 
socio-economic status, medical history, and diet. Final models for the impact of 
risk factors on deferral, ID, and IDA will include demographics and a selection of 
covariates found to have a statistically significant univariate association with each 
of these outcomes. 
The analysis for the primary outcome of haemoglobin levels at 4 months will be 
conducted using a linear model with haemoglobin levels at 4 months as the 
response variable. It is unlikely that there is a need to transform the response 
variable as haemoglobin levels are usually symmetrically distributed with tails that 
decay at rates consistent with the normal distribution. However, if informal 
univariate assessments of normality (e.g., qq-plots) indicate strong departures 
from these expectations, the Box-Cox transformation will be used to select a 
transformation. The set of explanatory variables will be group membership (i.e., 

 
 
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received iron supplementation or not), baseline haemoglobin, sex, and age. A 1-
sided t-test for the regression coefficient associated with group membership will 
be conducted with a significance level of 0.025 to test the inferiority hypothesis. 
This analysis will exclude individuals who did not receive iron supplementation at 
baseline but received it during follow-up due to changes in ferritin or haemoglobin 
values. The frequency of this will be closely tracked and if more than 10% of 
participants in the group initially not receiving iron supplementation receive iron 
supplementation during follow-up, alternative analysis approaches will be 
considered and presented to the DSMB. At a minimum, sensitivity analyses which 
include those requiring iron supplementation during follow-up will be pursued. 
These analyses will include those requiring supplementation during follow-up in 
each of the 2 groups. 
Several secondary outcomes relate to the efficacy of iron supplementation. The 
treatment of those not requiring iron supplementation at baseline but requiring iron 
supplementation during follow-up will be the same as for the primary outcome. 
These secondary outcomes include:  
• 
change in haemoglobin over 4 months,  
• 
ferritin levels at 4 months,  
• 
diagnosis of ID or IDA at 4 months,  
• 
attempt to return for donation within 6 months,  
• 
successful donation within 6 months.   
The first 2 of these outcomes will be treated as continuous variables and will serve 
as response variables in multiple regression models. It is anticipated that there will 
not be a need to transform the change in haemoglobin (however the Box-Cox 
transformation will be pursued if there is evidence for skewness), but it is 
anticipated that ferritin will need to be transformed. Usually logarithmic 
transformations are required to reduce the skewness of variables of this sort (i.e., 
measured by an ELISA), and this will be pursued, but other transformations may 
be more appropriate. The multiple regression models will include group 

 
 
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37 
membership, baseline haemoglobin, baseline ferritin, sex, and age. The remaining 
3 outcomes will be examined using logistic regression models with group 
membership, baseline haemoglobin, baseline ferritin, sex, and age as covariates. 
A significance level of 5% will be used to determine statistical significance of effects 
and 95% confidence intervals will be used to summarize effect sizes. 
Several secondary outcomes relate to the safety of iron supplementation. To 
maximize the power to detect an association between group membership and 
safety outcomes a composite of SAEs, gastro-intestinal problems, malaria, and 
bacterial infections will be constructed and compared between the groups. The 
frequency of this composite will be compared between groups using Fisher’s exact 
test. Furthermore, logistic regression models will be fit with group membership, 
sex, and age as covariates and the odds ratio associated with group membership 
will be estimated along with a 95% confidence interval. Components of the 
composite will also be investigated using a similar approach. The incidence of 
grade 3 or 4 AEs will be treated in a similar fashion. The frequency of responses 
to specific questions about known side effects to iron supplementation will be 
compared between the groups using logistic regression, controlling for sex and 
age. Each question will be investigated in addition to a response to any of the 
questions. 
Since the treatment is not assigned at random there is a strong potential that 
confounders will introduce bias into the estimates of the treatment effects. As an 
attempt to remedy this, sensitivity analyses using inverse probability weighting will 
be conducted. If we use to represent group membership for participant 𝑖 and 𝑍! is 
a vector of predictors for this participant, the first step of the analysis is to estimate 
the stabilized inverse probability of “treatment” weights 𝑊!  for subject 𝑖, 𝑊! =
𝑃(𝑋! = 𝑥!) 𝑃(𝑋! = 𝑥!|𝑍!)
⁄
. An estimate of 𝑃(𝑋! = 𝑥!|𝑍!") can be obtained by logistic 
regression and 𝑃(𝑋! = 𝑥!) can be estimated by the sample proportion. One then 
uses these weights in a regression model to adjust for participant characteristics 
that differ between the groups. 

 
 
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The incidence of ID or IDA will be examined among participants in the control group 
(who are not ID and do not have IDA at baseline by definition). These estimates 
will be in the form of events per unit time. If someone is found to be ID or IDA and 
then resolves that person re-enters the risk pool for an event. To account for 
multiple events in the same individual, the generalized estimating equation version 
of Poisson regression will be used with the robust standard error if necessary. The 
same approach will be used to examine the incidence of ID and IDA separately. 
Questionnaires developed to investigate responses to questions around feasibility 
and acceptability will serve as response variables in logistic (for binary responses) 
or proportional odds (for Likert scale type responses) regression models with group 
membership, sex, and age as covariates. There will likely be many such items and 
no attempt to control for multiple hypothesis testing will be conducted. As such, the 
results will be interpreted with caution.    Additional analyses will include 
longitudinal models for ID, IDA, haemoglobin levels and ferritin levels. These 
models will use generalized estimating equations to account for the repeat 
measurements from subjects. Conventional significance levels will be utilized for 
model interpretation. Comparison of the results from the cupper sulphate test and 
haemoglobin levels from the FBC will be examined with logistic regression models. 
These models will model the probability of the cupper sulphate test being positive 
as a function of haemoglobin levels. Models will be fit separately for men and 
women. Exploratory analyses will investigate if age or factors relating to diet impact 
the nature of this relationship.   
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 
and gender. These analyses will be performed by modelling an interaction between 
the subgroup factor and group membership and testing the null hypothesis that the 
regression coefficient associated with the interaction is zero.  
If necessary, missing data will be handled by multiple imputation via chained 
equations (MICE), as implemented in SAS PROC MI procedure28. 

 
 
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All statistical analyses will be completed using SAS or R by the University of 
Minnesota (UMN) DCC 
Data Monitoring Guidelines for an Independent DSMB 
A 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 without access to the data and 
a closed report will be generated by statisticians from the DCC with access to the 
full data set. 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 will 
review adverse event data, other safety data, quality and completeness of study 
data, and enrolment 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. In 
addition to regular meetings, it may be necessary to convene the DSMB urgently 
on an ad hoc basis to discuss new data or other information that raises questions 
about equipoise, safety, or other issues identified by DSMB members.  
DISSEMINATION OF RESULTS 
The study results will be disseminated to the National Institute of Health, Ghana 
Health Service, Hospitals, Community leaders and members, Church leaderships 
within communities and all other policy makers who are relevant where issues of 
blood are concerned.  
Results of the study will also be disseminated at workshops, conferences and 
seminars and posted on www.clinicaltrials.gov and published in a peer-reviewed 
journal. 
The final clinical study reports will be submitted to regulatory authorities. 

 
 
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ETHICAL ISSUES 
Local Review of Protocol and Informed Consent  
The study protocol and consent procedures will be reviewed by the College of 
Health Sciences (University of Ghana) Institutional Review Board (IRB) and the 
Ghana Health Service IRB, and written approvals obtained will be from these 
institutions prior to 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 one of the senior project staff trained in obtaining informed 
consent. Consent and assent forms will be Institutional Review Board (IRB)-
approved and the participant will be asked to read and review the document.  
The 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 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, witnessed where 
required by law or regulation) the consent form. The informed consent process will 
be conducted and documented in the source document (including the date), and 
the form signed, before the participant undergoes any study-specific procedures. 

 
 
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The participants 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. 
The investigators will explain the research study to the participant and answer any 
questions that may arise. Participants will have the opportunity to carefully review 
the written consent/assent form and ask questions prior to signing. The participants 
will be given a copy of the informed consent/assent form so that they may discuss 
the study with their family or think about it prior to agreeing to participate.  
For participants who are under 18 years, where their legal guardian(s) gives 
consent, the participant will be informed about the study to the extent possible 
given his/her understanding. If the participant is capable of doing so, he/she will 
be required to indicate agreement by personally signing and dating the written 
informed consent document. Participants who turn 18 years during the study 
period will be required to re-consent.  
The ICF used will comply with the International Conference for Harmonization of 
Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical 
Practice (GCP) guidelines and regulatory requirements. 
Information about common side effects already known about iron supplements, 
can be found in the protocol. This information will be included in the participant 
informed consent and will be discussed with the participant during the study as 
needed. Any new information about this drug that is relevant to this study will lead 
to an update to the informed consent which will then be discussed with the study 
participants. 
• 
Confidentiality of Study Participants 
At study entry each potential blood donor will be assigned a unique study 
identification number (Study ID). To maintain confidentiality, study specific ID 
numbers will be used on all samples and related documentation ensure anonymity 
(samples will be coded with a distinct identifier to ensure the laboratory is blinded). 
Participants’ privacy will also be maintained using standard operating procedures 
that are already in place at the National Blood Service for engaging with blood 

 
 
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42 
donors. Briefly these involve interviewing and counseling participants in a private 
area or by phone after confirming their identity, using a pre-defined procedure. 
Standardized questionnaires administered by trained interviewers will be used to 
collect demographic and clinical information from all study subjects into an 
electronic form directly linked to a password protected database. This database 
can only be accessed by investigators or study staff designated by the Principal 
investigators. Paper consent/assent forms which as a matter of necessity have 
participant names or initials and signatures on them, will be stored securely in a 
locked cabinet at the study site and accessible only to the principal investigators. 
These will be stored for 3 years after study procedures, primary analyses, study 
publications are completed. They will be destroyed by agencies that provide such 
services. The data collection on all study subjects will conform to requirements of 
international legislation on data protection. Databases will be password protected. 
The electronic databases will be kept for a minimum of 5 to 10 years after 
completion of study reports and publications. No study participant will be identified 
in data collection, publication, meeting abstract or report derived from the study 
results or the information collected. Regular data backups will mitigate against 
risks of fire/flooding. All personnel who handle any personal data will be required 
to undertake and maintain Good Clinical Practice (GCP) and Human Subjects 
Protection (HSP) training. 
• 
Regulatory Oversight 
Before initiating this trial, we will obtain approval/favourable opinion from the 
Steering Committee, DCC, PRC/ NHLBI and IRB/IEC for the trial protocol, written 
ICF, consent form updates, participant recruitment procedures and any other 
written information to be provided to study participants. Prior to study start, all of 
the instructions and procedures found in this protocol will be read and accepted by 
study team. An inspection of the clinical site (site initiation visit) will be done by 
NHLBI (or a designated representative) before start of study. This visit may be 
virtual due to the ongoing COVID-19 pandemic. 

 
 
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Monitoring will occur in coordination with the DCC, the PI and an independent 
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 US National Heart, Lung, and Blood Institute 
(NHLBI) will be responsible for providing program oversight through an 
independent DSMB.  
Study initiation and site initiation 
This pilot study will be registered on clinicaltrials.gov by the DCC prior to enrolment 
into the trial. 
The principal investigator will ensure the required documentation has been 
submitted to the DCC for each site participating in this pilot study. This includes:  
• 
A federal-wide Assurance (FWA) number and expiration date 
• 
The required IRB numbers linked to the FWA.  
• 
The required IRB approval letters (original letter and an English translation 
if not in English and a Translation Verification Statement in the latter case) 
• 
Approved site consent (if different from overall consent, and if not in English, 
an English translation, and a Translation Verification Statement) 
• 
Information on the investigator of record (name, contact information, 
completion date of HSP training, completion date of Good Clinical Practice 
(GCP) training, a signed investigator of record form, and a signed curriculum 
vitae). 
• 
Medical license of investigator of record 
• 
Information on sub-investigators (name, contact information, completion 
date of Human Subjects Protection (HSP) training, completion date of GCP 
training, and a signed curriculum vitae) 
• 
Information on study coordinator (name, contact information, completion 
date of HSP training, completion date of GCP training, and a signed 
curriculum vitae) 

 
 
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Laboratory reference ranges (and if available online, URL). 
Data collection towards the objectives of this pilot study will not be initiated until 
the required documentation has been reviewed by the DCC and a site activation 
letter has been issued to the site investigator of record and the protocol PI. 
Interim site level monitoring 
In addition, all individuals participating in this pilot study will need to sign an ICF. 
All study sites will maintain a copy of the ICF for all participants at that study site. 
Any individuals who are less than 18 years old will have an ICF signed by a parent 
or other representative with required assent as needed. Upon a site monitoring 
visit, study data and case report forms will be made available to site monitoring 
personnel. 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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JAMA, 313(6), 575–583. https://doi.org/10.1001/jama.2015.119 
17.  Bryant, B. J., Yau, Y. Y., Arceo, S. M., Daniel-Johnson, J., Hopkins, J. A., & 
Leitman, S. F. (2012). Iron Replacement Therapy in the Routine Management of 
Blood Donors. Transfusion, 52(7), 1566–1575. https://doi.org/10.1111/j.1537-
2995.2011.03488.x 
18.  Zimmermann, M. B., & Hurrell, R. F. (2007). Nutritional iron deficiency. Lancet 
(London, 
England), 
370(9586), 
511–520. 
https://doi.org/10.1016/S0140-
6736(07)61235-5 
19.  Nielsen, A. V. F., Tetens, I., & Meyer, A. S. (2013). Potential of phytase-mediated 
iron release from cereal-based foods: A quantitative view. Nutrients, 5(8), 3074–
3098. https://doi.org/10.3390/nu5083074 

 
 
BloodSafe Ghana 
 
 
47 
20. Hurrell, R. F. (2003). Influence of vegetable protein sources on trace element and 
mineral 
bioavailability. 
The 
Journal 
of 
Nutrition, 
133(9), 
2973S-7S. 
https://doi.org/10.1093/jn/133.9.2973S 
21.  Ahmed, S. G., Ibrahim, U. A., & Hassan, A. W. (2007). Adequacy and pattern of 
blood donations in north–eastern Nigeria: The implications for blood safety. Annals 
of 
Tropical 
Medicine 
& 
Parasitology, 
101(8), 
725–731. 
https://doi.org/10.1179/136485907X241442 
22.  Contreras, M., Taylor, C. P., & Barbara, J. A. (2010). Clinical Blood Transfusion. 
In 
Postgraduate 
Haematology 
(pp. 
268–299). 
Wiley-Blackwell. 
https://doi.org/10.1002/9781444323160.ch16 
23.  World Health Organization. (2013). Blood Donor Selection: Guidelines on 
Assessing Donor Suitability for Blood Donation. World Health Organization. 
24.  National Blood Service, Ghana. (2014). Blood Donor Selection and Care Manual. 
25.  World Health Organization. (2011) Haemoglobin concentrations for the diagnosis 
of anaemia and assessment of severity.  
26.  WHO. (2008). Worldwide prevalence of anaemia 1993-2005. WHO: Globa. 
Database on Anaemia. Geneva: World Health Organization. 
 
27.  Knobel, H., Alonso, J., Casado, J. L., Collazos, J., González, J., Ruiz, I., Kindelan, 
J. M., Carmona, A., Juega, J., Ocampo, A., & GEEMA Study Group. (2002). 
Validation of a simplified medication adherence questionnaire in a large cohort of 
HIV-infected patients: The GEEMA Study. AIDS (London, England), 16(4), 605–
613. https://doi.org/10.1097/00002030-200203080-00012 
28.  White, I. R., Royston, P., & Wood, A. M. (2011). Multiple imputation using 
chained equations: Issues and guidance for practice. Statistics in Medicine, 30(4), 
377–399. https://doi.org/10.1002/sim.4067 
 
 
 

 
 
BloodSafe Ghana 
 
 
48 
APPENDICES 
APPENDIX 1 –Data Collection Instruments 
FOCUS GROUP DISCUSSION GUIDE 
Aim: To identify barriers and recommendations for using iron supplementation and 
nutritional counseling to increase the blood donor pool.  
 
DATE: ______________     LOCATION:  _________________  
NUMBER OF FGD PARTICIPANTS:  ____________________  
FGD FACILITATOR:  _________________________________  
FGD NOTE-TAKER:  _________________________________  
FGD START TIME (HH:MM):  __________  
FGD END TIME (HH:MM):  ____________  
Welcome the focus group participants: 
Good morning/afternoon. My name is _________________________________ 
and I will be your moderator for this focus group discussion. I am part of the 
BLOODSAFE Project Team, which is a group of researchers from within and 
outside of Ghana carrying out a study to understand and improve blood donation 
in Ghana.  
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. 
I am accompanied by____________________________ who will be responsible 
for note taking. Other project staff from the Project Team 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 
• 
You have been invited here to offer your views and opinions. We will like to 
have a successful discussion where everyone feels comfortable expressing 
their perspectives and opinions 
• 
 Again, there are no right or wrong answers and it is okay to be critical. I want 
to  
hear your views and opinions about whether you like or dislike 
something you see  or hear. 
• 
 There will be observers. 
• 
 You may excuse yourself from the conversation at any time for any reason. 

 
 
BloodSafe Ghana 
 
 
49 
• 
 This session will be audio taped so that we can capture everything being 
discussed  
today, for the purpose of listening to it again to get the 
message well. All the  
discussions will remain confidential. Please feel 
free to say exactly what is on your  
mind as nothing will be attributed 
to any particular person in our report. 
• 
Everyone’s participation is important. 
• 
Please speak one at a time and avoid side conversations. 
• 
 Please use any of your names that you are comfortable with only during the 
 discussion. 
• 
 Respect each other’s opinions. 
• 
 Lastly, please turn off the ringers on your cell phones. 
Views from Individual Members in the FGD 
Demography and social characteristics of participants 
• 
Name:  _______________________________________  
• 
Name of Community (Group):  ____________________  
• 
Age:  __________  
• 
Sex:  __________  
• 
Highest Educational level attained:  ________________  
• 
Religion:  _____________________________________  
• 
Ethnic background:  _____________________________  
• 
Occupation:  __________________________________  
 
You participated in this project, which involved blood donors.  
• 
How did the project influence your knowledge about iron supplementation 
for deferred blood donors?  
Probe:  
• 
Are you aware of any cultural reasons why people do not use iron 
supplements? 
• 
Are you aware of any religious reasons why people do not use iron 
supplements? 
• 
Did it increase your awareness of iron supplements? 
• 
Did it improve your knowledge on the usefulness of iron 
supplements? 
• 
Do you believe people will like to use iron supplements after the 
project? 

 
 
BloodSafe Ghana 
 
 
50 
• 
How did the project influence your attitudes to iron supplementation for 
deferred blood donors?   
Probe:  
• 
Are you aware of any cultural reasons why people do not use iron 
supplements? 
• 
Are you aware of any religious reasons why people do not use iron 
supplements? 
• 
Did it increase your attitude to use of iron supplements? 
• 
Do you believe people will like to use iron supplements after the 
project? 
• 
How did the project influence your beliefs about iron supplementation for 
deferred blood donors?  
Probe:  
• 
Are you aware of any cultural beliefs why people do not use iron 
supplements? 
• 
Are you aware of any religious beliefs why people do not use iron 
supplements? 
• 
Did it influence your beliefs (either positively or negatively) of iron 
supplements? 
• 
Do you believe people will like to use iron supplements after the 
project? 
• 
What influenced your participation in this project?  
Probe:  
• 
Was the colour of the iron supplement culturally acceptable? 
• 
Was the dosage of the iron supplement culturally acceptable? 
• 
Did taking these supplement affect your participation, negatively or 
positively? 
• 
Was there in any religious and cultural aspects of your life that 
affected how you participated in the project generally?  
• 
Please describe the counselling you received about iron supplementation?  
Probe:  
• 
Were you given adequate information and guidance on eating iron or 
micronutrient-rich foods? 
• 
Were any cultural or religious concerns or inhibitions to eating these 
foods addressed? 

 
 
BloodSafe Ghana 
 
 
51 
• 
Were there issues you did not understand during the counselling 
sessions? 
• 
Were there issues you disagreed with during the counselling 
sessions? 
• 
What other information would have preferred to receive? 
• 
How will you describe the quality of the nutritional counselling you received 
as part of the project? 
Probe:  
• 
Were you given adequate information and guidance on nutrition? 
• 
Were any cultural or religious concerns or inhibitions on adequate 
nutrition addressed? 
• 
Were there issues you did not understand during the counselling 
sessions? 
• 
Were there issues you disagreed with during the counselling 
sessions? 
• 
What other information would have preferred to receive? 
• 
From your experience, what do you consider as barriers to people like you 
participating in an iron supplementation and nutritional counselling project? 
Probe:  
• 
Do you have any concerns or fears in being able to adhere to the use 
of the iron supplements/ medications? 
• 
Do you have any concerns or fears on the side effects of the 
medications? 
• 
Do you have any concerns in making time for the counselling 
sessions and visits? 
• 
Do you have any concerns or fears of repeat donation if your iron 
stores improve? 
• 
Do you have any concerns or fears that iron supplements may cause 
you to eat more? 
• 
Do you have any concerns or fears that iron supplements may cause 
you to eat more and come with additional cost to you? 
 
• 
How do you think we could carry out this intervention differently to ensure 
people participate fully?  
Probe:  
What do you propose to be solutions to these?  

 
 
BloodSafe Ghana 
 
 
52 
• 
Concerns or fears in being able to adhere to the use of the iron 
supplements/ medications? 
• 
Concerns or fears on the side effects of the medications? 
• 
Concerns in making time for the counselling sessions and visits? 
• 
Concerns or fears of repeat donation if your iron stores improve? 
• 
Concerns or fears that iron supplements may cause you to eat more? 
• 
Concerns or fears that iron supplements may cause you to eat more 
and come with additional cost to you? 
• 
What recommendations do you have for using iron supplementation and 
nutritional counselling for improving the blood donor pool?  
Probe:  
• 
Do you have any ideas from the discussions so far on the use of iron 
supplementation and nutritional counselling for improving the blood 
donor pool in Ghana? 
 
Composite Views from Members in the FGD 
• 
How many participants have ever donated blood? __________________  
• 
For those who have never donated, what are the main reasons?   
  _________________________________________________________  
  _________________________________________________________  
  _________________________________________________________   
  _________________________________________________________  
  _________________________________________________________  
• 
How 
many 
times 
have 
participants 
been 
donating 
blood? 
average:______________ 
minimum:____________ 
maximum: ____________ 
• 
How 
long 
ago 
was 
the 
last 
donation?  
average:______________                            minimum: ____________ 
maximum: ____________ 
• 
How many participants have ever used iron supplementation after blood 
donation? 
  _________________________________________________________     
• 
 How many participants have ever had nutritional counselling after blood 
donation?  
  _________________________________________________________  

 
 
BloodSafe Ghana 
 
 
53 
• 
What are the views of participants on the usefulness of iron supplementation 
and 
nutritional 
counselling 
after 
blood 
donation? 
  _________________________________________________________    
• 
What have been the major barriers to blood donation in the community/ 
cluster?  
 _________________________________________________________  
 _________________________________________________________  
 _________________________________________________________  
 _________________________________________________________   
• 
What are the key suggestions / recommendation to improve blood donation 
in 
the 
community/group?  
 _________________________________________________________  
 _________________________________________________________  
 _________________________________________________________  
 _________________________________________________________  
 _________________________________________________________  
• 
 What 
will 
make 
participants 
be 
willing 
to 
re-donate 
blood?  
 _________________________________________________________  
 _________________________________________________________  
 _________________________________________________________  
 _________________________________________________________  
 _________________________________________________________  
• 
Any 
other 
comments 
you 
have 
on 
the 
project?  
  _________________________________________________________  
  _________________________________________________________  
  _________________________________________________________  
  _________________________________________________________  
  _________________________________________________________  
  _________________________________________________________  
 
KEY INFORMANT INTERVIEW GUIDE 
 
Basic characteristics  
• 
Name:  _______________________________________  
• 
Age:  ________________________________________  
• 
Sex:  ________________________________________  

 
 
BloodSafe Ghana 
 
 
54 
• 
Designation/position ____________________________  
• 
Organization:  _________________________________  
 
• 
How do you envisage iron supplementation to influence knowledge of 
deferred blood donors?  
Probe:  
• 
Are you aware of any cultural reasons why people do not use iron 
supplements? 
• 
Are you aware of any religious reasons why people do not use iron 
supplements? 
• 
Do you believe people will like to use iron supplements after the 
project? 
• 
How do you envisage iron supplementation to influence attitudes of deferred 
blood donors?  
Probe:  
• 
Are you aware of any cultural attitudes why people do not use iron 
supplements? 
• 
Are you aware of any religious attitudes why people do not use iron 
supplements? 
• 
Do you believe people will like to use iron supplements after the 
project? 
• 
How do you envisage iron supplementation to influence belief systems of 
deferred blood donors?  
Probe:  
• 
Are you aware of any cultural beliefs why people do not use iron 
supplements? 
• 
Are you aware of any religious beliefs why people do not use iron 
supplements? 
• 
Do you believe people will like to use iron supplements after the 
project? 
• 
What aspects of your culture affected your participation in the project?  
Probe:  
• 
Will the colour of the iron supplement affect culturally acceptability? 
• 
Will the dosage (number of tablets or frequency of dosing in a day) 
of the iron supplement affect culturally acceptability? 

 
 
BloodSafe Ghana 
 
 
55 
• 
Are there in any religious and cultural aspects that may influence the 
use of iron supplementation by deferred donors?  
• 
What should go into the quality and quantity of the counseling on taking iron 
as recommended for deferred blood donors?  
Probe:  
• 
What key issues should be discussed?  
• 
What other information would you preferred to include? 
• 
From your experience, what do you consider as barriers to deferred donors 
participating in an iron supplementation and nutritional counseling project? 
Probe:  
• 
What are the fears and concerns?  
• 
What do you consider as solutions to the barriers?  
Probe:  
What do you propose to be solutions to these?  
• 
Concerns or fears in being able to adhere to the use of the iron 
supplements/ medications 
• 
Concerns or fears on the side effects of the medications 
• 
Concerns in making time for the counseling sessions and visits? 
• 
Do you have any concerns or fears of repeat donation if iron stores 
improve? 
• 
What recommendations do you have for using iron supplementation and 
nutritional counseling for improving the blood donor pool?  
Probe:  
• 
Do you have any ideas from the discussions so far on the use of iron 
supplementation and nutritional counseling for improving the blood 
donor pool in Ghana? 
• 
Any policy guide or direction on use of iron supplementation for deferred 
blood donors? 
APPENDIX 2: Informed Consent Forms 
 
PARTICIPANT INFORMATION AND CONSENT TO BE PART OF A 
RESEARCH STUDY  
ON BLOOD SAFETY AND AVAILABILITY 

 
 
BloodSafe Ghana 
 
 
56 
 
Protocol 
Title: 
Iron 
supplementation 
and 
nutritional 
counselling 
interventions to improve availability and safety of blood in Ghana. 
Participant number: ____________________ 
 
Name of Investigator: __________________ 
 
Hello, my name is ______________________________________. I am a Study 
Doctor/Research Assistant. I would like to invite you to consider participating in a 
research study entitled ‘Iron supplementation and nutritional counselling 
interventions to improve availability and safety of blood in Ghana. 
 
Principal Investigators:  
Dr Yvonne Dei-Adomakoh 
Dr Lucy Asamoah- Akuoko 
Consultant Haematologist,  
Head, Research and Development,  
Department of Haematology,  
National Blood Service, Korle-Bu, Accra 
University of Ghana Medical School  
Phone: +233206301006 
Phone: +233-24-355-0980,  
Email: lucyasamoah@yahoo.com 
Email: yadei-adomakoh@ug.edu.gh 
1. Why have I been given this document to read? 
We would like to invite you to join this research study to find out if giving iron pills 
will improve the nutritional status and blood level of blood donors with anaemia so 
that they will be able to donate blood. 
Participants signing this consent form will be aged 18 years and older. Please read 
the information carefully and discuss it with the study doctors and family.  The 
study doctors will be happy to answer all questions. 
Decision to participate in this study is voluntary. This means: 
• You are free to decide to participate in this study or not  
• You are free to stop study treatment and study-related activities at any time 
and without the need of giving any reason 

 
 
BloodSafe Ghana 
 
 
57 
• If you do not want to participate in this study, then this decision will not affect 
your care as a blood donor 
This trial protocol has been submitted to the College of Health Sciences Ethical 
Review Board and has been granted written approval. 
2. What is the purpose of this study? 
This trial is funded by National Heart, Lung, and Blood Institute (NHLBI), USA.  
The amount of iron that a blood donor has is an important safety issue. Iron 
deficiency is initially without anaemia and affects red blood cell production only. 
Without intervention anaemia occurs. Major causes of iron deficiency are 
inadequate dietary iron, reduced absorption and loss of iron. Knowledge of donors’ 
iron status provides evidence for blood centres to provide appropriate and timely 
donor care. With deferrals from donation-induced anaemia minimized, more willing 
blood donors are fit enough to repeat blood donations on schedule, thus 
contributing to blood adequacy for patients requiring blood transfusion therapy.  
This project is directed towards transforming the blood donor pool in Ghana from 
family replacement donations to sustainable voluntary collections.  
What do I need to know if I join this study? 
The study is designed as an open label trial with nutrition counselling and iron 
supplementation. Iron supplementation will be an oral medication and will be given 
for 4 months duration. 291 other participants may be recruited to join the study.  
If you accept to participate baseline assessment will be conducted. Those who are 
found to have adequate iron will receive counselling on good nutrition only. Those 
found to have very low iron stores will be invited to share baseline assessment 
results and then referred to a doctor specializing in care for those with very low 
iron stores.  Those who are found to be moderately low in iron stores will receive 
both nutritional counselling and oral iron supplementation. For these participants, 
iron supplementation will be prescribed by a haematologist in accordance with 
standard treatment guidelines for Ghana and this will include education on side 
effects of iron supplementation. Those study participants who are moderately low 
in iron will be given a two-month supply of the iron tablets by the study pharmacist, 
which they will take home. They will be instructed to take the iron tablets with water 
3 times in a week.  All participants will receive standard nutritional counselling 
provided by the study nutritionist and trained counsellors. The duration of the 
intervention period is 4 months with two interim visits (approximately 2 months 
apart) and a final visit at 6 months.  

 
 
BloodSafe Ghana 
 
 
58 
Following baseline assessments, all study participants will have blood sampling 
done every 8 weeks for Full Blood Count (FBC), peripheral film comment, malaria 
RDT and ferritin concentration, with follow-up phone calls to see how you are doing 
and if you are taking your pills if you are receiving any.  Any participant who started 
with adequate iron stores and is later found to have moderately low iron stores will 
be given iron supplementation.  Any participant who is found to have very low iron 
stores over the course of the study will be referred to a doctor specializing in care 
for those with very low iron stores.   
In case you experience concerning signs or symptoms, kindly call a study doctor. 
In addition, you might be asked, through another questionnaire, to provide 
feedback and take part in our focus group discussion, on your personal experience 
in this trial. This is optional and will not affect the care you receive.  It might help 
to improve the trial experience for others in the future. Side effects reported as part 
of a feedback questionnaire, may need to be shared with the study doctors or study 
team, who will follow up to collect more information.  All other feedback will remain 
anonymous and confidential. 
After the study is completed and all data examined, a summary of the study results 
will be shared with the National Blood Service Ghana (NBSG). The NBSG may 
share these results with you if you wish.  
3. Can I decide to stop my participation in the study? 
You are free to stop your participation in this study at any time by notifying the 
study doctors/research assistants.  
The information already collected during the study including samples (defined as 
Personal Data in this consent) will still be used together with the data collected 
from other participants in the study according to this informed consent.  
We still care about how everything is going therefore, the study research assistant 
may ask if they can call you to check on you. 
4. Can I withdraw my consent to collect and use my Personal Data? 
You may decide to withdraw your consent from this study by informing your study 
doctor at any time in writing. This means that full participation in the study will be 
stopped and any further collection of your Personal Data. 
The study team will continue to keep and use your collected study information 
(including any data resulting from the analysis of your samples until your time of 
withdrawal) according to applicable law.  This is done to guarantee the validity of 
the study, to determine the effects of the study treatment, and to ensure complete 
study documentation. 

 
 
BloodSafe Ghana 
 
 
59 
5. Are there any reasons that my study treatment or participation may be 
stopped early? 
The study doctor may remove you from this study for any justified reason and will 
discuss your options. 
Examples why you may have to stop some or all study-related activities, 
including study treatment are: 
i. You need treatment that is not allowed in this study 
ii. Instructions for the study are not being followed 
iii. You become pregnant (for female participants) 
iv. Side effects from the study treatment are unacceptable 
v. The study doctor thinks keeping you in the study might be harmful and/or is 
not in your best interest  
6. Who owns the data and results created during the study? 
NHLBI and study team will own all data and results created during this study.   
7. What are the possible benefits if I join this study? 
This study might not be of direct benefit for you however, with your participation in 
this research, the results of this research will likely help us better understand 
acceptability of iron supplementation among blood donors deferred for iron 
deficiency anaemia and other reasons why people do not donate blood. 
Additionally, this research will help us find a strategy to manage and prevent 
prospective blood donors with iron deficiency and iron deficiency anaemia thereby 
improving the voluntary blood donor pool in Ghana.  
 
 
 
8. What are the possible risks if I join this study? 
Some risks or discomforts may be experienced. Collecting blood from a vein in 
someone's arm is a standard medical procedure, although you may feel some pain 
where we use the needle to take blood from your vein. You may get a bruise from 
the needle. Some people feel faint when they give a blood sample. In addition, side 
effects usually minor, may be experienced when taking iron tablets and include: 
unpleasant taste, constipation, dark stools, nausea, vomiting, abdominal pain and 
diarrhoea. 
Kindly tell us about any unusual effects even when these effects are mild. 

 
 
BloodSafe Ghana 
 
 
60 
9. What are my responsibilities and are there any costs for me if I agree to 
join this study? 
Follow the instructions given by the study doctor and staff. Attend all of the study 
appointments. If you have to miss an appointment, reschedule with the study 
doctor or research assistant. Inform the study doctor about any medicines you 
are currently taking or may take during the course of the study (e.g. prescription, 
vitamins, over the counter herbal supplements etc.) You will be reimbursed for 
out of pocket expenses to and from the study site. A minimum amount of 10 USD 
(in cedi equivalent) per visit will be reimbursed for such expenses.  If study 
related costs exceed the specified amount and you have proof of such expenses, 
please discuss it with the study team. 
10. Your rights as a Participant 
This research has been reviewed and approved by the Ethical and Protocol 
Review Committee of the College of Health Sciences (CHS-EPRC). If you have 
any questions about your rights as a research participant you can contact the 
College of Health Sciences EPRC office (UGMS Research Office, GEMP Building, 
Korle-Bu) between the hours of 8am-5pm through the landline +233 03-02-
665103/4 or email addresses: eprc@chs.edu.gh. 
11. Where can I receive more information? 
If you are injured because of the study or if you have questions about the study, 
please contact:  
Study Doctor: .......................................... 
Telephone number: .................................. 
After office hours number: .......................  
 
 
VOLUNTEER AGREEMENT 
The above document describing the benefits, risks and procedures for the 
research title ‘Iron supplementation and nutritional counselling interventions to 
improve availability and safety of blood in Ghana’ has been read and explained to 
me. I have been given an opportunity to have any questions about the research 
answered to my satisfaction. I agree to participate as a volunteer. 
 
 ________________________ 
 ____________________________________  
Date 
Name and signature or mark of volunteer 

 
 
BloodSafe Ghana 
 
 
61 
 
If volunteers cannot read the form themselves, a witness must sign here: 
I was present while the benefits, risks and procedures were read to the volunteer. 
All questions were answered and the volunteer has agreed to take part in the 
research. 
 
 ________________________ 
 ____________________________________  
Date 
Name and signature of witness 
 
I certify that the nature and purpose, the potential benefits, and possible risks 
associated with participating in this research have been explained to the above 
individual. 
 
 ________________________ 
 ____________________________________  
Date 
Name Signature of Person Who Obtained 
Consent

 
 
BloodSafe Ghana 
 
 
62 
ASSENT FORM FOR 17-YEAR-OLD PARTICIPANTS 
 
Protocol 
Title: 
Iron 
supplementation 
and 
nutritional 
counselling 
interventions to improve availability and safety of blood in Ghana. 
Participant number:____________________ 
Name of Investigator: __________________ 
Hello, my name is  ________________________. I am a Study doctor/Research 
Assistant. I would like to invite you to consider participating in a research study 
entitled ‘Iron supplementation and nutritional counselling interventions to 
improve availability and safety of blood in Ghana. 
Principal Investigators:  
Dr Yvonne Dei-Adomakoh 
Dr Lucy Asamoah- Akuoko 
Consultant Haematologist,  
Head, Research and Development,  
Department of Haematology,  
National Blood Service, Korle-Bu, Accra 
University of Ghana Medical School  
Phone: +233206301006 
Phone: +233-24-355-0980,  
Email: lucyasamoah@yahoo.com 
Email: yadei-adomakoh@ug.edu.gh 
 
1. 
Why have I been given this document to read? 
We would like to invite you to join this research study to find out if giving iron pills 
will improve the nutritional status and blood level of blood donors with anaemia so 
that they will be able to donate blood. 
Participants signing this consent form will be aged 18 years and older. Please read 
the information carefully and discuss it with the study doctors and family.  The 
study doctors will be happy to answer all questions. 
Decision to participate in this study is voluntary. This means: 
• You are free to decide to participate in this study or not  
• You are free to stop study treatment and study-related activities at any time 
and without the need of giving any reason 

 
 
BloodSafe Ghana 
 
 
63 
• If you do not want to participate in this study, then this decision will not affect 
your care as a blood donor 
This trial protocol has been submitted to the College of Health Sciences Ethical 
Review Board and has been granted written approval. 
2. What is the purpose of this study? 
This trial is funded by National Heart, Lung, and Blood Institute (NHLBI), USA.  
The amount of iron that a blood donor has is an important safety issue. Iron 
deficiency is initially without anaemia and affects red blood cell production only. 
Without intervention anaemia occurs. Major causes of iron deficiency are 
inadequate dietary iron, reduced absorption and loss of iron. Knowledge of donors’ 
iron status provides evidence for blood centres to provide appropriate and timely 
donor care. With deferrals from donation-induced anaemia minimized, more willing 
blood donors are fit enough to repeat blood donations on schedule, thus 
contributing to blood adequacy for patients requiring blood transfusion therapy.  
This project is directed towards transforming the blood donor pool in Ghana from 
family replacement donations to sustainable voluntary collections.  
3. What do I need to know if I join this study? 
The study is designed as an open label trial with nutrition counselling and iron 
supplementation. Iron supplementation will be an oral medication and will be given 
for 4 months duration. 291 other participants may be recruited to join the study.  
If you accept to participate baseline assessment will be conducted. Those who are 
found to have adequate iron will receive counselling on good nutrition only. Those 
found to have very low iron stores will be invited to share baseline assessment 
results and then referred to a doctor specializing in care for those with very low 
iron stores.  Those who are found to be moderately low in iron stores will receive 
both nutritional counselling and oral iron supplementation. For these participants, 
iron supplementation will be prescribed by a haematologist in accordance with 
standard treatment guidelines for Ghana and this will include education on side 
effects of iron supplementation. Those study participants who are moderately low 
in iron will be given a two-month supply of the iron tablets by the study pharmacist, 
which they will take home. They will be instructed to take the iron tablets with water 
3 times in a week.  All participants will receive standard nutritional counselling 
provided by the study nutritionist and trained counsellors. The duration of the 
intervention period is 4 months with two interim visits (approximately 2 months 
apart) and a final visit at 6 months.  

 
 
BloodSafe Ghana 
 
 
64 
Following baseline assessments, all study participants will have blood sampling 
done every 8 weeks for Full Blood Count (FBC), peripheral film comment, malaria 
RDT and ferritin concentration, with follow-up phone calls to see how you are doing 
and if you are taking your pills if you are receiving any.  Any participant who started 
with adequate iron stores and is later found to have moderately low iron stores will 
be given iron supplementation.  Any participant who is found to have very low iron 
stores over the course of the study will be referred to a doctor specializing in care 
for those with very low iron stores.   
In case you experience concerning signs or symptoms, kindly call a study doctor. 
In addition, you might be asked, through another questionnaire, to provide 
feedback and take part in our focus group discussion, on your personal experience 
in this trial. This is optional and will not affect the care you receive.  It might help 
to improve the trial experience for others in the future. Side effects reported as part 
of a feedback questionnaire, may need to be shared with the study doctors or study 
team, who will follow up to collect more information.  All other feedback will remain 
anonymous and confidential. 
After the study is completed and all data examined, a summary of the study results 
will be shared with the National Blood Service Ghana (NBSG). The NBSG may 
share these results with you if you wish.  
4. Can I decide to stop my participation in the study? 
You are free to stop your participation in this study at any time by notifying the 
study doctors/research assistants.  
The information already collected during the study including samples (defined as 
Personal Data in this consent) will still be used together with the data collected 
from other participants in the study according to this informed consent.  
We still care about how everything is going therefore the study research assistant 
may ask if they can call you to check on you. 
5. Can I withdraw my consent to collect and use my Personal Data? 
You may decide to withdraw your consent from this study by informing your study 
doctor at any time in writing. This means that full participation in the study will be 
stopped and any further collection of your Personal Data. 
The study team will continue to keep and use your collected study information 
(including any data resulting from the analysis of your samples until your time of 
withdrawal) according to applicable law.  This is done to guarantee the validity of 
the study, to determine the effects of the study treatment, and to ensure complete 
study documentation. 

 
 
BloodSafe Ghana 
 
 
65 
6. Are there any reasons that my study treatment or participation may be 
stopped early? 
The study doctor may remove you from this study for any justified reason and will 
discuss your options. 
Examples why you may have to stop some or all study-related activities, 
including study treatment are: 
vi. You need treatment that is not allowed in this study 
vii. Instructions for the study are not being followed 
viii. You become pregnant (for female participants) 
ix. Side effects from the study treatment are unacceptable 
x. The study doctor thinks keeping you in the study might be harmful and/or is 
not in your best interest  
7. Who owns the data and results created during the study? 
NHLBI and study team will own all data and results created during this study.   
8. What are the possible benefits if I join this study? 
This study might not be of direct benefit however, with your participation in this 
research, the results of this research will likely help us better understand 
acceptability of iron supplementation among blood donors deferred for iron 
deficiency anaemia and other reasons why people do not donate blood. 
Additionally, this research will help us find a strategy to manage and prevent 
prospective blood donors with iron deficiency and iron deficiency anaemia thereby 
improving the voluntary blood donor pool in Ghana.  
9. What are the possible risks if I join this study? 
Some risks or discomforts may be experienced. Collecting blood from a vein in 
someone's arm is a standard medical procedure, although you may feel some pain 
where we use the needle to take blood from your vein. You may get a bruise from 
the needle. Some people feel faint when they give a blood sample. In addition, side 
effects usually minor, may be experienced when taking iron tablets and include: 
unpleasant taste, constipation, dark stools, nausea, vomiting, abdominal pain and 
diarrhoea. 
Kindly tell us about any unusual effects even when these effects are mild. 
10. 
What are my responsibilities and are there any costs for me if I agree to 
join this study? 
Follow the instructions given by the study doctor and staff. Attend all of the study 
appointments. If you have to miss an appointment, reschedule with the study 

 
 
BloodSafe Ghana 
 
 
66 
doctor or research assistant. Inform the study doctor about any medicines you 
are currently taking or may take during the course of the study (e.g. prescription, 
vitamins, over the counter herbal supplements etc.) You will be reimbursed for 
out of pocket expenses to and from the study site. A minimum amount of 10 USD 
(in cedi equivalent) per visit will be reimbursed for such expenses.  If study 
related costs exceed the specified amount and you have proof of such expenses, 
please discuss it with the study team. 
Your rights as a Participant 
This research has been reviewed and approved by the Ethical and Protocol 
Review Committee of the College of Health Sciences (CHS-EPRC). If you have 
any questions about your rights as a research participant you can contact the 
College of Health Sciences EPRC office (UGMS Research Office, GEMP Building, 
Korle-Bu) between the hours of 8am-5pm through the landline +233 03-02-
665103/4 or email addresses: eprc@chs.edu.gh. 
Where can I find more information? 
If you are injured because of the study or if you have questions about the study, 
please contact:  
Study Doctor: .......................................... 
Telephone number: .................................. 
After office hours number: .......................  
 
VOLUNTEER AGREEMENT 
The above document describing the benefits, risks and procedures for the 
research title ‘Iron supplementation and nutritional counselling interventions 
to improve availability and safety of blood in Ghana has been read and 
explained to me. I have been given an opportunity to have any questions about the 
research answered to my satisfaction. I agree to participate as a volunteer. 
 ________________________ 
 ____________________________________  
Date 
Name and signature or mark of volunteer 
 
A parent or Guardian must sign here: 
I was present while the benefits, risks and procedures were read to the volunteer. 
All questions were answered and the volunteer has agreed to take part in the 
research. 

 
 
BloodSafe Ghana 
 
 
67 
 
 ________________________ 
 ____________________________________  
Date 
Name and signature of parent/guardian 
 
I certify that the nature and purpose, the potential benefits, and possible risks 
associated with participating in this research have been explained to the above 
individual. 
 
 ________________________ 
 ____________________________________  
Date Name Signature of Person Who Obtained Consent 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PARTICIPANT INFORMATION SHEET FOR FOCUS GROUP DISCUSSION 
Title of Study: - Iron supplementation and nutritional counseling 
interventions to improve availability and safety of blood in Ghana 

 
 
BloodSafe Ghana 
 
 
68 
 
Introduction 
Thank you for taking the time to listen to what I have to say. My name is 
______________________, and I am here because I am working on behalf of 
BLOODSAFE GHANA concerning the documentation of iron deficiency anaemia 
in blood donors. This work is being led by Dr. Yvonne Dei-Adomakoh from the 
Department of Haematology, University of Ghana Medical School/ Korle Bu 
Teaching Hospital. Her telephone number is 0243550980, and her email is 
deiadom@yahoo.com.  
Background and Purpose of research 
The amount of iron that a blood donor has is an important safety issue. Iron 
deficiency is initially without anaemia, manifesting as reduced iron stores (iron 
depletion) affecting red blood cell production, and without intervention is 
complicated by overt anaemia. Major causes of iron deficiency are inadequate 
dietary iron, reduced absorption and loss of iron. With continuous loss of iron from 
repeat whole blood donations and inadequate replacement, blood donors 
inevitably develop iron deficiency and, later, iron deficiency anaemia. Knowledge 
of donors’ iron status provides evidence for blood centres to provide appropriate 
and timely donor care. With deferrals from donation-induced anaemia minimized, 
more willing blood donors are fit enough to repeat blood donations on schedule, 
thus contributing to blood adequacy for patients requiring blood transfusion 
therapy.  
This project is directed towards transforming the blood donor pool in Ghana from 
family replacement donations to sustainable voluntary collections, in support of 
Ghana’s national blood policy that aims at a 100% voluntary blood donation pool 
to secure and sustain an adequate and safe blood supply. Treatment of iron 
deficiency and iron deficiency anaemia require iron supplementation as well as 
nutritional counseling as standard of care in Ghana.  
Nature of research 
We are aiming to have a discussion with you concerning your knowledge about 
blood transfusion practices and iron deficiency anaemia in Ghana. All interviews 
and other data collected as part of this documentation will be summarized into a 
report for the Data Collecting Centre (DCC) based in the University of Minnesota, 
USA, and the National Heart Lung Blood Institute (NHLBI), USA, which may be 
shared with others. 

 
 
BloodSafe Ghana 
 
 
69 
Participant’s involvement 
We would like to ask you to take part in this discussion. If you agree to do so, we 
will ask you questions concerning iron deficiency anaemia, iron supplementation, 
nutrition interventions for blood donors, factors that contribute to iron deficiency 
anaemia, cultural practices that may affect iron supplementation. The discussion 
will last up to one hour of your time. The discussions will be audio recorded. 
Potential Risks 
Some of the issues we will discuss with you may make you uncomfortable, 
because you may have to talk about the performance of a project/intervention you 
were involved in. You may feel tired whilst going through the interview. Having an 
interview with the researcher may expose you to COVID-19. Apart from these, we 
do not think there are any other major risks associated with your participation. 
 
To prevent the spread of COVID-19, we will do the following to protect you:  
• 
All field workers will wear a face mask throughout all project activities. 
• 
We will provide a face mask for study participants attending a data collection 
session if they arrived at the session without a mask. 
• 
Before data collection, one field worker will check the temperature of each 
participant using a thermometer gun. He/she will also ask whether the 
participant has a cough/cold, difficulty in breathing or sore throat. Anyone 
with a temperature above 37.4°C (i.e. considered to have fever) and/or 
showing flu-like symptoms will be asked to return home and subsequently 
seek medical attention. 
• 
We will spend at least 5 minutes each morning before the start of work to 
educate participants who have come for office visit on Covid-19. In addition, 
videos on Covid-19 measures will be shown to the participants. We will 
display approved health promotion materials on COVID-19 at vantage 
points to remind study workers and participants to keep to social distancing 
protocols, wearing of the masks, regular handwashing, coughing and 
sneezing etiquettes. 
• 
We will maintain at least 2m distance between participants at all time during 
project work. 
• 
Interviews will be conducted in a place with adequate ventilation (i.e. open 
windows to allow for the maximum circulation of fresh air, if possible, avoid 
confined air-conditioned rooms) as much as possible. 
• 
We will provide handwashing and drying facilities including liquid soap, 
running water and paper napkins and/or FDA-approved alcohol-based hand 
sanitizer at interview venues so participants can wash/sanitize their hands. 

 
 
BloodSafe Ghana 
 
 
70 
Benefits 
You will not benefit directly by participating in this discussion, but the report we will 
produce will help to further efforts to address iron deficiency anaemia among blood 
donors and hopefully will improve donor care and increase voluntary blood 
donations in Ghana.  
Costs 
If you take part in this interview, it will not cost you any money. 
Compensation 
We will give participants a hand sanitizer as a small gift for your participation.  
Confidentiality 
The information you provide will be protected to the best of our ability. The things 
you tell us will be kept securely by the DCC, NHLBI and the Research Team. The 
data generated in this documentation will be stored for 5 years after completing 
this documentation and after the 5 years, we will work with the DCC, to ensure that 
the data are destroyed correctly, without being able to be recreated. Your name 
will not be mentioned in any in any public communications, documents or reports 
and all the things we will hear from participants will be put together as one so that 
people won’t know anything about you.  
Voluntary participation/withdrawal 
You are free to decide if you want to take in the interview. Participation is entirely 
voluntary. In the course of the interview, you may choose not to answer a question 
at any time without penalty and without having to give any reasons. 
Outcome and Feedback 
After we have finished the documentation, the DCC and NHLBI will know the 
findings. 
Funding information 
This study is being sponsored (funded) by National Heart, Lung, and Blood 
Institute (NHLBI), USA. 
Sharing of participants Information/Data 
The DCC and NHLBI, will solely own the data that will be generated from the study.   
Provision of Information and Consent for participants 
A copy of the Information sheet and Consent form will be given to you after it has 
been signed or thumb-printed to keep.  

 
 
BloodSafe Ghana 
 
 
71 
Whom to Contact for Further Clarification/Questions:  
Key study contacts: 
Dr. 
Yvonne 
Dei- 
Adomakoh  
(Principal Investigator) 
Department 
of 
Haematology,  
Korle-Bu Teaching Hospital 
Tel: +233 243 550980  
Email: 
deiadom@yahoo.com 
yadei-adomakoh@ug.edu.gh  
 
Dr 
Lucy 
Asamoah- 
Akuoko  
(Principal Investigator) 
Head, Research and Development 
National 
Blood 
Service, 
Ghana 
Tel: +233 302 663701 Ext 339  
lucyasamoah@yahoo.com 
For further clarification on ethical issues and rights of participants, contact:  
Administrator 
College of Health Sciences ethical committee 
Tel:  +233 03-02-665103/4 
Email: eprc@chs.edu.gh   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PARTICIPANT INFORMATION SHEET FOR KEY INFORMANTS  
Title of Study: - Iron supplementation and nutritional counseling 
interventions to improve availability and safety of blood in Ghana 

 
 
BloodSafe Ghana 
 
 
72 
Introduction 
Thank you for taking the time to listen to what I have to say. My name is 
___________________________, and I am here because I am working on behalf 
of BLOODSAFE GHANA concerning the documentation of iron deficiency anaemia 
in blood donors. This work is being led by Dr. Yvonne Dei-Adomakoh from the 
Department of Haematology, University of Ghana Medical School/ Korle Bu 
Teaching Hospital. Her telephone number is 0243550980, and her email is 
deiadom@yahoo.com.  
Background and Purpose of research 
The amount of iron that a blood donor has is an important safety issue. Iron 
deficiency is initially without anaemia, manifesting as reduced iron stores (iron 
depletion) affecting red blood cell production, and without intervention is 
complicated by overt anaemia. Major causes of iron deficiency are inadequate 
dietary iron, reduced absorption and loss of iron. With continuous loss of iron from 
repeat whole blood donations and inadequate replacement, blood donors 
inevitably develop iron deficiency and, later, iron deficiency anaemia. Knowledge 
of donors’ iron status provides evidence for blood centres to provide appropriate 
and timely donor care. With deferrals from donation-induced anaemia minimized, 
more willing blood donors are fit enough to repeat blood donations on schedule, 
thus contributing to blood adequacy for patients requiring blood transfusion 
therapy.  
This project is directed towards transforming the blood donor pool in Ghana from 
family replacement donations to sustainable voluntary collections, in support of 
Ghana’s national blood policy that aims at a 100% voluntary blood donation pool 
to secure and sustain an adequate and safe blood supply. Treatment of iron 
deficiency and iron deficiency anaemia require iron supplementation as well as 
nutritional counseling as standard of care in Ghana.  
Nature of research 
We are aiming to have interviews with key informants (Director and Deputy-
Southern Zone Blood Service, Director- Family Health Division-GHS, Deputy 
Director- Reproductive and Child Health –GHS, Staff of the national blood service 
Ghana, study team) who have experience working with blood donors and have 
taken part in blood donation drives for over 2 years or being instrumental in the 
design and implementation of national blood policies and programs. All interviews 
and other data collected as part of this documentation will be summarized into a 
report for the funding agency, the National Heart, Lung, Blood Institute (NHLBI), 
USA, and the Data Collecting Centre (DCC) based in the University of Minnesota, 
USA. 

 
 
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73 
Participants’ involvement 
We would like to ask you to take part in this interview. If you agree to do so, we will 
ask you questions concerning iron deficiency anaemia, iron supplementation, 
nutrition interventions for blood donors, factors that contribute to iron deficiency 
anaemia, cultural practices that may affect iron supplementation. The interview will 
last up to 30 minutes of your time. The interviews will be audio recorded. 
Potential Risks 
Some of the issues we will discuss with you may make you uncomfortable, 
because you may have to talk about the performance of a project/intervention you 
were involved in. You may feel tired whilst going through the interview. Having an 
interview with the researcher may expose you to COVID-19. Apart from these, we 
do not think there are any other major risks associated with your participation. 
To prevent the spread of COVID-19, we will do the following to protect you:  
• 
All field workers will wear a face mask throughout all project activities. 
• 
We will provide a face mask for study participants attending a data collection 
session if they arrived at the session without a mask. 
• 
Before data collection, one field worker will check the temperature of each 
participant using a thermometer gun. He/she will also ask whether the 
participant has a cough/cold, difficulty in breathing or sore throat. Anyone 
with a temperature above 37.4°C (i.e. considered to have fever) and/or 
showing flu-like symptoms will be asked to return home and subsequently 
seek medical attention. 
• 
We will spend at least 5 minutes each morning before the start of work to 
educate participants who have come for office visit on Covid-19. In addition, 
videos on Covid-19 measures will be shown to the participants. We will 
display approved health promotion materials on COVID-19 at vantage 
points to remind study workers and participants to keep to social distancing 
protocols, wearing of the masks, regular handwashing, coughing and 
sneezing etiquettes. 
• 
We will maintain at least 2m distance between participants at all time during 
project work. 
• 
Interviews will be conducted in a place with adequate ventilation (i.e. open 
windows to allow for the maximum circulation of fresh air, if possible, avoid 
confined air-conditioned rooms) as much as possible. 
• 
We will provide hand washing and drying facilities including liquid soap, 
running water and paper napkins and/or FDA-approved alcohol-based hand 
sanitizer at interview venues so participants can wash/sanitize their hands. 

 
 
BloodSafe Ghana 
 
 
74 
Benefits 
You will not benefit directly by participating in this documentation, but the report 
we will produce will help to further efforts to address iron deficiency anaemia 
among blood donors and hopefully will improve donor care and increase voluntary 
blood donations in Ghana.  
Costs 
If you take part in this interview, it will not cost you any money. 
Compensation 
We will give participants a hand sanitizer as a small gift for your participation.  
Confidentiality 
The information you provide will be protected to the best of our ability. The things 
you tell us will be kept securely by the DCC, NHLBI and research Team. The data 
generated in this documentation will be stored for 5 years after completing this 
documentation and after the 5 years, we will work with the DCC, to ensure that the 
data are destroyed correctly, without being able to be recreated. Your name will 
not be mentioned in any in any public communications, documents or reports and 
all the things we will hear from participants will be put together as one so that 
people won’t know anything about you.  
Voluntary participation/withdrawal 
You are free to decide if you want to take in the interview. Participation is entirely 
voluntary. In the course of the interview, you may choose not to answer a question 
at any time without penalty and without having to give any reasons. 
Outcome and Feedback 
After we have finished the documentation, the DCC and NHLBI will know the 
findings. 
Funding information 
This study is being sponsored (funded) by National Heart, Lung, and Blood 
Institute (NHLBI), USA.  
Sharing of participants Information/Data 
The DCC and NHLBI, will solely own the data that will be generated from the study.   
Provision of Information and Consent for participants 
A copy of the Information sheet and Consent form will be given to you after it has 
been signed or thumb-printed to keep.  

 
 
BloodSafe Ghana 
 
 
75 
Whom to Contact for Further Clarification/Questions:  
Key study contacts: 
Dr. 
Yvonne 
Dei-Adomakoh  
(Principal Investigator) 
Department 
of 
Haematology,  
Korle-Bu Teaching Hospital 
Tel: +233 243 550980  
Email: 
deiadom@yahoo.com 
yadei-adomakoh@ug.edu.gh  
 
Dr 
Lucy 
Asamoah-Akuoko  
(Principal Investigator) 
Head, Research and Development 
National 
Blood 
Service, 
Ghana 
Tel: +233 302 663701 Ext 339  
lucyasamoah@yahoo.com 
For further clarification on ethical issues and rights of participants, contact:  
Administrator 
College of Health Sciences ethical committee 
Tel:  +233 03-02-665103/4 
Email: eprc@chs.edu.gh  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
BloodSafe Ghana 
 
 
76 
 CONSENT FORM - KEY INFORMANTS 
 
STUDY 
TITLE: 
Iron 
supplementation 
and 
nutritional 
counseling 
interventions to improve availability and safety of blood in Ghana 
 
Participant’s Statement 
I acknowledge that I have read or have had the purpose and contents of the 
Participants’ Information Sheet read and all questions satisfactorily explained to 
me in a language I understand (English, Ga, Twi). 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. 
 
I voluntarily agree to be part of this research. 
Name of Participant___________________________________________ 
 
Participant’s 
Signature 
_____________________________or 
Thumb 
Print__________________ 
 
Date: _________________________________ 
 
Our interview with you may be recorded. However, before we can record the 
interview, we need your consent. All recordings will be kept securely by the 
Department of Haematology, University of Ghana and the DCC. Your personal 
information will not be used to label audio recordings and transcriptions. 
Identification codes will be assigned to you. If you agree or not agree that we 
should record the interview, kindly indicate below: 
 
 
Should we record this interview? 
(Kindly tick if you want to be record or 
not) 
Yes 
 
No 
 
 
Interpreter’s Statement 
I interpreted the purpose and contents of the Participants’ Information Sheet to the  
afore named participant to the best of my ability in the (English, Ga, Twi) language 
to his proper understanding. 
All questions, appropriate clarifications sort by the participant and answers were 
also duly interpreted to his/her satisfaction. 
Name of Interpreter___________________________________________ 

 
 
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77 
Interpreter’s 
Signature 
_____________________________or 
Thumb 
Print_________________ 
Date: _________________________________ 
 
Contact 
Details___________________________________________________________
______ 
Statement of Witness 
I was present when the purpose and contents of the Participant Information Sheet 
was read and explained satisfactorily to the participant in the language he/she 
understood (English, Ga, Twi). 
 
I confirm that he/she was given the opportunity to ask questions/seek clarifications 
and same were duly answered to his/her satisfaction before voluntarily agreeing to 
be part of the research. 
 
Name of Witness___________________________________________ 
 
 
Witness’ 
Signature 
_____________________________or 
Thumb 
Print_________________ 
 
Date: _________________________________ 
 
 
Investigator Statement and Signature 
 
I certify that the participant has been given ample time to read and learn about the 
study. All questions and clarifications raised by the participant have been 
addressed.  
Name ___________________________________________ 
Signature _____________________________ 
 
Date: _________________________________ 
 
 
 
 
 

 
 
BloodSafe Ghana 
 
 
78 
Nutritional Counselling  
Preventing Iron deficiency and Iron Deficiency anaemia (Iron rich and 
balanced meals) 
What you eat is important in the treatment of iron deficiency anaemia. Good 
nutrition can help to reduce the risk of iron deficiency anaemia and help with 
effective management.  
Common foods rich in iron 
Vegetables  
Dark green leafy vegetables are rich in iron and should be consumed frequently. 
Examples of such vegetables include kontomire, borkorborkor, gboma, ademe, 
aleefi, spinach, abeduru, and okro.  
Meat and Fish 
Try to include protein-rich foods in your diet. Protein is needed for the growth and 
repair of the body’s tissues and cells and can be used as an energy source if 
energy intake is low. Examples of foods rich in protein are lean beef, lean pork, 
goat meat, kidney, liver (pregnant women should avoid liver), poultry, fish, shrimps, 
sardines, tuna, salmon, nuts, beans, and milk. Eggs are also a good source of 
protein. 
Legumes, Nuts and seeds  
Pumpkin seeds (Egusi), wrewre, cashews, Groundnuts/peanuts, soybeans, black-
eyed Beans, peas, fortified breakfast cereals 
Foods that can interfere with iron absorption:  
• foods that contain tannins, such as grapes, corn, and sorghum 

 
 
BloodSafe Ghana 
 
 
79 
• foods that contain phytates or phytic acid, such as whole-grain wheat 
products 
• tea and coffee  
Iron supplements can interact with some medications such as decreasing the 
absorption of tetracycline antibiotics. Other antibiotics include calcium lowering 
drugs (Bisphosphonates) Ciprofloxacin, norfloxacin, antihypertensives such as 
levodopa and many more. Discuss with the study doctor when you are prescribed 
other drugs by your regular physician during the study period.  
Some important tips: 
Avoid drinking tea and coffee when eating green leafy vegetables and other iron-
rich foods, a substance in them (tannic acid) lowers iron absorption.  
Ensure adequate fluid intake – 12 cups or glasses (approximately 2-3 litres daily).  
Eat iron-rich foods alongside vitamin C such as citrus fruits e.g., oranges, 
tangerines, pineapples, alassa, and yooyi. It is also a good idea to enrich foods 
whenever possible; for example, you may add groundnuts to porridge, soy beans 
to cereals. 

 
 
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BloodSafe Ghana 
 
 
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APPENDIX 4: Study Design Flowchart 
 
 

 
 
BloodSafe Ghana 
 
 
83 
APPENDIX 5: Study Timelines  
BLOOSAFE Ghana Site Project - UG3 Timelines 
UG
3 
ACTIVITY 
YEAR 1 
YEAR 2 
 
 
2020 
2021 
2022 
 
 
J
U
L 
A
U
G
S
E
P 
O
C
T 
N
O
V
D
E
C
J
A
N
F
E
B
M
A
R 
A
P
R 
M
A
Y
J
U
N
J
U
L 
A
U
G
S
E
P 
O
C
T 
N
O
V
D
E
C
J
A
N
F
E
B
M
A
R
A
P
R
M
A
Y
J
U
N
1 
Systematic 
Literature 
Review 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol Development 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Literature Search 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Extraction 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data 
Analysis 
& 
Synthesis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Write up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Revisions and submission  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 
Study Protocol Development and Approvals 
 
Protocol Version 0.1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Steering C’tee Review 1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol Version 0.2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Steering C’tee Review 2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol Version 0.3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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84 
 
DSMB Review 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol version 0.4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DSMB Review 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
UH3 Protocols 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(Nutritional Counseling + Iron Supplemention)  
 
Baseline 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
25% Enrollment 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
50% Enrollment 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
75% Enrollment 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
100% Enrollment 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
Pilot 2- (Iron Supplement and nutritional 
counselling and Follow-Up 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
Data Collection, Analysis (adherence, 
Return) 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
Reports, Manuscripts 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
UH3 Protocols