This study registered a total of 2056 PLWSCD out which 1745(84.9%) of were aged less than 18 years and therefore dependent on their parents or guardians while only 23 (1.1%) were aged more than 45 years. Those who indicated that they knew of some relative(s) with SCD were 859(41.8%). Regarding the diagnostic work up, only 357(17.3%) had a confirmatory test (HB Electrophoresis/ HPLC) while majority 1500 (73.0%) had a screening test (sickling test) done. Most of the PLWSCD reported having had multiple hospital admissions and multiple blood transfusions. The families of PLWSCD who had ever enrolled in a medical cover were 941 (45.8%) with majority 730(77.6%) of them paying the premiums by direct remission in to the fund, however only 34.1% (702 out of 2056) had an active and beneficial medical cover with only 30.8% (633) PLWSCD being able to access and afford hydroxyurea. These findings call for establishment of SCD registries (PLWSCD, Haemoglobin Variants, Organizations that deal with SCD) and strengthening of specialized clinics by ensuring that medications, supplies, reagents and equipment are available, accessible and affordable so that the communities are able to receive the services required for the control of SCD. To make the services affordable, all families including those of PLWSCD should be encouraged, guided and supported to purchase a medical insurance cover. The health care leadership and other stakeholders need also to lobby for an, ‘essential package’ from the existing Health Insurance Fund for PLWSCD. As an appropriate way forward towards the realization of a SCD registries and Control Programme (SCDRCP), the study team has designed various tools to assist collect standardized information which can be analyzed and used for intervention projects.

1. Organizations that deal with SCD (Appendix I)
The organizations that deal with SCD are expected to register, indicate the scope (care, advocacy, capacity building, etc.) of their activities and periodically provide reports of their work to the relevant authorities. The study team also recommends that appropriate standards of the activities are set and adhered to.

2. Encounter (Initial and Return) Forms (Appendix IV & V).
These are to be used for the patients’ files and retained in the clinics/ facilities.

The initial encounter forms are designed to provide data for the registry of PLWSCD and collect information on the demographics, family set up and whether the family has a medical insurance, whether it also identifies with a community health worker/promoter, mode of diagnosis of the SCD, medical treatment and name of facility.

The return encounter forms are designed to collect information on whether the client has an active medical insurance or not, intercurrent information (use of medications, hospital admissions, blood transfusions, interaction with Community Health Workers) since last visit and referral for specialized care.

3. Haemoglobin Variant Forms (Appendix III).
These are to provide data for the registry of the type of haemoglobin different persons have. People are encouraged to screen and know the type of haemoglobin variant they have and there make informed choices about their spouses and offspring.

4. Sickle Cell Federation of Kenya (SFK) Membership Forms (Appendix II).
The SFK membership forms seek to register any stakeholders (PLWSCD and their caretakers, Health Care Providers, any other individuals) that are interested in the welfare of PLWSCD within the jurisdiction of Kenya.

The SFK is an umbrella organization whose aim is to work closely with the Ministry of Health (MOH) and the County Health Management Teams (CHMT) to set the appropriate standards of CARE, EDUCATION and RESEARCH in SCD.

Another appropriate way forward is to have the Ministry of Health and County Health Management Teams to take charge of the activities and ensure that the implementation of the WHO interventional strategies is carried out concurrently in an organized manner.

Duration: (6 MONTHS) - NOVEMBER 2021 TO APRIL 2022.

1.0 Introduction
Sickle Cell Disease (SCD) affects millions of people throughout the world. [1] More than three quarters (75-85%) of the cases occur in Africa, it affects 3% of births with an estimate of 300,000 to 400,000 infants born with SCD annually. [2, 3] The carrier (Sickle Cell Trait) frequency ranges between 10% to 40% across equatorial Africa decreasing to 1% to 2% on the North African coast and less than 1% in South Africa. [2] The prevalence of SCD in the United States is approximately 1 in 5,000 mostly affecting Americans of Sub-Saharan descent. It is estimated that about 2.5 million Americans are heterozygous carriers and 90,000 are affected with the sickle cell disease In France, overall birth prevalence was found to be 1 in 2415 with about 8744 carriers^. In the United Kingdom, one baby in every 2000 is born with SCD. In South Arabia, about 4.2% of the population carry the sickle cell trait and 0.26% have sickle cell disease. The prevalence of SCD in India ranges from 9.4% to 22.2%. [4]

In Kenya, most of the cases are found in Western, Nyanza, Coast, Nairobi and parts of Eastern regions or provinces. [4, 5] Aluoch J. R. et al in 1993 documented that more than 80% of patients with sickle cell anaemia were of Luo and Luhya origin with Sickle Cell Trait (SCT) rate of 28% among them while among the Kamba and Mijikenda, the SCT rate is about 35%. [5] Kuta E et al in 2016 documented the prevalence of SCD of 3.2% and SCT of 13.2% among newborns in Kisumu while Watenga et al in 2017 found the prevalence of SCT of 18.7 % among adolescents in Bungoma county, Kenya. [6, 7]

There is paucity of population level data in general regarding the burden of SCD and the sickle cell trait (SCT) in Kenya, East Africa and the African continent at large. [1] Based on model projections, it is estimated that in Kenya, almost 6,000 newborns (one in every 150 newborns) had sickle cell in 2010, and this could rise to over 10,000 (one in every 100 newborns) per year if appropriate control measures are not put in place. [1] The distribution reflects the fact that Sickle Cell Trait (HB AS) confers a survival advantage against malaria and that selection pressure due to malaria has resulted in high frequencies of the mutant gene especially in high malarial transmission areas. [8] SCD is a hereditary blood disorder. It is inherited in an autosomal recessive fashion. Any person carrying the sickle cell gene can transmit it to his/her offspring. [4, 7] Two categories exist
1. Those who have inherited the gene from one parent and are referred to as carriers or have the Sickle Cell Trait (SCT). They generally lead normal lives, do not show signs of disease but are often unaware that they carry the gene. However, they have the potential to transmit the gene. [4, 7]
2. Those who have inherited the gene from both parents and are referred to as having Sickle Cell Anaemia (SCA). They suffer lifelong signs of sickness, which include anaemia, occlusion of blood vessels, infections and damage to various organs. [4, 7]

A person who has normal haemoglobin is referred to as having Hb AA, while the one who is a carrier is referred to as having Hb AS and the one who has the disease is referred as having Hb SS. The likelihood that a pregnancy will result into an offspring with Sickle Cell Anaemia (Hb SS) is 25 percent if both parents are carriers (Hb AS & Hb AS)), is 50 percent if one parent is a carrier and the other one is a sickler (Hb AS & Hb SS) and 100 percent if both parents are sicklers (Hb SS & Hb SS). [4, 7]

It is therefore, advisable that those who carry the gene (Hb AS and Hb SS) get spouses who have the normal haemoglobin (Hb AA) so that their offspring can have either the normal haemoglobin (Hb AA) or the trait (Hb AS). [4, 7] We argue that if we provide information to the public, screen, test and counsel, we can prevent the birth of sicklers in Kenya and therefore reduce the burden. [4, 6, 7]

The interventional strategies for control of SCD are categorized into primary, secondary and tertiary by the World Health Organization (WHO). [4, 6, 7] The tertiary interventional strategy entails managing the complications as the patients present with the signs and symptoms. The secondary interventional strategy entails screening the newborns, identifying those with SCD, follow them up and provide prophylactic management. The primary interventional strategy entails preventing birth of sicklers by ensuring persons are aware of their carrier status, there is pre-conception genetic counselling and reproductive choices made. [4, 6, 7] In order to be effective, all these intervention strategies should be carried out concurrently in an organized manner and in a SCD Control Programme. That is the focus of our project.

1.1 Objectives
1. To assess the level of awareness about Sickle Cell Disease (SCD) among the Health Care Providers.
2. To evaluate the existing Health Care services for SCD.
3. To register the persons living with Sickle Cell Disease (PLWSCD).
4. To determine the haemoglobin variants of different demographic groups including New Born.

1.2 Description Of Approach
The first essential step towards addressing the burden is to create a harmonized SCD data base, identify the patients and profile them in a standard format so as to help plan for their comprehensive care.⁽⁴⁾ Another step is to set up services which can provide the appropriate facilities: for determination of haemoglobin variants so that individuals can test and know their ‘sickle cell status’; public health education on prevention especially pre-conception genetic counselling and reproductive choices. The other very important step is to have an organized way in which all the relevant stakeholders can provide their support in terms of guidelines and policies, technical and expert services, funds for drugs, equipment and personnel among others. [4] In Kenya the prevalence of sickle cell trait (SCT or HB AS) and sickle cell disease (SCD or HB SS) is not well established, therefore, if the interventional  strategies  are  implemented  appropriately  through collaborative efforts of all stakeholders, establishment of a national registry of the various haemoglobin variants as well as a Sickle Cell Disease Registry and Control Programme (SCDRCP) can be realized.

1.2.1 Study Procedures
1.2.1.1 Phase I
The researchers first prepared registry forms for PLWSCD as well as the Haemoglobin variants (Appendix III) and the questionnaire for evaluating the health facilities (Appendix VI) plus the relevant information about SCD together with the need for implementation of Sickle Cell Disease Registries and Control Programme (SCDRCP). The information prepared targeted different groups of people and different cadres of staff and was modified from time to time depending on the audience and situation.

The researchers also prepared the pre-test and post-test questionnaires together with the categories of the test questions and narratives that provide the answers (Appendix VIII).

The tools were developed from scratch and subjected to various stakeholders for comments and improvement. In collaboration with the Ministry of Health and other stakeholders, targeted messages in form of Brochures (Appendix VII) to provide basic information on SCD were also developed and distributed.

1.2.1.2 Phase II
The researchers then interacted with the members of the County Health Management Teams (CHMT) in each of the 5 counties and gave presentations on the burden of SCD, the genetics, the interventional strategies and what can be done to control it and thus requested for their support. They also handed over to the CHMTs copies of the concept note, data collection tools, IREC- MU&MTRH and NACOSTI ethical approvals for the study together with the first edition of the Kenyan Guidelines for Management of SCD.

1.2.1.3 Phase III
After the approval of the activities by the CHMTs, the researchers planned the dates of the Continuous Medical Education (CME) sessions. The researchers also requested for the company of a member of the CHMT in each county during the activities. The researchers worked hand in hand with the County Health Management teams in all the activities in order to achieve the objectives.

Data Management
Data entry was done in an Excel Data Collection Template. Subsequent to this, data cleaning and management ensued through the comparison of the unprocessed data entered in Excel against the tangible data gathered via conventional paper data collection instruments, specifically targeting instances flagged by the data quality checks implemented during the data processing phase. This methodical approach facilitated the identification and resolution of discrepancies. Further to this, a comprehensive Excel workbook was programmed, designed to afford intricate data drill-down capabilities. The workbook encapsulated the refined data, presenting descriptive statistical outputs viewable from the overarching project level and allowing for a granular exploration of the data at the facility level. This hierarchical presentation served to enhance the analytical depth and interpretative potential of the aggregated data, ultimately contributing to a more nuanced comprehension of the research findings.

The qualitative data collected through field notes was thematically grouped based on the research objectives and was used to augment the quantitative data.

The analysed data is presented in tables, pie charts and bar charts.

Phase IV
Dissemination Of Information
Feedback of the study findings was given in June 2023 to the CHMTs and suggestions on way forward provided.

A copy of the Power Point Presentation on the study findings was also given to the CHMT of each county.

This technical report has been shared with the Moi University, the Sickle Cell Federation of Kenya (SFK), the Ministry of Health and the various County Governments.

Information from the research study has been retained by the local health institution and the County, Moi University and the Sickle Cell Federation (SFK) and in future may be included in a de-identified public use data base managed by the Ministry of Health in compliance with the appropriate Public-Access Policy.

Data obtained will be useful to guide policy formulation and decision making and will therefore be shared appropriately with the relevant stakeholders.

2.0 Methodology And Results
2.1 Objective One
Assessment Of The Level Of Awareness About Sickle Cell Disease (SCD) Among Health Care Provider (HCPS).

Methodology
The researchers prepared the pre-test and post test questions which covered different aspects of Sickle Cell Disease. These included the history and first description of SCD, the epidemiology, the genetics and mode of inheritance, the pathogenesis and clinical features, the management with special reference to the World Health Organization (WHO) interventional strategies and the need for SCD registries and Control Programme (SCDRCP). There were 4 different sets of the questionnaires labelled Pre-test A, B, C, D and Post-test A, B, C, D. Each set had 15 Multiple Choice Questions (MCQs) items with 4 choices that included an option of DO NOT KNOW with one answer being correct. At the time of the CME, the Health Care Providers were first subjected to a given set of Pre-test questions, then a Continuous Medical Education (CME) session of about 45 minutes was given and thereafter a different set of questions testing the same information was given as a post-test. The questions were marked out of 15. The sum of the total marks of all the HCPs was obtained and divided by the number of HCPs to get the average per facility and County. Analysis of the performance was done qualitatively. The number and cadre of the participants were determined and analysed quantitatively.

Results
Table 1: Distribution of the Health Care Providers (HCPs) by cadre per county.

	TOTAL	%	BUNGOMA	BUSIA	KAKAMEGA	VIHIGA	TRANS-NZOIA
No of HCP
Reached
Consultants	43	1.6	10	3	11	14	5
MO	102	3.8	18	23	32	15	14
CO	401	15.0	84	98	92	65	62
NO	1000	37.5	246	196	315	114	129
Lab Techs	253	9.5	49	55	56	42	51
PHO	109	4.1	27	28	22	10	22
Nutritionist	81	3.0	25	17	13	11	15
Social worker	60	2.2	16	16	7	9	12
Counsellor	103	3.9	19	35	12	19	18
HRIO	112	4.2	20	24	30	22	16
Pharm Tech	110	4.1	21	20	38	14	17
Others	296	11.1	88	32	65	58	53
	2,670	100	623	547	693	393	414

A total of 2670 Health Care Providers were assessed in the 5 counties with 623 in Bungoma, 547 in Busia, 693 in Kakamega, 393 in Vihiga and 414 in Trans- Nzoia. The numbers and the different cadres of staff assessed are as indicated in Table 1.

Tables 2, 3, 4, 5 and 6 show the average performance of the Health Care Providers in Bungoma, Busia, Kakamega, Vihiga and Trans-Nzoia respectively in the Pre-test and Post- tests.

Table 2: The pre-test and post-test performance of HCPs in Bungoma County

Table 3: The pre-test and post-test performance of HCPs in Busia County.

Table 4: The pre-test and post-test performance of HCPs in Kakamega County.

Table 5: The pre-test and post-test performance of HCPs in Vihiga County.

Table 6: The pre-test and post- test performance of HCPs in Trans-Nzoia County

Table 7: Summary of the pre-test and post-test performance of the HCPs in the 5 Counties.

COUNTY	PRE-TEST			POST-TEST
	NO.	MARKS	AVERAGE	NO.	MARKS	AVERAGE
BUNGOMA	491	2306	4.7	623	4610	7.4
BUSIA	417	2236	5.3	547	4652	8.5
KAKAMEGA	585	2574	4.4	693	6158	8.9
VIHIGA	293	1591	5.4	393	3566	9.1
TRANS-NZOIA	332	1570	4.7	414	3258	7.9
TOTAL	2118	10277	4.9	2670	22244	8.3

Figure 1: Average score in the Pre-tests and Post-tests in each of the five counties.

Narrative (Objective one)
​​​​​​The average knowledge score on Sickle Cell Disease of the Health Care Providers was initially low with the HCPs scoring about one third (4.9 out of 15) of the total marks in the pre-test. Trends in improvement in knowledge were observed as evidenced in the post- test where the average mark improved to over half (8.3 out of 15) of the total marks.

Recommendation
1. Need to prepare Information, Education and Communication (IEC) materials with specific messages for dissemination.
2. Need to organize for more Continuous Medical Education (CME) sessions in order to reach more HCPs. 

2.2 Objective Two
Evaluation Of The Existing Health Care Services For SCD.

Methodology
An interviewer administered questionnaire (Appendix II) was filled by the researchers when they visited each facility. The facility in charge available at the time of the visit was asked as the Key Informant to provide the required information. The information collected included the name, level and type (public, faith based or private) of facility, whether the facility is NHIF accredited or not, whether it has pharmacy and laboratory departments, whether it attends to SCD clients, whether it stocks the specific medications (hydroxyurea, folate, Pen V, paludrine) for SCD and suggestions on what can be done to improve care services.

Results
Table 8: Names of the health facilities evaluated in each of the 5 counties

COUNTY	Health Facility Evaluated	Total
BUNGOMA	Bungoma CRH, Ndalu SCH, Kimalewa HC, Kameti HC, Cheptais SCH, Chwele SCH, Kimilili SCH, Lugulu Mission Hosp, Sirisia SCH, Malakisi SCH, Webuye SCH, Bumula SCH, Bokoli SCH, Naitiri SCH, Mt. Elgon SCH.	15
BUSIA	Busia CRH, Moding HC, West Side Cottage, Nasewa HC, Khunyangu SCH, Budalangi HC, Sio Port SCH, Lukolis HC, Amukura SCH, Matayos SCH, Alupe SCRH, Port Victoria SCH, Changara Dispensary, Mukhobola SCH, Holy Family Mission Hospital Nangina, Butula Mission HC, Ang'urai HC, Teso North SCH (Kocholia), Nambale SCH.	19
KAKAMEGA	Kakamega County General Hospital, Makunga SCH, Shinyalu SCH, Iguhu CH, Mautuma SCH, Shibwe SCH, Matunda SCH, Khwisero HC, Manyala SCH, Likuyani SCH, Navakholo SCH, Matungu SCH, Malava CH, ST. Mary's Mission Hosp Mumias, Butere CH, Lumakanda HC.	16
VIHIGA	Vihiga County Referral Hospital, Emuhaya SCH, Ebusiratsi SCH, Emusire HC, Bugina Model HC, Hamisi Sub-County Hospital, Jumuia Kaimosi Hosp, Ipali HC, Coptic Hospital, Mbale Rural Health Training Centre, Sabatia SHC.	11
TRANS- NZOIA	Kitale County Referral Hospital, Kwanza SCH Bikeke HC, Gitwamba HC, Matunda SCH, Saboti SCH, Lukhome HC, Kiminini HC, Kitale CRH, Kaplamai HC, Andersen Medical Centre, Kobos Heath Centre, Endebess Subcounty Hospital, Kapsara Subcounty Hospital, Cherangany Subcounty Hospital, Nzoia HC	15
TOTAL		76

A total of 76 facilities in the 5 counties were evaluated as shown in Table 8. (Bungoma-15, Busia-19, Kakamega – 16, Vihiga-11, Trans-Nzoia- 15).

Figure 2: Category of Health Facilities evaluated

The public facilities were 67(88.2%), Faith based/ Mission were 7(9.2%) while private were 2(2.6%) as shown in Figure 2.

Figure 3: Level of Health Facilities evaluated in each of the 5 counties

The level 5 facilities were 5(6.6%), level 4 was 43 (56.6%), level 3 were 25 (32.9%) and level 2 were 3 (3.9%) as shown in Figure 3.

Figure 4: Facilities that attend to SCD Clients

The facilities which attend to SCD clients were 50 (65.8%) as shown in Figure 4.

All the facilities were NHIF accredited, had pharmacy and laboratory departments and had skilled medical staff and non-medical staff (security, hospitality and grounds people).

Table 9: Facilities able to stock Medications and Vaccines for SCD

	WESTERN		BUNGOMA		BUSIA	KAKAMEGA	VIHIGA		TRANS-NZOIA
	No.% 76		No. %b15		No. % 19	No. % 16	No.% 11		No. % 15
MEDICATIONS
FOLATE
YES	56	73.7	12	80.0	57.9	81.3	81.8	11	73.3
NO	20	26.3	3	20.0	42.1	18.7	18.2	4	26.7
PEN V
YES	16	21.0	3	20.0	26.3	18.7	27.3	2	13.3
NO	60	78.9	12	80.0	73.7	81.3	72.7	13	86.7
PALUDRINE
YES	11	14.5	2	13.3	15.8	18.7	18.2	1	6.7
NO	65	85.5	13	86.7	84.2	81.3	81.8	14	93.3
HYDROXYUR EA
YES	12	15.8	2	13.3	15.8	18.7	27.3	1	6.7
NO	64	84.2	13	86.7	84.2	81.3	72.7	14	93.3
VACCINES
PNEUMOCOCCAL
YES	31	40.8	5	33.3	52.6	31.3	45.5	6	40.0
NO	45	59.2	10	66.7	47.4	68.7	54.5	9	60.0
MENINGOCOCCAL
YES	4	5.3	2	13.3	10.5	0.0	0.0	0	0.0
NO	72	94.7	13	86.7	89.5	100.0	100.0	15	100.0

Narrative (Objective Two)
1. Majority of the health facilities evaluated were public (67 ,88.2%) with most (68 ,89.5%) of them being level 3 and 4.
2. All the facilities are NHIF accredited, have both laboratory and pharmacy departments and have skilled (medical staff) and support (non-medical) staff.
3. Majority (50, 65.8%) of the facilities attend to SCD clients but only a few (12, 15.8%) could occasionally stock the main medication (Hydroxyurea) required by the PLWSCD and majority of the facilities cited challenges in getting reagents and equipment required for screening, diagnosis and monitoring of SCD.

Recommendations
1. There is need to capacitate the laboratories with reagents and purchase at least one equipment for confirmatory (HPLC or HB Electrophoresis) test for each county.
2. Stock the pharmacies with the basic medications (Hydroxyurea, Pen V, Folate and analgesics) required by PLWSCD. Consider preparation or purchase of the appropriate formulations (Dispersible tablets and syrups) for children.
3. Consider setting up revolving fund (Laboratory and Pharmacy) services.
4. Request for an ‘essential package’ from the medical insurance cover for SCD care services.

2.3 Objective Three
Registration Of Persons Living With Sickle Cell Disease (PLWSCD).

Methodology
The researchers prepared interviewer administered questionnaires which were used to collect the data required for the registry of PLWSCD. The data that was collected included the demographics (Gender, Age, Residence, and Occupation), family (Socio- Economic status of parents), genetics (family history of SCD), possession of a medical insurance cover and its mode of payment, mode of diagnosis, hospital admissions, blood transfusions and ability to access and afford the medications required by PLWSCD. The researchers engaged Registry Administrators (RA) who were trained to collect the information. The registration was done either at the facilities where patients go for clinics or at the facilities where and when the researchers gave the CMEs.

Table 10: Number of PLWSCD registered per subcounty in each of the 5 counties

BUNGOMA SUBCOUNTIES
Bumula	Kanduyi	Sirisia	Kabuchai	Kimilili	Tongaren	Webuye East	Webuye West	Mt.Elgon	TOTAL
79	158	48	99	49	38	28	68	39	606

BUSIA SUBCOUNTIES
Teso North	Teso South	Nambale	Matayos	Butula	Samia	Bunyala	TOTAL
95	148	32	80	46	97	69	567

KAKAMEGA SUBCOUNTIES
Butere	Matungu	Mumias East	Mumias West	Ikolomani	Khwisero	Lurambi	Shinyalu	Navakholo	Malava	Lugari	Likuyani	TOTAL
77	81	46	11	12	17	41	7	72	74	19	37	494

VIHIGA SUBCOUNTIES
Vihiga	Sabatia	Hamisi	Emuhaya	Luanda	TOTAL
29	25	24	11	20	109

TRANS-NZOIA SUBCOUNTIES.
Cherengany	Endebes	Kwanza	Kiminini	Saboti	TOTAL
29	32	44	125	50	280

Table 11: Demographic characteristics of PLWSCD

	WESTERN 2056		BUNGOMA 606		BUSIA 567		KAKAMEGA 494		VIHIGA 109		TRANS- NZOIA 280
	No.	%	No.	%	No.	%	No.	%	No.	%	No.	%
No. of PLWSCD (2056)
Male	972	47.3	279	46.0	278	49.0	216	43.7	59	54.1	140	50.0
Female	1084	52.7	327	54.0	289	51.0	278	56.3	50	45.9	140	50.0
Referrals (2056)
NO	1826	88.8	572	94.4	550	97.0	422	85.4	105	96.3	177	63.2
YES	230	11.2	34	5.6	17	3.0	72	14.6	4	3.7	103	36.8
Age Distribution (2056)
< 1 year	264	12.8	91	15.1	63	11.1	69	14.0	19	17.4	22	7.8
1 to < 5 yrs.	552	26.8	219	36.1	119	21.0	121	24.4	27	24.8	66	23.6
5 to < 18 yrs.	929	45.2	239	39.4	279	49.2	235	47.6	45	41.4	131	46.8
18 to < 25	143	7.0	28	4.6	40	7.1	35	7.1	6	5.5	34	12.1
25 to 45 yrs.	145	7.1	28	4.6	61	10.7	30	6.1	9	8.3	17	6.1
>45 yrs.	23	1.1	1	0.2	5	0.9	4	0.8	3	2.6	10	3.6
< 18 yrs.	1745	84.9	549	90.6	461	81.3	425	86.0	91	83.5	219	78.2
>=18 yrs.	311	15.1	57	9.4	106	18.7	69	14.0	18	6.5	61	21.8
Patient Occupation
(2056)
Child	776	37.7	373	61.5	167	29.5	104	21.1	85	78.3	47             16.8
Student	856	41.7	121	20.0	305	53.7	233	47.1	15	13.8	182             65.0
Unemployed	395	19.2	109	18.0	81	14.3	149	30.2	8	7.3	48             17.1
Employed (Informal)	20	1.0	3	0.5	10	1.8	4	0.8	0	0.0	3               1.1
Employed (Formal)	9	0.4	0	0.0	4	0.7	4	0.8	1	0.9	0               0.0

Figure 5: Age distribution of PLWSCD

Table 12: Socio-economic status of parents of the PLWSCD

	WESTERN 2056		BUNGOMA 606		BUSIA 567		KAKAMEGA 494		VIHIGA 109		TRANS-NZOIA 280
	No.	%	No.	%	No.	%	No.	%	No.	%	No.	%
MOTHER (2056)
Alive	1985	96.4	597	98.5	544	96.0	490	99.2	105	96.3	249	88.9
Dead	71	3.6	9	1.5	23	4.0	4	0.8	4	3.7	31	11.1
Education
None	670	32.6	116	19.1	249	44.0	169	34.2	29	26.6	107	38.2
Primary	689	33.5	195	32.2	193	34.0	175	35.4	35	32.1	91	32.5
Secondary	457	22.2	185	30.5	87	15.3	96	19.4	30	27.5	59	21.1
Tertiary	240	11.7	110	18.2	38	6.7	54	11.0	15	13.8	23	8.2
Employment (2056)
YES	627	30.5	190	31.4	174	30.7	179	36.2	23	21.1	61	21.8
NO	1358	66.0	407	67.1	370	65.3	311	63.0	82	75.2	188	67.1
N/A(DEAD)	71	3.5	9	1.5	23	4.0	4	0.8	4	3.7	31	11.1
Marital status
Married	1626	79.1	513	84.7	407	71.8	399	80.8	85	78.0	222	79.3
Not Married	430	20.9	93	15.3	160	28.2	95	19.2	24	22.0	58	20.7
FATHER (2056)
Alive	1591	77.4	529	87.3	440	77.6	323	65.4	83	76.1	216	77.2
Dead	154	7.5	26	4.3	44	7.8	29	5.9	9	8.3	46	16.4
Unknown	311	15.1	51	8.4	83	14.6	142	28.7	17	15.6	18	6.4
Education
None	576	28.0	143	23.6	211	37.2	107	21.7	24	22.0	91	32.5
Primary	453	22.0	115	19.0	139	24.5	96	19.4	17	15.6	86	30.7
Secondary	440	21.4	169	27.9	95	16.8	85	17.2	29	26.6	62	22.2
Tertiary	276	13.4	128	21.1	39	6.9	64	13.0	22	20.2	23	8.2
Unknown	311	15.2	51	8.4	83	14.6	142	28.7	17	15.6	18	6.4
Employment
YES	1438	69.9	505	83.3	367	64.7	196	59.9	54	49.5	216	77.1
NO	618	30.1	101	16.7	200	35.3	198	40.1	55	50.5	64	22.9
Father Marital status
Married	1626	79.1	513	84.7	407	71.8	399	80.8	85	78.0	222	79.3
Not Married	430	20.9	93	15.3	160	28.2	95	19.2	24	22.0	58	20.7

Table 13: History of SCD in the family

Table 14: Status of medical insurance cover of families of PLWSCD

Figure 6: Proportion of PLWSCD with Active and Beneficial Medical Cover

Figure 7: Mode of payment of the premiums for the medical insurance cover.

Table 15: Mode of diagnosis of SCD

	WESTERN 2056		BUNGOMA 606		BUSIA 567		KAKAMEGA 494		VIHIGA 109		TRANS-NZOIA 280
	No.	%	No.	%	No.	%	No.	%	No.	%	No.	%
Mode of Diagnosis of SCD (2056) Clinically only	199	9.7	52	8.6	28	4.9	50	10.1	7	6.4	62	22.1
Screening Test (Sickling Test)	1500	73.0	373	61.5	489	86.3	417	84.4	60	55.1	161	57.5
Confirmatory Test (HPLC/HB Ele)	357	17.3	181	29.9	50	8.8	27	5.5	42	38.5	57	20.4

 Figure 8: Proportion of types of tests used for diagnosis of SCD.

Table 16: Number and frequency of hospital admissions of PLWSCD

Table 17: Number and frequency of Blood Transfusions

Table 18: Access to special Vaccines and Hydroxyurea by PLWSCD

	WESTERN No.         %		BUNGOMA No.       %		BUSIA No.            %		KAKAMEGA No.          %		VIHIGA No.         %		TRANS-NZOIA No.            %
Vaccines (2056)
Meningococcal	15	0.7	1	0.2	5	0.9	2	0.4	4	3.7	3	1.1
Pneumococcal	107	5.2	28	4.6	18	3.2	22	4.6	6	5.5	33	11.8
None	1934	94.1	577	95.2	544	95.9	470	95.0	99	90.8	244	87.1
Medicatio (2056) Hydroxyurea	633	30.8	261	43.1	123	21.7	102	20.6	39	35.8	108	38.6
NO Hydroxyurea	1423	69.2	345	56.9	444	78.3	392	79.4	70	64.2	172	61.4

Narrative–Objective 3
1. The Male to Female ratio was 1:1.1
2. Majority (1745 ,84.7%) of the PLWSCD were aged less than 18 years.
3. A total of 859 (41.8%) knew of a relative with SCD.
4. Those who had ever had a medical cover were 941 (45.8%) out of which 730 (77.6%) were settling the premiums by direct remission to the fund while only 702 (34.1%) out of the total 2056 PLWSCD had a medical cover that was active and beneficial.
5. Only 357(17.3%) had a confirmatory test done while 1500(73.0%) had a screening (sickling) test done to diagnose SCD.
6. Majority (1773, 86.2%) of the PLWSCD had had multiple hospital admissions and multiple blood and blood product transfusions.
7. Only 633(30.8%) out of the total 2056 PLWSCD were able to access and afford hydroxyurea.

Recommendations
1. Set up specialized clinics for SCD, continue registrations of PLWSCD and collect standardized information by using encounter (initial and return) forms. The information collected by the initial encounter forms (Appendix IV) will be useful for setting up a SCD registry. The standardized information collected by the return encounter forms (Appendix V) will be useful in working out intervention activities.
2. Purchase and install relevant equipment for screening, diagnosis and monitoring.
3. Facilitate and encourage families to enroll into a medical cover.
4. Stock the medications and vaccines required by PLWSCD at an affordable price in order to make them accessible. Revolving fund services (laboratory and Pharmacy) are recommended.

2.4 Objective 4
Determination of The Haemoglobin Variants of Different Demographic Groups Including New Born.
This objective was not easy to test during the study period because of the fact that all the 5 pilot counties did not have machines (HPLC, HB Electrophoresis) for confirmatory test. However, by the time the study team was exiting the field, Bungoma County had acquired a HPLC machine while the rest of the 4 counties were in the process of sourcing for one each.

The process is on-going but data has not been collected and analysed. All the ethical procedures are to be taken into consideration and followed. The target population are all the residents in the included counties. Blood samples will be drawn from each of the participants through the appropriate standard sterile procedures and will be done by trained personnel.

The tests to be done will be agreed upon depending on the cost and availability. These will include the Point of Care (Haemotype SC or Sickle Scan) or confirmatory test (IEF, HPLC or Hb Electrophoresis). The relevant machines (Isoelectric Focusing, HB Electrophoresis, and High-Performance Liquid Chromatography) will be used to determine the different Haemoglobin variants. The relevant personnel will be trained to carry out the tests. 

Screening centres (Newborn and other age groups) are to be set up in identified health facilities.

Purchase of the relevant test kits, equipment, machines, reagents, supplies and training of the required personnel is required for these crucial activities to be realised. 

3.0 Discussion
Sickle Cell Disease (SCD) was first described in 1910 and later got its name in 1922. [4] Since then, a lot of discoveries have been made with regard to the cell biology, genetics, epidemiology, clinical features and its management. [4] In December 2008 at the 63^rd session of the UNITED NATIONS(UN) general assembly SCD was described as “the world’s foremost and lethal genetic disease” which requires global efforts “to bring the disease out of the shadows” [4, 8, 9]

The fact that SCD is a genetic disorder whose inheritance is autosomal recessive such that those who inherit the gene from both parents (Hb SS) suffer lifelong symptoms while those who inherit from one parent (Hb AS) are carriers who generally lead normal lives but can transmit the gene to their offspring is important information whose application can be a useful strategy in its control [4, 8, 9]^.

The control of SCD requires the concurrent implementation of the WHO interventional strategies categorized into primary, secondary and tertiary in which appropriate care is given to those already born and living with SCD , Babies and infants are screened so that those found to have SCD are started on care early and public health education on SCD is provided, people are encouraged to test and know their haemoglobin variant/ genotype and therefore make informed choices about their lives, spouses and offspring with an aim of preventing birth of sicklers^.[4, 6, 7, 9] Programmes in the developed countries have been successful and have demonstrated that where they exist, survival of patients is steadily improving, affected births are falling and an increasing number of patients are stabilizing. [4, 6, 7, 9]^. It is high time that the region also embraces this. The recommendation by WHO that at least 50 percent of member states should have established SCD control programmes by 2020 is a dream though overdue that should be realized by all African countries including Kenya and indeed TEAM (Together Each one Achieves More) work by all stakeholders is necessary in this situation. [4, 9] This study found a low knowledge (4.9 out of 15) by HCPs on SCD in the pre-test. The average knowledge and mark improved to more than half (8.3 out of 15) the total mark in the post-test which was done soon after a 45-minute Continuous Medical Education (CME) session. The health care providers assessed were of different cadres including community health workers, social workers, nurses, clinicians, doctors and etc. The initial low level of knowledge is an indication that majority of the HCPs are not equipped with the basic knowledge and skills on SCD and are therefore, unlikely to effectively play a significant role in the activities required for the control of SCD. The positive trends in improvement of knowledge observed is quite promising and that therefore calls for more CME sessions as well as the preparation and dissemination of standardized Information, Education and Communication (IEC) materials with specific messages in order to reach more health care providers and other communities. 

This study evaluated a total of 76 health facilities out of which 67 (88.1%) were public and 68 (88.5%) were either level 3 or 4. With the understanding that 60 to 70 % of Kenyans seek for care in public facilities, the determination of the status of those facilities when taking into consideration the services to PLWSCD can assist in knowing the existing gaps and challenges that require to be addressed. All the 76 facilities were found to be NHIF accredited, had both laboratory and pharmacy departments as well as both medical (Doctors, Clinicians, Nurses, Laboratory officers, Pharmacists and etc.) and non-medical (security, hospitality, grounds people) staff. The available infrastructure and staff are a significant strength which should not be taken for granted but should provide the opportunity to improve care services. 

The facilities which reported that they attend to SCD clients were 50(65.8%) but only 12(15.8%) were able to occasionally stock hydroxyurea which is the main medication required to manage SCD illustrating the frustrations that clients and care givers go through in seeking for care. These findings call for combined efforts by stakeholders to purchase the relevant equipment and reagents to capacitate the laboratories as well as stock the pharmacies with the required basic medications. Revolving fund services for the two departments whereby the bureaucracies encountered in the existing government procedures are avoided. This is a workable option to improve the accessibility, affordability and sustainability of the care services. 

This study registered a total of 2056 PLWSCD in the 5 counties, majority of whom (1745,84.9%) were aged less than 18 years while only 23 (1.1%) were aged more than 45 years. This dependent group (children and students) on their parents or guardians accounted for 1632 (79.4%) of the participants, while those who were adults but unemployed were 395(19.2%) with only 29(1.4%) who had some form of employment. These findings indicate the challenges associated with a lifelong illness where the morbidity and mortality are high together with low levels of employment. 

The PLWSCD who indicated that they knew of a relative with SCD were 859(41.8%) which confirms the fact that it is a genetic disease that can run in families if awareness is not created. To mitigate this situation, efforts to prevent further birth of more sicklers by utilization of the facts that inheritance of SCD is autosomal recessive, people need to test and know their genotype and therefore make informed choices about their spouses, offspring and lives are required. Meanwhile stakeholders should ensure that those already born and are living with SCD receive appropriate care. 

This study found that out of the registered 2056 PLWSCD, 941 (45.8%) had ever had a medical cover with those having the cover active and beneficial being 702(34.1%). When asked about the mode of payment, 730 (77.6%) indicated that they remit directly to the fund (voluntary). These findings indicate low enrollment into the medical fund (NHIF) with majority (more than three quarters) enrolling directly on voluntary basis. Considering that SCD being a lifelong illness that requires frequent hospital visits and admissions, absence of a medical cover can have a negative socio-economic impact on families with PLWSCD. Efforts to encourage and support families to obtain medical cover as a priority activity are necessary. The coming on board of the Community Health Workers / Promoters (CHW/CHP) is timely for they can be tasked with the role of guiding families in putting together the documents required for enrolment and payment of the premiums into the medical fund. 

This study found that in the diagnostic work up, only 357(17.3%) had had a confirmatory test (HPLC/Hb Electrophoresis), 1500 (73%) a screening test (sickling test) while 199(9.7%) had no laboratory diagnostic test done. These findings indicate the difficulties communities encounter in accessing the appropriate laboratory services. Efforts to equip the laboratories with the relevant machines and reagents are necessary. 

This study found that out of the 2056 PLWSCD, 1773 (86.2%) had ever been admitted with the last admission occurring within the last 24 months with most of them having had multiple admissions. Out of those admitted, 1645(92.8%) had received blood transfusions within the last 12 months. These findings indicate the difficult medical journey experienced by PLWSCD who have to suffer a lifelong illness. This observation calls for mechanisms to provide blood and blood products as well as capacitate lower level (3 &4) health facilities with the basics. 

In this study, only 633(30.8%) were able to access and afford Hydroxyurea which is the main drug used in the management of SCD and only 122(5.9%) had received either of the special vaccines (Pneumococcal 23 and Meningococcal) recommended for PLWSCD. These findings coincide with those in the evaluation of the health facilities whereby an average of 15.8% (12 out of 76) were able to stock Hydroxyurea. This further highlight the difficulties encountered by PLWSCD and their caretakers in accessing the basic medications and therefore calls for stakeholders to combine their efforts in ensuring accessibility, affordability and sustainability of the medical services required by the PLWSCD. The setting up of the revolving fund services (Pharmacy and Laboratory) is an option that should be considered as an appropriate way forward which can effectively sort out the issues of accessibility and affordability. 

The setting up and strengthening of existing specialized clinics for SCD and use of encounter forms (initial and return) to assist collect standardized data is what is required in order to have evidence and therefore work towards provision of effective services. The information collected by the initial encounter forms (Appendix IV) can provide data for the SCD registry while that collected in the return encounter forms (Appendix V) can be used as evidence for possible intervention activities.

4.0 Conclusion And Recommendation
4.1  Conclusion
1. Significant knowledge gaps on SCD among HCPs exist.
2. Health care facilities have good infrastructure, are NHIF accredited and have staff but are not able to provide the required services to PLWSCD because of lack of medicines, supplies and equipment.
3. Majority of the PLWSCD were aged less than 18 years, about one third had a medical cover.
4. Only a few (30.8%) could access and afford the medications required by PLWSCD.

4.2 Recommendations/ Call To Action
1. Enhance level of knowledge on SCD through CMEs, IEC materials and other forums.
2. Purchase, stock and install the required medications, supplies, reagents and equipment in the health facilities.
3. Encourage families to enroll and have medical insurance.
4. Set up specialized clinics for sickle cell disease and collect standardized information (using encounter forms) that can be analysed and used for intervention.
4. Encourage the Ministry of Health and the County Health Management Teams to take leadership in the provision of the services.

Specialized clinics should be set up in health facilities where significant clusters of PLWSCD were registered. There should also be consideration of the distance between the health facilities whereby accessibility of the services by the clients is easily possible. The following are the tentative sites in order of priority in each of the counties. 

Table 19: Tentative sites proposed for specialized clinics

	County
	Bungoma	Busia	Kakamega	Vihiga	Trans- Nzoia
Registered No. of PLWSCD	606	567	494	109	280
1.	NAITIRI SCH  (Tongaren)	AMUKURASCH  (Teso South)	NAVAKHOLO  (Navakholo)	HAMISI  (Hamisi)	MATUNDA (Kiminini)
2.	MALAKISISCH (Bumula)	PORTVICTORIASCH (Bunyala)	BUTERE (Butere)	EMUHAYA  (Emuhaya)	ENDEBES (Endebes)
3.	CHWELESCH (Kabuchai)	KHUNYANGU  (Samia)	MATUNGU  (Matungu)	EBUSIRATSI  (Luanda)	KAPSARA  (Cherangany)
4.	KAPSOKWONYSCH  (Mt. Elgon)	KOCHOLYA  (Teso North)	LIKUYANI (Likuyani)		KWANZA  (Kwanza)
5.	SIRISIA SCH  (Sirisia)	MATAYOS (Matayos)	IGUHU  (Ikolomani)
6.	BUMULA SCH  (Bumula)	ALUPE (Teso South)	MALAVA (Malava)

Abbreviations And Acronyms
CHMT – County Health Management Team CME - Continuous Medical Education
Hb AA – Normal Haemoglobin Variant Hb AS - Haemoglobin variants of carriers
Hb SS – Haemoglobin variant of the warriors
HPLC – High Performance Liquid Chromatography. IEF-Iso Electric Focusing
PLWSCD – Persons living with Sickle Cell Disease. POC - Point of Care
RA- Registry Administrator SCA- Sickle Cell Anaemia SCD – Sickle Cell Disease SCT - Sickle Cell Trait
SCDRCP – Sickle Cell Disease Registries and Control Programme WHO - World

Funder
1. Moi University – College Of Health Sciences Research Development Fund (RDF)
2. Department Child Health & Paediatrics (CHAP) School of Medicine

Researchers
1. Professor Constance Nalianya Tenge is the Principal Investigator of the Sickle Cell Disease Registries and Control Programme (SCDRCP). She is a Paediatrician and Professor of Paediatrics at the Moi University, College of Health Sciences, School of Medicine, Department of Child Health and Paediatrics. She is a member of the Sickle Cell Federation of Kenya (SFK) where she serves as the chair of the scientific committee.
2. Professor Mabel Namubuya Nangami is a Co- Principal Investigator of the SCDRCP. She is an Associate Professor of Health Policy and Health Systems management at the Moi University, School of Arts and Social Sciences (SASS). She is a member of the Sickle Cell Federation of Kenya (SFK).
3. Professor Benard Mwori Sore is a Co- Principal Investigator of the SCDRCP. He is an Associate Professor of Anthropology at the Moi University, School of Arts and Social Sciences (SASS), Department of Sociology, Psychology and Anthropology. He is a member of the Sickle Cell Federation of Kenya (SFK).
4. Dr. Fredrick Otieno Okinyi is a Co- Investigator of the SCDRCP. He is a Consultant Clinical Pathologist and Haematologist in Kenyatta National Hospital and a Lecturer at the University of Nairobi, School of Medicine, Department of Pathology. He is the chairman of the Sickle Cell Federation of Kenya (SFK).
5. Dr. Meshack Wekesa Liru is a Co- Investigator of the SCDRCP. He is a Paediatrician and Child Health Specialist in Homabay County, Kenya. He serves as a member of the Scientific Committee of the Sickle Cell Federation of Kenya (SFK).
6. Mr. Maurice Shilabula is a Co- Investigator of the SCDRCP. He is a Programmer and Information and Communication Technology (ICT) Consultant based in Eldoret. He is a member of the Sickle Cell Federation of Kenya (SFK).
7. Ms. Eunice Owino is a Co- Investigator of the SCDRCP. She is the founder and executive director of the Sickle Cell Uhuru Trust (SCUT) and member of the PEN- PLUS (Package of Essential Non- Communicable Disease interventions) Advocacy voices. She a member of the Board of Directors of the Sickle Cell Federation of Kenya (SFK).

Acknowledgement
1. The Registry Administrators
Stephen Nalyanya, Absolom Simiyu, Anne Wanyonyi, Joy Watitwa - Bungoma
Henry Kafuna, Anthony Lubuka and Susan Lwande                          - Busia
Mwanaarabu Risper and Felix Senah                                                  - Kakamega
Nancy waliaula                                                                                    - Vihiga
Oscar Wanyonyi, Velma Olunga and Justus Maloba                            -Trans-Nzoia
Their role in coordinating the SCDRCP activities in the counties, administering and marking the pre-tests and post-tests and collecting the data of the PLWSCD,

2. The County Health Management Team (CHMT) members.
Their role in providing leadership in Care, Education and Research activities in the counties.

3. The Consultants
Dr. David Lubanga, Dr. Zacheus Were, Dr. Millicent Wanyama - Bungoma
Dr. Emma Namulala                                                                    - Busia
Dr. Roselyne Malangachi and Dr. Bonface Nyumbile                - Kakamega
​​​​​​Dr. Beatrice Shiruli                                                                     - Vihiga
Dr. Rachel Inginia Kokwo                                                          - Trans-Nzoia
Their role in the care of patients and their willingness to take charge of the SCD control activities in the respective counties.

4. The Non-communicable Disease (NCD) coordinators.
Ms. R Nyangau                                   - Bungoma
Ms. Grace Midambo                           - Busia
Ms. Rose Muhando                             - Kakamega.
Mr. Arnold Kihima                              - Vihiga
Mr, Silas Wambulwa                            - Trans-Nzoia
Their role in coordinating the registration of PLWSCD and the CME activities.

5. The Health Care Providers (HCP)
Their role in taking care of the patients, participating in the Pre-test and Post-test assessments and promising to effectively participate in the setting up of SCD registries, specialized clinics and control activities.

6. The PLWSCD and their Care takers.
Their role in providing the information that was analyzed and used to make generalization in order to provide the recommendations on the way forward in the improvement of Care, Education and Research activities required for the implementation of SCD registries, specialized clinics and control programme.

7. The Data Team.

Mr. Paul Obwong, Ms. Velma Olunga and Mr. Davis Nalyanya for their role in the data entry and cleaning as well as the preparation of the power point slides for presentations. Mr. Michael Odawa, Maurice Shilabula and Ms. Faith Yego for their role in the data analysis.

8. The Funders.
The International Cancer Institute (ICI), Eldoret which funded the preparation of the data collection tools and the initial visits to counties to inform the County Health Management Teams (CHMT) about the study activities.
The Research Development Fund (RDF) of the Department of Child Health and Paediatrics, School of Medicine, College of Health Sciences for funding the field activities (Data collection, the Continuous Medical Education), data entry and analysis, Feedback to the CHMT, writing of the Technical Report and dissemination of the findings.

Special thanks to Mr. James Kipsang Cheruiyot a seasoned resource mobilization consultant who currently serves as the managing director of Holistic Resources International Limited for guiding the team through the process of grant applications.

9. The Sickle Cell Federation of Kenya (SFK).
The umbrella body whose platform was used by the investigators to carry out the activities. The SFK seeks to support the welfare of PLWSCD within the jurisdiction of Kenya and also aims is to work closely with the Ministry of Health (MOH) and the County Health Management Teams (CHMT) to set the appropriate standards of CARE, EDUCATION and RESEARCH in SCD.

10. The Reviewers.
Prof.Fabian Esamai, Prof. Samwel Ayaya, Prof. Lameck Diero and Prof. Sherri Bucher for reviewing the work and providing professional guidance in writing the technical report. 

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