Seroprevalence and determinants of transfusion transmissible infections among voluntary blood donors in Homabay, Kisumu and Siaya counties in western Kenya

Objective Since the implementation of a series of blood donation safety improvements in Kenya, information about seroprevalence and determinants of transfusion transmissible infections among voluntary blood donors especially in high HIV burden regions of Homabay, Kisumu and Siaya counties remain scanty. A cross-sectional study examining HIV, syphilis, hepatitis B and C virus sero-markers and associated determinants was conducted among voluntary blood donors. Their demographic characteristics and previous risk exposure were recorded in a pre-donation questionnaire, while blood samples collected were screened for hepatitis B, hepatitis C, human immunodeficiency viruses by ELISA and RPR (syphilis), then confirmed using CMIA. Results Overall TTIs seroprevalence was 114 (9.4%), distributed among HIV, HBV, HCV and syphilis at 14 (1.15%), 42 (3.46%), 39 (3.21%) and 19 (1.56%), respectively, with co-infections of 3 (0.25%). There were no significant differences in proportions distributions among demographic variables. However, high risk sex was significantly associated with higher odds of HBV infections [> 1 partner vs. 0–1 partner; odd ratio (OR) 2.60; 95% confidence interval (CI) 1.098–6.86; p = 0.046]. In conclusion, a substantial percentage of blood donors still harbor transfusion transmissible infections despite recent safety improvements with greater majority cases caused by HBV infections arising from previous exposure to high risk sex. Electronic supplementary material The online version of this article (10.1186/s13104-018-3276-y) contains supplementary material, which is available to authorized users.


Determinants of Transfusion Transmissible Infections (TTIs) -As used in this study
includes; (1). Demographic characteristics such as age (2). Risk factors such as illicit drug use. e-Progesa Blood Establishment Computerized System (BECs)-Is a vein to vein system that interface computer technology with automated blood screening equipment to generate results in real time with boosted efficiency Family Replacement Donors (FRDs) -These are blood donors brought into the hospital by relatives of patients to donate blood specifically to replace units of blood given to a patient often for payment. Majority are known to have high risk exposure to TTIs.
Regional blood drive recruiter -A personnel within NBTS tasked with responsibility of booking dates for blood donation with heads of institution Residual risk -Is the threat that remains after all efforts to identify risk have been made Seroprevalence -Is the number of persons in a population who test positive for Transfusion Transmissible Infection (TTIs) mainly based on test done on blood sample.

Strata -A wider region under study represented in this study by counties.
Texts for life -A short text message platform launched in Kenya in 2014 to help KNBTS capture bio-data, notify and re-call regular blood donors.
Transfusion Transmissible Infections (TTIs) -These are pathogens found in blood, majorly HIV, HBV, HCV and syphilis and can be transmitted to recipient during blood transfusion.  (Jayaraman & Chelabi, 2010). Transfusion transmissible infections especially human immunodeficiency virus, syphilis, hepatitis B and C virus, are a constant threat to blood safety for the recipient, and more endemic in Africa, thus making donors in this region vulnerable to risk of exposure (Tessema et al., 2010). Moreover, co-infection is also common due to similar routes of transmission (Muriuki, Gicheru, & Wachira, 2013), with prevalence varying with time and regions (Jehuda-Cohen, 2011). Infections with HIV compromise immunological status of a person, hepatitis B and C viral infections cause liver cirrhosis and hepatocellular carcinoma while infections with syphilis results in neonatal mortality (CDC, 2014), hence making the four TTI markers mandatory and irreducible minimum that must be tested in blood donations to achieve safety threshold (WHO., 2009).

LIST OF TABLES
Globally, about 1.6 million blood units are destroyed annually owing to TTIs seropositivity , with 10% reported in sub-Saharan Africa (Murphy, 2007), where risk of transfusion-transmitted HIV, HBV and HCV is estimated at 1.0, 4.3 and 2.5 infections per 1000 donations respectively, (Jayaraman & Chelabi, 2010). In Kenya, transfusion -related HIV transmission of 2% had been observed (Moore et al., 2001). Moreover, despite of recent safety improvements in blood donations by KNBTS such as stringent donor selection, enhanced haemovigilance through e-progesa blood computerized system (BECs), (KNBTS, 2015), and implementation of fourth generation p24 antigen and HIV antibody screening assays (Basavaraju et al., 2010), a substantial amount of blood units estimated at 5.26% are still destroyed annually in the country owing to TTIs seropositivity (WHO-CDC, 2011). Furthermore, HIV, HBV, HCV and syphilis seropositive blood discards estimated at 2.6%, 3.9%, 2.2% and 0.5%, respectively, were reported earlier in Kisumu region under KNBTS covering Homabay, Kisumu and Siaya counties (NASCOP, 2005). The three counties experience the greatest burden of HIV and other co-infections in the region (NACC, 2016,), but also serve as major blood basket supplying most hospital in western Kenya based on their proximity to regional blood donor center of Kisumu and ease for transport during donations. To date, there is no published data on blood donation safety assessment from this region; hence this study sought to establish the seroprevalence of TTIs among voluntary donors in the region following a series of blood donation safety interventions.
Socio-demographic characteristics influence the distribution of TTIs among blood donors. In Kenya, National blood transfusion services (NBTS) rely mainly on young voluntary blood donors, particularly secondary schools, colleges and University students, majority in the age range of 15 -24 years (Kimani et al., 2011). Blood donations from school students are preferred over adult donors owing to lower HIV prevalence estimated at 1% compared to 6.6% prevalence recorded in adults aged 30 -34 years (Kimani et al., 2011). However, a study carried out in Kenya using stimmunology still detected a significant number of early pre-seroconversion of HIV carriers both among adults and teenage population (Mumo, Vansover, & Jehuda-Cohen, 2009). This study sought to establish the dominant demographic and other risk factors still playing a role in TTIs seropositivity recorded in the region.

Statement of the Problem
In regions with high burden of HIV, risk reduction of TTIs is threatened by the number of blood donors infected and the emergence of co-infections among donor population. In Kenya, risk of HIV infections due to blood transfusion is estimated at 2%, with overall TTIs seropositive blood discards of 5.26%. Furthermore, earlier studies in Kisumu region under KNBTS had shown that HIV, HBV, HCV and syphilis seropositive blood units of 2.6%, 3.9%, 2.2% and 0.5%, respectively, were discarded from blood donations for the year 2003. To date, there is no published data from the region on blood donation safety assessment. This study sought to establish the seroprevalence of TTIs in the region following a series of donation safety improvements.
Socio-demographic characteristics influence the distribution of TTIs among blood donors.
Despite of blood collection exclusively from youthful voluntary donors, and rigorous predonation screening, a study carried out in Kenya using stimmunology still detected a significant number of early-preseroconversion of HIV carriers both in adults and teenage donor population.
This study sought to establish the demographic and other risk factors still driving HIV, HBV, HCV and syphilis seropositivity among donors in the region.

Epidemiology of TTIs in Africa
In sub-Saharan Africa, blood safety remains a major public health concern because of high prevalence of TTIs and increased demand for transfusion (Tessema et al., 2010), majorly due to anemia caused by malaria, pregnancy complication and malnutrition (Osaro & Charles, 2011).
Moreover, a greater majority of voluntary donors in Africa are below 25years, and contributing about 38% of annual blood collection (WHO., 2010), of which nearly 10% are destroyed owing to TTIs seropositivity (Murphy, 2007). Co-infections with TTIs is also common due to similar route of transmission (Muriuki et al., 2013), with prevalence varying with time and region of study (Jehuda-Cohen, 2011). Moreover, serological early-HIV carriers within the donor population often remain undetected, as HIV-induced immunological window periods can span into months (Mumo et al., 2009), while detection of acute and occult HBV and HCV infections in blood donors remain elusive during seronegative window periods (Husam-Has & Sting-Lansen., 2009). Studies have shown that incubation period following HBV exposure varies from 1-6 months and correlates with magnitude of inoculums (Webale et al., 2015), while resolution and outcome of infection is dependent on host immunity, age, gender, infection route and genotype (Webale et al., 2015), thus resulting in more silent TTIs carriers fueling epidemic (Anyiwo clement, 2014) and variation in epidemiology that requires repeat testing several months later (Jehuda-Cohen, 2011).
The risk of becoming infected with HIV, HBV and HCV from blood transfusion in sub-Saharan Africa is 1.0, 4.3 and 2.5 infections per 1000 donations, respectively, (Jayaraman & Chelabi, 2010

Epidemiology of TTIs in Kenya
A study in Trans-Nzoia County, Kenya reported seroprevalence of HBV at 10.5% among febrile patients visiting health facilities (Demba & Mwau, 2013). Likewise, 56% prevalence of HBV was reported among outpatients attending three district hospitals in the towns of Mombasa, Kilifi and Malindi, Kenya (Hyams et al., 1989), relative to 8.8% reported among asymptomatic nomads in Turkana, Kenya (Mutuma & Mbuchi, 2011). Moreover, a study involving pregnant women from the former Kenya six provinces estimated national prevalence of HBV at 9.3% (Okoth et al., 2006), while co-infections with hepatitis B and C virus, among HIV-1 infected individuals in Nairobi was reported at 10.3% (Muriuki et al., 2013), Meanwhile, earlier studies in Kisumu region which also represent Homabay, Kisumu and Siaya counties, reported prevalence peak of HBV, HCV and HIV among blood donors in the region at 3.9%, 2.2%, and 5%, respectively, (NASCOP, 2005), thus suggesting high risk of TTIs among donors in the region. Furthermore, a series of blood donation safety improvements have since been implemented in the recent past, among them, enhanced donor notification, retentions of safe seronegative donors, and deferral of seropositive through text for life initiatives (KNBTS, 2015).
In addition, haemovigilance has also been improved through the implementation of e-progesa blood establishment computerized system (BECS), with enhanced donor selection exclusively from voluntary donors (KNBTS, 2015), and use of fourth generation p24 antigen and HIV antibody assays (Basavaraju et al., 2010). However, blood donation safety assessment has not been conducted in this region and published following those safety improvements.

Demographic Characteristic and Risk Factors among Voluntary Blood Donors 2.2.1 Demographics Characteristics of Voluntary Blood Donors
Demographic characteristics of blood donors such as age, gender, marital status, region and level of education influence the distribution of TTIs in the donor population (Kimani et al., 2011). For safe blood, NBTS rely mainly on young voluntary blood donors, particularly secondary schools, colleges and University student for donation (Mumo et al., 2009), majority of whom are in the age range of 15 -24 years (NASCOP, 2005). This fact is echoed in another study in Egypt, showing low prevalence of HBV and HCV among student population (El-Gilany & El-Fedawy, 2006 of enhanced pre-donation selection from teenagers and young adults, majority being students in schools, a substantial amount of blood units are still discarded owing to TTIs seropositivity.

High Risk Sexual Behaviour
Multiple sexual partners and casual sex are drivers for TTIs positivity, and common among voluntary blood donors (Kimani et al., 2011). Studies have shown that, about 4.7% of voluntary donors in Kenya had multiple sexual partners of whom 2.6% of them tested HIV positive (Kimani et al., 2011). Moreover, local reports have also shown that men and women with more sexual partners experienced higher prevalence of HIV at 9.0% and 15.5%, respectively, while individuals with more lifetime sexual partners and being unmarried increases risk of acquiring HIV and other sexually transmitted diseases . In a local study, about 66% of University students admitted engaging in sex or drug related risk behavior even after knowledge of their HIV status, with 42% engaging in both risk (Magu & Wanzala, 2012). More importantly, the three counties under study fall within the fishing lakeshore where multiple sexual partners are synonymous with fishing business (Kwena et al., 2010), with majority participants interacting and intermingle with each other. Although NBTS have always excluded individuals with previous exposure to high risk sex from blood donation, local estimates still show increasing cases of TTIs seropositivity in blood donations from the region.

Blood Transfusion
Unsafe blood transfusions have historically contributed to a substantial burden of TTIs in sub-Saharan Africa (WHO., 2009). In Brazil, blood donors with transfusion history are 10 times more likely to test HCV positive (Brandao & Fuchs, 2002). And nearly three quarters (72%) of blood donors with history of blood transfusion tested positive for HCV in Egypt (Awadalla, Ragab, Nassar, & Osman, 2011 However, despite of stringent donor selection and exclusion from donations individuals with blood transfusion exposure in a period less than three months, substantial cases of TTIs seropositivity are still reported in donations.

Drug Use
Drug use is also a driver for TTIs (Webale et al., 2015). In Egypt, studies have shown that 47.5% of drug abusers who donated blood tested positive for HCV infections (Awadalla et al., 2011). In Kenya, drug users in Kisumu, Mombasa and Nairobi tested for HIV, HBV and HCV infections recorded prevalence of 11.4%, 4.4% and 5.9%, respectively, (Oyaro & Wylie, 2012). However, despite of rigorous selection, and a subsequent exclusion from blood donation all high risk group, TTIs seropositive cases were still recorded in donations from this region, thus calling for safety assessment.

Study Area
The study was conducted at Regional Blood Transfusion Center ( and 4, 836 blood units, respectively, owing to their proximity to the regional blood donor center, and ease for transport. Key health challenges in the three study sites are HIV/AIDS, Malaria, and pregnancy related hemorrhages (KNBTS, 2015), thus raising blood transfusion demand in many hospitals in the region.

Study Design and Population
This was a cross-sectional study in the reference population of voluntary donors in the regions of Homabay, Kisumu and Siaya counties in western Kenya. All voluntary blood donors of age range 16 -65 years who underwent donor selection process and qualified as suitable donor as per the KNBTS selection protocol (Appendix II), were eligible to participate in the study.

Participants Recruitment and Consent Process
Permission to conduct blood donation and to recruit study participants was sought through institutions administration (Appendix III). Study participant were recruited among voluntary blood donors who presented themselves to donate blood during blood donation days. A brief health talk was provided during which a complete description of purpose of the study and assurance of confidentiality were explained. Participants aged ≥ 18 years who qualified as suitable donors were approached and requested to provide informed written consent (Appendix IV), in order to participate in the study, while participants aged 16-17 years obtained informed written consent from their parents (Appendix V) before appending their signature to participate in the study; that is, their assent was obtained. All consenting participants were then provided with pre-donation questionnaire (Appendix VI) to fill their demographic details, medical history and any other information of previous risk exposure. Successful participants were then registered and blood samples collected.

Inclusion Criteria
Voluntary blood donors with; (i) hemoglobin ≥ 12.5gms/dl; (ii) body weight ≥ 50kgs; (iii) normal blood pressure and (iv) resident of the county under study. In addition, the participants must have signed an informed consent and/or assent and feeling well by the time of recruitment and registration.

Exclusion Criteria
(i) Previous blood donation in less than 3 months for males, or 4 months for females. (ii) Previous vaccination for HBV in less than 6 months. (iii) Family replacement donors (FRDs) and walk-in-donors visiting RBTC of Kisumu. (iv). All individuals with previous exposure to high risk contacts based on selection protocol and counselor's own assessment. (v) All donors who declined to sign a written consent were excluded.(vi) All individuals aged < 16 and > 65 years.

Sample Size Determination
The sample size was determined by Yamane formula. The choice for the formula was based on the fact that this was a proportion study on a large population; hence Yamane formula provides a

Sample size adjustment
In order to detect difference in prevalence among the three counties of at least 10% with a significance level of 95% and test power of 90% given baseline overall prevalence of TTIs is

Data Collection Process
After providing for the informed consent, qualified donors were given a pre-donation questionnaire to record their demographic details, social and medical history before samples collection.

Laboratory Techniques
3.6.1 Determination of Human Immunodeficiency Virus-1 and 2 using Sandwich ELISA Test Determination of antigen or /antibody to HIV-1/2 was done using HIVAg/Ab. test kit (Biomerieux SA, Microelisa system). This was done according to manufacturer's instruction.
Briefly, 100µl of specimen diluents was dispensed into each test well; 50µl of serum sample or control was added and mixed using a micro shaker for 15 seconds then incubated at37°C for 60 minutes. The test was then washed six times with phosphate buffer; 100µl of TMB substrate was then added into each well and incubated at room temperature (15C°-30°C) for 30 minutes in dark cabinet. Finally, 100µl of 1mol/L sulfuric acid was added to stop reaction, mixed and absorbance read at 450 nm within 15 minutes. Cut-off value was obtained from mean of three negative controls plus factor 1.000. Test sample was positive if absorbance was ≥ cutoff value but negative if absorbance was < cut-off value.

Determination of Hepatitis B Virus using Sandwich ELISA Test
Hepatitis B surface antigen (HBsAg) was determined using Hepanostika HBsAg Ultra test (Biomerieux SA, Microelisa system). This was done according to the manufacturer's instruction.
Briefly, 25µl of specimen diluents was dispensed into each test well; 100µl of sample or control was added and incubated at 37°C for 60 minutes. Using a multi-channel pipette, 50µl of HRPconjugate solution was added and incubated at 37°C for 60 minutes. The test was then washed six times with phosphate buffer and 100µl of TMB substrate added and incubated in the dark cabinet at room temperature (15C° -30°C) for 30minutes. There action was then stopped with 100 µl of 1mol/L sulfuric acid and absorbance read at 450 nm within 15 minutes. Cut-off value was then calculated from the mean of three negative controls plus factor 0.040.Test sample was positive if the absorbance was ≥ cutoff value but negative if absorbance was < cut-off value.

Determination of Hepatitis C Virus using Sandwich ELISA Test
Hepatitis C antibodies (Anti-HCV) were determined using Abbott Murex Anti-HCV (version

Chemiluminescent Micro Particle Immunoassay (CMIA) Technique (Abbott/Architect i 2000 SR USA).
Determination of HIV-1/2Ag.Ab, HBVsAg. Anti-HCV and Anti-Treponema pallidum (syphilis) was done using architect HIVAg/Ab Combo, Architect HBsAg. Qualitative II, Architect Anti-HCV and Architect syphilis TP, respectively. Briefly, a file for a specific assay obtained from Architect j CD-ROM was inserted and installed on the Architect i 2000 SR system. The reagent carrier was then loaded with Micro particles, acridinium-labeled conjugate, diluents, pre-trigger, trigger solutions and wash buffer according to the manufacturer instructions. Similarly, serum sample panels were also loaded into sample holder according to samples IDs. Sample processing was then initiated by pressing the run key on the processing keypad. Immediately, the Instrument & Control Technique (ICT) pipettor aspirated samples and micro particles into Reaction Vessels (RV), mixed and incubated for 18 minutes. The reaction mixture was then washed to remove unbound materials before acridinium-labeled conjugate was added and mixed and further incubated for 4 minutes before a second wash. A pre-trigger was then added, mixed and CMIA optical system took background reading before a trigger solution was added to obtain activated reading. To obtain the final results for the analytes, the Architet i 2000 SR system calculated the cut-off value using the mean chemiluminescent signal (Relative Light Unit) from three replicates of calibrator. Results were determined based on the ratio of sample signal to the cut-off value (S/CO), (Relative Light Unit (RLU) to the cut-off for each specimen and control. Specimens with signal cut-off values less than 1.00 were considered non-reactive (Negative) while specimens with signal cut-off value ≥ 1.00 were considered reactive (positive). Samples with S/CO value in the range of 0.9 -1.0 was classified as equivocal and were repeat tested using same protocol. Test result was ready in 30 minutes.

Validity and Reliability
For validation of conventional ELISA and CMIA test protocols, a subset of 10 samples randomly selected was re-analyzed at Huqas-laboratory, Nairobi, Kenya using similar techniques and results were concordant.

Data Management and Statistical Analysis
All information touching on participants' socio-demographics and test results were entered in data excel sheet and secured using secret password accessible to only study staffs. Statistical confidence intervals was used to determine the association between TTIs seropositivity and various risk factors.

Ethical Consideration
Initial approval to conduct the study was provided by School of Graduate Studies (SGS) of (Appendix X). Written informed consent was obtained from each participant before enrolment.
All study participants were provided with free health education on Transfusion Transmissible Infections (TTIs) including HIV, syphilis, hepatitis B and C, hygiene and nutrition.
Arrangements were made to refer participants tested positive for any of the four TTIs markers to the comprehensive care centers at Jaramogi Oginga Odinga Teaching and Referral Hospital for treatment, care and support.

Demographic Characteristics of Reactive and Non-Reactive Participants
Demographic characteristics of study participants are presented in

4.2: TTIs Seroprevalence Distribution Proportion Indifferent Categories
TTIs seroprevalence distribution proportion among different categories is presented in  29%) Data shown are numbers (n) and proportions (%); Difference in proportions distribution was compared using Chi-square test for independence. A p-value of < 0.05 was considered statistically significant. There were no significant differences in proportion distribution among the variables tested. Furthermore, none of the pre-determined risk factors were associated with HIV seropositivity.    Moreover, none of the pre-determined risk factors were associated with HCV seropositivity.
Moreover, none of the risk factors were associated with syphilis seropositivity. Data shown are numbers (n), and proportion (%); OR (95%), Odds ratio at 95% Confidence interval; ref. Reference group; (-) denotes no analysis done due to lack of cases. None of the demographic and risk factors tested was associated with syphilis seroprevalence..

Seroprevalence of HIV, HBV, HCV and Syphilis
The present study was set to determine the seroprevalence and determinants of HIV, HBV, HCV and syphilis among voluntary blood donors in Homabay, Kisumu and Siaya counties in western Kenya. Results established that, overall seroprevalence of TTIs among voluntary blood donors was 9.4%. Similar results have been reported in studies done in Ethiopia showing 9.5% seroprevalence (Tessema et al., 2010), and in Benin, Nigeria showing 12.5% seroprevalence (Halim & Ajayi, 2000 TTIs seroprevalence in the three study sites was relatively higher compared to earlier reports of 5.26% national seroprevalence (WHO-CDC, 2011). This variation may be attributed to HIV endemicity experienced in the three study sites as compared to the rest of the country showing difference in HIV/STIs profile. Meanwhile, co-infection of 0.25% detected in the study population was comparable to 0.02% reported in a previous local study (Karuru, Lule, Joshi, & Anzala, 2005), and 0.8% reported in the neighboring Ethiopia (Tessema et al., 2010).
The HIV seroprevalence of 1.15% detected among blood donors is indicative of low seroprevalence and decreased susceptibility to HIV infections. Similar studies in DRC reported similar result of 1.1% seroprevalence (Kabinda & Bulabula, 2014). However, in Ethiopia, a relatively higher seroprevalence of 3.8% was reported (Tessema et al., 2010). These findings were comparable to the previous national estimates of 0.96% -1.43% seroprevalence reported for the periods 2007-2010 (KNBTS, 2011)), and 0.5% -1.5% seroprevalence for the periods -2012(KNBTS, 2012. Likewise, the result was also comparable to other national estimates of 1.2% -2.5% seroprevalence reported earlier in a local study (Basavaraju et al., 2010). This study observation could be results of exclusion of family replacement donors (FRDs) from the study, and milestones of beyond zero campaign initiatives in the country. In contrast, the findings were relatively low compared to 2.6% national seroprevalence reported in a similar local study (Kimani et al., 2011), and 2.6% seroprevalence reported from same study sites (NASCOP, 2005).
In this study, HBV seroprevalence of 3.46% detected among blood donors is indicative of in Nigeria (Nwankwo & Imoru-Momodu, 2012), and 1.8% in Cameroon (Carole & Francoise, 2014), compared to this study results. The variation observed in HCV seroprevalence may be attributed to difference in geographical settings and study methodology adopted by different authors. In this study, HCV seroprevalence was relatively higher compared 0.79% -0.99% national estimates for the period 2007-2010(KNBTS, 2011, and 0 -0.9% seroprevalence estimates for the period -2012(KNBTS, 2012. In addition, this study result was relatively higher compared 2.2% seroprevalence previously reported in the same study sites (NASCOP, 2005), Thus, it is evident from the study that HCV infection remains a challenge in blood donation safety, being a major contributor to many blood discards experienced in the region.
Syphilis seroprevalence of 1.56% detected among blood donors is indicative of low seroprevalence and decreased susceptibility to syphilis infection. Similar studies in Ethiopia reported similar results of 1.3% seroprevalence (Tessema et al., 2010). However, different results were reported in Ghana showing seroprevalence of 13.5% (Ampofo et al., 2002), and in Cameroon showing 9.1% seroprevalence (Mbaya & Takam, 2003). Variation observed in seroprevalence may be attributed to difference in geographical setting. In this study, syphilis seroprevalence was similar to the national estimates of 0.15% -0.28% (KNBTS, 2011), and 0.5% seroprevalence reported earlier in the same study area (NASCOP, 2005). This observation may be attributed to milestones of beyond zero campaign programs and enhanced pre-donation selection.

Demographic and Risk Factors of TTIs
In the analysis of demographic and risk factors, HBV infection was significantly associated with previous exposure to high risk sex. This may be explained by the low economic status initiating young adolescents to multiple sexual relationships, thus making them vulnerable to HBV and other co-infections. The findings corroborate local studies that found sex for cash payment associated with HIV and other co-infections (NACC, 2016,). In contrast, different results were observed in Egypt showing that TTIs was not associated with high risk sex (Awadalla et al., 2011). In relation to age and gender subcategories, none was associated with any of the TTIs seroprevalence, although previous local studies had reported different results showing that adults' aged ≥ 20 years were more likely to get infected by HIV compared to young adolescents aged 10 -19 years (NACC, 2016,). Moreover, females were more likely to test HIV positive compared to males (Kimani et al., 2011). The variation observed may be related to the difference in study population since voluntary donors is a low risk group compared to the general population. In relation to blood transfusion history, there was no association with any of the  (Awadalla et al., 2011).

Limitation of the Study
This study only used HBVsAg marker to detect infections of HBV without considering IgM and IgG antibodies to the core protein (HBcAb-Ig M & IgG) which are ideal for a complete and accurate diagnosis of acute, occult and chronic infection stages of HBV (Webale et al., 2015), hence some cases may have been missed.

Summary of the findings
In this study, the overall seroprevalence of TTIs observed was higher among voluntary donors.
In addition, seroprevalence of HBV and HCV was relatively higher compared to the seroprevalence of HIV and syphilis infections. HBV seropositivity was detected with higher frequency noted among voluntary blood donors with previous exposure to high risk sex. Objective of the study: The purpose of this study is to find out the magnitude of TTIs among our potential voluntary blood donors. The results obtained will help us review our current donor selection criteria and formulate new strategies that will improve adequacy and safety of blood to the local recipients.

Study location:
The study will be done at RBTC in Kisumu and NBTC Nairobi while blood samples will be collected from schools and colleges in Homabay, Kisumu and Siaya.
Anticipated benefit: Participation in this study is free. Refreshments would however be provided to all those who donate a unit of blood. All donors will also get donors card showing blood group. Results of TTIs will be provided on an individual request.
Risk and discomfort: Drawing blood during blood donation will be accompanied by a small amount of pain and bleeding that is short lived and may cause minor discomfort. Occasionally mild dizziness and sweating may also follow a blood donation. You do not have to take part in the study if you do not wish to do so. You do not need to give any reason of refusing.

Compensation:
No compensation is provided for. First aid will however be provided to those with minor adverse events. You are not obliged to participate and can withdraw from the study at any time. No special treatment is provided to study participants.
Voluntary participation: Your participation in this study is voluntary. If you choose not to participate; you will still be our potential donor and will continue to get our services. Please be assured that the test results obtained will not be linked to any names or identifications.

Sample type, amount and time:
Overall, 15 minutes is enough for donor selection, bleeding and recovery. About 6mls of blood samples will be collected from the single unit of blood you donate. Long Elisa test will be used to detect the presence of Human Immunodeficiency Virus, Hepatitis B, Hepatitis C virus and syphilis in the blood. A minimum of 1, 215 participants will be registered for the study.
Follow-up schedule: All donors who test positive for any of the TTIs will be notified appropriately for further counseling and referral to medical care. The visiting date shall be communicated to the head of school or college.
Confidentiality: Every effort will be made to keep your study records confidential. Any information about you will be reported anonymously. If you think that you were harmed because of this study, contact the Principle or co-Investigators on the contact provided bellow. The research is being done by Calleb Onyango as principle investigator. About 1215 people will be asked to take part in the study.

PURPOSE OF THE RESEARCH:
The purpose of this study is to find out the magnitude of TTIs among our potential voluntary blood donors. The results obtained will help us review our current donor selection criteria and formulate new strategies that will improve adequacy and safety of blood to the local recipients.

WHO WILL TAKE PART
To be in this research, you must be living in Homabay, Kisumu or Siaya, be between the ages of 16 and 65 and feeling well and healthy.

TAKING PART IS YOUR CHOICE
Because you are a minor, you will need two things before you can be in this study.
1. Your parent's or legal guardian's permission and 2. Your assent. Your parent or guardian must give permission for you to be in the study. But, if you do not want to be in the study, you do not have to sign this assent. Without your assent, you will not be included in the study. It is important for you to know from your parent or guardian that he/she has allowed you to take part in the study.

WHAT WILL HAPPEN IN THE RESEARCH
We will ask you to answer questions about yourself. We will also ask you basic questions about your sexual partners. These questions will be asked on a questionnaire. This will help keep your information private. You will be shown how to answer the questions in the questionnaire. You can ask a staff person for help at any time.
We will also ask you to have a medical examination. The examination requires some medical tests. These medical tests include tests for hemoglobin, blood pressure and weight. You will be asked to donate one unit of blood from where 6mls of blood sample will be collected and used to test HIV, HBV, HCV, syphilis and blood group. Your blood will only be used for research purposes.

IF YOUR RESULTS SHOW YOU HAVE HIV, HBV, HCV OR SYPHILIS
If your blood tests results show you have any of the above diseases, we will help link you to support and medical services you might need. The soonest we can give you the results of your blood test is at least two weeks during our donor notification program. At that visit, we will give you the results of your TTIs test and other medical tests.

RISKS AND/OR DISCOMFORTS
You may not feel that this study is directly helpful to you.
You may feel pain when blood is taken from your arm. You may bruise, feel dizzy, or get light-headed. There is a small chance of an infection where the blood is taken from. Clinical staff will use proper procedures to lessen this risk.
You may find it hard to answer questions. Some may make you feel embarrassed or uncomfortable.
You may be afraid to get your HIV, HBV, HCV or syphilis test results. You may be embarrassed that others will find out that you have been tested. You may worry that your HIV test results will be made known to other people.
People in your community, including your family, may learn that you are taking part in this study. They may not be pleased that you are doing so.

BENEFITS
This study can help show if you do not have HIV, HBV, HCV or syphilis You will also know your blood group and get donor card It can link you to other health facilities for treatment of some illnesses.
It will tell you about what causes HIV, HBV, HCV, and syphilis and how to prevent spreading them.
It may help you to change behaviors that may put you at risk for TTIs infection.
Your community may learn more about TTIs because you have taken part in this study.
PRIVACY: All information you give will be kept private by the study staff. No one else will be told your answers to questions or results of medical tests. Findings from this study will use information from everyone who took part. It will not focus just on your answers and medical test results.
You will be given a special study number. This number will be used on all your study records.
Your name will not be on any of these records. Your name and personal information will only be used to reach you. It will not be included in any reports.
Overall findings from this study will be shared with the Kisumu community. Nothing about you specifically will be included in these findings.

YOUR RIGHTS TO REFUSE TO TAKE PART IN THE RESEARCH OR LEAVE THE
RESEARCH: You may choose to take part in this study or you can choose not to take part in it. If you choose not to take part, your participation in blood donation will still continue and we shall still recognize you as our potential blood donor with KNBTS.

STORAGE OF BLOOD FOR FUTURE TESTING:
Some of the blood taken from you in this study may be used for tests that will not be done until the study has ended. This blood will be stored securely. Only a very small number of study staff will have access to it. If this blood is used this way, your name and personal information will not be linked to it. You may take part in the study even if you decide not to have your blood stored.

PROBLEMS OR QUESTIONS
For any question or concern about research study or study related injuries, contact George