Prevalence and predictors of cigarette smoking among people with HIV in Western Jamaica.

With highly active antiretroviral therapy, HIV infection has become a treatable chronic disease. However, modifiable risk factors such as cigarette smoking continue to impact the morbidity and mortality of people with HIV (PWH). We assessed the prevalence and factors associated with cigarette smoking and motivation to quit among PWH in Western Jamaica. A cross-sectional study was conducted in which 392 adults seeking HIV care at health facilities in Western Jamaica completed an interviewer-administered questionnaire. Current smoking prevalence among participants was 17.4%. Current smoking was significantly associated with being male (OR = 2.99), non-Christian/non-Rastafarian (OR = 2.34), living or working with another smoker (aOR =1.86), being moderate to severely depressed (OR = 3.24), having an alcohol drinking problem (OR = 1.84), and never being asked by a healthcare provider if they smoked (OR = 3.24). Among the PWH who currently smoke, 36.7% are moderately to highly dependent on nicotine. One-third of people who smoke (33.8%) started smoking for the first time after HIV diagnosis, while 66.2% initiated smoking before; 88% were willing to quit smoking. These findings provide baseline information for designing and implementing a comprehensive smoking cessation program that considers the needs of PWH in Jamaica, with the potential of becoming a replicable model for other HIV-specialized healthcare settings in the Caribbean.

Intimate partner violence among HIV-positive women in Nairobi, Kenya.

PURPOSE: This study was conducted to identify the prevalence and sociodemographic factors associated with four forms of intimate partner violence (IPV) among HIV-positive women attending the Comprehensive Care Centre at the Kenyatta National Hospital in Nairobi, Kenya. METHODS: A cross-sectional study was conducted among 600 sexually active HIV-positive women aged 18-69 years from May to August of 2012. A structured questionnaire including questions pertaining to sociodemographic characteristics, health care decisions, and forms of IPV (controlling behavior, emotional abuse, physical violence, and sexual violence) was administered to each woman. RESULTS: All women reported experiencing emotional abuse; 20%, 17%, and 15% experienced controlling behavior, physical violence, and sexual violence, respectively. Women who reported low/below average socioeconomic status (SES) had a greater likelihood of experiencing controlling behavior than women with high/average SES (adjusted odds ratio [aOR] =1.62, 95% CI 1.05-2.51). Women who were unemployed had greater odds of experiencing physical violence than those who were employed (aOR =2.35, 95% CI 1.31-4.23). Non-Christian women had higher odds of experiencing controlling behavior, physical violence, and sexual violence than Christian women (aOR =4.41, 95% CI 1.81-10.76 and aOR =3.33, 95% CI 1.43-7.80). CONCLUSION: Based on the prevalence of IPV and the sociodemographic factors identified to be associated with IPV among women in this study it may be beneficial to include IPV screening as part of routine clinic visits for HIV-positive and other women. Furthermore, women who report emotional abuse or controlling behavior from spouse should not be overlooked, as these two forms of IPV may precede or accompany physical and sexual IPV. Women who report experiencing IPV during clinic visits may be referred to organizations and resources available to battered women in Kenya. Increased funding for anti-IPV programs and changes in policy may also contribute to a reduction in IPV among HIV-positive and other women in Kenya.

The Epidemiology of Prostate Cancer in Western Jamaica: Risk Factors, Knowledge, Attitudes and Practices.

OBJECTIVES: To investigate the epidemiology of prostate cancer (PCa) in western Jamaica and describe the health-seeking behaviour of at-risk men. METHODS: This study contained both quantitative and qualitative components. The quantitative portion consisted of a retrospective, matched case-control study of two hundred and four men attending outpatient clinics who completed an interviewer-administered questionnaire. The qualitative component consisted of two focus group discussions designed to further investigate health-seeking behaviour and preferred educational channels regarding PCa. RESULTS: Four risk factors were identified: family history of PCa (OR 3.39, 95% CI 1.73, 6.66), age (OR 1.97, 95% CI 1.41, 2.74), any sexually transmitted disease (STD) history (OR 2.02, 95% CI 1.07, 3.83) and alcohol consumption (OR 1.86, 95% CI 1.00, 3.47). Knowledge of primary risk factors was low, especially for race (37%). Although 81% of controls knew tests were available, a stigma was associated with testing. The screening rate was higher than previously reported but still low (56% of controls), and PCa in the western region is discovered by symptoms 61% of the time. Focus group participants blamed a "male mentality" that is antagonistic to routine medical care and preventive testing. CONCLUSIONS: Family history, age, STDs and alcohol consumption were identified as risk factors for PCa in western Jamaica. Sexually transmitted disease history and alcohol consumption are interesting results that merit further investigation. Prostate cancer continues to be diagnosed primarily by symptoms, indicating that routine testing is not widespread enough to catch the disease in its early stages when treatment is most effective. A negative image of prostate screenings persists, and targeted educational interventions are needed to improve outcomes.

Prostate Cancer Knowledge, Attitudes and Screening Practices among Men in Western Jamaica.

BACKGROUND: African-Caribbean men, particularly Jamaican men, have one of the highest incidences of prostate cancer in the world. This cross-sectional study was conducted to investigate knowledge, attitudes, practices and factors associated with prostate cancer screening among men in western Jamaica. METHODS: A questionnaire was administered to men 40-93 years old during May to August 2007. The outcome variable of interest was previous prostate cancer screening. RESULTS: Approximately 35% of men were previously screened for prostate cancer. Men > 70 years were 93% less likely to be screened compared to men 40-49 years (95% CI: 0.01, 0.56). Men living in the parish of Trelawny were 10.5 times more likely not to be screened compared to men in St James (95% CI: 2.33, 47.17) and manual labourers were 5.5 times less likely to have been screened than non-manual labourers (95% CI: 0.97, 31.68). Men who had not been advised to have prostate cancer screening were 92% less likely to be screened than those advised (95% CI: 0.02, 0.29), and men who were not sure of how frequently screening should be conducted were 6.1 times more likely not to be screened compared to those who knew that screening should be conducted annually (95% CI: 1.10, 33.35). Men who visit healthcare providers only when they feel sick were 6.4 times more likely not to be screened compared to men who visit annually (95% CI: 1.63, 25.41). CONCLUSION: A substantial proportion of Jamaican men ≥ 40 years had never been screened for prostate cancer. Interventions should be instituted to make prostate cancer screening readily available and to promote active participation of men in these programmes especially men ≥ 70 years, men with less economic resources, and men who do not routinely visit a physician or health facility.

ANTIBIOTIC SUSCEPTIBILITY OF ORGANISMS CAUSING URINARY TRACT INFECTION IN PATIENTS PRESENTING AT KENYATTA NATIONAL HOSPITAL, NAIROBI.

BACKGROUND: Changes in susceptibility patterns of bacterial pathogens isolated from urinary tract infections emphasize the need for regional surveillance to generate information that can be used in management of patients. Knowledge on the current status of antimicrobial resistance in uropathogens, and the prevalence of expanding spectrum beta-lactamases (ESBLs) in the isolates will guide policy formulations and encourage prudent use of antimicrobials. OBJECTIVE: Identify bacterial pathogens causing UTI and determine the association between the pathogens isolated from patients attending KNH. Determine antimicrobial susceptibility patterns of the UTI pathogens and the prevalence of ESBL in the isolated pathogens. DESIGN: Laboratory-based study. SETTING: Department of Medical Microbiology University of Nairobi and Kenyatta National Hospital microbiology laboratory, Nairobi, Kenya. SUBJECTS: Nine hundred and forty eight patients presenting directly to the Kenyatta National Hospital's diagnostic lab. Patients were only classified as in-patients if at the time of specimen collection they were being admitted to one of KNH wards. RESULTS: Out of the 948 urine samples processed, 189 in-patients and 37 out-patients samples had significant bacterial growth. The uropathogens identified from in-patient specimens were Escherichia coli (56), Klebsiellapneumoniae (33), Enterococcus spp. (34) and Entrobacter (16) making up 30%, 18%, 18% and 9% respectively. ESBL isolates were found to be resistant to the locally administered antibiotics; Augmentin (37%), Levofloxacin (37%), Cefoperazone (37%), Ampicillin (39%), Doxycyline (41%), Gentamicin (30%) and Nalidixic Acid (38%). CONCLUSION: The increased prevalence of multidrug resistant ESBL pathogens poses challenges for health care providers at KNH and signifies the need for new approach to treat UTI. It would be prudent for laboratories to include specialized tests for detection of ESBL producing pathogens from isolates obtained from in-patients. Further studies on the mechanisms and pathways utilized by these bacteria to cause UTI will highlight other avenues in patient management.

MORTALITY AFTER CLINICAL MANAGEMENT OF AIDS-ASSOCIATED CRYPTOCOCCAL MENINGITIS IN KENYA.

BACKGROUND: Cryptococcal meningitis (CM) is an increasingly prevalent infection among HIV/AIDS patients and is becoming a leading cause of morbidity and mortality in Africa. The short-term prognosis and management of patients with CM may be improved by identifying factors leading to mortality in patients with CM. OBJECTIVE: To assess the clinical management and mortality associated with cryptococcal meningitis (CM) in patients with acquired immunodeficiency syndrome (AIDS) in Kenya. DESIGN: A retrospective study. SETTING: Kenyatta National Hospital and Mbagathi District Hospital, between August 2008 and March 2009. SUBJECTS: Seventy six HIV-infected patients confirmed to be CM positive. RESULTS: Results show that 30 (40%) of 76 patients diagnosed with CM died during hospitalisation after a median hospital stay of ten days (range, 2-73 days). Significant predictors of mortality in the univariate model were Mycobacterium tuberculosis (TB) co-infection (P = 0.04), having been diagnosed with a co-morbid condition such as diabetes mellitus, oral candidiasis and hypertension (P = 0.01), and a low median CD4+ T lymphocyte count (P < 0.001). The multivariable model revealed that male sex, previous or current anti-retroviral therapy (ART) at admission and CD4+ T lymphocyte count less than 50 were significant predictors of mortality. Conversely, a minimum of two weeks of amphotericin B treatment (P < 0.001), initiation of ART (P = 0.007) and monitoring of creatinine and electrolyte levels (P = 0.02) were significantly associated with survival in the univariate model. CONCLUSIONS: CM-associated mortality in Kenya is high; there is an opportunity to improve the management and the short-term outcomes of hospitalised HIV positive patients with CM in Kenya.

Association between high aflatoxin B1 levels and high viral load in HIV-positive people.

Since both aflatoxin and the human immunodeficiency virus (HIV) cause immune suppression, chronic exposure to aflatoxin in HIV-positive people could lead to higher levels of virus replication. This study was conducted to examine the association between aflatoxin B1 albumin adduct (AF-ALB) levels and HIV viral load. Antiretroviral naive HIV-positive people (314) with median CD4 count of 574 cells/µl blood (mean ± standard deviation = 630±277) were recruited in Kumasi, Ghana. Sociodemographic and health data, and blood samples were collected from participants. The plasma samples were tested for AF-ALB and HIV viral load. Univariate logistic regression analysis was conducted using viral load (high/low) as the outcome and AF-ALB quartiles as exposure. Multivariable logistic regression analysis was performed between quartile AF-ALB, viral load and CD4 adjusting for sex, age, and year of HIV diagnosis. Both univariate and multivariable logistic regression showed that viral load increased as AF-ALB levels increased. By univariate analysis, high viral load was 2.3 times more likely among persons in the third AF-ALB quartile (95% confidence interval (Cl): 1.13, 4.51), and 2.9 times more likely among persons in the fourth AF-ALB quartile (Cl: 1.41, 5.88), compared to persons in the first quartile. In the multivariable model, persons in the fourth AF-ALB quartile were about 2.6 times more likely to have high viral loads than persons in the first quartile (Cl: 1.19-5.69). When AF-ALB and viral load were log transformed and linear regression analysis conducted, the univariate linear regression analysis showed that for each pg/mg increase in AF-ALB, viral load increased by approximately 1.6 copies/ml (P=0.0006). The association was marginally significant in the adjusted linear regression model (i.e. for each pg/mg increase in AF-ALB, the mean viral load increased by approximately 1.3 copies/ml, P=0.073). These data show strong and consistent increases in HIV viral load with increasing AF-ALB levels. Since the median and mean CD4 were greater than 500 cells for participants in each AF-ALB quartile, the results indicate that the immune modulating and virus transcription effects of aflatoxin may occur quite early in HIV infection, even while the CD4 count is still above 500, resulting in higher viral loads.

Correlates of symptoms of depression and anxiety among clinic patients in western Jamaica.

OBJECTIVES: There is a paucity of studies on psychosocial disorders in clinic populations in Jamaica. Therefore, we sought to determine the prevalence and correlates of symptoms of depression and anxiety in a clinic population in western Jamaica. METHODS: A total of 338 participants from four outpatient clinics of : A total of 338 participants from four outpatient clinics of the Western Regional Health Authority (WRHA) were screened for symptoms of depression and anxiety using questions from the Beck Depression Inventory-II and the Beck Anxiety Inventory. The Chi-square test was used to examine differences in symptoms of anxiety and depression by gender. Multivariate linear and logistic regression were used to examine the associations between symptoms and sociodemographic variables with significance set at p<0.05. RESULTS: Approximately 30% of participants had moderate or severe depression symptoms while 18.6% had moderate or severe anxiety symptoms. Participants aged 30-39 years were more likely than older participants to have moderate or severe anxiety symptoms (odds ratio [OR]: 2.0, 95% confidence interval [CI]: 1.39, 5.56). Women reported a statistically significant higher prevalence of anxiety symptoms (10.0% vs 7.1%, p = 0.003). There was also a statistically significant difference between anxiety means by gender. Furthermore, income was found to be a significant predictor of anxiety for women only (p = 0.0113). Married persons were more likely than those who had never married to have moderate or severe anxiety symptoms (OR: 2.57, 95% CI: 1.14, 5.76). CONCLUSIONS: Our findings suggest that the prevalence of depression may be higher than global estimates in similar outpatient settings. Screening and intervention efforts may need to focus on younger persons, women, and married persons.

Sexual risk behaviour among HIV-positive persons in Kumasi, Ghana.

OBJECTIVES: To assess the prevalence and predictors of sexual risk behaviours among HIV-positive individuals in clinical care in Kumasi, Ghana. DESIGN: Cross-sectional survey of 267 (43 males and 224 females) HIV-positive individuals attending Kumasi South Regional Hospital. METHODS: An interviewer-administered questionnaire was used to asses demographic and health characteristics, HIV/AIDS knowledge, attitudes, and beliefs and sexual risk behaviours. RESULTS: Forty-four percent of the sample reported having sex after testing positive for HIV. Of the 175 participants with regular sex partners, 24% had HIV-positive partners. Majority (67%) had HIV-negative partners (serodiscordant couples) or partners of unknown status. More than half (51%) of the study population with regular sex partners reported that they had unprotected anal or vaginal sex. Participants who scored < 50% on the HIV/AIDS knowledge scale were 90% less likely to have used condoms during their last sexual intercourse. Disclosure of HIV status was associated with protective patterns of condom use (OR=2.2; 95% CI: 1.3-12.9). Participants on ARV were 80% less likely to have used condoms during the last sexual intercourse (OR=0.2; 95% CI: 0.04-0.6). CONCLUSION: The high rates of sexual risk behaviour among HIV-positive individuals in this sample place others at risk of HIV infection. It also places these HIV positive individuals at risk for infection with sexually transmitted infections and super-infection with other HIV strains. These findings highlight the need to integrate HIV prevention in routine medical care in Ghana.

Calcium montmorillonite clay reduces urinary biomarkers of fumonisin B1 exposure in rats and humans.

Fumonisin B1 (FB1) is often a co-contaminant with aflatoxin (AF) in grains and may enhance AF's carcinogenicity by acting as a cancer promoter. Calcium montmorillonite (i.e. NovaSil, NS) is a possible dietary intervention to help decrease chronic aflatoxin exposure where populations are at risk. Previous studies show that an oral dose of NS clay was able to reduce AF exposure in a Ghanaian population. In vitro analyses from our laboratory indicated that FB1 (like aflatoxin) could also be sorbed onto the surfaces of NS. Hence, our objectives were to evaluate the efficacy of NS clay to reduce urinary FB1 in a rodent model and then in a human population highly exposed to AF. In the rodent model, male Fisher rats were randomly assigned to either FB1 control, FB1 + 2% NS or absolute control group. FB1 alone or with clay was given as a single dose by gavage. For the human trial, participants received NS (1.5 or 3 g day⁻¹) or placebo (1.5 g day⁻¹) for 3 months. Urines from weeks 8 and 10 were collected from the study participants for analysis. In rats, NS significantly reduced urinary FB1 biomarker by 20% in 24 h and 50% after 48 h compared to controls. In the humans, 56% of the urine samples analysed (n = 186) had detectable levels of FB1. Median urinary FB1 levels were significantly (p < 0.05) decreased by >90% in the high dose NS group (3 g day⁻¹) compared to the placebo. This work indicates that our study participants in Ghana were exposed to FB1 (in addition to AFs) from the diet. Moreover, earlier studies have shown conclusively that NS reduces the bioavailability of AF and the findings from this study suggest that NS clay also reduces the bioavailability FB1. This is important since AF is a proven dietary risk factor for hepatocellular carcinoma (HCC) in humans and FB1 is suspected to be a dietary risk factor for HCC and oesophageal cancer in humans.

Evaluating a theory-based health education intervention to improve awareness of prostate cancer among men in Western Jamaica.

OBJECTIVE: To evaluate the impact of a theory-based health education intervention on awareness of prostate cancer and intention to screen among men in Western Jamaica. METHODS: One hundred and eighty-eight men attending outpatient clinics in a hospital in Western Jamaica completed an interviewer-administered pretest survey. Following the pretest, participants received a health education intervention related to prostate cancer and an immediate post-test survey RESULTS: There were statistically significant increases in the percentage of correct responses between the pretest and post-test (p < 0.05). The greatest improvement was among items measuring knowledge of prostate cancer screening tests. Participants moved across the Stages of Change theoretical constructs indicating intention to screen. CONCLUSION: The sample was receptive to information about prostate cancer and the use of a theory-based educational intervention positively influenced knowledge of prostate cancer risk factors, symptoms, and types of screenings. PRACTICE IMPLICATIONS: This theory-based patient education programme can be replicated to promote awareness of prostate cancer and informed screening methods including potential risk associated with screening behaviours.

Socio-demographic determinants of aflatoxin B1-lysine adduct levels among pregnant women in Kumasi, Ghana.

OBJECTIVES: Aflatoxins are fungal metabolites that contaminate staple food crops in many developing countries. Although studies have linked these toxins to adverse birth outcomes and poor infant development, no study has investigated the socio-demographic and economic determinants of aflatoxin levels among pregnant women living in sub-Saharan Africa. DESIGN: A cross-sectional study was conducted among 785 pregnant women in Kumasi. Aflatoxin B1 lysine adduct levels (AF-ALB) were determined by High Performance Liquid Chromatography. Analysis of variance was used to determine mean log AF-ALB levels and significance of differences in these levels according to socio-demographic variables. Logistic regression was used to identify independent associations of socio-demographics with having AF-ALB levels (≥ 11.34 pg/mg; upper quartile). RESULTS: AF-ALB levels ranged from 0.44 pg/mg to 268.73 pg/mg albumin with a median level of 5.0 pg/mg. Bivariate analyses indicates that mean ln AF-ALB as well as the percent of women having high AF-ALB levels (≥ 11.34 pg/mg; upper quartile) were inversely associated with indices of higher socioeconomic status: higher education and income, being employed and having a flush toilet. Higher income, being employed, having one child (verses no children) and having a flush toilet (verses no toilet facilities) were each independently associated with a 30-40% reduced odds of high AF-ALB levels. CONCLUSIONS: Additional research is needed to investigate how socio-demographic and economic factors interact to influence aflatoxin ingestion by individuals in regions with high aflatoxin crop contamination. This knowledge can be used to formulate and implement policies that will reduce exposure of women and their unborn children to these toxins.

Association of high viral load and abnormal liver function with high aflatoxin B1-albumin adduct levels in HIV-positive Ghanaians: preliminary observations.

We examined the association between certain clinical factors and aflatoxin B(1)-albumin adduct (AF-ALB) levels in HIV-positive people. Plasma samples collected from 314 (155 HIV-positive and 159 HIV-negative) people were tested for AF-ALB levels, viral load, CD4+ T-cell count, liver function profile, malaria parasitaemia, and hepatitis B and C virus infections. HIV-positive participants were divided into high and low groups based on their median AF-ALB of 0.93 pmol mg(-1) albumin and multivariable logistic and linear regression methods used to assess relationships between clinical conditions and AF-ALB levels. Multivariable logistic regression showed statistically significant increased odds of having higher HIV viral loads (OR=2.84; 95% CI=1.17-7.78) and higher direct bilirubin levels (OR=5.47; 95% CI=1.03-22.85) among HIV-positive participants in the high AF-ALB group. There were also higher levels of total bilirubin and lower levels of albumin in association with high AF-ALB. Thus, aflatoxin exposure may contribute to high viral loads and abnormal liver function in HIV-positive people and so promote disease progression.

Knowledge, attitudes and practices regarding dengue infection in Westmoreland, Jamaica.

BACKGROUND: Dengue virus infection causes significant morbidity and mortality in most tropical and sub-tropical countries of the world. Dengue fever is endemic in Jamaica and continues to be a public health concern. There is a paucity of information on knowledge, attitudes and practices (KAP) of Jamaicans regarding dengue infection. OBJECTIVE: To describe dengue-related knowledge, attitudes and practices (KAP) of residents of Westmoreland, Jamaica. METHODS: A cross-sectional questionnaire survey of 192 parents attending child health clinics in the Parish of Westmoreland was conducted. RESULTS: More than half of the parents (54%) had good knowledge about signs, symptoms and mode of transmission of dengue. Approximately 47% considered dengue to be a serious but preventable disease to which they are vulnerable. Nevertheless, a majority (77%) did not use effective dengue preventive methods such as screening of homes and 51% did not use bed nets. Educational attainment (OR, 2.98; CI, 1.23, 7.23) was positively associated with knowledge of dengue. There was no correlation between knowledge about dengue and preventive practices (p = 0.34). Radio and TV were the predominant sources of information about dengue fever. CONCLUSION: Findings suggest that the good knowledge about dengue fever among residents of Westmoreland did not translate to adoption of preventive measures. Health programme planners and practitioners need to identify and facilitate removal of barriers to behaviour change related to control of dengue fever among the population. Future campaigns should focus on educating and encouraging individuals and families to adopt simple, preventive actions, such as, use of insecticide treated bed nets and screening of homes.

The prevalence, clinical features, risk factors and outcome associated with cryptococcal meningitis in HIV positive patients in Kenya.

OBJECTIVES: To determine the prevalence, clinical features, risk factors and outcomes associated with cryptococcal meningitis (CM) in human immunodeficiency virus (HIV) positive patients at two referral hospitals in Nairobi, Kenya. DESIGN: Prospective, observational study. SETTING: Kenyatta National Hospital (KNH) and Mbagathi District Hospital (MDH), Nairobi, Kenya. SUBJECTS: Three hundred and forty HIV patients presenting with suspected CM. RESULTS: Of three hundred and forty suspected CM patients, 111 (33%) were diagnosed with CM by CrAg. Among CM patients, in-hospital mortality was 36% (38/106), median age was 35 years (range, 19-60 years) and median CD4 count was 41 cells/microL (n = 89, range 2-720 cells/microL). Common clinical manifestations among CM patients included headache 103 (93%), neck stiffness 76 (69%) and weight loss 53 (48%). Factors independently associated with CM were male sex, headache, blurred vision and previous antifungal drug use. Night sweats and current use of anti-retroviral therapy were associated with reduced risk for CM. CONCLUSIONS: There is a high prevalence of CM and CM-associated mortality in HIV patients at KNH and MDH despite treatment with antifungal and anti-retroviral drugs. This study demonstrates the need to address the existing inadequacies of CM patient outcomes in Kenya.

NovaSil clay does not affect the concentrations of vitamins A and E and nutrient minerals in serum samples from Ghanaians at high risk for aflatoxicosis.

To assess the potential interference of NovaSil (NS) clay with micronutrients in humans, vitamins A and E and minerals (15 nutrient and 15 non-nutrient minerals) were measured in serum samples from a 3-month intervention trial with NS. Participants (n = 177) were randomly divided into three groups that received 3.0 g NS day(-1) (high dose, HD), 1.5 g NS day(-1) (low dose, LD), or placebo (PL). Levels of vitamins A and E in serum were comparable among the three study groups at baseline, 1 month and 3 months of NS intervention. Gender-stratified non-parametric mixed-effect model analysis showed no significant effects of dose and dose-time interaction for levels of vitamins A and E. A significant time effect was detected; however, it was limited to an increase in vitamin E in the male participants over the course of the study. No significant differences were found in levels of the nutrient and non-nutrient minerals between the HD and PL groups at baseline and 3 months of NS intervention, except for strontium levels. Strontium was significantly increased (p < 0.001) in the HD group (male = 113.65 +/- 28.00 microg l(-1); female = 116.40 +/- 24.26 microg l(-1)) compared with the PL group (male = 83.55 +/- 39.90 microg l(-1); female = 90.47 +/- 25.68 microg l(-1)) following the 3-month intervention with NS. These results, combined with safety and efficacy data, confirm that NS clay is highly effective in reducing aflatoxin exposure and acts as a selective enterosorbent that does not affect the serum concentrations of important vitamins and nutrient minerals in humans.

NovaSil clay intervention in Ghanaians at high risk for aflatoxicosis: II. Reduction in biomarkers of aflatoxin exposure in blood and urine.

The efficacy of NovaSil clay (NS) to reduce aflatoxin (AF) biomarkers of exposure was evaluated in 656 blood samples and 624 urine samples collected from study participants during a 3-month phase IIa clinical intervention trial in Ghana. NS was delivered before meals via capsules. Serum AFB (1)-albumin adduct was measured by radioimmunoassay and urinary AFM (1) metabolites were quantified by immunoaffinity-high-performance liquid chromatography (HPLC)-fluorescence methods. Levels of AFB (1) -albumin adduct in serum samples collected at baseline and at 1 month were similar (p = 0.2354 and p = 0.3645, respectively) among the placebo (PL), low dose (LD, 1.5 g NS day (-1)), and high dose (HD, 3.0 g NS day (-1)) groups. However, the levels of AFB (1)-albumin adduct at 3 months were significantly decreased in both the LD group (p < 0.0001) and the HD group (p < 0.0001) compared with levels in the PL group. Levels of AFM(1) in urine samples collected at baseline and at 1 month were not statistically different among the three study groups. However, a significant decrease (up to 58%) in the median level of AFM (1) in samples collected at 3 months was found in the HD group when compared with the median level in the PL group (p < 0.0391). In addition, significant effects were found for dose, time, and dose-time interaction with serum AFB(1)-albumin adduct and dose-time interaction with urinary AFM (1) metabolites. The results suggest that capsules containing NS clay can be used to reduce effectively the bioavailability of dietary AF based on a reduction of AF-specific biomarkers.

NovaSil clay intervention in Ghanaians at high risk for aflatoxicosis. I. Study design and clinical outcomes.

A 3-month double-blind and placebo-controlled, phase IIa clinical trial was conducted in Ghana to investigate the safety, tolerance and aflatoxin-sorption efficacy of dietary NovaSil (NS). Volunteers (507 subjects) were clinically screened to evaluate their general health, pregnancy status and blood AFB(1)-albumin adduct levels. Of these subjects, 177 were randomly assigned to three groups: high-dose (HD), low-dose (LD) and placebo-control (PL) groups receiving 3.0, 1.5 and 0 g NS day(-1) in capsules. Trained study-monitors supervised NS capsule administration to participants and recorded side-effects daily. Physical examinations were performed monthly. Blood and urine samples were collected for laboratory analysis. Approximately 92% of the participants (162 of 177) completed the study and compliance rate was over 97%. Overall, 99.5% of person x time reported no side-effects throughout the study. Mild to moderate health events ( approximately 0.5% of person x time) were recorded in some participants. Symptoms included nausea, diarrhea, heartburn and dizziness. These side-effects were statistically similar among all three groups. No significant differences were shown in hematology, liver and kidney function or electrolytes in the three groups. These findings demonstrate that NS clay is apparently safe and practical for the protection of humans against aflatoxins in populations at high risk for aflatoxicosis.

Determinants of the variability of aflatoxin-albumin adduct levels in Ghanaians.

Hepatocellular carcinoma (HCC) is a multifactorial disease with various host and environmental factors involved in its etiology. Of these, aflatoxin exposure has been established as an important risk factor in the development of HCC; the presence of aflatoxin-albumin (AA) adducts in the blood serves as a valuable biomarker of human exposure. In this study, the relationship between a variety of different HCC host factors and the incidence of AA adduct levels was examined in a Ghanaian population at high risk for HCC. These factors included age, gender, hepatitis virus B (HVB) and hepatitis C virus (HCV) status, and genetic polymorphisms in both microsomal epoxide hydrolase (mEH) and glutathione S-transferases (GSTs). Blood samples were analyzed for AA adducts and HBV and HCV status. GSTM1 and GSTT1 deletion polymorphisms and mEH exon 3 and exon 4 single-nucleotide polymorphisms (SNPs) were determined from urine samples. In univariate analysis, age, HBV and HVC status, and GSTT1 and mEH exon 3 genotypes were not associated with AA adduct levels. However, mean adduct levels were significantly higher in both females and individuals typed heterozygous for mEH exon 4 (vs. wild types). Stratification analysis also showed that gender along with mEH exon 4 genotype and HBV status had a significant effect on adduct levels. Both females typed HBsAg+ and males with mEH exon 4 heterozygote genotypes showed significantly higher adduct levels as compared to the HBsAg- and wild types, respectively. Understanding the relationships between these host factors and the variability in aflatoxin-adduct levels may help in identifying susceptible populations in developing countries and for targeting specific public health interventions for the prevention of aflatoxicoses in populations with HCC and chronic liver diseases.

Noninvasive identification of interindividual variation in xenobiotic-metabolizing enzymes: implications for cancer epidemiology and biomarker studies.

In this study, DNA extracted from frozen urine was used in the analysis of polymorphisms in genes coding for xenobiotic-metabolizing enzymes (XMEs). These included single-nucleotide polymorphisms (SNP) in microsomal epoxide hydrolase (mEH), that is, substitutions of tyrosine by histidine in codon 113 (Y113H) and histidine by arginine in codon 139 (H139R), and deletion polymorphisms in glutathione S-transferase (GST) M1 and T1 genes. The concentration of DNA extracted from urine of a Ghanaian population (n = 91) exposed to aflatoxins in their diet ranged from 82.5 to 573 ng/ml urine. Polymerase chain reaction (PCR) restriction fragment length polymorphism (RFLP) procedures were used for the characterization of mEH polymorphisms, whereas a multiplex PCR method was utilized to identify GST deletion polymorphisms. In total, 91% and 94% of 91 samples were genotyped for mEH exon 3 and exon 4 polymorphisms, respectively. In the multiplex analysis of GST polymorphisms, 94% and 91% of 91 individuals were genotyped for GSTM1 and GSTT1 polymorphisms, respectively. The polymorphisms in the mEH exon 4, GSTM1 and GSTT1, were not in Hardy-Weinberg equilibrium (HWE) except for mEH exon 3. Representative genotypes identified by PCR-RFLP were cloned and sequenced, then confirmed by comparison with reference sequences of human DNA published in the GenBank BLAST database. These results demonstrate that XMEs can be genotyped from urine with reliable accuracy and may be useful in cancer and molecular epidemiology studies.