John Tumbo

Co-administration study in South African infants of a live-attenuated oral human rotavirus vaccine (RIX4414) and poliovirus vaccines.

A double-blind, placebo-controlled phase II trial (e-Track 444563-014/NCT00346892) was conducted in South Africa to evaluate the co-administration of RIX4414 (live-attenuated human G1P[8] rotavirus vaccine) and oral poliovirus vaccine (OPV) administered simultaneously. Healthy infants (n=450) were randomized into three groups (RIX4414+OPV, RIX4414+IPV or Placebo+OPV) to receive two oral doses of RIX4414/placebo with OPV or IPV using two vaccination schedules (6-10 weeks and 10-14 weeks). Serum anti-rotavirus IgA antibodies (ELISA) and neutralizing antibodies (micro-neutralization assay) to poliovirus serotypes 1, 2 and 3 were measured. Co-administration of RIX4414 with OPV did not result in a decrease in the high sero-protection rates against poliovirus serotypes 1, 2 and 3 detected after the third OPV dose (98-100%). The anti-rotavirus IgA antibody sero-conversion rates were higher for the 10-14 weeks schedule (55-61%) compared to the 6-10 weeks schedule (36-43%). Solicited symptoms were reported at similar rates between RIX4414 and placebo groups and no serious adverse events related to RIX4414 were reported. This study provided evidence that RIX4414 can be co-administered with routine EPI immunizations including OPV and that two doses of RIX4414 were well tolerated and immunogenic in South African infants.

Safety, Reactogenicity, and Immunogenicity of Human Rotavirus Vaccine RIX4414 in Human Immunodeficiency Virus-positive Infants in South Africa.

Background: Rotavirus and human immunodeficiency virus (HIV) infections are a cause of great public health concern in developing countries. The current study evaluated the safety, reactogenicity, and immunogenicity of RIX4414 vaccine in asymptomatic or mildly symptomatic (clinical stages I and II according to WHO classification) HIV-infected South African infants. Methods: A total of 100 HIV-positive infants aged 6 to 10 weeks enrolled in this double-blind, 1:1 randomized, placebo-controlled study were allocated into 2 groups to receive 3 doses of RIX4414 vaccine/placebo according to a 0-, 1-, and 2-month schedule. Routine vaccines were concomitantly administered. Solicited and unsolicited symptoms were recorded for 15 and 31 days after each dose, respectively. Serious adverse events were recorded throughout the study period. Serum antirotavirus IgA concentrations (enzyme-linked immunosorbent assay, cut-off ≥20 U/mL) and the immunodeficiency status were determined at screening and 2 months post-Dose 3. Stool samples were analyzed for rotavirus using enzyme-linked immunosorbent assay at predetermined points and during diarrhea episodes. Results: All symptoms (solicited and unsolicited) occurred at a similar frequency in both groups. Six fatal serious adverse events in RIX4414 and 9 in placebo groups were reported. At 2 months post-Dose 3, the seroconversion rates were 57.1% (95% CI: 34–78.2) in RIX4414 and 18.2% (95% CI: 5.2–40.3) in the placebo group. The mean absolute CD4+ cell count, CD4+ percentage, and HIV-1 viral load were comparable in both groups at screening and 2 months post-Dose 3. Rotavirus shedding peaked at Day 7 after Dose 1 of RIX4414 with prolonged shedding was observed in 1 infant only. Conclusions: Three doses of RIX4414 vaccine was tolerated well by the South African HIV-positive infants. A satisfactory immune response was mounted without aggravating their immunologic or HIV condition.

A Review of Rotavirus Infection in and Vaccination of Human Immunodeficiency Virus–Infected Children

Diarrhea caused by infection with rotavirus annually results in an estimated 611,000 deaths among infants and young children <5 years of age worldwide, and these deaths primarily occur in developing countries. Infection with human immunodeficiency virus (HIV) is also common among young children in many developing countries, particularly in sub-Saharan Africa and Asia. The need for a vaccine to reduce the number of deaths caused by rotavirus infection among children in developing countries is substantial, but current rotavirus vaccines comprise live attenuated oral viruses, the behaviors of which are unknown in HIV-infected children. Therefore, we reviewed available data on natural rotavirus infection in HIV-infected children and examined unpublished data on a small group of HIV-infected infants in South Africa who were given a live rotavirus vaccine. Together, these data suggest that vaccination programs against rotavirus infection could include HIV-infected populations. However, studies addressing the safety, reactogenicity, and immunogenicity of rotavirus vaccines in an HIV-infected population are urgently needed.

Comparison of 2 Different Regimens for Reactogenicity, Safety, and Immunogenicity of the Live Attenuated Oral Rotavirus Vaccine RIX4414 Coadministered with Oral Polio Vaccine in South African Infants

BACKGROUND A phase II, randomized, double-blind, placebo-controlled study was conducted in South Africa during 2003-2004 to evaluate the safety, reactogenicity, and immunogenicity of 2 regimens of the live attenuated oral human rotavirus vaccine RIX4414 when coadministered with the Expanded Program on Immunization childhood vaccines, including oral polio vaccine. METHODS Healthy infants were randomized (2:2:1) to receive either 2 doses of RIX4414 (n = 190; at 10 and 14 weeks, with placebo at 6 weeks), 3 doses of RIX4414 (n = 189; at 6, 10, and 14 weeks), or 3 doses of placebo (n = 96), all with concomitant routine vaccinations. The antirotavirus IgA seroconversion rate was assessed using enzyme-linked immunosorbent assay at 2 months after the last dose of RIX4414 or placebo. Antipolio types 1, 2, and 3 antibodies were measured using a virus neutralization assay. Solicited symptoms were recorded for 15 days after each dose. RESULTS The antirotavirus IgA seroconversion rates were similar in the RIX4414 2- and 3-dose groups (44.3% and 44.4%, respectively; P = .544, by 1-sided Fisher exact test) and antirotavirus IgA geometric mean concentrations were also comparable. Seroprotection rates for antipolio types 1, 2, and 3 antibodies were high (93%-100%) and were not significantly different among groups. Solicited symptoms reported within 15 days after vaccination were similar in all groups. CONCLUSIONS The immune seroconversion response to the RIX4414 vaccine with 3 doses was not superior to the 2-dose regimen. There was no interference by either regimen with antibody response to oral polio vaccine, and RIX4414 was well tolerated when given with routine vaccinations.

Rural-origin health science students at South African universities

BACKGROUND Rural areas in all countries suffer from a shortage of health care professionals. In South Africa, the shortage is particularly marked; some rural areas have a doctor-to-population ratio of 5.5:100 000. Similar patterns apply to other health professionals. Increasing the proportion of rural-origin students in faculties of health sciences has been shown to be one way of addressing such shortages, as the students are more likely to work in rural areas after graduating. OBJECTIVE To determine the proportion of rural-origin students at all medical schools in South Africa. DESIGN A retrospective descriptive study was conducted in 2003. Lists of undergraduate students admitted from 1999 to 2002 for medicine, dentistry, physiotherapy and occupational therapy were obtained from 9 health science faculties. Origins of students were classified as city, town and rural by means of postal codes. The proportion of rural-origin students was determined and compared with the percentage of rural people in South Africa (46.3%). RESULTS . Of the 7 358 students, 4 341 (59%) were from cities, 1 107 (15%) from towns and 1 910 (26%) from rural areas. The proportion of rural-origin students in the different courses nationally were: medicine--27.4%, physiotherapy--22.4%, occupational therapy--26.7%, and dentistry--24.8%. CONCLUSION The proportion of rural-origin students in South Africa was considerably lower than the national rural population ratio. Strategies are needed to increase the number of rural-origin students in universities via preferential admission to alleviate the shortage of health professionals in rural areas.

Prospective hospital-based surveillance to estimate rotavirus disease burden in the Gauteng and North West Province of South Africa during 2003–2005

BACKGROUND Rotavirus is considered to be the most common cause of serious acute dehydrating diarrhea worldwide. However, there is a scarcity of information on rotavirus disease burden in sub-Saharan Africa. METHODS We conducted prospective, hospital-based surveillance for rotavirus diarrhea among children <5 years of age at the tertiary care Dr. George Mukhari Hospital (DGM) and at the Brits district Hospital (BH) in the Gauteng and North West Provinces in South Africa; we estimated that up to 80% of children <5 years of age in their catchment areas who are hospitalized for diarrhea are admitted to one of these hospitals. RESULTS At DGM, 2553 children <5 years of age were admitted for diarrhea from January 2003 through December 2005, and 852 children <5 years of age were treated for diarrhea at BH during 2004-2005. We examined stool specimens from 450 children (53%) at BH and from 1870 children (73%) admitted to DGM. An estimated 22.8% (95% confidence interval [CI], 21.2%-24.5%) of the children hospitalized with diarrhea at DGM were rotavirus positive, and the corresponding figure at BH was 18.2% (95% CI, 14.9%-22.1%). Among children <5 years of age admitted to DGM for any reason, an estimated 5.5% (95% CI, 5.1%-6.0%) had rotavirus diarrhea. Our incidence estimates suggest that 1 in 43-62 children in the area is likely to be hospitalized with rotavirus diarrhea by 2 years of age. CONCLUSIONS Prevention of serious rotavirus illness by vaccination will substantially reduce not only the disease burden among young children but also the case load in South African health care facilities.

Key issues in clinic functioning - a case study of two clinics

OBJECTIVE The aim of this research was to understand key issues in the functioning of two different primary care clinics serving the same community, in order to learn more about clinic management. DESIGN An in-depth case study was conducted. A range of qualitative information was collected at both clinics. Data collected in the two clinics were compared, to gain an understanding of the important issues. SETTING Data were collected in a government and an NGO clinic in North West province. SUBJECTS This report presents the findings from patient and staff satisfaction surveys and in-depth individual interviews with senior staff. RESULTS Key findings included the following: (i) there are attitudinal differences between the staff at the two clinics; (ii) the patients appreciate the services of both clinics, though they view them differently; (iii) clinic A provides a wider range of services to more people more often; (iv) clinic B presents a picture of quality of care, related to the environment and approach of staff; (v) waiting time is not as important as how patients are treated; (vi) medications are a crucial factor, in the minds of staff and patients; and (vii) a supportive, empowering organisational culture is needed to encourage staff to deliver better care to their patients. The management of the clinic is part of this culture. CONCLUSIONS This research provides lessons regarding key issues in clinic functioning which can make a major difference to the way services are experienced. A respectful and caring approach to patients, and an organisational culture which supports and enables staff, can achieve much of this without any additional resources.

Complications of traditional circumcision amongst young Xhosa males seen at St Lucy’s Hospital, Tsolo, Eastern Cape, South Africa

Abstract Background Traditional circumcision of males is common amongst many societies in sub-Saharan Africa. Circumcision amongst the Xhosa people of South Africa represents a rite of passage to manhood. Traditional male circumcision has an increased risk for complications that include sepsis, genital mutilation, gangrenous penis, excessive bleeding, dehydration, renal failure and death. The aim of this study was to describe the complications of traditional circumcisions amongst Xhosa men as seen at St. Lucys Hospital in the Eastern Cape Province. Method A cross-sectional descriptive quantitative study was conducted in 2008. Records of 105 males admitted to St. Lucys Hospital with complications following traditional circumcision were reviewed. Data collected included age, education level, race, reasons for circumcision, complications, the period of circumcision, duration of hospital stay and the outcomes. Descriptive data analysis was performed using statistical software SPSS 17.0. Results The ages ranged from 15–35 years with 68 (64.8%) between 15–19 years. 83 (79%) had a secondary level of education, 16 (15.2%) primary, 5 (4.8%) tertiary and 1% had no education. 60 (57%) were circumcised as initiation to manhood, 21 (20.0%) due to peer pressure, 20 (19.0%) for cultural reasons, and 1 (1.0%) was forced. The complications were sepsis (59 [56.2%]), genital mutilation (28 [26.7%]), dehydration (12 [11.4%]) and amputation of genitalia (6 [5.7%]).Fifty-nine (56.2%) patients were circumcised in winter. 79 (75.2%) were circumcised in the forest, and 25 (23.8%) in initiation centres. Fifty-eight (55.2%) were circumcised by traditionalists, and 47 (44.8%) by tribal elders (initiators). Hospital stays ranged from 8 to 28 days. 66% were healed and discharged, and 29 (27.6%) were referred to higher centres of care. Conclusion Genital sepsis was the most common complication of traditional male circumcision. Complications were related to the circumciser, advanced age of the patient and place of circumcision. There is need for training of the traditional circumcisers on safe techniques and use of hygienic practices in order to reduce the complications identified in this study.

Factors that influence contraceptive use amongst women in Vanga health district, Democratic Republic of Congo

Abstract Background Contraception is often necessary in order to plan for children and without it there is a risk of unplanned pregnancies. In the Democratic Republic of Congo, this often results in abortions by untrained persons with resultant morbidity and mortality. Aim To investigate the factors that influence contraceptive use amongst women of childbearing age in the Vanga health zone. Methods Cross-sectional survey using interviewer-administered questionnaires. Results Of the 384 women recruited, a majority (46.1%) were in the 31–40 year age group; 52% had reached primary school and 88% did not have formal employment. One hundred and forty of the participants reported current use of contraception, with 60% of them using modern methods of contraception; 36.1% of them had begun using contraception before the age of 20; and the most common methods were oral contraceptive pills and injection, each accounting for 22.9%. There was variation in the duration of contraceptive use and the main reason for using contraception was to space children. Of the participants, 20.7% had been using contraception for more than two years. Seventy-seven (31.5%) of the women reported they did not use contraception because of a fear of side effects. Forty-four (18%) reported that they are unable to afford contraception, 38 (15.6%) had husbands who disapproved of contraceptive usage, 26 (10.6%) had a fear of infertility, 18 (7.4%) practised a religion that did not allow them to use contraception and 12 of the women (4.9%) did not use contraception because it was unavailable to them. Conclusion Barriers to contraception in our study were fears of side effects and infertility, cost, male partners objection, unavailability of contraception and religious beliefs.

Factors associated with pulmonary tuberculosis outcomes among inmates in Potchefstroom Prison in North West province

Tuberculosis is the leading cause of death among the world’s prison populations. Prisons are reservoirs of tuberculosis and threaten inmates, prison staff, visitors and the surrounding community. This study was carried out to explore the associated factors with pulmonary tuberculosis treatment outcomes at Potchefstroom Prison. A retrospective record review of 202 inmates with tuberculosis, whose treatment outcomes as of March 2010 were known, was conducted. Data on sex; racial group; level of education; weight; smoking habits; existence and type of co-morbidity, diagnostic classification; treatment regimen, initiation date, completion date and outcome; use of directly observed treatment; allergy and hospitalisation were captured. The majority of the inmates (142, 70.3%) were aged 21-37 years, while 48 (23.8%) were aged 38-53 years. There were 198 (98%) male and 4 (2%) female inmates. Fifty-five inmates (27.3%) had attained Grade 6 and lower, 71 (35.1%) grade 7-9, 68 (33.7%) Grade 10-12, and 8 (3.9%) above grade 12. One hundred and fifty-eight (78.2%) received occasional visitors. There were 121 (59.9%) smokers. The adverse outcomes for tuberculosis were significantly increased by an age < 37 years, human immunodeficiency virus co-infection, smoking, a lack of support and an absence of directly observed treatment. Inmates who received fewer visits and less social support must be supported by community volunteers, counsellors and psychologists in order to motivate them and enhance favourable treatment outcomes. Smokers need to stop smoking. Younger inmates require peer support groups.