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Introduction: Voluntary medical male circumcision (VMMC) remains an effective biomedical intervention for HIV prevention in high HIV prevalence countries. In South Africa, United States Agency for International Development VMMC partners provide technical assistance to the Department of Health, at national and provincial levels in support of the establishment of VMMC sites as well as in providing direct VMMC services at site level since April 2012. We describe the outcomes of the Right to Care (RTC) VMMC program implemented in South Africa from 2012 to 2017. Methods: This retrospective study was undertaken at RTC supported facilities across six provinces. Young males aged ≥10 years who presented at these facilities from 1 July 2012 to 31 September 2017 were included. Outcomes were VMMC uptake, HIV testing uptake and rate of adverse events (AEs). Using a de-identified observational database of these clients, summary statistics of the demographic characteristics and outcomes were calculated. Results: There were a total 1,001,226 attendees of which 998,213 (99.7%) were offered VMMC and had a median age of 15 years (IQR = 12–23 years). Of those offered VMMC, 99.6% (994,293) consented, 96.7% (965,370) were circumcised and the majority (46.3%) were from Gauteng province. HIV testing uptake was 71% with a refusal rate of 15%. Of the newly diagnosed HIV positives, 64% (6,371 / 9,972) referrals were made. The rate of AEs, defined as bleeding, infection, and insufficient skin removal) declined from 3.26% in 2012 to 1.17% in 2017. There was a reduction in infection-related AEs from 2,448 of the 2,602 adverse events (94.08%) in 2012 to 129 of the 2,069 adverse events (6.23%) in 2017. Conclusion: There was a high VMMC uptake with a decline in AEs over time. Adolescent men contributed the most to the circumcised population, an indication that the young population accesses medical circumcision more. VMMC programs need to implement innovative demand creation strategies to encourage older males (20–34 years) at higher risk of HIV acquisition to get circumcised for immediate impact in reduction of HIV incidence. HIV prevalence in the total population increased with increasing age, notably in clients above 25 years. [ABSTRACT FROM AUTHOR]

Three clinical trials have demonstrated the partial efficacy (40–60%) of surgically conducted medical male circumcision (MMC) in preventing HIV transmission to circumcised men. This research formed part of a larger study exploring the importance of integration of sexual and reproductive health with HIV services. The objective was to elicit key informant views on the introduction of MMC for HIV prevention in South Africa. Twenty-one key informants representing the South African Health Department, local and international NGOs and universities, were asked, via semi-structured interviews about their views on introducing MMC as an HIV prevention strategy in South Africa. Interviews were transcribed and all discussions on MMC were coded for analysis using NVivo 8. The majority of the key informants were knowledgeable about MMC for HIV prevention and felt that making MMC available in South Africa was a good idea, with some recommending immediate introduction. Others felt that MMC should be introduced with caution. Various factors were recommended for consideration, including culture, the impact of circumcision on women, possible increase in sexual risk behaviour from behavioural disinhibition and that MMC may become another vertical health service programme. Most felt that MMC should be undertaken in neonates, however, acknowledged concerns about cultural responses to this. Recommendations on the implementation of MMC ranged from integrating services at primary health care level, to provision by private medical practitioners. In conclusion, MMC is viewed as a key HIV prevention strategy. However, there are numerous factors which could hinder introduction and uptake in South Africa and in the region. It is important to explore and understand these factors and for these to be aligned in the national MMC policy. [ABSTRACT FROM PUBLISHER]

The objective of this study was to assess home-based care (HBC) kits and programs in South Africa to evaluate the feasibility of scaling up kit production and distribution. South African HBC organizations received structured questionnaires; key informant interviews and a literature review were completed to assess systems for production, distribution and supply of HBC kits. Meetings with stakeholders were held in two Provinces to share and analyze the study findings. The study team distributed questionnaires to 466 organizations and conducted interviews with representatives from 45 organizations, the Provincial Department of Health (DoH) and manufacturers of kits. All identifiable HBC organizations in South Africa were included in the survey. As a result 215 HBC organizations returned questionnaires; including non-governmental organizations (56%), community-based organizations (32%) and organizations affiliated with government health departments. Two types of kits were available: a home kit and a professional kit. The demand for HBC kits exceeded availability, kit contents and availability varied considerably and the supply chain was irregular. Kit production and distribution systems were fragmented. Replenishment of kit items was problematic. End-users are mostly caregivers who have not received adequate training on their use. The study shows that substantial work has been done by HBC organizations in South Africa to respond to the need for palliative care supplies within resource constraints. The growing demand for kits exceeds the supply. There is a need to improve the supply chain management of HBC kits, strengthen referral systems and links between community-based organizations and government departments, expand training opportunities for care givers, and develop monitoring and evaluation systems. [ABSTRACT FROM AUTHOR]

Background Since the study by Dean, almost 40 years ago, there has been no systematic South African study on the prevalence of multiple sclerosis (MS) using the modern diagnostic criteria. KwaZulu-Natal (KZN), one of the nine provinces in South Africa, is home to 9.9 million people belonging to all racial groups. Aim To determine the period prevalence of MS in KZN in the different racial groups, using the revised McDonald's criteria. Methods The charts of all KZN patients given the diagnosis of MS were reviewed to confirm the diagnosis. All patients were contacted telephonically over a period of one month (July 2005) to determine whether they were still alive and still resident in KZN. Clinical, laboratory and treatment data were also extracted from the charts. Results The crude period prevalence per 100 000 for whites was 25.63, for Indians 7.59, people of mixed ancestry 1.94 and for blacks 0.22. The corresponding age standardized prevalence per 100 000 were 25.64, 7.15, 1.72 and 0.23, respectively. The clinical features were similar to that seen in the Western world. Up to half of the 167 patients had significant motor disability and optic neuritis was seen in 43/167 (25.7%) of patients. Whilst all traceable MRI brain scans showed some abnormality, 96/139 (69.1%) met three of the four McDonald's MRI criteria. CSF oligoclonal bands were present in 102 of 124 (82.3%) samples tested. Conclusion MS in KZN is more frequent than previously believed and occurs in all racial groups being most frequent in whites followed by Indians. MS, although rare, does occur in blacks. The increased prevalence figures may reflect better case ascertainment and use of modern diagnostic techniques. However, an absolute increase in numbers cannot be excluded. [ABSTRACT FROM AUTHOR]

Background: In 2013, a pregnancy exposure registry and birth defects surveillance (PER/BDS) system was initiated in eThekwini District, KwaZulu-Natal (KZN), to assess the impact of antiretroviral treatment (ART) on birth outcomes. Objectives: At the end of the first year, we assessed the risk of major congenital malformations (CM) and other adverse birth outcomes (ABOs) detected at birth, in children born to women exposed to ART during pregnancy. Method: Data were collected from women who delivered at Prince Mshiyeni Memorial Hospital, Durban, from 07 October 2013 to 06 October 2014, using medicine exposure histories and birth outcomes from maternal interviews, clinical records and neonatal surface examination. Singleton births exposed to only one ART regimen were included in bivariable analysis for CM risk and multivariate risk analysis for ABO risk. Results: Data were collected from 10 417 women with 10 517 birth outcomes (4013 [38.5%] HIV-infected). Congenital malformations rates in births exposed to Efavirenz during the first trimester (T1) (RR 0.87 [95% CI 0.12–6.4; p = 0.895]) were similar to births not exposed to ART during T1. However, T1 exposure to Nevirapine was associated with the increased risk of CM (RR 9.28 [95% CI 2.3–37.9; p = 0.002]) when compared to the same group. Other ABOs were more frequent in the combination of HIV/ART-exposed births compared to HIV-unexposed births (29.9% vs. 26.0%, adjusted RR 1.23 [1.14–1.31; p < 0.001]). Conclusion: No association between T1 use of EFV-based ART regimens and CM was observed. Associations between T1 NVP-based ART regimen and CM need further investigation. HIV- and ART-exposed infants had more ABOs compared to HIV-unexposed infants. [ABSTRACT FROM AUTHOR]

HIV care and antiretroviral treatment (ART) provision is largely hospital-based with an over-reliance on doctors. Existing ART sites are reaching capacity and are increasingly unable to initiate new patients and also see follow up patients. In response, the Reproductive Health and HIV Research Unit (RHRU), has supported the KwaZulu-Natal provincial Department of Health with developing a model to decentralise services to primary health care (PHC) level. The programme has been in operation since 2006, and currently nine ART initiation sites down refer stable patients to 24 PHC clinics. Data on patient numbers, treatment outcomes and patient retention rates were collected through a file audit of 2071 adult patient files and analyzed. Results indicate that a file audit is a feasible mechanism to provide this data and can be used to identify gaps and improve quality of care. PHC sites in resource-constrained settings are able to manage stable patients on ART; however, sites need support with monitoring and evaluation and with tracking patients that have been down referred. In terms of quality of care, PHC sites need to ensure that clients receive CD4 count tests and viral load monitoring at six monthly intervals to ensure that treatment failure does not go undetected. Patients suspected of experiencing adverse events or treatment failure appear to be managed according to standard operating procedures, but there is a need to ensure that adverse events are clearly documented in patient files.

Background: Prevention and early treatment of sexually transmitted infections (STIs) is a high public health priority in South Africa. In 2002 a national survey of public health care (PHC) facilities was conducted to develop measurable indicators for monitoring and evaluation of the National STI programme. In this paper we present maps of key indicators obtained from the survey, and discuss their programmatic implications. We also address some methodological issues that arise in the context of producing appropriate maps., Methods: A national sample, stratified by subdistrict/municipality, of 962 PHC facilities was randomly selected. In each facility the senior nurse was telephonically contacted and interviewed to answer questions related to the implementation of STI prevention and management from a structured questionnaire. Responses were validated through a second phone call, and inconsistencies recorded. The following key variables were mapped: stock-outs of drugs and condoms, knowledge of correct treatment procedures, consistent record keeping, number of STI clients seen per month per 1000 adult population, number of condoms distributed per adult male, and number of trained nurses per 1000 population. Using conditional autoregressive models and Markov Chain Monte Carlo (MCMC) simulation, smoothed subdistrict level clinic responses were computed and 95% confidence limits estimated., Results and Discussion: Drug stock-outs were reported by 13% [95% CI 10-15%] and condom stock-outs were reported by 4% [95% CI 2-5%] of facilities. Underlying geographical patterns of risk were more clearly observed when maps had been smoothed and were not dominated by sampling error. Smoothed maps show that there is a finite, low risk of drug stock-outs in all areas with higher risk regions more clearly identified. The maps of indicators of STI services at PHC facilities show that there are important differences in quality of service within South Africa and underscore the usefulness of facility level routine data both for local programme monitoring and planning and for providing a national "bird's eye view" of programme performance.

Background: The current study evaluated the reactogenicity and immunogenicity of Typherix, a recently developed Vi polysaccharide typhoid vaccine, in adolescents., Methods: This phase II, open, single-group study was conducted at a single centre in South Africa. Healthy adolescents, aged between 11 and 18 years received a single 0.5ml dose of typhoid Vi polysaccharide vaccine 25 microg via intramuscular injection in the left deltoid. Safety and reactogenicity were assessed from solicited and unsolicited symptoms and signs reported during the 5-day and 28-day postvaccination follow-up periods. Seroconversion rates were calculated at 28 days after vaccination., Results: A total of 100 adolescents received the vaccine. Seropositivity to Vi antigen was measured in 95 subjects and showed a rate of 98.9% [geometric mean titre (GMT) of 1966 enzyme-linked immunosorbent assay (ELISA) units/ml] at day 28. Of 99 subjects included in the reactogenicity analysis, 46.5% reported clinical symptoms, 40.4% general symptoms, and 18.2% local symptoms or signs. Solicited symptoms were reported in 46.5% of subjects. Local solicited symptoms involved mainly soreness. General solicited symptoms were most frequently headache (19% of subjects) and general aches (13%). All solicited symptoms were mild or moderate except for two reports of fever >39 degrees C. Unsolicited symptoms (all moderate) were recorded in 8.1% of subjects, and were most frequently of an upper respiratory tract nature and viral-like syndrome. No serious adverse events were reported., Conclusions: The typhoid Vi polysaccharide vaccine Typherix proved to be well tolerated and immunogenic when administered to adolescents.

Objectives: To investigate the safety of live attenuated varicella vaccine (Oka strain) and the optimal virus titre/dose required for immunogenicity in healthy South African children., Design: Double-blind randomised clinical study using two different lots of varicella vaccine, each at two different titres. Subjects were randomly allocated to groups 1, 2, 3 and 4 to receive vaccine containing a mean virus titre of 10(4,5), 10(3,1), 10(3,9) and 10(2,7) PFUs per dose respectively. Clinical signs and symptoms were followed up for 42 days post-vaccination. Specific varicella antibodies were measured by an indirect immunofluorescence method in sera obtained on day 0 and day 42., Setting: City Health Clinic, Chatsworth, Durban., Participants: A total of 200 healthy 9-24-month-old children were vaccinated, of whom 189 (44,5%) completed the study., Main Outcome Measures: Pre- and post-vaccination varicella antibody levels. Adverse events following varicella vaccination., Results: The vaccine was safe and well tolerated. No local symptoms were reported. Skin reactions were specifically solicited in this study: 21 reactions were reported in 8.5% (17/200) of children. Vesicles were reported in 2 vaccines (< or = 10 vesicles in both cases). One serious adverse event was reported: hospitalisation for bronchopneumonia on day 16 post-vaccination which resolved without sequelae. Around day 42 post-vaccination (range 35-63 days) all the 176 initially seronegative subjects had seroconverted for varicella antibodies. Post-vaccination geometric mean titres (GMTs) were 104.1, 66.2, 69.5 and 77.0 for groups 1-4 respectively. Six subjects who were initially seropositive maintained or increased their titres post-vaccination; 3 of the 6 showed a booster response (a > or = 4-fold increase from the pre-vaccination titre)., Conclusions: Varicella vaccine was found to be safe, immunogenic and well tolerated. No difference in seroconversion rates or GMTs, either between groups receiving the two vaccine lots or between groups receiving the different titres of each lot, was shown.

The whole-cell pertussis vaccine currently used in South Africa has not been adequately evaluated for post-vaccination events and immunogenicity. A trial of this vaccine combined with diphtheria and tetanus toxoids (DTP) was undertaken in 115 black babies who received primary vaccination at 2, 4 and 6 months of age. Serological IgG responses to the major antigens of Bordetella pertussis, filamentous haemagglutinin (FHA), pertussis toxin (PT) and fimbriae (agglutinogens 2 and 3 (AGG 2 + 3), were evaluated by enzyme-linked immunosorbent assay in sera obtained at birth, and before vaccination at 2, 4 and 6 months and at 9 months. Surprisingly, after 3 doses of DTP, responses to PT and FHA were found merely to restore levels of IgG to PT and FHA to those found in cord blood. In contrast with the positive increases in these antibodies found in other series of whole-cell vaccination, the anti-PT seroconversion rate was only 19% and the anti-FHA rate only 24%. High levels of anti-AGG 2 + 3 were produced with 67.2% seroconversion. The frequency and nature of post-vaccination events were recorded. Incidences of all reactions to the vaccine were low (7.6%). Fever (3.2%) and excessive crying (2.4%) were the most frequently occurring minor events. The rate of neurological post-vaccination events (without sequelae) during the brief follow-up period was 2 hypotonic-hyporesponsive episodes (8.03/1,000 doses) and 1 convulsion (4.02/1,000 doses). Significant pertussis antibody levels were found in maternal and cord sera with levels in the latter frequently being higher.(ABSTRACT TRUNCATED AT 250 WORDS)