Voluntary medical male circumcision for HIV prevention among adolescents in Kenya: Unintended consequences of pursuing service-delivery targets.

INTRODUCTION: Voluntary medical male circumcision (VMMC) provides significant reductions in the risk of female-to-male HIV transmission. Since 2007, VMMC has been a key component of the United States President's Emergency Plan for AIDS Relief's (PEPFAR) strategy to mitigate the HIV epidemic in countries with high HIV prevalence and low circumcision rates. To ensure intended effects, PEPFAR sets ambitious annual circumcision targets and provides funding to implementation partners to deliver local VMMC services. In Kenya to date, 1.9 million males have been circumcised; in 2017, 60% of circumcisions were among 10-14-year-olds. We conducted a qualitative field study to learn more about VMMC program implementation in Kenya. METHODS AND RESULTS: The study setting was a region in Kenya with high HIV prevalence and low male circumcision rates. From March 2017 through April 2018, we carried out in-depth interviews with 29 VMMC stakeholders, including "mobilizers", HIV counselors, clinical providers, schoolteachers, and policy professionals. Additionally, we undertook observation sessions at 14 VMMC clinics while services were provided and observed mobilization activities at 13 community venues including, two schools, four public marketplaces, two fishing villages, and five inland villages. Analysis of interview transcripts and observation field notes revealed multiple unintended consequences linked to the pursuit of targets. Ebbs and flows in the availability of school-age youths together with the drive to meet targets may result in increased burdens on clinics, long waits for care, potentially misleading mobilization practices, and deviations from the standard of care. CONCLUSION: Our findings indicate shortcomings in the quality of procedures in VMMC programs in a low-resource setting, and more importantly, that the pursuit of ambitious public health targets may lead to compromised service delivery and protocol adherence. There is a need to develop improved or alternative systems to balance the goal of increasing service uptake with the responsible conduct of VMMC.

Patient Characteristics Associated With Voluntary Safety Event Reporting in the Acute Care Setting.

OBJECTIVES: Adverse events are increasingly important to health care delivery and financial reimbursement. Most hospitals use voluntary event reporting (VER) systems to detect safety events, which may be vulnerable to individual and systemic biases. We tested the hypothesis that patient demographic factors such as weight status and race would be associated with safety event reporting in the acute care setting. METHODS: We reviewed all acute care encounters for patients 2 to 17 years of age and corresponding safety events entered in the VER system of a tertiary-care children's hospital from February 2015 to February 2016. Data collected included patient demographics, clinical characteristics, incident description, and reported harm score. Our primary outcome was any report of a safety event. Using χ2 and multivariable logistical regression methods, we determined patient characteristics associated with safety event reporting. RESULTS: A total of 22 056 patient encounters were identified, and 341 (1.5%) of those had a reported safety event. In univariate analysis, age, weight category, and race were found to be significantly associated with event reporting, whereas sex and insurance provider were not. In the multivariable logistic regression model, obesity (odds ratio [OR] 0.69; 95% confidence interval [CI] 0.49-0.97) and African American race (OR 0.65; 95% CI 0.46-0.93) were negatively associated with event reporting, whereas length of stay was positively associated (OR 1.51; 95% CI 1.46-1.55). CONCLUSIONS: We identified associations between patient demographic factors and voluntary safety event reporting in the acute care setting. In future studies, we will compare VER to event identification by more objective measures, such as a trigger tool.

Highly deficient alcohol health warning labels in a high-income country with a voluntary system.

INTRODUCTION AND AIMS: To examine the prevalence and design elements of the voluntary health warning labels and related industry initiatives on a purposive sample of alcoholic beverage containers sold in New Zealand (NZ), a country with no mandatory health warning labels. DESIGN AND METHODS: We selected a purposive (e.g. low-cost) sample of 59 local and imported beers, wines and ready-to-drink alcoholic beverage containers available in NZ in 2016-2017. We documented the occurrence, content, size, appearance and position of messages concerning drinking during pregnancy, drink-driving, other health effects and industry-led initiatives that could relate to warnings; and collected data about alcohol content, standard drinks, ingredients and energy information. RESULTS: A majority (80%) of the alcoholic beverage containers had a pregnancy-related warning, 73% had industry-led initiatives (e.g. advising 'responsible' consumption) and 19% had drink-driving/heavy machinery warnings. Warning labels were small, with the average area of pregnancy-related and drink-driving/heavy machinery pictograms being 45 and 36 mm2 , respectively (i.e. pea-size). The average heights of pregnancy-related and drink-driving text were 1.6 and 2.2 mm, respectively. Pregnancy-related pictograms occupied between an average of 0.13% (wine) and 0.21% (ready-to-drink) of the available surface area of the alcoholic beverage container (i.e. less than 1/400th of the available space). Drink-driving pictograms occupied an average of 0.12% (imported beer), and 0.13% (NZ beer) of the available surface area. DISCUSSION AND CONCLUSIONS: Voluntary recommendations in NZ appear to have been inadequate for producing health warnings on alcoholic beverage containers that are consistent with evidence-informed recommendations for effective labels. This finding suggests that mandatory standardised labelling outlining alcohol-related risks may be required to ensure adequate consumer information.

Student researchers' perceived prerequisites for voluntary research collaboration in the context of Flemish and Chinese universities.

While numerous papers have illuminated the worthiness of research collaboration, relatively few have addressed its prerequisites. In our study, seven prerequisites for research collaboration were extracted from the existing literature, and 460 student researchers were surveyed for their perceptions of the prerequisites' importance. Focusing on voluntary research collaborations rather than brokered ones, it was found that socially oriented prerequisites such as reciprocal interactions, accountability, trust, and equality are perceived of more importance than prerequisites of psychical proximity, networking channels, and funds and material supplies (substance- and entity-related prerequisites). With latent regression analyses, we also found that Chinese and older, more experienced researchers are inclined to stress the importance of equality. Researchers of different cohorts prioritise substance- and entity-related prerequisites disparately. Specifically, Chinese researchers emphasise the necessity of funds, while researchers from first-tier universities place more value on networking channels. Disciplinary differences for the prerequisite of proximity were also discovered. Based on these results, discussion and implications were referred. Further suggestions on research collaboration studies are rendered.

Classification and rates of adverse events in a Malawi male circumcision program: impact of quality improvement training.

BACKGROUND: Assessing safety outcomes is critical to inform optimal scale-up of voluntary medical male circumcision (VMMC) programs. Clinical trials demonstrated adverse event (AE) rates from 1.5 to 8 %, but we have limited data on AEs from VMMC programs. METHODS: A group problem-solving, quality improvement (QI) project involving retrospective chart audits, case-conference AE classification, and provider training was conducted at a VMMC clinic in Malawi. For each identified potential AE, the timing, assessment, treatment, and resolution was recorded, then a clinical team classified each event for type and severity. During group discussions, VMMC providers were queried regarding lessons learned and challenges in providing care. After baseline evaluation, clinicians and managers initiated a QI plan to improve AE assessment and management. A repeat audit 6 months later used similar methods to assess the proportions and severity of AEs after the QI intervention. RESULTS: Baseline audits of 3000 charts identified 418 possible AEs (13.9 %), including 152 (5.1 %) excluded after determination of provider misclassification. Of the 266 remaining AEs, the team concluded that 257 were procedure-related (8.6 AEs per 100 VMMC procedures), including 6 (0.2 %) classified as mild, 218 (7.3 %) moderate, and 33 (1.1 %) severe. Structural factors found to contribute to AE rates and misclassification included: provider management of post-operative inflammation was consistent with national guidelines for urethral discharge; available antibiotics were from the STI formulary; providers felt well-trained in surgical skills but insecure in post-operative assessment and care. After implementation of the QI plan, a repeat process evaluating 2540 cases identified 115 procedure-related AEs (4.5 AEs per 100 VMMC procedures), including 67 (2.6 %) classified as mild, 28 (1.1 %) moderate, and 20 (0.8 %) severe. Reports of AEs decreased by 48 % (from 8.6 to 4.5 per 100 VMMC procedures, p < 0.001). Reports of moderate-plus-severe (program-reportable) AEs decreased by 75 % (from 8.4 to 1.9 per 100 VMMC procedures, p < 0.001). CONCLUSIONS: AE rates from our VMMC program implementation site were within the range of clinical trial experiences. A group problem-solving QI intervention improved post-operative assessment, clinical management, and AE reporting. Our QI process significantly improved clinical outcomes and led to more accurate reporting of overall and program-reportable AEs.

Implementation of adolescent-friendly voluntary medical male circumcision using a school based recruitment program in rural KwaZulu-Natal, South Africa.

BACKGROUND: Epidemiological data from South Africa demonstrate that risk of human immunodeficiency virus (HIV) infection in males increases dramatically after adolescence. Targeting adolescent HIV-negative males may be an efficient and cost-effective means of maximising the established HIV prevention benefits of voluntary medical male circumcision (VMMC) in high HIV prevalence-, low circumcision practice-settings. This study assessed the feasibility of recruiting male high school students for VMMC in such a setting in rural KwaZulu-Natal. METHODS AND FINDINGS: Following community and key stakeholder consultations on the acceptability of VMMC recruitment through schools, information and awareness raising sessions were held in 42 high schools in Vulindlela. A three-phase VMMC demand-creation strategy was implemented in partnership with a local non-governmental organization, ZimnadiZonke, that involved: (i) community consultation and engagement; (ii) in-school VMMC awareness sessions and centralized HIV counselling and testing (HCT) service access; and (iii) peer recruitment and decentralized HCT service access. Transport was provided for volunteers to the Centre for the AIDS Programme of Research in South Africa (CAPRISA) clinic where the forceps-guided VMMC procedure was performed on consenting HIV-negative males. HIV infected volunteers were referred to further care either at the CAPRISA clinic or at public sector clinics. Between March 2011 and February 2013, a total of 5165 circumcisions were performed, the majority (71%) in males aged between 15 and 19 years. Demand-creation strategies were associated with an over five-fold increase in VMMC uptake from an average of 58 procedures/month in initial community engagement phases, to an average of 308 procedures/month on initiation of the peer recruitment-decentralized service phase. Post-operative adverse events were rare (1.2%), mostly minor and self-resolving. CONCLUSIONS: Optimizing a high volume, adolescent-targeted VMMC program was feasible, acceptable and safe in this setting. Adaptive demand-creation strategies are required to sustain high uptake.

Estudio de estabilidad de las concentraciones de cortisol, 25-hidroxivitamina D y corticotropina (ACTH) / Study of the stability of Cortisol, 25 OH vitamin D and adrenocorticotrophic hormone (ACTH) in plasma

Objetivo. Evaluar la estabilidad de las concentraciones de cortisol y 25-hidroxivitamina D (25OH-vit D) en suero y de corticotropina (ACTH) en plasma en función del tiempo de almacenamiento en las condiciones habituales de trabajo para estas muestras y comparar dos protocolos diferentes de centrifugación. Material y método. Se obtuvieron muestras de 25 voluntarios sanos (5 hombres y 20 mujeres) para el estudio de cortisol y 25OH-vit D. Para el estudio de ACTH se utilizaron muestras de 15 de estos voluntarios sanos. Las muestras se procesaron en el analizador Liaison® DiaSorin en tiempos comprendidos entre 90 minutos y 7 días desde la toma de la muestra hasta la obtención del resultado. Resultados. El cortisol y 25OH-vit D se mantuvieron estables a lo largo de todo el estudio en las condiciones especificadas. La ACTH se mantuvo estable hasta 8 horas a 4°C. En ninguna de las tres magnitudes se observaron diferencias significativas entre los resultados obtenidos en muestras centrifugadas tras su obtención o inmediatamente antes de su procesamiento hasta 6 horas después de la obtención de la muestra. Conclusiones. Las condiciones habituales de manejo de las muestras, 8 horas a temperatura ambiente con o sin centrifugación previa y posteriormente almacenadas a 4°C durante una semana, no comprometen la estabilidad en el caso de cortisol y 25OH-vit D. En el caso de ACTH es preciso congelar las muestras tras su obtención si no van a ser procesadas en un tiempo inferior a 8 horas (AU)

Objective. To asses the stability of cortisol, and 25 (OH)-Vitamin D concentrations in serum, and adrenocorticotrophic hormone (ACTH) in plasma samples, according to the storage time under normal working conditions for these samples, and to compare two different centrifugation protocols. Material and method. The samples were obtained from 25 healthy volunteers (5 men and 20 women) for the study of cortisol and 25 OH-vit D. For the ACTH only 15 of the 25 samples were used. The samples were processed in the Liaison® DiaSorin analyser at times between 90minutes and 7 days from the time the sample was taken until the result was obtained. Results. Cortisol and 25 OH-Vit D remained stable during the time of the study under the specified conditions. ACTH remained stable only until the 8th hour at 4° C. There were no significant differences in relation to the time of centrifugation. Conclusions. The regular management conditions of the samples, 8hours at room temperature with or without previous centrifugation and later storage at 4° C for a week does not jeopardize the stability of cortisol and 25 OH-vit D. In the case of ACTH the samples have to be frozen after they are obtained if they are not going to be processed in less than 8 hours (AU)

The UK nephrostomy audit. Can a voluntary registry produce robust performance data?

AIM: To investigate the effectiveness of the Royal College of Radiologists Audit Sub-Committee's national prospective registry of percutaneous nephrostomy, which enables participants to audit their practice and compare performance with predetermined standards. METHODS: Following a limited retrospective audit, which permitted setting of achievable targets, a dataset was developed and all UK NHS acute hospitals were invited to participate in web-based prospective data collection. RESULTS: Eighty-five out of 285 (29.8%) hospitals contributed 3262 cases over a 29 month period. A satisfactory level of performance was achieved with an overall technical success rate of 98% and a complication rate of 6.3%. Significant risk factors for complications included rigors, anaemia, and impaired renal function. Low frequency operators were shown to have a lower technical success rate and a higher complication rate than high frequency operators; however, target thresholds were exceeded in all groups. Sepsis was identified as a risk factor in the majority of serious complications and all deaths. Some anomalous results were found due to unusual interpretation of the data entry form in two centres, but no evidence of under-performance was identified at any centre. CONCLUSIONS: Some weaknesses of the registry are discussed. In view of the low response rate, the possibility of significant bias cannot be excluded. In addition, there is no objective verification of the data; therefore, the results have limited credibility. However, individual centres that accurately completed a representative sample of cases can have confidence that their performance achieves an acceptable standard.

The process of establishing, implementing and maintaining a social support infant feeding programme.

OBJECTIVE: To describe the process of establishing and implementing a social support infant feeding intervention. DESIGN: This paper outlines the initial stages of a randomised controlled trial which assessed the effectiveness of a social support intervention on a range of infant feeding outcomes. Details are presented of the processes involved in recruiting, training and supporting a group of volunteers who provided support to the study sample. SETTING: Camden and Islington, London, UK. RESULTS: Initial networking with local agencies and organisations provided invaluable information and contacts. Employing a dedicated volunteer co-ordinator is vitally important in the recruitment, training and support of volunteers. Providing child care and travel expenses is an essential incentive for volunteers with young children. Advertisements placed in local newspapers were the most successful means of recruiting volunteers. Appropriate training is needed to equip volunteers with the necessary knowledge and skills to provide effective support. Particular emphasis in the training focused upon developing the necessary interpersonal skills and self-confidence. The evaluation of the training programme demonstrated that it improved volunteers' knowledge and reported confidence. The provision of ongoing support is also essential to maintain volunteers' interest and enthusiasm. The retention of volunteers is, however, a key challenge. CONCLUSIONS: The processes outlined in this paper have demonstrated the feasibility of successfully establishing, implementing and maintaining a community-based social support infant feeding programme. The experiences described provide useful insights into the practical issues that need to be addressed in setting up a social support intervention.

Quality and quantity of antenatal HIV counselling in a PMTCT programme in Mombasa, Kenya.

A recent report from a PMTCT implementation study in Mombasa, Kenya, points at an important gap between the efficacy in clinical trial circumstances and the effectiveness of PMTCT programmes when implemented in real life. Hence, the quality and quantity of antenatal HIV counselling in a routine setting were appraised. The counsellors' social and communicative skills, duration and topics covered during pre- and post-test counselling sessions were assessed by means of the VCT assessment tools published by UNAIDS. A total of 14 group educational sessions, 66 pre-test counselling sessions and 50 post-test counselling sessions were observed and assessed. In general, the frequency and duration of the counselling was low. Crucial topics such as window period and partner involvement and follow-up support were covered haphazardly. The counsellor's social and communicative skills were given high marks, yet information was rarely repeated or summarized. The limited time dedicated to women receiving antenatal VCT contrasts with the heavy and comprehensive load of health information and advice they are supposed to receive. Ample pre- and post-test counselling including follow-up should be pursued for optimal effectiveness of PMTCT. We propose a number of health system interventions preceded and guided by ongoing audit.

Feminist ethics must inform practice: interventions with perinatal substance users.

Substance use during pregnancy is a major health and social issue in countries around the world. Even though many health professional associations recommend a voluntary health promotion approach to treatment, some professionals and legislators have pursued mandatory treatment, or protective intervention. A feminist ethic perspective of treatment invites us to consider a broader notion of autonomy, which includes the contexts in which women live, the difficulty they often have in accessing treatment services, and their endurance of systematic oppression related to ethnicity, socioeconomics, and politics. A punitive approach to treatment is not associated with improved outcomes for the fetus; in fact, the fetus may be at greater risk as women are fearful of accessing health services. Treatment is best pursued on a common ground basis within an embodied model of maternal-fetal relationship that will help support women and at the same time help ensure fetal health.

Community-based health insurance in low-income countries: a systematic review of the evidence.

Health policy makers are faced with competing alternatives, and for systems of health care financing. The choice of financing method should mobilize resources for health care and provide financial protection. This review systematically assesses the evidence of the extent to which community-based health insurance is a viable option for low-income countries in mobilizing resources and providing financial protection. The review contributes to the literature on health financing by extending and qualifying existing knowledge. Overall, the evidence base is limited in scope and questionable in quality. There is strong evidence that community-based health insurance provides some financial protection by reducing out-of-pocket spending. There is evidence of moderate strength that such schemes improve cost-recovery. There is weak or no evidence that schemes have an effect on the quality of care or the efficiency with which care is produced. In absolute terms, the effects are small and schemes serve only a limited section of the population. The main policy implication of the review is that these types of community financing arrangements are, at best, complementary to other more effective systems of health financing. To improve reliability and validity of the evidence base, analysts should agree on a more coherent set of outcome indicators and a more consistent assessment of these indicators. Policy makers need to be better informed as to both the costs and the benefits of implementing various financing options. The current evidence base on community-based health insurance is mute on this point.

Socio-demographic correlates of desire for HIV testing in Tanzania.

BACKGROUND: Over 60% of women and men interviewed in the Tanzania Demographic Health Survey (TDHS) of 1996 and the Tanzania Reproductive and Child Health Survey (TRCHS) of 1999 indicated that they would like to be tested for AIDS virus (HIV-antibody test). This is encouraging in view of the fact that voluntary HIV testing coupled with appropriate counselling is now believed to be quite effective for the prevention of HIV infection. This paper seeks to identify some socio-demographic factors that are associated with desire for HIV testing in Tanzania. METHODS: The study used data from the 1999 Tanzania Reproductive and Health Survey in which 4029 women and 3542 men were interviewed. A logistic regression analysis was used to identify correlates of desire for HIV testing for both men and women. RESULTS: For both men and women the logistic regression results show that significant correlates of desire for HIV testing are education, residence and knowledge of HIV prevention. In particular the odds of desire for AIDS test were found to be lower for respondents with secondary school education than those with primary school education. The odds were also significantly lower for urban respondents than for rural ones. The findings further show that the odds of desire for having an AIDS test were lowest for respondents with no knowledge of HIV prevention. CONCLUSIONS: Strategic campaigns to convince people to go for HIV testing should put more emphasis on radio programmes since these are effective means of communication in rural areas where desire for testing seems to be high. Such programmes should also focus on raising awareness on HIV prevention. HIV testing facilities should also be extended to the rural areas and be offered at affordable prices.

Use of UNAIDS tools to evaluate HIV voluntary counselling and testing services for mineworkers in South Africa.

HIV voluntary counselling and testing (VCT) is now an integral part of many HIV care and control programmes. However, very little work has been done to assess the quality of VCT services. An evaluation of VCT services for mineworkers in Welkom, South Africa was conducted to assess client and counsellor satisfaction, the quality of the services and to identify barriers to uptake of VCT. A cross-sectional survey was carried out using tools developed by UNAIDS, consisting of semi-structured interviews and observation of counselling sessions. Twenty-two nurse counsellors and six community volunteers were interviewed. Twenty-four counselling sessions were observed and 24 client exit interviews were conducted. Although nine of the 22 nurse counsellors had only in-service rather than formal training for HIV counselling whereas all community volunteers had been formally trained, nurse counsellors demonstrated better interpersonal skills than did community volunteers. Both clients and counsellors identified fear of a positive result as a major barrier to HIV testing. Clients also raised concerns about confidentiality. UNAIDS evaluation tools were a feasible and an acceptable method of assessing VCT in this operational setting. The study identified areas where training needs to be strengthened and suggested ways of improving the services, and changes to the service have now been implemented in line with these recommendations.