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Background: Self-interviews, where the respondent rather than the interviewer enters answers to questions, have been proposed as a way to reduce social desirability bias associated with interviewer-led interviews. Computer-assisted self-interviews (CASI) are commonly proposed since the computer programme can guide respondents; however they require both language and computer literacy. We evaluated the feasibility and acceptability of using electronic methods to administer quantitative sexual behaviour questionnaires in the Somkhele demographic surveillance area (DSA) in rural KwaZulu-Natal, South Africa.Methods: We conducted a four-arm randomized trial of paper-and-pen-interview, computer-assisted personal-interview (CAPI), CASI and audio-CASI with an age-sex-urbanicity stratified sample of 504 adults resident in the DSA in 2015. We compared respondents' answers to their responses to the same questions in previous surveillance rounds. We also conducted 48 cognitive interviews, dual-coding responses using the Framework approach.Results: Three hundred forty (67%) individuals were interviewed and covariates and participation rates were balanced across arms. CASI and audio-CASI were significantly slower than interviewer-led interviews. Item non-response rates were higher in self-interview arms. In single-paper meta-analysis, self-interviewed individuals reported more socially undesirable sexual behaviours. Cognitive interviews found high acceptance of both self-interviews and the use of electronic methods, with some concerns that self-interview methods required more participant effort and literacy.Conclusions: Electronic data collection methods, including self-interview methods, proved feasible and acceptable for completing quantitative sexual behaviour questionnaires in a poor, rural South African setting. However, each method had both benefits and costs, and the choice of method should be based on context-specific criteria. [ABSTRACT FROM AUTHOR]

Introduction: The South African National Department of Health sought to improve syndromic management of sexually transmitted infections (STIs). Continuing medical education on STIs was delivered at primary healthcare (PHC) clinics using one of three training methods: (1) lecture, (2) computer and (3) paper-based. Clinics with training were compared with control clinics.Methods: Ten PHC clinics were randomly assigned to control and 10 to each training method arm. Clinicians participated in on-site training on six modules; two per week for three weeks. Each clinic was visited by three or four unannounced standardised patient (SP) actors pre-training and post-training. Male SPs reported symptoms of male urethritis syndrome and female SPs reported symptoms of vaginal discharge syndrome. Quality of healthcare was measured by whether or not clinicians completed five tasks: HIV test, genital exam, correct medications, condoms and partner notification.Results: An average of 31% of clinicians from each PHC attended each module. Quality of STI care was low. Pre-training (n=128) clinicians completed an average of 1.63 tasks. Post-training (n=114) they completed 1.73. There was no change in the number of STI tasks completed in the control arm and an 11% increase overall in the training arms relative to the control (ratio of relative risk (RRR)=1.11, 95% CI 0.67 to 1.84). Across training arms, there was a 26% increase (RRR=1.26, 95% CI 0.77 to 2.06) associated with lecture, 17% increase (RRR=1.17, 95% CI 0.59 to 2.28) with paper-based and 13% decrease (RRR=0.87, 95% CI 0.40 to 1.90) with computer arm relative to the control.Conclusions: Future interventions should address increasing training attendance and computer-based training effectiveness.Trial Registration Number: AEARCTR-0000668. [ABSTRACT FROM AUTHOR]

Aim: To describe the trajectory of clinical signs in children who developed human immunodeficiency virus encephalopathy (HIVE) after starting early antiretroviral therapy (ART).Method: This was a retrospective case-cohort description of HIVE among Cape Town participants from the Children with HIV Early AntiRetroviral treatment (CHER) trial. Criteria for HIVE diagnosis were at least two of: (1) acquired central motor deficit, (2) impaired brain growth, and (3) failure to attain or loss of developmental milestones in the absence of an alternative aetiology.Results: Of 133 surviving participants who initiated ART at a median age of 9 weeks and who were followed until a median age of 6 years, 20 (12%) developed HIVE at a median age 31 months (interquartile range 19-37). In these, the first neurological deterioration was noticed at a median age of 19 months, when 16 were on ART and nine had undetectable HIV viral load for a median of 12 months. Signs of upper motor neurons were present in 18, of whom 12 resolved and four had persistent spastic diplegia; 19 had motor delay, of whom 14 resolved; 12 had language delay, of whom 11 resolved; and 16 had impaired brain growth, of whom only five recovered. For the 16 participants already on ART at HIVE diagnosis, regimens were not altered in response to diagnosis.Interpretation: HIVE may occur despite early ART initiation and virological suppression and then resolve on unchanged ART, most likely as intrathecal inflammation subsides.What This Paper Adds: Despite suppressive antiretroviral therapy, children can develop human immunodeficiency virus encephalopathy, The most common manifestations are motor deficits and impaired brain growth. Most experience improvement, with many resolving without additional intervention. [ABSTRACT FROM AUTHOR]

Background: Interventions targeting community health workers (CHWs) aim to optimise the delivery of health services to underserved rural areas. Whilst interventions are evaluated against their objectives, there remains limited evidence on the economic costs of these interventions, and the practicality and value of scale up. The aim of this paper is to undertake a cost analysis on a CHW training and supervision intervention using exclusive breastfeeding rates amongst mothers as an outcome measure.Methods: This is a retrospective cost analysis, from an implementer's perspective, of a cluster randomised controlled trial investigating the effectiveness of a continuous quality improvement (CQI) intervention aimed at CHWs providing care and support to pregnant women and women with babies aged < 1 year in South Africa.Results: One of the outcomes of the RCT revealed that the prevalence of exclusive breastfeeding (EBF) significantly improved, with the cost per mother EBF in the control and intervention arm calculated at US$760,13 and US$1705,28 respectively. The cost per additional mother practicing EBF was calculated to be US$7647, 88, with the supervision component of the intervention constituting 64% of the trial costs. In addition, women served by the intervention CHWs were more likely to have received a CHW visit and had significantly better knowledge of childcare practices.Conclusion: Whilst the cost of this intervention is high, adapted interventions could potentially offer an economical alternative for achieving selected maternal and child health (MCH) outcomes. The results of this study should inform future programmes aimed at providing adapted training and supervision to CHWs with the objective of improving community-level health outcomes. [ABSTRACT FROM AUTHOR]

The HIV response is hampered by many obstacles to progression along the HIV care cascade, with men, in particular, experiencing different forms of disruption. One group of men, whose stories remain untold, are those who have succumbed to HIV-related illness. In this paper, we explore how next-of-kin account for the death of a male relative. We conducted 26 qualitative after-death interviews with family members of male PLHIV who had recently died from HIV in health and demographic surveillance sites in Malawi, Tanzania, Kenya, Uganda, Zimbabwe and South Africa. The next-of-kin expressed frustration about the defiance of their male relative to disclose his HIV status and ask for support, and attributed this to shame, fear and a lack of self-acceptance of HIV diagnosis. Next-of-kin painted a picture of their male relative as rebellious. Some claimed that their deceased relative deliberately ignored instructions received by the health worker. Others described their male relatives as unable to maintain caring relationships that would avail day-to-day treatment partners, and give purpose to their lives. Through these accounts, next-of-kin vocalised the perceived rebellious behaviour of these men, and in the process of doing so neutralised their responsibility for the premature death of their relative. [ABSTRACT FROM AUTHOR]

Background: In South Africa, HIV is increasingly becoming a chronic disease as a result of advances in HIV treatment and prevention in the last three decades. This has changed the perception from a life threating to a potentially manageable disease. However, little is known about self-perceived health status of HIV-infected individuals. Self-rated health (SRH) has been shown to be a sensitive indicator of health-relatedchanges directly linked to HIV, but can also be influenced by differences in social and material conditions. The aim of this paper was to identify determinants of excellent/good SRH among HIV-infected individuals using socio-demographic, life style and health related data.Methods: The study used data from the nationally representative 2012 South African population-based household survey on HIV prevalence, incidence and behaviour conducted using multi-stage stratified cluster sampling design. Bivariate and multivariate logistic regression models were used to identify determinants of SRH among HIV-infected individuals.Results: Out of a total of 2632 HIV positive participants 74.1% (95% CI: 68.4-74.2) reported excellent/good SRH. Increased likelihood of reporting excellent/good SRH was significantly associated with being Black African [OR= 1.97 (95%CI: 1.12-3.46), p = 0.019] and belonging to least poor household [OR= 3.13 (95%CI: 1.26-7.78), p = 0.014]. Decreased likelihood of reporting excellent/good SRH was significantly associated with those aged 25 to 34 years [OR= 0.49 (95% CI: 0.31-0.78), p = 0.003], 35 to 44 years[OR= 0.27 (95% CI: 0.17-0.44), p < 0.001], 45 to 54 years [OR= 0.20 (95% CI: 0.12-0.34), p < 0.001], and those 55 years and older [OR= 0.15 (95% CI: 0.09-0.26), p < 0.001], hospitalization in the past twelve months [OR= 0.40 (95% CI: 0.26-0.60), p < 0.001].Conclusion: To have positive health effects and improve the perceived health status for PLWH social interventions should seek to enhance to support for the elderly HIV-positive individuals, and address the challenge of socio-economic inequalities and underlying comorbid conditions resulting in hospitalization. [ABSTRACT FROM AUTHOR]

Nurses experience high levels of work related stress and burnout as well as low job satisfaction and poor general health owing to the nature of their work. This paper seeks to provide a better understanding of the nature of relationships between work related stress, burnout, job satisfaction and general health of nurses over one year. This study involved a longitudinal design. Two hundred and seventy seven nurses from four hospitals completed a follow up survey consisting of five questionnaires. Data were collected between 2013 and 2014. The data were analysed using generalized estimation equation analysis. Lack of support was associated with burnout, patient care was associated with job satisfaction and staff issues were associated with general health of nurses. Burnout is more strongly related to job satisfaction than general health. The findings of this study could inform evidence based policy and practice through interventions aimed at improving job satisfaction and reducing the impact of burnout on general health of nurses. [ABSTRACT FROM AUTHOR]

In order to achieve optimal benefits of antiretroviral therapy (ART), caregivers of children receiving ART are required to attend routine clinic visits monthly and administer medication to the child as prescribed. Yet, the level of adherence to these behaviours varies considerably in many settings. As a way to achieve optimal adherence in rural KwaZulu-Natal, caregivers are required to attend routine counselling sessions at HIV treatment clinics that are centred on imparting information, motivation, and behavioural skills related to medication administration. According to the information-motivation-behavioural skills model, information related to adherence, motivation, and behavioural skills are necessary and fundamental determinants of adherence to ART. The purpose of the study was to observe and document the content of adherence counselling sessions that caregivers attending rural clinics in KwaZulu Natal receive. We observed 25 adherence counselling sessions, which lasted on average 8.1 minutes. Counselling typically consisted of counsellors recording patient attendance, reporting CD4 count and viral load results to caregivers, emphasising dose times, and asking caregivers to name their medications and dosage amounts. Patients were seldom asked to demonstrate how they measure the medication. They were also not probed for problems regarding treatment, even when an unsuppressed VL was reported to a caregiver. This paper calls attention to the sub-optimal level of counselling provided to patients on ART and the urgent need to standardise and improve the training, support, and debriefing provided to counsellors. [ABSTRACT FROM PUBLISHER]

Objective: To determine if either prophylactic tramadol 50 mg or ibuprofen 400 mg/metoclopramide 10 mg result in lower maximal pain compared to placebo in women ≤63 days' gestation having a mifepristone-misoprostol medical abortion.Study Design: We conducted a randomized, placebo-controlled trial in Nepal, South Africa, and Vietnam. Participants seeking medical abortion received active treatment or placebo, taken at time of misoprostol and repeated 4 hours later. All had access to additional analgesia. The primary outcome was mean maximum pain score within 8 hours. Participants self-assessed maximum pain using an 11-point numeric rating scale recorded in paper diaries; we analyzed these data using intention-to-treat analysis. Secondary outcomes included use of additional analgesia, side effects, and satisfaction.Results: We enrolled 563 patients between June 2016 and October 2017; 5 participants failed to follow up. Mean adjusted maximum pain scores within 8 hours in both active arms were lower than placebo (tramadol: n = 188, 6.78 (95% confidence interval [CI] 6.46, 7.11); ibuprofen/metoclopramide: n = 187, 6.43 (95% CI 6.10, 6.75); placebo: n = 188, 7.42 (95% CI 7.10, 7.74); p = 0.0001). Additional analgesia was used by 97 (52.2%) participants in the tramadol group, 80 (43.0%) in the ibuprofen/metoclopramide group, and 103 (55.7%) in the placebo group, p = 0.04. More dizziness (p = 0.004), headache (p = 0.03), and vomiting (p < 0.001) occurred in the tramadol group. More participants reported experienced pain was the same or less than expected in the ibuprofen/metoclopramide group (p = 0.05); overall abortion satisfaction did not differ by group (p = 0.44).Conclusions: Compared with placebo, tramadol or ibuprofen/metoclopramide co-administered with misoprostol and repeated 4 h later resulted in lower mean maximum pain scores that failed to achieve clinical significance. Women who received ibuprofen/metoclopramide were least likely to use additional analgesia and reported fewer side effects.Implications: Given that tramadol, ibuprofen, and metoclopramide are inexpensive, globally available; and, ibuprofen and metoclopramide are included on the World Health Organization Essential Medicines List, these medicines could be considered for prophylactic pain management during medical abortion. [ABSTRACT FROM AUTHOR]

While much research has documented unsatisfactory sexual and reproductive health (SRH) awareness among young people in South Africa, understanding of gender differences in access to and evaluation of SRH information is limited. This paper concerned itself with men and women's informal sources and content of SRH, and gendered divergences around accessibility, evaluation, and impact of such information. Fifty sexual history narrative interviews and twenty-five narrative interviews with women were conducted with participants purposively sampled from a range of ages, cultural and racial backgrounds, and in urban and rural sites across five provinces in South Africa. Data were analysed using thematic analysis. While young women were more likely to learn about SRH information from family members, they also reported greater regulation concerning their sexuality. This could enhance stigma surrounding women's sexuality and hinder open communication. Men predominantly learned about sex through pornography and peers, which was reported to encourage sexual prowess to the neglect of practising safer sex. Lack of adequate SRH instruction for young people as revealed through the narratives had significant and often negative implications for men and women's early safer sex behaviours. In response to these insights, recommendations are offered to strengthen informal sources of SRH awareness. [ABSTRACT FROM AUTHOR]

The integrated chronic disease management (ICDM) model was introduced as a response to the dual burden of HIV/AIDS and non-communicable diseases (NCDs) in South Africa, one of the first of such efforts by an African Ministry of Health. The aim of the ICDM model is to leverage HIV programme innovations to improve the quality of chronic disease care. There is a dearth of literature on the perspectives of healthcare providers and users on the quality of care in the novel ICDM model. This paper describes the viewpoints of operational managers and patients regarding quality of care in the ICDM model. In 2013, we conducted a case study of the seven PHC facilities in the rural Agincourt sub-district in northeast South Africa. Focus group discussions (n = 8) were used to obtain data from 56 purposively selected patients ≥18 years. In-depth interviews were conducted with operational managers of each facility and the sub-district health manager. Donabedian’s structure, process and outcome theory for service quality evaluation underpinned the conceptual framework in this study. Qualitative data were analysed, with MAXQDA 2 software, to identify 17 a priori dimensions of care and unanticipated themes that emerged during the analysis. The manager and patient narratives showed the inadequacies in structure (malfunctioning blood pressure machines and staff shortage); process (irregular prepacking of drugs); and outcome (long waiting times). There was discordance between managers and patients regarding reasons for long patient waiting time which managers attributed to staff shortage and missed appointments, while patients ascribed it to late arrival of managers to the clinics. Patients reported anti-hypertension drug stock-outs (structure); sub-optimal defaulter-tracing (process); rigid clinic appointment system (process). Emerging themes showed that patients reported HIV stigmatisation in the community due to defaulter-tracing activities of home-based carers, while managers reported treatment of chronic diseases by traditional healers and reduced facility-related HIV stigma because HIV and NCD patients attended the same clinic. Leveraging elements of HIV programmes for NCDs, specifically hypertension management, is yet to be achieved in the study setting in part because of malfunctioning blood pressure machines and anti-hypertension drug stock-outs. This has implications for the nationwide scale up of the ICDM model in South Africa and planning of an integrated chronic disease care in other low- and middle-income countries. [ABSTRACT FROM AUTHOR]

Background: South Africa is at present undertaking a series of reforms to transform public health services to make them more effective and responsive to patient and provider needs. A key focus of these reforms is primary care and its overburdened, somewhat dysfunctional and hierarchical nature. This comparative case study examines how patients and providers respond in this system and cope with its systemic demands through mechanisms of endurance, resistance and resilience, using coping and agency literatures as the theoretical lenses.Methods: As part of a larger research project carried out between 2009 and 2010, this study conducted semi-structured interviews and observations at health facilities in three South African provinces. This study explored patient experiences of access to health care, in particular, ways of coping and how health care providers cope with the health care system's realities. From this interpretive base, four cases (two patients, two providers) were selected as they best informed on endurance, resistance and resilience. Some commentary from other respondents is added to underline the more ubiquitous nature of these coping mechanisms.Results: The cases of four individuals highlight the complexity of different forms of endurance and passivity, emotion- and problem-based coping with health care interactions in an overburdened, under-resourced and, in some instances, poorly managed system. Patients' narratives show the micro-practices they use to cope with their treatment, by not recognizing victimhood and sometimes practising unhealthy behaviours. Providers indicate how they cope in their work situations by using peer support and becoming knowledgeable in providing good service.Conclusions: Resistance and resilience narratives show the adaptive power of individuals in dealing with difficult illness, circumstances or treatment settings. They permit individuals to do more than endure (itself a coping mechanism) their circumstances, though resistance and resilience may be limited. These are individual responses to systemic forces. To transform health care, mutually supportive interactions are required among and between both patients and providers but their nature, as micro-practices, may show a way forward for system change. [ABSTRACT FROM AUTHOR]

Background: Failure to take medicines for diabetes as prescribed contributes to poor outcomes from the condition. Mobile phones are ubiquitous and short message service (SMS) texts have shown promise as a low-cost intervention. We tested the effectiveness of SMS-text messaging in improving outcomes in adults with type 2 diabetes.Methods: StAR2D was a 12-month two-arm randomised trial of SMS-text messaging and usual care in Cape Town, South Africa and Lilongwe, Malawi. Messages used behaviour change theory and were developed with patients and staff. The intervention group received four messages each week. The primary outcome was change in HbA1c. Secondary outcomes were the proportion of patients who collected > 80% medication and changes in systolic blood pressure, lipids, cardiovascular risk, and the proportion of the participants reaching treatment goals.Results: The trial took place between 1 October, 2016 and 1 October 2018, 1186 participants were randomised to intervention (593) and control (593) groups. 91% of participants completed follow-up. There was a reduction in HbA1c (DCCT) in both groups but not in mean change (95% CI) between groups (- 0.08% (- 0.31 to 0.16) (IFCC - 0.82 mmol/mol (- 3.44 to 1.79). There was a small but not significant increase in the proportions of participants likely to have collected 80% or more of medication (Relative risk 1.11 (0.84 to 1.47; P = 0.47). There was a significant difference between groups in change in systolic blood pressure from baseline of 3.46 mmHg (1.48 to 5.44, P = 0.001) in favour of the intervention group. The between group difference in change in 10-year risk of coronary heart disease was - 0.71% (- 1.46 to 0.04, P = 0.064). The proportion of participants meeting treatment goals in the intervention group was 36.0% and in the control group 26.8% (Relative risk 1.36 (1.13 to 1.63, P = 0.001). Participants reported many challenges to adherence despite finding messages acceptable and useful.Conclusions: Whilst SMS text messages do not lead to improved glycaemia in these low-resource settings there appeared to be an impact on blood pressure and achievement of treatment goals but the mechanisms for this are unclear. Text messages alone, may be unsuccessful unless accompanied by health system strengthening and other forms of self-management support for type 2 diabetes.Trial Registration: Trial registration: ISRCTN, ISRCTN70768808. Registered 1 July 2015, http://www.isrctn.com/I ISRCTN70768808. [ABSTRACT FROM AUTHOR]

Objective: Childhood obesity is of increasing concern in South Africa, and interventions to promote healthy behaviours related to obesity in children are needed. Young children in urban low-income settings are particularly at risk of excess adiposity. The current study aimed to describe how parents of preschool children in an urban South African township view children's movement and dietary behaviours, and associated barriers and facilitators.Design: A contextualist qualitative design was utilised with in-depth interviews conducted in the home setting and analysed using reflexive thematic analysis. Field notes were used to contextualise findings.Setting: Four neighbourhoods in a predominantly low-income urban township.Participants: Sixteen parents (fourteen mothers, two fathers) of preschool-age children were recruited via preschools.Results: Four themes were developed: children's autonomy and the limits of parental control; balancing trust and fears; the appeal of screens; and aspirations and pressures of parenthood. Barriers to healthy behaviours included children's food preferences, aspirations and pressures to consume unhealthy foods, other adults giving children snacks, lack of safe places to play, unhealthy food environments and underlying structural factors. Facilitators included set routines, the preschool environment, safe places to play and availability of healthy foods.Conclusions: Low-income families in Soweto face many structural challenges that cannot easily be addressed through public health interventions, but there may be opportunities for behavioural interventions targeting interpersonal and organisational aspects, such as bedtime routines and preschool snacks, to achieve positive changes. More research on preschoolers' movement and dietary behaviours, and related interventions, is needed in South Africa. [ABSTRACT FROM AUTHOR]

Objective: To explore community perceptions on maternal and child nutrition issues in Sub-Saharan Africa.Design: Thirty focus groups with men and women from three communities facilitated by local researchers.Setting: One urban (Soweto, South Africa) and two rural settings (Navrongo, Ghana and Nanoro, Burkina Faso) at different stages of economic transition.Participants: Two hundred thirty-seven men and women aged 18-55 years, mostly subsistence farmers in Navrongo and Nanoro and low income in Soweto.Results: Differences in community concerns about maternal and child health and nutrition reflected the transitional stage of the country. Community priorities revolved around poor nutrition and hunger caused by poverty, lack of economic opportunity and traditional gender roles. Men and women felt they had limited control over food and other resources. Women wanted men to take more responsibility for domestic chores, including food provision, while men wanted more involvement in their families but felt unable to provide for them. Solutions suggested focusing on ways of increasing control over economic production, family life and domestic food supplies. Rural communities sought agricultural support, while the urban community wanted regulation of the food environment.Conclusions: To be acceptable and effective, interventions to improve maternal and child nutrition need to take account of communities' perceptions of their needs and address wider determinants of nutritional status and differences in access to food reflecting the stage of the country's economic transition. Findings suggest that education and knowledge are necessary but not sufficient to support improvements in women's and children's nutritional status. [ABSTRACT FROM AUTHOR]

Background: Little is known about the relationship between sarcopenia and mild cognitive impairment (MCI) in low- and middle-income countries (LMICs).Objective: This study aimed to investigate this association among community-dwelling adults aged≥65 years from six LMICs.Methods: Cross-sectional, nationally representative data from the Study on Global Ageing and Adult Health (SAGE) were analyzed. These data were obtained in China, Ghana, India, Mexico, Russia, and South Africa in 2007-2010. Participants were considered to have sarcopenia if they had low skeletal muscle mass (i.e., lower skeletal mass index) and a weak handgrip strength. MCI was defined using the National Institute on Aging-Alzheimer's Association criteria. Multivariable logistic regression analysis was conducted to assess associations.Results: The final analytical sample consisted of 12,912 individuals aged≥65 years with preservation in functional abilities without stroke (mean [standard deviation] age 72.2 [10.8] years; 45.2% males). The overall prevalence of sarcopenia and MCI were 11.3% and 18.1%, respectively. After adjusting for potential confounders, there was a positive association between sarcopenia and MCI in all countries (i.e., odds ratio [OR] > 1) with the exception of South Africa, and the overall estimate was OR = 1.60 (95% confidence interval [CI] = 1.32-1.93) with a low level of between-country heterogeneity (I2 = 0.0%).Conclusion: There was a positive association between sarcopenia and MCI in this sample of older adults living in LMICs. Causality should be assessed in future longitudinal research, while the utility of sarcopenia as a marker of MCI should also be investigated. [ABSTRACT FROM AUTHOR]

Inadequate toilet facilities may increase women's risk of experiencing non-partner sexual violence. We sought to assess the association between young (18–24 year-olds) women's access to toilets and past year non-partner rape experience, in deprived communities in South Africa. Data came from cross-sectional, population-based survey from poor communities from four health districts in two provinces, namely, City of Johannesburg, and Ekurhuleni in Gauteng, and eThekwini and uMgungundlovu, in KwaZulu-Natal. Descriptive, unadjusted and adjusted associations, were estimated in STATA/IC16, accounting for study design. In total, 10,635 young women provided data on toilet access. Past year non-partner rape prevalence was 5.7%. In adjusted analyses, those reporting a shared toilet were more likely to report past year experience of non-partner rape (adjusted odds ratio: 1.45, 95% confidence intervals [1.17, 1.80]), compared to those with their own toilet indoors. Improving access to private, secure toilets is an important component for the prevention of non-partner sexual violence. [ABSTRACT FROM AUTHOR]

Background/objectives: Childhood rapid growth and earlier puberty onset have been associated with adult obesity. However, the association between childhood stunting, pubertal timing and adult obesity is unclear. We examined whether the relationship between stunting at age 2 years (y) and body composition at 23 years is mediated by adolescent body mass index, and pubertal development, using the Birth-to-Twenty Plus cohort (South Africa).Subjects/methods: For 1036 participants, data on anthropometrics between birth and 23 years, maternal factors, and pubertal development (Tanner scale at 9-16 years) were collected. Stunting at 2 years (height-for-age z-score < -2), 5-18 years BMI-for-age trajectories, pubertal development trajectories, and DXA-derived fat mass (FM) and fat free mass (FFM) at 23 years were determined. Data were analysed using hierarchical regressions and structural equation models.Results: Stunting was directly associated with slower pubertal development and with shorter adult stature, but was not associated with adolescent BMI trajectories, adult FM or FFM. However, stunting was indirectly associated with adult FM and FFM through the direct associations between slower pubertal development and lower FM and between shorter height and lower FFM. BMI trajectories were independently associated with FM and FFM.Conclusions: Being stunted in this population predicted adult body composition through slower pubertal development and shorter adult stature. [ABSTRACT FROM AUTHOR]

Background: Home visits by paraprofessional community health workers (CHWs) has been shown to improve maternal and child health outcomes in research studies in many countries. Yet, when these are scaled or replicated, efficacy disappears. An effective CHW home visiting program in peri-urban Cape Town found maternal and child health benefits over the 5 years point but this study examines if these benefits occur in deeply rural communities.Methods: A non-randomized, two-group comparison study evaluated the impact of CHW in the rural Eastern Cape from August 2014 to May 2017, with 1310 mother-infant pairs recruited in pregnancy and 89% were reassessed at 6 months post-birth.Results: Home visiting had limited, but important effects on child health, maternal wellbeing and health behaviors. Mothers reported fewer depressive symptoms, attended more antenatal visits and had better baby-feeding practices. Intervention mothers were significantly more likely to exclusively breastfeed for 6 months (OR: 1.8; 95% CI: 1.1, 2.9), had lower odds of mixing formula with baby porridge (regarded as detrimental) (OR: 0.4; 95% CI: 0.2, 0.8) and were less likely to consult traditional healers. Mothers living with HIV were more adherent with co-trimoxazole prophylaxis (p < 0.01). Intervention-group children were significantly less likely to be wasted (OR: 0.5; 95% CI 0.3-0.9) and had significantly fewer symptoms of common childhood illnesses in the preceding two weeks (OR: 0.8; 95% CI: 0.7,0.9).Conclusion: The impact of CHWs in a rural area was less pronounced than in peri-urban areas. CHWs are likely to need enhanced support and supervision in the challenging rural context. [ABSTRACT FROM AUTHOR]

Understanding how sexual behaviors cluster in distinct population subgroups along the life course is critical for effective targeting and tailoring of HIV prevention messaging and intervention activities. We examined interrelatedness of sexual behaviors and variation between men and women across a wide age range in a rural South African setting with a high HIV burden. Data come from the Ha Nakekela population-based survey of people aged 15-85-plus drawn from the Agincourt Health and Socio-Demographic Surveillance System. We used latent class analysis of six sexual behavior indicators to identify distinct subgroup sexual behavior clusters. We then examined associations between class membership and sociodemographic and other behavioral risk factors and assessed the accuracy of a reduced set of sexual behavior indicators to classify individuals into latent classes. We identified three sexual behavior classes: (1) single with consistent protective behaviors; (2) risky behaviors; and (3) in union with lack of protective behaviors. Patterns of sexual behaviors varied by gender. Class membership was also associated with age, HIV status, nationality, and alcohol use. With only two sexual behavior indicators (union status and multiple sexual partners), individuals were accurately assigned to their most likely predicted class. There were distinct multidimensional sexual behavior clusters in population subgroups that varied by sex, age, and HIV status. In this population, only two brief questions were needed to classify individuals into risk classes. Replication in other situations is needed to confirm these findings. [ABSTRACT FROM AUTHOR]

Background: Bacterial vaginosis (BV) increases HIV risk and adverse reproductive outcomes. Standard-of-care (SOC) for BV are antibiotics; however, cure rates are low. Probiotics for vaginal health may be useful in improving cure and recurrence although the regulatory framework governing probiotics and the conduct of randomized clinical trials to evaluate these has not been established in South Africa. We performed an exploratory single-blind trial evaluating a commercial oral-vaginal-combination probiotic as adjunct to SOC for BV treatment.Methods: Women with symptomatic vaginal discharge were screened for BV and common sexually transmitted infections (STIs). BV+ (Nugent 7-10) but STI- women were randomized to vaginal metronidazole alone (n = 12) or to metronidazole followed by a commercial oral/vaginal probiotic (n = 18). The primary qualitative outcome was to test the regulatory landscape for conducting randomized probiotic trials in South Africa; and acceptability of vaginal application by women. BV cure at 1 month (Nugent≤3) was the primary quantitative endpoint. Secondary quantitative endpoints were BV recurrence, symptoms, vaginal microbiota and genital cytokine changes over 5 months post-treatment.Results: The  South African Health Products Regulatory Authority (SAHPRA) reviewed and approved this trial. As probiotics continue to be regulated as health supplements in South Africa, SAHPRA required a notification application for this trial. Acceptability and adherence to the oral and vaginal application of the probiotic were high, although women reported a preference for oral capsules. 44.8% of women cleared BV one-month post-treatment, and no significant differences in BV cure (RR = 0.52, 95% CI = 0.24-1.16), recurrence, vaginal pH, symptoms, microbiota or vaginal IL-1α concentrations were found between SOC and intervention groups in this pilot study with an over-the-counter product.Conclusion: Navigation of the SAHPRA registration process for evaluating a commercial probiotic in a randomised trial laid the foundation for planned larger trials of improved probiotic products for vaginal health in South Africa. Although adherence to the vaginally delivered probiotic was high, women preferred oral application and we recommend that improvements in the content and method of application for future probiotics for vaginal health should be considered.Trial Registration: This trial was registered on 17 October 2017 with the South African National Clinical Trial Register ( http://www.sanctr.gov.za/ ; BV-trial1; DOH-27-1117-5579 ). [ABSTRACT FROM AUTHOR]

Background: Current models of HIV service delivery, with frequent facility visits, have led to facility congestion, patient and healthcare provider dissatisfaction, and suboptimal quality of services and retention in care. The Zambian urban adherence club (AC) is a health service innovation designed to improve on-time drug pickup and retention in HIV care through off-hours facility access and pharmacist-led group drug distribution. Similar models of differentiated service delivery (DSD) have shown promise in South Africa, but observational analyses of these models are prone to bias and confounding. We sought to evaluate the effectiveness and implementation of ACs in Zambia using a more rigorous study design.Methods and Findings: Using a matched-pair cluster randomized study design (ClinicalTrials.gov: NCT02776254), 10 clinics were randomized to intervention (5 clinics) or control (5 clinics). At each clinic, between May 19 and October 27, 2016, a systematic random sample was assessed for eligibility (HIV+, age ≥ 14 years, on ART >6 months, not acutely ill, CD4 count not <200 cells/mm3) and willingness to participate in an AC. Clinical and antiretroviral drug pickup data were obtained through the existing electronic medical record. AC meeting attendance data were collected at intervention facilities prospectively through October 28, 2017. The primary outcome was time to first late drug pickup (>7 days late). Intervention effect was estimated using unadjusted Kaplan-Meier survival curves and a Cox proportional hazards model to derive an adjusted hazard ratio (aHR). Medication possession ratio (MPR) and implementation outcomes (adoption, acceptability, appropriateness, feasibility, and fidelity) were additionally evaluated as secondary outcomes. Baseline characteristics were similar between 571 intervention and 489 control participants with respect to median age (42 versus 41 years), sex (62% versus 66% female), median time since ART initiation (4.8 versus 5.0 years), median CD4 count at study enrollment (506 versus 533 cells/mm3), and baseline retention (53% versus 55% with at least 1 late drug pickup in previous 12 months). The rate of late drug pickup was lower in intervention participants compared to control participants (aHR 0.26, 95% CI 0.15-0.45, p < 0.001). Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001). Although 18% (683/3,734) of AC group meeting visits were missed, on-time drug pickup (within 7 days) still occurred in 51% (350/683) of these missed visits through alternate means (use of buddy pickup or early return to the facility). Qualitative evaluation suggests that the intervention was acceptable to both patients and providers. While patients embraced the convenience and patient-centeredness of the model, preference for traditional adherence counseling and need for greater human resources influenced intervention appropriateness and feasibility from the provider perspective. The main limitations of this study were the small number of clusters, lack of viral load data, and relatively short follow-up period.Conclusions: ACs were found to be an effective model of service delivery for reducing late ART drug pickup among HIV-infected adults in Zambia. Drug pickup outside of group meetings was relatively common and underscores the need for DSD models to be flexible and patient-centered if they are to be effective.Trial Registration: ClinicalTrials.gov NCT02776254. [ABSTRACT FROM AUTHOR]

Background: Despite policies and guidelines recommending integration of health services in South Africa, provision of maternal and child health services remains fragmented. This study evaluated a rapid, scaleable, quality improvement (QI) intervention to improve integration of maternal and child health and HIV services at a primary health level, in KwaZulu-Natal, South Africa.Methods: A three-month intervention comprised of six QI mentoring visits, learning sessions with clinic staff to share learnings, and a self-administered checklist aimed to assist health workers monitor and implement an integrated package of health services for mothers and children. The study evaluated 27 clinics in four sub-districts using a stepped-wedge design. Each sub-district received the intervention sequentially in a randomly selected order. Five waves of data collection were conducted in all participating clinics between December 2016-February 2017. A multi-level, mixed effects logistic regression was used to account for random cluster fixed time and group effects using Stata V13.1.Results: Improvements in some growth monitoring indicators were achieved in intervention clinics compared to control clinics, including measuring the length of the baby (77% vs 63%; p = 0.001) and health workers asking mothers about the child's feeding (74% vs 67%; p = 0.003), but the proportion of mothers who received feeding advice remained unchanged (38% vs 35%; p = 0.48). Significantly more mothers in the intervention group were asked about their baby's health (44% vs 36%; p = 0.001), and completeness of record keeping improved (40% vs 26%; I = < 0.0001). Discussions with the mother about some maternal health services improved: significantly more mothers in the intervention group were asked about HIV (26.5% vs 19.5%; p = 0.009) and family planning (33.5% vs 19.5%; p <  0.001), but this did not result in additional services being provided to mothers at the clinic visit.Conclusion: This robust evaluation shows significant improvements in coverage of some services, but the QI intervention was unable to achieve the substantial changes required to provide a comprehensive package of services to all mothers and children. We suggest the QI process be adapted to complex under-resourced health systems, building on the strengths of this approach, to provide workable health systems strengthening solutions for scalable implementation.Trial Registration: ClinicalTrials.gov NCT04278612. Date of Registration: February 19, 2020. Retrospectively registered. [ABSTRACT FROM AUTHOR]

Despite empirical support for "Self-control theory" in criminology, there is controversy about how self-control should be operationalized. Working within the framework of "self-control theory," we investigated if violence and criminal behaviors are associated with nine distinct dimensions of cognitive control in a community sample of young men (n = 654) living in peri-urban townships in South Africa. Cognitive control was assessed using the Behavior Rating Inventory of Executive Function. Multivariate statistical analysis was used, to identify associations between violence and criminality, and deaggregated measures of nine distinct components of cognitive control. Fifteen percent of the sample reported recent violence, 27% had been in physical fights with family/friends in the preceding 6 months, 10% reported being arrested, 4% reported forced sexual contact, and 26% reported intimate partner violence (IPV). Controlling for substance use and sociodemographic variables, contact with the criminal justice system and violence were associated with deficits in all domains of cognitive control. Forced sexual contact was associated with behavioral dysregulation. IPV was associated with behavior dysregulation and executive control dysfunction. Future studies might utilize deaggregated measures of self-control to provide further insight into links between particular components of cognitive control and various forms of offending and violence. [ABSTRACT FROM AUTHOR]

Literature indicates a high prevalence and burden of mental illness in youths world-wide, which may be even higher in low- and middle-income countries (LMIC), such as South Africa and Zambia. Additionally, there is a lack of knowledge regarding youth depression amongst many primary health care (PHC) practitioners. The principal goal of the MEGA project is to provide youth with better access to mental health services and appropriate care, by developing a mental health screening mobile application tool to be used in PHC settings in South Africa and Zambia. In this study, we will use a mixed methods multi-center study design. In phase one, we will investigate the mental health literacy of PHC practitioners to identify areas in need of development. Based on the needs identified, we will develop and test a mobile health application to screen for common youth mental health problems in phase two. In phase three, we will implement and evaluate a tiered education and training program in the use of the m-health application. In the final phase, we will evaluate the acceptability and feasibility of the m-health application in PHC centres across South Africa and Zambia. Evidence suggests that PHC practitioners should routinely consider mental illness when assessing youth. However, common psychiatric disorders remain largely undetected and untreated in PHC settings. By identifying limitations in PHC workers knowledge with regard to youth mental health, we aspire to improve the depression care provided to youth in Southern Africa and Zambia by developing and implementing a locally relevant m-health application. [ABSTRACT FROM AUTHOR]

Background: There is a high global burden of neonatal mortality, with many newborn babies dying of preventable and treatable conditions, particularly in low and middle-income countries. Improving quality of newborn care could save the lives of many thousands of babies. Quality of care (QoC) is a complex and multifaceted construct that is difficult to measure, but patients' experiences of care are an important component in any measurement of QoC. We report the findings of a qualitative study exploring observations and experiences of health workers (HWs) and mothers of babies in neonatal units in South Africa.Methods: A qualitative case study approach was adopted to explore care of newborn babies admitted to neonatal units in district hospitals. Observation data were collected by a registered nurse during working hours over a continuous five-day period. Doctors and nurses working in the neonatal unit and mothers of babies admitted during the observation period were interviewed using a semi-structured interview guide. All interviews were audio recorded. Observation data were transcribed from hand written notes. Audiotapes of interviews were transcribed verbatim and, where necessary, translated into English. A thematic content analysis was used to analyse the data.Results: Observations and interviews were conducted in seven participating hospitals between November 2015 and May 2016. Our findings highlight the importance of information sharing between HWs and mothers of babies, contrasting the positive communication reported by many mothers which led to them feeling empowered and participating actively in the care of their babies, with incidents of poor communication. Poor communication, rudeness and disrespectful behaviour of HWs was frequently described by mothers, and led to mothers feeling anxious, unwilling to ask questions and excluded from their baby's care. In some cases poor communication and misunderstandings led to serious mismanagement of babies with HWs delaying or withholding care, or to mothers putting their babies at risk by not following instructions.Conclusion: Good communication between mothers and HWs is critical for building mothers' confidence, promoting bonding and participation of mothers in the care of their baby and may have long term benefits for the health and well-being of the mother and her baby. [ABSTRACT FROM AUTHOR]

Background: Clinical practice guidelines risk having little impact on healthcare if not effectively implemented. Theory informed, targeted implementation may maximise their impact. Our study explored barriers to and facilitators of guideline implementation and use by South African primary care nurses and allied healthcare workers in four provinces in South Africa. We also proposed interventions to address the issues identified.Methods: We used qualitative research methods, comprising focus group discussions using semi-structured topic guides. Seven focus group discussions were conducted (48 providers) in four South African provinces (Eastern Cape, Western Cape, Kwazulu-Natal, Limpopo). Participants included mostly nurses, dieticians, dentists, and allied health practitioners, from primary care facilities in rural and peri-urban settings. The analysis proceeded in three phases. Firstly, two analysts conducted inductive thematic content analysis to develop themes of data. This was followed by fitting emergent themes to the Theoretical Domains Framework and finally to the associated Behaviour Change Wheel to identify relevant interventions.Results: Participants are knowledgeable about guidelines, generally trust their credibility and are receptive and motivated to use them. Guidelines are seen by nurses to provide confidence and reassurance, as well as professional authority and independence where doctors are scarce. Barriers to guideline use include: inadequate systems for printed book distribution, insufficient and substandard photocopies, linguistic inappropriateness (e.g. complicated language, lack of summaries, unavailable in local languages), unsupportive auditing procedures, limited involvement of end-users in guideline development, and patchy training that may not filter back to all providers. Future aspirations identified include: improving the design features of guidelines, accessible places to find guidelines, making digitally-formatted versions available, more supplementary materials (e.g. posters) to support patient engagement, accessible clinical support following training, and in-facility training for all professional cadres to ensure fair access, similar levels of capability and interdisciplinary consistency.Conclusions: South African primary care nurses and allied health practitioners have high levels of motivation to use guidelines, but face many systemic barriers. We used the Behaviour Change Wheel to suggest relevant, implementable interventions addressing identified barriers. This theory-informed approach may improve clinical guideline implementation and impact healthcare for South Africa. [ABSTRACT FROM AUTHOR]

Background: Use of the Xpert MTB/RIF assay has increased the number of people diagnosed with rifampicin-resistant tuberculosis (RR-TB), especially in South Africa where Xpert is now the initial diagnostic for individuals with TB symptoms. We hypothesized that a proportion of RR-TB patients determined by Xpert can be treated with a rifabutin-containing regimen.Methods: Rifabutin susceptibility by rpoB mutation was assessed in 349 individuals from South Africa and 172 from Belgium. rpoB polymorphisms were identified by Sanger sequencing. Rifampicin and rifabutin susceptibility was assessed phenotypically. A systematic review was performed to comprehensively collate information on rifabutin susceptibility by rpoB polymorphism. Rifabutin susceptibility was assigned to rpoB polymorphisms based on their positive likelihood ratios and ORs.Results: One hundred and twelve rpoB polymorphisms (67.9% from literature) were identified from all 2045 RR-TB patients, of which 17 polymorphisms could be classified as susceptible/resistant to rifabutin. Eleven polymorphisms were associated with rifabutin susceptibility. The 516GTC mutation was the most common, representing 70% (South Africa) and 76% (Belgium) of all rifabutin-susceptible isolates. At a population level, the 11 polymorphisms associated with rifabutin susceptibility occurred in 33.2% and 16.6% of all South African and Belgian patients diagnosed with RR-TB, respectively.Conclusions: Identification of the exact rpoB polymorphism leading to the diagnosis of RR-TB has the potential to allow inclusion of rifabutin in the treatment regimen of a substantial proportion of RR-TB patients. A randomized controlled trial evaluating the efficacy of a rifabutin-containing TB treatment regimen in these selected patients is needed to provide the evidence required for a change in policy. [ABSTRACT FROM AUTHOR]

Background: Obstetric hemorrhage (OH) and access to peripartum blood transfusion remains a global health challenge. The rates of peripartum transfusion in South Africa exceed those in high-income countries despite comparable rates of OH. We sought to evaluate factors associated with peripartum transfusion.Study Design and Methods: A case-control study was conducted at four large South African hospitals. Transfused peripartum women (cases) and nontransfused controls were stratum matched 1:2 by hospital and delivery date. Data on obstetric, transfusion, and human immunodeficiency virus (HIV) history were abstracted from medical records. Blood was obtained for laboratory evaluation. We calculated unadjusted and adjusted odds ratios (ORs) for transfusion using logistic regression.Results: A total of 1200 transfused cases and 2434 controls were evaluated. Antepartum hemorrhage (OR, 197.95; 95% confidence interval [CI], 104.27-375.78), hemorrhage with vaginal delivery (OR, 136.46; 95% CI, 75.87-245.18), prenatal anemia (OR, 22.76; 95% CI, 12.34-41.93 for prenatal hemoglobin level < 7 g/dL), and failed access to prenatal care (OR, 6.71; 95% CI, 4.32-10.42) were the major risk factors for transfusion. Platelet (PLT) count (ORs, 4.10, 2.66, and 1.77 for ≤50 × 109 , 51 × 109 -100 × 109 , and 101 × 109 -150 × 109 cells/L, respectively), HIV infection (OR, 1.29; 95% CI, 1.02-1.62), and admitting hospital (twofold variation) were also associated with transfusion. Mode of delivery, race, age category, gravidity, parity, gestational age, and birthweight were not independently associated with transfusion.Conclusion: Major risk factors of peripartum transfusion in South Africa, namely, prenatal anemia and access to prenatal care, may be amenable to intervention. HIV infection and moderately low PLT count are novel risk factors that merit further investigation. [ABSTRACT FROM AUTHOR]

Background: Sexually transmitted infections (STIs) and bacterial vaginosis (BV) are associated with increased transmission of HIV, and poor reproductive and sexual health. The burden of STIs/BV among young people is unknown in many high HIV prevalence settings. We conducted an acceptability, feasibility, and prevalence study of home-based sampling for STIs/BV among young men and women aged 15-24 years old in a health and demographic surveillance site (HDSS) in rural KwaZulu-Natal, South Africa.Methods and Findings: A total of 1,342 young people, stratified by age (15-19 and 20-24 years) and sex were selected from the HDSS sampling frame; 1,171/1,342 (87%) individuals had ≥1 attempted home visit between 4 October 2016 and 31 January 2017, of whom 790 (67%) were successfully contacted. Among the 645 who were contacted and eligible, 447 (69%) enrolled. Consenting/assenting participants were interviewed, and blood, self-collected urine (men), and vaginal swabs (women) were tested for herpes simplex virus type 2 (HSV-2), chlamydia, gonorrhoea, syphilis, trichomoniasis, and BV. Both men and women reported that sample collection was easy. Participants disagreed that sampling was painful; more than half of the participants disagreed that they felt anxious or embarrassed. The weighted prevalence of STIs/BV among men and women, respectively, was 5.3% and 11.2% for chlamydia, 1.5% and 1.8% for gonorrhoea, 0% and 0.4% for active syphilis, 0.6% and 4.6% for trichomoniasis, 16.8% and 28.7% for HSV-2, and 42.1% for BV (women only). Of the women with ≥1 curable STI, 75% reported no symptoms. Factors associated with STIs/BV included having older age, being female, and not being in school or working. Among those who participated in the 2016 HIV serosurvey, the prevalence of HIV was 5.6% among men and 19% among women. Feasibility was impacted by the short study duration and the difficulty finding men at home.Conclusions: A high prevalence of STIs/BV was found in this rural setting with high HIV prevalence in South Africa. Most STIs and HIV infections were asymptomatic and would not have been identified or treated under national syndromic management guidelines. A nested STI/BV survey within a HDSS proved acceptable and feasible. This is a proof of concept for population-based STI surveillance in low- and middle-income countries that could be utilised in the evaluation of STI/HIV prevention and control programmes. [ABSTRACT FROM AUTHOR]

Objective: To estimate the prevalence and describe the patterns of concurrent human papillomavirus (HPV) and STIs and associated factors among HIV-negative young Western Cape, South African women participating in the Efficacy of HPV Vaccine to Reduce HIV Infection (EVRI) trial.Methods: HIV-negative women aged 16-24 years old were enrolled in the EVRI trial (NCT01489527) and randomised to receive the licensed four-valent HPV vaccine or placebo. At study entry, participants were clinically evaluated for five STIs: herpes simplex virus type 2 (HSV-2), chlamydia, gonorrhoea, syphilis and disease-causing HPV genotypes (6/11/16/18/31/33/35/39/45/51/52/56/58/59/68). Demographic and sexual history characteristics were compared among women with STI co-infections, single infection and no infection using Pearson χ2 and Mann-Whitney tests. ORs were calculated to evaluate factors associated with STI co-infection prevalence.Results: Among 388 young women, STI co-infection prevalence was high: 47% had ≥2 concurrent STIs, 36% had a single STI and 17% had none of the five evaluated STIs. HPV/HSV-2 (26%) was the most prevalent co-infection detected followed by HPV/HSV-2/Chlamydia trachomatis (CT) (17%) and HPV/CT (15%). Co-infection prevalence was independently associated with alcohol use (adjusted OR=2.01, 95% CI 1.00 to 4.06) and having a sexual partner with an STI (adjusted OR=6.96, 95% CI 1.53 to 30.08).Conclusions: Among high-risk young women from underserved communities such as in Southern Africa, a multicomponent prevention strategy that integrates medical and behavioural interventions targeting both men and women is essential to prevent acquisition of concurrent STI infections and consequent disease.Trial Registration Number: NCT01489527; Post-results. [ABSTRACT FROM AUTHOR]

Background: Since the beginning of the HIV epidemic, numerous behavior change, risk-reduction, and biomedical interventions have been developed and tested. While some of these interventions have shown to be efficacious in randomized trials, it often takes almost two decades for an intervention to be translated into practice. Meanwhile, South Africa continues to have among the highest prevalence of HIV globally, with women of childbearing age bearing the burden of the epidemic. Given the urgency of the HIV epidemic among vulnerable women in South Africa, it is imperative that evidence-based interventions be implemented rapidly into practice. This study presents a first step toward examining the acceptability and feasibility of implementing the Women's Health CoOp (WHC) in clinics and substance abuse rehab settings in Cape Town, South Africa.Methods: We conducted focus group discussions with women who use substances and with service providers, we also conducted in-depth interviews with health service planners. Our goal was to examine implementation and clinical outcomes associated with delivery of the WHC across clinics and substance abuse rehab programs.Results: All participants agreed on the need for the WHC. Perceived facilitators to implementing the WHC included the recognizable need for programs to empower women and to build the capacity of staff to address issues of substance use, sexual risk, and intimate partner violence. Participants also identified potential barriers to women engaging with this program, including the stigma women experience when seeking services and the lack of person-centered care at healthcare facilities.Conclusions: In a country with the largest number of women of childbearing age living with HIV, an evidence-based woman-focused intervention that comprehensively addresses women's risk for suboptimal antiretroviral adherence may be essential for reducing HIV incidence. However, potential barriers to implementing the WHC successfully must be addressed before the program can be fully integrated into the services delivered by healthcare facilities.Trial Registration: Clinical trials NCT02733003 . Date of Registration: January 21, 2016, registered retroactively after participant enrollment. [ABSTRACT FROM AUTHOR]

Background: A large and compelling clinical evidence base has shown that integrated TB and HIV services leads to reduction in human immunodeficiency virus (HIV)- and tuberculosis (TB)-associated mortality and morbidity. Despite official policies and guidelines recommending TB and HIV care integration, its poor implementation has resulted in TB and HIV remaining the commonest causes of death in several countries in sub-Saharan Africa, including South Africa. This study aims to reduce mortality due to TB-HIV co-infection through a quality improvement strategy for scaling up of TB and HIV treatment integration in rural primary healthcare clinics in South Africa.Methods: The study is designed as an open-label cluster randomized controlled trial. Sixteen clinic supervisors who oversee 40 primary health care (PHC) clinics in two rural districts of KwaZulu-Natal, South Africa will be randomized to either the control group (provision of standard government guidance for TB-HIV integration) or the intervention group (provision of standard government guidance with active enhancement of TB-HIV care integration through a quality improvement approach). The primary outcome is all-cause mortality among TB-HIV patients. Secondary outcomes include time to antiretroviral therapy (ART) initiation among TB-HIV co-infected patients, as well as TB and HIV treatment outcomes at 12 months. In addition, factors that may affect the intervention, such as conditions in the clinic and staff availability, will be closely monitored and documented.Discussion: This study has the potential to address the gap between the establishment of TB-HIV care integration policies and guidelines and their implementation in the provision of integrated care in PHC clinics. If successful, an evidence-based intervention comprising change ideas, tools, and approaches for quality improvement could inform the future rapid scale up, implementation, and sustainability of improved TB-HIV integration across sub-Sahara Africa and other resource-constrained settings.Trial Registration: Clinicaltrials.gov, NCT02654613 . Registered 01 June 2015. [ABSTRACT FROM AUTHOR]

Aims and objectives To determine the incidence of medication administration errors, medication administration-related deviations from safe practice as well as factors associated with these errors in medical and surgical units of public hospitals in the Gauteng Province of South Africa. Background Several studies have been published on the incidence of medication administration errors, but only a few have studied the incidence of medication administration-related deviations from safe practice. Context-specific research on the incidence of medication administration errors and associated factors (patient acuity, bed occupancy, staffing levels, medication administrators' qualifications, dose calculation skills, level of hospital, unit type, medication administration route and interruptions) within the continent of Africa is lacking. Design A cross-sectional, observational design. Methods Direct observation was conducted incorporating a previously validated checklist based on basic medication guidelines including the five rights, asepsis and medication documentation. In addition, a knowledge test on dose calculations was performed. Medication administration to 315 patients (1847 medications administered) was observed between February-August 2015 in medical and surgical units from eight public hospitals. Twenty-five medication administrators completed dose calculations. Results In total, 296 medication errors were identified, of which most were wrong-time errors and omissions. Interruptions and patient acuity were significantly associated with wrong-dose and wrong-route errors, respectively. Most medication administration-related deviations from safe practice were related to patient identification or asepsis. Sixteen of 50 dosage calculations were answered incorrectly. Incorrect answers most often occurred in the calculation of parenteral dosages. Conclusions Medication administration errors, especially wrong-time errors and omissions, are prevalent in public hospitals in the Gauteng Province. Interruptions lower the risk of wrong-dose errors, while patient acuity exacerbates this risk. Relevance to clinical practice Factors associated with wrong-time errors and omissions should be addressed. Patient identification and asepsis protocols should be adhered to. Dosage calculation training is indicated. [ABSTRACT FROM AUTHOR]

Background: Accurately identifying individuals who are on antiretroviral therapy (ART) is important to determine ART coverage and proportion on ART who are virally suppressed. ART is also included in recent infection testing algorithms used to estimate incidence. We compared estimates of ART coverage, viral load suppression rates and HIV incidence using ART self-report and detection of antiretroviral (ARV) drugs and we identified factors associated with discordance between the methods.Methods: Cross-sectional population-based survey in KwaZulu-Natal, South Africa. Individuals 15-59 years were eligible. Interviews included questions about ARV use. Rapid HIV testing was performed at the participants' home. Blood specimens were collected for ARV detection, LAg-Avidity HIV incidence testing and viral load quantification in HIV-positive individuals. Multivariate logistic regression models were used to identify socio-demographic covariates associated with discordance between self-reported ART and ARV detection.Results: Of the 5649 individuals surveyed, 1423 were HIV-positive. Median age was 34 years and 76.3% were women. ART coverage was estimated at 51.4% (95%CI:48.5-54.3), 53.1% (95%CI:50.2-55.9) and 56.1% (95%CI:53.5-58.8) using self-reported ART, ARV detection and both methods combined (classified as ART exposed if ARV detected and/or ART reported) respectively. ART coverage estimates using the 3 methods were fairly similar within sex and age categories except in individuals aged 15-19 years: 33.3% (95%CI:23.3-45.2), 33.8% (95%CI:23.9-45.4%) and 44.3% (95%CI:39.3-46.7) using self-reported ART, ARV detection and both methods combined. Viral suppression below 1000cp/mL in individuals on ART was estimated at 89.8% (95%CI:87.3-91.9), 93.1% (95%CI:91.0-94.8) and 88.7% (95%CI:86.2-90.7) using self-reported ART, ARV detection and both methods combined respectively. HIV incidence was estimated at 1.4 (95%CI:0.8-2.0) new cases/100 person-years when employing no measure of ARV use, 1.1/100PY (95%CI:0.6-1.7) using self-reported ART, and 1.2/100PY (95%CI:0.7-1.7) using ARV detection. In multivariate analyses, individuals aged 15-19 years had a higher risk of discordance on measures of ARV exposure (aOR:9.4; 95%CI:3.9-22.8), while migrants had a lower risk (aOR:0.3; 95%CI:0.1-0.6).Conclusions: In KwaZulu-Natal, the method of identifying ARV use had little impact on estimates of ART coverage, viral suppression rate and HIV incidence. However, discordant results were more common in younger individuals. This may skew estimates of ART coverage and viral suppression, particularly in adolescent surveys. [ABSTRACT FROM AUTHOR]

Objective To assess and compare health system performance across six middle-income countries that are strengthening their health systems in pursuit of universal health coverage. Design Cross-sectional analysis from the World Health Organization Study on global AGEing and adult health, collected between 2007 and 2010. Setting Six middle-income countries: China, Ghana, India, Mexico, Russia and South Africa. Participants Nationally representative sample of adults aged 50 years and older. Main outcome measures We present achievement against key indicators of health system performance across effectiveness, cost, access, patient-centredness and equity domains. Results We found areas of poor performance in prevention and management of chronic conditions, such as hypertension control and cancer screening coverage. We also found that cost remains a barrier to healthcare access in spite of insurance schemes. Finally, we found evidence of disparities across many indicators, particularly in the effectiveness and patient centredness domains. Conclusions These findings identify important focus areas for action and shared learning as these countries move towards achieving universal health coverage. [ABSTRACT FROM AUTHOR]

Background: Concurrent epidemics of HIV, depression, alcohol abuse, and partner violence threaten maternal and child health (MCH) in South Africa. Although home visiting has been repeatedly demonstrated efficacious in research evaluations, efficacy disappears when programs are scaled broadly. In this cluster randomized controlled trial (RCT), we examine whether the benefits of ongoing accountability and supervision within an existing government funded and implemented community health workers (CHW) home visiting program ensure the effectiveness of home visiting.Methods/design: In the deeply rural, Eastern Cape of South Africa, CHW will be hired by the government and will be initially trained by the Philani Programme to conduct home visits with all pregnant mothers and their children until the children are 2 years old. Eight clinics will be randomized to receive either (1) the Accountable Care Condition in which additional monitoring and accountability systems that Philani routinely uses are implemented (4 clinics, 16 CHW, 450 households); or (2) a Standard Care Condition of initial Philani training, but with supervision and monitoring being delivered by local government structures and systems (4 clinics, 21 CHW, 450 households). In the Accountable Care Condition areas, the CHW's mobile phone reports, which are time-location stamped, will be monitored and data-informed supervision will be provided, as well as monitoring growth, medical adherence, mental health, and alcohol use outcomes. Interviewers will independently assess outcomes at pregnancy at 3, 6, 15, and 24 months post-birth. The primary outcome will be a composite score of documenting maternal HIV/TB testing, linkage to care, treatment adherence and retention, as well as child physical growth, cognitive functioning, and child behavior and developmental milestones.Discussion: The proposed cluster RCT will evaluate whether routinely implementing supervision and accountability procedures and monitoring CHWs' over time will improve MCH outcomes over the first 2 years of life.Trial Registration: ClinicalTrials.gov registration #NCT02957799 , registered on October 26, 2016. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular risk factors are increasing in most developing countries. To date, however, very little standardized data has been collected on the primary risk factors across the spectrum of economic development. Data are particularly sparse from Africa.Methods: In the Modeling the Epidemiologic Transition Study (METS) we examined population-based samples of men and women, ages 25-45 of African ancestry in metropolitan Chicago, Kingston, Jamaica, rural Ghana, Cape Town, South Africa, and the Seychelles. Key measures of cardiovascular disease risk are described.Results: The risk factor profile varied widely in both total summary estimates of cardiovascular risk and in the magnitude of component factors. Hypertension ranged from 7% in women from Ghana to 35% in US men. Total cholesterol was well under 200 mg/dl for all groups, with a mean of 155 mg/dl among men in Ghana, South Africa and Jamaica. Among women total cholesterol values varied relatively little by country, following between 160 and 178 mg/dl for all 5 groups. Levels of HDL-C were virtually identical in men and women from all study sites. Obesity ranged from 64% among women in the US to 2% among Ghanaian men, with a roughly corresponding trend in diabetes. Based on the Framingham risk score a clear trend toward higher total risk in association with socioeconomic development was observed among men, while among women there was considerable overlap, with the US participants having only a modestly higher risk score.Conclusions: These data provide a comprehensive estimate of cardiovascular risk across a range of countries at differing stages of social and economic development and demonstrate the heterogeneity in the character and degree of emerging cardiovascular risk. Severe hypercholesterolemia, as characteristic in the US and much of Western Europe at the onset of the coronary epidemic, is unlikely to be a feature of the cardiovascular risk profile in these countries in the foreseeable future, suggesting that stroke may remain the dominant cardiovascular event. [ABSTRACT FROM AUTHOR]

Background: The Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 targets require that, by 2020, 90% of those living with HIV know their status, 90% of known HIV-positive individuals receive sustained antiretroviral therapy (ART), and 90% of individuals on ART have durable viral suppression. The HPTN 071 (PopART) trial is measuring the impact of a universal testing and treatment intervention on population-level HIV incidence in 21 urban communities in Zambia and South Africa. We report observational data from four communities in Zambia to assess progress towards the UNAIDS targets after 1 y of the PopART intervention.Methods and Findings: The PopART intervention comprises annual rounds of home-based HIV testing delivered by community HIV-care providers (CHiPs) who also support linkage to care, ART retention, and other services. Data from four communities in Zambia receiving the full intervention (including immediate ART for all individuals with HIV) were used to determine proportions of participants who knew their HIV status after the CHiP visit; proportions linking to care and initiating ART following referral; and overall proportions of HIV-infected individuals who knew their status (first 90 target) and the proportion of these on ART (second 90 target), pre- and post-intervention. We are not able to assess progress towards the third 90 target at this stage of the study. Overall, 121,130 adults (59,283 men and 61,847 women) were enumerated in 46,714 households during the first annual round (December 2013 to June 2015). Of the 45,399 (77%) men and 55,703 (90%) women consenting to the intervention, 80% of men and 85% of women knew their HIV status after the CHiP visit. Of 6,197 HIV-positive adults referred by CHiPs, 42% (95% CI: 40%-43%) initiated ART within 6 mo and 53% (95% CI: 52%-55%) within 12 mo. In the entire population, the estimated proportion of HIV-positive adults who knew their status increased from 52% to 78% for men and from 56% to 87% for women. The estimated proportion of known HIV-positive individuals on ART increased overall from 54% after the CHiP visit to 74% by the end of the round for men and from 53% to 73% for women. The estimated overall proportion of HIV-positive adults on ART, irrespective of whether they knew their status, increased from 44% to 61%, compared with the 81% target (the product of the first two 90 targets). Coverage was lower among young men and women than in older age groups. The main limitation of the study was the need for assumptions concerning knowledge of HIV status and ART coverage among adults not consenting to the intervention or HIV testing, although our conclusions were robust in sensitivity analyses.Conclusions: In this analysis, acceptance of HIV testing among those consenting to the intervention was high, although linkage to care and ART initiation took longer than expected. Knowledge of HIV-positive status increased steeply after 1 y, almost attaining the first 90 target in women and approaching it in men. The second 90 target was more challenging, with approximately three-quarters of known HIV-positive individuals on ART by the end of the annual round. Achieving higher test uptake in men and more rapid linkage to care will be key objectives during the second annual round of the intervention.Trial Registration: ClinicalTrials.gov NCT01900977. [ABSTRACT FROM AUTHOR]

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The objective of this study was to describe the impact of intense counseling to reduce vaginal hygiene practices and its effect on bacterial vaginosis. A secondary data analysis of the HIV Prevention Trials Network 035 study was undertaken, focusing on HIV-negative, nonpregnant women who were at least 18 years old, in seven African sites and one US site. At enrollment and during follow-up quarterly visits, vaginal hygiene practices were determined by face-to-face administration of a behavioral assessment questionnaire. Vaginal hygiene practices were categorized as insertion into the vagina of (1) nothing, (2) water only, and (3) other substances with or without water. Each practice was quantified by frequency and type/combination of inserted substances. At quarterly visits, diagnosis of bacterial vaginosis was made using the Nugent score. Trends for vaginal hygiene practices and bacterial vaginosis were evaluated using generalized estimating equation models. A total of 3087 participants from the HIV Prevention Trials Network 035 study were eligible for this analysis. At enrollment, 1859 (60%) reported recent vaginal hygiene practices. By one year, this figure had decreased to 1019 (33%) with counseling. However, bacterial vaginosis prevalence remained consistent across the study observation period, with 36%-38% of women testing positive for the condition ( p for trend = 0.27). Overall, those who reported douching with water only (AOR = 1.03, 95%CI: 0.94-1.13) and those who reported inserting other substances (AOR= 0.98, 95%CI: 0.88-1.09) in the past quarter were not more likely to have bacterial vaginosis compared to those who reported no insertions. However, in South Africa, an increase in bacterial vaginosis was seen among those who reported inserting other substances (AOR: 1.48, 95%CI: 1.17, 1.88). In conclusion, targeted counseling against vaginal hygiene practices resulted in change in self-reported behavior but did not have an impact on bacterial vaginosis diagnosis in all but one site. [ABSTRACT FROM AUTHOR]

We investigated psychological distress and symptoms of depression and anxiety among 485 South Africans seeking HIV testing. The mean scores of the sample were 45.78 (SD = 16.81) on the Hopkins Symptom Checklist; 15.8 (SD = 12.4) on the Beck Depression Inventory and 12.44 (SD = 13.00) on the Beck Anxiety Inventory, which fell in the elevated, mild and low ranges on these instruments, respectively. For more than a third of participants, symptoms of depression and clinically significant distress were at least moderate and in some cases severe, indicating that they may have benefitted from psychological help. We make the case that symptoms of depression and distress are common among persons seeking HIV testing and are therefore not a consequence of an HIV-positive test result. [ABSTRACT FROM PUBLISHER]

Background: Poor clinical record keeping hinders health systems monitoring and patient care in many low resource settings. We develop and validate a novel method to impute dates of antiretroviral treatment (ART) initiation from routine laboratory data in South Africa's public sector HIV program. This method will enable monitoring of the national ART program using real-time laboratory data, avoiding the error potential of chart review.Methods: We developed an algorithm to impute ART start dates based on the date of a patient's "ART workup", i.e. the laboratory tests used to determine treatment readiness in national guidelines, and the time from ART workup to initiation based on clinical protocols (21 days). To validate the algorithm, we analyzed data from two large clinical HIV cohorts: Hlabisa HIV Treatment and Care Programme in rural KwaZulu-Natal; and Right to Care Cohort in urban Gauteng. Both cohorts contain known ART initiation dates and laboratory results imported directly from the National Health Laboratory Service. We assessed median time from ART workup to ART initiation and calculated sensitivity (SE), specificity (SP), positive predictive value (PPV), and negative predictive value (NPV) of our imputed start date vs. the true start date within a 6 month window. Heterogeneity was assessed across individual clinics and over time.Results: We analyzed data from over 80,000 HIV-positive adults. Among patients who had a workup and initiated ART, median time to initiation was 16 days (IQR 7,31) in Hlabisa and 21 (IQR 8,43) in RTC cohort. Among patients with known ART start dates, SE of the imputed start date was 83% in Hlabisa and 88% in RTC, indicating this method accurately predicts ART start dates for about 85% of all ART initiators. In Hlabisa, PPV was 95%, indicating that for patients with a lab workup, true start dates were predicted with high accuracy. SP (100%) and NPV (92%) were also very high.Conclusions: Routine laboratory data can be used to infer ART initiation dates in South Africa's public sector. Where care is provided based on protocols, laboratory data can be used to monitor health systems performance and improve accuracy and completeness of clinical records. [ABSTRACT FROM AUTHOR]

Introduction and Aim: Given the high prevalence and detrimental consequences of alcohol or other drug (AOD) use in low- and middle-income countries, a screening tool for early detection in health care, including emergency care, is critical. We set out to validate the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) for the South African context.Design and Methods: We interviewed emergency centre patients (n = 200) in Cape Town for this cross-sectional study conducted from January to March 2013 utilising a questionnaire battery, including the ASSIST and Mini International Neuropsychiatric Interview. Internal consistency (Cronbach's alpha) and screening properties of the ASSIST (receiver operating characteristic analysis) were examined utilising the Mini International Neuropsychiatric Interview AOD use modules as the gold standard.Results: Cronbach's alpha for alcohol and illicit drugs ranged from 0.81 to 0.95 indicating good internal consistency. ASSIST cut-off scores show a good sensitivity and specificity for discrimination particularly when distinguishing between substance use and abuse, rather than dependence. For alcohol, the area under the curve was 0.94 for distinguishing between use and abuse, and this dropped to 0.68 for distinguishing between abuse and dependence, while the statistic remained high for both use/abuse and abuse/dependence for illicit drugs: 0.95 and 0.96.Discussion and Conclusion: AOD abuse was associated with cut-off scores below the World Health Organization recommended levels, in keeping with various international studies suggesting that individuals with lower scores be offered interventions. The ASSIST was found to be useful for South African health care and holds promise for cost-effective task-shifting approaches in lower resourced settings. [van der Westhuizen C, Wyatt G, Williams JK, Stein DJ, Sorsdahl K. Validation of  the  Alcohol, Smoking and Substance Involvement Screening Test in a low- and middle-income country cross-sectional emergency centre study. Drug Alcohol Rev 2016;35:702-709]. [ABSTRACT FROM AUTHOR]

Almost all pregnant women (98 %) in 24 Cape Town neighborhoods were randomized by neighborhood to (1) the standard care (SC) condition (n = 12 neighborhoods; n = 594 pregnant women) or (2) the Philani Intervention Program (PIP) in which home visits by Community Health Workers (CHW) were conducted (n = 12 neighborhoods; n = 644 pregnant women). At 36 months post-birth (84.6 % follow-up), PIP mothers were significantly less depressed compared to the SC mothers. Children in PIP were significantly less likely to be stunted (24.3 vs 18.1 %, p = 0.013), to have better vocabularies, and were less likely to be hospitalized than children in the SC condition. These data suggest home visits may need to continue for several years post-birth. Sustainable, scalable perinatal intervention models are needed in LMIC. [ABSTRACT FROM AUTHOR]

ABSTRACT BACKGROUND Bullying behavior in schools can lead to psychosocial problems. School-based interventions are important in raising student awareness, developing their skills and in planning to reduce bullying behavior. METHODS A randomized controlled trial, using a school-based educational intervention to reduce verbal bullying, was conducted among grade 10 students in 16 urban and rural schools in KwaZulu-Natal, South Africa in 2013. Baseline and postintervention questionnaires, developed using the Integrated Model for Behavior Change theoretical model, were used to assess changes in verbal bullying. RESULTS Postintervention there were reduced verbal bullying experiences. Improved social norms and awareness of verbal bullying were associated with reduced verbal bullying experiences and behavior. Although less likely to bully others verbally, girls were more likely to experience verbal bullying. Students with no living father were more likely to bully others verbally. CONCLUSIONS The study findings indicate that a school-based intervention can positively impact on verbal bullying experiences and behavior. [ABSTRACT FROM AUTHOR]

Objective: The WHO application of the tenth edition of the International Classification of Diseases (ICD-10) to deaths during the perinatal period (ICD Perinatal Mortality, ICD-PM) captures the essential characteristics of the mother-baby dyad that contribute to perinatal deaths. We compare the capture of maternal conditions in the existing ICD-PM with the maternal codes from the WHO application of ICD-10 to deaths during pregnancy, childbirth, and the puerperium (ICD Maternal Mortality, ICD-MM) to explore potential benefits in the quality of data received.Design: Retrospective application of ICD-PM.Setting: South Africa and the UK.Population: Perinatal death databases.Methods: The maternal conditions were classified using the ICD-PM groupings for maternal condition in perinatal death, and then mapped to the ICD-MM groupings of maternal conditions.Main Outcome Measures: Main maternal conditions in perinatal deaths.Results: We reviewed 9661 perinatal deaths. The largest group (4766 cases, 49.3%) in both classifications captures deaths where there was no contributing maternal condition. Each of the other ICD-PM groups map to between three and six ICD-MM groups. If the cases in each ICD-PM group are re-coded using ICD-MM, each group becomes multiple, more specific groups. For example, the 712 cases in group M4 in ICD-PM become 14 different and more specific main disease categories when the ICD-MM is applied instead.Conclusions: As we move towards ICD-11, the use of the more specific, applicable, and relevant codes outlined in ICD-MM for both maternal deaths and the maternal condition at the time of a perinatal death would be preferable, and would provide important additional information about perinatal deaths.Tweetable Abstract: Improving the capture of maternal conditions in perinatal deaths provides important actionable information. [ABSTRACT FROM AUTHOR]

Background: Pain is often cited as one of the worst features of medical abortion. Further, inadequate pain management may motivate some women to seek unnecessary clinical care. There is a need to identify effective methods for pain control in this setting. Methods/Design: We propose a randomized, placebo-controlled trial. 576 participants (288 nulliparous; 288 parous) from study sites in Nepal, South Africa and Vietnam will be randomly allocated to one of three treatments: (1) ibuprofen 400 mg PO and metoclopramide 10 mg PO; (2) tramadol 50 mg PO and a placebo; or (3) two placebo pills, to be taken immediately before misoprostol and repeated once four hours later. All women will be provided with supplementary analgesia for use as needed during the medical abortion. We hypothesize that women receiving prophylactic analgesia will report lower maximal pain scores in the first 8 h following misoprostol administration compared to women receiving placebos for medical abortion through 63 days' gestation. Our primary objective is to determine whether prophylactic administration of ibuprofen and metoclopramide or tramadol provides superior pain relief compared to analgesia administration after pain begins, measured during the first eight hours after misoprostol administration. Secondary objectives include identifying covariates associated with higher reported pain scores; determining any impact of the study medicines on medical abortion success; and, qualitatively exploring women's physical experiences of medical abortion, especially related to pain, and how can they be improved. Data sources include medical records, participant symptom diaries and interview data obtained on the day of enrollment, during the medical abortion, and at follow-up. Participants will be contacted via telephone on day 3 and return for follow-up will occur approximately 14 days after mifepristone, concluding study participation. A subset of 42 women will also be invited to undergo in-depth qualitative interviews following study completion. Discussion: Although pain is one of the most common side effects encountered with medical abortion, little is known about optimal pain management for this process. This multi-arm trial design offers an efficient approach to evaluating two prophylactic pain management regimens compared to use of pain medication as needed. [ABSTRACT FROM AUTHOR]

Objectives: Optimizing antiretroviral drug combination on an individual basis in resource-limited settings is challenging because of the limited availability of drugs and genotypic resistance testing. Here, we describe our latest computational models to predict treatment responses, with or without a genotype, and compare the potential utility of global and local models as a treatment tool for South Africa.Methods: Global random forest models were trained to predict the probability of virological response to therapy following virological failure using 29 574 treatment change episodes (TCEs) without a genotype, 3179 of which were from South Africa and were used to develop local models. In addition, 15 130 TCEs including genotypes were used to develop another set of models. The 'no-genotype' models were tested with an independent global test set (n = 1700) plus a subset from South Africa (n = 222). The genotype models were tested with 750 independent cases.Results: The global no-genotype models achieved area under the receiver-operating characteristic curve (AUC) values of 0.82 and 0.79 with the global and South African tests sets, respectively, and the South African models achieved AUCs of 0.70 and 0.79. The genotype models achieved an AUC of 0.84. The global no-genotype models identified more alternative, locally available regimens that were predicted to be effective for cases that failed their new regimen in the South African clinics than the local models. Both sets of models were significantly more accurate predictors of outcomes than genotyping with rules-based interpretation.Conclusions: These latest global models predict treatment responses accurately even without a genotype, out-performed the local South African models and have the potential to help optimize therapy, particularly in resource-limited settings. [ABSTRACT FROM AUTHOR]

This study examined how the perception of the availability of leisure opportunities may prevent substance use initiation through HealthWise, a school-based program focused on reducing risky behavior. In this study, we specifically focused on whether HealthWise increased student perceptions of leisure opportunities between 8th grade and 10th grade (N = 5610) in an under-resourced community in South Africa. Path analyses were used to test hypotheses. Given gender differences in substance use patterns, societal norms, and leisure opportunities in under-resourced communities, such as the townships of Cape Town, South Africa, it was especially important to examine associations within each gender. Results suggested that HealthWise directly reduced the likelihood of initiating alcohol and cigarette use and increased the amount of perceived leisure opportunities among girls but not boys. Perceived leisure opportunities mediated the effect of HealthWise on reducing the initiation of alcohol and cigarette use directly, and marijuana use indirectly, among girls but not boys. This is the first study to demonstrate how experimentally targeting leisure through an intervention can increase perceived leisure opportunities and thereby prevent early substance use initiation for a specific population. The importance of considering the context of gender, age, and location is discussed. [ABSTRACT FROM AUTHOR]