Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomized controlled trial to evaluate effects on breastfeeding, child health, and survival outcomes, among women living with HIV (MTI-MI).

BACKGROUND: Many infants in low-resourced settings at high risk of infectious disease morbidity and death are deprived of the immunological and nutritional benefits of breast milk, through an attenuated duration of breast milk exposure. South Africa has one of the lowest exclusive breastfeeding rates in Africa, with 8% of infants under 6 months of age. We assume that breastfeeding is sustained among women living with HIV receiving weekly text messages and motivational interviewing and that this contributes to improved infant health outcomes. OBJECTIVES: (1) To evaluate the effectiveness of a combined intervention of mobile phone text messaging and motivational interviewing in promoting (a) exclusive breastfeeding and (b) any form of breastfeeding, until 6 months of child age, compared to usual care, among mothers living with HIV. (2) To evaluate the effectiveness of a combined intervention on (a) reduction in all-cause hospitalization and mortality rates and (b) improvements in infant linear growth, compared to usual care, among HIV-exposed infants aged 0-6 months. METHODS: We are conducting a clinical trial to determine whether text messaging plus motivational interviewing prolongs breastfeeding and improves infant health outcomes. We are recruiting 275 women living with HIV and their HIV-exposed infants at birth and randomly assign study interventions for 6 months. STATISTICAL METHODS: Breastfeeding rates are compared between the study groups using a standard proportion test and binomial regression. Survival endpoints are presented using Kaplan-Meier survival curves and compared between the study groups using the Cox proportional-hazards regression model. The count endpoint is analysed using the Poisson random-effects model and mean cumulative function. We use mixed linear regression models to assess the evolution of infant growth over time. The maximum likelihood method will be used to handle missing data. DISCUSSION: The study findings may facilitate decision-making on (1) whether implementation of the breastfeeding policy achieved the desired outcomes, (2) interventions needed to sustain breastfeeding, and (3) whether the interventions do have an impact on child health. TRIAL REGISTRATION: ClinicalTrials.gov NCT05063240. Pan African Clinical Trial Registry PACTR202110870407786. Oct. 1, 2021.

Evaluating interactive weekly mobile phone text messaging plus motivational interviewing for breastfeeding promotion among women living with HIV, giving normal birth at a primary healthcare facility in South Africa: a feasibility randomised controlled trial.

OBJECTIVES: We assessed the feasibility of an appropriately powered randomised trial by evaluating whether participants could be recruited and retained, and sought preliminary information on exclusive breastfeeding rates. SETTING: Primary healthcare facility, serving a rural community. PARTICIPANTS: Women initiating breast feeding within 24 hours of giving birth, on antiretroviral treatment and aged ≥18 years. INTERVENTIONS: We randomised mother-infant pairs to receive weekly text messaging encouraging exclusive breast feeding plus in-person individual motivational interviews post partum at weeks 2, 6 and 10, or standard infant feeding counselling. OUTCOME MEASURES: The feasibility endpoints included number of participants who consented to participate and number with complete evaluation of infant feeding practices at study visits. Exploratory endpoints included number of participants who exclusively breast fed at 24 weeks post partum and number of participants adhering to study protocol. RESULTS: Of 123 mothers screened, 52 participants consented for participation. We recruited an average of five participants per month over 11 months. Most participants were unemployed (75%), had some high school education (84%) and had disclosed their HIV status to someone close (88%). About 65% participants completed outcome evaluation at week 10, decreasing to 35% at week 24. Twenty participants had the week 24 visit planned between 20 March and August 2020, during COVID-19 lockdown. Of these, 4 completed the visit telephonically, 16 were lost to follow-up. Exclusive breastfeeding rate remained relatively high across both groups through week 24. The difference in exclusive breastfeeding rates between the intervention and control groups was minimal: rate difference 22.2% (95% CI -20.1% to 64.5%). CONCLUSIONS: With a large eligible target population, recruitment targets could be achieved for a large trial. Strategies to retain participants, such as remote monitoring and in-person follow-up visits, will be essential. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT02949713) and Pan African Clinical Trial Registry (PACTR201611001855404).

COVID-19 lockdown effect on healthcare utilization and in-hospital mortality in children under 5 years in Cape Town, South Africa: a cross-sectional study.

BACKGROUND: COVID-19 pandemic measures resulted in the de-escalation of non-COVID-19 healthcare provision. METHODS: A retrospective cross-sectional study of routinely collected data was done to investigate the effect of COVID-19 policies on the healthcare utilization and mortality of children younger than 5 years in Eastern Cape Town, South Africa. We compared visits to primary and urgent care facilities, hospitalization, in-hospital deaths, and vaccine uptake from 1 January to 31 December 2020 to similar periods in 2018 and 2019. RESULTS: During April and May 2020, the most restricted period, visits to primary care facilities declined from 126 049 in 2019 to 77 000 (1.8-fold; p < 0.05). This corresponded with a 1.2-fold reduction in the provision of the first dose of measles vaccine at 6 months compared to 2019. Throughout 2020 there was a 4-fold decline in the number of fully immunized children at 1 year of age (p = 0.84). Emergency room visits fell by 35.7% in 2020 (16 368) compared to 2019 (25 446). Hospital admissions decreased significantly (p < 0.01) in 2020 (9810) compared to 2018 (11 698) and 2019 (10 247). The in-hospital mortality rate increased from 2.3% (96/4163) in 2019 to 3.8% (95/2498) (p < 0.01) in Tygerberg Hospital, where 80% (95/119) of deaths were recorded. Twelve of the 119 (10%) deaths occurred in HIV-positive children (p = <0.01). CONCLUSION: Measures instituted during the COVID-19 pandemic disrupted access to healthcare services for children. This resulted in an immediate, and potential future, indirect effect on child morbidity and mortality in Cape Town.

During the COVID-19 pandemic in 2020, lockdown policies restricted movement of people and non-COVID-19 healthcare services were de-escalated. In a large district, Metro East, in Cape Town, South Africa, this resulted in a 1.8-fold decline in primary healthcare clinic visits in children less than 5 years of age. Routine immunizations were negatively impacted with a 1.2-fold decline in the uptake of the first dose of measles vaccine at 6 months of age and a 1.4-fold decline in the number of fully immunized children at 1 year of age. Hospital admissions decreased significantly from 10 247 and 11 698 in 2019 and 2018, respectively, to 9810 admissions in 2020. Although fewer deaths (119) were reported in hospitals in Metro East District, Cape Town, South Africa in 2020, the deaths per number of admissions increased from 2.3% (96/4163) in 2019 to 3.8% (95/2498) in Tygerberg Hospital, where 80% (95/119) of deaths were recorded. Measures instituted during the COVID-19 pandemic in 2020 thus disrupted the access to healthcare services for children. This resulted in an immediate, and potential future, indirect effect on child health and survival in Cape Town.

Survival and health of children who are HIV-exposed uninfected: study protocol for the CHERISH (Children HIV-Exposed Uninfected - Research to Inform Survival and Health) dynamic, prospective, maternal-child cohort study.

INTRODUCTION: CHERISH is designed to establish a long-term sustainable system for measurement of in utero and postnatal exposures and outcomes in children who are HIV-exposed uninfected (HEU) and HIV-unexposed to compare survival, hospitalisation, growth and neurodevelopment in the Western Cape, South Africa. METHODS AND ANALYSIS: During 2022-2025, the CHERISH dynamic cohort is prospectively enrolling pregnant people with and without HIV at 24-36 weeks gestation from one urban and one rural community, following mother-child pairs, including children who are HEU (target N=1200) and HIV-unexposed (target N=600) for 3 years from the child's birth. In-person visits occur at enrolment, delivery, 12 months, 24 months and 36 months with intervening 3-monthly telephone data collection. Children and mothers without HIV are tested for HIV at all in-person visits. Data on exposures and outcomes are collected from routine standardised healthcare documentation, maternal interview, measurement (growth and neurodevelopment) at in-person visits and linkage to the Western Cape Provincial Health Data Centre (survival and hospitalisation). A priori adverse birth outcomes, advanced maternal HIV and maternal mental health are considered potential mediators of outcome disparities in children who are HEU and will be evaluated as such in multivariable models appropriate for each outcome. ETHICS AND DISSEMINATION: Mothers interested in joining the study are taken through a visual informed consent document for their and their child's participation, with the option to consent to anonymised de-identified data being contributed to a public data repository. All data is captured directly into an electronic database using alphanumeric identifiers devoid of identifying information. The cohort study is approved by Human Research Ethics Committees of Stellenbosch University (N20/08/084), University of Cape Town (723/2021) and Western Cape Government (WC_2021_09_007). Findings will be shared with participants, participating communities, local and provincial stakeholders, child health clinicians, researchers and policymakers at local, national and international forums and submitted for publication in peer-reviewed journals.

Health research publications by South African authors from 1996 to 2015: a bibliometric analysis.

Introduction: research publications have a vital role in the scientific process, providing a strategic connection between the generation of new knowledge and its conversion into policy, practice, and positive health outcomes. There was a substantial increase in research funding in South Africa from the dawn of multi-party democracy in the mid-1990s to 2015. However, it is not known whether there was a corresponding increase in research publications from the country. Therefore, the objective of this bibliometric study was to assess trends and factors associated with health research publications from South Africa between 1996 and 2015. Methods: in July 2016, we searched Scopus for health science articles published between 01 January 1996 and 31 December 2015 with at least one author affiliated to an institution based in South Africa. We sought annual data on national-level indicators from Statistics South Africa and World Bank data. We used Poisson regression to examine trends in publication outputs and negative binomial regression to explore national-level factors associated with a change in the number of publications over time. Results: we identified 51,133 publications, with a mean of 2,557 publications per year. Four universities (University of Cape Town, University of the Witwatersrand, Stellenbosch University, and the University of Pretoria) contributed more than half of the publications. The top destination journals were the South African Medical Journal (14.57% of the articles), PLoS ONE (5.77%), South African Family Practice (4.68%), Journal of the South African Veterinary Association (2.48%), and The Lancet (2.37%). The annual number of publications increased five-fold from 1133 in 1996, with an upsurge after 2003, to 5820 in 2015. The average annual percentage growth in the number of publications rose from 3.31% in 1996-2000 to 13.63% in 2011-2015. Year of publication (incidence rate ratio 1.16, 95% confidence interval 1.14 to 1.18) and annual private expenditure on health (incidence rate ratio 1.08, 95% confidence interval 1.05 to 1.10) were independent predictors of publication output. Conclusion: the number of health research publications from South Africa grew substantially between 1996 and 2015, with wide variation in output among universities. Private expenditure on health may be a proxy of health research funding, which probably explains its association with publication output in this study.

Peripheral-blood cytopenia, an early indicator of inborn errors of immunity.

Inborn errors of immunity (IEI) are inherited monogenic disorders resulting in defective immune response. Non-infectious presentations are increasingly more apparent. Widely available, cost-effective early indicators are needed. Peripheral-blood cytopenia may be a presenting laboratory feature or an observed secondary phenomenon. This retrospective review of the South African Primary Immunodeficiency Registry (SAPIDR) aimed to assess the haematological indices at presentation and their association with the International Union of Immunological Societies (IUIS) 2019 IEI classification and mortality. Of 396 patients on the SAPIDR, 66% (n = 257) had available haematological results. Sixty percent were males and 85% under 18 years. A majority (53%) had predominantly antibody deficiency. At presentation, infection was prominent (86%) followed by cytopenia (62%). Neutropenia was associated with IUIS III [odds ratio (OR) 3.65, confidence interval (CI) 1.44-9.25], thrombocytopenia with IUIS II (OR 14.39, CI 2.89-71.57), lymphopenia with IUIS I (OR 12.16, CI 2.75-53.73) and pancytopenia with IUSI I (OR 12.24, CI 3.82-39.05) and IUIS II (OR 5.99, CI 2.80-12.76). Cytopenia showed shorter overall survival (OR 2.81, CI 1.288-4.16). Cytopenias that are severe, persistent, unusual and/or recurrent should prompt further investigation for IEI. The full blood count and leucocyte differential may facilitate earlier identification and serve as an adjunct to definitive molecular classification.

Cross-sectional study of acral melanoma awareness in a group of South African final phase medical students.

BACKGROUND: Acral melanoma refers to melanoma arising on the palms, soles and nail unit, which are sun-protected areas and ultraviolet exposure is not a risk factor. Acral melanoma is associated with a poorer prognosis than other melanoma subtypes most likely due to the high rates of delayed diagnosis. Acral melanoma affects all skin types equally. There is a misconception that people with more pigmented skin types (Fitzpatrick 4-6) do not develop melanoma, due to the protective effect of melanin. OBJECTIVES: The aim of the study was to determine acral melanoma knowledge and awareness of a group of South African, final phase medical students. METHODS: This was a quantitative and cross-sectional study. A questionnaire consisting of 20 clinical images of skin lesions requiring a diagnosis and management plan was distributed. Responses to six images of melanomas were analysed. Further questions to measure acral melanoma knowledge and related issues were included in the study. A biostatistician appropriately managed statistical analysis. RESULTS: Hundred and one final phase medical students' answers were gathered and analysed. Only 7.9% of the participants diagnosed all six melanomas correctly; 61.4% correctly diagnosed ≥50% of the melanomas. While 77.2% of the participants identified all non-acral cutaneous melanoma correctly, only 8.9% identified all acral melanomas. However, of all participants making the correct diagnosis, >90% selected the appropriate management plan (urgent referral). LIMITATIONS: This study examined a small sample of trainee healthcare workers. The results cannot be assumed to apply to all South African healthcare workers. Responses given in a questionnaire may not reflect actual behaviour. The dermatology division in question has made acral melanoma a research priority, thus acral melanoma knowledge in this group may in fact be better than in other institutions. CONCLUSION: The present study demonstrates that groups of imminent doctors have low rates of recognition of melanoma, particularly acral melanoma. This is consistent with high levels of primary misdiagnosis of acral melanoma reported in the literature. Fortunately, these participants managed the melanomas they diagnosed appropriately in >90% of cases. This confirms that the deficit in the participant group is awareness and knowledge. Those aware of the disease immediately acknowledged the need for urgent referral.

Incidence and factors associated with being a victim of community assault; retrospective review of medical records in an Emergency Centre.

INTRODUCTION: Community assault is an interpersonal violence frequently seen in the emergency centres around South Africa. Its aim is to inflict serious injuries to a suspected perpetrator. Data has not been published in Mamelodi Regional Hospital setting whereas the cases have been observed in the emergency centre (EC). The study objectives were to determine the incidence and factors associated with being a victim of community assault in the EC in a regional hospital in Pretoria and clinical outcomes. METHODS: We retrospectively reviewed the medical records of adult patients who were treated for assault in the EC of Mamelodi Regional Hospital between 5 March 2017 and 5 March 2018. EC electronic registries and medical file were used to identify all patients who presented with body injuries due to assault. RESULTS: Only 807 of 1070 medical records had complete data on the exposure variables of study interest. Of the 807 participants who presented with body injury due to assault, 77 (9.544% (95% CI 7.52 to 11.57)) were due to community assault. The majority of the victims were young adults, of male gender and not married. More than half of the participants were unemployed. Young adult age doubled the odds of being a victim of community assault odds ratio (OR) 2.19 (95% CI 1.02 to 4.70). The odds of being a victim of community assault for males were 11 times the odds of females OR 11.30 (95% CI 2.74 to 46.49). Of the 77 victims of community assault, 45 (58%) were admitted, 25 (32%) were discharged after receiving treatment, 6 (8%) refused treatment and 1 (1%) died. DISCUSSION: We describe the incidence of, and factors associated with, community assault in the EC of Mamelodi Regional Hospital in Pretoria. Our findings suggest that a modest incidence rate of being a victim of community assault. Young adult males are mostly the target victims of community and non-community assault. Further research is needed to understanding factors precipitating community assault and to test potential community and non-community assault prevention interventions, targeting young adult males.

Viral hepatitis associated hepatocellular carcinoma on the African continent, the past, present, and future: a systematic review.

BACKGROUND: Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related deaths in Africa. In Africa, the major causes of HCC include chronic infection with hepatitis B virus (HBV) and/or hepatitis C virus (HCV). Knowledge of the changes in the incidence of viral hepatitis-associated HCC over time and the factors responsible for such changes is key in informing policies for the prevention of viral hepatitis-associated HCC in Africa. AIM: The study aimed to systematically summarize the changes in the prevalence of viral hepatitis among HCC patients and the overall effect of the prevalence of viral hepatitis on the incidence of HCC over the past four decades in Africa (1980-2019). METHODS: A literature search was conducted in MEDLINE (PubMed), Google Scholar, Science Direct, Scopus, Web of Science, and African wide web for articles published on viral hepatitis-associated HCC in Africa from 1980 to 2019. The abstracts of the articles were screened for eligibility and those meeting the inclusion criteria were retrieved and reviewed. RESULTS: A total of 272 studies were included in the analysis. Viral hepatitis-related HCC incidence changed by 1.17% (95% confidence interval (CI): 0.63-1.71, p < 0.001), 0.82% (95% CI: 0.45-1.18, p < 0.001), and 3.34% (95% CI: 2.44-4.25, p < 0.001) for every 1% change in the prevalence of HBV, HCV, and hepatitis D virus (HDV) respectively, per decade. The incidence of HBV-related HCC decreased by - 0.50% (95% CI: - 0.74 - - 0.25, p < 0.001) over the last 40 years, while HCV-related HCC increased. CONCLUSION: Overall, the incidence of viral hepatitis-associated HCC has not declined, mainly due to no decline in the prevalence of HCV, HDV, and the high number of chronic hepatitis B carriers on the African continent. There is an urgent need for the allocation of resources for the implementation of treatment and preventive programs for HBV, HCV, HDV, and HCC in Africa. This systematic review is registered with PROSPERO®, number CRD42020169723.

Clozapine-Associated Leukopenia and Agranulocytosis in Western Cape, South Africa: A 3-Year Retrospective Cohort Study.

BACKGROUND: Clozapine may cause life-threatening hematological side effects (HSEs). Hematological side effect incidence data from Sub-Saharan Africa are lacking. Furthermore, clozapine reduces cellular immunity, and it is unknown whether clozapine is a risk factor for tuberculosis or whether HIV is a risk factor for developing HSEs. We assessed the incidence of HSEs in South Africans from the Western Cape Province on clozapine, and the secondary objective was to determine the association of HIV and tuberculosis with clozapine exposure. METHODS: We conducted a 24-week retrospective descriptive study of patients initiated on clozapine between January 2015 and December 2017 using anonymized data from the Provincial Health Data Centre. A control group of patients initiated on risperidone was selected. RESULTS: We identified 23,328 patients and included 5213 who had white blood cell monitoring (n = 1047 clozapine, n = 4166 risperidone). The incidence of leukopenia in patients on clozapine was 0.38% (95% confidence interval [CI], 0.01%-0.76%) measured over a 24-week period and was 0.41% in patients on risperidone (95% CI, 0.21%-0.6%) (P = 0.91). The incidence of agranulocytosis in patients on clozapine was 0.19% (95% CI, 0.00%-0.46%) measured over a 24-week period and was 0.24% in patients on risperidone (95% CI, 0.09%-0.39%) (P = 0.266). HIV-infected patients had a 7.46 times increased risk of developing leukopenia (95% CI, 3.37-16.48; P < 0.01). Patients who developed leukopenia had a 6.24 times increased risk of contracting tuberculosis (95% CI, 1.84-21.11; P < 0.01). CONCLUSIONS: Our incidence of clozapine-induced HSEs was lower than previously reported and not significantly different compared with risperidone. HIV infection was associated with HSEs. Patients with HSEs had an increased risk of developing tuberculosis.

A Review of Adherence and Predictors of Adherence to the CONSORT Statement in the Reporting of Tuberculosis Vaccine Trials.

The statement on Consolidated Standards of Reporting Trials (CONSORT) ensures transparency in the reporting of randomized trials. However, it is unclear if the statement has led to improvement in the quality of reporting of tuberculosis (TB) vaccine trials. We explored the quality of reporting of TB vaccine trials according to the latest version of the CONSORT statement, released in 2010. We searched PubMed and the Cochrane Central Register of Controlled Trials in August 2019. We conducted screening, study selection, and data extraction in duplicate; and resolved differences through discussion. We assessed reporting to be adequate if trials reported at least 75% of the CONSORT 2010 items. We conducted a trend analysis to assess if there was improvement in reporting over time. We also used logistic regression to assess factors associated with adequate reporting. We included 124 trials in the analyses. The mean proportion of adherence was 67.3% (95% confidence interval 64.4% to 70.1%), with only 46 (37%) trials having adequate reporting. There was a significant improvement in the quality of reporting over time (p < 0.0001). Trials published in journals with impact factors between 10 and 20 were more likely to have adequate reporting (odds ratio 9.4; 95% confidence interval 1.30 to 67.8), compared to lower-impact-factor journals. Despite advances over time, the reporting of TB vaccine trials is still inadequate and requires improvement.

Determinants of poor adherence to antiretroviral treatment using a combined effect of age and education among human immunodeficiency virus infected young adults attending care at Letaba Hospital HIV Clinic, Limpopo Province, South Africa.

INTRODUCTION: sustained viral suppression using antiretroviral treatment (ART) occurs with adherence to treatment of at least 95%. Non-adherence promotes the development of drug-resistance and treatment failure in individuals infected with Human Immunodeficiency Virus. In Limpopo Province, the adherence rate is approximately 61%, but the prevalence and the factors associated with adherence at Letaba hospital HIV clinic are not well established. Therefore, the aim of this study was to identify the factors associated with adherence among HIV-infected young adults, aged 18-35 years, attending the clinic. METHODS: a cross-sectional survey was conducted in Letaba HIV clinic among young adults of 18-35 years old. Logistic regression analysis was performed to determine factors associated with ART adherence. We reported odds ratios with the corresponding 95% confidence intervals and p-values. A p-value < 0.1 was considered as statistically significant. ART adherence was defined as taking more than 95% of the prescribed treatment, 3 days prior to completion of the questionnaire. RESULTS: a total of 281 participants were enrolled with 163 (58.0%) females and more than three quarter, 222 (79.0%) between the ages of 18 and 29 years. The overall ART adherence stood at (87.2%) (95% CI: 63.0%-89.0%) representing 245 participants. Non-adherers to treatment, 36 (12.8%): patients reported no reason (3.9%), forgetting (3.2%), feeling good (3.2%), fear and running out of treatment (2.5%) as some of the reasons for not taking treatment within the three days prior to data collection. The following factors: tertiary education (p = 0.07), age (30-35; p-value: 0.07), drug availability (p-value: 0.07), were only marginally significantly associated with ART adherence. CONCLUSION: the study found unsatisfactory ART adherence among our participants. Our study suggests that factors other than sociodemographic and clinical factors might better explain differences in adherence. This highlights the need for a more complex study that would look at the entire system in which these patients are navigating as well as their mental models.

Intervention for alcohol use disorders at an HIV care clinic in Harare: a pilot and feasibility study.

BACKGROUND: Alcohol use in HIV infected patients is associated with risky sexual behaviour, poor adherence to Highly Active Antiretroviral Therapy, treatment failure and increased physiologic harm. The objectives of the study were to pilot the outcome assessments to be used in the trial proper, assess the feasibility of delivery of a brief MI/CBT intervention compared to an WHO mhGAP intervention for problematic alcohol use in PLWH in Zimbabwe, and pilot the effectiveness (on alcohol use, functionality and CD4 count) of these interventions at 3 months in a randomised controlled trial design. METHODS: An intervention for HIV infected patients with problematic alcohol use, developed through adaptation of existing evidence based psychological treatments, was assessed for its feasibility at a tertiary HIV care clinic in Zimbabwe. Registered general nurses, using a manualised protocol, delivered the intervention. Forty patients were recruited and randomised to receive either an MI/CBT intervention or the WHO mhGAP Intervention Guide for AUDs (n = 20 patients per group). RESULTS: Out of 40 participants enrolled, 31 were successfully followed up for 3 months with a loss to follow-up rate of 23%. There was a statistically significant decrease in AUDIT score over time in both groups (p < 0.001), however no statistically significant group difference with a mean difference of 0.80, standard error of 2.07 and p = 0.70. For the CD4 count, the median and interquartile ranges at baseline for MI/CBT and WHO mhGAP IG groups were 218 (274) and 484 (211.50), respectively. At follow-up, median and interquartile ranges for the CD4 count for MI/CBT and WHO mhGAP IG groups were 390 (280) and 567 (378), respectively, indicative of improvement in immunological parameters in both arms. CONCLUSION: The findings from this pilot study suggests that a brief MI/CBT delivered by Registered General Nurses for problematic alcohol use is feasible in this population but will require the implementation of additional measures to improve retention. However, mechanisms to improve retention need special attention. Trial registration Pan African Clinical Trial Registry, current PACTR201509001211149.

Combination antiretroviral treatment use in prevention of mother-to-child transmission programmes: 6-week HIV prevalence and relationship to time of antiretroviral treatment initiation and mixed feeding.

BACKGROUND: In Zimbabwe, 16% of pregnant women aged 15-49 years are infected with HIV. More than 90% of HIV infection in children is through mother-to-child transmission (MTCT). We investigated the effectiveness of the Option B+ in reducing HIV infection and factors associated with HIV transmission among infants born to mothers enrolled in the prevention of mother-to-child transmission (PMTCT) programme. METHODS: We randomly selected 1204 early infant HIV diagnosis test results for HIV-exposed infants and linked these results to maternal clinical records at primary healthcare clinics in Harare to estimate the prevalence of MTCT and to determine the clinical factors associated with MTCT of HIV at 6 weeks. RESULTS: Of the 1204 infants in the study, 2.5% (95% confidence interval [CI], 1.7-3.5) were infected with HIV at 6 weeks post-delivery. Antiretroviral adherence reduced the odds of HIV infection by about 99% (odds ratio [OR] 0.01 [95% CI, 0.00-0.06]). Both mixed feeding (OR 3.89 [95% CI, 0.92-16.50]) and late initiation of antiretroviral treatment (ART) (after delivery) (OR 3.18 [95% CI, 0.42-23.94]) increased the odds of HIV infection. CONCLUSION: Early initiation of combination ART reduces 6-week MTCT of HIV in PMTCT programmes to levels similar to those found in controlled trial settings. Exclusive breastfeeding remains important even in the presence of ART.

Output from the CIHR Canadian HIV Trials Network international postdoctoral fellowship for capacity building in HIV clinical trials.

As a response to the human immunodeficiency virus (HIV) epidemic and part of Canadian Institutes for Health Research's mandate to support international health research capacity building, the Canadian Institutes for Health Research Canadian HIV Trial Network (CTN) developed an international postdoctoral fellowship award under the CTN's Postdoctoral Fellowship Awards Program to support and train young HIV researchers in resource-limited settings. Since 2010, the fellowship has been awarded to eight fellows in Cameroon, China, Lesotho, South Africa, Uganda and Zambia. These fellows have conducted research on a wide variety of topics and have built a strong network of collaboration and scientific productivity, with 40 peer-reviewed publications produced by six fellows during their fellowships. They delivered two workshops at international conferences and have continued to secure funding for their research, using the fellowship as a stepping stone. The CTN has been successful in building local HIV research capacity and forming a strong network of like-minded junior low- and middle-income country researchers with high levels of research productivity. They have developed into mentors, supervisors and faculty members, who, in turn, build local capacity. The sustainability of this international fellowship award relies on the recognition of its strengths and the involvement of other stakeholders for additional resources.

Early Breastfeeding Cessation Among HIV-Infected and HIV-Uninfected Women in Western Cape Province, South Africa.

As part of the Mother-Infant Health Study, we describe infant feeding practices among HIV-infected and HIV-uninfected mothers over a 12-month period when the Western Cape Province prevention of mother-to-child transmission (PMTCT) program was transitioning from a policy of exclusive formula feeding to one of exclusive breastfeeding. Two hundred pairs of mother and HIV-uninfected infant were included in the analysis, among whom 81 women were HIV uninfected and breastfeeding. Of the 119 HIV-infected mothers, 50 (42%) were breastfeeding and 69 (58%) were formula feeding. HIV-infected mothers predominantly breastfed for 8.14 (7.71-15.86) weeks; HIV-uninfected mothers predominantly breastfed for 8.29 (8.0-16.0) weeks; and HIV-infected mothers predominantly formula fed for 50.29 (36.43-51.43) weeks. A woman's HIV status had no influence on the time to stopping predominant breastfeeding (P = 0.20). Our findings suggest suboptimal duration of breastfeeding among both HIV-infected and HIV-uninfected mothers. Providing support for all mothers postdelivery, regardless of their HIV status, may improve breastfeeding practices.

Quality of pilot trial abstracts in heart failure is suboptimal: a systematic survey.

BACKGROUND: Pilot trials are miniature researches carried out with the sole aim of acting as the precursor for larger more definitive studies. Abstracts are used to summarize and introduce the findings to the reading audience. There is substantive empirical evidence showing that abstracts, despite their important roles, are not informative enough, lacking the necessary details. This systematic survey was designed to assess the quality of reporting of heart failure pilot trial abstracts. The quality of reporting was defined as the completeness of reporting based on adherence to the CONSORT extension for reporting of pilot trial abstracts. We also identified factors associated with reporting quality. METHODS: We searched MEDLINE (PubMed), Cochrane Controlled Trials Register, Scopus, and African-wide information databases for abstracts from heart failure pilot trials in humans published from 1 January 1990 to 30 November 2016. These were assessed to determine the extent of adherence to CONSORT extension checklist for reporting of abstracts of pilot trials. We screened identified studies for inclusion based on title and abstract. Data were independently extracted by two reviewers using the checklist. We used regression analysis to assess the association between completeness of reporting (measured as the number of items in the CONSORT extension checklist for reporting of abstracts in pilot trials contained in each abstract) and factors influencing the quality of the reports. RESULTS: Two hundred and twenty-eight (228) articles were retrieved, of which 92 met the inclusion criteria. The mean CONSORT extension score was 8.3/16 (standard deviation 1.7); the least reported items were the source of funding (1% [1/92]), trial registration (13% [12/92]), randomization sequence (13% [12/92]), number randomized to each arm (16% [15/92]), and number analyzed in each arm (16% [15/92]). Multivariable regression analysis showed that pharmacological intervention pilot trials [incidence rate ratio (IRR) = 0.88; 95% confidence interval (CI), 0.81-0.97] were significantly associated with better reporting. Other factors such as structured abstract (IRR = 1.10; 95% CI, 0.99-1.23) and CONSORT endorsement (IRR = 1.10; 95% CI, 0.99-1.23) only showed minimal relationship with better reporting quality. CONCLUSION: The quality of reporting of abstracts of heart failure pilot trials was suboptimal. Pharmacological intervention was significantly associated with better reporting. These findings are consistent with previous research on reporting of trials.

The impact of family physician supply on district health system performance, clinical processes and clinical outcomes in the Western Cape Province, South Africa (2011-2014).

BACKGROUND:  A revised family physician (FP) training programme was introduced in South Africa in 2007. A baseline assessment (2011) of the impact of FP supply on district health system performance was performed within the Western Cape Province, South Africa. The impact of an increased FP supply within this province required re-evaluation. AIM:  To assess the impact of FP supply on indicators of district health system performance, clinical processes and clinical outcomes in the Western Cape Province. The objectives were to determine the impact of FPs, nurses, medical officers (MOs) and other specialists. SETTING:  The study sample included all five rural districts and eight urban subdistricts of the Western Cape Province. METHODS:  A secondary analysis was performed on routinely collected data from the Western Cape Department of Health from 01 March 2011 until 30 April 2014. RESULTS:  The FP supply did not significantly impact the indicators analysed. The supply of nurses and MOs had an impact on some of the indicators analysed. CONCLUSION:  This study did not replicate the positive associations between an increase in FP supply and improved health indicators, as described previously for high-income country settings. The impact of FP supply on clinical processes, health system performance and outcome indicators in the Western Cape Province was not statistically significant. Future re-evaluation is recommended to allow for more time and an increase in FP supply.

Inter-rater reliability in the radiological classification of renal injuries.

INTRODUCTION: Although many radiologists invoke the surgical classification of renal injury proposed by the American Association for Surgery in Trauma (AAST), there has been only limited work on the role of the AAST system as an imaging stratification. The aim was to determine the inter-rater reliability (IRR) amongst radiologists and urologists using the AAST system. METHODS: A 1-year retrospective study of consecutive patients with computed tomography (CT) evidence of renal trauma managed at a Level 1 trauma center. Three radiologists and three urologists independently stratified the presentation CT findings according to the AAST renal trauma classification. Agreement between independent raters and mutually exclusive groups was determined utilizing weighted kappa coefficients. RESULTS: One hundred and one patients were included. Individual inter-observer agreements ranged from 54/101 (53.4%) to 62/101 (61.4%), with corresponding weighted kappa values from 0.61 to 0.69, constituting substantial agreement. Urologists achieved intra-disciplinary agreement in 49 cases (48.5%) and radiologists in 36 cases (35.6%). Six-reader agreement was achieved in 24 cases (23.7%). The AAST grade I injuries had the highest level of agreement, overall. CONCLUSION: The finding of substantial IRR amongst radiologists and urologists utilizing the AAST system supports continued use of the broad parameters of the AAST system, with some modification in specific categories with lower agreement.

Isoniazid for preventing tuberculosis in HIV-infected children.

BACKGROUND: Tuberculosis (TB) is an important cause of illness and death in HIV-positive children living in areas of high TB prevalence. We know that isoniazid prophylaxis prevents TB in HIV-negative children following TB exposure, but there is uncertainty related to its role in TB preventive treatment in HIV-positive children. OBJECTIVES: To summarise the effects of TB preventive treatment versus placebo in HIV-positive children with no known TB contact on active TB, death, and reported adverse events. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE/PubMed, Embase and two trial registers up to February 2017. SELECTION CRITERIA: We included trials of HIV-positive children with and without known TB exposure, randomized to receive TB preventive treatment or placebo. DATA COLLECTION AND ANALYSIS: Two review authors independently used the study selection criteria, assessed risk of bias, and extracted data. We assessed effects using risk, incidence rate and hazard ratios and assessed the certainty of evidence using GRADE. MAIN RESULTS: We included three trials, involving 991 participants, below the age of 13 years, from South Africa and Botswana. Children were randomized to isoniazid prophylaxis or placebo, given daily or three times weekly. The median length of follow-up ranged from 5.7 to 34 months; some were on antiretroviral therapy (ART).In HIV-positive children not on ART, isoniazid prophylaxis may reduce the risk of active TB (hazard ratio (HR) 0.31, 95% confidence interval (CI) 0.11 to 0.87; 1 trial, 240 participants, low certainty evidence), and death (HR 0.46, 95% CI 0.22 to 0.95; 1 trial, 240 participants, low certainty evidence). One trial (182 participants) reported number of children with laboratory adverse events, which was similar between the isoniazid prophylaxis and placebo groups. No clinical adverse events were reported.In HIV-positive children on ART, we do not know if isoniazid prophylaxis reduces the risk of active TB (risk ratio (RR) 0.76, 95% CI 0.50 to 1.14; 3 trials, 737 participants, very low certainty evidence) or death (RR 1.45, 95% CI 0.78 to 2.72; 3 trials, 737 participants, very low certainty evidence). Two trials (714 participants) reported number of clinical adverse events and three trials (795 participants) reported number of laboratory adverse events; for both categories, the number of adverse events were similar between the isoniazid prophylaxis and placebo groups. AUTHORS' CONCLUSIONS: Isoniazid prophylaxis given to all children diagnosed with HIV may reduce the risk of active TB and death in HIV-positive children not on ART in studies from Africa. For children on ART, no clear benefit was detected. .