Fediša Modikologo: breaking the intergenerational cycle of violence against women and children. Theoretical framework and protocol for a prospective cohort study.

In South Africa, after two decades of national femicide surveillance, we know comparatively little about what places women who experience intimate partner violence (IPV) at risk of intimate partner femicide. Further we have not mapped the multi-generational health, social and economic impact of severe IPV on women subjected to it, and their children, nor the consequences of help-seeking, nor described what helps, STET recovery trajectories. This study aims to deepen understanding of risk factors for femicide and the health, social and economic impacts of severe IPV on women and their families, including understanding risk and resilience to intergenerational cycling of violence.

The epidemiology of malaria in four districts in southern Mozambique receiving indoor residual spray as part of a cross-border initiative.

Background: Imported malaria from southern Mozambique drives low levels of disease transmission in KwaZulu-Natal, South Africa. Therefore, the South African Department of Health funded implementation of indoor residual spraying (IRS) in Mozambiquan districts identified as sources of malaria infection for border communities in KwaZulu-Natal. IRS was initiated in districts of Guija, Inharrime, Panda and Zavala.

Safety, effectiveness and immunogenicity of heterologous mRNA-1273 boost after prime with Ad26.COV2.S among healthcare workers in South Africa: The single-arm, open-label, phase 3 SHERPA study.

Limited studies have been conducted on the safety and effectiveness of heterologous COVID-19 vaccine boosting in lower income settings, especially those with high-HIV prevalence., The Sisonke Heterologous mRNA-1273 boost after prime with Ad26.COV2.

The injectable contraceptives depot medroxyprogesterone acetate and norethisterone enanthate substantially and differentially decrease testosterone and sex hormone binding globulin levels: A secondary study from the WHICH randomized clinical trial.

HIV acquisition risk with norethisterone (NET) enanthate (NET-EN) is reportedly less than for depo-medroxyprogesterone acetate intramuscular (DMPA-IM). We investigated the effects of these progestin-only injectable contraceptives on serum testosterone and sex hormone binding globulin (SHBG) levels, since these may play a role in sexual behavior and HIV acquisition. The open-label WHICH clinical trial, conducted at two sites in South Africa from 2018-2019, randomized HIV-negative women aged 18-40 years to 150 mg DMPA-IM 12-weekly (n = 262) or 200 mg NET-EN 8-weekly (n = 259).

Risk factors associated with medical encounters in ultramarathon race starters - Data from 103,131 race starters over 90 km: SAFER XLI.

Objectives: To identify the risk factors associated with all medical encounters (MEs) and serious/life-threatening MEs (SLMEs) during the Comrades Marathon.

Design: Prospective cohort study, with cross-sectional analyses.

Methods: During the 2014-2019 Comrades Marathon, all MEs (including SLMEs) were recorded in 103,131 starters.

Safety and pharmacokinetics of subcutaneous administration of broadly neutralizing anti-HIV-1 monoclonal antibodies (bNAbs), given to HIV-1 exposed, uninfected neonates and infants: study protocol for a phase I trial.

Background: The ambitious goal to eliminate new pediatric HIV infections by 2030 requires accelerated prevention strategies in high-risk settings such as South Africa. One approach could be pre-exposure prophylaxis (PrEP) with broadly neutralizing anti-HIV-1 monoclonal antibodies (bNAbs). The aim of our study is to define the optimal dose(s), the ideal combination(s) of bNAbs in terms of potency and breadth, and timing of subcutaneous (SC) administration(s) to prevent breast milk transmission of HIV.

Field evaluation of the residual efficacy of new generation insecticides for potential use in indoor residual spray programmes in South Africa.

Background: The decreasing residual efficacy of insecticides is an important factor when making decisions on insecticide choice for national malaria control programmes. The major challenge to using chemicals for vector control is the selection for the development of insecticide resistance. Since insecticide resistance has been recorded for most of the existing insecticides used for indoor residual spraying, namely, DDT, pyrethroids, organophosphates and carbamates, and new chemicals are necessary for the continued success of indoor residual spraying.

Effects of injectable contraception with depot medroxyprogesterone acetate or norethisterone enanthate on estradiol levels and menstrual, psychological and behavioral measures relevant to HIV risk: The WHICH randomized trial.

Background: Observational data suggest lower HIV risk with norethisterone enanthate (NET-EN) than with depo-medroxyprogesterone acetate intramuscular (DMPA-IM) injectable contraceptives. If confirmed, a switch between these similar injectable methods would be programmatically feasible and could impact the trajectory of the HIV epidemic. We aimed in this paper to investigate the effects of DMPA-IM and NET-EN on estradiol levels, measures of depression and sexual activity and menstrual effects, relevant to HIV risk; and to ascertain whether these measures are associated with estradiol levels.

Safety of a second homologous Ad26.COV2.S vaccine among healthcare workers in the phase 3b implementation Sisonke study in South Africa.

The Sisonke 2 study provided a homologous boost at least 6 months after administration of the priming dose of Ad26.COV2.S for healthcare workers enrolled on the Sisonke phase 3b implementation study.

Misreporting contraceptive use and the association of peak study progestin levels with weight and BMI among women randomized to the progestin-only injectable contraceptives DMPA-IM and NET-EN.

Progestin-only injectable contraceptives, mainly depo-medroxyprogesterone acetate intramuscular (DMPA-IM), are the most widely used contraceptive methods in sub-Saharan Africa. Insufficient robust data on their relative side-effects and serum concentrations limit understanding of reported outcomes in contraception trials. The WHICH clinical trial randomized HIV-negative women to DMPA-IM (n = 262) or norethisterone enanthate (NET-EN) (n = 259) at two South African sites between 2018-2019.

Vascular thrombosis after single dose Ad26.COV2.S vaccine in healthcare workers in South Africa: open label, single arm, phase 3B study (Sisonke study).

Objective: To assess the rates of vascular thrombotic adverse events in the first 35 days after one dose of the Ad26.COV2.S vaccine (Janssen/Johnson & Johnson) in healthcare workers in South Africa and to compare these rates with those observed in the general population.

The effect of the COVID-19 lockdown on malaria transmission in South Africa.

Background: For a country such as South Africa which is targeting malaria elimination, mobile and migrant populations pose a substantial risk to importation of malaria parasites. It has been hypothesized that halting cross-border movement of mobile and migrant populations will decrease the importation of malaria, however this option is not a politically, operationally, and financially viable prospect. It has social impacts as well, since families live on either side of the border and preventing travel will challenge family ties.

Symptom Number and Reduced Preinfection Training Predict Prolonged Return to Training after SARS-CoV-2 in Athletes: AWARE IV.

Purpose: This study aimed to determine factors predictive of prolonged return to training (RTT) in athletes with recent SARS-CoV-2 infection.

Methods: This is a cross-sectional descriptive study. Athletes not vaccinated against COVID-19 ( n = 207) with confirmed SARS-CoV-2 infection (predominantly ancestral virus and beta-variant) completed an online survey detailing the following factors: demographics (age and sex), level of sport participation, type of sport, comorbidity history and preinfection training (training hours 7 d preinfection), SARS-CoV-2 symptoms (26 in 3 categories; "nose and throat," "chest and neck," and "whole body"), and days to RTT.

Safety evaluation of the single-dose Ad26.COV2.S vaccine among healthcare workers in the Sisonke study in South Africa: A phase 3b implementation trial.

Background: Real-world evaluation of the safety profile of vaccines after licensure is crucial to accurately characterise safety beyond clinical trials, support continued use, and thereby improve public confidence. The Sisonke study aimed to assess the safety and effectiveness of the Janssen Ad26.COV2.

Prevalence of bacteriologically confirmed pulmonary tuberculosis in South Africa, 2017-19: a multistage, cluster-based, cross-sectional survey.

Background: Tuberculosis remains an important clinical and public health issue in South Africa, which has one of the highest tuberculosis burdens in the world. We aimed to estimate the burden of bacteriologically confirmed pulmonary tuberculosis among people aged 15 years or older in South Africa.

Methods: This multistage, cluster-based, cross-sectional survey included eligible residents (age ≥15 years, who had slept in a house for ≥10 nights in the preceding 2 weeks) in 110 clusters nationally (cluster size of 500 people; selected by probability proportional-to-population size sampling).

High Asymptomatic Carriage With the Omicron Variant in South Africa.

We report a 23% asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) Omicron carriage rate in participants being enrolled into a clinical trial in South Africa, 15-fold higher than in trials before Omicron. We also found lower CD4 + T-cell counts in persons with human immunodeficiency virus (HIV) strongly correlated with increased odds of being SARS-CoV-2 polymerase chain reaction (PCR) positive.

Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study): results from a single-arm, open-label, phase 3B, implementation study.

Background: We aimed to assess the effectiveness of a single dose of the Ad26.COV2.S vaccine (Johnson & Johnson) in health-care workers in South Africa during two waves of the South African COVID-19 epidemic.

High Rate of Asymptomatic Carriage Associated with Variant Strain Omicron.

The early widespread dissemination of Omicron indicates the urgent need to better understand the transmission dynamics of this variant, including asymptomatic spread among immunocompetent and immunosuppressed populations. In early December 2021, the Ubuntu clinical trial, designed to evaluate efficacy of the mRNA-1273 vaccine (Moderna) among persons living with HIV (PLWH), began enrolling participants. Nasal swabs are routinely obtained at the initial vaccination visit, which requires participants to be clinically well to receive their initial jab.

Pre-race self-reported medical conditions and allergies in 133 641 Comrades ultramarathon (90km) runners - SAFER XXIII.

Objectives: To determine the prevalence of self-reported pre-race chronic medical conditions and allergies in ultramarathon race entrants and to explore if these are associated with an increased risk of race-day medical encounters (MEs).

Methods: Data from two voluntary open-ended pre-race medical screening questions (Q1 - history of allergies; Q2 - history of chronic medical conditions/prescription medication use) were collected in 133641 Comrades Marathon race entrants (2014-2019). Race-day ME data collected prospectively over 6 years are reported as incidence (per 1000 starters) and incidence ratios (IR: 95%CI's).

Medical Encounters in a 90-km Ultramarathon Running Event: A 6-year Study in 103 131 Race Starters-SAFER XVII.

Objective: To determine the incidence and nature of illness-related medical encounters (MEs) at a 90-km, ultramarathon, mass, community-based, endurance running event.

Design: Retrospective, descriptive epidemiological study.

Setting: Comrades Marathon (90 km), South Africa.

Symptom cluster is associated with prolonged return-to-play in symptomatic athletes with acute respiratory illness (including COVID-19): a cross-sectional study-AWARE study I.

Background: There are no data relating symptoms of an acute respiratory illness (ARI) in general, and COVID-19 specifically, to return to play (RTP).

Objective: To determine if ARI symptoms are associated with more prolonged RTP, and if days to RTP and symptoms (number, type, duration and severity) differ in athletes with COVID-19 versus athletes with other ARI.

Design: Cross-sectional descriptive study.

Effectiveness and cost-effectiveness of reactive, targeted indoor residual spraying for malaria control in low-transmission settings: a cluster-randomised, non-inferiority trial in South Africa.

Background: Increasing insecticide costs and constrained malaria budgets could make universal vector control strategies, such as indoor residual spraying (IRS), unsustainable in low-transmission settings. We investigated the effectiveness and cost-effectiveness of a reactive, targeted IRS strategy.

Methods: This cluster-randomised, open-label, non-inferiority trial compared reactive, targeted IRS with standard IRS practice in northeastern South Africa over two malaria seasons (2015-17).

Decadal epidemiology of malaria in KwaZulu-Natal, a province in South Africa targeting elimination.

Background: Although malaria remains a noteworthy disease in South Africa, the provinces are at differing stages of the malaria elimination continuum. KwaZulu-Natal has consistently reported the lowest number of cases over the past 5 years and it is expected that the goal of elimination will be achieved in this province over the next few years. The study reports on few key indicators that realistically represents the provinces progress over the past decade.