Point-of-care testing for sexually transmitted infections and HIV pre-exposure prophylaxis among pregnant women in South Africa, 2021-2022: randomised controlled trial.

OBJECTIVE: Pregnant and postpartum women (PPW) in Southern Africa are at increased risk of acquiring HIV and curable sexually transmitted infections (STIs). Oral pre-exposure prophylaxis (PrEP) is safe and effective to use during pregnancy to reduce HIV acquisition and vertical transmission. Point-of-care (POC) STI testing can identify PPW at risk of HIV and facilitate risk-differentiated and person-centred counselling to improve PrEP initiation, persistence and adherence. We evaluated the impact of POC STI testing compared with STI syndromic management on PrEP outcomes among PPW in Cape Town, South Africa. METHODS: The STI and PrEP in Pregnancy Study enrolled PPW without HIV and ≤34 weeks pregnant at their regular antenatal care visit with follow-up after 1 month. PPW were randomised to receive POC STI testing or STI syndromic management. PPW randomised to POC STI testing self-collected vaginal swabs for Chlamydia trachomatis, Neisseria gonorhoeae and Trichomonas vaginalis (Cepheid GeneXpert) testing and were offered same-day treatment if diagnosed. We compared PrEP initiation at baseline, PrEP prescription refill at 1 month (persistence) and adherence through tenofovir-diphosphate detection in dried blood spots by randomisation arm. In a secondary analysis, we evaluated the association between an STI diagnosis (positive STI test or reporting STI symptoms) with PrEP outcomes. RESULTS: We enrolled and randomised 268 pregnant women. Twenty-eight per cent of women were diagnosed with ≥1 STI. Overall, 65% of women initiated and 79% persisted on PrEP with no significant differences by randomisation arm. Secondary analysis demonstrated that an STI diagnosis (positive STI test or reporting STI symptoms) was associated with higher PrEP initiation (adjusted relative risk=1.28; 95% CI 1.08 to 1.52), controlling for arm, maternal and gestational age. CONCLUSIONS: POC STI testing was not associated with PrEP initiation or persistence relative to syndromic management. However, improving STI diagnosis by supplementing syndromic management with POC STI testing could improve PrEP initiation among PPW. TRIAL REGISTRATION NUMBER: NCT03902418; Clinical Trials.gov; 1 April 2019.

Factors associated with an unsuppressed viral load among HIV-positive individuals attending STI services in South Africa, 2019.

BACKGROUND: Sexually transmitted infections (STIs), particularly in the absence of viral suppression, increase the risk of HIV transmission to uninfected partners. We determined factors associated with having an unsuppressed VL among HIV-positive individuals attending STI services in South Africa (SA). METHODS: We analysed secondary cross-sectional data collected on HIV-positive individuals presenting with STI symptoms s at sentinel sites in Western Cape and Gauteng provinces between January-December 2019 in SA. We compared demographic characteristics of individuals on ART or not on ART, and a Poisson regression model to identify factors associated with having an unsuppressed VL (≥ 50 copies/ml) was used. RESULTS: Among 93 HIV-positive individuals attending STI services with VL data, the median age was 32 years (IQR 27-37). Thirty-two (34.41%) individuals were on ART compared to 61 (65.59%) not on ART. Most of those on ART (56.25%) had an unsuppressed VL, while 86.89% of those not on ART had an unsuppressed VL. ART use was associated with a 33% lower prevalence of having unsuppressed VL. In a model adjusting for age, age at first sex and oral sex, none of the factors were significant. Among those on ART, individuals < 25 years were more likely to have an unsuppressed VL (aPRR = 1.94: 95% CI = 1.27-2.97) compared to those ≥ 25 years. CONCLUSION: ART use among HIV-positive individuals was low and VL suppression among those on ART was sub-optimal. Intensified ART initiation and adherence support to HIV-positive individuals seeking STI services could improve VL suppression.

The impact of colistin-based regimens on mortality compared to other antimicrobials in patients with carbapenem-resistant Enterobacterales bacteremia in South African hospitals: a cross-sectional study.

BACKGROUND: Treatment of carbapenem-resistant Enterobacterales (CRE) infections in low-resource settings is challenging particularly due to limited treatment options. Colistin is the mainstay drug for treatment; however, nephrotoxicity and neurotoxicity make this drug less desirable. Thus, mortality may be higher among patients treated with alternative antimicrobials that are potentially less efficacious than colistin. We assessed mortality in patients with CRE bacteremia treated with colistin-based therapy compared to colistin-sparing therapy. METHODS: We conducted a cross-sectional study using secondary data from a South African national laboratory-based CRE bacteremia surveillance system from January 2015 to December 2020. Patients hospitalized at surveillance sentinel sites with CRE isolated from blood cultures were included. Multivariable logistic regression modeling, with multiple imputations to account for missing data, was conducted to determine the association between in-hospital mortality and colistin-based therapy versus colistin-sparing therapy. RESULTS: We included 1 607 case-patients with a median age of 29 years (interquartile range [IQR], 0-52 years) and 53% (857/1 607) male. Klebsiella pneumoniae caused most of the infections (82%, n=1 247), and the most common carbapenemase genes detected were blaOXA-48-like (61%, n=551), and blaNDM (37%, n=333). The overall in-hospital mortality was 31% (504/1 607). Patients treated with colistin-based combination therapy had a lower case fatality ratio (29% [152/521]) compared to those treated with colistin-sparing therapy 32% [352/1 086]) (p=0.18). In our imputed model, compared to colistin-sparing therapy, colistin-based therapy was associated with similar odds of mortality (adjusted odds ratio [aOR] 1.02; 95% confidence interval [CI] 0.78-1.33, p=0.873). CONCLUSION: In our resource-limited setting, the mortality risk in patients treated with colistin-based therapy was comparable to that of patients treated with colistin-sparing therapy. Given the challenges with colistin treatment and the increasing resistance to alternative agents, further investigations into the benefit of newer antimicrobials for managing CRE infections are needed.

Gaps in the prevention of mother-to-child transmission of syphilis: a review of reported cases, South Africa, January 2020-June 2022.

INTRODUCTION: Congenital syphilis (CS) is preventable through timely antenatal care (ANC), syphilis screening and treatment among pregnant women. Robust CS surveillance can identify gaps in this prevention cascade. We reviewed CS cases reported to the South African notifiable medical conditions surveillance system (NMCSS) from January 2020 to June 2022. METHODS: CS cases are reported using a case notification form (CNF) containing limited infant demographic and clinical characteristics. During January 2020-June 2022, healthcare workers supplemented CNFs with a case investigation form (CIF) containing maternal and infant testing and treatment information. We describe CS cases with/without a matching CIF and gaps in the CS prevention cascade among those with clinical information. FINDINGS: During January 2020-June 2022, 938 CS cases were reported to the NMCSS with a median age of 1 day (interquartile range: 0-5). Nine percent were diagnosed based on clinical signs and symptoms only. During January 2020-June 2022, 667 CIFs were reported with 51% (343) successfully matched to a CNF. Only 57% of mothers of infants with a matching CIF had an ANC booking visit (entry into ANC). Overall, 87% of mothers were tested for syphilis increasing to 98% among mothers with an ANC booking visit. Median time between first syphilis test and delivery was 16 days overall increasing to 82 days among mothers with an ANC booking visit. DISCUSSION: Only 37% of CS cases had accompanying clinical information to support evaluation of the prevention cascade. Mothers with an ANC booking visit had increased syphilis screening and time before delivery to allow for adequate treatment.

Untreated maternal syphilis has devastating consequences for the foetus. Congenital syphilis (CS) is preventable through timely maternal screening and treatment with robust surveillance. We evaluated CS surveillance data to identify gaps in CS surveillance and in the prevention cascade in South Africa.

An agent-based model of binge drinking, inequitable gender norms and their contribution to HIV transmission, with application to South Africa.

BACKGROUND: Binge drinking, inequitable gender norms and sexual risk behaviour are closely interlinked. This study aims to model the potential effect of alcohol counselling interventions (in men and women) and gender-transformative interventions (in men) as strategies to reduce HIV transmission. METHODS: We developed an agent-based model of HIV and other sexually transmitted infections, allowing for effects of binge drinking on sexual risk behaviour, and effects of inequitable gender norms (in men) on sexual risk behaviour and binge drinking. The model was applied to South Africa and was calibrated using data from randomized controlled trials of alcohol counselling interventions (n = 9) and gender-transformative interventions (n = 4) in sub-Saharan Africa. The model was also calibrated to South African data on alcohol consumption and acceptance of inequitable gender norms. Binge drinking was defined as five or more drinks on a single day, in the last month. RESULTS: Binge drinking is estimated to be highly prevalent in South Africa (54% in men and 35% in women, in 2021), and over the 2000-2021 period 54% (95% CI: 34-74%) of new HIV infections occurred in binge drinkers. Binge drinking accounted for 6.8% of new HIV infections (0.0-32.1%) over the same period, which was mediated mainly by an effect of binge drinking in women on engaging in casual sex. Inequitable gender norms accounted for 17.5% of incident HIV infections (0.0-68.3%), which was mediated mainly by an effect of inequitable gender norms on male partner concurrency. A multi-session alcohol counselling intervention that reaches all binge drinkers would reduce HIV incidence by 1.2% (0.0-2.5%) over a 5-year period, while a community-based gender-transformative intervention would reduce incidence by 3.2% (0.8-7.2%) or by 7.3% (0.6-21.2%) if there was no waning of intervention impact. CONCLUSIONS: Although binge drinking and inequitable gender norms contribute substantially to HIV transmission in South Africa, recently-trialled alcohol counselling and gender-transformative interventions are likely to have only modest effects on HIV incidence. Further innovation in developing locally-relevant interventions to address binge drinking and inequitable gender norms is needed.

Detection of Lymphogranuloma Venereum-Associated Chlamydia trachomatis L2 Serovars in Remnant Rectal Specimens Collected from 7 US Public Health Laboratories.

ABSTRACT: The frequency of lymphogranuloma venereum or invasive Chlamydia trachomatis infection with serovar L1, L2, or L3 is unknown in the United States. While no diagnostic test is commercially available, we used a laboratory-developed test and detected lymphogranuloma venereum-associated serovar L2 in 14% of 132 remnant C. trachomatis-positive rectal swabs.

Prevalence of Self-reported Neurologic and Ocular Symptoms in Early Syphilis Cases.

BACKGROUND: Neurosyphilis, a complication of syphilis, can occur at any stage of infection. Measuring the prevalence of neurosyphilis is challenging, and there are limited data on the prevalence of neurologic or ocular symptoms among patients with syphilis. We sought to describe the prevalence of neurologic and/or ocular symptoms among early syphilis (ES) cases and the clinical management of symptomatic cases enrolled in the STD Surveillance Network (SSuN) Neuro/Ocular Syphilis Surveillance project. METHODS: Persons diagnosed with ES were selected for interviews based on current health department protocols in 5 participating SSuN jurisdictions from November 2016 through October 2017. All interviewed ES cases were screened for self-reported neurologic and/or ocular symptoms. Additional clinical information on diagnostic testing and treatment for cases concerning for neurosyphilis/ocular syphilis was obtained from providers. RESULTS: Among 9123 patients with ES who were interviewed, 151 (1.7%; 95% confidence interval [CI], 1.4%-1.9%) reported ≥ 1 neurologic or ocular symptom. Of the 53 (35%) who underwent lumbar puncture, 22 (42%) had documented abnormal cerebrospinal fluid, of which 21 (95%) were treated for neurosyphilis/ocular syphilis. Among the remaining 98 symptomatic patients with no documented lumbar puncture (65%), 12 (12%) were treated for and/or clinically diagnosed with neurosyphilis/ocular syphilis. CONCLUSIONS: We observed a low prevalence of self-reported neurologic and/or ocular symptoms in interviewed ES cases. Approximately one-third of ES cases who self-reported symptoms underwent further recommended diagnostic evaluation. Understanding barriers to appropriate clinical evaluation is important to ensuring appropriate management of patients with possible neurologic and/or ocular manifestations of syphilis.

Genital Mycoplasma, Shigellosis, Zika, Pubic Lice, and Other Sexually Transmitted Infections: Neither Gone Nor Forgotten.

ABSTRACT: Most estimates of the combined burden and cost of sexually transmitted infections (STIs) in the United States have focused on 8 common STIs with established national surveillance strategies (chlamydia, gonorrhea, syphilis, trichomoniasis, genital herpes, human papillomavirus, and sexually transmitted human immunodeficiency virus and hepatitis B). However, over 30 STIs are primarily sexually transmitted or sexually transmissible. In this article, we review what is known about the burden of "other STIs" in the United States, including those where sexual transmission is not the primary transmission route of infection. Although the combined burden of these other STIs may be substantial, accurately estimating their burden due to sexual transmission is difficult due to diagnostic and surveillance challenges. Developing better estimates will require innovative strategies, such as leveraging existing surveillance systems, partnering with public health and academic researchers outside of the STI field, and developing methodology to estimate the frequency of sexual transmission, particularly for new and emerging STIs.

Syphilis Testing Among Sexually Active Men Who Have Sex With Men and Who Are Receiving Medical Care for Human Immunodeficiency Virus in the United States: Medical Monitoring Project, 2013-2014.

BACKGROUND: Guidelines recommend that sexually active men who have sex with men (MSM) including human immunodeficiency virus (HIV)-positive MSM be tested at least annually for syphilis, with testing every 3-6 months for MSM at elevated risk. We examined the proportion of HIV-positive MSM tested for syphilis in the past 3, 6, and 12 months by their HIV care provider during 2013-2014. METHODS: Using data from the Medical Monitoring Project, a population-based HIV surveillance system, we evaluated the proportion of MSM who had documentation of being tested for syphilis by their HIV care provider in the past 3, 6, and 12 months. RESULTS: During 2013-2014, 71% (95% confidence interval [CI]: 69%-73%) of sexually active HIV-positive MSM were tested for syphilis in the past year. This proportion was higher among MSM reporting condomless sex: (75%; 95% CI: 72%-78%), and among MSM reporting ≥ 2 sex partners (77%; 95% CI: 74%-79%), in the past 12 months. Among MSM reporting condomless sex, 49% (95% CI: 45%-53%) were tested in the past 6 months, and 26% (95% CI: 22%-30%) in the past 3 months. Among MSM reporting ≥ 2 sex partners, 49% (95% CI: 44%-54%) were tested in the past 6 months and 26% (95% CI: 22%-29%) in the past 3 months. CONCLUSIONS: Nearly one-third of sexually active HIV-positive MSM were not tested annually, and many at increased risk were not tested at recommended frequencies. Efforts to improve compliance with screening guidelines for high-risk HIV-positive MSM are warranted.

Self-Reported Extragenital Chlamydia and Gonorrhea Testing in the Past 12 Months Among Men Who Have Sex with Men in the United States-American Men's Internet Survey, 2017.

BACKGROUND: Current guidelines recommend that sexually active men who have sex with men (MSM) be screened at least annually for bacterial sexually transmitted infections (STIs) at sites of sexual contact regardless of condom use. Extragenital (rectal and pharyngeal) STI are common in MSM and associated with an increased risk of human immunodeficiency virus. We describe the prevalence of MSM who reported any STI test and an extragenital STI test in the past 12 months (p12m) in the United States. METHODS: Data were obtained from the 2017 American Men's Internet Survey, an annual cross-sectional behavioral internet survey of MSM in the United States. We examined the prevalence of MSM who reported any STI test and an extragenital STI test in the p12m and compared the prevalence across demographic, clinical, and behavioral factors. RESULTS: Of 10,049 sexually active MSM who participated in American Men's Internet Survey 2017, 42% reported any STI test in the p12m and 16% reported an extragenital (rectal or pharyngeal) STI test in the p12m. Among those who reported getting an extragenital STI test in the p12m, 19% reported providing a throat swab only, 14% reported providing a rectal swab only, and 68% reported providing both a rectal and throat swab for STI testing. CONCLUSIONS: In a large sample of internet-using MSM in the United States, levels of STI screening were suboptimal, with fewer than half (42%) of MSM reporting any STI test and even fewer reporting an extragenital STI test in the p12m. Increased efforts are needed to ensure annual STI screening guidelines among MSM are implemented.

Reported Cases of Neurosyphilis Among Early Syphilis Cases-United States, 2009 to 2015.

The surveillance of neurosyphilis, an uncommon but severe consequence of syphilis, is complex; surveillance classification of neurosyphilis requires a lumbar puncture and cerebrospinal fluid analysis. We examined the prevalence of reported neurosyphilis among primary, secondary, and early latent syphilis cases reported in the United States from 2009 to 2015. Overall, the prevalence of reported neurosyphilis from 2009 to 2015 was low (0.84%); however, this is likely an underestimate of the true burden in the United States.

Point-of-Care Sexually Transmitted Infection Testing Improves HIV Preexposure Prophylaxis Initiation in Pregnant Women in Antenatal Care in Cape Town, South Africa, 2019 to 2021.

Preexposure prophylaxis (PrEP) programs present a platform for diagnostic sexually transmitted infection (STI) testing in low- and middle-income countries, and availability of targeted STI testing has been hypothesized to influence PrEP use. We evaluated the association of STI testing modality and PrEP uptake among pregnant women in antenatal care. We enrolled pregnant, HIV-uninfected women (16 years or older) at their first antenatal visit with follow-up through 12 months postpartum. Women were offered oral PrEP and tested for Chlamydia trachomatis and Neisseria gonorrhoeae using a point-of-care (POC; Cepheid, August 2019­November 2020) or laboratory-based (Thermofisher, December 2020­October 2021) test. We compared the proportion of women initiating and continuing PrEP by STI test adjusting for confounders. We evaluated 1194 women (median age, 26 years [interquartile range, 22­31 years]) with an STI result (46% POC and 54% laboratory-based). The prevalence of any STI was the same in POC-tested (28%) and laboratory-tested (28%) women­25% versus 23% for C. trachomatis ( P = 0.35) and 7% versus 9% for N. gonorrhoeae ( P = 0.11). Mean time from testing to result was 0 day for POC and 26 days for laboratory testing, and mean time from testing to treatment was 3 days for POC and 38 days for laboratory testing. Receiving a POC STI test was associated with higher PrEP initiation compared with women receiving a laboratory-based test (90% vs. 78%; adjusted odds ratio, 2.1; 95% confidence interval, 1.5­2.9), controlling for age, gravidity, STI diagnosis, intimate partner violence, gestational age, employment, HIV risk perception, and cohabiting status. Point-of-care STI testing, offering same-day results and treatment initiation, may increase PrEP initiation among pregnant women in antenatal care.

Laboratory Processes for Confirmation of Lymphogranuloma Venereum Infection During a 2015 Investigation of a Cluster of Cases in the United States.

In September 2015, the Centers for Disease Control and Prevention were notified of a suspected outbreak investigation of lymphogranuloma venereum (LGV) cases by the Michigan Department of Health and Human Services. The Centers for Disease Control and Prevention offered support with a laboratory-developed polymerase chain reaction test for LGV. This note describes the laboratory workflow and procedures used for the laboratory confirmation of LGV infection.

State-Specific Rates of Primary and Secondary Syphilis Among Men Who Have Sex with Men - United States, 2015.

In 2015, the rate of reported primary and secondary syphilis in the United States was 7.5 cases per 100,000 population, nearly four times the previous lowest documented rate of 2.1 in 2000 (1). In 2015, 81.7% of male primary and secondary syphilis cases with information on the sex of the sex partner were among gay, bisexual, and other men who have sex with men (collectively referred to as MSM) (1). These data suggest a disproportionate incidence of disease among MSM. However, attempts to quantify this disparity have been hindered by limited data on the size of the MSM population at the state level. To produce the first estimates of state-specific rates of primary and secondary syphilis among MSM, CDC used MSM population estimates based on a new methodology (2) and primary and secondary syphilis case counts reported in 2015 to the National Notifiable Diseases Surveillance System. Among 44 states reporting information on the sex of sex partners for ≥70% of male cases, the overall rate of primary and secondary syphilis among all men (aged ≥18 years) in the United States in 2015 was 17.5 per 100,000, compared with 309.0 among MSM and 2.9 among men who reported sex with women only. The overall rate of primary and secondary syphilis among MSM was 106.0 times the rate among men who have sex with women only and 167.5 times the rate among women.* These data highlight the disproportionate impact of syphilis among MSM and underscore the need for innovative and targeted syphilis prevention measures at the state and local level, especially among MSM. It is important that health care providers recognize the signs and symptoms of syphilis, screen sexually active MSM for syphilis at least annually, and provide timely treatment according to national sexually transmitted diseases treatment guidelines (3).

Notes from the Field: Cluster of Lymphogranuloma Venereum Cases Among Men Who Have Sex with Men - Michigan, August 2015-April 2016.

Lymphogranuloma venereum (LGV) is a sexually transmitted disease (STD) caused by infection with invasive Chlamydia trachomatis serovars L1-L3 (1). LGV is characterized by inguinal and/or femoral lymphadenopathy, typically following a transient, self-limited genital ulcer or papule that might go unnoticed. Rectal infection can result in proctocolitis that can present with mucoid and/or hemorrhagic rectal discharge, anal pain, constipation, fever, and tenesmus, and signs of granulomas and/or ulcerations on anoscopy (1,2). LGV can be an invasive, systemic infection, and if it is not treated early, LGV proctocolitis can lead to chronic colorectal fistulas and strictures (2). In Europe, outbreaks of LGV have been reported among men who have sex with men (MSM), often in association with human immunodeficiency virus (HIV) coinfection (3-5). The prevalence of LGV in the United States is unknown (1), because diagnostic tests to differentiate LGV from non-LGV Chlamydia trachomatis are not widely available (6), and providers might not know that they should report cases that are presumptively treated.

A social network typology and sexual risk-taking among men who have sex with men in Cape Town and Port Elizabeth, South Africa.

Despite the high prevalence of HIV among men who have sex with men in South Africa, very little is known about their lived realities, including their social and sexual networks. Given the influence of social network structure on sexual risk behaviours, a better understanding of the social contexts of men who have sex with men is essential for informing the design of HIV programming and messaging. This study explored social network connectivity, an understudied network attribute, examining self-reported connectivity between friends, family and sex partners. Data were collected in Cape Town and Port Elizabeth, South Africa, from 78 men who have sex with men who participated in in-depth interviews that included a social network mapping component. Five social network types emerged from the content analysis of these social network maps based on the level of connectivity between family, friends and sex partners, and ranged from disconnected to densely connected networks. The ways in which participants reported sexual risk-taking differed across the five network types, revealing diversity in social network profiles. HIV programming and messaging for this population can greatly benefit from recognising the diversity in lived realities and social connections between men who have sex with men.

Exploring repeat HIV testing among men who have sex with men in Cape Town and Port Elizabeth, South Africa.

Despite the high prevalence of HIV among men who have sex with men (MSM) - and the general adult population - in South Africa, there is little data regarding the extent to which MSM seek repeat testing for HIV. This study explores reported histories of HIV testing, and the rationales for test seeking, among a purposive sample of 34 MSM in two urban areas of South Africa. MSM participated in activity-based in-depth interviews that included a timeline element to facilitate discussion. Repeat HIV testing was limited among participants, with three-quarters having two or fewer lifetime HIV tests, and over one-third of the sample having one or fewer lifetime tests. For most repeat testers, the time gap between their HIV tests was greater than the one-year interval recommended by national guidelines. Analysis of the reasons for seeking HIV testing revealed several types of rationale. The reasons for a first HIV test were frequently one-time occurrences, such as a requirement prior to circumcision, or motivations likely satisfied by a single HIV test. For MSM who reported repeat testing at more timely intervals, the most common rationale was seeking test results with a sex partner. Results indicate a need to shift HIV test promotion messaging and programming for MSM in South Africa away from a one-off model to one that frames HIV testing as a repeated, routine health maintenance behavior.

Determinants of sub-optimal glycemic control among patients enrolled in a medicine dispensing programme in KwaZulu-Natal: A cohort study, 2018-2021.

BACKGROUND:  The Central Chronic Medicines Dispensing and Distribution (CCMDD) programme facilitates clinically stable patients to collect their chronic medication from community-based pick-up points. AIM:  We determined baseline glycaemic control and rates and predictors of becoming sub-optimally controlled for type 2 diabetes mellitus (T2DM) CCMDD-enrolled patients. SETTING:  The setting of the study was eThekwini, KwaZulu-Natal, South Africa. METHODS:  We performed a cohort study (April 2018- December 2021). We linked T2DM CCMDD-enrolled patients to glycated haemoglobin (HbA1c) data from the National Health Laboratory Service. We selected patients optimally controlled at their baseline HbA1c, with ≥ 1 repeat-test available. We used Kaplan-Meier analysis to assess survival rates and extended Cox regression to determine associations between time to sub-optimal control (HbA1c 7%) and predictors. Adjusted hazard ratios (aHRs), 95% confidence interval (CI), and p-values are reported. RESULTS:  Of the 41145 T2DM patients enrolled in the CCMDD programme, 7960 (19%) had a HbA1c result available. Twenty-seven percent (2147/7960) were optimally controlled at their baseline HbA1c. Of those controlled at baseline, 695 (32%) patients had a repeat test available, with 35% (242/695) changing to sub-optimal status. The HbA1c testing frequency as per national guidelines was associated with a lower hazard of sub-optimal glycaemic control (aHR: 0.46; 95% CI: 0.24-0.91; p-value = 0.024). Patients prescribed dual-therapy had a higher hazard of sub-optimal glycaemic control (aHR: 1.50; 95% CI: 1.16-1.95; p-value = 0.002) versus monotherapy. CONCLUSIONS:  The HbA1c monitoring, in-line with testing frequency guidelines, is needed to alert the CCMDD programme of patients who become ineligible for enrolment. Patients receiving dual-therapy require special consideration.Contribution: Addressing identified shortfalls can assist programme implementation.

Vaccine value profile for Neisseria gonorrhoeae.

Neisseria gonorrhoeae infection (gonorrhoea) is a global public health challenge, causing substantial sexual and reproductive health consequences, such as infertility, pregnancy complications and increased acquisition or transmission of HIV. There is an urgency to controlling gonorrhoea because of increasing antimicrobial resistance to ceftriaxone, the last remaining treatment option, and the potential for gonorrhoea to become untreatable. No licensed gonococcal vaccine is available. Mounting observational evidence suggests that N. meningitidis serogroup B outer membrane vesicle-based vaccines may induce cross-protection against N. gonorrhoeae (estimated 30%-40% effectiveness using the 4CMenB vaccine). Clinical trials to determine the efficacy of the 4CMenB vaccine against N. gonorrhoeae are underway, as are Phase 1/2 studies of a new gonococcal-specific vaccine candidate. Ultimately, a gonococcal vaccine must be accessible, affordable and equitably dispensed, given that those most affected by gonorrhoea are also those who may be most disadvantaged in our societies, and most cases are in less-resourced settings. This vaccine value profile (VVP) provides a high level, holistic assessment of the current data to inform the potential public health, economic and societal value of pipeline vaccines. This was developed by a working group of subject matter experts from academia, non-profit organizations, public private partnerships and multi-lateral organizations. All contributors have extensive expertise on various elements of the N. gonorrhoeae VVP and collectively aimed to identify current research and knowledge gaps. The VVP was developed using published data obtained from peer-reviewed journals or reports.

Evaluation of the rubella surveillance system in South Africa, 2016-2018: A cross-sectional study.

BACKGROUND: Rubella is a leading vaccine-preventable cause of birth defects. We conducted this study to evaluate the rubella surveillance system in South Africa from 2016 to 2018. The rubella surveillance system had not been evaluated since its inception; therefore, a formal evaluation is necessary to assess key attributes and to ascertain the extent to which the system achieves its objectives. METHODS: We conducted a cross-sectional study to assess the usefulness, simplicity, positive predictive value, timeliness, and data quality of the rubella surveillance system from 2016 to 2018. We reviewed retrospective rubella surveillance data and conducted a survey with key stakeholders of the system. We compiled a summary report from the survey and calculated the annualized detection rate of rubella and non-rubella febrile rash, positive predictive value, the proportion of complete records, and timeliness between the surveillance steps. We compared our results with recommended performance indicators from the 2015 revised World Health Organization African regional guidelines for measles and rubella surveillance. RESULTS: The rubella surveillance system was useful but weak in terms of simplicity. The annualized detection rate of rubella febrile rash was 1.5 per 100,000 populations in 2016, 4.4 in 2017, and 2.1 in 2018. The positive predictive value was 29.1% in 2016, 40.9% in 2017, and 32.9% in 2018. The system did not meet the timeliness goal in the health facility component but met this goal in the laboratory component. The system had poor data quality, particularly in the health facility component. CONCLUSIONS: The rubella surveillance system was useful, although it was not simple to use and had low PPV, poor timeliness, and poor data quality. Efforts should be made to improve the system's simplicity, PPV, timeliness, and data quality at the facility level.