BACKGROUND
The global epidemic of Mycoplasma genitalium (MG) is marked by its widespread prevalence, varied resistance patterns, and significant impact on sexual health. This study aimed to understand the prevalence and interaction of MG infections with other sexually transmitted infections (STIs) in a low-resource setting, as well as the implications for routine STIs care.
METHODS
This nested cross-sectional study was conducted from July 2022 to April 2023 across six outpatient care sites in Shiselweni, Eswatini. Participants completed a self-questionnaire, underwent syndromic case management, and provided urine samples for parallel molecular-based testing using the Cepheid GeneXpert® platform for MG, Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV). The proportion of MG mono-infection and coinfections were calculated. Multivariable logistic regression models identified predictors of symptomatic MG mono-infections, which could be used to streamline at-risk patients for MG testing.
RESULTS
Among 735 participants, the median age was 27 (interquartile range 23—34) years, 65.9% were women, and 9.5% were HIV-positive. MG infection was detected in 10.5% (n = 77) of clients, with 45.5% (n = 35) coinfected with any of CT/NG/TV, and one case (0.1%) showing macrolide resistance. Among women with vaginal discharge syndrome (28.1%, n = 136), 0.7% (n = 1) had MG mono-infection, and 10.3% (n = 14) had MG and CT/NG/TV coinfections. Among men with male urethral syndrome (31.9%, n = 80), 3.8% (n = 3) had MG mono-infection, and 2.5% (n = 2) had MG and CT/NG/TV coinfections. Most MG-positive cases (66.2%, n = 51) did not receive antibiotic therapy, despite 68.6% (n = 35) reporting symptoms of STIs. Of treated cases, 26.0% (n = 20) received azithromycin monotherapy, 6.5% (n = 5) doxycycline monotherapy, and 1.3% (n = 1) both drugs. Of 305 individuals reporting STIs symptoms but tested negative for CT/NG/TV, 23 (7.5%) had symptomatic MG mono-infections. Unemployment and never having been tested for HIV were identified as risk factors. Streamlining 108/305 (35.4%) at-risk individuals for molecular-based MG testing would identify 14.8% (16/108) as positive, capturing 69.6% (16/23) of all symptomatic MG mono-infections.
CONCLUSIONS
MG was common among outpatients and frequently co-occurred with CT, NG, and TV infections. Syndromic case management often misclassified MG infections, leading to ineffective treatment. Expanding molecular-based MG testing could enhance antibiotic stewardship, crucial for preventing the spread of drug-resistant strains.
BACKGROUND
Access to safe abortion care (SAC) should be improved in fragile and humanitarian settings, and the implementation of interventions in that regard are currently limited. This is especially true for self-managed abortion (SMA), although it holds the potential of revolutionizing the prevention of maternal death and suffering.
CASE PRESENTATION
The medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) piloted a self-managed abortion model of care in the Middle East. 22 women were remotely supported in managing their safe abortions with a counsellor over the phone, using misoprostol doses that they took at home after having taken mifepristone in our health facility. We share our experience by describing the model of care and discussing the lessons learned through its implementation.
CONCLUSIONS
The program delivered abortion services successfully and required few resources. This paper also reflects on the importance of facilitating SMA in humanitarian contexts. It increases access to care by providing increased confidentiality, close support, ample information, autonomy, and flexibility. It is simple to implement, effective, often preferred by women, and can be linked to information about contraception. The implementation of self-managed models should be expanded, notably in projects that do not have a sexual and reproductive health focus and in restrictive and challenging contexts. It represents a true revolution for access to safe abortion care.
INTRODUCTION
Hepatitis E causes high mortality among pregnant women, with case fatality risks over 30% and adverse fetal outcomes. There is an evidence gap on the safety of the only licensed vaccine, Hecolin®, in pregnancy. In 2015, WHO recommended vaccine use in response to outbreaks, including pregnant women. In 2022, the first mass reactive vaccination campaign against Hepatitis E was conducted in Bentiu displaced persons camp in South Sudan. We aimed to determine whether vaccination against hepatitis E in pregnancy increased the risk of fetal loss in a cohort of vaccinated and unvaccinated pregnant women.
METHODS
An exhaustive pregnancy census was conducted from 16 May 2022 until 30 June 2022 after the second vaccination round, and women were revisited 28 days after delivery date to document the pregnancy outcome. We used an emulated target trial framework to address biases inherent in observational studies. We matched (1:1, with replacement) vaccinated to unvaccinated women on age, gestational age, and vaccination propensity score, and we estimated cumulative incidence functions for fetal loss in vaccinated compared with unvaccinated women using the Nelson-Aalen estimator.
RESULTS
Among 2741 women who had a pregnancy outcome after the start of the vaccination campaign, 67 (2.4%) were vaccinated before conception, 2036 (74.3%) were vaccinated during pregnancy, and 638 (23.3%) were not vaccinated. Among the 2407 women retained in the matched analyses, the cumulative risk of fetal loss in women vaccinated during pregnancy was 6.38% (95% CI 4.93–7.26) compared with 6.26% (3.9–9.19) among unvaccinated women (risk ratio [RR] 1.02 [95% CI 0.64–1.53]). In an analysis restricted to women vaccinated during pregnancy with less than 90 days gestation, the cumulative risk of miscarriage was 11.01% (95% CI 8.45–13.13) among vaccinated women and 11.62% (6.45–17.09) among unvaccinated women (RR 0.95 [95% CI 0.59–1.66]). In sensitivity analyses, we explored the impact of different matching criteria on the estimated RR and found no qualitative differences with the main analyses, with no evidence of increased risk of fetal loss among vaccinated women.
CONCLUSION
We used an emulated target trial methodology with matching to simulate a vaccine trial in pregnant women after a reactive vaccination campaign. This robust analytical method simulating a vaccine trial attempts to control for bias inherent in observational data. We found no evidence for increased risk of fetal loss among women vaccinated during pregnancy.
Sexually transmitted infections (STIs) can impact individuals of any demographic. The most common pathogens causing STIs are Chlamydia trachomatis, Neisseria gonorrhea and Trichomonas vaginalis; these can be treated with specific antibiotics.
OBJECTIVE
To compare the GeneXpert CT/NG test-and-treat algorithm to the syndromic approach algorithm and their impact on antibiotic prescription for gonorrhoea and chlamydia STIs.
DESIGN
A retrospective observational study on women aged ≥18 years who accessed the Médecins Sans Frontières Day Care Centre in Athens with complaints related to urogenital infections between January 2021 and March 2022. Women with abnormal vaginal discharge, excluding clinically diagnosed candidiasis, were eligible for Xpert CT/NG testing.
RESULTS
Of the 450 women who accessed care, 84 were eligible for Xpert CT/NG testing, and only one was positive for chlamydia, therefore resulting in saving 81 doses of ceftriaxone and azithromycin, and 19 doses of metronidazole. The cost of Xpert CT/NG testing, including treatment was €4,606.37, while full antibiotic treatment would have costed €536.76.
CONCLUSION
The overall cost of the Xpert CT/NG test-and-treat algorithm was higher than the syndromic approach. However, quality of care should be weighed against the potential benefits of testing and syndromic treatment to determine the best option for each patient; we therefore advocate for decreasing the costs.
Sexually transmitted infections (STI’s) are a public health threat. Syndromic approaches based on clinical symptoms have been suggested as having poor diagnostic performance, particularly in the type of settings where MSF is operational. We assessed the burden of STI’s and the diagnostic performance of a syndromic approach within an MSF-supported HIV/STI project in Eswatini.
METHODS
We conducted a cross-sectional study, enrolling adults accessing routine HIV testing and antiretroviral care services in six clinics in Shiselweni, from July 2022 to January 2023. HIV testing counselors performed HIV testing and nurses assessed patients for STI’s. Laboratory investigations included antibody-based rapid diagnostic tests (RDT’s) for Treponema pallidum (TP), hepatitis B (HBV) and hepatitis C (HBC). The molecular platform Xpert was used to test urine samples for Chlamydia trachomatis (CT), Neisseria gonorrhoea (NG), Trichomonas vaginalis (TV), Mycoplasma genitalium (MG), vaginal/anal swabs for human papillomavirus (HPV), and plasma for HIV viraemia to test for acute HIV infection (HIV). We calculated the prevalence of STI’s, and assessed diagnostic performance of a syndromic approach to diagnose male urethritis (MUS) and vaginal discharge (VDS) syndromes, versus laboratory-based testing.
ETHICS
This study was approved by the Eswatini Health and Human Research Review Board and by the MSF Ethics Review Board.
RESULTS
Of 1,041 study participants, 682 were women (65.5%), and the median age was 30 (interquartile range, IQR, 24-38) years. Overall, 280 (26.9%) were known HIV-positive and of 755 with unknown HIV status, 30 (4.0%) were newly diagnosed with HIV, of whom seven (23.3%) had AHI. 308 (29.6%) patients had at least one of the following three pathogens identified: NG 121 (11.6%); CT 155 (14.9%); TV 109 (10.5%). MG was detected in 33/330 participants (10.0%). In addition, 105 (10.1%) had antibodies against TP, 49 (4.7%) against HBV, and three (0.3%) against HCV. HPV prevalence was higher in tested women (104/196; 53.1%) versus men (5/27; 18.5%; p=0.001). Prevalence of NG/CT/TP was highest in newly-diagnosed HIV cases (48.2%) versus known HIV-positive cases (26.8%, p=0.019). Based on the syndromic approach, 188/634 (29.7%) had a VDS, and 97/334 (29.0%) a MUS. Diagnostic performance of the syndromic approach was better in men (MUS: sensitivity: 66.7%, specificity 87.5%; positive predictive value, PPV, 70.1%, negative predictive value, NPV, 85.7%), versus women (VDS: sensitivity 35.9%, specificity 72.9%; PPV 35.1%, NPV 73.5%).
CONCLUSION
A high burden of STI’s in Eswatini and poor diagnostic ability of the syndromic approach in this setting, calls for new approaches for STI care in MSF-supported sexual and reproductive health programmes in resource-poor settings.
CONFLICTS OF INTEREST
None declared
Since 2010, WHO has recommended oral cholera vaccines as an additional strategy for cholera control. During a cholera episode, pregnant women are at high risk of complications, and the risk of fetal death has been reported to be 2-36%. Due to a lack of safety data, pregnant women have been excluded from most cholera vaccination campaigns. In 2012, reactive campaigns using the bivalent killed whole-cell oral cholera vaccine (BivWC), included all people living in the targeted areas aged ≥ 1 year regardless of pregnancy status, were implemented in Guinea. We aimed to determine whether there was a difference in pregnancy outcomes between vaccinated and non-vaccinated pregnant women.
METHODS AND FINDINGS
From 11 November to 4 December 2013, we conducted a retrospective cohort study in Boffa prefecture among women who were pregnant in 2012 during or after the vaccination campaign. The primary outcome was pregnancy loss, as reported by the mother, and fetal malformations, after clinical examination. Primary exposure was the intake of the BivWC vaccine (Shanchol) during pregnancy, as determined by a vaccination card or oral history. We compared the risk of pregnancy loss between vaccinated and non-vaccinated women through binomial regression analysis. A total of 2,494 pregnancies were included in the analysis. The crude incidence of pregnancy loss was 3.7% (95%CI 2.7-4.8) for fetuses exposed to BivWC vaccine and 2.6% (0.7-4.5) for non-exposed fetuses. The incidence of malformation was 0.6% (0.1-1.0) and 1.2% (0.0-2.5) in BivWC-exposed and non-exposed fetuses, respectively. In both crude and adjusted analyses, fetal exposure to BivWC was not significantly associated with pregnancy loss (adjusted risk ratio (aRR = 1.09 [95%CI: 0.5-2.25], p = 0.818) or malformations (aRR = 0.50 [95%CI: 0.13-1.91], p = 0.314).
CONCLUSIONS
In this large retrospective cohort study, we found no association between fetal exposure to BivWC and risk of pregnancy loss or malformation. Despite the weaknesses of a retrospective design, we can conclude that if a risk exists, it is very low. Additional prospective studies are warranted to add to the evidence base on OCV use during pregnancy. Pregnant women are particularly vulnerable during cholera episodes and should be included in vaccination campaigns when the risk of cholera is high, such as during outbreaks.
Universal antiretroviral therapy (ART) for all pregnant/ breastfeeding women living with Human Immunodeficiency Virus (HIV), known as Prevention of mother-to child transmission of HIV (PMTCT) Option B+ (PMTCTB+), is being scaled up in most countries in Sub-Saharan Africa. In the transition to PMTCTB+, many countries face challenges with proper implementation of the HIV care cascade. We aimed to describe the feasibility of a PMTCTB+ approach in the public health sector in Swaziland.
Methods
Lifelong ART was offered to a cohort of HIV+ pregnant women aged ≥16 years at the first antenatal care (ANC1) visit in 9 public sector facilities, between 01/2013 and 06/2014. The study enrolment period was divided into 3 phases (early: 01–06/2013, mid: 07–12/2013 and late: 01–06/2014) to account for temporal trends. Kaplan-Meier estimates and Cox proportional-hazards regression models were applied for ART initiation and attrition analyses.
Results
Of 665 HIV+ pregnant women, 496 (74.6%) initiated ART. ART initiation increased in later study enrolment phases (mid: aHR: 1.41; later: aHR: 2.36), and decreased at CD4 ≥ 500 (aHR: 0.69). 52.9% were retained in care at 24 months. Attrition was associated with ANC1 in the third trimester (aHR: 2.37), attending a secondary care facility (aHR: 1.98) and ART initiation during later enrolment phases (mid aHR: 1.48; late aHR: 1.67). Of 373 women eligible, 67.3% received a first VL. 223/251 (88.8%) were virologically suppressed (< 1000 copies/mL). Of 670 infants, 53.6% received an EID test, 320/359 had a test result recorded and of whom 7 (2.2%) were HIV+.
Conclusions
PMTCTB+ was found to be feasible in this setting, with high rates of maternal viral suppression and low transmission to the infant. High treatment attrition, poor follow-up of mother-baby pairs and under-utilisation of VL and EID testing are important programmatic challenges.
Cervical cancer is among the most common preventable cancers with the highest morbidity and mortality. The World Health Organization (WHO) recommends visual inspection of the cervix with acetic acid (VIA) as cervical cancer screening strategy in resource-poor settings. However, there are barriers to the sustainability of VIA programs including declining providers’ VIA competence without mentorship and quality assurances and challenges of integration into primary healthcare. This study seeks to evaluate the impact of smartphone-based strategies in improving reliability, reproducibility, and quality of VIA in humanitarian settings.
METHODS AND FINDINGS
We implemented smartphone-based VIA that included standard VIA training, adapted refresher, and 6-month mHealth mentorship, sequentially, in the rural Shiselweni region of Eswatini. A remote expert reviewer provided diagnostic and management feedback on patients’ cervical images, which were reviewed weekly by nurses. Program’s outcomes, VIA image agreement rates, and Kappa statistic were compared before, during, and after training. From September 1, 2016 to December 31, 2018, 4,247 patients underwent screening; 247 were reviewed weekly by a VIA diagnostic expert. Of the 247, 128 (49%) were HIV–positive; mean age was 30.80 years (standard deviation [SD]: 7.74 years). Initial VIA positivity of 16% (436/2,637) after standard training gradually increased to 25.1% (293/1,168), dropped to an average of 9.7% (143/1,469) with a lowest of 7% (20/284) after refresher in 2017 (p = 0.001), increased again to an average of 9.6% (240/2,488) with a highest of 17% (17/100) before the start of mentorship, and dropped to an average of 8.3% (134/1,610) in 2018 with an average of 6.3% (37/591) after the start of mentorship (p = 0.019). Overall, 88% were eligible for and 68% received cryotherapy the same day: 10 cases were clinically suspicious for cancer; however, only 5 of those cases were confirmed using punch biopsy. Agreement rates with the expert reviewer for positive and negative cases were 100% (95% confidence interval [CI]: 79.4% to 100%) and 95.7% (95% CI: 92.2% to 97.9%), respectively, with negative predictive value (NPV) (100%), positive predictive value (PPV) (63.5%), and area under the curve of receiver operating characteristics (AUC ROC) (0.978). Kappa statistic was 0.74 (95% CI; 0.58 to 0.89); 0.64 and 0.79 at 3 and 6 months, respectively. In logistic regression, HIV and age were associated with VIA positivity (adjusted Odds Ratio [aOR]: 3.53, 95% CI: 1.10 to 11.29; p = 0.033 and aOR: 1.06, 95% CI: 1.0004 to 1.13; p = 0.048, respectively). We were unable to incorporate a control arm due to logistical constraints in routine humanitarian settings.
CONCLUSIONS
Our findings suggest that smartphone mentorship provided experiential learning to improve nurses’ competencies and VIA reliability and reproducibility, reduced false positive, and introduced peer-to-peer education and quality control services. Local collaboration; extending services to remote populations; decreasing unnecessary burden to screened women, providers, and tertiary centers; and capacity building through low-tech high-yield screening are promising strategies for scale-up of VIA programs.