Journal Article > ResearchAbstract Only
Journal of the National Cancer Institute . 18 March 2025; DOI:10.1093/jnci/djaf054
Befano B, Kalpathy-Cramer J, Egemen D, Inturrisi F, Jeronimo J, et al.
Journal of the National Cancer Institute . 18 March 2025; DOI:10.1093/jnci/djaf054
The HPV-Automated Visual Evaluation (PAVE) Consortium is validating a cervical screening strategy enabling accurate cervical screening in resource-limited settings. A rapid, low-cost HPV assay permits sensitive HPV testing of self-collected vaginal specimens; HPV-negative women are reassured. Triage of positives combines HPV genotyping (four groups in order of cancer risk) and visual inspection assisted by automated cervical visual evaluation (AVE) that classifies cervical appearance as severe, indeterminate, or normal. Together, the combination predicts which women have precancer, permitting targeted management to those most needing treatment.
We analyzed CIN3+ yield for each PAVE risk level (HPV genotype crossed by AVE classification) from nine clinical sites (Brazil, Cambodia, Dominican Republic, El Salvador, Eswatini, Honduras, Malawi, Nigeria, and Tanzania). Data from 1832 HPV-positive participants confirmed that HPV genotype and AVE classification each strongly and independently predict risk of histologic CIN3+. The combination of these low-cost tests provided excellent risk stratification, warranting pre-implementation demonstration projects.
Conference Material > Poster
Haider A, Goossens S, Desforges C, Chilinda G, Osman H, et al.
International Papillomavirus 2024. 12 November 2024
Journal Article > ResearchFull Text
BMC Infect Dis. 4 March 2024; Volume 24 (Issue S1); 277.; DOI:10.1186/s12879-024-09018-4
Shephard M, Matthews S, Kularatne R, Andrewartha K, Blondeel K, et al.
BMC Infect Dis. 4 March 2024; Volume 24 (Issue S1); 277.; DOI:10.1186/s12879-024-09018-4
BACKGROUND
In 2018, the World Health Organization commenced a multi-country validation study of the Cepheid GeneXpert for a range of molecular-based point-of-care (POC) tests in primary care settings. One study arm focused on the evaluation of POC tests for screening ‘women at risk’ for chlamydia (CT), gonorrhoea (NG) and trichomonas (TV) in four countries – Australia, Guatemala, Morocco and South Africa.
METHODS
Study participants completed a pre-test questionnaire which included demographics, clinical information and general questions on POC testing (POCT). Two vaginal swab samples (either self-collected or clinician collected) from each patient were tested on the GeneXpert at the POC and at a reference laboratory using quality-assured nucleic acid amplification tests (NAATs).
RESULTS
One thousand three hundred and eighty-three women were enrolled: 58.6% from South Africa, 29.2% from Morocco, 6.2% from Guatemala, and 6.0% from Australia. 1,296 samples for CT/NG and 1,380 samples for TV were tested by the GeneXpert and the reference NAAT. The rate of unsuccessful tests on the GeneXpert was 1.9% for CT, 1.5% for NG and 0.96% for TV. The prevalence of CT, NG and TV was 31%, 13% and 23%, respectively. 1.5% of samples were positive for all three infections; 7.8% were positive for CT and NG; 2.4% were positive for NG and TV; and 7.3% were positive for CT and TV. Compared to reference NAATs, pooled estimates of sensitivity for the GeneXpert tests were 83.7% (95% confidence intervals 69.2-92.1) for CT, 90.5% (85.1-94.1) for NG and 64.7% (58.1-70.7) for TV (although estimates varied considerably between countries). Estimates for specificity were ≥96% for all three tests both within- and between-countries. Pooled positive and negative likelihood ratios were: 32.7 ([CI] 21.2-50.5) and 0.17 (0.08-0.33) for CT; 95.3 (36.9-245.7) and 0.10 (0.06-0.15) for NG; and 56.5 (31.6-101.1) and 0.35 (0.27-0.47) for TV.
CONCLUSION
This multi-country evaluation is the first of its kind world-wide. Positive likelihood ratios, as well as specificity estimates, indicate the GeneXpert POC test results for CT, NG and TV were clinically acceptable for ruling in the presence of disease. However, negative likelihood ratios and variable sensitivity estimates from this study were poorer than expected for ruling out these infections, particularly for TV.
In 2018, the World Health Organization commenced a multi-country validation study of the Cepheid GeneXpert for a range of molecular-based point-of-care (POC) tests in primary care settings. One study arm focused on the evaluation of POC tests for screening ‘women at risk’ for chlamydia (CT), gonorrhoea (NG) and trichomonas (TV) in four countries – Australia, Guatemala, Morocco and South Africa.
METHODS
Study participants completed a pre-test questionnaire which included demographics, clinical information and general questions on POC testing (POCT). Two vaginal swab samples (either self-collected or clinician collected) from each patient were tested on the GeneXpert at the POC and at a reference laboratory using quality-assured nucleic acid amplification tests (NAATs).
RESULTS
One thousand three hundred and eighty-three women were enrolled: 58.6% from South Africa, 29.2% from Morocco, 6.2% from Guatemala, and 6.0% from Australia. 1,296 samples for CT/NG and 1,380 samples for TV were tested by the GeneXpert and the reference NAAT. The rate of unsuccessful tests on the GeneXpert was 1.9% for CT, 1.5% for NG and 0.96% for TV. The prevalence of CT, NG and TV was 31%, 13% and 23%, respectively. 1.5% of samples were positive for all three infections; 7.8% were positive for CT and NG; 2.4% were positive for NG and TV; and 7.3% were positive for CT and TV. Compared to reference NAATs, pooled estimates of sensitivity for the GeneXpert tests were 83.7% (95% confidence intervals 69.2-92.1) for CT, 90.5% (85.1-94.1) for NG and 64.7% (58.1-70.7) for TV (although estimates varied considerably between countries). Estimates for specificity were ≥96% for all three tests both within- and between-countries. Pooled positive and negative likelihood ratios were: 32.7 ([CI] 21.2-50.5) and 0.17 (0.08-0.33) for CT; 95.3 (36.9-245.7) and 0.10 (0.06-0.15) for NG; and 56.5 (31.6-101.1) and 0.35 (0.27-0.47) for TV.
CONCLUSION
This multi-country evaluation is the first of its kind world-wide. Positive likelihood ratios, as well as specificity estimates, indicate the GeneXpert POC test results for CT, NG and TV were clinically acceptable for ruling in the presence of disease. However, negative likelihood ratios and variable sensitivity estimates from this study were poorer than expected for ruling out these infections, particularly for TV.
Journal Article > ResearchFull Text
Public Health Action. 1 March 2024; Volume 14 (Issue 1); 14-19.; DOI:10.5588/pha.23.0022
Tsorou C, Williams A, van den Boogaard W, Staderini N, Repetto E, et al.
Public Health Action. 1 March 2024; Volume 14 (Issue 1); 14-19.; DOI:10.5588/pha.23.0022
SETTING
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 (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.
Journal Article > ResearchFull Text
IJID Reg. 13 July 2023; Volume 8; 111-117.; DOI:10.1016/j.ijregi.2023.07.004
Mhlanga L, Welte A, Grebe E, Ohler L, Van Cutsem G, et al.
IJID Reg. 13 July 2023; Volume 8; 111-117.; DOI:10.1016/j.ijregi.2023.07.004
OBJECTIVE
We estimated changes in the HIV incidence from 2013 to 2018 in Eshowe/Mbongolwane, KwaZulu Natal, South Africa where Médecins Sans Frontières is engaged in providing HIV testing and care since 2011.
METHODS
Using data from two cross-sectional household-based surveys conducted in 2013 and 2018, with consenting participants aged 15-59 years, we applied the incidence estimation frameworks of Mahiane et al and Kassanjee et al.
RESULTS
In total 5599 (62.4% women) and 3276 (65.9% women) individuals were included in 2013 and 2018 respectively. We found a mean incidence in women 20-29 years of 2.71 cases per 100 person-years (95% CI: 1.23; 4.19) in 2013 and 0.4 cases per 100 person-years (95% CI: 0.0; 1.5) in 2018. The incidence in men 20-29 years was 1.91 cases per 100 person years (95% CI: 0.87; 2.93) in 2013 and 0.53 cases per 100 person-years (95% CI: 0.0; 1.4) s in 2018. The incidence decline among women aged 15-19 was -0.34 cases per 100 person-years (95% CI: -1.31;0.64).
CONCLUSIONS
The lack of evidence of incidence decline among adolescent girls is noteworthy and disconcerting our findings suggest that large scale surveys should seriously consider focusing their resources on the core group of women aged 15-19.
We estimated changes in the HIV incidence from 2013 to 2018 in Eshowe/Mbongolwane, KwaZulu Natal, South Africa where Médecins Sans Frontières is engaged in providing HIV testing and care since 2011.
METHODS
Using data from two cross-sectional household-based surveys conducted in 2013 and 2018, with consenting participants aged 15-59 years, we applied the incidence estimation frameworks of Mahiane et al and Kassanjee et al.
RESULTS
In total 5599 (62.4% women) and 3276 (65.9% women) individuals were included in 2013 and 2018 respectively. We found a mean incidence in women 20-29 years of 2.71 cases per 100 person-years (95% CI: 1.23; 4.19) in 2013 and 0.4 cases per 100 person-years (95% CI: 0.0; 1.5) in 2018. The incidence in men 20-29 years was 1.91 cases per 100 person years (95% CI: 0.87; 2.93) in 2013 and 0.53 cases per 100 person-years (95% CI: 0.0; 1.4) s in 2018. The incidence decline among women aged 15-19 was -0.34 cases per 100 person-years (95% CI: -1.31;0.64).
CONCLUSIONS
The lack of evidence of incidence decline among adolescent girls is noteworthy and disconcerting our findings suggest that large scale surveys should seriously consider focusing their resources on the core group of women aged 15-19.
Conference Material > Video
Mukooza E
MSF Scientific Day International 2023. 7 June 2023; DOI:10.57740/bg0s-y318
Conference Material > Slide Presentation
Kerschberger B, Mukooza E, Berto A, Ntshalintshali N, Mafomisa M, et al.
MSF Scientific Day International 2023. 7 June 2023; DOI:10.57740/h6j7-s634
Conference Material > Abstract
Kerschberger B, Ntshalintshali N, Mafomisa M, Mabhena E, Daka M, et al.
MSF Scientific Day International 2023. 7 June 2023; DOI:10.57740/4e0e-e138
INTRODUCTION
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
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
Journal Article > ResearchFull Text
PLOS One. 30 December 2022; Volume 17 (Issue 12); e0279692.; DOI:10.1371/journal.pone.0279692
Bossard C, Chihana ML, Nicholas S, Mauambeta D, Weinstein D, et al.
PLOS One. 30 December 2022; Volume 17 (Issue 12); e0279692.; DOI:10.1371/journal.pone.0279692
Female Sex Workers (FSWs) are a hard-to-reach and understudied population, especially those who begin selling sex at a young age. In one of the most economically disadvantaged regions in Malawi, a large population of women is engaged in sex work surrounding predominantly male work sites and transport routes. A cross-sectional study in February and April 2019 in Nsanje district used respondent driven sampling (RDS) to recruit women ≥13 years who had sexual intercourse (with someone other than their main partner) in exchange for money or goods in the last 30 days. A standardized questionnaire was filled in; HIV, syphilis, gonorrhea, and chlamydia tests were performed. CD4 count and viral load (VL) testing occurred for persons living with HIV (PLHIV). Among 363 study participants, one-quarter were adolescents 13–19 years (25.9%; n = 85). HIV prevalence was 52.6% [47.3–57.6] and increased with age: from 14.7% (13–19 years) to 87.9% (≥35 years). HIV status awareness was 95.2% [91.3–97.4], ART coverage was 98.8% [95.3–99.7], and VL suppression 83.2% [77.1–88.0], though adolescent FSWs were less likely to be virally suppressed than adults (62.8% vs. 84.4%). Overall syphilis prevalence was 29.7% [25.3–43.5], gonorrhea 9.5% [6.9–12.9], and chlamydia 12.5% [9.3–16.6]. 72.4% had at least one unwanted pregnancy, 17.9% had at least one abortion (40.1% of which were unsafe). Half of participants reported experiencing sexual violence (SV) (47.6% [42.5–52.7]) and more than one-tenth (14.2%) of all respondents experienced SV perpetrated by a police officer. Our findings show high levels of PLHIV-FSWs engaged in all stages of the HIV cascade of care. The prevalence of HIV, other STIs, unwanted pregnancy, unsafe abortion, and sexual violence remains extremely high. Peer-led approaches contributed to levels of ART coverage and HIV status awareness similar to those found in the general district population, despite the challenges and risks faced by FSWs.
Journal Article > ResearchFull Text
Ethiop Med J. 1 July 2004; Volume 42 (Issue 3); 173-177.
Reilley B, Hiwot ZG, Mesure J
Ethiop Med J. 1 July 2004; Volume 42 (Issue 3); 173-177.
OBJECTIVES
A study was conducted to assess the acceptability and utilization of voluntary counselling and testing (VCT) and sexually transmitted infection (STI) services in Kahsey Abera Hospital, Humera.
METHODS
Retrospective data was taken from hospital consultation logbooks from January 2002 to February 2003, and focus group discussions were conducted in March 2003 in the community.
RESULTS
While the services were known and utilization is increasing, important misconceptions about the medical services, disease transmission, and STI treatment persist. Although hospital care was generally considered of high quality, persons often go to pharmacies to self-treat for STIs due to concerns about confidentiality, and the stigma of HIV deters many from wanting to know their serostatus.
CONCLUSIONS
Additional education is needed on HIV/AIDS, STIs, and the medical services provided. Education may make use of community health workers or outreach workers in a small group where participants can feel comfortable to ask sensitive questions. HIV/AIDS treatment is planned for the near future and may be significant in reducing HIV/AIDS stigma.
A study was conducted to assess the acceptability and utilization of voluntary counselling and testing (VCT) and sexually transmitted infection (STI) services in Kahsey Abera Hospital, Humera.
METHODS
Retrospective data was taken from hospital consultation logbooks from January 2002 to February 2003, and focus group discussions were conducted in March 2003 in the community.
RESULTS
While the services were known and utilization is increasing, important misconceptions about the medical services, disease transmission, and STI treatment persist. Although hospital care was generally considered of high quality, persons often go to pharmacies to self-treat for STIs due to concerns about confidentiality, and the stigma of HIV deters many from wanting to know their serostatus.
CONCLUSIONS
Additional education is needed on HIV/AIDS, STIs, and the medical services provided. Education may make use of community health workers or outreach workers in a small group where participants can feel comfortable to ask sensitive questions. HIV/AIDS treatment is planned for the near future and may be significant in reducing HIV/AIDS stigma.