Journal Article > ResearchFull Text
J Acquir Immune Defic Syndr; JAIDS. 2019 September 1; Volume 82 (Issue 1); 96-104.; DOI: 10.1097/QAI.0000000000002101
Kerschberger B, Ntshalintshali N, Mpala Q, Uribe PAD, Maphalala G, et al.
J Acquir Immune Defic Syndr; JAIDS. 2019 September 1; Volume 82 (Issue 1); 96-104.; DOI: 10.1097/QAI.0000000000002101
BACKGROUND
Viral load (VL) testing is being scaled up in resource-limited settings. However, not all commercially available VL testing methods have been evaluated under field conditions. This study is one of a few to evaluate the Biocentric platform for VL quantification in routine practice in Sub-Saharan Africa.
METHODS
Venous blood specimens were obtained from patients eligible for VL testing at two health facilities in Swaziland from October 2016 to March 2017. Samples were centrifuged at two laboratories (LAB-1, LAB-2) to obtain paired plasma specimens for VL quantification with the national reference method and on the Biocentric platform. Agreement (correlation, Bland–Altman) and accuracy (sensitivity, specificity) indicators were calculated at the VL thresholds of 416 (2.62 log10) and 1000 (3.0 log10) copies/mL. Leftover samples from patients with discordant VL results were re-quantified and accuracy indicators recalculated. Logistic regression was used to compare laboratory performance.
RESULTS
A total of 364 paired plasma samples (LAB-1: n = 198; LAB-2: n = 166) were successfully tested using both methods. The correlation was high (R = 0.82, p < 0.01), and the Bland–Altman analysis showed a minimal mean difference (− 0.03 log10 copies/mL; 95% CI: -1.15 to 1.08). At the clinical threshold level of 3.0 log10 copies/mL, the sensitivity was 88.6% (95% CI: 78.7 to 94.9) and the specificity was 98.3% (95% CI: 96.1 to 99.4). Sensitivity was higher in LAB-1 (100%; 95% CI: 71.5 to 100) than in LAB-2 (86.4%; 95% CI: 75.0 to 94.0). Most upward (n = 8, 2.2%) and downward (n = 11, 3.0%) misclassifications occurred at the 2.62 log threshold, with LAB-2 having a 16 (95% CI: 2.26 to 113.27; p = 0.006) times higher odds of downward misclassification. After retesting of discordant leftover samples (n = 17), overall sensitivity increased to 93.5% (95% CI: 85.5 to 97.9) and 97.1% (95% CI: 90.1 to 99.7) at the 2.62 and 3.0 thresholds, and specificity increased to 98.6% (95% CI: 96.5 to 99.6) and 99.0% (95% CI: 97.0 to 99.8) respectively.
CONCLUSIONS
The test characteristics of the Biocentric platform were overall comparable to the national reference method for VL quantification. One laboratory tended to misclassify VL results downwards, likely owing to unmet training needs and lack of previous hands-on practice.
Viral load (VL) testing is being scaled up in resource-limited settings. However, not all commercially available VL testing methods have been evaluated under field conditions. This study is one of a few to evaluate the Biocentric platform for VL quantification in routine practice in Sub-Saharan Africa.
METHODS
Venous blood specimens were obtained from patients eligible for VL testing at two health facilities in Swaziland from October 2016 to March 2017. Samples were centrifuged at two laboratories (LAB-1, LAB-2) to obtain paired plasma specimens for VL quantification with the national reference method and on the Biocentric platform. Agreement (correlation, Bland–Altman) and accuracy (sensitivity, specificity) indicators were calculated at the VL thresholds of 416 (2.62 log10) and 1000 (3.0 log10) copies/mL. Leftover samples from patients with discordant VL results were re-quantified and accuracy indicators recalculated. Logistic regression was used to compare laboratory performance.
RESULTS
A total of 364 paired plasma samples (LAB-1: n = 198; LAB-2: n = 166) were successfully tested using both methods. The correlation was high (R = 0.82, p < 0.01), and the Bland–Altman analysis showed a minimal mean difference (− 0.03 log10 copies/mL; 95% CI: -1.15 to 1.08). At the clinical threshold level of 3.0 log10 copies/mL, the sensitivity was 88.6% (95% CI: 78.7 to 94.9) and the specificity was 98.3% (95% CI: 96.1 to 99.4). Sensitivity was higher in LAB-1 (100%; 95% CI: 71.5 to 100) than in LAB-2 (86.4%; 95% CI: 75.0 to 94.0). Most upward (n = 8, 2.2%) and downward (n = 11, 3.0%) misclassifications occurred at the 2.62 log threshold, with LAB-2 having a 16 (95% CI: 2.26 to 113.27; p = 0.006) times higher odds of downward misclassification. After retesting of discordant leftover samples (n = 17), overall sensitivity increased to 93.5% (95% CI: 85.5 to 97.9) and 97.1% (95% CI: 90.1 to 99.7) at the 2.62 and 3.0 thresholds, and specificity increased to 98.6% (95% CI: 96.5 to 99.6) and 99.0% (95% CI: 97.0 to 99.8) respectively.
CONCLUSIONS
The test characteristics of the Biocentric platform were overall comparable to the national reference method for VL quantification. One laboratory tended to misclassify VL results downwards, likely owing to unmet training needs and lack of previous hands-on practice.
Journal Article > ResearchFull Text
BMC Infect Dis. 2018 November 14; Volume 18 (Issue 1); DOI:10.1186/s12879-018-3474-1
Mpala Q, Maphalala G, Uribe PAD, de la Tour R, Kalombola S, et al.
BMC Infect Dis. 2018 November 14; Volume 18 (Issue 1); DOI:10.1186/s12879-018-3474-1
Viral load (VL) testing is being scaled up in resource-limited settings. However, not all commercially available VL testing methods have been evaluated under field conditions. This study is one of a few to evaluate the Biocentric platform for VL quantification in routine practice in Sub-Saharan Africa.
Journal Article > ResearchFull Text
J Acquir Immune Defic Syndr. 2019 September 1; Volume 82 (Issue 1); 96-104.; DOI:10.1097/QAI.0000000000002101
Kerschberger B, Ntshalintshali N, Mpala Q, Diaz Uribe PA, Maphalala G, et al.
J Acquir Immune Defic Syndr. 2019 September 1; Volume 82 (Issue 1); 96-104.; DOI:10.1097/QAI.0000000000002101
BACKGROUND
To assess the performance and suitability of dried blood spot (DBS) sampling using filter paper to collect blood for viral load (VL) quantification under routine conditions.
METHODS
We compared performance of DBS VL quantification using the Biocentric method with plasma VL quantification using Roche and Biocentric as reference methods. Adults (≥18 years) were enrolled at 2 health facilities in Eswatini from October 12, 2016 to March 1, 2017. DBS samples were prepared through finger-prick by a phlebotomist (DBS-1), and through the pipetting of whole venous blood by a phlebotomist (DBS-2) and by a laboratory technologist (DBS-3). We calculated the VL-testing completion rate, correlation, and agreement, as well as diagnostic accuracy estimates at the clinical threshold of 1000 copies/mL.
RESULTS
Of 362 patients enrolled, 1066 DBS cards (DBS-1: 347; DBS-2: 359; DBS-3: 360) were tested. Overall, test characteristics were comparable between DBS-sampling methods, irrespective of the reference method. The Pearson correlation coefficients ranged from 0.67 to 0.82 (P < 0.001) for different types of DBS sampling using both reference methods, and the Bland-Altman difference ranged from 0.15 to 0.30 log10 copies/mL. Sensitivity estimates were from 85.3% to 89.2% and specificity estimates were from 94.5% to 98.6%. The positive predictive values were between 87.0% and 96.5% at a prevalence of 30% VL elevations, and negative predictive values were between 93.7% and 95.4%.
CONCLUSIONS
DBS VL quantification using the newly configured Biocentric method can be part of contextualized VL-testing strategies, particularly for remote settings and populations with higher viral failure rates.
To assess the performance and suitability of dried blood spot (DBS) sampling using filter paper to collect blood for viral load (VL) quantification under routine conditions.
METHODS
We compared performance of DBS VL quantification using the Biocentric method with plasma VL quantification using Roche and Biocentric as reference methods. Adults (≥18 years) were enrolled at 2 health facilities in Eswatini from October 12, 2016 to March 1, 2017. DBS samples were prepared through finger-prick by a phlebotomist (DBS-1), and through the pipetting of whole venous blood by a phlebotomist (DBS-2) and by a laboratory technologist (DBS-3). We calculated the VL-testing completion rate, correlation, and agreement, as well as diagnostic accuracy estimates at the clinical threshold of 1000 copies/mL.
RESULTS
Of 362 patients enrolled, 1066 DBS cards (DBS-1: 347; DBS-2: 359; DBS-3: 360) were tested. Overall, test characteristics were comparable between DBS-sampling methods, irrespective of the reference method. The Pearson correlation coefficients ranged from 0.67 to 0.82 (P < 0.001) for different types of DBS sampling using both reference methods, and the Bland-Altman difference ranged from 0.15 to 0.30 log10 copies/mL. Sensitivity estimates were from 85.3% to 89.2% and specificity estimates were from 94.5% to 98.6%. The positive predictive values were between 87.0% and 96.5% at a prevalence of 30% VL elevations, and negative predictive values were between 93.7% and 95.4%.
CONCLUSIONS
DBS VL quantification using the newly configured Biocentric method can be part of contextualized VL-testing strategies, particularly for remote settings and populations with higher viral failure rates.
Conference Material > Abstract
Kerschberger B, Ntshalintshali N, Maphalala G, Aung A, Mamba C, et al.
MSF Scientific Days International 2021: Research. 2021 May 19
INTRODUCTION
Acute HIV infection (AHI) is rarely diagnosed in resource-limited settings. Barriers to diagnosis include the high costs of viral load (VL)-based diagnostic testing algorithms and lack of
availability of reliable point-of-care (POC) tests. We assessed the performance of a new POC test for the detection of AHI in Eswatini, Alere™ HIV-Combo.
METHODS
Adult outpatients testing HIV-negative on Alere™ Determine through finger-prick testing by lay counselors, or with discordant result (Alere™ Determine-positive and Uni-Gold™-negative)
were enrolled at the Nhlangano Health Centre, between March 2019 and March 2020. Participants were then tested with the quantitative Xpert HIV-1 VL assay, used as the gold standard
test for AHI. AHI was defined as a VL result ≥40 copies/mL. Leftover paired venous whole blood and plasma specimens were tested with the lateral flow fourth-generation antibody/p24 POC Alere™ HIV-Combo. Both Xpert and HIV-Combo tests were performed in the laboratory by a laboratory technician. A positive result for AHI using the HIV-Combo test was defined as reactivity on the p24 antigen and/or antibody bars. Diagnostic test characteristics were evaluated for plasma (HIV-Comboplasma) and whole blood (HIV-Combo-wb), as compared with the results of Xpert testing.
ETHICS
This study was approved by the MSF Ethics Review Board and the Eswatini Ethics Committee.
RESULTS
A total of 745 (HIV-Combo-plasma/Xpert) and 429 (HIV-Combowb/ Xpert) paired test results were available. 29/745 (3.9%) and 19/429 (4.4%) were AHI-positive based on the results of Xpert testing. 26/745 (3.5%) were reactive on HIV-Combo-plasma and 16 (3.7%) on HIV-Combo-wb. Most positive test results with HIV-Combo showed reactivity to antibodies only (76.9% HIV-Combo-plasma; 75.0% HIV-Combo-wb), and the remainder to p24 antigen (15.4%, 18.8%) only, or both p24 antigen and antibodies (7.7%, 6.3%). The area under the receiver operating characteristic curve was 0.93 for HIV-Combo-plasma and 0.89 for HIV-Combo-wb. Test sensitivity tended to be slightly higher for HIV-Combo-plasma (86.2%) as compared to HIV-Combo-wb (78.9%), and specificity was high for both tests (≥99.8%). The negative predictive value was above 99.0% for both tests, and positive predictive values were 93.8% for HIV-Combo-wb and 96.2% for HIV-Combo-plasma.
CONCLUSION
Lateral flow POC HIV-Combo testing in this setting was able to diagnose most cases of AHI, in comparison to the gold standard. This test therefore has potential for use in routine settings due to low cost and ease of use. However, further studies are needed to evaluate its performance when used in routine outpatient care settings by lay counselors on finger-prick samples.
CONFLICTS OF INTEREST
None declared.
Acute HIV infection (AHI) is rarely diagnosed in resource-limited settings. Barriers to diagnosis include the high costs of viral load (VL)-based diagnostic testing algorithms and lack of
availability of reliable point-of-care (POC) tests. We assessed the performance of a new POC test for the detection of AHI in Eswatini, Alere™ HIV-Combo.
METHODS
Adult outpatients testing HIV-negative on Alere™ Determine through finger-prick testing by lay counselors, or with discordant result (Alere™ Determine-positive and Uni-Gold™-negative)
were enrolled at the Nhlangano Health Centre, between March 2019 and March 2020. Participants were then tested with the quantitative Xpert HIV-1 VL assay, used as the gold standard
test for AHI. AHI was defined as a VL result ≥40 copies/mL. Leftover paired venous whole blood and plasma specimens were tested with the lateral flow fourth-generation antibody/p24 POC Alere™ HIV-Combo. Both Xpert and HIV-Combo tests were performed in the laboratory by a laboratory technician. A positive result for AHI using the HIV-Combo test was defined as reactivity on the p24 antigen and/or antibody bars. Diagnostic test characteristics were evaluated for plasma (HIV-Comboplasma) and whole blood (HIV-Combo-wb), as compared with the results of Xpert testing.
ETHICS
This study was approved by the MSF Ethics Review Board and the Eswatini Ethics Committee.
RESULTS
A total of 745 (HIV-Combo-plasma/Xpert) and 429 (HIV-Combowb/ Xpert) paired test results were available. 29/745 (3.9%) and 19/429 (4.4%) were AHI-positive based on the results of Xpert testing. 26/745 (3.5%) were reactive on HIV-Combo-plasma and 16 (3.7%) on HIV-Combo-wb. Most positive test results with HIV-Combo showed reactivity to antibodies only (76.9% HIV-Combo-plasma; 75.0% HIV-Combo-wb), and the remainder to p24 antigen (15.4%, 18.8%) only, or both p24 antigen and antibodies (7.7%, 6.3%). The area under the receiver operating characteristic curve was 0.93 for HIV-Combo-plasma and 0.89 for HIV-Combo-wb. Test sensitivity tended to be slightly higher for HIV-Combo-plasma (86.2%) as compared to HIV-Combo-wb (78.9%), and specificity was high for both tests (≥99.8%). The negative predictive value was above 99.0% for both tests, and positive predictive values were 93.8% for HIV-Combo-wb and 96.2% for HIV-Combo-plasma.
CONCLUSION
Lateral flow POC HIV-Combo testing in this setting was able to diagnose most cases of AHI, in comparison to the gold standard. This test therefore has potential for use in routine settings due to low cost and ease of use. However, further studies are needed to evaluate its performance when used in routine outpatient care settings by lay counselors on finger-prick samples.
CONFLICTS OF INTEREST
None declared.
Conference Material > Abstract
Aung A, Mamba C, Ntshalintshali N, Mpala Q, Mthethwa-Hleza S, et al.
MSF Scientific Days International 2020: Research. 2020 May 26
INTRODUCTION
Acute HIV infection (AHI) cannot be detected with routine point-of-care antibody tests and is rarely diagnosed in resource-limited settings. However, characteristics of AHI, including its non-specific clinical presentation accompanied by high levels of plasma viraemia, may contribute to uncontrolled onward transmission within high-prevalence settings. Improving early detection of AHI in such settings could conceivably contribute to reducing onward transmission and thus impact on HIV elimination goals. We aimed to assess the programmatic feasibility of identifying and treating AHI patients in Eswatini, which has already achieved 90-90-90 targets.
METHODS
From March to December 2019, adults aged 16-49 years and attending outpatient departments at Nhlangano Health Center were screened for symptoms suggestive of AHI, including fever, sore throat, and current symptoms of a sexually transmitted infection. Individuals were enrolled into the study on testing negative or inconclusive for HIV using serial rapid diagnostic tests (RDT) Alere Determine™ HIV-1/2 (Abbott, USA) and Uni-Gold™ HIV (Trinity Biotech, Ireland), and on referral from HIV pre- and post-exposure prophylaxis programmes, if AHI was suspected. AHI was diagnosed using the Xpert platform (Cepheid, Sunnyvale, USA) to perform quantitative HIV RNA detection. Patients with AHI were offered immediate initiation of antiretroviral therapy (ART), follow-up care, and assisted partner notification.
ETHICS
This study was approved by the National Health Research and Review Board, Eswatini, and the MSF Ethics Review Board.
RESULTS
Of 2177 patients initially screened, 997 (46%) had symptoms suggestive of AHI. Of those, 611 (61%) patients were enrolled and tested with Xpert to assay HIV RNA viral load; this included n=586 because their HIV RDT test was negative; n=12 because HIV RDT was inconclusive; and seven and six were presumptive AHI cases identified in the pre- and post-exposure prophylaxis programmes respectively. Of those enrolled, 26 (4.3%) had a detectable HIV viral load. Median viral load was 4.70 log10 (interquartile range (IQR), 3.70-5.96). The most common complaints of those with AHI were fever, sore throat, headache, genital discharge and lower abdominal pain. 16 (62%) patients initiated ART. After two weeks, eight of 11 patients who were followed up had a suppressed viral load below 1000 copies/ml, and by three months, all patients who were on treatment achieved virological suppression. CD4 count was scheduled at every visit and among those with available test results, the median CD4 count was 476 cells/mm3 (IQR 305-768, n=16) at ART initiation, 522 cells/mm3 (IQR 426-713, n=eight) at one month, and 406 cells/mm3 (IQR 400-452, n=five) at three months. Only 11 partners were notified through the index patient; nine of them were HIV-negative and offered prevention methods, and two were HIV-positive.
CONCLUSION
Identifying and treating AHI in a routine outpatient setting can contribute to linkage with prompt HIV diagnosis and treatment. Conceivably, this could help contribute towards epidemic control in high HIV incidence settings. However, contact tracing and rapid linkage to care are vital challenges that need to be addressed.
CONFLICTS OF INTEREST
None declared.
Acute HIV infection (AHI) cannot be detected with routine point-of-care antibody tests and is rarely diagnosed in resource-limited settings. However, characteristics of AHI, including its non-specific clinical presentation accompanied by high levels of plasma viraemia, may contribute to uncontrolled onward transmission within high-prevalence settings. Improving early detection of AHI in such settings could conceivably contribute to reducing onward transmission and thus impact on HIV elimination goals. We aimed to assess the programmatic feasibility of identifying and treating AHI patients in Eswatini, which has already achieved 90-90-90 targets.
METHODS
From March to December 2019, adults aged 16-49 years and attending outpatient departments at Nhlangano Health Center were screened for symptoms suggestive of AHI, including fever, sore throat, and current symptoms of a sexually transmitted infection. Individuals were enrolled into the study on testing negative or inconclusive for HIV using serial rapid diagnostic tests (RDT) Alere Determine™ HIV-1/2 (Abbott, USA) and Uni-Gold™ HIV (Trinity Biotech, Ireland), and on referral from HIV pre- and post-exposure prophylaxis programmes, if AHI was suspected. AHI was diagnosed using the Xpert platform (Cepheid, Sunnyvale, USA) to perform quantitative HIV RNA detection. Patients with AHI were offered immediate initiation of antiretroviral therapy (ART), follow-up care, and assisted partner notification.
ETHICS
This study was approved by the National Health Research and Review Board, Eswatini, and the MSF Ethics Review Board.
RESULTS
Of 2177 patients initially screened, 997 (46%) had symptoms suggestive of AHI. Of those, 611 (61%) patients were enrolled and tested with Xpert to assay HIV RNA viral load; this included n=586 because their HIV RDT test was negative; n=12 because HIV RDT was inconclusive; and seven and six were presumptive AHI cases identified in the pre- and post-exposure prophylaxis programmes respectively. Of those enrolled, 26 (4.3%) had a detectable HIV viral load. Median viral load was 4.70 log10 (interquartile range (IQR), 3.70-5.96). The most common complaints of those with AHI were fever, sore throat, headache, genital discharge and lower abdominal pain. 16 (62%) patients initiated ART. After two weeks, eight of 11 patients who were followed up had a suppressed viral load below 1000 copies/ml, and by three months, all patients who were on treatment achieved virological suppression. CD4 count was scheduled at every visit and among those with available test results, the median CD4 count was 476 cells/mm3 (IQR 305-768, n=16) at ART initiation, 522 cells/mm3 (IQR 426-713, n=eight) at one month, and 406 cells/mm3 (IQR 400-452, n=five) at three months. Only 11 partners were notified through the index patient; nine of them were HIV-negative and offered prevention methods, and two were HIV-positive.
CONCLUSION
Identifying and treating AHI in a routine outpatient setting can contribute to linkage with prompt HIV diagnosis and treatment. Conceivably, this could help contribute towards epidemic control in high HIV incidence settings. However, contact tracing and rapid linkage to care are vital challenges that need to be addressed.
CONFLICTS OF INTEREST
None declared.
Conference Material > Poster
Kerschberger B, Mpala Q, Aung A, Ntshalintshali N, Mamba C, et al.
MSF Scientific Days International 2021: Research. 2021 May 18
Conference Material > Slide Presentation
Kerschberger B, Mukooza E, Berto A, Ntshalintshali N, Mafomisa M, et al.
MSF Scientific Day International 2023. 2023 June 7; 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. 2023 June 7; 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
J Acquir Immune Defic Syndr; JAIDS. 2021 December 15; Volume 88 (Issue 5); 506-517.; DOI:10.1097/QAI.0000000000002794
Kerschberger B, Aung A, Mpala Q, Ntshalintshali N, Mamba C, et al.
J Acquir Immune Defic Syndr; JAIDS. 2021 December 15; Volume 88 (Issue 5); 506-517.; DOI:10.1097/QAI.0000000000002794
BACKGROUND
The lack of acute and early HIV infection (AEHI) diagnosis and care contributes to high HIV incidence in resource-limited settings. We aimed to assess the yield, predict and diagnose AEHI, and describe AEHI care outcomes in a public sector setting in Eswatini.
SETTING
This study was conducted in Nhlangano outpatient department, from March 2019 to March 2020.
METHODS
Adults at risk of AEHI underwent diagnostic testing for AEHI with the quantitative Xpert HIV-1 viral load (VL) assay. AEHI was defined as the detection of HIV-1 VL on Xpert and either a HIV-seronegative/HIV-serodiscordant third-generation antibody-based rapid-diagnostic test (RDT) result. First, the cross-sectional analysis obtained the yield of AEHI and established a predictor risk score (PRS) for the prediction of AEHI using Lasso logistic regression. Second, diagnostic accuracy statistics described the ability of the fourth-generation antibody/p24 antigen-based Alere™HIV-Combo RDT to diagnose AEHI (vs Xpert VL testing). Third, we described AHI care outcomes of AEHI-positive patients using survival analysis.
RESULTS
Of 795 HIV-seronegative/HIV-serodiscordant outpatients recruited, 30 (3.8%, 95%CI 2.6-5.3%) had AEHI. The PRS contained several factors (HIV-serodiscordant RDT, women, feeling at risk of HIV, swollen glands, fatigue) and had a sensitivity and specificity of 83.3% and 65.8% to predict AEHI. The HIV-Combo RDT had a sensitivity and specificity of 86.2% and 99.9% to diagnose AEHI. Of 30 AEHI-positive patients, the 1-month cumulative treatment initiation was 74% (95%CI 57-88%), and the 3-month viral suppression (<1000 copies/mL) was 87% (67-98%).
CONCLUSION
AEHI diagnosis and care appears possible in resource-limited settings.
The lack of acute and early HIV infection (AEHI) diagnosis and care contributes to high HIV incidence in resource-limited settings. We aimed to assess the yield, predict and diagnose AEHI, and describe AEHI care outcomes in a public sector setting in Eswatini.
SETTING
This study was conducted in Nhlangano outpatient department, from March 2019 to March 2020.
METHODS
Adults at risk of AEHI underwent diagnostic testing for AEHI with the quantitative Xpert HIV-1 viral load (VL) assay. AEHI was defined as the detection of HIV-1 VL on Xpert and either a HIV-seronegative/HIV-serodiscordant third-generation antibody-based rapid-diagnostic test (RDT) result. First, the cross-sectional analysis obtained the yield of AEHI and established a predictor risk score (PRS) for the prediction of AEHI using Lasso logistic regression. Second, diagnostic accuracy statistics described the ability of the fourth-generation antibody/p24 antigen-based Alere™HIV-Combo RDT to diagnose AEHI (vs Xpert VL testing). Third, we described AHI care outcomes of AEHI-positive patients using survival analysis.
RESULTS
Of 795 HIV-seronegative/HIV-serodiscordant outpatients recruited, 30 (3.8%, 95%CI 2.6-5.3%) had AEHI. The PRS contained several factors (HIV-serodiscordant RDT, women, feeling at risk of HIV, swollen glands, fatigue) and had a sensitivity and specificity of 83.3% and 65.8% to predict AEHI. The HIV-Combo RDT had a sensitivity and specificity of 86.2% and 99.9% to diagnose AEHI. Of 30 AEHI-positive patients, the 1-month cumulative treatment initiation was 74% (95%CI 57-88%), and the 3-month viral suppression (<1000 copies/mL) was 87% (67-98%).
CONCLUSION
AEHI diagnosis and care appears possible in resource-limited settings.
Journal Article > ResearchFull Text
Public Health Action. 2018 April 25; Volume 8 (Issue 1); DOI:10.5588/pha.17.0043
Dlamini N, Zulu Z, Kunene S, Geoffroy E, Ntshalintshali N, et al.
Public Health Action. 2018 April 25; Volume 8 (Issue 1); DOI:10.5588/pha.17.0043
Background: Swaziland is one of the southern African countries that aim to eliminate malaria by 2020. In 2010, the country introduced an Immediate Disease Notification System (IDNS) for immediate reporting of notifiable diseases, including malaria. Health facilities are to report malaria cases within 24 h through a toll-free telephone number (977), triggering an alert for case investigation at the patient's household within 48 h. We assessed the completeness of reporting in the IDNS, the subsequent case investigation, and whether it was done within the stipulated timelines. Methods: A cross-sectional study using routine country-wide data. Results: Of 1991 malaria cases notified between July 2011 and June 2015, 76% were reported in the IDNS, of which 68% were investigated-a shortfall of 24% in reporting and 32% in case investigations. Of the 76% of cases reported through the IDNS, 62% were reported within 24 h and 20% were investigated within 48 h. These shortcomings were most pronounced in hospitals and private facilities. Investigated cases (n = 1346) were classified as follows: 60% imported, 35% local and 5% undetermined. Conclusion: The utilisation of the IDNS for case reporting to trigger investigation is crucial for active surveillance. There is a need to address the reporting and investigation gaps identified to ensure that malaria cases receive appropriate interventions.