Journal Article > ResearchFull Text
PLOS One. 2020 April 3; Volume 15 (Issue 4); e0230453.; DOI:10.1371/journal.pone.0230453.
Ndlovu Z, Massaquoi L, Bangwen NE, Batumba JN, Bora RU, et al.
PLOS One. 2020 April 3; Volume 15 (Issue 4); e0230453.; DOI:10.1371/journal.pone.0230453.
BACKGROUND
In sub-Saharan Africa, a third of people starting antiretroviral therapy and majority of patients returning to HIV-care after disengagement, present with advanced HIV disease (ADH), and are at high risk of mortality. Simplified and more affordable point-of-care (POC) diagnostics are required to increase access to prompt CD4 cell count screening for ambulatory and asymptomatic patients. The Visitect CD4 Lateral Flow Assay (LFA) is a disposable POC test, providing a visually interpreted result of above or below 200 CD4cells/mm3. This study evaluated the diagnostic performance of this index test.
METHODS
Consenting patients above 18years of age and eligible for CD4 testing were enrolled in Nsanje district hospital (Malawi), Gutu mission hospital (Zimbabwe) and Centre hopitalier de Kabinda (DRC). A total of 708 venous blood samples were tested in the index test and in the BD FACSCount assay (reference test method) in the laboratories (Phase 1) to determine diagnostic accuracy. A total of 433 finger-prick (FP) samples were tested on the index test at POC by clinicians (Phase 2) and a self-completed questionnaire was administered to all testers to explore usability of the index test.
RESULTS
Among 708 patients, 67.2% were female and median CD4 was 297cells/mm3. The sensitivity of the Visitect CD4 LFA using venous blood in the laboratory was 95.0% [95% CI: 91.3-97.5] and specificity was 81.9% [95% CI: 78.2-85.2%]. Using FP samples, the sensitivity of the Visitect CD4 LFA was 98.3% [95% CI: 95.0-99.6] and specificity was 77.2% [95% CI: 71.6-82.2%]. Usability of the Visitect CD4 LFA was high across the study sites with 97% successfully completed tests. Due to the required specific multiple incubation and procedural steps during the Visitect CD4 LFA testing, few health workers (7/26) were not confident to manage testing whilst multi-tasking in their clinical work.
CONCLUSIONS
Visitect CD4 LFA is a promising test for decentralized CD4 screening in resource-limited settings, without access to CD4 testing and and it can trigger prompt management of patients with AHD. Lay health cadres should be considered to conduct Visitect CD4 LFA testing in PHCs as well as coordinating all other POC quality assurance.
In sub-Saharan Africa, a third of people starting antiretroviral therapy and majority of patients returning to HIV-care after disengagement, present with advanced HIV disease (ADH), and are at high risk of mortality. Simplified and more affordable point-of-care (POC) diagnostics are required to increase access to prompt CD4 cell count screening for ambulatory and asymptomatic patients. The Visitect CD4 Lateral Flow Assay (LFA) is a disposable POC test, providing a visually interpreted result of above or below 200 CD4cells/mm3. This study evaluated the diagnostic performance of this index test.
METHODS
Consenting patients above 18years of age and eligible for CD4 testing were enrolled in Nsanje district hospital (Malawi), Gutu mission hospital (Zimbabwe) and Centre hopitalier de Kabinda (DRC). A total of 708 venous blood samples were tested in the index test and in the BD FACSCount assay (reference test method) in the laboratories (Phase 1) to determine diagnostic accuracy. A total of 433 finger-prick (FP) samples were tested on the index test at POC by clinicians (Phase 2) and a self-completed questionnaire was administered to all testers to explore usability of the index test.
RESULTS
Among 708 patients, 67.2% were female and median CD4 was 297cells/mm3. The sensitivity of the Visitect CD4 LFA using venous blood in the laboratory was 95.0% [95% CI: 91.3-97.5] and specificity was 81.9% [95% CI: 78.2-85.2%]. Using FP samples, the sensitivity of the Visitect CD4 LFA was 98.3% [95% CI: 95.0-99.6] and specificity was 77.2% [95% CI: 71.6-82.2%]. Usability of the Visitect CD4 LFA was high across the study sites with 97% successfully completed tests. Due to the required specific multiple incubation and procedural steps during the Visitect CD4 LFA testing, few health workers (7/26) were not confident to manage testing whilst multi-tasking in their clinical work.
CONCLUSIONS
Visitect CD4 LFA is a promising test for decentralized CD4 screening in resource-limited settings, without access to CD4 testing and and it can trigger prompt management of patients with AHD. Lay health cadres should be considered to conduct Visitect CD4 LFA testing in PHCs as well as coordinating all other POC quality assurance.
Journal Article > ResearchAbstract Only
Int J Tuberc Lung Dis. 2022 October 1; Volume 26 (Issue 10); 956-962.; DOI:DOI: 10.5588/ijtld.22.0115
Mangochi P, Bossard C, Catacutan C, Van Laeken D, Kwitonda C, et al.
Int J Tuberc Lung Dis. 2022 October 1; Volume 26 (Issue 10); 956-962.; DOI:DOI: 10.5588/ijtld.22.0115
BACKGROUND
Incarcerated individuals, especially in high HIV and TB burden settings, are at increased risk of latent TB infection and/or TB disease. We implemented a comprehensive HIV-TB intervention in a Malawi prison and studied its feasibility.
METHODS
Between February and December 2019, consenting individuals underwent screening for HIV, TB infection and TB disease. HIV-positive individuals without TB disease were treated with a fixed-dose combination of isoniazid, cotrimoxazole and vitamin B6 (INH-CTX-B6). HIV-negative persons with TB infection received 12 weeks of isoniazid and rifapentine (3HP).
RESULTS
Of 1,546 consenting individuals, 1,498 (96.9%) were screened and 1,427 (92.3%) included in the analysis: 96.4% were male, the median age was 31 years (IQR 25–38). Twenty-nine (2.1%) participants were diagnosed with TB disease, of whom 89.7% started and 61.5% completed TB treatment. Of the 1,427 included, 341 (23.9%) were HIV-positive, of whom 98.5% on antiretroviral therapy and 95% were started on INH-CTX-B6. Among 1,086 HIV-negative participants, 1,015 (93.5%) underwent the tuberculin skin test (TST), 670 (65.9%) were TST-positive, 666 (99.4%) started 3HP and 570 (85.5%) completed 3HP treatment.
CONCLUSION
A comprehensive TB screening and treatment package among incarcerated individuals was acceptable and feasible, and showed high prevalence of HIV, TB disease and TB infection. Treatment uptake was excellent, but treatment completion needs to be improved. Greater investment in comprehensive HIV-TB services, including access to shorter TB regimens and follow-up upon release, is needed for incarcerated individuals.
Incarcerated individuals, especially in high HIV and TB burden settings, are at increased risk of latent TB infection and/or TB disease. We implemented a comprehensive HIV-TB intervention in a Malawi prison and studied its feasibility.
METHODS
Between February and December 2019, consenting individuals underwent screening for HIV, TB infection and TB disease. HIV-positive individuals without TB disease were treated with a fixed-dose combination of isoniazid, cotrimoxazole and vitamin B6 (INH-CTX-B6). HIV-negative persons with TB infection received 12 weeks of isoniazid and rifapentine (3HP).
RESULTS
Of 1,546 consenting individuals, 1,498 (96.9%) were screened and 1,427 (92.3%) included in the analysis: 96.4% were male, the median age was 31 years (IQR 25–38). Twenty-nine (2.1%) participants were diagnosed with TB disease, of whom 89.7% started and 61.5% completed TB treatment. Of the 1,427 included, 341 (23.9%) were HIV-positive, of whom 98.5% on antiretroviral therapy and 95% were started on INH-CTX-B6. Among 1,086 HIV-negative participants, 1,015 (93.5%) underwent the tuberculin skin test (TST), 670 (65.9%) were TST-positive, 666 (99.4%) started 3HP and 570 (85.5%) completed 3HP treatment.
CONCLUSION
A comprehensive TB screening and treatment package among incarcerated individuals was acceptable and feasible, and showed high prevalence of HIV, TB disease and TB infection. Treatment uptake was excellent, but treatment completion needs to be improved. Greater investment in comprehensive HIV-TB services, including access to shorter TB regimens and follow-up upon release, is needed for incarcerated individuals.
Conference Material > Abstract
Ronoh Y, Some D, Ortuno R, Kuwenyi K, Mupepe T, et al.
MSF Scientific Days International 2020: Research. 2020 May 20
INTRODUCTION
Cervical cancer is now largely a preventable disease; however, implementation of highly sensitive molecular screening technologies in low-resource settings is partly hindered by the need for intensive investment in equipment and highly trained, skilled laboratory personnel. Resource limitations often preclude the possibility of same-day screening and treatment, as recommend by WHO. We sought to assess the diagnostic accuracy of self-collected versus nurse-collected high vaginal samples (HVS) for human papillomavirus (HPV) screening using GeneXpert, for within-country validation and to further inform its scale-up within routine point-of-care testing in primary healthcare systems.
METHODS
Consenting women presenting for routine cervical screening in selected health facilities in Gutu District, Zimbabwe, were asked to provide three HVS obtained at the same time on a single visit; the first, self-collected, and the following two, nurse-collected. Nurse-collected HVS were tested with GeneXpert (Cepheid, Sunnyvale, USA) and Cobas HPV (Roche, Pleasanton, USA; used as the reference test), whilst self-collected HVS were tested only using GeneXpert. Those testing positive on the reference test were offered visual inspection with acetic acid and cervicography (VIAC). Women with a positive VIAC examination were offered cryotherapy or loop electrosurgical excision procedure.
ETHICS
This study was approved by the MSF Ethics Review Board.
RESULTS
279 participants consented to provide HVS; none reported discomfort or side effects during or after swabbing. Among nurse-collected HVS, 11/279 participants were found positive on genotyping for HPV-16 using Cobas HPV, and nine of 279 were positive using GeneXpert. Eight out of 279 were identified on genotyping for HPV-18/45 using both platforms. The sensitivities of testing for HPV-16 and 18/45 using GeneXpert as compared to the reference test, Cobas, were 89% (95%CI 53-100) and 63% (95%CI 25-92) respectively. The sensitivity of self- and nurse-collected HVS for HPV-16 tested using GeneXpert, as compared to the reference test, was 89% (eight of nine; 95%CI 52-100). Specificity was 100% (95%CI 97-100), with a positive predictive value of 89% (95%CI 52-100), and negative predictive value of 100% (95%CI 97-100). However, sensitivity for detection of HPV-18/45 was 68.3% (95%CI 34-100).
CONCLUSION
Performance of cervical cancer screening using self-collected HVS tested with GeneXpert is comparable to that with nurse-collected HVS. Integrated GeneXpert platforms are already in wide use, enabling rapid diagnosis of tuberculosis, detection of HIV viral load, and early infant diagnosis of HIV, using a single piece of equipment. Deploying GeneXpert for HPV screening using self-collected HVS could help to provide timely results, especially in settings where VIAC is unavailable.
Cervical cancer is now largely a preventable disease; however, implementation of highly sensitive molecular screening technologies in low-resource settings is partly hindered by the need for intensive investment in equipment and highly trained, skilled laboratory personnel. Resource limitations often preclude the possibility of same-day screening and treatment, as recommend by WHO. We sought to assess the diagnostic accuracy of self-collected versus nurse-collected high vaginal samples (HVS) for human papillomavirus (HPV) screening using GeneXpert, for within-country validation and to further inform its scale-up within routine point-of-care testing in primary healthcare systems.
METHODS
Consenting women presenting for routine cervical screening in selected health facilities in Gutu District, Zimbabwe, were asked to provide three HVS obtained at the same time on a single visit; the first, self-collected, and the following two, nurse-collected. Nurse-collected HVS were tested with GeneXpert (Cepheid, Sunnyvale, USA) and Cobas HPV (Roche, Pleasanton, USA; used as the reference test), whilst self-collected HVS were tested only using GeneXpert. Those testing positive on the reference test were offered visual inspection with acetic acid and cervicography (VIAC). Women with a positive VIAC examination were offered cryotherapy or loop electrosurgical excision procedure.
ETHICS
This study was approved by the MSF Ethics Review Board.
RESULTS
279 participants consented to provide HVS; none reported discomfort or side effects during or after swabbing. Among nurse-collected HVS, 11/279 participants were found positive on genotyping for HPV-16 using Cobas HPV, and nine of 279 were positive using GeneXpert. Eight out of 279 were identified on genotyping for HPV-18/45 using both platforms. The sensitivities of testing for HPV-16 and 18/45 using GeneXpert as compared to the reference test, Cobas, were 89% (95%CI 53-100) and 63% (95%CI 25-92) respectively. The sensitivity of self- and nurse-collected HVS for HPV-16 tested using GeneXpert, as compared to the reference test, was 89% (eight of nine; 95%CI 52-100). Specificity was 100% (95%CI 97-100), with a positive predictive value of 89% (95%CI 52-100), and negative predictive value of 100% (95%CI 97-100). However, sensitivity for detection of HPV-18/45 was 68.3% (95%CI 34-100).
CONCLUSION
Performance of cervical cancer screening using self-collected HVS tested with GeneXpert is comparable to that with nurse-collected HVS. Integrated GeneXpert platforms are already in wide use, enabling rapid diagnosis of tuberculosis, detection of HIV viral load, and early infant diagnosis of HIV, using a single piece of equipment. Deploying GeneXpert for HPV screening using self-collected HVS could help to provide timely results, especially in settings where VIAC is unavailable.
Conference Material > Poster
Ngwa W, Manangazira P, Some D, Ortuno R, Ronoh Y, et al.
MSF Scientific Days International 2021: Research. 2021 May 18
Journal Article > ResearchFull Text
PLOS One. 2021 April 22; Volume 16 (Issue 4); DOI:10.1371/journal.pone.0248410
Conan N, Paye CP, Ortuno R, Chijuwa A, Chiwandira B, et al.
PLOS One. 2021 April 22; Volume 16 (Issue 4); DOI:10.1371/journal.pone.0248410
Conference Material > Slide Presentation
Ronoh Y, Some D, Ortuno R, Kuwenyi K, Mupepe T, et al.
MSF Scientific Days International 2020: Research. 2020 May 13
Journal Article > ResearchFull Text
S Afr Med J. 2021 August 2; Volume 111 (Issue 8); 768-776.; DOI:10.7196/SAMJ.2021.v111i8.15489
Chihana ML, Conan N, Ellman T, Poulet E, Garone DB, et al.
S Afr Med J. 2021 August 2; Volume 111 (Issue 8); 768-776.; DOI:10.7196/SAMJ.2021.v111i8.15489
BACKGROUND
HIV-serodiscordant couples are at high risk of HIV transmission. In sub-Saharan Africa, HIV-serodiscordant couples contribute ~30% of all new infections in the region.
OBJECTIVES
To quantify the prevalence of HIV-serodiscordant couples and evaluate steps of the HIV cascade of care among people living with HIV in serodiscordant relationships in four high-prevalence settings in sub-Saharan Africa.
METHODS
Four HIV prevalence surveys were conducted: in Ndhiwa (Kenya) in 2012, in Chiradzulu (Malawi) in 2013, and in Gutu (Zimbabwe) and Nsanje (Malawi) in 2016. Eligible individuals aged 15 - 59 years were asked to participate in voluntary rapid HIV testing. Viral load and CD4 counts were measured on those who tested HIV-positive. A couple was defined as a man and a woman who reported being married or cohabiting and were living together in the same household.
RESULTS
Among 4 385 couples, the prevalence of HIV serodiscordancy was 10.9% (95% confidence interval (CI) 10.2 - 11.5) overall, ranging from 6.7% (95% CI 5.6 - 7.9) in Nsanje to 15.8% (95% CI 14.5 - 17.3) in Ndhiwa. Men were the HIV-positive partner in 62.7% of the serodiscordant couples in Ndhiwa, in 60.4% in Gutu, in 48.8% in Chiradzulu and in 50.9% in Nsanje. Status awareness among HIV-positive partners in serodiscordant couples ranged from 45.4% in Ndhiwa to 70.7% in Gutu. Viral load suppression (VLS) ranged from 33.9% in Ndhiwa to 68.5% in Nsanje. VLS was similar by sex in three settings, Ndhiwa (37.8% (men) v. 27.8% (women); p=0.16), Nsanje (60.7% v. 76.9%; p=0.21) and Gutu (48.2% v. 55.6%; p=0.63), and dissimilar by sex in Chiradzulu (44.4% v. 62.7%; p=0.03).
CONCLUSIONS
Low HIV status awareness and poor VLS among HIV-positive partners are major gaps in preventing transmission among serodiscordant couples. Intensifying programmes that target couples to test for HIV and timely antiretroviral therapy initiation could increase VLS and reduce HIV transmission.
HIV-serodiscordant couples are at high risk of HIV transmission. In sub-Saharan Africa, HIV-serodiscordant couples contribute ~30% of all new infections in the region.
OBJECTIVES
To quantify the prevalence of HIV-serodiscordant couples and evaluate steps of the HIV cascade of care among people living with HIV in serodiscordant relationships in four high-prevalence settings in sub-Saharan Africa.
METHODS
Four HIV prevalence surveys were conducted: in Ndhiwa (Kenya) in 2012, in Chiradzulu (Malawi) in 2013, and in Gutu (Zimbabwe) and Nsanje (Malawi) in 2016. Eligible individuals aged 15 - 59 years were asked to participate in voluntary rapid HIV testing. Viral load and CD4 counts were measured on those who tested HIV-positive. A couple was defined as a man and a woman who reported being married or cohabiting and were living together in the same household.
RESULTS
Among 4 385 couples, the prevalence of HIV serodiscordancy was 10.9% (95% confidence interval (CI) 10.2 - 11.5) overall, ranging from 6.7% (95% CI 5.6 - 7.9) in Nsanje to 15.8% (95% CI 14.5 - 17.3) in Ndhiwa. Men were the HIV-positive partner in 62.7% of the serodiscordant couples in Ndhiwa, in 60.4% in Gutu, in 48.8% in Chiradzulu and in 50.9% in Nsanje. Status awareness among HIV-positive partners in serodiscordant couples ranged from 45.4% in Ndhiwa to 70.7% in Gutu. Viral load suppression (VLS) ranged from 33.9% in Ndhiwa to 68.5% in Nsanje. VLS was similar by sex in three settings, Ndhiwa (37.8% (men) v. 27.8% (women); p=0.16), Nsanje (60.7% v. 76.9%; p=0.21) and Gutu (48.2% v. 55.6%; p=0.63), and dissimilar by sex in Chiradzulu (44.4% v. 62.7%; p=0.03).
CONCLUSIONS
Low HIV status awareness and poor VLS among HIV-positive partners are major gaps in preventing transmission among serodiscordant couples. Intensifying programmes that target couples to test for HIV and timely antiretroviral therapy initiation could increase VLS and reduce HIV transmission.