168 results on '"Naniche D"'
Search Results
2. HIV infection in Eastern and Southern Africa: Highest burden, largest challenges, greatest potential
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Parker, E, Judge, MA, Macete, E, Nhampossa, T, Dorward, J, Langa, DC, De Schacht, C, Couto, A, Vaz, P, Vitoria, M, Molfino, L, Idowu, RT, Bhatt, N, Naniche, D, and Le Souëf, PN
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medicine.medical_specialty ,Economic growth ,Surveillance data ,Human immunodeficiency virus (HIV) ,030312 virology ,medicine.disease_cause ,03 medical and health sciences ,0302 clinical medicine ,hemic and lymphatic diseases ,Opinion Paper ,medicine ,risk factors ,Vulnerable population ,prevention and control ,030212 general & internal medicine ,Support services ,High rate ,0303 health sciences ,business.industry ,Public health ,public health ,Hiv epidemiology ,Retention in care ,Infectious Diseases ,HIV epidemiology ,Public aspects of medicine ,RA1-1270 ,business ,vulnerable populations ,early diagnosis - Abstract
Background: The burden of HIV is especially concerning for Eastern and Southern Africa (ESA), as despite expansion of test-and-treat programmes, this region continues to experience significant challenges resulting from high rates of morbidity, mortality and new infections. Hard-won lessons from programmes on the ground in ESA should be shared. Objectives: This report summarises relevant evidence and regional experts’ recommendations regarding challenges specific to ESA. Method: This commentary includes an in-depth review of relevant literature, progress against global goals and consensus opinion from experts. Results: Recommendations include priorities for essential research (surveillance data collection, key and vulnerable population education and testing, in-country testing trials and evidence-based support services to improve retention in care) as well as research that can accelerate progress towards the prevention of new infections and achieving ambitious global goals in ESA. Conclusion: The elimination of HIV in ESA will require continued investment, commitment to evidence-based programmes and persistence. Local research is critical to ensuring that responses in ESA are targeted, efficient and evaluated.
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- 2021
3. Operation Warp Speed: implications for global vaccine security
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Lall, B., Kim, J.H., Naniche, D., Gilbert, S., Bottazzi, M.E., Ergonul, O., Lancet Commission on COVID-19 Vaccines and Therapeutics Task Force Members, Yadav, P., Batista, C., Larson, H., Wilder-Smith, A., Hotez, P., Shoham, S., Strub-Wourgaft, N., Hassanain, M., Sheahan, T., Gursel, M., Kang, G., and Figueroa, J.P.
- Abstract
Several global efforts are underway to develop COVID-19 vaccines, and interim analyses from phase 3 clinical testing have been announced by nine organisations: Pfizer, the Gamaleya Research Institute of Epidemiology and Microbiology, Moderna, AstraZeneca, Sinopharm Group, Sinovac Biotech, Johnson & Johnson, Novavax, and CanSino Biologics. The US programme known as Operation Warp Speed provided US$18 billion in funding for development of vaccines that were intended for US populations. Depending on safety and efficacy, vaccines can become available through mechanisms for emergency use, expanded access with informed consent, or full licensure. An important question is: how will these Operation Warp Speed vaccines be used for COVID-19 prevention in global health settings? We address some key questions that arise in the transition from US to global vaccine prevention efforts and from ethical and logistical issues to those that are relevant to global vaccine security, justice, equity, and diplomacy. © 2021 The Authors. Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license
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- 2021
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4. Impact of CD14 promoter variants on measles vaccine responses and vaccine failure in children from Australia and Mozambique
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Clifford, H. D., Hayden, C. M., Khoo, S.-K., Naniche, D., Mandomando, I. M., Zhang, G., Richmond, P., and Le Souëf, P. N.
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- 2013
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5. High HIV prevalence in a southern semi-rural area of Mozambique: a community-based survey
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González, R, Munguambe, K, Aponte, J J, Bavo, C, Nhalungo, D, Macete, E, Alonso, P L, Menéndez, C, and Naniche, D
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- 2012
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6. Generalized immunosuppression: how viruses undermine the immune response
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Naniche*, D. and Oldstone, M. B. A.
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- 2000
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7. Reduction of antimalarial antibodies by HIV infection increases the risk of Plasmodium falciparum cord blood infection
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Naniche, D., Serra-Casas, E., Bardaji, A., Quinto, L., Dobaño, C., Sigaúque, B., Chitnis, C., Alonso, P., Menéndez, C., and Mayor, A.
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- 2011
8. Stabilization of HIV incidence in women of reproductive age in southern Mozambique
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Perez-Hoyos, S, Naniche, D, Macete, E, Aponte, J J, Sacarlal, J, Sigauque, B, Bardaji, A, Moraleda, C, de Deus, N, Alonso, P L, and Menéndez, C
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- 2011
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9. Mother-to-child transmission of HIV-1: association with malaria prevention, anaemia and placental malaria*
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Naniche, D, Lahuerta, M, Bardaji, A, Sigauque, B, Romagosa, C, Berenguera, A, Mandomando, I, David, C, Sanz, S, Aponte, J, Ordi, J, Alonso, P, and Menendez, C
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- 2008
10. Clinically relevant thresholds for ultrasensitive HIV drug resistance testing: a multi-country nested case-control study
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Inzaule, SC, Hamers, RL, Noguera-Julian, M, Casadella, M, Parera, M, Kityo, C, Steegen, K, Naniche, D, Clotet, B, de Wit, TFR, and Paredes, R
- Abstract
Background Implementation of ultrasensitive HIV drug resistance tests for routine clinical use is hampered by uncertainty about the clinical relevance of drug-resistant minority variants. We assessed different detection thresholds for pretreatment drug resistance to predict an increased risk of virological failure. Methods We did a case-control study nested within a prospective multicountry cohort. Our study included patients from 12 clinical sites in Kenya, Nigeria, South Africa, Uganda, and Zambia. We defined cases as patients with virological failure (ie, those who had either viral load >= 400 copies per mL at 12 months or had switched to second-line antiretroviral therapy [ART] as a result of virological failure before 12 months) and controls as those with viral suppression (viral load
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- 2018
11. The pathogenetic aspects of measles virus infection: memorandum from a WHO meeting
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Billeter, M, Bellini, W, Vanbinnendijk, R, Borrow, P, Brown, F, Cutts, F, Fennelly, G, Gellin, B, Griffin, D, Katz, S, Kolakofsky, D, Kreth, H, Liebert, U, Leopardi, R, Mcintosh, K, Termeulen, V, Minor, P, Moyer, S, Murphy, B, Naniche, D, Norrby, E, Ogra, P, Osterhaus, A, Paoletti, E, and Rima, B
- Abstract
Over the last three years considerable progress has been made in various areas related to measles virus and infection. A meeting to discuss the currently available data on the molecular biology of measles virus, measles immunology, immunopathology, as well as animal models for measles infection, and to identify studies that need to be carried out towards developing new vaccines was organized jointly by WHO and the U.S. National Institutes of Health and held in Montreux, Switzerland, on 20-21 April 1993. This Memorandum summarizes the discussions and recommendations made by the participants.
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- 2016
12. Decrease in measles virus-specific CD4 T cell memory in vaccinated subjects
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Naniche, D., Garenne, Michel, Rae, C., Manchester, M., Buchta, R., Brodine, S.K., and Oldstone, M.B.A.
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TEST ELISA ,ETUDE COMPARATIVE ,VIRUS ,VACCINATION ,DYNAMIQUE DE POPULATION ,ROUGEOLE ,CYTOMETRIE DE FLUX ,IMMUNOLOGIE ,IMMUNITE ,ANTICORPS ,ANALYSE STATISTIQUE - Published
- 2004
13. Human Immunology of Measles Virus Infection
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Naniche, D., primary
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14. Kaposi Sarcoma-Associated Immune Reconstitution Inflammatory Syndrome: In Need of a Specific Case Definition
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Letang, E., primary, Naniche, D., additional, Bower, M., additional, and Miro, J. M., additional
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- 2012
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15. P2-404 High HIV prevalence rates in a semi-rural area of southern Mozambique: population-based data compared with antenatal clinic prevalence estimations
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Gonzalez, R., primary, Bavo, C., additional, Pedro, E., additional, Munguambe, K., additional, Boene, H., additional, Nhalungo, D., additional, Menendez, C., additional, and Naniche, D., additional
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- 2011
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16. The pathogenetic aspects of measles virus infection: memorandum from a WHO meeting
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BILLETER, M, BELLINI, W, VANBINNENDIJK, R, BORROW, P, BROWN, F, CUTTS, F, FENNELLY, G, GELLIN, B, GRIFFIN, D, KATZ, S, KOLAKOFSKY, D, KRETH, H, LIEBERT, U, LEOPARDI, R, MCINTOSH, K, TERMEULEN, V, MINOR, P, MOYER, S, MURPHY, B, NANICHE, D, NORRBY, E, OGRA, P, OSTERHAUS, A, PAOLETTI, E, RIMA, B, SCHNEIDERSCHAULIES, S, STEPHENSON, J, WILD, T, CROWLEY, J, GLUCK, R, VANDERHEYDEN, R, HOMANN, H, LEROY, O, MAKINO, S, NAKAYAMA, T, MEEGAN, J, RABOURDINCOMBE, C, ROTA, P, ROUX, L, CLEMENTS, C, LAMBERT, P, PERVIKOV, Y, and SCOTT, R
- Abstract
Over the last three years considerable progress has been made in various areas related to measles virus and infection. A meeting to discuss the currently available data on the molecular biology of measles virus, measles immunology, immunopathology, as well as animal models for measles infection, and to identify studies that need to be carried out towards developing new vaccines was organized jointly by WHO and the U.S. National Institutes of Health and held in Montreux, Switzerland, on 20-21 April 1993. This Memorandum summarizes the discussions and recommendations made by the participants.
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- 1994
17. Estimating the vaccine-preventable burden of hospitalized pneumonia among young Mozambican children
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Roca, A., primary, Sigaúque, B., additional, Quintó, Ll., additional, Morais, L., additional, Berenguera, A., additional, Corachan, M., additional, Ribó, J.L., additional, Naniche, D., additional, Bassat, Q., additional, Sacoor, Ch., additional, Nhalungo, D., additional, Macete, E., additional, Schuchat, A., additional, Soriano-Gabarró, M., additional, Flannery, B., additional, and Alonso, P.L., additional
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- 2010
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18. Predictors of immune reconstitution inflammatory syndrome associated with Kaposi sarcoma (IRIS-KS) in a rural area of Mozambique
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Letang, E, primary, Almeida, J, additional, Ayala, E, additional, Miro, JM, additional, Carrilho, C, additional, Bastos, R, additional, Nhassone, D, additional, Gascon, J, additional, Menendez, C, additional, Alonso, PL, additional, and Naniche, D, additional
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- 2008
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19. Neutralizing antibodies to human immunodeficiency virus type-1 gp120 induce envelope glycoprotein subunit dissociation.
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Poignard, P, primary, Fouts, T, additional, Naniche, D, additional, Moore, J P, additional, and Sattentau, Q J, additional
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- 1996
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20. Glycosyl-phosphatidylinositol-anchored and transmembrane forms of CD46 display similar measles virus receptor properties: virus binding, fusion, and replication; down-regulation by hemagglutinin; and virus uptake and endocytosis for antigen presentation by major histocompatibility complex class II molecules
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Varior-Krishnan, G, primary, Trescol-Biémont, M C, additional, Naniche, D, additional, Rabourdin-Combe, C, additional, and Gerlier, D, additional
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- 1994
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21. Factors involved in entry of the human immunodeficiency virus type 1 into permissive cells: lack of evidence of a role for CD26
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Lazaro, I, primary, Naniche, D, additional, Signoret, N, additional, Bernard, A M, additional, Marguet, D, additional, Klatzmann, D, additional, Dragic, T, additional, Alizon, M, additional, and Sattentau, Q, additional
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- 1994
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22. Efficient MHC Class II‐restricted presentation of measles virus to T cells relies on its targeting to its cellular receptor human CD46 and involves an endosomal pathway
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Gerlier, D., primary, Trescol‐Biémont, M.‐C., additional, Varior‐Krishnan, G., additional, Naniche, D., additional, Fugier‐Vivier, I., additional, and Rabourdin‐Combe, C., additional
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- 1994
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23. Efficient major histocompatibility complex class II-restricted presentation of measles virus relies on hemagglutinin-mediated targeting to its cellular receptor human CD46 expressed by murine B cells.
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Gerlier, D, primary, Trescol-Biémont, M C, additional, Varior-Krishnan, G, additional, Naniche, D, additional, Fugier-Vivier, I, additional, and Rabourdin-Combe, C, additional
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- 1994
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24. Human membrane cofactor protein (CD46) acts as a cellular receptor for measles virus
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Naniche, D, primary, Varior-Krishnan, G, additional, Cervoni, F, additional, Wild, T F, additional, Rossi, B, additional, Rabourdin-Combe, C, additional, and Gerlier, D, additional
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- 1993
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25. Measles virus haemagglutinin induces down-regulation of gp57/67, a molecule involved in virus binding
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Naniche, D., primary, Wild, T. F., additional, Rabourdin-Combe, C., additional, and Gerlier, D., additional
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- 1993
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26. A Monoclonal Antibody Recognizes a Human Cell Surface Glycoprotein Involved In Measles Virus Binding
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Naniche, D., primary, Wild, T. F., additional, Rabourdin-Combe, C., additional, and Gerlier, D., additional
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- 1992
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27. Reduction of Antimalarial Antibodies by HIV Infection Is Associated With Increased Risk of Plasmodium falciparum Cord Blood Infection.
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Naniche D, Serra-Casas E, Bardají A, Quintó L, Dobaño C, Sigauque B, Cisteró P, Chauhan VS, Chitnis CE, Alonso PL, Menéndez C, and Mayor A
- Abstract
Background. Plasmodium falciparum infection in pregnancy can lead to congenital malaria, which has detrimental health consequences for infants. Human immunodeficiency virus (HIV) might increase cord blood P. falciparum infection by decreasing maternal antimalarial-specific antibodies. Methods. HIV-negative (n=133) and HIV-positive (n=55) Mozambican pregnant women were assessed at delivery for maternal and cord P. falciparum infection by quantitative polymerase chain reaction (qPCR) and P. falciparum-specific antibodies by enzyme-linked immunosorbent assay and flow cytometry. Results. Prevalence of qPCR-detected cord blood infection was 8.0%. Risk of cord infection was increased in presence of HIV (adjusted odds ratio [AOR], 3.80; P=.04) and placental malaria (AOR, 22.08; P=.002) after adjusting for clinical variables. The odds of having a high immunoglobulin G response to chondrotin sulphate A-binding infected erythrocytes, parasite lysate, and erythrocyte-binding antigen-175 were reduced among HIV-positive women (P < .001, .048, and .056, respectively) and among women with cord P. falciparum infection (P = .009, .04, and .046, respectively). In multivariate analysis including maternal HIV status, placental malaria, and antibody responses, HIV was no longer associated with cord blood infection (P = .11). Conclusions. HIV-associated impairment of antibody responses in pregnant women may contribute to a higher transmission of P. falciparum to their infants. [ABSTRACT FROM AUTHOR]
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- 2012
28. Reduction of antimalarial antibodies by HIV infection increases the risk of Plasmodium falciparum cord blood infection
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Naniche, D., Serra-Casas, E., Bardaji, A., Quinto, L., Dobano, C., Sigauque, B., Chitnis, C., Pedro Luis Alonso, Menendez, C., and Mayor, A.
29. Mode of entry of morbilliviruses
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Wild, T. F., Naniche, D., Rabourdin-Combe, C., and Gerlier, D.
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- 1995
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30. Differentiated service delivery in HIV care and treatment: An exploration of sustainability and impact from patients' and providers' perspectives
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Okere, N. E., Rinke de Wit, T.F., Naniche, D., Gomez Guillen, G.B., Hermans, S.M., Faculteit der Geneeskunde, Rinke de Wit, Tobias F., Naniche, Denise, Gomez Guillen, Gabriela B., Hermans, Sabine M., APH - Global Health, APH - Personalized Medicine, APH - Quality of Care, APH - Methodology, AII - Infectious diseases, and Graduate School
- Abstract
The immediate initiation of antiretroviral treatment following a positive HIV diagnosis is currently recommended by WHO. To facilitate implementation, the global fast track target to end the AIDS epidemic by 2030 was set and aims that 95% of HIV positive people know their status, of those, that 95% are placed on antiretroviral treatment (ART) and of those on ART that 95% are virally suppressed. Differentiating HIV services according to patients’ status and preferences while considering health system constraints appears a promising strategy for achieving global targets especially in low- and middle-income countries. The successful implementation of differentiated service delivery (DSD) approaches is however required to achieve global targets and therefore warrants an investigation into their sustainability and how they impact patients. This thesis employed a multi-disciplinary implementation research design to elucidate the sustainability of DSD as well as the impact of a DSD ART club model from a patients’ perspective highlighting the progress made and opportunities for further improvement. Specifically, the research queried the impact of DSD on quality of life, quality of care, and patient costs. The sustainability of various DSD approaches as well as barriers faced by patients as they navigate the health system were also investigated. DSD was considered potentially sustainable, showed significant cost reduction for stable patients, and comparable quality of life and quality of care compared to standard clinic-based service delivery.
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- 2022
31. Operation Warp Speed: implications for global vaccine security
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Onder Ergonul, Mazen Hassanain, Sarah C. Gilbert, Denise Naniche, Jerome H. Kim, Prashant Yadav, Carolina Batista, Gagandeep Kang, Mayda Gursel, J. Peter Figueroa, Timothy P. Sheahan, Nathalie Strub-Wourgaft, Peter J. Hotez, Bhavna Lall, Heidi J. Larson, Annelies Wilder-Smith, Maria Elena Bottazzi, Shmuel Shoham, Ergönül, Mehmet Önder (ORCID 0000-0003-1935-9235 & YÖK ID 110398), Kim, J. H., Hotez, P., Bottazzi, M. E., Lall, B., Sheahan, T., Shoham, S., Yadav, P., Batista, C., Gürsel, M., Figueroa, J. P., Gilbert, S., Larson, H., Wilder-Smith, A., Hassanain, M., Kang, G., Naniche, D., Strub-Wourgaft, N., Lancet Commission COVID-19 Vaccine, Therapeutics Task Force Members, Koç Üniversitesi İş Bankası Enfeksiyon Hastalıkları Uygulama ve Araştırma Merkezi (EHAM) / Koç University İşbank Center for Infectious Diseases (KU-IS CID), and School of Medicine
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COVID-19 Vaccines ,media_common.quotation_subject ,030231 tropical medicine ,Global Health ,03 medical and health sciences ,Public environmental and occupational health ,0302 clinical medicine ,Viewpoint ,Drug Development ,Informed consent ,Interim ,Global health ,Humans ,030212 general & internal medicine ,Justice (ethics) ,Diplomacy ,COVID-19 ,COVID-19 vaccines ,Drug development ,media_common ,Randomized Controlled Trials as Topic ,Licensure ,business.industry ,Equity (finance) ,General Medicine ,Public relations ,United States ,Expanded access ,Public aspects of medicine ,RA1-1270 ,business - Abstract
Several global efforts are underway to develop COVID-19 vaccines, and interim analyses from phase 3 clinical testing have been announced by nine organisations: Pfizer, the Gamaleya Research Institute of Epidemiology and Microbiology, Moderna, AstraZeneca, Sinopharm Group, Sinovac Biotech, Johnson & Johnson, Novavax, and CanSino Biologics. The US programme known as Operation Warp Speed provided US$18 billion in funding for development of vaccines that were intended for US populations. Depending on safety and efficacy, vaccines can become available through mechanisms for emergency use, expanded access with informed consent, or full licensure. An important question is: how will these Operation Warp Speed vaccines be used for COVID-19 prevention in global health settings? We address some key questions that arise in the transition from US to global vaccine prevention efforts and from ethical and logistical issues to those that are relevant to global vaccine security, justice, equity, and diplomacy., NA
- Published
- 2021
32. Towards achieving the third '90'of the 90-90-90 global HIV targets in sub-Saharan Africa: Adherence, drug resistance and molecular diagnostics
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Inzaule, S.C., Rinke de Wit, T.F., Naniche, D., Hamers, R.L., and Faculteit der Geneeskunde
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Global efforts for HIV/AIDS have now been galvanized around achieving the UNAIDS 90-90-90 targets (90% of people living with HIV knowing their status, 90% of those infected receiving ART, and 90% of those on ART having sustained viral suppression) which if achieved by 2020, would lead to HIV epidemic control by 2030. There are multiple factors challenging the attainment of these targets. This thesis focus on the challenge for achieving the third ‘90’ goal for viral suppression with specific focus on adherence, drug resistance and need for better molecular diagnostics in sub-Saharan Africa.
- Published
- 2019
33. HIV care retention in three multi-month ART dispensing: a retrospective cohort study in Mozambique.
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Saura-Lázaro A, Augusto O, Fernández-Luis S, López-Varela E, Fuente-Soro L, Bila D, Tovela M, Macuacua N, Vaz P, Couto A, Bruno C, and Naniche D
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- Humans, Mozambique, Retrospective Studies, Male, Female, Adult, Adolescent, Young Adult, Child, Anti-HIV Agents therapeutic use, Anti-HIV Agents administration & dosage, Middle Aged, Anti-Retroviral Agents therapeutic use, Medication Adherence statistics & numerical data, Lost to Follow-Up, HIV Infections drug therapy, Retention in Care statistics & numerical data
- Abstract
Objective: Evaluate the effect of three multimonth dispensing (3MMD) of antiretroviral therapy (ART) on HIV care retention in southern Mozambique., Design: Retrospective cohort study., Methods: We analyzed routine health data from people with HIV (PWH) aged 10 years old and older who started ART between January 2018 and March 2021. Individuals were followed until December 2021. Cox proportional-hazards models were used to compare attrition (lost to follow-up, death, and transfer out) between 3MMD and monthly ART dispensing. Results were stratified by time on ART before 3MMD enrolment: 'early enrollers' (<6 months on ART) and 'established enrollers' (≥6 months on ART), and age groups: adolescents and youth (AYLHIV) (10-24 years) and adults (≥25 years)., Results: We included 7378 PWH (25% AYLHIV, 75% adults), with 59% and 62% enrolled in 3MMD, respectively. Median follow-up time was 11.3 [interquartile range (IQR): 5.7-21.6] months for AYLHIV and 10.2 (IQR: 4.8-20.9) for adults. Attrition was lower in PWH enrolled in 3MMD compared with monthly ART dispensing, in both established (aHR AYLHIV = 0.65; 95% CI: 0.54-0.78 and aHR adults = 0.50; 95% confidence interval (CI): 0.44-0.56) and early enrollers (aHR AYLHIV = 0.70; 95% CI: 0.58-0.85 and aHR adults = 0.63; 95% CI: 0.57-0.70). Among individuals in 3MMD, male gender (aHR = 1.30; 95% CI: 1.18-1.44) and receiving care in a medium-volume/low-volume healthcare facility (aHR = 1.18; 95% CI: 1.03-1.34) increased attrition risk. Conversely, longer ART time before 3MMD enrolment (aHR = 0.93; 95% CI: 0.92-0.94 per 1 month increase) and age at least 45 years (aHR = 0.77, 95% CI: 0.67-0.89) reduced risk of attrition., Conclusion: 3MMD improves retention in care compared with monthly dispensing among established and early enrollers, although to a lesser extent among the latter., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)
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- 2024
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34. Enhancing HIV positivity yield in southern Mozambique: The effect of a Ministry of Health training module in targeted provider-initiated testing and counselling.
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Saura-Lázaro A, Fernández-Luis S, Nhampossa T, Fuente-Soro L, López-Varela E, Bernardo E, Augusto O, Sánchez T, Vaz P, Wei SC, Kerndt P, Honwana N, Young P, Amane G, Boene F, and Naniche D
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- Humans, Mozambique epidemiology, Female, Male, Adult, Middle Aged, HIV Testing methods, Young Adult, Adolescent, Mass Screening methods, Triage methods, Emergency Service, Hospital, Counseling, HIV Infections diagnosis, HIV Infections epidemiology, Health Personnel education
- Abstract
In Mozambique, targeted provider-initiated HIV testing and counselling (PITC) is recommended where universal PITC is not feasible, but its effectiveness depends on healthcare providers' training. This study aimed to evaluate the effect of a Ministry of Health training module in targeted PITC on the HIV positivity yield, and identify factors associated with a positive HIV test. We conducted a single-group pre-post study between November 2018 and November 2019 in the triage and emergency departments of four healthcare facilities in Manhiça District, a resource-constrained semi-rural area. It consisted of two two-month phases split by a one-week targeted PITC training module ("observation phases"). The HIV positivity yield of targeted PITC was estimated as the proportion of HIV-positive individuals among those recommended for HIV testing by the provider. Additionally, we extracted aggregated health information system data over the four months preceding and following the observation phases to compare yield in real-world conditions ("routine phases"). Logistic regression analysis from observation phase data was conducted to identify factors associated with a positive HIV test. Among the 7,102 participants in the pre- and post-training observation phases (58.5% and 41.5% respectively), 68% were women, and 96% were recruited at triage. In the routine phases with 33,261 individuals (45.8% pre, 54.2% post), 64% were women, and 84% were seen at triage. While HIV positivity yield between pre- and post-training observation phases was similar (10.9% (269/2470) and 11.1% (207/1865), respectively), we observed an increase in yield in the post-training routine phase for women in triage, rising from 4.8% (74/1553) to 7.3% (61/831) (Yield ratio = 1.54; 95%CI: 1.11-2.14). Age (25-49 years) (OR = 2.43; 95%CI: 1.37-4.33), working in industry/mining (OR = 4.94; 95%CI: 2.17-11.23), unawareness of partner's HIV status (OR = 2.50; 95%CI: 1.91-3.27), and visiting a healer (OR = 1.74; 95%CI: 1.03-2.93) were factors associated with a positive HIV test. Including these factors in the targeted PITC algorithm could have increased new HIV diagnoses by 2.6%. In conclusion, providing refresher training and adapting the current targeted PITC algorithm through further research can help reach undiagnosed PLHIV, treat all, and ultimately eliminate HIV, especially in resource-limited rural areas., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Saura-Lázaro et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2024
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35. Field performance and cost-effectiveness of a point-of-care triage test for HIV virological failure in Southern Africa.
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Saura-Lázaro A, Bock P, Bogaart EVD, van Vliet J, Granés L, Nel K, Naidoo V, Scheepers M, Saunders Y, Leal N, Ramponi F, Paulussen R, de Wit TR, Naniche D, and López-Varela E
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- Adult, Humans, Chemokine CXCL10 pharmacology, Chemokine CXCL10 therapeutic use, Cost-Benefit Analysis, Point-of-Care Systems, Triage, Cross-Sectional Studies, Africa, Southern, Viral Load, HIV Infections diagnosis, HIV Infections drug therapy, Anti-HIV Agents therapeutic use, Anti-HIV Agents pharmacology
- Abstract
Introduction: Antiretroviral therapy (ART) monitoring using viral load (VL) testing is challenging in high-burden, limited-resources settings. Chemokine IP-10 (interferon gamma-induced protein 10) strongly correlates with human immunodeficiency virus (HIV) VL. Its determination could serve to predict virological failure (VF) and to triage patients requiring VL testing. We assessed the field performance of a semi-quantitative IP-10 lateral flow assay (LFA) for VF screening in South Africa, and the cost-effectiveness of its implementation in Mozambique., Methods: A cross-sectional study was conducted between June and December 2021 in three primary health clinics in the Western Cape. Finger prick capillary blood was collected from adults on ART for ≥1 year for direct application onto the IP-10 LFA (index test) and compared with a plasma VL result ≤1 month prior (reference test). We estimated the area under the receiver operating characteristic curves (AUC), sensitivity and specificity, to evaluate IP-10 LFA prediction of VF (VL>1000 copies/ml). A decision tree model was used to investigate the cost-effectiveness of integrating IP-10 LFA combined with VL testing into the current Mozambican ART monitoring strategy. Averted disability-adjusted life years (DALYs) and HIV acquisitions, and incremental cost-effectiveness ratios were estimated., Results: Among 209 participants (median age 38 years and 84% female), 18% had VF. Median IP-10 LFA values were higher among individuals with VF compared to those without (24.0 vs. 14.6; p<0.001). The IP-10 LFA predicted VF with an AUC = 0.76 (95% confidence interval (CI) 0.67-0.85), 91.9% sensitivity (95% CI 78.1-98.3) and 35.1% specificity (95% CI 28.0-42.7). Integrating the IP-10 LFA in a setting with 20% VF prevalence and 61% VL testing coverage could save 13.0% of costs and avert 14.9% of DALYs and 55.7% new HIV acquisitions. Furthermore, its introduction was estimated to reduce the total number of routine VL tests required for ART monitoring by up to 68%., Conclusions: The IP-10 LFA is an effective VF triage test for routine ART monitoring. Combining a highly sensitive, low-cost IP-10 LFA-based screening with targeted VL confirmatory testing could result in significant healthcare quality improvements and cost savings in settings with limited access to VL testing., (© 2023 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)
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- 2023
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36. Reasons for non-disclosure of HIV-Positive status to healthcare providers: a mixed methods study in Mozambique.
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Fuente-Soro L, Figueroa-Romero A, Fernández-Luis S, Augusto O, López-Varela E, Bernardo E, Saura-Lázaro A, Vaz P, Wei SC, Kerndt PR, Nhampossa T, and Naniche D
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- Humans, Cross-Sectional Studies, Mozambique epidemiology, Databases, Factual, Health Personnel, HIV Infections diagnosis, HIV Infections epidemiology
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Background: Non-disclosure of known HIV status by people living with HIV but undergoing HIV testing leads to waste of HIV testing resources and distortion of estimates of HIV indicators. In Mozambique, an estimated one-third of persons who tested positive already knew their HIV-positive status. To our knowledge, this study is the first to assess the factors that prevent people living with HIV (PLHIV) from disclosing their HIV-positive status to healthcare providers during a provider-initiated counseling and testing (PICT) campaign., Methods: This analysis was nested in a larger PICT cross-sectional study performed in the Manhiça District, Southern Mozambique from January to July 2019, in which healthcare providers actively asked patients about their HIV-status. Patients who tested positive for HIV were crosschecked with the hospital database to identify those who had previously tested positive and were currently or previously enrolled in care. PLHIV who did not disclose their HIV-positive status were invited to participate and provide consent, and were interviewed using a questionnaire designed to explore barriers, patterns of community/family disclosure, and stigma and discrimination., Results: We found that 16.1% of participants who tested positive during a PICT session already knew their HIV-positive status but did not disclose it to the healthcare provider. All the participants reported previous mistreatment by general healthcare providers as a reason for nondisclosure during PICT. Other reasons included the desire to know if they were cured (33.3%) or to re-engage in care (23.5%). Among respondents, 83.9% reported having disclosed their HIV-status within their close community, 48.1% reported being victims of verbal or physical discrimination following their HIV diagnosis, and 46.7% reported that their HIV status affected their daily activities., Conclusion: Previous mistreatment by healthcare workers was the main barrier to disclosing HIV-positive status. The high proportion of those disclosing their HIV status to their community but not to healthcare providers suggests that challenges with patient-provider relationships affect this care behavior rather than social stigma and discrimination. Improving patient-provider relationships could increase trust in healthcare providers, reduce non-disclosures, and help optimize resources and provide accurate estimates of the UNAIDS first 95 goal., (© 2023. BioMed Central Ltd., part of Springer Nature.)
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- 2023
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37. Using testing history to estimate HIV incidence in mothers living in resource-limited settings: Maximizing efficiency of a community health survey in Mozambique.
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Augusto O, Fernández-Luis S, Fuente-Soro L, Nhampossa T, Lopez-Varela E, Nhacolo A, Bernardo E, Guambe H, Tibana K, Juga AJC, Cowan JG, Urso M, and Naniche D
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Obtaining rapid and accurate HIV incidence estimates is challenging because of the need for long-term follow-up for a large cohort. We estimated HIV incidence among women who recently delivered in southern Mozambique by leveraging data available in routine health cards. A cross-sectional household HIV-testing survey was conducted from October 2017 to April 2018 among mothers of children born in the previous four years in the Manhiça Health Demographic Surveillance System area. Randomly-selected mother-child pairs were invited to participate and asked to present documentation of their last HIV test result. HIV-testing was offered to mothers with no prior HIV-testing history, or with negative HIV results obtained over three months ago. HIV incidence was estimated as the number of mothers newly diagnosed with HIV per total person-years, among mothers with a prior documented HIV-negative test. Among 5000 mother-child pairs randomly selected, 3069 were interviewed, and 2221 reported a previous HIV-negative test. From this group, we included 1714 mothers who had taken a new HIV test during the survey. Most of mothers included (83.3%,1428/1714) had a previous documented HIV test result and date. Median time from last test to survey was 15.5 months (IQR:8.0-25.9). A total of 57 new HIV infections were detected over 2530.27 person-years of follow-up. The estimated HIV incidence was 2.25 (95% CI: 1.74-2.92) per 100 person-years. Estimating HIV incidence among women who recently delivered using a community HIV-focused survey coupled with previous HIV-testing history based on patients' clinical documents is an achievable strategy., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)
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- 2023
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38. Vaccines and therapeutics for immunocompromised patients with COVID-19.
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Shoham S, Batista C, Ben Amor Y, Ergonul O, Hassanain M, Hotez P, Kang G, Kim JH, Lall B, Larson HJ, Naniche D, Sheahan T, Strub-Wourgaft N, Sow SO, Wilder-Smith A, Yadav P, and Bottazzi ME
- Abstract
The COVID-19 pandemic has disproportionately impacted immunocompromised patients. This diverse group is at increased risk for impaired vaccine responses, progression to severe disease, prolonged hospitalizations and deaths. At particular risk are people with deficiencies in lymphocyte number or function such as transplant recipients and those with hematologic malignancies. Such patients' immune responses to vaccination and infection are frequently impaired leaving them more vulnerable to prolonged high viral loads and severe complications of COVID-19. Those in turn, have implications for disease progression and persistence, development of immune escape variants and transmission of infection. Data to guide vaccination and treatment approaches in immunocompromised people are generally lacking and extrapolated from other populations. The large clinical trials leading to authorisation and approval of SARS-CoV-2 vaccines and therapeutics included very few immunocompromised participants. While experience is accumulating, studies focused on the special circumstances of immunocompromised patients are needed to inform prevention and treatment approaches., Competing Interests: The authors report the following potential competing interests: PH and MEB are co-inventors of a COVID-19 recombinant protein vaccine technology owned by Baylor College of Medicine (BCM) that was licensed by BCM non-exclusively and with no patent restrictions to several companies committed to advancing vaccines for low- and middle-income countries. The co-inventors have no involvement in license negotiations conducted by BCM. Similar to other research universities, a long-standing BCM policy provides its faculty and staff, who make discoveries that result in a commercial license, a share of any royalty income. To date, BCM has not distributed any royalty income to the co-inventors on the COVID-19 recombinant protein vaccine technology. Any such distribution will be undertaken in accordance with BCM policy. MH is Founder and Managing Director of SaudiVax. GK is a member of the WHO SAGE Working Group on COVID-19 vaccines. GK is independent director appointed by the Wellcome Trust, MSD Wellcome Trust Hilleman Laboratories Private Limited and Vice Chair of the Board, Coalition of Epidemic Preparedness Innovations (CEPI). HL reports grants and honoraria from GlaxoSmithKline for training talks and from Merck as a member of the Merck Vaccine Confidence Advisory Board, grants from J&J outside the submitted work. AWS serves as Consultant to WHO. The views presented here reflect her views and not necessarily those of WHO. TS reports grants from National Institute of Allergy and Infectious Disease and Fast Grants and research contracts from GlaxoSmithKline, and ViiV Healthcare. SS reports grants or contracts made to institution from U.S. Department of Defense (Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense), Defense Health Agency, Shionogi, Shire, Ansun, Cidara, Zeteo Tech Inc., F2G, Emergent Biosolutions, Bloomberg Philanthropies, the State of Maryland, NIH National Center for Advancing Translational Sciences, Mental Wellness Foundation, Moriah Fund, Octopharma, Shear Family Foundation, HealthNetwork Foundation, Mayo Clinic, University of Nebraska; consulting fees made directly to author from Immunome, Adagio Therapeutics, Celltrion Healthcare, Karius; payment or honoraria to author for lectures, presentations, speakers bureaus, manuscript writing or educational events from Prime Inc. and Peerview; travel support from Peerview for American Transplant Congress 2022, from NCCN for NCCN Guideline meeting, and from ACP for ACP board of governors meeting; paid participation on a Data Safety Monitoring Board or Advisory Board for Intermountain Health, Karyopharm, Adamis Health; a role on guideline panels for NCCN, IDSA, MSG/EORTC, on RSV vaccine workgroup for ACIP/CDC, as Governor of Washington DC Chapter of ACP, and as member of Board of Governors of ACP; stock or stock options from Immunome. JHK reports personal fees from SK biosciences. CB, YBA, OE, BL, DN, NSW, SOS, and PY declare no conflict of interests. The authors views and opinions in the Review do not necessarily represent the views, decisions, or policies of the institutions, universities, or health systems with which they are affiliated., (© 2023 The Author(s).)
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- 2023
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39. Gene dysregulation in acute HIV-1 infection - early transcriptomic analysis reveals the crucial biological functions affected.
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Parker E, Judge MA, Pastor L, Fuente-Soro L, Jairoce C, Carter KW, Anderson D, Mandomando I, Clifford HD, Naniche D, and Le Souëf PN
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- Humans, Transcriptome, Leukocytes, Mononuclear metabolism, Gene Expression Profiling, Nuclear Proteins metabolism, HIV Infections, HIV-1 genetics
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Introduction: Transcriptomic analyses from early human immunodeficiency virus (HIV) infection have the potential to reveal how HIV causes widespread and lasting damage to biological functions, especially in the immune system. Previous studies have been limited by difficulties in obtaining early specimens., Methods: A hospital symptom-based screening approach was applied in a rural Mozambican setting to enrol patients with suspected acute HIV infection (Fiebig stage I-IV). Blood samples were collected from all those recruited, so that acute cases and contemporaneously recruited, uninfected controls were included. PBMC were isolated and sequenced using RNA-seq. Sample cellular composition was estimated from gene expression data. Differential gene expression analysis was completed, and correlations were determined between viral load and differential gene expression. Biological implications were examined using Cytoscape, gene set enrichment analysis, and enrichment mapping., Results: Twenty-nine HIV infected subjects one month from presentation and 46 uninfected controls were included in this study. Subjects with acute HIV infection demonstrated profound gene dysregulation, with 6131 (almost 13% of the genome mapped in this study) significantly differentially expressed. Viral load was correlated with 1.6% of dysregulated genes, in particular, highly upregulated genes involved in key cell cycle functions, were correlated with viremia. The most profoundly upregulated biological functions related to cell cycle regulation, in particular, CDCA7 may drive aberrant cell division, promoted by overexpressed E2F family proteins. Also upregulated were DNA repair and replication, microtubule and spindle organization, and immune activation and response. The interferome of acute HIV was characterized by broad activation of interferon-stimulated genes with antiviral functions, most notably IFI27 and OTOF. BCL2 downregulation alongside upregulation of several apoptotic trigger genes and downstream effectors may contribute to cycle arrest and apoptosis. Transmembrane protein 155 (TMEM155) was consistently highly overexpressed during acute infection, with roles hitherto unknown., Discussion: Our study contributes to a better understanding of the mechanisms of early HIV-induced immune damage. These findings have the potential to lead to new earlier interventions that improve outcomes., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Parker, Judge, Pastor, Fuente-Soro, Jairoce, Carter, Anderson, Mandomando, Clifford, Naniche and Le Souëf.)
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- 2023
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40. Costs and cost-effectiveness of HIV counselling and testing modalities in Southern Mozambique.
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Choo JH, Lopez-Varela E, Fuente-Soro L, Augusto O, Sacoor C, Nhacolo A, Wei S, Naniche D, Thomas R, and Sicuri E
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Objective: Despite the high HIV associated burden, Mozambique lacks data on HIV counselling and testing (HCT) costs. To help guide national HIV/AIDS programs, we estimated the cost per test for voluntary counselling and testing (VCT) from the patient's perspective and the costs per person tested and per HIV-positive individual linked to care to the healthcare provider for VCT, provider-initiated counselling and testing (PICT) and home-based testing (HBT). We also assessed the cost-effectiveness of these strategies for linking patients to care., Methods: Data from a cohort study conducted in the Manhiça District were used to derive costs and linkage-to-care outcomes of the three HCT strategies. A decision tree was used to model HCT costs according to the likelihood of HCT linking individuals to care and to obtain the incremental cost-effectiveness ratios (ICERs) of PICT and HBT with VCT as the comparator. Sensitivity analyses were performed to assess robustness of base-case findings., Findings: Based on costs and valuations in 2015, average and median VCT costs to the patient per individual tested were US$1.34 and US$1.08, respectively. Costs per individual tested were greatest for HBT (US$11.07), followed by VCT (US$7.79), and PICT (US$7.14). The costs per HIV-positive individual linked to care followed a similar trend. PICT was not cost-effective in comparison with VCT at a willingness-to-accept threshold of US$4.53, but only marginally given a corresponding base-case ICER of US$4.15, while HBT was dominated, with higher costs and lower impact than VCT. Base-case results for the comparison between PICT and VCT presented great uncertainty, whereas findings for HBT were robust., Conclusion: PICT and VCT are likely equally cost-effective in Manhiça. We recommend that VCT be offered as the predominant HCT strategy in Mozambique, but expansion of PICT could be considered in limited-resource areas. HBT without facilitated linkage or reduced costs is unlikely to be cost-effective., (© 2022. The Author(s).)
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- 2022
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41. Prompt HIV diagnosis and antiretroviral treatment in postpartum women is crucial for prevention of mother to child transmission during breastfeeding: Survey results in a high HIV prevalence community in southern Mozambique after the implementation of Option B.
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Fernández-Luis S, Fuente-Soro L, Nhampossa T, Lopez-Varela E, Augusto O, Nhacolo A, Vazquez O, Saura-Lázaro A, Guambe H, Tibana K, Ngeno B, Juga AJC, Cowan JG, Urso M, and Naniche D
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- Anti-Retroviral Agents therapeutic use, Breast Feeding, Cross-Sectional Studies, Female, Humans, Infant, Infectious Disease Transmission, Vertical prevention & control, Mozambique epidemiology, Postpartum Period, Pregnancy, Prevalence, HIV Infections diagnosis, HIV Infections drug therapy, HIV Infections epidemiology, Pregnancy Complications, Infectious drug therapy
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Objective: World Health Organization recommends promoting breastfeeding without restricting its duration among HIV-positive women on lifelong antiretroviral treatment (ART). There is little data on breastfeeding duration and mother to child transmission (MTCT) beyond 24 months. We compared the duration of breastfeeding in HIV-exposed and HIV-unexposed children and we identified factors associated with postpartum-MTCT in a semi-rural population of Mozambique., Methods: This cross-sectional assessment was conducted from October-2017 to April-2018. Mothers who had given birth within the previous 48-months in the Manhiça district were randomly selected to be surveyed and to receive an HIV-test along with their children. Postpartum MTCT was defined as children with an initial HIV positive result beyond 6 weeks of life who initiated breastfeeding if they had a first negative PCR result during the first 6 weeks of life or whose mother had an estimated date of infection after the child's birth. Cumulative incidence accounting for right-censoring was used to compare breastfeeding duration in HIV-exposed and unexposed children. Fine-Gray regression was used to assess factors associated with postpartum-MTCT., Results: Among the 5000 mother-child pairs selected, 69.7% (3486/5000) were located and enrolled. Among those, 27.7% (967/3486) children were HIV-exposed, 62.2% (2169/3486) were HIV-unexposed and for 10.0% (350/3486) HIV-exposure was unknown. Median duration of breastfeeding was 13.0 (95%CI:12.0-14.0) and 20.0 (95%CI:19.0-20.0) months among HIV-exposed and HIV-unexposed children, respectively (p<0.001). Of the 967 HIV-exposed children, 5.3% (51/967) were HIV-positive at the time of the survey. We estimated that 27.5% (14/51) of the MTCT occurred during pregnancy and delivery, 49.0% (2551) postpartum-MTCT and the period of MTCT remained unknown for 23.5% (12/51) of children. In multivariable analysis, mothers' ART initiation after the date of childbirth was associated (aSHR:9.39 [95%CI:1.75-50.31], p = 0.001), however breastfeeding duration was not associated with postpartum-MTCT (aSHR:0.99 [95%CI:0.96-1.03], p = 0.707)., Conclusion: The risk for postpartum MTCT was nearly tenfold higher in women newly diagnosed and/or initiating ART postpartum. This highlights the importance of sustained HIV screening and prompt ART initiation in postpartum women in Sub-Saharan African countries. Under conditions where HIV-exposed infants born to mothers on ART receive adequate PMTCT, extending breastfeeding duration may be recommended., Competing Interests: The authors have declared that no competing interests exist.
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- 2022
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42. Optimizing the World Health Organization algorithm for HIV vertical transmission risk assessment by adding maternal self-reported antiretroviral therapy adherence.
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Fernández-Luis S, Lain MG, Serna-Pascual M, Domínguez-Rodríguez S, Kuhn L, Liberty A, Barnabas S, Lopez-Varela E, Otwombe K, Danaviah S, Nastouli E, Palma P, Cotugno N, Spyer M, Giannuzzi V, Giaquinto C, Violari A, Cotton MF, Nhampossa T, Klein N, Ramsagar N, van Rensburg AJ, Behuhuma O, Vaz P, Maiga AI, Oletto A, Naniche D, Rossi P, Rojo P, and Tagarro A
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- Algorithms, Anti-Retroviral Agents therapeutic use, Female, Humans, Infant, Infectious Disease Transmission, Vertical prevention & control, Male, Pregnancy, Retrospective Studies, Risk Assessment, Self Report, World Health Organization, Anti-HIV Agents therapeutic use, HIV Infections prevention & control, Pregnancy Complications, Infectious drug therapy
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Background: The World Health Organization (WHO) risk assessment algorithm for vertical transmission of HIV (VT) assumes the availability of maternal viral load (VL) result at delivery and early viral control 4 weeks after initiating antiretroviral treatment (ART). However, in many low-and-middle-income countries, VL is often unavailable and mothers' ART adherence may be suboptimal. We evaluate the inclusion of the mothers' self-reported adherence into the established WHO-algorithm to identify infants eligible for enhanced post-natal prophylaxis when mothers' VL result is not available at delivery., Methods: We used data from infants with perinatal HIV infection and their mothers enrolled from May-2018 to May-2020 in Mozambique, South Africa, and Mali. We retrospectively compared the performance of the WHO-algorithm with a modified algorithm which included mothers' adherence as an additional factor. Infants were considered at high risk if born from mothers without a VL result in the 4 weeks before delivery and with adherence <90%., Results: At delivery, 143/184(78%) women with HIV knew their status and were on ART. Only 17(12%) obtained a VL result within 4 weeks before delivery, and 13/17(76%) of them had VL ≥1000 copies/ml. From 126 women on ART without a recent VL result, 99(79%) had been on ART for over 4 weeks. 45/99(45%) women reported suboptimal (< 90%) adherence. A total of 81/184(44%) infants were classified as high risk of VT as per the WHO-algorithm. The modified algorithm including self-adherence disclosure identified 126/184(68%) high risk infants., Conclusions: In the absence of a VL result, mothers' self-reported adherence at delivery increases the number of identified infants eligible to receive enhanced post-natal prophylaxis., (© 2022. The Author(s).)
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- 2022
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43. Quality of care in a differentiated HIV service delivery intervention in Tanzania: A mixed-methods study.
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Okere NE, Meta J, Maokola W, Martelli G, van Praag E, Naniche D, Gomez GB, Pozniak A, Rinke de Wit T, de Klerk J, and Hermans S
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- CD4 Lymphocyte Count, Humans, Quality of Health Care, Tanzania epidemiology, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, HIV Infections therapy
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Background: Differentiated service delivery (DSD) offers benefits to people living with HIV (improved access, peer support), and the health system (clinic decongestion, efficient service delivery). ART clubs, 15-30 clients who usually meet within the community, are one of the most common DSD options. However, evidence about the quality of care (QoC) delivered in ART clubs is still limited., Materials and Methods: We conducted a concurrent triangulation mixed-methods study as part of the Test & Treat project in northwest Tanzania. We surveyed QoC among stable clients and health care workers (HCW) comparing between clinics and clubs. Using a Donabedian framework we structured the analysis into three levels of assessment: structure (staff, equipment, supplies, venue), processes (time-spent, screenings, information, HCW-attitude), and outcomes (viral load, CD4 count, retention, self-worth)., Results: We surveyed 629 clients (40% in club) and conducted eight focus group discussions, while 24 HCW (25% in club) were surveyed and 22 individual interviews were conducted. Quantitative results revealed that in terms of structure, clubs fared better than clinics except for perceived adequacy of service delivery venue (94.4% vs 50.0%, p = 0.013). For processes, time spent receiving care was significantly more in clinics than clubs (119.9 vs 49.9 minutes). Regarding outcomes, retention was higher in the clubs (97.6% vs 100%), while the proportion of clients with recent viral load <50 copies/ml was higher in clinics (100% vs 94.4%). Qualitative results indicated that quality care was perceived similarly among clients in clinics and clubs but for different reasons. Clinics were generally perceived as places with expertise and clubs as efficient places with peer support and empathy. In describing QoC, HCW emphasized structure-related attributes while clients focused on processes. Outcomes-related themes such as improved client health status, self-worth, and confidentiality were similarly perceived across clients and HCW., Conclusion: We found better structure and process of care in clubs than clinics with comparable outcomes. While QoC was perceived similarly in clinics and clubs, its meaning was understood differently between clients. DSD catered to the individual needs of clients, either technical care in the clinic or proximate and social care in the club. Our findings highlight that both clinic and DSD care are required as many elements of QoC were individually perceived., Competing Interests: The Shinyanga and Simiyu Test & Treat program in Tanzania is funded by Gilead Sciences (USA). This does not alter our adherence to PLOS ONE policies on sharing data and materials. [GBG is currently employed by Sanofi Pasteur. Sanofi Pasteur was not involved in any way and did not provide funding for this study]. All other authors declare that they have no competing interests.
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- 2022
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44. Beyond viral suppression: Quality of life among stable ART clients in a differentiated service delivery intervention in Tanzania.
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Okere NE, Censi V, Machibya C, Costigan K, Katambi P, Martelli G, de Klerk J, Hermans S, Gomez GB, Pozniak A, de Wit TR, and Naniche D
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- Ambulatory Care Facilities, Cross-Sectional Studies, Humans, Male, Tanzania, HIV Infections drug therapy, Quality of Life psychology
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Background: With antiretroviral therapy, more people living with HIV (PLHIV) in resource-limited settings are virally suppressed and living longer. WHO recommends differentiated service delivery (DSD) as an alternative, less resource-demanding way of expanding HIV services access. Monitoring client's health-related quality of life (HRQoL) is necessary to understand patients' perceptions of treatment and services but is understudied in sub-Saharan Africa. We assessed HRQoL among ART clients in Tanzania accessing two service models., Methods: Cross-sectional survey from May-August 2019 among stable ART clients randomly sampled from clinics and clubs in the Shinyanga region providing DSD and clinic-based care. HRQoL data were collected using a validated HIV-specific instrument-Functional Assessment of HIV infection (FAHI), in addition to socio-demographic, HIV care, and service accessibility data. Descriptive analysis of HRQoL, logistic regression and a stepwise multiple linear regression were performed to examine HRQoL determinants., Results: 629 participants were enrolled, of which 40% accessed DSD. Similar HRQoL scores [mean (SD), p-value]; FAHI total [152.2 (22.2) vs 153.8 (20.6), p 0.687] were observed among DSD and clinic-based care participants. Accessibility factors contributed more to emotional wellbeing among DSD participants compared to the clinic-based care participants (53.4% vs 18.5%, p = < 0.001). Satisfactory (> 80% of maximum score) HRQoL scoring was associated with (OR [95% CI], p-value) being male (2.59 [1.36-4.92], p 0.004) among clinic participants and with urban residence (4.72 [1.70-13.1], p 0.001) among DSD participants., Conclusions: Similar HRQoL was observed in DSD and clinic-based care. Our research highlights focus areas to identify supporting interventions, ultimately optimizing HRQoL among PLHIV., (© 2021. The Author(s).)
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- 2022
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45. The silent and dangerous inequity around access to COVID-19 testing: A call to action.
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Batista C, Hotez P, Amor YB, Kim JH, Kaslow D, Lall B, Ergonul O, Figueroa JP, Gursel M, Hassanain M, Kang G, Larson H, Naniche D, Sheahan T, Wilder-Smith A, Shoham S, Sow SO, Yadav P, Strub-Wourgaft N, Loveday SJ, Hannay E, and Bottazzi ME
- Abstract
Competing Interests: MEB and PJH are developers of a COVID-19 vaccine construct, which was licensed by Baylor College of Medicine to Biological E Ltd., a commercial vaccine manufacturer for scale up, production, testing and licensure. MG participates in one of eight SARS-CoV-2 vaccine development projects supported by The Scientific and Technological Research Council of Turkey (TÜBİTAK) since March 2020. MH is Founder and Managing Director of SaudiVax. JPF, GK and DCK are members of the WHO SAGE Working Group on COVID-19 vaccines. GK is independent director appointed by the Wellcome Trust, MSD Wellcome Trust Hilleman Laboratories Private Limited and Vice Chair of the Board, Coalition of Epidemic Preparedness Innovations (CEPI). DCK reports grants from Bill and Melinda Gates Foundation (BMGF) and grants from CEPI, JHK reports personal fees from SK biosciences. HL reports grants and honoraria from GlaxoSmithKline for training talks and from Merck as a member of the Merck Vaccine Confidence Advisory Board, grants from J&J outside the submitted work. AWS serves as Consultant to WHO. The views presented here reflect her views and not necessarily those of WHO. TS reports grants from National Institute of Allergy and Infectious Disease and Fast Grants and research contracts from GlaxoSmithKline, and ViiV Healthcare. SS reports grants from Ansun BioPharma, Astellas Pharma, Cidara Therapeutics, F2G, Merck, T2 Biosystems, Shire Pharmaceuticals, Shionogi, and Gilead Sciences, outside the submitted work; and personal fees from Amplyx Pharmaceuticals, Acidophil, Janssen Pharmaceuticals, Reviral, Intermountain Healthcare, Karyopharm Therapeutics, Immunome, Celltrion, and Adagio outside the submitted work. EH and S-JL are currently employed by FIND. All the other authors report no conflicts.
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- 2022
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46. Interferon-γ-Inducible Protein 10 (IP-10) Kinetics after Antiretroviral Treatment Initiation in Ethiopian Adults with HIV.
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Thorman J, Björkman P, Marrone G, Tolera Balcha T, Tesfaye F, Abdissa T, Naniche D, Medstrand P, and Reepalu A
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- Adult, Chemokine CXCL10 metabolism, Coinfection microbiology, Ethiopia, Female, HIV-1 drug effects, Humans, Interferon-gamma immunology, Male, Viral Load, Anti-Retroviral Agents therapeutic use, Chemokine CXCL10 analysis, Chemokine CXCL10 pharmacokinetics, HIV Infections drug therapy, HIV-1 immunology, Tuberculosis, Pulmonary immunology
- Abstract
Interferon-γ-inducible protein 10 (IP-10) has been suggested as a marker for targeted viral load (VL) monitoring during antiretroviral treatment (ART). We aimed to determine the kinetics of IP-10 during the initial year of ART, with particular regard to the impact of tuberculosis (TB) co-infection on IP-10 secretion. Longitudinal plasma IP-10 levels were quantified in 112 treatment-naive HIV-positive adults at Ethiopian health centers, through enzyme-linked immunosorbent assay (ELISA) using samples obtained before and during the initial 12 months of ART. All participants underwent bacteriological TB investigation before starting ART. In virological responders (VRs; defined as VL < 150 copies/ml with no subsequent VL ≥ 1,000 copies/ml), IP-10 kinetics were analyzed using linear regression models. Among 91/112 (81.3%) participants classified as VRs, 17 (18.7%) had concomitant TB. Median baseline IP-10 was 650 pg/ml (interquartile range [IQR], 428-1,002) in VRs. IP-10 decline was more rapid during the first month of ART (median 306 pg/ml/month) compared with later time intervals (median 7-48 pg/ml/month, P < 0.001 in each comparison). Although VRs with TB had higher IP-10 levels at baseline (median 1106 pg/ml [IQR, 627-1,704]), compared with individuals without TB (median 628 pg/ml [IQR, 391-885]; P = 0.003), the rate of IP-10 decline during ART was similar, regardless of TB-status. During the initial year of ART, IP-10 kinetics followed a biphasic pattern in VRs, with a more rapid decline in the first month of ART compared with later time intervals. Baseline IP-10 was higher in individuals with TB versus individuals without TB, but the kinetics during ART were similar. IMPORTANCE To reach the goal of elimination of HIV as public health threat, access to antiretroviral treatment (ART) has to be further scaled up. To ensure viral suppression in individuals receiving ART, novel and robust systems for treatment monitoring are required. Targeting viral load monitoring to identify individuals at increased likelihood of treatment failure, using screening tools, could be an effective use of limited resources for viral load testing. Interferon-γ-inducible protein 10 (IP-10), a host inflammation mediator, has shown potential for this purpose. Here, we have investigated IP-10 kinetics in Ethiopian adults with HIV during the initial year after ART initiation. IP-10 levels decreased in parallel with viral load during ART, and prevalent tuberculosis at ART initiation did not influence IP-10 kinetics. This study shows satisfactory performance for IP-10 as a surrogate marker for viral load in persons starting ART, with no influence of concomitant tuberculosis.
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- 2021
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47. The impact of the caregiver mobility on child HIV care in the Manhiça District, Southern Mozambique: A clinical based study.
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Nhampossa T, Fernández-Luis S, Fuente-Soro L, Bernardo E, Nhacolo A, Augusto O, Nhacolo A, Sacoor C, Saura-Lázaro A, Lopez-Varela E, and Naniche D
- Subjects
- Adult, Ambulatory Care Facilities, Anti-HIV Agents therapeutic use, Anti-Retroviral Agents administration & dosage, Anti-Retroviral Agents therapeutic use, Caregiver Burden psychology, Child, Child, Preschool, Cross-Sectional Studies, Female, HIV Infections therapy, HIV-1 pathogenicity, Humans, Male, Middle Aged, Mozambique epidemiology, Caregivers psychology, Health Services Accessibility trends, Human Migration trends
- Abstract
Introduction: Manhiça District, in Southern Mozambique harbors high HIV prevalence and a long history of migration. To optimize HIV care, we sought to assess how caregiver's mobility impacts children living with HIV (CLHIV)´s continuation in HIV care and to explore the strategies used by caregivers to maintain their CLHIV on antiretroviral treatment (ART)., Methods: A clinic-based cross-sectional survey conducted at the Manhiça District Hospital between December-2017 and February-2018. We enrolled CLHIV with a self-identified migrant caregiver (moved outside of Manhiça District ≤12 months prior to survey) and non-migrant caregiver, matched by the child age and sex. Survey data were linked to CLHIV clinical records from the HIV care and treatment program., Results: Among the 975 CLHIV screened, 285 (29.2%) were excluded due to absence of an adult at the appointment. A total of 232 CLHIV-caregiver pairs were included. Of the 41 (35%) CLHIV migrating with their caregivers, 38 (92.6%) had access to ART at the destination because either the caregivers travelled with it 24 (63%) or it was sent by a family member 14 (36%). Among the 76 (65%) CLHIV who did not migrate with their caregivers, for the purpose of pharmacy visits, 39% were cared by their grandfather/grandmother, 28% by an aunt/uncle and 16% by an adult brother/sister. CLHIV of migrant caregivers had a non-statistically significant increase in the number of previous reported sickness episodes (OR = 1.38, 95%CI: 0.79-2.42; p = 0.257), ART interruptions (OR = 1.73; 95%CI: 0.82-3.63; p = 0.142) and lost-to-follow-up episodes (OR = 1.53; 95%CI: 0.80-2.94; p = 0.193)., Conclusions: Nearly one third of the children attend their HIV care appointments unaccompanied by an adult. The caregiver mobility was not found to significantly affect child's retention on ART. Migrant caregivers adopted strategies such as the transportation of ART to the mobility destination to avoid impact of mobility on the child's HIV care. However this may have implications on ART stability and effectiveness that should be investigated in rural areas., Competing Interests: The authors have declared that no competing interests exist.
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- 2021
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48. Assessing the prospect of a common health-related stigma reduction response: Cross-perspectives of people living with stigmatised health conditions in Indonesia.
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Rai SS, Syurina EV, Peters RMH, Irwanto I, Naniche D, and Zweekhorst MBM
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- Focus Groups, Humans, Indonesia, Social Stigma, Surveys and Questionnaires, HIV Infections, Leprosy
- Abstract
ABSTRACT This study explored the possibility of a common health-related stigma reduction intervention among people living with HIV, leprosy, schizophrenia and diabetes in Indonesia by assessing their perspectives towards others with the same (within group) and different health conditions (across groups), and willingness to participate in such a program. This mixed-methods study was conducted in West Java, Indonesia between March and June 2018. Eighty participants completed a survey with social distance scale (SDS), while 12 focus group discussion were conducted. Participants with HIV, leprosy and diabetes reported lower within-group SDS scores (4.14 ± 3.65; 4.25 ± 3.95; 7.23 ± 5.31, respectively) while those with schizophrenia reported the highest within-group SDS score (7.76 ± 4.63). Participants with diabetes reported a twofold higher across-group SDS score towards people with the other three health conditions ( p < 0.05). The qualitative findings showed that the perception of participants towards one another was shaped by knowledge, understanding and relatedness to the experience of living with health-related stigma. Overall, participants supported the idea of a common stigma reduction intervention for different health conditions, but recommended step-wise implementation of such interventions. Accordingly, this study recommends piloting a common stigma reduction intervention with special focus on fostering understanding, awareness and empathy between people living with different health conditions.
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- 2021
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49. Achieving global equity for COVID-19 vaccines: Stronger international partnerships and greater advocacy and solidarity are needed.
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Figueroa JP, Hotez PJ, Batista C, Ben Amor Y, Ergonul O, Gilbert S, Gursel M, Hassanain M, Kang G, Kaslow DC, Kim JH, Lall B, Larson H, Naniche D, Sheahan T, Shoham S, Wilder-Smith A, Sow SO, Strub-Wourgaft N, Yadav P, and Bottazzi ME
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- COVID-19 immunology, Global Health, Humans, COVID-19 prevention & control, COVID-19 Vaccines immunology, COVID-19 Vaccines therapeutic use, SARS-CoV-2 immunology, SARS-CoV-2 pathogenicity
- Abstract
Peter Figueroa and co-authors advocate for equity in the worldwide provision of COVID-19 vaccines., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: MEB and PJH are developers of a COVID-19 vaccine construct, which was licensed by Baylor College of Medicine to Biological E Ltd., a commercial vaccine manufacturer for scale up, production, testing and licensure. MG participates in one of eight SARS-CoV-2 vaccine development projects supported by The Scientific and Technological Research Council of Turkey (TÜBİTAK) since March 2020. SG is cofounder of Vaccitech and has a patent on ChAdOx1 nCoV-19 licensed to AstraZeneca. MH is Founder and Managing Director of SaudiVax. JPF, GK and DCK are members of the WHO SAGE Working Group on COVID-19 vaccines. GK is independent director appointed by the Wellcome Trust, MSD Wellcome Trust Hilleman Laboratories Private Limited and Vice Chair of the Board, Coalition of Epidemic Preparedness Innovations (CEPI). DCK reports grants from Bill and Melinda Gates Foundation (BMGF) and grants from CEPI, JHK reports personal fees from SK biosciences. HL reports grants and honoraria from GlaxoSmithKline for training talks and from Merck as a member of the Merck Vaccine Confidence Advisory Board, grants from J&J outside the submitted work. AWS serves as Consultant to WHO. The views presented here reflect her views and not necessarily those of WHO. TS reports grants from National Institute of Allergy and Infectious Disease and Fast Grants and research contracts from GlaxoSmithKline, and ViiV Healthcare. SS reports grants from Ansun BioPharma, Astellas Pharma, Cidara Therapeutics, F2G, Merck, T2 Biosystems, Shire Pharmaceuticals, Shionogi, and Gilead Sciences, outside the submitted work; and personal fees from Amplyx Pharmaceuticals, Acidophil, Janssen Pharmaceuticals, Reviral, Intermountain Healthcare, Karyopharm Therapeutics, Immunome, Celltrion, and Adagio outside the submitted work. All other authors declare no conflict of interests. The authors views and opinions in the Commentary do not necessarily represent the views, decisions, or policies of the institutions, universities, or health systems with which they are affiliated.
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- 2021
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50. Global public health security and justice for vaccines and therapeutics in the COVID-19 pandemic.
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Hotez PJ, Batista C, Amor YB, Ergonul O, Figueroa JP, Gilbert S, Gursel M, Hassanain M, Kang G, Kaslow DC, Kim JH, Lall B, Larson H, Naniche D, Sheahan T, Shoham S, Wilder-Smith A, Sow SO, Strub-Wourgaft N, Yadav P, and Bottazzi ME
- Abstract
A Lancet Commission for COVID-19 task force is shaping recommendations to achieve vaccine and therapeutics access, justice, and equity. This includes ensuring safety and effectiveness harmonized through robust systems of global pharmacovigilance and surveillance. G lobal production requires expanding support for development, manufacture, testing, and distribution of vaccines and therapeutics to low- and middle-income countries (LMICs). Global intellectual property rules must not stand in the way of research, production, technology transfer, or equitable access to essential health tools, and in context of pandemics to achieve increased manufacturing without discouraging innovation. Global governance around product quality requires channelling widely distributed vaccines through WHO prequalification (PQ)/emergency use listing (EUL) mechanisms and greater use of national regulatory authorities. A World Health Assembly (WHA) resolution would facilitate improvements and consistency in quality control and assurances. Global health systems require implementing steps to strengthen national systems for controlling COVID-19 and for influenza vaccinations for adults including pregnant and lactating women. A collaborative research network should strive to establish open access databases for bioinformatic analyses, together with programs directed at human capacity utilization and strengthening. Combating anti-science recognizes the urgency for countermeasures to address a global-wide disinformation movement dominating the internet and infiltrating parliaments and local governments., Competing Interests: MEB and PJH are developers of a COVID-19 vaccine construct, which was licensed by Baylor College of Medicine to Biological E Ltd., a commercial vaccine manufacturer for scale up, production, testing and licensure. MG participates in one of eight SARS-CoV-2 vaccine development projects supported by The Scientific and Technological Research Council of Turkey (TÜBİTAK) since March 2020. SG is cofounder of Vaccitech and has a patent on ChAdOx1 nCoV-19 licensed to AstraZeneca. MH is Founder and Managing Director of SaudiVax. JPF, GK and DCK are members of the WHO SAGE Working Group on COVID-19 vaccines. GK is independent director appointed by the Wellcome Trust, MSD Wellcome Trust Hilleman Laboratories Private Limited and Vice Chair of the Board, Coalition of Epidemic Preparedness Innovations (CEPI). DCK reports grants from Bill and Melinda Gates Foundation (BMGF) and grants from CEPI, JHK reports personal fees from SK biosciences. HL reports grants and honoraria from GlaxoSmithKline for training talks and from Merck as a member of the Merck Vaccine Confidence Advisory Board, grants from J&J outside the submitted work. AWS serves as Consultant to WHO. The views presented here reflect her views and not necessarily those of WHO. TS reports grants from National Institute of Allergy and Infectious Disease and Fast Grants and research contracts from GlaxoSmithKline, and ViiV Healthcare. SS reports grants from Ansun BioPharma, Astellas Pharma, Cidara Therapeutics, F2G, Merck, T2 Biosystems, Shire Pharmaceuticals, Shionogi, and Gilead Sciences, outside the submitted work; and personal fees from Amplyx Pharmaceuticals, Acidophil, Janssen Pharmaceuticals, Reviral, Intermountain Healthcare, Karyopharm Therapeutics, Immunome, Celltrion, and Adagio outside the submitted work. All other authors declare no conflict of interests. The authors views and opinions in the Commentary do not necessarily represent the views, decisions, or policies of the institutions, universities, or health systems with which they are affiliated., (© 2021 The Authors.)
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- 2021
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