24 results on '"Philip NM"'
Search Results
2. Prevalence of monoclonal gammopathy of undetermined significance in Eswatini: a population-based study in Africa.
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Cicero KI, Dlamini X, Mavengere Y, Justman J, Nuwagaba-Biribonwoha H, Dlamini S, Dlamini M, Ngwenyama S, Ngcamphalala C, Low A, Philip NM, El-Sadr WM, Sahabo R, Abreha T, Temesgen S, Mahlalela N, Chiuzan C, Chen Y, Pan SS, Lentzsch S, and Neugut AI
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- Humans, Female, Male, Prevalence, Middle Aged, Aged, Adult, Aged, 80 and over, Eswatini epidemiology, Minnesota epidemiology, Multiple Myeloma epidemiology, Incidence, Odds Ratio, Monoclonal Gammopathy of Undetermined Significance epidemiology, Monoclonal Gammopathy of Undetermined Significance blood, HIV Infections epidemiology, HIV Infections complications
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Background: Although monoclonal gammopathy of undetermined significance (MGUS) and multiple myeloma disproportionately affect Black individuals, few epidemiological studies have been conducted on these plasma cell disorders in Africa. Here we describe the prevalence of MGUS in Eswatini and compare our results to the landmark Olmsted County, Minnesota study., Methods: Between 2016 and 2017, 13 339 residents of Eswatini participated in the Swaziland HIV Incidence Measurement Survey, from which a nationally representative biorepository was created. Plasma samples were then randomly selected and analyzed for MGUS. MGUS prevalence in Eswatini was compared with that of Olmsted County. In addition, demographic and HIV-related associations with MGUS were assessed., Results: Of the 515 samples randomly selected, the median age was 50 years (range = 35-80 years); 60% were female; and 38.6% were HIV positive, of whom 82.4% were on antiretroviral therapy. We found that 68 participants had evidence of MGUS, for a prevalence of 13.2%. HIV status was not significantly associated with MGUS (odds ratio = 1.05, 95% confidence interval = 0.62 to 1.77), but among HIV-positive individuals, MGUS was less frequent for patients on antiretroviral therapy (adjusted odds ratio = 0.31, 95% confidence interval = 0.11 to 0.82). The prevalence of conventional MGUS was similar between Eswatini and Olmsted County (3.4% vs 3.2%-3.4%), whereas the incidence of light-chain MGUS was significantly greater in Eswatini (12.3% vs 0.8%)., Conclusion: Our study suggests that the incidence of MGUS is similar between ethnicities and raises the question of whether the current definition of light-chain MGUS reliably reflects a true monoclonal protein precursor state. Perhaps the current definition of light-chain MGUS may be capturing alternate etiologies, such as untreated HIV infection., (© The Author(s) 2024. Published by Oxford University Press.)
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- 2024
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3. HIV prevalence in transgender populations and cisgender men who have sex with men in sub-Saharan Africa 2010-2022: a meta-analysis.
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Stevens O, Anderson RL, Sabin K, Garcia SA, Fearon E, Manda K, Dikobe W, Crowell TA, Tally L, Mulenga L, Philip NM, Maheu-Giroux M, McIntyre A, Hladik W, Zhao J, Mahy M, and Eaton JW
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Introduction: The Global AIDS Strategy 2021-2026 calls for equitable and equal access to HIV prevention and treatment programmes for all populations to reduce HIV incidence and end HIV/AIDS as a public health threat by 2030. Transgender populations (TGP), including transmen (TGM) and transwomen (TGW) are populations that have been marginalised and are at high risk of HIV infection in sub-Saharan Africa (SSA). Limited surveillance data on HIV among TGP are available in the region to guide programmatic responses and policymaking. Surveillance data on cisgender men who have sex with men (cis-MSM) are comparatively abundant and may be used to infer TGP HIV prevalence., Methods: Data from key population surveys conducted in SSA between 2010-2022 were identified from existing databases and survey reports. Studies that collected HIV prevalence on both TGP and cis-MSM populations were analysed in a random effect meta-analysis to estimate the ratio of cis-MSM:TGW HIV prevalence., Results: Eighteen studies were identified encompassing 8,052 TGW and 19,492 cis-MSM. TGW HIV prevalence ranged from 0-71.6% and cis-MSM HIV prevalence from 0.14-55.7%. HIV prevalence in TGW was 50% higher than in cis-MSM (prevalence ratio (PR) 1.50 95% CI 1.26-1.79). TGW HIV prevalence was highly correlated with year/province-matched cis-MSM HIV prevalence (R
2 = 0.62), but poorly correlated with year/province-matched total population HIV prevalence (R2 = 0.1). Five TGM HIV prevalence estimates were identified ranging from 1-24%. Insufficient TGM data were available to estimate cis-MSM:TGM HIV prevalence ratios., Conclusion: Transgender women experience a significantly greater HIV burden than cis-MSM in SSA. Bio-behavioural surveys designed and powered to measure determinants of HIV infection, treatment coverage, and risk behaviours among transgender populations, distinct from cis-MSM, will improve understanding of HIV risk and vulnerabilities among TGP and support improved programmes., Competing Interests: Competing interests None- Published
- 2023
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4. MK2 nonenzymatically promotes nuclear translocation of caspase-3 and resultant apoptosis.
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Del Rosario O, Suresh K, Kallem M, Singh G, Shah A, Zheng L, Yun X, Philip NM, Putcha N, McClure MB, Jiang H, D'Alessio F, Srivastava M, Bera A, Shimoda LA, Merchant M, Rane MJ, Machamer CE, Mock J, Hagan R, Koch AL, Punjabi NM, Kolb TM, and Damarla M
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- Humans, Apoptosis, Caspase 3 metabolism, Intracellular Signaling Peptides and Proteins metabolism, p38 Mitogen-Activated Protein Kinases metabolism, Phosphorylation, Protein Serine-Threonine Kinases metabolism, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
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We have previously identified mitogen-activated protein kinase-activated protein kinase 2 (MK2) is required for caspase-3 nuclear translocation in the execution of apoptosis; however, little is known of the underlying mechanisms. Therefore, we sought to determine the role of kinase and nonkinase functions of MK2 in promoting nuclear translocation of caspase-3. We identified two non-small cell lung cancer cell lines for use in these experiments based on low MK2 expression. Wild-type, enzymatic and cellular localization mutant MK2 constructs were expressed using adenoviral infection. Cell death was evaluated by flow cytometry. In addition, cell lysates were harvested for protein analyses. Phosphorylation of caspase-3 was determined using two-dimensional gel electrophoresis followed by immunoblotting and in vitro kinase assay. Association between MK2 and caspase-3 was evaluated using proximity-based biotin ligation assays and co-immunoprecipitation. Overexpression of MK2 resulted in nuclear translocation of caspase-3 and caspase-3-mediated apoptosis. MK2 directly phosphorylates caspase-3; however, phosphorylation status of caspase-3 or MK2-dependent phosphorylation of caspase-3 did not alter caspase-3 activity. The enzymatic function of MK2 was dispensable in nuclear translocation of caspase-3. MK2 and caspase-3 associated together and a nonenzymatic function of MK2, chaperoned nuclear trafficking, is required for caspase-3-mediated apoptosis. Taken together, our results demonstrate a nonenzymatic role for MK2 in the nuclear translocation of caspase-3. Furthermore, MK2 may function as a molecular switch in regulating the transition between the cytosolic and nuclear functions of caspase-3.
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- 2023
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5. Tumor MK2 transcript levels are associated with improved response to chemotherapy and patient survival in non-small cell lung cancer.
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Suresh K, Del Rosario O, Kallem M, Singh G, Shah A, Zheng L, Yun X, Philip NM, Putcha N, McClure MB, Jiang H, D'Alessio F, Srivastava M, Bera A, Shimoda LA, Merchant M, Rane MJ, Machamer CE, Mock J, Hagan R, Koch AL, Punjabi NM, Kolb TM, and Damarla M
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- Humans, Caspase 3 therapeutic use, Endothelial Cells, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung genetics, Lung Neoplasms drug therapy, Lung Neoplasms genetics, Adenocarcinoma of Lung
- Abstract
Non-small cell lung cancers (NSCLCs) demonstrate intrinsic resistance to cell death, even after chemotherapy. Previous work suggested defective nuclear translocation of active caspase-3 in observed resistance to cell death. We have identified mitogen-activated protein kinase-activated protein kinase 2 (MK2; encoded by the gene MAPKAPK2 ) is required for caspase-3 nuclear translocation in the execution of apoptosis in endothelial cells. The objective was to determine MK2 expression in NSCLCs and the association between MK2 and clinical outcomes in patients with NSCLC. Clinical and MK2 mRNA data were extracted from two demographically distinct NSCLC clinical cohorts, North American (The Cancer Genome Atlas, TCGA) and East Asian (EA). Tumor responses following first round of chemotherapy were dichotomized as clinical response (complete response, partial response, and stable disease) or progression of disease. Multivariable survival analyses were performed using Cox proportional hazard ratios and Kaplan-Meier curves. NSCLC exhibited lower MK2 expression than SCLC cell lines. In patients, lower tumor MK2 transcript levels were observed in those presenting with late-stage NSCLC. Higher MK2 expression was associated with clinical response following initial chemotherapy and independently associated with improved 2-yr survival in two distinct cohorts, 0.52 (0.28-0.98) and 0.1 (0.01-0.81), TCGA and EA, respectively, even after adjusting for common oncogenic driver mutations. Survival benefit of higher MK2 expression was unique to lung adenocarcinoma when comparing across various cancers. This study implicates MK2 in apoptosis resistance in NSCLC and suggests prognostic value of MK2 transcript levels in patients with lung adenocarcinoma.
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- 2023
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6. Incidence of Herpes Simplex Virus Type 2 Infection Among African Women Using Depot Medroxyprogesterone Acetate, a Copper Intrauterine Device, or a Levonorgestrel Implant for Contraception: A Nested Randomized Trial.
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Mugo NR, Stalter RM, Heffron R, Rees H, Scoville CW, Morrison C, Kourtis AP, Bukusi E, Beksinka M, Philip NM, Beesham I, Deese J, Edward V, Donnell D, and Baeten JM
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- Contraception adverse effects, Contraception methods, Female, Herpesvirus 2, Human, Humans, Incidence, Levonorgestrel, Male, Medroxyprogesterone Acetate adverse effects, Contraceptive Agents, Female adverse effects, HIV Infections, Herpes Simplex, Intrauterine Devices, Copper adverse effects
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Background: Globally, women have higher herpes simplex virus type 2 (HSV-2) prevalence than men; data from observational studies suggest a possible association of HSV-2 acquisition with use of intramuscular depot medroxyprogesterone acetate (DMPA-IM)., Methods: Within a randomized trial of the effect of 3 contraceptive methods-DMPA-IM, a copper intrauterine device (IUD), and a levonorgestrel (LNG) implant-on human immunodeficiency virus (HIV) acquisition, we assessed HSV-2 acquisition. HSV-2 and HIV seronegative women, aged 16-35 years, and seeking effective contraception were followed for 12-18 months at 12 sites in Eswatini, Kenya, South Africa, and Zambia from 2015 to 2018. HSV-2 serologic testing was done at enrollment and final study visits. Intention-to-treat analysis using Poisson regression with robust standard errors compared HSV-2 incidence by contraceptive method., Results: At baseline, 4062 randomized women were HSV-2 seronegative, of whom 3898 (96.0%) had a conclusive HSV-2 result at their final study visit. Of these, 614 (15.8%) acquired HSV-2, at an incidence of 12.4/100 person-years (p-y): 10.9/100 p-y among women assigned DMPA-IM, 13.7/100 p-y the copper IUD, and 12.7/100 p-y the LNG implant. Incidence rate ratios (IRR) for HSV-2 acquisition were 0.80 (95% confidence interval [CI], .65-.97) for DMPA-IM compared with copper IUD, 0.86 (95% CI, .71-1.05) for DMPA-IM compared with LNG implant, and 1.08 (95% CI, .89-1.30) for copper IUD compared with LNG implant. HSV-2 acquisition risk was significantly increased among women who also acquired HIV during follow-up (IRR 3.55; 95% CI, 2.78-4.48)., Conclusions: In a randomized trial, we found no association between HSV-2 acquisition and use of 3 contraceptive methods., Trial Registration: ClinicalTrials.gov number NCT02550067., Competing Interests: Potential conflicts of interest. E. A. B. reports support for the present manuscript from the WHO Department of RH. D. D. reports support for the present manuscript from National Institute of Mental Health paid to the institution and grants or contracts outside of the conduct of the study from the National Institute of Allergy and Infectious Diseases paid to the institution. J. B. reports grants or contracts outside of the conduct of the study from National Institutes of Health paid to the institution; personal consulting fees from Gilead, Janssen, and Merck; employee/stock/options from Gilead; donation of study medication from Gilead and IPM; and employee outside of the submitted work for Gilead Sciences. R. S. reports direct travel reimbursements and travel scholarships for Conference on Retroviruses and Opportunistic Infections, AIDS, Infectious Diseases Society for Obstetrics and Gynecology, and International Society for Pharmacoepidemiology conferences. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America.)
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- 2022
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7. Associations Between Mobility, Food Insecurity, and Transactional Sex Among Women in Cohabitating Partnerships: An Analysis From 6 African Countries 2016-2017.
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Khalifa A, Findley S, Gummerson E, Mantell JE, Hakim AJ, Philip NM, Ginindza C, Hassani AS, Hong SY, Jalloh MF, Kirungi WL, Maile L, Mgomella GS, Miller LA, Minchella P, Mutenda N, Njau P, Schwitters A, Ward J, and Low A
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- Female, Food Insecurity, Humans, Male, Sexual Behavior, Tanzania, HIV Infections epidemiology, HIV Infections prevention & control, Sex Work
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Background: Mobile women are at risk of HIV infection in sub-Saharan Africa, although we lack evidence for HIV risk among women in mobile partnerships, especially in the context of household food insecurity, a growing concern in the region., Setting: Women aged 15-59 years with a cohabitating male partner who participated in population-based HIV impact assessment surveys in Eswatini, Lesotho, Namibia, Tanzania, Uganda, and Zambia., Methods: We evaluated the association between women's and their partner's mobility (being away from home for more than 1 month or staying elsewhere) and transactional sex (selling sex or receiving money or goods in exchange for sex). We examined associations for effect measure modification by food insecurity level in the household in the past month. We used survey-weighted logistic regression, pooled and by country, adjusting for individual, partner, and household-level variables., Results: Among women with a cohabitating male partner, 8.0% reported transactional sex, ranging from 2.7% in Lesotho to 13.4% in Uganda. Women's mobility [aOR 1.35 (95% CI: 1.08 to 1.68)], but not their partner's mobility [aOR 0.91 (0.74-1.12)], was associated with transactional sex. Food insecurity was associated with transactional sex independent of mobility [aOR 1.29 (1.10-1.52)]. Among those who were food insecure, mobility was not associated with increased odds of transactional sex., Conclusion: Food insecurity and women's mobility each increased the odds of transactional sex. Because transactional sex is associated with HIV risk, prevention programs can address the needs of mobile and food-insecure women, including those in cohabitating relationships., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2022
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8. High HIV incidence among young women in South Africa: Data from a large prospective study.
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Palanee-Phillips T, Rees HV, Heller KB, Ahmed K, Batting J, Beesham I, Heffron R, Justman J, Makkan H, Mastro TD, Morrison SA, Mugo N, Nair G, Kiarie J, Philip NM, Pleaner M, Reddy K, Selepe P, Steyn PS, Scoville CW, Smit J, Thomas KK, Donnell D, and Baeten JM
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- Adult, Female, Humans, Incidence, Prospective Studies, South Africa epidemiology, Young Adult, Acquired Immunodeficiency Syndrome complications, Contraceptive Agents, Female, HIV Infections epidemiology, HIV Infections etiology, HIV Infections prevention & control, Sexually Transmitted Diseases complications
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Introduction: South Africa has the highest national burden of HIV globally. Understanding drivers of HIV acquisition in recently completed, prospective studies in which HIV was an endpoint may help inform the strategy and investments in national HIV prevention efforts and guide the design of future HIV prevention trials. We assessed HIV incidence and correlates of incidence among women enrolled in ECHO (Evidence for Contraceptive Options and HIV Outcomes), a large, open-label randomized clinical trial that compared three highly effective. reversible methods of contraception and rates of HIV acquisition., Methods: During December 2015 to October 2018, ECHO followed sexually active, HIV-seronegative women, aged 16-35 years, seeking contraceptive services and willing to be randomized to one of three contraceptive methods (intramuscular depot medroxyprogesterone acetate, copper intrauterine device, or levonorgestrel implant) for 12-18 months at nine sites in South Africa. HIV incidence based on prospectively observed HIV seroconversion events. Cox proportional hazards regression models were used to define baseline cofactors related to incident HIV infection., Results: 5768 women were enrolled and contributed 7647 woman-years of follow-up. The median age was 23 years and 62.5% were ≤24 years. A total of 345 incident HIV infections occurred, an incidence of 4.51 per 100 woman-years (95%CI 4.05-5.01). Incidence was >3 per 100 woman-years at all sites. Age ≤24 years, baseline infection with sexually transmitted infections, BMI≤30, and having new or multiple partners in the three months prior to enrollment were associated with incident HIV., Conclusions: HIV incidence was high among South African women seeking contraceptive services. Integration of diagnostic management of sexually transmitted infections alongside delivery of HIV prevention options in health facilities providing contraception services are needed to mitigate ongoing risks of HIV acquisition for this vulnerable population., Clinical Trial Registration: ClinicalTrials.gov, number NCT02550067 was the main Clinical Trial from which this secondary, non-randomized / observational analysis was derived with data limited to just South African sites., Competing Interests: The authors have declared that no competing interests exist.
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- 2022
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9. Upregulation of Aquaporin 1 Mediates Increased Migration and Proliferation in Pulmonary Vascular Cells From the Rat SU5416/Hypoxia Model of Pulmonary Hypertension.
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Yun X, Philip NM, Jiang H, Smith Z, Huetsch JC, Damarla M, Suresh K, and Shimoda LA
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Pulmonary arterial hypertension (PAH) is a progressive disorder characterized by exuberant vascular remodeling leading to elevated pulmonary arterial pressure, maladaptive right ventricular remodeling, and eventual death. The factors controlling pulmonary arterial smooth muscle cell (PASMC) and endothelial cell hyperplasia and migration, hallmark features of the vascular remodeling observed in PAH, remain poorly understood. We previously demonstrated that hypoxia upregulates the expression of aquaporin 1 (AQP1), a water channel, in PASMCs, and that this upregulation was required for hypoxia-induced migration and proliferation. However, whether the same is true in a model of severe PAH and in pulmonary microvascular endothelial cells (MVECs) is unknown. In this study, we used the SU5416 plus hypoxia (SuHx) rat model of severe pulmonary hypertension, which mimics many of the features of human PAH, to determine whether AQP1 levels were altered in PASMCs and MVECs and contributed to a hyperproliferative/hypermigratory phenotype. Rats received a single injection of SU5416 (20 mg/kg) and then were placed in 10% O
2 for 3 weeks, followed by a return to normoxic conditions for an additional 2 weeks. We found that AQP1 protein levels were increased in both PASMCs and MVECs from SuHx rats, even in the absence of sustained hypoxic exposure, and that in MVECs, the increase in protein expression was associated with upregulation of AQP1 mRNA levels. Silencing of AQP1 had no significant effect on PASMCs from control animals but normalized enhanced migration and proliferation observed in cells from SuHx rats. Loss of AQP1 also reduced migration and proliferation in MVECs from SuHx rats. Finally, augmenting AQP1 levels in MVECs from control rats using forced expression was sufficient to increase migration and proliferation. These results demonstrate a key role for enhanced AQP1 expression in mediating abnormal migration and proliferation in pulmonary vascular cells from a rodent model that reflects many of the features of human PAH., Competing Interests: JH is currently employed by Arrowhead Pharmaceutical. However, his participation in this study was conducted while he was employed by Johns Hopkins. The remaining 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 © 2021 Yun, Philip, Jiang, Smith, Huetsch, Damarla, Suresh and Shimoda.)- Published
- 2021
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10. HIV incidence, viremia, and the national response in Eswatini: Two sequential population-based surveys.
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Nkambule R, Philip NM, Reid G, Mnisi Z, Nuwagaba-Biribonwoha H, Ao TT, Ginindza C, Duong YT, Patel H, Saito S, Solmo C, Brown K, Moore CS, Voetsch AC, Bicego G, Bock N, Mhlanga F, Dlamini T, Mabuza K, Zwane A, Sahabo R, Dobbs T, Parekh BS, El-Sadr W, Ryan C, and Justman J
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- Adolescent, Adult, Cross-Sectional Studies, Eswatini epidemiology, Female, HIV Infections virology, Humans, Incidence, Male, Middle Aged, Surveys and Questionnaires, Viremia virology, Young Adult, HIV Infections epidemiology, HIV-1 isolation & purification, Viral Load, Viremia epidemiology
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With the highest HIV incidence and prevalence globally, the government of Eswatini started a substantial scale-up of HIV treatment and prevention services in 2011. Two sequential large population-based surveys were conducted before and after service expansion to assess the impact of the national response. Cross-sectional, household-based, nationally representative samples of adults, ages 18 to 49 years, were sampled in 2011 and 2016. We measured HIV prevalence, incidence (recent infection based on limiting antigen ≤1.5 optical density units and HIV RNA ≥1000 copies/mL), viral load suppression (HIV RNA <1000 copies/mL among all seropositive adults) and unsuppressed viremia (HIV RNA ≥1000 copies/mL among all, regardless of HIV status) and assessed for temporal changes by conducting a trend analysis of the log ratio of proportions, using a Z statistic distribution. HIV prevalence remained stable from 2011 to 2016 [32% versus 30%, p = 0.10]. HIV incidence significantly declined 48% [2.48% versus 1.30%, p = 0.01]. Incidence remained higher among women than men [2011: 3.16% versus 1.83%; 2016: 1.76% versus 0.86%], with a smaller but significant relative reduction among women [44%; p = 0.04] than men [53%; p = 0.09]. The proportion of seropositive adults with viral load suppression significantly increased from 35% to 71% [p < .001]. The proportion of the total adult population with unsuppressed viremia decreased from 21% to 9% [p < .001]. National HIV incidence in Eswatini decreased by nearly half and viral load suppression doubled over a five-year period. Unsuppressed viremia in the total population decreased 58%. These population-based findings demonstrate the national impact of expanded HIV services in a hyperendemic country., Competing Interests: As an inventor of LAg-Avidity EIA, BSP receives royalties from the sale of test kits sold by the manufacturer per US government policy. The other authors have no conflicts of interest to disclose.
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- 2021
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11. Is Interview Length Associated With Blood Test Participation? Evidence From Three Population-Based HIV Impact Assessment Surveys Conducted From 2016 to 2017.
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Bray R, Palma AM, Philip NM, Brown K, Levin B, Thompson JLPS, Ginindza C, and Mulenga LB
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- Humans, Interviews as Topic, Time Factors, HIV Infections epidemiology, HIV Testing, HIV-1, Health Surveys
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Background: High response rates in surveys are critical to ensuring that findings are unbiased and representative of the target population. Questionnaire length affects response rates, with long interviews associated with partially complete surveys, higher item nonresponse ("don't know" and "refuse" responses), and willingness to participate in future surveys. Our aim is to determine the impact of questionnaire length on blood test participation in population-based HIV surveys., Methods: Data are from population-based HIV impact assessments conducted in Zambia, Eswatini, and Lesotho in 2016-2017. The population-based HIV impact assessments consist of an interview followed by a blood draw. Consent for blood draw was obtained before the interview in Eswatini and after the interview in Zambia and Lesotho. Interview length was measured by the survey tablet as the time to complete the survey (interview duration) and the number of questions answered by the participant (questionnaire length). We assessed the effects of questionnaire length and interview duration on blood test participation using logistic regression., Results: Across all 3 surveys, the median interview duration was 16 minutes and the median number of questions was 77. In adjusted analyses, there was a negative impact of interview duration on blood draw consent for individuals with unknown status in Lesotho and a positive relationship between questionnaire length and blood draw consent in Zambia for those with HIV-negative and unknown status., Conclusion: Although interview length is an important consideration to reduce respondent burden, a longer questionnaire does not necessarily result in lower consent rates for blood testing., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2021
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12. A randomized double-blind controlled trial of convalescent plasma in adults with severe COVID-19.
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O'Donnell MR, Grinsztejn B, Cummings MJ, Justman JE, Lamb MR, Eckhardt CM, Philip NM, Cheung YK, Gupta V, João E, Pilotto JH, Diniz MP, Cardoso SW, Abrams D, Rajagopalan KN, Borden SE, Wolf A, Sidi LC, Vizzoni A, Veloso VG, Bitan ZC, Scotto DE, Meyer BJ, Jacobson SD, Kantor A, Mishra N, Chauhan LV, Stone EF, Dei Zotti F, La Carpia F, Hudson KE, Ferrara SA, Schwartz J, Stotler BA, Lin WW, Wontakal SN, Shaz B, Briese T, Hod EA, Spitalnik SL, Eisenberger A, and Lipkin WI
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- Adult, Aged, Aged, 80 and over, Brazil epidemiology, COVID-19 immunology, COVID-19 mortality, Double-Blind Method, Female, Humans, Immunization, Passive, Kaplan-Meier Estimate, Male, Middle Aged, New York City epidemiology, Pandemics, Severity of Illness Index, Treatment Outcome, COVID-19 Serotherapy, COVID-19 therapy, SARS-CoV-2 immunology
- Abstract
BACKGROUNDAlthough convalescent plasma has been widely used to treat severe coronavirus disease 2019 (COVID-19), data from randomized controlled trials that support its efficacy are limited.METHODSWe conducted a randomized, double-blind, controlled trial among adults hospitalized with severe and critical COVID-19 at 5 sites in New York City (USA) and Rio de Janeiro (Brazil). Patients were randomized 2:1 to receive a single transfusion of either convalescent plasma or normal control plasma. The primary outcome was clinical status at 28 days following randomization, measured using an ordinal scale and analyzed using a proportional odds model in the intention-to-treat population.RESULTSOf 223 participants enrolled, 150 were randomized to receive convalescent plasma and 73 to receive normal control plasma. At 28 days, no significant improvement in the clinical scale was observed in participants randomized to convalescent plasma (OR 1.50, 95% confidence interval [CI] 0.83-2.68, P = 0.180). However, 28-day mortality was significantly lower in participants randomized to convalescent plasma versus control plasma (19/150 [12.6%] versus 18/73 [24.6%], OR 0.44, 95% CI 0.22-0.91, P = 0.034). The median titer of anti-SARS-CoV-2 neutralizing antibody in infused convalescent plasma units was 1:160 (IQR 1:80-1:320). In a subset of nasopharyngeal swab samples from Brazil that underwent genomic sequencing, no evidence of neutralization-escape mutants was detected.CONCLUSIONIn adults hospitalized with severe COVID-19, use of convalescent plasma was not associated with significant improvement in day 28 clinical status. However, convalescent plasma was associated with significantly improved survival. A possible explanation is that survivors remained hospitalized at their baseline clinical status.TRIAL REGISTRATIONClinicalTrials.gov, NCT04359810.FUNDINGAmazon Foundation, Skoll Foundation.
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- 2021
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13. Correction to: Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial.
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Eckhardt CM, Cummings MJ, Rajagopalan KN, Borden S, Bitan ZC, Wolf A, Kantor A, Briese T, Meyer BJ, Jacobson SD, Scotto D, Mishra N, Philip NM, Stotler BA, Schwartz J, Shaz B, Spitalnik SL, Eisenberger A, Hod Jessica Justman EA, Cheung K, Lipkin WI, and O'Donnell MR
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An amendment to this paper has been published and can be accessed via the original article.
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- 2020
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14. Prevalence of nonsuppressed viral load and associated factors among HIV-positive adults receiving antiretroviral therapy in Eswatini, Lesotho, Malawi, Zambia and Zimbabwe (2015 to 2017): results from population-based nationally representative surveys.
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Haas AD, Radin E, Hakim AJ, Jahn A, Philip NM, Jonnalagadda S, Saito S, Low A, Patel H, Schwitters AM, Rogers JH, Frederix K, Kim E, Bello G, Williams DB, Parekh B, Sachathep K, Barradas DT, Kalua T, Birhanu S, Musuka G, Mugurungi O, Tippett Barr BA, Sleeman K, Mulenga LB, Thin K, Ao TT, Brown K, Voetsch AC, and Justman JE
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- Adolescent, Adult, CD4 Lymphocyte Count, Cross-Sectional Studies, Eswatini epidemiology, Female, HIV Infections epidemiology, Humans, Incidence, Lesotho epidemiology, Malawi epidemiology, Male, Middle Aged, Nevirapine therapeutic use, Prevalence, Surveys and Questionnaires, Viral Load, Young Adult, Zambia epidemiology, Zimbabwe epidemiology, Anti-HIV Agents therapeutic use, HIV physiology, HIV Infections drug therapy, HIV Infections virology
- Abstract
Introduction: The global target for 2020 is that ≥90% of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) will achieve viral load suppression (VLS). We examined VLS and its determinants among adults receiving ART for at least four months., Methods: We analysed data from the population-based HIV impact assessment (PHIA) surveys in Eswatini, Lesotho, Malawi, Zambia and Zimbabwe (2015 to 2017). PHIA surveys are nationally representative, cross-sectional household surveys. Data collection included structured interviews, home-based HIV testing and laboratory testing. Blood samples from PLHIV were analysed for HIV RNA, CD4 counts and recent exposure to antiretroviral drugs (ARVs). We calculated representative estimates for the prevalence of VLS (viral load <1000 copies/mL), nonsuppressed viral load (NVL; viral load ≥1000 copies/mL), virologic failure (VF; ARVs present and viral load ≥1000 copies/mL), interrupted ART (ARVs absent and viral load ≥1000 copies/mL) and rates of switching to second-line ART (protease inhibitors present) among PLHIV aged 15 to 59 years who participated in the PHIA surveys in Eswatini, Lesotho, Malawi, Zambia and Zimbabwe, initiated ART at least four months before the survey and were receiving ART at the time of the survey (according to self-report or ARV testing). We calculated odds ratios and incidence rate ratios for factors associated with NVL, VF, interrupted ART, and switching to second-line ART., Results: We included 9200 adults receiving ART of whom 88.8% had VLS and 11.2% had NVL including 8.2% who experienced VF and 3.0% who interrupted ART. Younger age, male sex, less education, suboptimal adherence, receiving nevirapine, HIV non-disclosure, never having married and residing in Zimbabwe, Lesotho or Zambia were associated with higher odds of NVL. Among people with NVL, marriage, female sex, shorter ART duration, higher CD4 count and alcohol use were associated with lower odds for VF and higher odds for interrupted ART. Many people with VF (44.8%) had CD4 counts <200 cells/µL, but few (0.31% per year) switched to second-line ART., Conclusions: Countries are approaching global VLS targets for adults. Treatment support, in particular for younger adults, and people with higher CD4 counts, and switching of people to protease inhibitor- or integrase inhibitor-based regimens may further reduce NVL prevalence., (© 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)
- Published
- 2020
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15. Age-Specific Risk Scores Do Not Improve HIV-1 Prediction Among Women in South Africa.
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Peebles K, Palanee-Phillips T, Balkus JE, Beesham I, Makkan H, Deese J, Smit J, Heffron R, Morrison CS, Philip NM, Malahleha M, Kasaro M, Naidoo Y, Nielson T, Reddy K, Kotze P, Ahmed K, Rees H, Baeten JM, and Barnabas RV
- Subjects
- Adolescent, Adult, Age Factors, Female, HIV Infections etiology, Humans, Risk Assessment, Risk Factors, South Africa epidemiology, Young Adult, HIV Infections epidemiology, HIV-1
- Abstract
Background: HIV-1 risk scoring tools could help target provision of prevention modalities such as pre-exposure prophylaxis. Recent research suggests that risk scores for women aged 18-45 may not predict risk well among young women aged 18-24. We evaluated the predictive performance of age-specific risk scores compared with the existing non-age-specific VOICE risk score, developed for women aged 18-45., Methods: We conducted a secondary analysis of the Evidence for Contraceptive Options and HIV Outcomes Trial to develop and internally validate HIV-1 risk scores for women aged 18-24 and 25-35 in South Africa. Candidate predictors included baseline demographic, clinical, behavioral, and contextual characteristics readily available in clinical settings. The VOICE risk score was applied to women aged 18-35. We evaluated predictive performance of each risk score by area under the receiver operating characteristic curve (AUC)., Results: Predictive performance of all risk scores was moderate, with AUC (95% confidence interval) of 0.64 (0.60 to 0.67) among women aged 18-24, 0.68 (0.62 to 0.73) among those aged 25-35, and 0.61 (0.58 to 0.65) for the VOICE risk score applied to women aged 18-35; The AUC was similar in internal validation. Among women aged 18-24, HIV-1 incidence was high even at low risk scores, at 3.9 per 100 person-years (95% confidence interval: 3.2 to 4.7)., Conclusions: All risk scores were moderately predictive of HIV-1 acquisition, and age-specific risk scores performed only marginally better than the VOICE non-age-specific risk score. Approaches for targeted pre-exposure prophylaxis provision to women in South Africa may require more extensive data than are currently available to improve prediction.
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- 2020
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16. Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial.
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Eckhardt CM, Cummings MJ, Rajagopalan KN, Borden S, Bitan ZC, Wolf A, Kantor A, Briese T, Meyer BJ, Jacobson SD, Scotto D, Mishra N, Philip NM, Stotler BA, Schwartz J, Shaz B, Spitalnik SL, Eisenberger A, Hod EA, Justman J, Cheung K, Lipkin WI, and O'Donnell MR
- Subjects
- Adult, Antibodies, Viral blood, Antibodies, Viral immunology, COVID-19, Clinical Trials, Phase II as Topic, Humans, Immunization, Passive adverse effects, Immunization, Passive methods, Pandemics, Prospective Studies, SARS-CoV-2, COVID-19 Serotherapy, Betacoronavirus immunology, Coronavirus Infections therapy, Pneumonia, Viral therapy, Randomized Controlled Trials as Topic
- Abstract
Objectives: The aim of this study is to evaluate the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in hospitalized adults with severe SARS-CoV-2 infection., Trial Design: This is a prospective, single-center, phase 2, randomized, controlled trial that is blinded to participants and clinical outcome assessor., Participants: Eligible participants include adults (≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air, and/or need for supplemental oxygen, non-invasive mechanical ventilation, or invasive mechanical ventilation, who are willing and able to provide written informed consent prior to performing study procedures or who have a legally authorized representative available to do so. Exclusion criteria include participation in another clinical trial of anti-viral agent(s)* for coronavirus disease-2019 (COVID-19), receipt of any anti-viral agent(s)* with possible activity against SARS-CoV-2 <24 hours prior to plasma infusion, mechanical ventilation (including extracorporeal membrane oxygenation [ECMO]) for ≥ 5 days, severe multi-organ failure, history of allergic reactions to transfused blood products per NHSN/CDC criteria, known IgA deficiency, and pregnancy. Included participants will be hospitalized at the time of randomization and plasma infusion. *Use of remdesivir as treatment for COVID-19 is permitted. The study will be undertaken at Columbia University Irving Medical Center in New York, USA., Intervention and Comparator: The investigational treatment is anti-SARS-CoV-2 human convalescent plasma. To procure the investigational treatment, volunteers who recovered from COVID-19 will undergo testing to confirm the presence of anti-SARS-CoV-2 antibody to the spike trimer at a 1:400 dilution. Donors will also be screened for transfusion-transmitted infections (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T. cruzi, ZIKV). If donors have experienced COVID-19 symptoms within 28 days, they will be screened with a nasopharyngeal swab to confirm they are SARS-CoV-2 PCR-negative. Plasma will be collected using standard apheresis technology by the New York Blood Center. Study participants will be randomized in a 2:1 ratio to receive one unit (200 - 250 mL) of anti-SARS-CoV-2 plasma versus one unit (200 - 250 mL) of the earliest available control plasma. The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis., Main Outcomes: The primary endpoint is time to clinical improvement. This is defined as time from randomization to either discharge from the hospital or improvement by one point on the following seven-point ordinal scale, whichever occurs first. 1. Not hospitalized with resumption of normal activities 2. Not hospitalized, but unable to resume normal activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, requiring high-flow oxygen therapy or non-invasive mechanical ventilation 6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both 7. Death This scale, designed to assess clinical status over time, was based on that recommended by the World Health Organization for use in determining efficacy end-points in clinical trials in hospitalized patients with COVID-19. A recent clinical trial evaluating the efficacy and safety of lopinavir- ritonavir for patients hospitalized with severe COVID-19 used a similar ordinal scale, as have recent clinical trials of novel therapeutics for severe influenza, including a post-hoc analysis of a trial evaluating immune plasma. The primary safety endpoints are cumulative incidence of grade 3 and 4 adverse events and cumulative incidence of serious adverse events during the study period., Randomization: Study participants will be randomized in a 2:1 ratio to receive anti-SARS-CoV-2 plasma versus control plasma using a web-based randomization platform. Treatment assignments will be generated using randomly permuted blocks of different sizes to minimize imbalance while also minimizing predictability., Blinding (masking): The study participants and the clinicians who will evaluate post-treatment outcomes will be blinded to group assignment. The blood bank and the clinical research team will not be blinded to group assignment., Numbers to Be Randomized (sample Size): We plan to enroll 129 participants, with 86 in the anti-SARS-CoV-2 arm, and 43 in the control arm. Among the participants, we expect ~70% or n = 72 will achieve clinical improvement. This will yield an 80% power for a one-sided Wald test at 0.15 level of significance under the proportional hazards model with a hazard ratio of 1.5., Trial Status: Protocol AAAS9924, Version 17APR2020, 4/17/2020 Start of recruitment: April 20, 2020 Recruitment is ongoing., Trial Registration: ClinicalTrials.gov: NCT04359810 Date of trial registration: April 24, 2020 Retrospectively registered FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
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- 2020
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17. Multiple abscesses in a renal transplant recipient.
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Philip NM, Naranje P, Bagchi S, Das CJ, and Agarwal SK
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- Abscess drug therapy, Abscess microbiology, Adult, Drug Therapy, Combination, Humans, Magnetic Resonance Imaging, Male, Muscular Diseases drug therapy, Muscular Diseases microbiology, Nocardia isolation & purification, Nocardia Infections drug therapy, Nocardia Infections microbiology, Transplant Recipients, Treatment Outcome, Abscess diagnosis, Anti-Bacterial Agents therapeutic use, Kidney Transplantation adverse effects, Muscular Diseases diagnosis, Nocardia Infections diagnosis
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- 2019
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18. Status of HIV Epidemic Control Among Adolescent Girls and Young Women Aged 15-24 Years - Seven African Countries, 2015-2017.
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Brown K, Williams DB, Kinchen S, Saito S, Radin E, Patel H, Low A, Delgado S, Mugurungi O, Musuka G, Tippett Barr BA, Nwankwo-Igomu EA, Ruangtragool L, Hakim AJ, Kalua T, Nyirenda R, Chipungu G, Auld A, Kim E, Payne D, Wadonda-Kabondo N, West C, Brennan E, Deutsch B, Worku A, Jonnalagadda S, Mulenga LB, Dzekedzeke K, Barradas DT, Cai H, Gupta S, Kamocha S, Riggs MA, Sachathep K, Kirungi W, Musinguzi J, Opio A, Biraro S, Bancroft E, Galbraith J, Kiyingi H, Farahani M, Hladik W, Nyangoma E, Ginindza C, Masangane Z, Mhlanga F, Mnisi Z, Munyaradzi P, Zwane A, Burke S, Kayigamba FB, Nuwagaba-Biribonwoha H, Sahabo R, Ao TT, Draghi C, Ryan C, Philip NM, Mosha F, Mulokozi A, Ntigiti P, Ramadhani AA, Somi GR, Makafu C, Mugisha V, Zelothe J, Lavilla K, Lowrance DW, Mdodo R, Gummerson E, Stupp P, Thin K, Frederix K, Davia S, Schwitters AM, McCracken SD, Duong YT, Hoos D, Parekh B, Justman JE, and Voetsch AC
- Subjects
- Adolescent, Africa epidemiology, Anti-HIV Agents therapeutic use, Female, HIV Infections epidemiology, Health Knowledge, Attitudes, Practice, Humans, Prevalence, Program Evaluation, Viral Load statistics & numerical data, Young Adult, Epidemics prevention & control, HIV Infections prevention & control
- Abstract
In 2016, an estimated 1.5 million females aged 15-24 years were living with human immunodeficiency virus (HIV) infection in Eastern and Southern Africa, where the prevalence of HIV infection among adolescent girls and young women (3.4%) is more than double that for males in the same age range (1.6%) (1). Progress was assessed toward the Joint United Nations Programme on HIV/AIDS (UNAIDS) 2020 targets for adolescent girls and young women in sub-Saharan Africa (90% of those with HIV infection aware of their status, 90% of HIV-infected persons aware of their status on antiretroviral treatment [ART], and 90% of those on treatment virally suppressed [HIV viral load <1,000 HIV RNA copies/mL]) (2) using data from recent Population-based HIV Impact Assessment (PHIA) surveys in seven countries. The national prevalence of HIV infection in adolescent girls and young women aged 15-24 years, the percentage who were aware of their status, and among those persons who were aware, the percentage who had achieved viral suppression were calculated. The target for viral suppression among all persons with HIV infection is 73% (the product of 90% x 90% x 90%). Among all seven countries, the prevalence of HIV infection among adolescent girls and young women was 3.6%; among those in this group, 46.3% reported being aware of their HIV-positive status, and 45.0% were virally suppressed. Sustained efforts by national HIV and public health programs to diagnose HIV infection in adolescent girls and young women as early as possible to ensure rapid initiation of ART should help achieve epidemic control among adolescent girls and young women., Competing Interests: Bharat Parekh reports receipt of royalties from CDC from the sale of LAg-Avidity Enzyme Immunoassay during conduct of the study. No other conflicts of interest were reported.
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- 2018
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19. Swaziland HIV Incidence Measurement Survey (SHIMS): a prospective national cohort study.
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Justman J, Reed JB, Bicego G, Donnell D, Li K, Bock N, Koler A, Philip NM, Mlambo CK, Parekh BS, Duong YT, Ellenberger DL, El-Sadr WM, and Nkambule R
- Subjects
- Adolescent, Adult, Counseling, Eswatini epidemiology, Family Characteristics, Female, HIV Infections immunology, HIV Infections virology, Humans, Incidence, Male, Mass Screening, Middle Aged, Prevalence, Proportional Hazards Models, Prospective Studies, Regression Analysis, Risk Factors, Sex Counseling, Surveys and Questionnaires, Young Adult, HIV Infections diagnosis, HIV Infections epidemiology, HIV-1 isolation & purification
- Abstract
Background: Swaziland has the highest national HIV prevalence worldwide. The Swaziland HIV Incidence Measurement Survey (SHIMS) provides the first national HIV incidence estimate based on prospectively observed HIV seroconversions., Methods: A two-stage survey sampling design was used to select a nationally representative sample of men and women aged 18-49 years from 14 891 households in 575 enumeration areas in Swaziland, who underwent household-based counselling and rapid HIV testing during 2011. All individuals aged 18-49 years who resided or had slept in the household the night before and were willing to undergo home-based HIV testing, answer demographic and behavioural questions in English or siSwati, and provide written informed consent were eligible for the study. We performed rapid HIV testing and assessed sociodemographic and behavioural characteristics with use of a questionnaire at baseline and, for HIV-seronegative individuals, 6 months later. We calculated HIV incidence with Poisson regression modelling as events per person-years × 100, and we assessed covariables as predictors with Cox proportional hazards modelling. Survey weighting was applied and all models used survey sampling methods., Findings: Between Dec 10, 2010, and June 25, 2011, 11 897 HIV-seronegative adults were enrolled in SHIMS and 11 232 (94%) were re-tested. Of these, 145 HIV seroconversions were observed, resulting in a weighted HIV incidence of 2·4% (95% CI 2·1-2·8). Incidence was nearly twice as high in women (3·1%; 95% CI 2·6-3·7) as in men (1·7%; 1·3-2·1, p<0·0001). Among men, partner's HIV-positive status (adjusted hazard ratio [aHR] 2·67, 1·06-6·82, p=0·040) or unknown serostatus (aHR 4·64, 2·32-9·27, p<0·0001) in the past 6 months predicted HIV seroconversion. Among women, significant predictors included not being married (aHR 2·90, 1·44-5·84, p=0·0030), having a spouse who lives elsewhere (aHR 2·66, 1·29-5·45, p=0·0078), and having a partner in the past 6 months with unknown HIV status (aHR 2·87, 1·44-5·84, p=0·0030)., Interpretation: Swaziland has the highest national HIV incidence in the world. In high-prevalence countries, population-based incidence measures and programmes that further expand HIV testing and support disclosure of HIV status are needed., Funding: President's Emergency Plan for AIDS Relief (PEPFAR) by the Centers for Disease Control and Prevention., (Copyright © 2017 Elsevier Ltd. All rights reserved.)
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- 2017
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20. Changing Antiretroviral Eligibility Criteria: Impact on the Number and Proportion of Adults Requiring Treatment in Swaziland.
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Bock NN, Emerson RC, Reed JB, Nkambule R, Donnell DJ, Bicego GT, Okello V, Philip NM, Ehrenkranz PD, Duong YT, Moore JS, and Justman JE
- Subjects
- Adolescent, Adult, CD4 Lymphocyte Count, Cross-Sectional Studies, Eswatini epidemiology, Female, Humans, Incidence, Male, Middle Aged, Patient Compliance, Practice Guidelines as Topic, Prevalence, Viral Load, Young Adult, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, HIV Infections epidemiology
- Abstract
Objective: Early initiation of antiretroviral treatment (ART) at CD4 cell count ≥ 500 cells per microliter reduces morbidity and mortality in HIV-infected adults. We determined the proportion of HIV-infected people with high viral load (VL) for whom transmission prevention would be an additional benefit of early treatment., Design: A randomly selected subset of a nationally representative sample of HIV-infected adults in Swaziland in 2012., Methods: Eight to 12 months after a national survey to determine adult HIV prevalence, 1067 of 5802 individuals identified as HIV-infected were asked to participate in a follow-up cross-sectional assessment. CD4 cell enumeration, VL measurements, and ART status were obtained to estimate the proportion of currently untreated adults and of the entire HIV-infected population with high VL (≥ 1000 copies/mL) whose treatment under a test-and-treat or VL threshold eligibility strategy would reduce HIV transmission., Results: Of the 927 (87% of 1067) participants enrolled, 466 (50%) reported no ART use. Among them, 424 (91%) had VL ≥ 1000 copies per milliliter; of these, 148 (35%) were eligible for ART at the then existing CD4 count threshold of <350 cells per microliter; an additional 107 (25%) were eligible with expanded CD4 criterion of <500 cells per microliter; and 169 (40%) remained ART ineligible. Thus, 36% of the 466 currently untreated and 18% of the total 927 had high VL yet remained ART ineligible under a CD4 criterion of <500 cells per microliter., Conclusions: A test-and-treat or VL threshold for treatment eligibility is necessary to maximize the HIV transmission prevention benefits of ART.
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- 2016
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21. The Link4Health study to evaluate the effectiveness of a combination intervention strategy for linkage to and retention in HIV care in Swaziland: protocol for a cluster randomized trial.
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McNairy ML, Gachuhi AB, Lamb MR, Nuwagaba-Biribonwoha H, Burke S, Ehrenkranz P, Mazibuko S, Sahabo R, Philip NM, Okello V, and El-Sadr WM
- Subjects
- Adult, Anti-HIV Agents therapeutic use, Eswatini, HIV Infections diagnosis, HIV Infections drug therapy, Humans, Medication Adherence psychology, Program Evaluation, Clinical Protocols, HIV Infections therapy, Patient Compliance psychology
- Abstract
Background: Gaps in the HIV care continuum contribute to suboptimal individual health outcomes and increased risk of HIV transmission at the population level. Implementation science studies are needed to evaluate clinic-based interventions aimed at improving retention of patients across the continuum., Methods/design: Link4Health uses an unblended cluster site-randomized design to evaluate the effectiveness of a combination intervention strategy (CIS) as compared to standard of care on linkage to and retention in care among HIV-diagnosed adults in Swaziland. The CIS intervention targets a multiplicity of structural, behavioral, and biomedical barriers through five interventions: (1) point-of-care CD4 testing at time of HIV testing, (2) accelerated antiretroviral therapy (ART) initiation for eligible patients, (3) mobile phone appointment reminders, (4) care and prevention packages, and (5) non-cash financial incentives for linkage and retention. The unit of randomization is a network of HIV clinics inclusive of a secondary facility coupled with an affiliated primary facility. Ten study units were randomized based on implementing partner, geographic location, and historic volume of HIV patients. Target enrollment was 2200 individuals, each to be followed for 12 months. Eligibility criteria includes HIV-positive test, age >18 years, willing to receive HIV care at a clinic in the study unit and consent to study procedures. Exclusion criteria included previous HIV care in the past 6 months, planning to leave the community, and current pregnancy. The primary study outcome is linkage within 1 month and retention at 12 months after testing HIV positive. Secondary outcomes include viral load suppression at 12 months, time to ART eligibility and initiation, participant acceptability, and cost-effectiveness. The trial status is that study enrollment is complete and follow-up procedures are ongoing., Discussion: Link4Health evaluates a novel and pragmatic combination intervention strategy to improve linkage to and retention in care among adults with HIV in Swaziland. If the strategy is found to be effective, this study has the potential to inform HIV service delivery in resource-limited settings., Trial Registration: Clinicaltrials.gov NCT01904994.
- Published
- 2015
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22. Letting HIV transform academia--embracing implementation science.
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El-Sadr WM, Philip NM, and Justman J
- Subjects
- Epidemics, Humans, Role, United States, Biomedical Research organization & administration, HIV Infections epidemiology, Research Personnel, Universities organization & administration
- Published
- 2014
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23. A consensus regimen for early abortion with misoprostol.
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Philip NM, Winikoff B, Moore K, and Blumenthal P
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- Abortifacient Agents, Nonsteroidal analysis, Chills chemically induced, Congenital Abnormalities etiology, Diarrhea chemically induced, Drug Administration Schedule, Female, Fever chemically induced, Gestational Age, Humans, Milk, Human chemistry, Misoprostol analysis, Muscle Cramp chemically induced, Nausea chemically induced, Pregnancy, Uterine Hemorrhage chemically induced, Vomiting chemically induced, Abortifacient Agents, Nonsteroidal therapeutic use, Abortion, Induced, Misoprostol therapeutic use
- Published
- 2004
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24. Infection after medical abortion: a review of the literature.
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Shannon C, Brothers LP, Philip NM, and Winikoff B
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- Abortion, Induced methods, Canada epidemiology, Endometritis epidemiology, Endometritis etiology, Female, France epidemiology, Humans, Incidence, Infections etiology, Pregnancy, Pregnancy Trimesters, United Kingdom epidemiology, United States epidemiology, Abortion, Induced adverse effects, Infections epidemiology
- Abstract
Medical abortion regimens have become widely used, but the frequency of infection after medical abortion is not well documented. This systematic review provides data on infectious complications after medical abortion. We searched Medline for articles written before July 2003 to determine the frequency of infection after medical abortion up to 26 weeks of gestation. We reviewed all articles and extracted data on the frequency of infection from 65 studies. The frequency of diagnosed and/or treated infection after medical abortion was very low (0.92%, N = 46,421) and varied among regimens. Results of this review confirm that, with respect to infectious complications, medical abortion is a safe and effective option for first- and second-trimester pregnancy termination. After accounting for regional variations in diagnosis, there is little difference in frequency of infection among the regimens reviewed. Future studies should report clear diagnosis and treatment standards for infection so that more precise information becomes available.
- Published
- 2004
- Full Text
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