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2. A joint Bayesian hierarchical model for estimating SARS-CoV-2 diagnostic and subgenomic RNA viral dynamics and seroconversion

Author

Dong, Tracy Q. and Brown, Elizabeth R.

Subjects
Statistics - Applications, Quantitative Biology - Biomolecules, Statistics - Methodology
Abstract

Understanding the viral dynamics and immunizing antibodies of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is crucial for devising better therapeutic and prevention strategies for COVID-19. Here, we present a Bayesian hierarchical model that jointly estimates the diagnostic RNA viral load reflecting genomic materials of SARS-CoV-2, the subgenomic RNAs (sgRNA) viral load reflecting active viral replication, and the rate and timing of seroconversion reflecting presence of antibodies. Our proposed method accounts for the dynamical relationship and correlation structure between the two types of viral load, allows for borrowing of information between viral load and antibody data, and identifies potential correlates of viral load characteristics and propensity for seroconversion. We demonstrate the features of the joint model through application to the COVID-19 PEP study and conduct a cross-validation exercise to illustrate the model's ability to impute the sgRNA viral trajectories for people who only had diagnostic viral load data.

Published
2023
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3. Retrospective, Observational Studies for Estimating Vaccine Effects on the Secondary Attack Rate of SARS-CoV-2

Author

Bannick, Marlena S., Gao, Fei, Brown, Elizabeth R., and Janes, Holly E.

Subjects
Statistics - Applications, Statistics - Methodology
Abstract

COVID-19 vaccines are highly efficacious at preventing symptomatic infection, severe disease, and death. Most of the evidence that COVID-19 vaccines also reduce transmission of SARS-CoV-2 is based on retrospective, observational studies. Specifically, an increasing number of studies are evaluating vaccine efficacy against the secondary attack rate of SARS-CoV-2 using data available in existing healthcare databases or contact tracing databases. Since these types of databases were designed for clinical diagnosis or management of COVID-19, they are limited in their ability to provide accurate information on infection, infection timing, and transmission events. In this manuscript, we highlight challenges with using existing databases to identify transmission units and confirm potential SARS-CoV-2 transmission events. We discuss the impact of common diagnostic testing strategies including event-prompted and infrequent testing and illustrate their potential biases in estimating vaccine efficacy against the secondary attack rate of SARS-CoV-2. We articulate the need for prospective observational studies of vaccine efficacy against the SARS-CoV-2 SAR, and we provide design and reporting considerations for studies using retrospective databases.

Published
2022

4. Using time‐weighted average change from baseline of SARS‐CoV‐2 viral load to assess impact of hydroxychloroquine as postexposure prophylaxis and early treatment for COVID‐19

Author

Kumbhakar, Raaka, Neradilek, Moni, Barnabas, Ruanne V, Stewart, Jenell, Karita, Helen C Stankiewicz, Landovitz, Raphael J, Kissinger, Patricia J, Jerome, Keith R, Paasche‐Orlow, Michael K, Bershteyn, Anna, Chu, Helen Y, Neuzil, Kathleen M, Greninger, Alexander L, Luk, Alfred, Wald, Anna, Brown, Elizabeth R, and Johnston, Christine

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Pneumonia, Prevention, Infectious Diseases, Emerging Infectious Diseases, Clinical Research, Clinical Trials and Supportive Activities, Lung, Infection, Good Health and Well Being, COVID-19, Humans, Hydroxychloroquine, SARS-CoV-2, Viral Load, COVID-19 Drug Treatment, early treatment, hydroxychloroquine, PEP, Microbiology, Virology, Clinical sciences, Medical microbiology
Abstract

Two randomized controlled trials demonstrated no clinical benefit of hydroxychloroquine (HCQ) for either postexposure prophylaxis or early treatment of SARS-CoV-2 infection. Using data from these studies, we calculated the time-weighted average change from baseline SARS-CoV-2 viral load and demonstrated that HCQ did not affect viral clearance.

Published
2022

5. Durability of single-dose HPV vaccination in young Kenyan women: randomized controlled trial 3-year results

Author

Barnabas, Ruanne V., Brown, Elizabeth R., Onono, Maricianah A., Bukusi, Elizabeth A., Njoroge, Betty, Winer, Rachel L., Galloway, Denise A., Pinder, Leeya F., Donnell, Deborah, N. Wakhungu, Imelda, Biwott, Charlene, Kimanthi, Syovata, Heller, Kate B., Kanjilal, Diane G., Pacella, Daniel, Morrison, Susan, A. Rechkina, Elena, L. Cherne, Stephen, Schaafsma, Torin T., McClelland, R. Scott, Celum, Connie, Baeten, Jared M., and Mugo, Nelly R.

Published
2023
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6. Population-Level Correlation Between Incidence of Curable Sexually Transmitted Infections and Human Immunodeficiency Virus (HIV)-1 Among African Women Participating in HIV-1 Pre-Exposure Prophylaxis Trials.

Author

Hunidzarira, Portia, Brown, Elizabeth R, Chirenje, Z Mike, Hillier, Sharon L, Marrazzo, Jeanne M, Palanee-Phillips, Thesla, Kiweewa, Flavia M, and Baeten, Jared M

Subjects
Biomedical and Clinical Sciences, Public Health, Clinical Sciences, Health Sciences, Medical Microbiology, Mental Health, Clinical Trials and Supportive Activities, HIV/AIDS, Clinical Research, Infectious Diseases, Prevention, Sexually Transmitted Infections, 2.2 Factors relating to the physical environment, Aetiology, Infection, Good Health and Well Being, Chlamydia Infections, Chlamydia trachomatis, Female, HIV Infections, HIV-1, Humans, Incidence, Neisseria gonorrhoeae, Pre-Exposure Prophylaxis, Prevalence, Sexually Transmitted Diseases, clinical trial design, HIV incidence, sexually transmitted infections, women, MTN-003/VOICE and MTN-020/ASPIRE Study Teams, Biological Sciences, Medical and Health Sciences, Microbiology, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundHighly efficacious oral pre-exposure prophylaxis (PrEP) is the global standard for human immunodeficiency virus (HIV)-1 prevention, including in clinical trials of novel PrEP agents using active-comparator designs. The analysis assessed whether incident sexually transmitted infections (STIs) can serve as a surrogate indicator of HIV-1 incidence that might occur in the absence of PrEP.MethodsWe analyzed data from 3256 women randomized to placebo groups of oral and vaginal PrEP trials (MTN-003/VOICE and MTN-020/ASPIRE). Regression modeling assessed the correlation between incident individual STIs (Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis, each considered separately) and incident HIV-1.ResultsAcross 18 sites in 4 countries (Malawi, South Africa, Uganda, Zimbabwe), STI and HIV-1 incidences were high: HIV-1 4.9, N gonorrhoeae 5.3, C trachomatis 14.5, and T vaginalis 7.1 per 100 person-years. There was limited correlation between HIV-1 incidence and incidence of individual STIs: N gonorrhoeae (r = 0.02, P = .871), C trachomatis (r = 0.49, P =

Published
2022

7. Self-Assessed Severity as a Determinant of Coronavirus Disease 2019 Symptom Specificity: A Longitudinal Cohort Study

Author

Bershteyn, Anna, Dahl, Angela M, Dong, Tracy Q, Deming, Meagan E, Celum, Connie L, Chu, Helen Y, Kottkamp, Angelica C, Greninger, Alexander L, Hoffman, Risa M, Jerome, Keith R, Johnston, Christine M, Kissinger, Patricia J, Landovitz, Raphael J, Laufer, Miriam K, Luk, Alfred, Neuzil, Kathleen M, Paasche-Orlow, Michael K, Pitts, Robert A, Schwartz, Mark D, Stankiewicz Karita, Helen C, Thorpe, Lorna E, Wald, Anna, Zheng, Crystal Y, Wener, Mark H, Barnabas, Ruanne V, and Brown, Elizabeth R

Subjects
Prevention, Biodefense, Clinical Research, Emerging Infectious Diseases, Infectious Diseases, Vaccine Related, Pneumonia & Influenza, Pneumonia, Lung, Good Health and Well Being, COVID-19, COVID-19 Testing, Humans, Longitudinal Studies, SARS-CoV-2, symptoms, screening, severity, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

Coronavirus disease 2019 symptom definitions rarely include symptom severity. We collected daily nasal swab samples and symptom diaries from contacts of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) case patients. Requiring ≥1 moderate or severe symptom reduced sensitivity to predict SARS-CoV-2 shedding from 60.0% (95% confidence interval [CI], 52.9%-66.7%) to 31.5% (95% CI, 25.7%- 38.0%) but increased specificity from 77.5% (95% CI, 75.3%-79.5%) to 93.8% (95% CI, 92.7%-94.8%).

Published
2022

8. Prevalent human papillomavirus infection increases the risk of HIV acquisition in African women: advancing the argument for human papillomavirus immunization

Author

Liu, Gui, Mugo, Nelly R, Brown, Elizabeth R, Mgodi, Nyaradzo M, Chirenje, Zvavahera M, Marrazzo, Jeanne M, Winer, Rachel L, Mansoor, Leila, Palanee-Phillips, Thesla, Siva, Samantha S, Naidoo, Logashvari, Jeenarain, Nitesha, Gaffoor, Zakir, Nair, Gonasagrie L, Selepe, Pearl, Nakabiito, Clemensia, Mkhize, Baningi, Mirembe, Brenda Gati, Taljaard, Marthinette, Panchia, Ravindre, Baeten, Jared M, Balkus, Jennifer E, Hladik, Florian, Celum, Connie L, and Barnabas, Ruanne V

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Clinical Sciences, Sexually Transmitted Infections, Infectious Diseases, Cancer, Cervical Cancer, Prevention, Immunization, HIV/AIDS, Adolescent Sexual Activity, Clinical Research, HPV and/or Cervical Cancer Vaccines, Vaccine Related, Pediatric, Prevention of disease and conditions, and promotion of well-being, 3.4 Vaccines, Infection, Good Health and Well Being, Adult, Alphapapillomavirus, Case-Control Studies, Female, HIV Infections, Humans, Papillomaviridae, Papillomavirus Infections, Papillomavirus Vaccines, Prevalence, Risk Factors, Vaccination, Young Adult, adolescent girls and young women, cervical cancer, HIV acquisition, human papillomavirus, Biological Sciences, Medical and Health Sciences, Psychology and Cognitive Sciences, Virology, Biomedical and clinical sciences, Health sciences
Abstract

ObjectiveVaccine-preventable human papillomavirus (HPV) infection is common, especially in sub-Saharan Africa where HIV risk is also high. However, unlike other sexually transmitted infections (STIs), HPV's role in HIV acquisition is unclear. We evaluated this relationship using data from MTN-003, a clinical trial of HIV chemoprophylaxis among cisgender women in sub-Saharan Africa.DesignA case-control study.MethodsWe matched 138 women who acquired HIV (cases) to 412 HIV-negative controls. Cervicovaginal swabs collected within 6 months before HIV seroconversion were tested for HPV DNA. We estimated the associations between carcinogenic (high-risk) and low-risk HPV types and types targeted by HPV vaccines and HIV acquisition, using conditional logistic regression models adjusted for time-varying sexual behaviors and other STIs.ResultsMean age was 23 (±4) years. Any, high-risk and low-risk HPV was detected in 84, 74 and 66% of cases, and 65, 55 and 48% of controls. Infection with at least two HPV types was common in cases (67%) and controls (49%), as was infection with nonavalent vaccine-targeted types (60 and 42%). HIV acquisition increased with any [adjusted odds ratio (aOR) 2.5, 95% confidence interval (95% CI) 1.3-4.7], high-risk (aOR 2.6, 95% CI 1.5-4.6) and low-risk (aOR 1.8, 95% CI 1.1-2.9) HPV. Each additional type detected increased HIV risk by 20% (aOR 1.2, 95% CI 1.1-1.4). HIV acquisition was associated with HPV types targeted by the nonavalent (aOR 2.1, 95% CI 1.3-3.6) and quadrivalent vaccines (aOR 1.9, 95% CI 1.1-3.2).ConclusionHPV infection is associated with HIV acquisition in sub-Saharan African women. In addition to preventing HPV-associated cancers, increasing HPV vaccination coverage could potentially reduce HIV incidence.

Published
2022

9. Immunogenicity of NVX-CoV2373 heterologous boost against SARS-CoV-2 variants

Author

Lyke, Kirsten E., Atmar, Robert L., Dominguez Islas, Clara, Posavad, Christine M., Deming, Meagan E., Branche, Angela R., Johnston, Christine, El Sahly, Hana M., Edupuganti, Srilatha, Mulligan, Mark J., Jackson, Lisa A., Rupp, Richard E., Rostad, Christina A., Coler, Rhea N., Bäcker, Martín, Kottkamp, Angelica C., Babu, Tara M., Dobrzynski, David, Martin, Judith M., Brady, Rebecca C., Frenck, Jr., Robert W., Rajakumar, Kumaravel, Kotloff, Karen, Rouphael, Nadine, Szydlo, Daniel, PaulChoudhury, Rahul, Archer, Janet I., Crandon, Sonja, Ingersoll, Brian, Eaton, Amanda, Brown, Elizabeth R., McElrath, M. Juliana, Neuzil, Kathleen M., Stephens, David S., Post, Diane J., Lin, Bob C., Serebryannyy, Leonid, Beigel, John H., Montefiori, David C., and Roberts, Paul C.

Published
2023
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10. Adherence, safety, and choice of the monthly dapivirine vaginal ring or oral emtricitabine plus tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis among African adolescent girls and young women: a randomised, open-label, crossover trial

Author

Nair, Gonasagrie, Celum, Connie, Szydlo, Daniel, Brown, Elizabeth R, Akello, Carolyne A, Nakalega, Rita, Macdonald, Pippa, Milan, Gakiema, Palanee-Phillips, Thesla, Reddy, Krishnaveni, Tahuringana, Eunice, Muhlanga, Felix, Nakabiito, Clemensia, Bekker, Linda-Gail, Siziba, Bekezela, Hillier, Sharon L, Baeten, Jared M, Garcia, Morgan, Johnson, Sherri, McClure, Tara, Levy, Lisa, Livant, Edward, Jacobson, Cindy, Soto-Torres, Lydia, van der Straten, Ariane, Hosek, Sybil, Rooney, James F, Steytler, John, Bunge, Katherine, Parikh, Urvi, Hendrix, Craig, Anderson, Peter, and Ngure, Kenneth

Published
2023
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11. Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection

Author

Barnabas, Ruanne V, Brown, Elizabeth R, Bershteyn, Anna, Stankiewicz Karita, Helen C, Johnston, Christine, Thorpe, Lorna E, Kottkamp, Angelica, Neuzil, Kathleen M, Laufer, Miriam K, Deming, Meagan, Paasche-Orlow, Michael K, Kissinger, Patricia J, Luk, Alfred, Paolino, Kristopher, Landovitz, Raphael J, Hoffman, Risa, Schaafsma, Torin T, Krows, Meighan L, Thomas, Katherine K, Morrison, Susan, Haugen, Harald S, Kidoguchi, Lara, Wener, Mark, Greninger, Alexander L, Huang, Meei-Li, Jerome, Keith R, Wald, Anna, Celum, Connie, Chu, Helen Y, and Baeten, Jared M

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Infectious Diseases, Coronaviruses, Prevention, Clinical Trials and Supportive Activities, Emerging Infectious Diseases, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, Antiviral Agents, COVID-19, COVID-19 Nucleic Acid Testing, Double-Blind Method, Female, Humans, Hydroxychloroquine, Male, Middle Aged, Post-Exposure Prophylaxis, SARS-CoV-2, Time Factors, Treatment Outcome, United States, Young Adult, COVID-19 Drug Treatment, Hydroxychloroquine COVID-19 PEP Study Team, Public Health and Health Services
Abstract

BackgroundEffective prevention against coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is currently limited to nonpharmaceutical strategies. Laboratory and observational data suggested that hydroxychloroquine had biological activity against SARS-CoV-2, potentially permitting its use for prevention.ObjectiveTo test hydroxychloroquine as postexposure prophylaxis for SARS-CoV-2 infection.DesignHousehold-randomized, double-blind, controlled trial of hydroxychloroquine postexposure prophylaxis. (ClinicalTrials.gov: NCT04328961).SettingNational U.S. multicenter study.ParticipantsClose contacts recently exposed ( 0.20). The frequency of participants experiencing adverse events was higher in the hydroxychloroquine group than the control group (66 [16.2%] versus 46 [10.9%], respectively; P = 0.026).LimitationThe delay between exposure, and then baseline testing and the first dose of hydroxychloroquine or ascorbic acid, was a median of 2 days.ConclusionThis rigorous randomized controlled trial among persons with recent exposure excluded a clinically meaningful effect of hydroxychloroquine as postexposure prophylaxis to prevent SARS-CoV-2 infection.Primary funding sourceBill & Melinda Gates Foundation.

Published
2021

12. Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study

Author

Baeten, Jared M, Palanee-Phillips, Thesla, Mgodi, Nyaradzo M, Mayo, Ashley J, Szydlo, Daniel W, Ramjee, Gita, Mirembe, Brenda Gati, Mhlanga, Felix, Hunidzarira, Portia, Mansoor, Leila E, Siva, Samantha, Govender, Vaneshree, Makanani, Bonus, Naidoo, Logashvari, Singh, Nishanta, Nair, Gonasagrie, Chinula, Lameck, Parikh, Urvi M, Mellors, John W, Balán, Iván C, Ngure, Kenneth, van der Straten, Ariane, Scheckter, Rachel, Garcia, Morgan, Peda, Melissa, Patterson, Karen, Livant, Edward, Bunge, Katherine, Singh, Devika, Jacobson, Cindy, Jiao, Yuqing, Hendrix, Craig W, Chirenje, Zvavahera M, Nakabiito, Clemensia, Taha, Taha E, Jones, Judith, Torjesen, Kristine, Nel, Annalene, Rosenberg, Zeda, Soto-Torres, Lydia E, Hillier, Sharon L, Brown, Elizabeth R, Aanyu, Dorothy, Abima, John, Abullarade, Janne, Agarwal, Priyanka, Ahluwalia, Surabhi, Akasiima, Simon Africa, Akello, Carolyne Agwau, Albert, Samuel, Alphale, Motsamai, Alphonse, Calins, Apeduno, Lucy, Aranda, Sara, Aridor, Orly, Arnolds, Shakeera, Asiimwe, Prossy, Atujuna, Millicent, Atwebembere, Didas, Baboolall, Lakshmi, Badana, Kiran, Balamusani, David, Banda, Gabriel, Banda, Towera Whitney, Baugh, Jennifer, Baziira, James Amos, Beamer, May, Bebeza, Sivuyisiwe Asanda, Bekker, Linda-Gail, Bell, Ian, Bemer, Meagan, Berman, Richard, Berthiaume, Jennifer, Bezak, Linda, Bhagwandin, Yashveer, Bhayat, Hassen Anwar, Bhengu, Nokulunga, Bhengu, Sonto, Bhoola, Aruna, Biira, Florence Asiimwe, Bittoni, Daniel, Black, Roberta, Blose, Nombuso Jacqueline, Boks, Pearl, Bolton, Stephen Gordon, Botya, Phathiswa, Brown, Amanda, Brown, Elizabeth, Brown, Helen, Bruce, Robyn Helen, Bukenya, Luke Erismus, Bukirwa, Aidah, Bunts, Lisa, Buthelezi, Fezile, Buthelezi, Mbongeleni William, Buthelezi, Samkelisiwe Dumisile, and Byogero, Rose

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Prevention, HIV/AIDS, Mental Health, Infectious Diseases, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Good Health and Well Being, Administration, Intravaginal, Adult, Anti-HIV Agents, Contraceptive Devices, Female, Female, HIV Infections, HIV-1, Humans, Malawi, Patient Compliance, Patient Safety, Pyrimidines, Seroconversion, South Africa, Tenofovir, Treatment Outcome, Uganda, Zimbabwe, MTN-025/HOPE Study Team, Medical and Health Sciences, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundTwo phase 3 clinical trials showed that use of a monthly vaginal ring containing 25 mg dapivirine was well tolerated and reduced HIV-1 incidence in women by approximately 30% compared with placebo. We aimed to evaluate use and safety of the dapivirine vaginal ring (DVR) in open-label settings with high background rates of HIV-1 infection, an important step for future implementation.MethodsWe did a phase 3B open-label extension trial of the DVR (MTN-025/HIV Open-label Prevention Extension [HOPE]). Women who were HIV-1-negative and had participated in the MTN-020/ASPIRE phase 3 trial were offered 12 months of access to the DVR at 14 clinical research centres in Malawi, South Africa, Uganda, and Zimbabwe. At each visit (monthly for 3 months, then once every 3 months), women chose whether or not to accept the offer of the ring. Used, returned rings were tested for residual amounts of dapivirine as a surrogate marker for adherence. HIV-1 serological testing was done at each visit. Dapivirine amounts in returned rings and HIV-1 incidence were compared with data from the ASPIRE trial, and safety was assessed. This study is registered with ClinicalTrials.gov, NCT02858037.FindingsBetween July 16, 2016, and Oct 10, 2018, of 1756 women assessed for eligibility, 1456 were enrolled and participated in the study. Median age was 31 years (IQR 27-37). At baseline, 1342 (92·2%) women chose to take the DVR; ring acceptance was more than 79% at each visit up until 12 months and 936 (73·2%) of 1279 chose to take the ring at all visits. 12 530 (89·3%) of 14 034 returned rings had residual dapivirine amounts consistent with some use during the previous month (>0·9 mg released) and the mean dapivirine amount released was greater than in the ASPIRE trial (by 0·21 mg; p

Published
2021

13. Correlates of Dapivirine Vaginal Ring Acceptance among Women Participating in an Open Label Extension Trial

Author

Mirembe, Brenda Gati, Cabrera, Maria Valdez, van der Straten, Ariane, Nakalega, Rita, Cobbing, Mandy, Mgodi, Nyaradzo M., Palanee-Phillips, Thesla, Mayo, Ashley J., Dadabhai, Sufia, Mansoor, Leila E., Siva, Samantha, Nair, Gonasagrie, Chinula, Lameck, Akello, Carolyne A., Nakabiito, Clemensia, Soto-Torres, Lydia E., Baeten, Jared M., and Brown, Elizabeth R.

Published
2023
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14. Spatially Weighted Coronary Artery Calcium Score and Coronary Heart Disease Events in the Multi-Ethnic Study of Atherosclerosis

Author

Shea, Steven, Navas-Acien, Ana, Shimbo, Daichi, Brown, Elizabeth R, Budoff, Matthew, Bancks, Michael P, Barr, R Graham, and Kronmal, Richard

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Sciences, Heart Disease, Prevention, Heart Disease - Coronary Heart Disease, Aging, Atherosclerosis, Clinical Research, Cardiovascular, Aged, Calcium, Coronary Angiography, Coronary Artery Disease, Coronary Vessels, Ethnicity, Female, Humans, Incidence, Male, Middle Aged, Predictive Value of Tests, Risk Assessment, Tomography, X-Ray Computed, United States, atherosclerosis, blood pressure, calcium, heart diseases, hypertension, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Clinical sciences
Abstract

BackgroundA limitation of the Agatston coronary artery calcium (CAC) score is that it does not use all of the calcium density information in the computed tomography scan such that many individuals have a score of zero. We examined the predictive validity for incident coronary heart disease (CHD) events of the spatially weighted coronary calcium score (SWCS), an alternative scoring method for CAC that assigns scores to individuals with Agatston CAC=0.MethodsThe MESA (Multi-Ethnic Study of Atherosclerosis) is a longitudinal study that conducted a baseline exam from 2000 to 2002 in 6814 participants including computed tomography scanning for CAC. Subsequent exams and systematic follow-up of the cohort for outcomes were performed. Statistical models were adjusted using the MESA risk score based on age, sex, race/ethnicity, systolic blood pressure, use of hypertension medications, diabetes, total and HDL (high-density lipoprotein) cholesterol, use of lipid-lowering medications, smoking status, and family history of heart attack.ResultsIn the 3286 participants with Agatston CAC=0 at baseline and for whom SWCS was computed, 98 incident CHD events defined as definite or probably myocardial infarction or definite CHD death occurred during a median follow-up of 15.1 years. In this group, SWCS predicted incident CHD events after multivariable adjustment (hazard ratio=1.30 per SD of natural logarithm [SWCS] [95% CI, 1.04-1.60]; P=0.005); and progression from Agatston CAC=0 at baseline to CAC>0 at subsequent exams (multivariable-adjusted incidence rate difference per SD of natural logarithm [SWCS] per 100 person-years 1.68 [95% CI, 1.03-2.33]; P0 at repeat computed tomography scanning at later exams. SWCS has predictive validity as a subclinical phenotype and marker of CHD risk in individuals with Agatston CAC=0.

Published
2021

15. Use of the dapivirine vaginal ring and effect on cervical cytology abnormalities.

Author

Reddy, Krishnaveni, Kelly, Cliff, Brown, Elizabeth R, Jeenarain, Nitesha, Naidoo, Logashvari, Siva, Samantha, Bekker, Linda-Gail, Nair, Gonasagrie, Makanani, Bonus, Chinula, Lameck, Mgodi, Nyaradzo, Chirenje, Zvavahera, Kiweewa, Flavia Matovu, Marrazzo, Jeanne, Bunge, Katherine, Soto-Torres, Lydia, Piper, Jeanna, Baeten, Jared M, and Palanee-Phillips, Thesla

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Topical Microbicides, Prevention, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Anti-HIV Agents, Contraceptive Devices, Female, Double-Blind Method, Female, HIV Infections, HIV Seropositivity, HIV-1, Humans, Pyrimidines, Vagina, Young Adult, cytology, dapivirine, preexposure prophylaxis, vaginal ring, MTN-020/ASPIRE and MTN-003/VOICE Study Teams, Biological Sciences, Medical and Health Sciences, Psychology and Cognitive Sciences, Virology, Biomedical and clinical sciences, Health sciences
Abstract

ObjectiveWe aimed to determine if the dapivirine vaginal ring and the ring device alone (flexible silicone matrix polymer) was associated with the development of cervical cytology abnormalities.DesignSecondary analysis comparing cervical cytology results between two randomized controlled microbicide trials (MTN-020/ASPIRE and MTN-003/VOICE).MethodsData from ASPIRE, a phase III, placebo-controlled trial of the dapivirine vaginal ring, were used in this analysis. Cervical cytology smears were evaluated at baseline and at the final visit with product use. We compared cytology results between women randomized to dapivirine versus placebo vaginal ring. We further assessed for the effect of the vaginal ring device on cervical cytology by comparing results with data from the oral placebo arm of VOICE, a prior HIV-1 prevention trial conducted in a similar population.ResultsCervical cytology results for 2394 women from ASPIRE (1197 per study arm) were used in this analysis; median time between baseline and final visit with product use was 22.1 months. Cytology smear findings were comparable between dapivirine and placebo vaginal ring arms: at final visit, normal: 90.6 versus 91.5%, ASC-US//LSIL: 7.8 versus 7.4%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 1.7 versus 1.1%, P = 0.44. Cytology data from VOICE had findings (normal: 87.8%, ASC-US/LSIL: 9.8%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 2.4%) comparable with that of both dapivirine (P = 0.93) and placebo vaginal ring arms (P = 0.24).ConclusionThese findings indicate that neither use of the dapivirine vaginal ring nor the vaginal ring device alone, over a period of 2 years, is associated with development of cervical cytology abnormalities that could lead to precancerous or cancerous lesions.

Published
2020

16. Words Matter: A Qualitative Content Analysis of Campus Crime Alerts and Considerations for Best Practices

Author

Wesely, Jennifer K., Brown, Elizabeth R., and Phills, Curtis E.

Abstract

Objective: An impediment to an informed discussion of the impact that campus crime alerts have on college campuses is the dearth of research on the topic. This study explores the composition of campus crime alerts and the ways they convey and (re)produce meanings concerning victimization, perpetration, responsibility, and consent. Methods: This study uses an qualitative content analysis of a sample of 3,702 campus crime alerts from 55 universities in the United States. Results: Three themes (Central Actor, Overgendering, and Gratuitous Content) emerge. When the victim is portrayed as the alert subject using a passive voice and the crime is framed within a gendered, editorialized narrative, the alert focus shifts to the victim's rather than the perpetrator's identity and behaviors. Conclusions: The wording of alerts may compromise the safety of the campus community by reinforcing misguided expectations for behavior and shaping misleading perceptions of risk; considerations for best practices are explored.

Published
2022
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17. Nevertheless, She Persisted (in Science Research): Enhancing Women Students' Science Research Motivation and Belonging through Communal Goals

Author

Allen, Jill, Brown, Elizabeth R., Ginther, Alexi, Graham, Jasmine Elise, Mercurio, Dominic, and Smith, Jessi L.

Abstract

There is no doubt that connections with other people motivate behavior; yet science is stereotyped as being lonely work devoid of communal connections. Drawing from self-regulation of motivation and goal congruity theories, we ask, does relationship-building in science foster communal perceptions that then increase women's persistence in and motivation for science research? In a scientific context designed to simulate a "typical" setting that emphasized gender and the male-dominated nature of STEM, women and men students interacted with a male confederate [Study 1 (N = 245)] or women students interacted with a female confederate [Study 2 (N = 152)]. In both cases, the student-confederate pair completed a series of getting-to-know-you questions to foster a relationship, engaged in a boring "data transcription" task together, and completed measures of communal goal perceptions, science research motivation, and belonging. We also assessed actual persistence on and future motivation for the science task. Across both studies, women's communal perceptions significantly predicted belonging and science research motivation. In turn, science research motivation led to significantly greater persistence and future motivation and significantly mediated the link between communal perceptions and science persistence (Study 1). Results for belonging were mixed. Study 2 results provided a conceptual replication, extending the model to same-gender peer interactions. Overall results suggest peer relationship-building exercises are one pathway to help women feel a sense of community in science education. Focusing on creative strategies to retain women students in science will enhance science innovation and contribute to a more inclusive teaching and learning environment.

Published
2021
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19. Hydroxychloroquine with or without azithromycin for treatment of early SARS-CoV-2 infection among high-risk outpatient adults: A randomized clinical trial

Author

Johnston, Christine, Brown, Elizabeth R., Stewart, Jenell, Karita, Helen C.Stankiewicz, Kissinger, Patricia J., Dwyer, John, Hosek, Sybil, Oyedele, Temitope, Paasche-Orlow, Michael K., Paolino, Kristopher, Heller, Kate B., Leingang, Hannah, Haugen, Harald S., Dong, Tracy Q., Bershteyn, Anna, Sridhar, Arun R., Poole, Jeanne, Noseworthy, Peter A., Ackerman, Michael J., Morrison, Susan, Greninger, Alexander L., Huang, Meei-Li, Jerome, Keith R., Wener, Mark H., Wald, Anna, Schiffer, Joshua T., Celum, Connie, Chu, Helen Y., Barnabas, Ruanne V., and Baeten, Jared M.

Published
2021
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20. Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study

Author

Aanyu, Dorothy, Abima, John, Abullarade, Janne, Agarwal, Priyanka, Ahluwalia, Surabhi, Akasiima, Simon Africa, Akello, Carolyne Agwau, Albert, Samuel, Alphale, Motsamai, Alphonse, Calins, Apeduno, Lucy, Aranda, Sara, Aridor, Orly, Arnolds, Shakeera, Asiimwe, Prossy, Atujuna, Millicent, Atwebembere, Didas, Baboolall, Lakshmi, Badana, Kiran, Baeten, Jared M., Balamusani, David, Balán, Iván C., Banda, Gabriel, Banda, Towera Whitney, Baugh, Jennifer, Baziira, James Amos, Beamer, May, Bebeza, Sivuyisiwe Asanda, Bekker, Linda-Gail, Bell, Ian, Bemer, Meagan, Berman, Richard, Berthiaume, Jennifer, Bezak, Linda, Bhagwandin, Yashveer, Bhayat, Hassen Anwar, Bhengu, Nokulunga, Bhengu, Sonto, Bhoola, Aruna, Biira, Florence Asiimwe, Bittoni, Daniel, Black, Roberta, Blose, Nombuso Jacqueline, Boks, Pearl, Bolton, Stephen Gordon, Botya, Phathiswa, Brown, Amanda, Brown, Elizabeth, Brown, Helen, Bruce, Robyn Helen, Bukenya, Luke Erismus, Bukirwa, Aidah, Bunge, Katherine, Bunts, Lisa, Buthelezi, Fezile, Buthelezi, Mbongeleni William, Buthelezi, Samkelisiwe Dumisile, Byogero, Rose, Byroo, Samiksha, Byuma, Robert, Carstens, Johanna Albertha, Carter, Allison, Cassim, Nazneen, Cebekhulu, Busisiwe, Cele, Bongekile, Cele, Dolly Judith, Cele, Phindile, Cele, Simangele, Cele, Sithabile, Chadza, Mary, Chakhtoura, Nahida, Chapdu, Claire, Chareka, Gift Tafadzwa, Chasakara, Charles, Chatani-Gada, Manju, Chetty, Diana, Chidanyika, Mary, Chifambi, Tafadzwa Tariro Lisa, Chihota, Emelder, Chikono, Sungano, Chikonyora, Anesu, Chikukwa, Brett Dzidzai, Chin, Craig, Chindevu, Mary, Chinula, Lameck, Chinyanda, Tendai Blessing, Chirenda, Thandiwe Hilda, Chirenje, Zvavahera Mike, Chirisa, Chiedza, Chisale, Patience, Chishanga, Angela, Chitambo, Tobias, Chitema, Fred, Chithila, Flora, Chitowa, Tinei Helen, Chitsinde, Catherine, Chitsulo, Gladys, Chitukuta, Miria, Chiveso, Spiwe, Chome, Nelecy, Chonco, Phumelele Fortune, Christopher, Emily, Chunderduri, Kerusha, Cibi, Vutomi, Cleland, Naana, Coba, Thobeka, Cobbing, Mandy Rae, Collins, Clare, Comer, Kim, Cozzi, Shameen, Crida, Danielle, Dadabhai, Sufia, Daki, Thembakazi, Danster, Nwabisa, Dassaye, Reshmi, David, Renita, Davis, Jontraye M., Dawood, Sumaya, Deb, Pallabi, Degnam, Leslie, Derrick, Tiffany Sharron, Devlin, Bríd Teresa, Dezzutti, Charlene, Dhlakama, Patricia Mae, Dias, Lorna, Dimairo, Jean Chivoniso, Dinnie, Elaine, Dlabanta, Avile, Dladla, Msizi, Dladla, Thandeka Immaculate, Dlungele, Andile Princess, Dolezal, Curtis, Donaty, Kristine, Dott, Clare, Dubbs, Jenna, Dubula-Majola, Vuyiseka, Dukwe, Pamella, Duma, Cebo Ivan, Duma, Portia Ignatia Makhosazana, Duma, Promise, Duncan, Vimbai Kudzanai, Duran, Luis, Dyabeni, Lindelwa, Edwards, Andrew, Etikala, Radhika, Etima, Juliane, Fairlie, Lee, Fischer, Henry, Fitzpatrick, Jacqueline, Fleurs, Llewellyn, Fowler, Mary Glenn, Freeman, Lester, Gaffoor, Zakir, Gama, Lizzy, Garcia, Morgan, Garg, Anita, Gatsi, Vanesa Margret, Gcwensa, Clifford, Gebashe, Emmanuel Lwandile, Geduld, Samantha, Gelant, Jennipher, Germuga, Donna, Ggita, Joseph, Giguere, Rebecca, Godo, Lucy, Goetz, B. Jay, Gogo, Litha, Goliati, Esther, Gondwe, Daniel Kondwani, Gordon, Kelley C., Goreraza, Rodney, Gounden, Jayandree, Govender, Dhevium, Govender, Justin Sivalingum, Govender, Nerusha, Govender, Subramonien, Govender, Vaneshree, Gqwara, Nonkululeko Nosipho, Gravelle, Anisa (Tracy), Guga, Phindile, Guma, Victor, Gumede, Delisile Zilungile, Gumede, Sibusiso, Gumede, Thembelihle, Gumede, Thobeka Winifred, Gundani, Orgrah, Gunnam, Ravi, Gupta, Rahul, Gwande, Mirriam, Gxako, Xolani, Hall, Kim, Hall, Wayne, Hargrave, Perry, Harkoo, Ishana, Harrell, Tanya, Heaps, Amy L., Hendricks, Simone Lara, Hendrix, Craig W., Hlabisa, Bongeka, Hlabisa, Lungile Bongeka, Hlahla, Kudzai, Hlela, Thulebona Martin, Hobongwana, Thandiwe, Horn, Eva, Howard, Ridley, Huang, Haixiao, Hunidzairia, Portia, Hurbans, Nivriti, Husnik, Marla, Hwehwe, Tendai Doreen, Imamdin, Rabia, Ismail, Amina, Jacobs, Ebrahiema, Jacobson, Cindy, Jacques, Ashleigh Catherine, Jamabya, Jane, James, Grace, Janse van Rensburg, Karla, Jaya, Ziningi Nobuhle, Jeenarain, Nitesha, Jennings, Lauren, Jiang, Haoping, Jiang, Ning, Jiao, Yuqing, Jijana, Nwabisa Laurianne, Jokoniya, Godfrey, Jones, Judith, Kabasonga, Mildred, Kabenge, Daniel Kizza, Kabwigu, Samuel, Kachale, Evans, Kachenjera, Lonely, Kachingamire, Fiona, Kachipapa, Emma, Kadiwa, Mary, Kadyamusuma, McLoddy, Kafufu, Bosco, Kagwa, Mary Mukasa, Kajura-Manyindo, Clare, Kakayi, Brenda Catherine, Kaliwo, Victoria, Kalonji, Dishiki Jenny, Kamanga, Nyasha Elizabeth, Kamira, Betty, Kampangire, Zerif, Kamwana, Getrude, Kamya, Justine, Kapa, La-Donna, Karugaba, Patrick, Kasambara, Khumbo, Kassim, Priya, Kassim, Sheetal, Katana, Milly, Katongole, Francis, Katongole, Sulaiman, Katsis, Alexis, Katumbi, Chaplain, Katz, Ariana W.K., Kawanje, Edmore, Kawuma, Caroline Nassozi, Kayongo, Sowedi, Kekana, Emily, Kemigisha, Doreen, Khanyile, Siphosihle, Khanyisile, Nombuso Happiness, Khaya, Babalwa, Khiya, Noluthando, Khoza, Norah Ntombikayise, Khumalo, Thembisile, Khwela, Christina, Khwela, Zamo, Kibiribiri, Edith, Kibirige, Ismael, Kiiza, Beatrice, Kikonyogo, Florence Sempa, Kin, Melissa, Kirkwood, Catherine, Kistnasami, Girisha, Kiweewa, Flavia Matovu, Kiweewa, Max, Konatham, Deepika, Kubheka, Lungile, Kufakunesu, Terrence, Kumwenda, Phaleda, Kumwenda, Wiza Wisdom Isaac, Kush, Maura, Kutner, Bryan A., Kwatsha, Ntomboxolo, Kwedza, Rosper, Kyomukama, Erinah, Lands, Debra, Langa, Phumelele Nokuthula, Lebeta, Kalkidan, Lentz, Cody, Leremi, Brendley Tebogo, Leszczewski, Michelle, Levy, Lisa, Livant, Edward, Livant, Ted, Lukas, Irene, Mabanga, Lungile Pearl, Mabaso, Nomusa, Machisa, Vimbainashe, Maddox, Toni M., Madlala, Bernadette, Magobiane, Nocwaka, Magolela, Melda, Maguramhinga, Fungai, Magwaza, Phumzile Desiree, Maharaj, Keshnee, Mahed, Ferial, Mahlase, Tankiso Vuyiswa, Maila, Moshukutjoane Lebogang, Makala, Yvonne, Makamure, Patrick, Makanani, Bonus, Makgoka, Kgabo Phineas, Makhamba, Pamela, Makhanya, Nompumelelo, Makondo, Rulani, Makoni, Rujeko, Makooka, Henry, Makunganya, Jennie, Makwenda, Sibongile, Malan, Gakiema, Malemia, Agnes, Malherbe, Mariette, Malunga, Faith, Mamba Nhassengo, Temantfulini, Mampa, Mogau, Mamvura, Tendai Karen, Manengamambo, Elmah, Mangove, Loreen Zandile, Mangxilana, Nomvuyo Thelma, Manjera, Tsungai Patience, Mans, Winifred Elizabeth, Mansoor, Leila, Maoko, Memory, Mapfunde, Annie, Maphumulo, Nonhlanhla Yvonne, Martinson, Francis E.A., Maruwo, Abel, Marx, Emmerentia Yvonne, Marzinke, Mark A., Masango, Moira, Mashego, Mmathabo Nnana, Mashinini, Gwendoline Thotele Refilwe, Masuko, Shingirayi Irene, Matambanadzo, Kudzai Viviana, Mathebula, Florence Tintswalo, Mathipa, Matheus, Matsa, Jacob Munyaradzi, Matta, Eleanor Agnes, Matubu, Allen Taguma, Mavundla, Ayanda Comfort, Mavundla, Sandile, Mawindo, Billy, Mayani, Josiah, Mayanja, Emmanuel, Mayekiso, Nombongo, Mayisela, Nonkululeko Precious, Mayo, Ashley J., Mbabali, Mary Speciosa, Mbanjwa, Nonhlakanipho Masibonge Gciniwe, Mbatha, Constance Seanokeng, Mbatha, Nomcedo Janice, Mbewe, Dorica, Mbichila, Tinkhani, Mbilizi, Yamikani Rose, Mbokazi, Sithokoza, Mbwerera, Mwandifitsa, Mchunu, Zethu, McKinstry, Laura, Mdlongwa, Bongiwe, Mellors, John W., Meyiwa, Sihle Perfect, Mgodi, Nyaradzo Mavis, Mhizha, Erasmus Samuel, Mhlanga, Felix, Mhlanga, Nomsa Sibongile, Mirembe, Brenda Gail, Mirembe, Dorothy, Mkandawire, Fumbani, Mkhabela, Ntombizethu Hazel, Mkhize, Baningi, Mkhize, Princess Hlengiwe, Mkhize, Zaba, Mlangeni, Elizabeth Gugu, Mlingo, Margaret, Mngqebisa, Bukiwe, Mngxekeza, Noluxolo, Mninzi, Anele, Mnqonywa, Nonzwakazi, Mogkoro, Mammekwa, Mogodiri, Thembisile Wilmah, Mohuba, Rebone Frengelina, Mokoena, Maseponki Cecilia, Mona, Noxolo, Montoya, Deidra, Monyethabeng, Willie, Moodley, Jayajothi, Moodley, Jeeva, Moodley, Kerushini, Moonsamy, Suri, Morar, Neetha Shagan, Morudu, Sophie Nomsa, Mpekula, Angela, Mphisa, Gerald Thsepo, Mpofu, Jayne, Mposula, Hlengiwe Theodora, Mqadi, Avril, Msiska, Emmie, Msumba, Lusungu, Mtambo, Nana, Mthalane, Emmanuel Sinothi, Mthembu, Thabisile Susan, Mthethi, Zanoxolo, Mthethwa, Magdeline Judith, Mthethwa, Ntokozo Zabathethwa, Mthimkhulu, Sicelo Samuel, Mtlokoa, Itsepheng, Mubiru, Michael Charles, Mudavanhu, Mary, Mufumisi, Anna Zvirevo, Mugagga, Agnes Mary, Muganga, Joanita, Mugava, Michelle, Mugenyi, Margaret, Mugocha, Caroline, Mugodhi, Faith, Mugwagwa, Norma, Muhlanga, Felix Godwin Sivhukile, Mukaka, Shorai, Mukasa, Dick, Mukasa, Restituta, Mukatipa, Mathews, Mukova, Shedina, Mulebeke, Sarah, Mulima, Joyce, Muller, Julio, Mulumba, Faith, Mupamombe, Tsitsi, Murandu, Constance, Murefu, Tarisai, Murewa, Fungai, Muringayi, Kudakwashe, Murombedzi, Caroline, Musara, Petina, Musisi, Jane Nsubuga, Musisi, Mary Maria, Musoke, Philippa, Mutebo, Joseph, Mutero, Prisca, Mutiti, Kudzai Santana, Mutizira, Shadreck, Mutsvunguma, Sharon, Muungani, Netsai, Muvunzi, Tariro, Muwawu, Rosemary, Mvelase, Samkelisiwe, Mvinjelwa, Priscilla Pamela, Mvuyane, Goodness Zoh, Mwafulirwa, Liness, Mwagomba, Pokiwe, Mwakhwawa, Thoko Gift, Mwebaza, Deborah, Mwenda, Wezi Longwe, Myeni, Nqobile, Mzolo, Angeline Doreen Nonhlanhla, Nabatanzi, Regina Bukenya, Nabisere, Joselyne, Nabukeera, Josephine, Nagawa, Christine Valerie, Naicker, Cherise, Naicker, Kumari, Naicker, Vimla, Naidoo, Ishana, Naidoo, Jason, Naidoo, Jayganthie, Naidoo, Kalendri, Naidoo, Logashvari, Naidoo, Renissa, Naidoo, Sandy, Naidu, Nalini, Nair, Gonasagrie Lulu, Nakabiito, Clemensia, Nakacwa, Susan, Nakakande, Joyce Gladys, Nakalega, Rita, Nakalema, Maria Gorreti, Nakibuka, Jesca, Nakyanzi, Teopista, Nakyeyune, Justine, Nalusiba, Stella, Namakula, Rhoda, Namalueso, Felix, Namayanja, Paula Mubiru, Nampala, Christine Tapuwa, Nampiira, Suzan Nkalubo, Namuddu, Agnes, Nandundu, Norah, Nansamba, Winnie, Nanyonga, Stella, Nanziri, Sophie Clare, Nassoma, Zainab Nakivumbi, Ncube, Duduzile Ethel, Ncube, Eva, Ncube, Sithabile, Ndadziyira, Pepukayi, Ndamase, Pamella Pumla, Nderecha, Walter Seth Taurayi, Ndhlovu-Forde, Zanele, Ndimande, Thembelihle Cynthia, Ndlovu, Bukekile, Ndlovu, Grecenia, Ndlovu, James, Ndlovu, Nontokozo Happiness, Ndlovu, Thakisile Nontokozo, Ndlovu, Zodwa, Ndovie, Margret, Nel, Annalene, Nemasango, Beauty, Neradilek, Blazej, Ngani, Susan, Ngcebethsha, Nokwanda Queeneth, Ngcobela, Lizbon, Ngcobo, Nolwazi, Ngcobo, Nompumelelo, Ngcobo, Sindisiwe Promise, Ngcukana, Nidleka, Ngo, Julie, Ngqabe, Nontshukumo, Ngqame, Siyabonga, Ngubane, Mduduzi Dawood, Ngure, Kenneth, Ngwenya, Nancy Nokuthula, Nhkoma, Mugowe, Nhlapho, Bongiwe Ntombizodwa, Nhleko, Sibusiso, Nkwanyana, Hlengiwe, Noble, Heather, Nobula, Lumka Lucia, Nolan, Monica, Nompondwana, Mluleki, Notshokovu, Busiwe, Ntanzi, Vukani Sandile, Nursaye, Nishi, Nutall, Jeremy Peter, Nyabadza, Omega, Nyaka, Evelesi, Nyakudya, Sandra, Nyakura, Envioletta Chiedza, Nyamadzawo, Shingayi, Nyamuzihwa, Tsitsi, Nyanzi, Zubayiri, Nyathi, Angel Tinny, Nyirenda, Fadire, Nyirenda, Makandwe, Nyirenda, Mary, Nzama, Sinqobile Charity, Nzuza, Lamec Sbongisomi, O'Byrne, Bhavesha, Okello, Fabian, Okumu, Eunice, Oluka, Emmanuel, Onen, Francis, Onyango, Carolyne Peris, Ostbye, Katherine, Padayachee, Kerusha, Palanee-Phillips, Thesla, Palichina, Victor, Pan, Zhenyu, Pappajohn, Colin, Paramanund, Levanya, Parikh, Urvi M., Patterson, Karen, Pearce, Nazmie, Peda, Melissa, Penrose, Kerri J., Phahlamohlaka, Bathandekile Molly, Phidane, Nokulunga Ruth, Pillay, Omisha, Premrajh, Anamika, Prosad, Nikita, Rabe, Lorna, Rajman, Alishka, Ramjee, Gita, Rampai, Keneoe Maphuti, Rampyapedi, Hlalifi Sylvia, Randhawa, April, Rasmeni, Sabelo, Rausch, Dianne, Reddy, Avanita, Reddy, Isayum, Reddy, Jerusha, Reddy, Krishnaveni, Rees, Vera Helen, Repetto, Andrea, Richards, Cheryl, Riddler, Sharon, Rini, Nobubele, Roeber, Brendon, Rohan, Lisa, Romer, Zachary, Rose, Matthew, Rosenberg, Zeda Fran, Rossi, Lisa, Ruch, Aviva, Rullo, Christine, Runeyi, Sinazo, Rupemba, Olivia, Rushwaya, Chenai, Russell, Marisa, Ruzive, Patience Sharai, Rwanzogyera, Godfrey, Saava, Margaret Nakato, Sagela, Tshepo Jimmy, Sakwa, Rebecca, Sayed, Fathima, Scheckter, Rachel, Schille, Jennifer, Scotch, Nokwayintombi, Scott, William, Scoville, Caitlin, Sebagala, Richard, Sebastian, Elaine, Sedze, Natasha Tina, Seedat, Nasreen Hoosen, Semakula, Joseph, Senn, Teri, Serugo, Francis, Seyama, Linly, Shabalala, Bhekanani Khumulani, Shangase, Charlotte Phumzile, Shanhinga, Pamela Caroline, Shaver, Jeremy, Shen, Hanjie, Shogole, Mogobalale Corlett, Shonhiwa, Rachel, Shozi, Claudia, Sibanda, Marvelous, Sibeko, Sylvia Sibongile, Sibisi, Ncamisile Teressa, Sibisi, Samuel Siphelele, Sibiya, Brighty Zweni, Sibiya, Happiness, Sichali, Dorothy, Sikosana, Phumzile Yvonne, Silva, Craig, Simelane, Ayanda Purity, Simon, Melissa, Sing, Triesha, Singh, Devika, Singh, Nishanta, Sithole, Hailey Virginia, Sitima, Edith, Siva, Samantha, Siyasiya, Alex, Sizane, Vuyane, Siziba, Bekezela, Slezinger, Edward, Smolinski, Daria, Snapinn, Katie, Sogoni, Olwethu, Soko, Dean, Solai, Leonard Nichiren, Somga, Mandiphumle, Song, Mei, Song, Xiaoling, Soobryan, Devarani, Soto-Torres, Lydia, Spence, Patrick Lawrence, Spooner, Elizabeth, Sseguya, Vincent, Ssentongo, Augustine, Ssenyonga, Mark, Sseremba, Lawrence Lollian, Stais, Michael, Steytler, John, Stockton, Sharon, Stofel, Julie, Stuurman, Tinyiko Reginah, Sukazi, Sizakele, Sukdao, Jasmin Lynn, Swarna, Kranthi, Szydlo, Daniel, Tagliaferri Rael, Christine, Taguta, Dorothy Rumbidzai, Taha, Taha, Tahuringana, Eunice, Tamale, Joshua, Tambama, Penelope, Taulo, Edna, Taulo, Frank, Tauya, Thelma Tonderai, Tegha, Gerald, Tembe, Sindisiwe Lucia, Tembo, Tchangani, Thatelo, Constance Lebo, Thobela, Pinky Mery, Thom, Annie, Thompson, Christine, Thompson, Monica, Thusi, Linda, Tock, Lauri, Tofile, Thandokazi, Torjesen, Kristine, Tranfaglia, Carol, Tseng, Jenny, Tshabalala, Themba, Tshongoyi, Nomvuselelo, Tsidya, Mercy, Tsikiwa, Wendy Rufaro, Tuswa-Haynes, NoCamagu, Tutshana, Bomkazi Onini, Twala, Andile Premrose, Udith, Ashvir Viren, Unten, Christine, van der Straten, Ariane, van Niekerk, Neliette, Varela, Amanda, Vatsha, Nangamso, Vijayendran, Gayathri, Vuma, Amukelani California, Wabwire, Deo Ogema, Walani, Madalo, Wanda, Bhekisisa, Wasberg, Lisa, White, Rhonda R., Windle, Kathleen Marie, Woeber, Kubashni, Wright, Danica, Wright, Tiffanee, Xaba, Thembalethu Nontokozo, Yambira, Makanaka Jean Savie, Yola, Ntando, Zaca, Sindisiwe Lydia, Zalwango, Aisha, Zemanek, Jullian, Zimba, Chifundo, Zinyengere, Tsitsi, Zinyongo, Margaret, Zondi, Thabile Goodness, Zou, Chun, Zuma, Jabulisile, Zungu, Nokuthula Princess, Zungu, Nompumelelo, Baeten, Jared M, Mgodi, Nyaradzo M, Mayo, Ashley J, Szydlo, Daniel W, Gati Mirembe, Brenda, Hunidzarira, Portia, Mansoor, Leila E, Nair, Gonasagrie, Parikh, Urvi M, Mellors, John W, Balán, Iván C, Hendrix, Craig W, Chirenje, Zvavahera M, Taha, Taha E, Rosenberg, Zeda, Soto-Torres, Lydia E, Hillier, Sharon L, and Brown, Elizabeth R

Published
2021
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22. Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women

Author

Baeten, Jared M, Palanee-Phillips, Thesla, Brown, Elizabeth R, Schwartz, Katie, Soto-Torres, Lydia E, Govender, Vaneshree, Mgodi, Nyaradzo M, Matovu Kiweewa, Flavia, Nair, Gonasagrie, Mhlanga, Felix, Siva, Samantha, Bekker, Linda-Gail, Jeenarain, Nitesha, Gaffoor, Zakir, Martinson, Francis, Makanani, Bonus, Pather, Arendevi, Naidoo, Logashvari, Husnik, Marla, Richardson, Barbra A, Parikh, Urvi M, Mellors, John W, Marzinke, Mark A, Hendrix, Craig W, van der Straten, Ariane, Ramjee, Gita, Chirenje, Zvavahera M, Nakabiito, Clemensia, Taha, Taha E, Jones, Judith, Mayo, Ashley, Scheckter, Rachel, Berthiaume, Jennifer, Livant, Edward, Jacobson, Cindy, Ndase, Patrick, White, Rhonda, Patterson, Karen, Germuga, Donna, Galaska, Beth, Bunge, Katherine, Singh, Devika, Szydlo, Daniel W, Montgomery, Elizabeth T, Mensch, Barbara S, Torjesen, Kristine, Grossman, Cynthia I, Chakhtoura, Nahida, Nel, Annalene, Rosenberg, Zeda, McGowan, Ian, and Hillier, Sharon

Subjects
Reproductive Medicine, Medical Microbiology, Biomedical and Clinical Sciences, Clinical Sciences, Sexually Transmitted Infections, HIV/AIDS, Prevention, Clinical Trials and Supportive Activities, Women's Health, Clinical Research, Infectious Diseases, 6.1 Pharmaceuticals, 5.1 Pharmaceuticals, Infection, Adolescent, Adult, Africa, Southern, Age Factors, Double-Blind Method, Drug Resistance, Viral, Female, HIV Infections, HIV-1, Humans, Incidence, Middle Aged, Patient Compliance, Pyrimidines, Reverse Transcriptase Inhibitors, Vagina, Young Adult, MTN-020–ASPIRE Study Team, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundAntiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may simplify use of antiretroviral medications and provide HIV-1 protection.MethodsWe conducted a phase 3, randomized, double-blind, placebo-controlled trial of a monthly vaginal ring containing dapivirine, a non-nucleoside HIV-1 reverse-transcriptase inhibitor, involving women between the ages of 18 and 45 years in Malawi, South Africa, Uganda, and Zimbabwe.ResultsAmong the 2629 women who were enrolled, 168 HIV-1 infections occurred: 71 in the dapivirine group and 97 in the placebo group (incidence, 3.3 and 4.5 per 100 person-years, respectively). The incidence of HIV-1 infection in the dapivirine group was lower by 27% (95% confidence interval [CI], 1 to 46; P=0.046) than that in the placebo group. In an analysis that excluded data from two sites that had reduced rates of retention and adherence, the incidence of HIV-1 infection in the dapivirine group was lower by 37% (95% CI, 12 to 56; P=0.007) than that in the placebo group. In a post hoc analysis, higher rates of HIV-1 protection were observed among women over the age of 21 years (56%; 95% CI, 31 to 71; P

Published
2016

23. Many Labs 3: Evaluating participant pool quality across the academic semester via replication

Author

Ebersole, Charles R, Atherton, Olivia E, Belanger, Aimee L, Skulborstad, Hayley M, Allen, Jill M, Banks, Jonathan B, Baranski, Erica, Bernstein, Michael J, Bonfiglio, Diane BV, Boucher, Leanne, Brown, Elizabeth R, Budiman, Nancy I, Cairo, Athena H, Capaldi, Colin A, Chartier, Christopher R, Chung, Joanne M, Cicero, David C, Coleman, Jennifer A, Conway, John G, Davis, William E, Devos, Thierry, Fletcher, Melody M, German, Komi, Grahe, Jon E, Hermann, Anthony D, Hicks, Joshua A, Honeycutt, Nathan, Humphrey, Brandon, Janus, Matthew, Johnson, David J, Joy-Gaba, Jennifer A, Juzeler, Hannah, Keres, Ashley, Kinney, Diana, Kirshenbaum, Jacqeline, Klein, Richard A, Lucas, Richard E, Lustgraaf, Christopher JN, Martin, Daniel, Menon, Madhavi, Metzger, Mitchell, Moloney, Jaclyn M, Morse, Patrick J, Prislin, Radmila, Razza, Timothy, Re, Daniel E, Rule, Nicholas O, Sacco, Donald F, Sauerberger, Kyle, Shrider, Emily, Shultz, Megan, Siemsen, Courtney, Sobocko, Karin, Sternglanz, R Weylin, Summerville, Amy, Tskhay, Konstantin O, van Allen, Zack, Vaughn, Leigh Ann, Walker, Ryan J, Weinberg, Ashley, Wilson, John Paul, Wirth, James H, Wortman, Jessica, and Nosek, Brian A

Subjects
Biological Psychology, Psychology, Clinical Research, Behavioral and Social Science, Social psychology, Cognitive psychology, Replication, Participant pool, Individual differences, Sampling effects, Situational effects, Cognitive Sciences, Social Psychology, Social and personality psychology
Abstract

The university participant pool is a key resource for behavioral research, and data quality is believed to vary over the course of the academic semester. This crowdsourced project examined time of semester variation in 10 known effects, 10 individual differences, and 3 data quality indicators over the course of the academic semester in 20 participant pools (N = 2696) and with an online sample (N = 737). Weak time of semester effects were observed on data quality indicators, participant sex, and a few individual differences—conscientiousness, mood, and stress. However, there was little evidence for time of semester qualifying experimental or correlational effects. The generality of this evidence is unknown because only a subset of the tested effects demonstrated evidence for the original result in the whole sample. Mean characteristics of pool samples change slightly during the semester, but these data suggest that those changes are mostly irrelevant for detecting effects.

Published
2016

24. Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Nonuse Increase at the Termination Visit?

Author

Mensch, Barbara S, Brown, Elizabeth R, Liu, Karen, Marrazzo, Jeanne, Chirenje, Zvavahera Mike, Gomez, Kailazarid, Piper, Jeanna, Patterson, Karen, and van der Straten, Ariane

Subjects
Public Health, Health Sciences, Clinical Trials and Supportive Activities, Infectious Diseases, HIV/AIDS, Behavioral and Social Science, Clinical Research, Sexually Transmitted Infections, 6.1 Pharmaceuticals, Administration, Oral, Adult, Anti-HIV Agents, Deception, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination, Female, Gels, HIV Infections, Humans, Medication Adherence, Middle Aged, Pre-Exposure Prophylaxis, Self Disclosure, South Africa, Tenofovir, Uganda, Young Adult, Zimbabwe, Microbicide trials, Self-reports of adherence, sub-Saharan Africa, Public Health and Health Services, Social Work, Public health
Abstract

VOICE-a phase 2B, placebo-controlled, randomized trial testing daily use of an antiretroviral tablet (tenofovir or Truvada) or daily use of tenofovir gel in 5029 women from South Africa, Uganda, and Zimbabwe-found none of the drug regimens effective in reducing HIV-1 acquisition in the intent-to-treat analysis. More than half of women assigned to active products in a case cohort sample had no drug detected in any plasma specimens tested during the trial. Yet, in response to questions asked of participants during the trial, ≥90 % of doses were reportedly taken. To explore factors associated with low adherence, a behavioral termination visit questionnaire was developed after early closure of the oral tenofovir and vaginal gel arms. We hypothesized that participants would be more forthcoming about nonuse after they exited the trial than during monthly/quarterly follow-up visits. Comparison of adherence reporting at routine follow-up visits with reporting at trial termination, however, indicates that disclosure of product nonadherence did not increase at the termination visit as anticipated. In resource-limited settings where women value the ancillary benefits provided by trial participation and are concerned that disclosure of nonuse may jeopardize trial participation, objective measures of adherence may yield more meaningful data regarding the inability or reluctance to use than measures of product use derived from self-report.

Published
2016

26. Greater dapivirine release from the dapivirine vaginal ring is correlated with lower risk of HIV-1 acquisition: a secondary analysis from a randomized, placebo-controlled trial

Author

Brown, Elizabeth R., Hendrix, Craig W., van der Straten, Ariane, Kiweewa, Flavia M., Mgodi, Nyaradzo M., Palanee-Philips, Thesla, Marzinke, Mark A., Bekker, Linda-Gail, Soto-Torres, Lydia, Hillier, Sharon L., and Baeten, Jared M.

Subjects
Antiviral agents -- Dosage and administration -- Testing, HIV infection -- Risk factors -- Prevention -- Diagnosis, Health
Abstract

Introduction: A vaginal ring containing 25 mg of the antiretroviral dapivirine has demonstrated efficacy in reducing women's risk of sexually acquiring HIV-1; however, imperfect ring use likely diluted efficacy estimates in clinical trials. The amount of dapivirine remaining in returned rings may reflect the extent of product use, permitting estimation of HIV protection in the context of consistent use. Methods: We measured the amount of dapivirine in returned rings from a placebo-controlled trial of the dapivirine vaginal ring conducted between August 2012 and June 2015 among 2629 African women. Phase I/II studies established that greater than 4 mg of dapivirine on average is released from the ring when used consistently over 28 days and [less than or equal to]0.9 mg released suggested non-use. We assessed the relative risk reduction associated with levels of ring use using residual dapivirine in returned rings as a time-dependent covariate for HIV-1 infection in multivariable Cox models, including multiple exploratory analyses designed to estimate upper limits of efficacy given uncertainty in timing of HIV-1 acquisition. All models were adjusted for baseline covariates associated with HIV risk and adherence. Results: Residual dapivirine levels indicating at least some use (>0.9 mg released over a month) were associated with a 48% relative reduction in HIV-1 acquisition risk (95% confidence interval (CI): 21% to 66%; p = 0.002) compared to the placebo. Exploratory analyses accounting for potential misclassification in timing of HIV-1 acquisition estimated 75% to 91% HIV-1 risk reduction with> 4 mg released when compared to placebo. Results limited to the subgroup of women Conclusions: Residual dapivirine levels, an objective measure of adherence, were correlated with HIV-1 protection in a secondary analysis of a randomized trial. Periods of ring use were associated with approximately 50% protection, with exploratory analyses suggesting higher protection with more consistent use. The dapivirine vaginal ring is the first method to fulfil the promise of a fully reversible, long-acting, woman-initiated approach for discreet HIV-1 prevention. Keywords: adherence; clinical trials; HIV prevention; women; HIV prevention trials; Africa, 1 | INTRODUCTION Worldwide, nearly 870 000 women and girls are infected with HIV-1 every year [1] , with the vast majority of infections occurring in sub-Saharan Africa. New, effective [...]

Published
2020
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27. Oral and injectable contraceptive use and HIV acquisition risk among women in four African countries: a secondary analysis of data from a microbicide trial

Author

Balkus, Jennifer E, Brown, Elizabeth R, Hillier, Sharon L, Coletti, Anne, Ramjee, Gita, Mgodi, Nyaradzo, Makanani, Bonus, Reid, Cheri, Martinson, Francis, Soto-Torres, Lydia, Karim, Salim S Abdool, and Chirenje, Zvavahera M

Subjects
HIV/AIDS, Prevention, Clinical Trials and Supportive Activities, Infectious Diseases, Contraception/Reproduction, Behavioral and Social Science, Clinical Research, Infection, Good Health and Well Being, Adult, Condoms, Contraceptive Agents, Female, Contraceptives, Oral, Hormonal, Delayed-Action Preparations, HIV Infections, Humans, Incidence, Injections, Intramuscular, Malawi, Proportional Hazards Models, Prospective Studies, Risk Factors, South Africa, Sterilization, Tubal, Young Adult, Zambia, Zimbabwe, Hormonal contraception, HIV infection, Injectables, Oral contraceptive pills, Southern Africa, Women, Clinical Sciences, Paediatrics and Reproductive Medicine, Public Health and Health Services, Obstetrics & Reproductive Medicine
Abstract

ObjectiveTo assess the effect of oral and injectable contraceptive use compared to nonhormonal contraceptive use on HIV acquisition among Southern African women enrolled in a microbicide trial.Study designThis is a prospective cohort study using data from women enrolled in HIV Prevention Trials Network protocol 035. At each quarterly visit, participants were interviewed about self-reported contraceptive use and sexual behaviors and underwent HIV testing. Cox proportional hazards regression was used to assess the effect of injectable and oral hormonal contraceptive use on HIV acquisition.ResultsThe analysis included 2830 participants, of whom 106 became HIV infected (4.07 per 100 person-years). At baseline, 1546 (51%) participants reported using injectable contraceptives and 595 (21%) reported using oral contraceptives. HIV incidence among injectable, oral and nonhormonal contraceptive method users was 4.72, 2.68 and 3.83 per 100 person-years, respectively. Injectable contraceptive use was associated with a nonstatistically significant increased risk of HIV acquisition [adjusted hazard ratio (aHR)=1.17; 95% confidence interval (CI) 0.70, 1.96], while oral contraceptive use was associated with a nonstatistically significant decreased risk of HIV acquisition (aHR=0.76; 95% CI 0.37,1.55).ConclusionIn this secondary analysis of randomized trial data, a marginal, but nonstatistically significant, increase in HIV risk among women using injectable hormonal contraceptives was observed. No increased HIV risk was observed among women using oral contraceptives. Our findings support the World Health Organization's recommendation that women at high risk for acquiring HIV, including those using progestogen-only injectable contraception, should be strongly advised to always use condoms and other HIV prevention measures.ImplicationsAmong Southern African women participating in an HIV prevention trial, women using injectable hormonal contraceptives had a modest increased risk of HIV acquisition; however, this association was not statistically significant. Continued research on the relationship between widely used hormonal contraceptive methods and HIV acquisition is essential.

Published
2016

29. Assessing the association between trends in a biomarker and risk of event with an application in pediatric HIV/AIDS

Author

Brown, Elizabeth R.

Subjects
Statistics - Applications
Abstract

We present a new joint longitudinal and survival model aimed at estimating the association between the risk of an event and the change in and history of a biomarker that is repeatedly measured over time. We use cubic B-splines models for the longitudinal component that lend themselves to straight-forward formulations of the slope and integral of the trajectory of the biomarker. The model is applied to data collected in a long term follow-up study of HIV infected infants in Uganda. Estimation is carried out using MCMC methods. We also explore using the deviance information criteria, the conditional predictive ordinate and ROC curves for model selection and evaluation., Comment: Published in at http://dx.doi.org/10.1214/09-AOAS251 the Annals of Applied Statistics (http://www.imstat.org/aoas/) by the Institute of Mathematical Statistics (http://www.imstat.org)

Published
2009
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31. 462. Infant antibody titers at birth following maternal COVID-19 vaccination and protection against infection in the first 6 months of life

Author

Cardemil, Cristina, primary, Munoz, Flor M, additional, Cao, Yi, additional, Gao, Fei, additional, Posavad, Christine M, additional, Badell, Martina L, additional, Bunge, Katherine E, additional, Mulligan, Mark J, additional, Parameswaran, Lalitha, additional, Olson-Chen, Courtney, additional, Novak, Richard M, additional, Brady, Rebecca C, additional, DeFranco, Emily A, additional, Gerber, Jeffrey S, additional, Pasetti, Marcela, additional, Shriver, Mallory C, additional, Coler, Rhea, additional, Berube, Bryan J, additional, Richardson, Barbra A, additional, Beigi, Richard H, additional, Neuzil, Kathy M, additional, and Brown, Elizabeth R, additional

Published
2023
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32. Urinary Metal Levels and Coronary Artery Calcification: Longitudinal Evidence in the Multi-Ethnic Study of Atherosclerosis (MESA)

Author

McGraw, Katlyn E., primary, Schilling, Kathrin, additional, Glabonjat, Ronald A., additional, Galvez-Fernandez, Marta, additional, Domingo-Relloso, Arce, additional, Martinez-Morata, Irene, additional, Jones, Miranda R., additional, Post, Wendy S., additional, Kaufman, Joel, additional, Tellez-Plaza, Maria, additional, Valeri, Linda, additional, Brown, Elizabeth R., additional, Kronmal, Richard A., additional, Barr, Graham R., additional, Shea, Steven, additional, Navas-Acien, Ana, additional, and Sanchez, Tiffany R., additional

Published
2023
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33. Tenofovir 1% vaginal gel for prevention of HIV-1 infection in women in South Africa (FACTS-001): a phase 3, randomised, double-blind, placebo-controlled trial

Author

Delany-Moretlwe, Sinead, Lombard, Carl, Baron, Deborah, Bekker, Linda-Gail, Nkala, Busi, Ahmed, Khatija, Sebe, Modulakgotla, Brumskine, William, Nchabeleng, Maposhane, Palanee-Philips, Thesla, Ntshangase, Julius, Sibiya, Sidney, Smith, Emilee, Panchia, Ravindre, Myer, Landon, Schwartz, Jill L, Marzinke, Mark, Morris, Lynn, Brown, Elizabeth R, Doncel, Gustavo F, Gray, Glenda, and Rees, Helen

Published
2018
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36. An alternative method for quantifying coronary artery calcification: the multi-ethnic study of atherosclerosis (MESA)

Author

Liang, C Jason, Budoff, Matthew J, Kaufman, Joel D, Kronmal, Richard A, and Brown, Elizabeth R

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Heart Disease - Coronary Heart Disease, Aging, Prevention, Cardiovascular, Heart Disease, Atherosclerosis, Aged, Aged, 80 and over, Calcinosis, Coronary Angiography, Coronary Artery Disease, Female, Humans, Male, Middle Aged, Prevalence, Reproducibility of Results, Risk Factors, Sensitivity and Specificity, Tomography, X-Ray Computed, United States, Nuclear Medicine & Medical Imaging, Clinical sciences
Abstract

BackgroundExtent of atherosclerosis measured by amount of coronary artery calcium (CAC) in computed tomography (CT) has been traditionally assessed using thresholded scoring methods, such as the Agatston score (AS). These thresholded scores have value in clinical prediction, but important information might exist below the threshold, which would have important advantages for understanding genetic, environmental, and other risk factors in atherosclerosis. We developed a semi-automated threshold-free scoring method, the spatially weighted calcium score (SWCS) for CAC in the Multi-Ethnic Study of Atherosclerosis (MESA).MethodsChest CT scans were obtained from 6814 participants in the Multi-Ethnic Study of Atherosclerosis (MESA). The SWCS and the AS were calculated for each of the scans. Cox proportional hazards models and linear regression models were used to evaluate the associations of the scores with CHD events and CHD risk factors. CHD risk factors were summarized using a linear predictor.ResultsAmong all participants and participants with AS > 0, the SWCS and AS both showed similar strongly significant associations with CHD events (hazard ratios, 1.23 and 1.19 per doubling of SWCS and AS; 95% CI, 1.16 to 1.30 and 1.14 to 1.26) and CHD risk factors (slopes, 0.178 and 0.164; 95% CI, 0.162 to 0.195 and 0.149 to 0.179). Even among participants with AS = 0, an increase in the SWCS was still significantly associated with established CHD risk factors (slope, 0.181; 95% CI, 0.138 to 0.224). The SWCS appeared to be predictive of CHD events even in participants with AS = 0, though those events were rare as expected.ConclusionsThe SWCS provides a valid, continuous measure of CAC suitable for quantifying the extent of atherosclerosis without a threshold, which will be useful for examining novel genetic and environmental risk factors for atherosclerosis.

Published
2012

37. An alternative method for quantifying coronaryartery calcification: the multi-ethnic study ofatherosclerosis (MESA)

Author

Liang, C, Budoff, Matthew J, Kaufman, Joel D, Kronmal, Richard A, and Brown, Elizabeth R

Abstract

AbstractBackgroundExtent of atherosclerosis measured by amount of coronary artery calcium (CAC) in computed tomography (CT) has been traditionally assessed using thresholded scoring methods, such as the Agatston score (AS). These thresholded scores have value in clinical prediction, but important information might exist below the threshold, which would have important advantages for understanding genetic, environmental, and other risk factors in atherosclerosis. We developed a semi-automated threshold-free scoring method, the spatially weighted calcium score (SWCS) for CAC in the Multi-Ethnic Study of Atherosclerosis (MESA).MethodsChest CT scans were obtained from 6814 participants in the Multi-Ethnic Study of Atherosclerosis (MESA). The SWCS and the AS were calculated for each of the scans. Cox proportional hazards models and linear regression models were used to evaluate the associations of the scores with CHD events and CHD risk factors. CHD risk factors were summarized using a linear predictor.ResultsAmong all participants and participants with AS > 0, the SWCS and AS both showed similar strongly significant associations with CHD events (hazard ratios, 1.23 and 1.19 per doubling of SWCS and AS; 95% CI, 1.16 to 1.30 and 1.14 to 1.26) and CHD risk factors (slopes, 0.178 and 0.164; 95% CI, 0.162 to 0.195 and 0.149 to 0.179). Even among participants with AS = 0, an increase in the SWCS was still significantly associated with established CHD risk factors (slope, 0.181; 95% CI, 0.138 to 0.224). The SWCS appeared to be predictive of CHD events even in participants with AS = 0, though those events were rare as expected.ConclusionsThe SWCS provides a valid, continuous measure of CAC suitable for quantifying the extent of atherosclerosis without a threshold, which will be useful for examining novel genetic and environmental risk factors for atherosclerosis.

Published
2012

39. Urine Cadmium Levels and Coronary Artery Calcification: A Longitudinal Study in the Multi-Ethnic Study of Atherosclerosis (MESA)

Author

Mcgraw, Katlyn E, primary, Schilling, Kathrin, additional, Glabonjat, Ronald A, additional, Sobel, Marisa, additional, Relloso, Arce Domingo, additional, Jones, Miranda R, additional, Post, Wendy, additional, Kaufman, Joel, additional, Plaza, Maria Tellez, additional, Valeri, Linda, additional, Kronmal, Richard, additional, Brown, Elizabeth R, additional, Shea, Steven, additional, Acien, Ana Navas, additional, and Sanchez, Tiffany R, additional

Published
2023
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43. Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring.

Author

Stalter, Randy M, Dong, Tracy Q, Hendrix, Craig W, Palanee-Phillips, Thesla, van der Straten, Ariane, Hillier, Sharon L, Kiweewa, Flavia M, Mgodi, Nyaradzo M, Marzinke, Mark A, Bekker, Linda-Gail, Soto-Torres, Lydia, Baeten, Jared M, Brown, Elizabeth R, and Team, for the MTN-020/ASPIRE Study

Subjects
HIV, CLINICAL trial registries, HUMAN sexuality, AT-risk behavior, GROUP rings
Abstract

Background Confounding introduced by individuals' sexual risk behavior is potentially a significant source of bias in HIV-1 prevention intervention studies. To more completely account for sexual behaviors when assessing the efficacy of the monthly dapivirine ring, a new longer-acting HIV-1 prevention option for women, we estimated per-sex-act risk reduction associated with product use. Methods We conducted a secondary analysis of data from MTN-020/ASPIRE, a phase 3, randomized, placebo-controlled efficacy trial of the dapivirine ring that recruited HIV-uninfected, African women aged 18–45 years. With cumulative sex acts as the time scale, we used multivariable Cox regression with inverse probability of censoring weights to estimate HIV-1 risk reduction associated with a rate of dapivirine release indicative of consistent product use. Results Women in the dapivirine ring group (n = 1187) had an estimated incidence rate of 2.3 (95% confidence interval [CI], 1.8–3.1) HIV-1 acquisition events per 10 000 sex acts versus 3.6 (95% CI, 2.9–4.4) per 10 000 acts in the placebo group (n = 1187). Dapivirine release indicative of consistent ring use was associated with a 63% (95% CI, 33%–80%) per-sex-act HIV-1 risk reduction. Conclusions These results support the efficacy of the dapivirine vaginal ring for HIV-1 prevention and help to inform decision-making for women, providers, and policymakers regarding product use. Clinical Trials Registration NCT01617096. [ABSTRACT FROM AUTHOR]

Published
2024
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44. A joint Bayesian hierarchical model for estimating SARS-CoV-2 genomic and subgenomic RNA viral dynamics and seroconversion.

Author

Dong, Tracy Q and Brown, Elizabeth R

Subjects
*SARS-CoV-2, *SEROCONVERSION, *COVID-19
Abstract

Understanding the viral dynamics of and natural immunity to the severe acute respiratory syndrome coronavirus 2 is crucial for devising better therapeutic and prevention strategies for coronavirus disease 2019 (COVID-19). Here, we present a Bayesian hierarchical model that jointly estimates the genomic RNA viral load, the subgenomic RNA (sgRNA) viral load (correlated to active viral replication), and the rate and timing of seroconversion (correlated to presence of antibodies). Our proposed method accounts for the dynamical relationship and correlation structure between the two types of viral load, allows for borrowing of information between viral load and antibody data, and identifies potential correlates of viral load characteristics and propensity for seroconversion. We demonstrate the features of the joint model through application to the COVID-19 post-exposure prophylaxis study and conduct a cross-validation exercise to illustrate the model's ability to impute the sgRNA viral trajectories for people who only had genomic RNA viral load data. [ABSTRACT FROM AUTHOR]

Published
2024
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49. Many Labs 3: Evaluating participant pool quality across the academic semester via replication

Author

Ebersole, Charles R., Atherton, Olivia E., Belanger, Aimee L., Skulborstad, Hayley M., Allen, Jill M., Banks, Jonathan B., Baranski, Erica, Bernstein, Michael J., Bonfiglio, Diane B.V., Boucher, Leanne, Brown, Elizabeth R., Budiman, Nancy I., Cairo, Athena H., Capaldi, Colin A., Chartier, Christopher R., Chung, Joanne M., Cicero, David C., Coleman, Jennifer A., Conway, John G., Davis, William E., Devos, Thierry, Fletcher, Melody M., German, Komi, Grahe, Jon E., Hermann, Anthony D., Hicks, Joshua A., Honeycutt, Nathan, Humphrey, Brandon, Janus, Matthew, Johnson, David J., Joy-Gaba, Jennifer A., Juzeler, Hannah, Keres, Ashley, Kinney, Diana, Kirshenbaum, Jacqeline, Klein, Richard A., Lucas, Richard E., Lustgraaf, Christopher J.N., Martin, Daniel, Menon, Madhavi, Metzger, Mitchell, Moloney, Jaclyn M., Morse, Patrick J., Prislin, Radmila, Razza, Timothy, Re, Daniel E., Rule, Nicholas O., Sacco, Donald F., Sauerberger, Kyle, Shrider, Emily, Shultz, Megan, Siemsen, Courtney, Sobocko, Karin, Weylin Sternglanz, R., Summerville, Amy, Tskhay, Konstantin O., van Allen, Zack, Vaughn, Leigh Ann, Walker, Ryan J., Weinberg, Ashley, Wilson, John Paul, Wirth, James H., Wortman, Jessica, and Nosek, Brian A.

Published
2016
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