696 results on '"Brown, Elizabeth R"'
Search Results
102. Characterization of Nevirapine resistance mutations in women with subtype A Vs. D HIV-1 6-8 weeks after single-dose Nevirapine (HIVNET 012)
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Eshleman, Susan H., Mwatha, Anthony,;, Brown, Elizabeth R., Guay, Laura A., Cunninggham, Shawn P., Musoke, Philippa, MBChB, Mmiro, Francis, and Jackson, J. Brooks
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HIV (Viruses) -- Research ,HIV patients -- Research ,Nevirapine -- Properties ,Nevirapine -- Research ,Health - Abstract
The study reveals the comparison between number and type of nevirapine (NVP) detected in Uganda women with subtype A vs. D HIV-1 infection after single-dose NVP prophylaxis. Result of the study confirms a higher rate of NVPR in women with subtype D than A.
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- 2004
103. Estimating the Efficacy of Preexposure Prophylaxis for HIV Prevention Among Participants With a Threshold Level of Drug Concentration
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Dai, James Y., Gilbert, Peter B., Hughes, James P., and Brown, Elizabeth R.
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- 2013
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104. Variants of Concern Are Overrepresented Among Postvaccination Breakthrough Infections of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Washington State.
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McEwen, Abbye E, Cohen, Seth, Bryson-Cahn, Chloe, Liu, Catherine, Pergam, Steven A, Lynch, John, Schippers, Adrienne, Strand, Kathy, Whimbey, Estella, Mani, Nandita S, Zelikoff, Allison J, Makarewicz, Vanessa A, Brown, Elizabeth R, Bakhash, Shah A Mohamed, Baker, Noah R, Castor, Jared, Livingston, Robert J, Huang, Meei-Li, Jerome, Keith R, and Greninger, Alexander L
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IMMUNIZATION ,GENETIC mutation ,SEQUENCE analysis ,CONFIDENCE intervals ,COVID-19 vaccines ,GENOMES ,INFECTIOUS disease transmission ,MESSENGER RNA ,DESCRIPTIVE statistics ,COVID-19 pandemic - Abstract
Across 20 vaccine breakthrough cases detected at our institution, all 20 (100%) infections were due to variants of concern (VOCs) and had a median Ct of 20.2 (IQR, 17.1–23.3). When compared with 5174 contemporaneous samples sequenced in our laboratory, VOCs were significantly enriched among breakthrough infections (P <.05). [ABSTRACT FROM AUTHOR]
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- 2022
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105. Effect of Subcutaneous Casirivimab and Imdevimab Antibody Combination vs Placebo on Development of Symptomatic COVID-19 in Early Asymptomatic SARS-CoV-2 Infection: A Randomized Clinical Trial.
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O'Brien, Meagan P., Forleo-Neto, Eduardo, Sarkar, Neena, Isa, Flonza, Hou, Peijie, Chan, Kuo-Chen, Musser, Bret J., Bar, Katharine J., Barnabas, Ruanne V., Barouch, Dan H., Cohen, Myron S., Hurt, Christopher B., Burwen, Dale R., Marovich, Mary A., Brown, Elizabeth R., Heirman, Ingeborg, Davis, John D., Turner, Kenneth C., Ramesh, Divya, and Mahmood, Adnan
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Importance: Easy-to-administer anti-SARS-CoV-2 treatments may be used to prevent progression from asymptomatic infection to symptomatic disease and to reduce viral carriage.Objective: To evaluate the effect of combination subcutaneous casirivimab and imdevimab on progression from early asymptomatic SARS-CoV-2 infection to symptomatic COVID-19.Design, Setting, and Participants: Randomized, double-blind, placebo-controlled, phase 3 trial of close household contacts of a SARS-CoV-2-infected index case at 112 sites in the US, Romania, and Moldova enrolled July 13, 2020-January 28, 2021; follow-up ended March 11, 2021. Asymptomatic individuals (aged ≥12 years) were eligible if identified within 96 hours of index case positive test collection. Results from 314 individuals positive on SARS-CoV-2 reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) testing are reported.Interventions: Individuals were randomized 1:1 to receive 1 dose of subcutaneous casirivimab and imdevimab, 1200 mg (600 mg of each; n = 158), or placebo (n = 156).Main Outcomes and Measures: The primary end point was the proportion of seronegative participants who developed symptomatic COVID-19 during the 28-day efficacy assessment period. The key secondary efficacy end points were the number of weeks of symptomatic SARS-CoV-2 infection and the number of weeks of high viral load (>4 log10 copies/mL).Results: Among 314 randomized participants (mean age, 41.0 years; 51.6% women), 310 (99.7%) completed the efficacy assessment period; 204 were asymptomatic and seronegative at baseline and included in the primary efficacy analysis. Subcutaneous casirivimab and imdevimab, 1200 mg, significantly prevented progression to symptomatic disease (29/100 [29.0%] vs 44/104 [42.3%] with placebo; odds ratio, 0.54 [95% CI, 0.30-0.97]; P = .04; absolute risk difference, -13.3% [95% CI, -26.3% to -0.3%]). Casirivimab and imdevimab reduced the number of symptomatic weeks per 1000 participants (895.7 weeks vs 1637.4 weeks with placebo; P = .03), an approximately 5.6-day reduction in symptom duration per symptomatic participant. Treatment with casirivimab and imdevimab also reduced the number of high viral load weeks per 1000 participants (489.8 weeks vs 811.9 weeks with placebo; P = .001). The proportion of participants receiving casirivimab and imdevimab who had 1 or more treatment-emergent adverse event was 33.5% vs 48.1% for placebo, including events related (25.8% vs 39.7%) or not related (11.0% vs 16.0%) to COVID-19.Conclusions and Relevance: Among asymptomatic SARS-CoV-2 RT-qPCR-positive individuals living with an infected household contact, treatment with subcutaneous casirivimab and imdevimab antibody combination vs placebo significantly reduced the incidence of symptomatic COVID-19 over 28 days.Trial Registration: ClinicalTrials.gov Identifier: NCT04452318. [ABSTRACT FROM AUTHOR]- Published
- 2022
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106. Extended prophylaxis with nevirapine and cotrimoxazole among HIV-exposed uninfected infants is well tolerated
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Aizire, Jim, Fowler, Mary Glenn, Wang, Jing, Shetty, Avinash K., Stranix-Chibanda, Lynda, Kamateeka, Moreen, Brown, Elizabeth R., Bolton, Steve G., Musoke, Philippa M., and Coovadia, Hoosen
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- 2012
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107. Taking stock of the present and looking ahead: envisioning challenges in the design of future HIV prevention efficacy trials
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Janes, Holly, Donnell, Deborah, Gilbert, Peter B, Brown, Elizabeth R, and Nason, Martha
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- 2019
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108. Malleability in Communal Goals and Beliefs Influences Attraction to STEM Careers: Evidence for a Goal Congruity Perspective
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Diekman, Amanda B., Clark, Emily K., Johnston, Amanda M., Brown, Elizabeth R., and Steinberg, Mia
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- 2011
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109. Evaluating the Incremental Value of New Biomarkers With Integrated Discrimination Improvement
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Kerr, Kathleen F., McClelland, Robyn L., Brown, Elizabeth R., and Lumley, Thomas
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- 2011
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110. LB-17. Efficacy of Hydroxychloroquine (HCQ) for Post-exposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Blinded, Randomized, Controlled Trial
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Brown, Elizabeth R, primary, Bershteyn, Anna, additional, Karita, Helen C Stankiewicz, additional, Johnston, Christine, additional, Thorpe, Lorna, additional, Kottkamp, Angelica, additional, Neuzil, Kathleen, additional, Laufer, Miriam K, additional, Deming, Meagan, additional, Paasche-Orlow, Michael K, additional, Kissinger, Patricia J, additional, Luk, Alfred, additional, Paolino, Kristopher M, additional, Landovitz, Raphael J, additional, Hoffman, Risa, additional, Schaafsma, Torin, additional, Krows, Meighan L, additional, Thomas, Katherine, additional, Morrison, Susan, additional, Kidoguchi, Lara, additional, Wener, Mark H, additional, Greninger, Alexander L, additional, Huang, Meei-Li, additional, Jerome, Keith, additional, Wald, Anna, additional, Celum, Connie, additional, Chu, Helen Y, additional, and Baeten, Jared M, additional
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- 2020
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111. Joint modeling of time-varying HIV exposure and infection for estimation of per-act efficacy in HIV prevention trials
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Brown, Elizabeth R., primary, Dominguez Islas, Clara P., additional, and Zhang, Jingyang, additional
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- 2020
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112. Vaccine optimization for COVID-19, who to vaccinate first?
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Matrajt, Laura, primary, Eaton, Julie, additional, Leung, Tiffany, additional, and Brown, Elizabeth R., additional
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- 2020
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113. Words matter: A qualitative content analysis of campus crime alerts and considerations for best practices
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Wesely, Jennifer K., primary, Brown, Elizabeth R., additional, and Phills, Curtis E., additional
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- 2020
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114. Accounting for informative sampling in estimation of associations between sexually transmitted infections and hormonal contraceptive methods
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Mishra, Anu, primary, Bůžková, Petra, additional, Balkus, Jennifer E., additional, and Brown, Elizabeth R., additional
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- 2020
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115. Hydroxychloroquine with or Without Azithromycin for Treatment of Early SARS-CoV-2 Infection Among High-Risk Outpatient Adults: A Randomized Clinical Trial
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Johnston, Christine, primary, Brown, Elizabeth R., additional, Stewart, Jenell, additional, Stankiewicz Karita, Helen C., additional, Kissinger, Patricia J., additional, Dwyer, John, additional, Hosek, Sybil, additional, Oyedele, Temitope, additional, Paasche-Orlow, Michael K., additional, Paolino, Kristopher, additional, Heller, Kate B., additional, Leingang, Hannah, additional, Haugen, Harald S., additional, Dong, Tracy Q., additional, Bershtyn, Anna, additional, Sridhar, Arun R., additional, Poole, Jeanne, additional, Noseworthy, Peter A., additional, Ackerman, Michael J., additional, Morrison, Susan, additional, Greninger, Alexander L., additional, Huang, Meei-Li, additional, Jerome, Keith R., additional, Wener, Mark H., additional, Wald, Anna, additional, Schiffer, Joshua, additional, Celum, Connie, additional, Chu, Helen Y., additional, Barnabas, Ruanne V., additional, and Baeten, Jared M., additional
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- 2020
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116. Longitudinal Data Analysis for Generalized Linear Models Under Participant-Driven Informative Follow-up: An Application in Maternal Health Epidemiology
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Bůžková, Petra, Brown, Elizabeth R., and John-Stewart, Grace C.
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- 2010
117. The Influence of Perceived Dapivirine Vaginal Ring Effectiveness on Social Disclosure and Ring Adherence.
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Stoner, Marie C. D., Brown, Elizabeth R., Palanee-Phillips, Thesla, Mansoor, Leila E., Tembo, Tchangani, Nair, Gonasagrie, Akello, Carolyne, Seyama, Linly, Jeenarain, Nitesha, Naidoo, Logashvari, Mgodi, Nyaradzo, Hunidzarira, Portia, Chitukuta, Miria, van der Straten, Ariane, for the MTN-020 ASPIRE and M-025 HOPE study teams, Baeten, Jared, Brown, Elizabeth, Soto-Torres, Lydia, Schwartz, Katie, and Mayo, Ashley
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HIV prevention ,SOCIAL support ,CERVICAL caps - Abstract
We analyzed data from 1428 users of the dapivirine vaginal ring, who participated in the MTN-020/ASPIRE phase III trial and subsequent open-label extension MTN-025/HOPE trial, to examine relationships between perceived ring protection, social disclosures, and self-reported ring adherence. In HOPE, 77% perceived the ring to be highly effective, and this view was associated with speaking: (a) to a greater number of people about the study, (b) with other participants, (c) to more people who were in favor of the ring, and (d) to more people whose opinions were valued. Reported adherence was not directly associated with perceived protection but was associated with disclosing to someone who was in favor of the ring. These findings suggest the importance of women's internalized ideas about the protective benefits of the DVR in sharing information about the ring and the importance of social support on adherence. [ABSTRACT FROM AUTHOR]
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- 2021
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118. Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study
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van der Straten, Ariane, Brown, Elizabeth R., Marrazzo, Jeanne M., Chirenje, Michael Z., Liu, Karen, Gomez, Kailazarid, Marzinke, Mark A., Piper, Jeanna M., and Hendrix, Craig W.
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HIV tests -- Analysis ,Pharmacokinetics -- Analysis ,Health - Abstract
Introduction: In the Microbicide Trial Network MTN-003 (VOICE) study, a Phase IIB pre-exposure prophylaxis trial of daily oral or vaginal tenofovir (TFV), product adherence was poor based on pharmacokinetic (PK) drug detection in a random subsample. Here, we sought to compare behavioural and PK measures of adherence and examined correlates of adherence misreporting. Methods: We included participants with PK and behavioural data from VOICE random subsample. Behavioural assessments included face-to-face interviews (FTFI), audio computer-assisted self-interviewing (ACASI) and pharmacy-returned product counts (PC). TFV concentrations Results: In this random adherence cohort of VOICE participants assigned to active products, (N =472), PK non-adherence was 69% in the oral group (N = 314) and 65% in the vaginal group (N = 158). Behaviourally, [less than or equal to] 10% of the cohort reported low/none use with any behavioural measure and accuracy was low ([less than or equal to] 43%). None of the regression models had an AUC >0.65 for any single or combined behavioural measures. Significant (p Conclusions: PK measures indicated similarly low adherence for the oral and vaginal groups. No behavioural measure accurately predicted PK non-adherence. Accurate real-time measures to monitor product adherence are urgently needed. Trial registration: ClinicalTrials.gov identifier: NCT00705679 Keywords: microbicide; pre-exposure prophylaxis; adherence measurement; pharmacokinetic drug detection; HIV., Introduction Daily oral pre-exposure prophylaxis (PrEP) is an effective prevention strategy for persons at risk of HIV-1 acquisition, and Truvada[TM] (tenofovir (TFV) disoproxil fumarate/emtricitabine) has received regulatory approval for PrEP [...]
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- 2016
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119. Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN‐003 (VOICE) study
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Straten, Ariane, Brown, Elizabeth R., Marrazzo, Jeanne M., Chirenje, Michael Z., Liu, Karen, Gomez, Kailazarid, Marzinke, Mark A., Piper, Jeanna M., and Hendrix, Craig W.
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Patient compliance -- Evaluation ,Pharmacokinetics -- Usage ,Sexually transmitted diseases -- Prevention ,Health behavior -- Evaluation ,Tenofovir -- Testing ,Health - Abstract
Introduction: In the Microbicide Trial Network MTN‐003 (VOICE) study, a Phase IIB pre‐exposure prophylaxis trial of daily oral or vaginal tenofovir (TFV), product adherence was poor based on pharmacokinetic (PK) drug detection in a random subsample. Here, we sought to compare behavioural and PK measures of adherence and examined correlates of adherence misreporting. Methods: We included participants with PK and behavioural data from VOICE random subsample. Behavioural assessments included face‐to‐face interviews (FTFI), audio computer‐assisted self‐interviewing (ACASI) and pharmacy‐returned product counts (PC). TFV concentrations Results: In this random adherence cohort of VOICE participants assigned to active products, (N=472), PK non‐adherence was 69% in the oral group (N=314) and 65% in the vaginal group (N=158). Behaviourally, ≤10% of the cohort reported low/none use with any behavioural measure and accuracy was low (≤43%). None of the regression models had an AUC >0.65 for any single or combined behavioural measures. Significant (p Conclusions: PK measures indicated similarly low adherence for the oral and vaginal groups. No behavioural measure accurately predicted PK non‐adherence. Accurate real‐time measures to monitor product adherence are urgently needed. Trial registration: ClinicalTrials.gov identifier: NCT00705679, Introduction Daily oral pre‐exposure prophylaxis (PrEP) is an effective prevention strategy for persons at risk of HIV‐1 acquisition, and Truvada[sup.TM] (tenofovir (TFV) disoproxil fumarate/emtricitabine) has received regulatory approval for PrEP [...]
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- 2016
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120. A phase III clinical trial of antibiotics to reduce chorioamnionitis-related perinatal HIV-1 transmission
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Taha, Taha E, Brown, Elizabeth R, Hoffman, Irving F, Fawzi, Wafaie, Read, Jennifer S, Sinkala, Moses, Martinson, Francis EA, Kafulafula, George, Msamanga, Gernard, Emel, Lynda, Adeniyi-Jones, Samuel, and Goldenberg, Robert
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- 2006
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121. Timing of maternal and neonatal dosing of nevirapine and the risk of mother-to-child transmission of HIV-1: HIVNET 024*
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Chi, Benjamin H, Wang, Lei, Read, Jennifer S, Sheriff, Muhsin, Fiscus, Susan, Brown, Elizabeth R, Taha, Taha E, Valentine, Megan, and Goldenberg, Robert
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- 2005
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122. HPTN 024 study: Histologic chorioamnionitis, antibiotics and adverse infant outcomes in a predominantly HIV-1-infected African population
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Goldenberg, Robert L., Mudenda, Victor, Read, Jennifer S., Brown, Elizabeth R., Sinkala, Moses, Kamiza, Steve, Martinson, Francis, Kaaya, Ephata, Hoffman, Irving, Fawzi, Wafaie, Valentine, Megan, and Taha, Taha E.
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Chorioamnionitis -- Research ,HIV infection -- Prevention ,Pregnant women -- Drug therapy ,Infants -- Health aspects ,Health - Abstract
A HIV Prevention Trials Network (HPTN) 024 study evaluates the relationship between polymorphonuclear and mononuclear cell placental (chorioamnion) infiltrations and adverse infant outcomes that include mother-to-child transmission (MTCT) of HIV-1in a predominantly HIV-1 infected African population. It is found that histologic chorioamnionitis (HCA) is associated with preterm birth and decreased gestational age and birth weight, but is not prevented or reduced by antibiotic treatment, and placental infiltrations are not associated with MTCT of HIV.
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- 2006
123. Single-dose HPV vaccination efficacy among adolescent girls and young women in Kenya (the KEN SHE Study): study protocol for a randomized controlled trial.
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Barnabas, Ruanne V., Brown, Elizabeth R., Onono, Maricianah, Bukusi, Elizabeth A., Njoroge, Betty, Winer, Rachel L., Donnell, Deborah, Galloway, Denise, Cherne, Stephen, Heller, Kate, Leingang, Hannah, Morrison, Susan, Rechkina, Elena, McClelland, R. Scott, Baeten, Jared M., Celum, Connie, Mugo, Nelly, and KEN SHE Study Team
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Background: HPV infection is the primary cause of cervical cancer, a leading cause of cancer among women in Kenya and many sub-Saharan African countries. High coverage of HPV vaccination is a World Health Organization priority to eliminate cervical cancer globally, but vaccine supply and logistics limit widespread implementation of the current two or three dose HPV vaccine schedule.Methods: We are conducting an individual randomized controlled trial to evaluate whether a single dose of the bivalent (HPV 16/18) or nonavalent (HPV 16/18/31/33/45/52/58/6/11) HPV vaccine prevents persistent HPV infection, a surrogate marker for precancerous lesions and cervical cancer. The primary objective is to compare the efficacy of immediate, single-dose bivalent or nonavalent vaccination with delayed HPV vaccination. Kenyan women age 15-20 years old are randomized to immediate bivalent HPV and delayed meningococcal vaccine (group 1), immediate nonavalent HPV vaccine and delayed meningococcal vaccine (group 2), or immediate meningococcal vaccine and delayed HPV vaccine (group 3) with 36 months of follow-up. The primary outcome is persistent vaccine-type HPV infection by month 18 and by month 36 for the final durability outcome. The secondary objectives include to (1) evaluate non-inferiority of antibody titers among girls and adolescents (age 9 to 14 years) from another Tanzanian study, the DoRIS Study (NCT02834637), compared to KEN SHE Study participants; (2) assess the memory B cell immune response at months 36 and 37; and (3) estimate cost-effectiveness using the trial results and health economic models.Discussion: This study will evaluate single-dose HPV vaccine efficacy in Africa and has the potential to guide public health policy and increase HPV vaccine coverage. The secondary aims will assess generalizability of the trial results by evaluating immunobridging from younger ages, durability of the immune response, and the long-term health benefits and cost of single-dose HPV vaccine delivery.Trial Registration: ClinicalTrials.gov NCT03675256 . Registered on September 18, 2018. [ABSTRACT FROM AUTHOR]- Published
- 2021
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124. Correlates of Adherence to the Dapivirine Vaginal Ring for HIV-1 Prevention.
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Husnik, Marla J., Brown, Elizabeth R., Dadabhai, Sufia S., Gaffoor, Zakir, Jeenarain, Nitesha, Kiweewa, Flavia Matovu, Livant, Edward, Mansoor, Leila E., Mirembe, Brenda Gati, Palanee-Phillips, Thesla, Singh, Devika, Siva, Samantha, Soto-Torres, Lydia, van der Straten, Ariane, Baeten, Jared M., for the M. T. N.-020/ASPIRE Study Team, Baeten, Jared, Brown, Elizabeth, Schwartz, Katie, and Makanani, Bonus
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HIV prevention ,MEDICAL equipment reliability ,CONFIDENCE intervals ,REVERSE transcriptase inhibitors ,HUMAN sexuality ,RANDOMIZED controlled trials ,DRUGS ,CERVICAL caps ,PREVENTIVE medicine ,PATIENT compliance ,STATISTICAL sampling ,ODDS ratio - Abstract
Understanding characteristics associated with adherence to pre-exposure prophylaxis (PrEP) methods for HIV-1 prevention may assist with optimizing implementation efforts. The dapivirine vaginal ring is a novel topical PrEP delivery method. Using data from a randomized, double-blind, placebo-controlled, phase III trial of the dapivirine vaginal ring conducted in four African countries, generalized estimating equation models were used to evaluate correlates of ring adherence. Two levels of quarterly dapivirine blood plasma, and dapivirine released from returned rings defined measures of adherence for recent and cumulative use, respectively. Time on study, calendar time, primary partner knowledge that the participant was taking part in the study, and use of long-acting contraceptive methods were associated with ring adherence whereas younger age, ring worries, condom use, episodes of menstrual bleeding and vaginal washing were associated with non-adherence. These findings may be useful for recruitment into future clinical studies and dapivirine ring implementation efforts. [ABSTRACT FROM AUTHOR]
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- 2021
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125. Elevated Risk of Bacterial Vaginosis Among Users of the Copper Intrauterine Device: A Prospective Longitudinal Cohort Study.
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Peebles, Kathryn, Kiweewa, Flavia M, Palanee-Phillips, Thesla, Chappell, Catherine, Singh, Devika, Bunge, Katherine E, Naidoo, Logashvari, Makanani, Bonus, Jeenarain, Nitesha, Reynolds, Doerieyah, Hillier, Sharon L, Brown, Elizabeth R, Baeten, Jared M, Balkus, Jennifer E, and team, MTN-020/ASPIRE study
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PATIENT aftercare ,BACTERIAL vaginitis ,CONFIDENCE intervals ,INTRAUTERINE contraceptives ,DESCRIPTIVE statistics ,TERMINATION of treatment ,LONGITUDINAL method ,SECONDARY analysis ,CONTRACEPTIVE drugs ,DISEASE risk factors - Abstract
Background Limited evidence suggests that the nonhormonal contraceptive copper intrauterine device (Cu-IUD) may increase bacterial vaginosis (BV) risk, possibly due to increased volume and duration of menses, a common side effect of Cu-IUD use. Although increases in bleeding typically resolve within 6–12 months following initiation, evaluations of the association between Cu-IUD and BV have not included more than 6 months of follow-up. Methods This secondary analysis of a human immunodeficiency virus type 1 prevention trial included 2585 African women ages 18–45 followed for up to 33 months. Women reported contraceptive use each month. BV was evaluated by Nugent score in 6-monthly intervals and, if clinically indicated, by Amsel criteria. Andersen-Gill proportional hazards models were used to (1) evaluate BV risk among Cu-IUD users relative to women using no/another nonhormonal contraceptive and (2) test changes in BV frequency before, while using, and following Cu-IUD discontinuation. Results BV frequency was highest among Cu-IUD users at 153.6 episodes per 100 person-years (95% confidence interval [CI]: 145.2, 162.4). In adjusted models, Cu-IUD users experienced 1.28-fold (95% CI: 1.12, 1.46) higher BV risk relative to women using no/another nonhormonal contraception. Compared to the 6 months prior to initiation, BV risk was 1.52-fold (95% CI: 1.16, 2.00) higher in the first 6 months of Cu-IUD use and remained elevated over 18 months of use (P < .05). Among women who discontinued Cu-IUD, BV frequency was similar to pre-initiation rates within 1 year. Conclusions Cu-IUD users experienced elevated BV risk that persisted throughout use. Women and their providers may wish to consider BV risk when discussing contraceptive options. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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126. Acceptability of the Dapivirine Vaginal Ring for HIV-1 Prevention and Association with Adherence in a Phase III Trial.
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Mayo, Ashley J., Browne, Erica N., Montgomery, Elizabeth T., Torjesen, Kristine, Palanee-Phillips, Thesla, Jeenarain, Nitesha, Seyama, Linly, Woeber, Kubashni, Harkoo, Ishana, Reddy, Krishnaveni, Tembo, Tchangani, Mutero, Prisca, Tauya, Thelma, Chitukuta, Miria, Gati Mirembe, Brenda, Soto-Torres, Lydia, Brown, Elizabeth R., Baeten, Jared M., van der Straten, Ariane, and for the MTN-020/ASPIRE study team
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HIV prevention ,RELATIVE medical risk ,CONFIDENCE intervals ,INVESTIGATIONAL drugs ,CONTRACEPTIVES ,VAGINA ,DESCRIPTIVE statistics ,PATIENT compliance ,STATISTICAL models ,POISSON distribution - Abstract
We evaluated the acceptability of the 25 mg dapivirine vaginal ring (DVR) as an HIV prevention intervention and its influence on DVR adherence in the MTN-020/ASPIRE phase III trial. Acceptability measures were captured using ACASI at month 3 and end of product use (median 24 months, IQR 15–30). Monthly returned rings were classified as nonadherent if dapivirine release rate was ≤ 0.9 mg/month. Associations between acceptability measures and nonadherence were estimated using Poisson regression models with robust standard errors. At month 3 (N = 2334), 88% reported DVR was comfortable, 80% were unaware of it during daily activities, and 74% never felt it during sex. At exit, 66% were 'very likely' to use DVR in the future. Acceptability was found to differ significantly by country across several measures including wearing the ring during sex, during menses, partner acceptability, impact on sexual pleasure and willingness to use the ring in the future. Risk of nonadherence at month 12 was elevated if DVR was felt during sex at month 3 (aRR 1.67, 95% CI 1.26, 2.23). Risk of nonadherence in the last year of study participation was elevated if, at exit, participants minded wearing during sex (aRR 2.08, 95% CI 1.52, 2.85), during menses (aRR 1.57, 95% CI 1.06, 2.32), reported a problematic change to the vaginal environment (aRR 1.57, 95% CI 1.12, 2.21), and were not "very likely" to use DVR in the future (aRR 1.31, 95% CI 1.02, 1.68). DVR acceptability was overall high yet varied by country. Addressing perceived ring interference with sex, menses, or problematic changes to the vaginal environment in future interventions could help improve adherence, as could embracing sex-positive messaging related to ring use and increased pleasure. Trial Registration ClinicalTrials.gov Identifier: NCT01617096. [ABSTRACT FROM AUTHOR]
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- 2021
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127. The incidence of prenatal syphilis at the Boston City Hospital: a comparison across four decades
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Klass, Perri E., Brown, Elizabeth R., and Pelton, Stephen I.
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Syphilis, Congenital, hereditary, and infantile -- Demographic aspects ,Syphilis -- Demographic aspects ,Pregnant women -- Diseases - Abstract
The incidence of syphilis among women delivering babies at the Boston City Hospital appeared to increase from 1951 to 1991. Blood samples from 647 women admitted for delivery were tested for syphilis in 1991. These results were compared with those from 1,005 women tested after delivery in 1951. In the earlier study 2.4% of the women tested positive for syphilis either before or during pregnancy. In the 1991 study, 3.9% of the women tested positive for syphilis during pregnancy or delivery. In the 1991 study women who tested positive were more likely to be infected with other sexually transmitted diseases and more likely to use illicit drugs. No cases of congenital syphilis were diagnosed in either study., Objective. To examine the incidence and epidemiologic correlates of congenital syphilis at an inner-city Boston hospital, and draw comparisons with the situation at the same hospital 40 years ago. Design. Chart review and comparison with data collected in 1951. Setting. Maternity and pediatric services at Boston City Hospital. Methods. A study conducted in 1951 on the maternity service of Boston City Hospital in which demographic data were collected on all women admitted in labor over a 5-month period was replicated. Serologic testing for syphilis was carried out on these women, and the demographic and medical correlates of positive maternal syphilis serology were examined. This study was repeated exactly 40 years later, using the cord blood screening for syphilis done routinely at delivery and a review of prenatal records. Results. From a group made up largely of married white women in 1951, the study population shifted in 1991 to a group made up mostly of minority women, with 75% unmarried. In 1951, 24 patients were diagnosed with syphilis either before or during the pregnancy, giving a prevalence rate of 2.4%. In 1991, 25 of 647 women were diagnosed with syphilis, for a prevalence rate of 3.9%. The women with positive cord blood serologies had a higher rate of other sexually transmitted diseases and substance abuse. No symptomatic cases of congenital syphilis were seen in 1951 or in 1991, although at least 11 of the 26 infants born to mothers with positive serologies in 1991 received intravenous penicillin therapy. Conclusions. The continued prevalence of diagnosed syphilis in women at delivery reflects an inner-city epidemic of congenital syphilis that is tied to substance abuse, human immunodeficiency virus, and changing social patterns, as well to older problems of serologic screening, prenatal care, treatment failures, and maternal reinfection. It is essential that screening programs be maintained and improved in this high-risk population, and that infants born to mothers with positive serologies receive full and adequate treatment if there is any doubt at all about their infection status. Pediatrics 1994;94: 24-28; syphilis, congenital; serologic tests, prenatal screening, epidemiology, history.
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- 1994
128. A Community-Wide Infant Mortality Review: Findings and Implications
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McCloskey, Lois, Plough, Alonzo L., Power, Karen L., Higgins, Cathleen A., Cruz, Alba N., and Brown, Elizabeth R.
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- 1999
129. Periventricular-intraventricular hemorrhage sonographic localization, phenobarbital, and motor abnormalities in low birth weight infants
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Krishnamoorthy, Kalpathy S., Kuban, Karl C.K., Leviton, Alan, Brown, Elizabeth R., Sullivan, Kathleen F., and Allred, Elizabeth N.
- Subjects
Brain damage -- Causes of ,Ultrasound imaging -- Usage ,Hemorrhage -- Complications ,Birth weight, Low -- Complications ,Cerebrovascular disease -- Complications ,Phenobarbital -- Physiological aspects - Abstract
Low birth weight (LBW), less than 3.6 pounds (1,750 grams), is associated with a poor infant outcome. LBW infants are at risk for periventricular-intraventricular hemorrhage, bleeding in or around the small cavities of the brain. The more severe the hemorrhage, the greater the brain damage. Phenobarbital, an anticonvulsant, is often given to control seizures in infants experiencing severe periventricular-intraventricular hemorrhage. The relationship between the location of the hemorrhage and the neurological deficit sustained has not been well-studied. The neurological outcome of 228 low birth weight infants who initially required mechanical ventilation and phenobarbital therapy to prevent seizures was evaluated. The results of ultrasonographic imaging, the use of high frequency sound to visualize internal structures, were related to motor abnormalities experienced by the surviving infants 18 months later. There were 51 infants with confirmed hemorrhage. Periventricular-intraventricular hemorrhage was related to neurological abnormalities such as decreased grasp maturity, persistent closure of the fingers, decreased parachute reaction (both arms extended when the infant is turned face-down), delayed walking, spastic palsy and abnormal movements. There was an increased risk for a neurological abnormality regardless of the type and location of the hemorrhage. The deficits were similar with and without phenobarbital prophylaxis. The most common abnormalities were abnormal jerky movements, exaggerated flexing of ankle or knee, and poor muscle tone. Infants experiencing substantial enlargement of the brain's ventricles were five times more likely to develop spastic cerebral palsy and delayed walking. They were three times more likely to have poor resistance to stretch and hyperactive, exaggerated knee-ankle reflexes. There is an increased risk for motor and reflex abnormalities among infants who experienced periventricular-intraventricular hemorrhage, particularly those infants having damage to the white matter of the brain. (Consumer Summary produced by Reliance Medical Information, Inc.)
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- 1990
130. Imaging Findings in Transgender Patients after Gender-affirming Surgery
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Stowell, Justin T., primary, Grimstad, Frances W., additional, Kirkpatrick, Daniel L., additional, Brown, Elizabeth R., additional, Santucci, Richard A., additional, Crane, Curtis, additional, Patel, Amy K., additional, Phillips, Jordana, additional, Ferreira, Marina A., additional, Ferreira, Felipe R., additional, Ban, Aroldo H., additional, Baroni, Ronaldo H., additional, Wu, Carol C., additional, Swan, Kimberly A., additional, Scott, Stephanie A., additional, and Andresen, Kelli J., additional
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- 2019
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131. Crossover and Repeated Randomization in Event Driven Trials for HIV Prevention: Addressing the Impact of Heterogeneity in Risk in the Trial Design
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Domínguez Islas, Clara P., primary and Brown, Elizabeth R., additional
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- 2019
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132. A coarsened multinomial regression model for perinatal mother to child transmission of HIV
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Brown Elizabeth R and Gard Charlotte C
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Medicine (General) ,R5-920 - Abstract
Abstract Background In trials designed to estimate rates of perinatal mother to child transmission of HIV, HIV assays are scheduled at multiple points in time. Still, infection status for some infants at some time points may be unknown, particularly when interim analyses are conducted. Methods Logistic regression models are commonly used to estimate covariate-adjusted transmission rates, but their methods for handling missing data may be inadequate. Here we propose using coarsened multinomial regression models to estimate cumulative and conditional rates of HIV transmission. Through simulation, we compare the proposed models to standard logistic models in terms of bias, mean squared error, coverage probability, and power. We consider a range of treatment effect and visit process scenarios, while including imperfect sensitivity of the assay and contamination of the endpoint due to early breastfeeding transmission. We illustrate the approach through analysis of data from a clinical trial designed to prevent perinatal transmission. Results The proposed cumulative and conditional models performed well when compared to their logistic counterparts. Performance of the proposed cumulative model was particularly strong under scenarios where treatment was assumed to increase the risk of in utero transmission but decrease the risk of intrapartum and overall perinatal transmission and under scenarios designed to represent interim analyses. Power to estimate intrapartum and perinatal transmission was consistently higher for the proposed models. Conclusion Coarsened multinomial regression models are preferred to standard logistic models for estimation of perinatal mother to child transmission of HIV, particularly when assays are missing or occur off-schedule for some infants.
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- 2008
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133. Identification of risk factors for increased cost, charges, and length of stay for cardiac patients
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MaWhinney, Samantha, Brown, Elizabeth R, Malcolm, Janet, VillaNueva, Catherine, Groves, Bertron M, Quaife, Robert A, Lindenfeld, JoAnn, Warner, Bradley A, Hammermeister, Karl E, Grover, Frederick L, and Shroyer, A.Laurie W
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- 2000
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134. Use of the dapivirine vaginal ring and effect on cervical cytology abnormalities.
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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., Palanee-Phillips, Thesla, and Kiweewa, Flavia M
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- 2020
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135. Anal Intercourse, HIV-1 Risk, and Efficacy in a Trial of a Dapivirine Vaginal Ring for HIV-1 Prevention.
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Peebles, Kathryn, van der Straten, Ariane, Palanee-Phillips, Thesla, Reddy, Krishnaveni, Hillier, Sharon L., Hendrix, Craig W., Harkoo, Ishana, Mirembe, Brenda Gati, Jeenarain, Nitesha, Baeten, Jared M., and Brown, Elizabeth R.
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- 2020
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136. Ain't She a Woman? How Warmth and Competence Stereotypes about Women and Female Politicians Contribute to the Warmth and Competence Traits Ascribed to Individual Female Politicians
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Brown, Elizabeth R., primary, Phills, Curtis E., additional, Mercurio, Dominic G., additional, Olah, Matthew, additional, and Veilleux, Candice J., additional
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- 2018
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137. Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials
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Mhlanga, Felix G., primary, Noguchi, Lisa, additional, Balkus, Jennifer E., additional, Kabwigu, Samuel, additional, Scheckter, Rachel, additional, Piper, Jeanna, additional, Watts, Heather, additional, O’Rourke, Colin, additional, Torjesen, Kristine, additional, Brown, Elizabeth R., additional, Hillier, Sharon L., additional, and Beigi, Richard, additional
- Published
- 2017
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138. Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study
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Baeten, Jared M, Palanee-Phillips, Thesla, Mgodi, Nyaradzo M, Mayo, Ashley J, Szydlo, Daniel W, Ramjee, Gita, Gati Mirembe, Brenda, 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, 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, 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, and Zungu, Nompumelelo
- Abstract
Two 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.
- Published
- 2021
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139. Is the Lone Scientist an American Dream? Perceived Communal Opportunities in STEM Offer a Pathway to Closing U.S.–Asia Gaps in Interest and Positivity
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Brown, Elizabeth R., primary, Steinberg, Mia, additional, Lu, Yun, additional, and Diekman, Amanda B., additional
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- 2017
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140. Oral and injectable contraceptive use and HIV acquisition risk among women in 4 African countries: a secondary analysis of data from a microbicide trial
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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
Adult ,Zimbabwe ,Malawi ,Sterilization, Tubal ,Incidence ,Zambia ,HIV Infections ,Injections, Intramuscular ,Article ,Contraceptives, Oral, Hormonal ,Condoms ,South Africa ,Young Adult ,Risk Factors ,Delayed-Action Preparations ,Contraceptive Agents, Female ,Humans ,Prospective Studies ,Proportional Hazards Models - Abstract
To 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.This 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.The 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).In 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.Among 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.
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- 2015
141. Brief Report: Preventing HIV-1 Infection in Women Using Oral Preexposure Prophylaxis: A Meta-analysis of Current Evidence
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Hanscom, Brett, primary, Janes, Holly E., additional, Guarino, Peter D., additional, Huang, Ying, additional, Brown, Elizabeth R., additional, Chen, Ying Qing, additional, Hammer, Scott M., additional, Gilbert, Peter B., additional, and Donnell, Deborah J., additional
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- 2016
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142. Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women
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Baeten, Jared M., primary, Palanee-Phillips, Thesla, additional, Brown, Elizabeth R., additional, Schwartz, Katie, additional, Soto-Torres, Lydia E., additional, Govender, Vaneshree, additional, Mgodi, Nyaradzo M., additional, Matovu Kiweewa, Flavia, additional, Nair, Gonasagrie, additional, Mhlanga, Felix, additional, Siva, Samantha, additional, Bekker, Linda-Gail, additional, Jeenarain, Nitesha, additional, Gaffoor, Zakir, additional, Martinson, Francis, additional, Makanani, Bonus, additional, Pather, Arendevi, additional, Naidoo, Logashvari, additional, Husnik, Marla, additional, Richardson, Barbra A., additional, Parikh, Urvi M., additional, Mellors, John W., additional, Marzinke, Mark A., additional, Hendrix, Craig W., additional, van der Straten, Ariane, additional, Ramjee, Gita, additional, Chirenje, Zvavahera M., additional, Nakabiito, Clemensia, additional, Taha, Taha E., additional, Jones, Judith, additional, Mayo, Ashley, additional, Scheckter, Rachel, additional, Berthiaume, Jennifer, additional, Livant, Edward, additional, Jacobson, Cindy, additional, Ndase, Patrick, additional, White, Rhonda, additional, Patterson, Karen, additional, Germuga, Donna, additional, Galaska, Beth, additional, Bunge, Katherine, additional, Singh, Devika, additional, Szydlo, Daniel W., additional, Montgomery, Elizabeth T., additional, Mensch, Barbara S., additional, Torjesen, Kristine, additional, Grossman, Cynthia I., additional, Chakhtoura, Nahida, additional, Nel, Annalene, additional, Rosenberg, Zeda, additional, McGowan, Ian, additional, and Hillier, Sharon, additional
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- 2016
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143. Closing the Communal Gap: The Importance of Communal Affordances in Science Career Motivation
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Brown, Elizabeth R., Thoman, Dustin B., Smith, Jessi L., and Diekman, Amanda B.
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Article - Abstract
To remain competitive in the global economy, the United States (and other countries) is trying to broaden participation in science, technology, engineering, and mathematics (STEM) by graduating an additional 1 million people in STEM fields by 2018. Although communion (working with, helping, and caring for others) is a basic human need, STEM careers are often (mis)perceived as being uncommunal. Across three naturalistic studies we found greater support for the communal affordance hypothesis, that perceiving STEM careers as affording greater communion is associated with greater STEM career interest, than two alternative hypotheses derived from goal congruity theory. Importantly, these findings held regardless of major (Study 1), college enrollment (Study 2), and gender (Studies 1-3). For undergraduate research assistants, mid-semester beliefs that STEM affords communion predicted end of the semester STEM motivation (Study 3). Our data highlight the importance of educational and workplace motivational interventions targeting communal affordances beliefs about STEM.
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- 2015
144. Preventive Misconception and Risk Behaviors in a Multinational HIV Prevention Trial.
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Sugarman, Jeremy, Lin, Li, Baeten, Jared M., Palanee-Phillips, Thesla, Brown, Elizabeth R., Matovu Kiweewa, Flavia, Mgodi, Nyaradzo M., Nair, Gonasagrie, Siva, Samantha, Seils, Damon M., and Weinfurt, Kevin P.
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RISK-taking behavior ,HIV infections ,HIV prevention ,CONDOM use ,HUMAN research subjects - Abstract
Background: Some HIV prevention research participants may hold a "preventive misconception" (PM), an overestimate of the probability or level of personal protection afforded by trial participation. However, these reports typically rely upon small, retrospective qualitative assessments that did not use a standardized approach. Methods: We administered a measure of PM called PREMIS, during Microbicide Trials Network 020—A Study to Prevent Infection with a Ring for Extended Use, a large, multicenter, placebo-controlled, phase III trial evaluating the safety and efficacy of a dapivirine vaginal ring among women at risk for HIV infection in Malawi, South Africa, Uganda, and Zimbabwe. The maximum follow-up period was 2.6 years. Results: One thousand two hundred sixty-one respondents completed PREMIS at their month 3 visit (M3); 2085 at their month 12 visit (M12); and 1010 at both visits. Most participants expressed high expectations of personal benefit (EPB) and that at least one of the rings used in the trial would reduce the risk of getting HIV (expectation of maximum aggregate benefit or EMAB). There was a moderate positive correlation between EPB and EMAB at M3 (r =.43, 95% CI:.37,.47) and M12 (r =.44, 95% CI:.40,.48). However, there was variability among sites in the strength of the relationship. There was no relationship between either expectation variable and condom use, adherence, or HIV infection. Conclusions: A majority of trial participants expressed some belief that their risk of HIV infection would be reduced by using a vaginal ring, which may signal PM. However, such beliefs were not associated with adherence, condom use, or subsequent HIV infection, and there was variability across sites. Further work is needed to understand these findings. [ABSTRACT FROM AUTHOR]
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- 2019
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145. Patterns of Oral PrEP Adherence and HIV Risk Among Eastern African Women in HIV Serodiscordant Partnerships.
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for the Partners Demonstration Project Team, Pyra, Maria, Heffron, Renee, Celum, Connie, Baeten, Jared M., Asiimwe, Stephen, Katabira, Elly, Bukusi, Elizabeth A., Mugo, Nelly R., Brown, Elizabeth R., and Haberer, Jessica E.
- Subjects
HIV infection risk factors ,DRUG monitoring ,DRUGS ,PREVENTIVE medicine ,ORAL drug administration ,PATIENT compliance ,RISK-taking behavior ,WOMEN'S health ,HUMAN services programs ,HIV seroconversion ,HIV seronegativity - Abstract
Understanding how women use PrEP is important for developing successful implementation programs. We hypothesized there are distinct patterns of adherence, related to HIV risk and other factors. We identified patterns of PrEP adherence and HIV risk behavior over the first 6 months of PrEP use, using data from 233 HIV-uninfected women in high-risk serodiscordant couples in a demonstration project in Kenya & Uganda. We modeled PrEP adherence, assessed by daily electronic monitoring, and HIV risk behavior using group-based trajectory models. We tested baseline covariates and risk behavior group as predictors of adherence patterns. There were four distinct adherence patterns: high steady adherence (55% of population), moderate steady (29%), late declining (8%), and early declining (9%). No baseline characteristics significantly differed between adherence patterns. Adherence patterns differed in average weekly doses (6.7 vs 5.4 vs 4.1 vs 1.5, respectively). Two risk behavior groups were identified: steady HIV risk (78% of population) and declining (22%). Compared to women with declining HIV risk behavior, women with steady risk behavior were more likely to have high steady adherence (61% vs 35%) and less likely to have early (6% vs 17%) or late (4% vs 19%) declining adherence. Women’s use of PrEP was associated with concurrent HIV risk behavior; higher risk was associated with higher, sustained adherence. [ABSTRACT FROM AUTHOR]
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- 2018
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146. Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women.
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Baeten, Jared M, 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, Hillier, Sharon, MTN-020–ASPIRE Study Team, Baeten, Jared M, 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, Hillier, Sharon, and MTN-020–ASPIRE Study Team
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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<0.001) but not among those 21 years of age or younger (-27%; 95% CI, -133 to 31; P=0.45), a difference that was correlated with reduced adherence. The rates of adverse medical events and antiretroviral resistance among women who acquired HIV-1 infection were similar in the two groups.ConclusionsA monthly vaginal ring containing dapivirine reduced the risk of HIV-1 infection among African women, with increased efficacy in subgroups with evidence of increased adherence. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01617096 .).
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- 2016
147. 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
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Balkus, Jennifer E, Balkus, Jennifer E, Brown, Elizabeth R, Hillier, Sharon L, Coletti, Anne, Ramjee, Gita, Mgodi, Nyaradzo, Makanani, Bonus, Reid, Cheri, Martinson, Francis, Soto-Torres, Lydia, Abdool Karim, Salim S, Chirenje, Zvavahera M, Balkus, Jennifer E, Balkus, Jennifer E, Brown, Elizabeth R, Hillier, Sharon L, Coletti, Anne, Ramjee, Gita, Mgodi, Nyaradzo, Makanani, Bonus, Reid, Cheri, Martinson, Francis, Soto-Torres, Lydia, Abdool Karim, Salim S, and Chirenje, Zvavahera M
- 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
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- 2016
148. Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Nonuse Increase at the Termination Visit?
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Mensch, Barbara S, Mensch, Barbara S, Brown, Elizabeth R, Liu, Karen, Marrazzo, Jeanne, Chirenje, Zvavahera Mike, Gomez, Kailazarid, Piper, Jeanna, Patterson, Karen, van der Straten, Ariane, Mensch, Barbara S, Mensch, Barbara S, Brown, Elizabeth R, Liu, Karen, Marrazzo, Jeanne, Chirenje, Zvavahera Mike, Gomez, Kailazarid, Piper, Jeanna, Patterson, Karen, and van der Straten, Ariane
- 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.
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- 2016
149. Concordance between SARS-CoV-2 index individuals and their household contacts on index individual COVID-19 transmission cofactors: a comparison of self-reported and contact-reported information.
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Dahl, Angela M., Brown, Clare E., Brown, Elizabeth R., O'Brien, Meagan P., and Barnabas, Ruanne V.
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SARS-CoV-2 , *COVID-19 treatment , *COVID-19 , *PSYCHOLOGY of the sick , *MEMORY bias - Abstract
Background: Following the outbreak of the COVID-19 pandemic, several clinical trials have evaluated postexposure prophylaxis (PEP) among close contacts of an index individual with a confirmed SARS-CoV-2 infection. Because index individuals do not directly inform the efficacy of prevention interventions, they are seldom enrolled in COVID-19 PEP studies. However, adjusting for prognostic covariates such as an index individual's COVID-19 illness and risk behaviors can increase precision in PEP efficacy estimates, so approaches to accurately collecting this information about the index individual are needed. This analysis aimed to assess whether surveying household contacts captures the same information as surveying the index individual directly. Methods: REGN 2069/CoVPN 3502, a randomized controlled trial of COVID-19 PEP, enrolled household contacts of SARS-CoV-2 index individuals. CoVPN 3502-01 retrospectively enrolled and surveyed the index individuals. We compared responses to seven similar questions about the index individuals' transmission cofactors that were asked in both studies. We estimated the percent concordance between index individuals and their household contacts on each question, with 50% concordance considered equivalent to random chance. Results: Concordance between index individuals and contacts was high on the most objective questions, approximately 97% (95% CI: 90–99%) for index individual age group and 96% (88–98%) for hospitalization. Concordance was moderate for symptoms, approximately 85% (75–91%). Concordance on questions related to the index individual's behavior was only slightly better or no better than random: approximately 62% (51–72%) for whether they received COVID-19 treatment, 68% (57–77%) for sharing a bedroom, 70% (59–79%) for sharing a common room, and 49% (39–60%) for mask wearing at home. However, while contacts were surveyed within 96 h of the index individual testing positive for SARS-CoV-2, the median time to enrollment in CoVPN 3502-01 was 240 days, which may have caused recall bias in our results. Conclusions: Our results suggest a need to survey index individuals directly in order to accurately capture their transmission cofactors, rather than relying on their household contacts to report on their behavior. The lag in enrolling participants into CoVPN 3502-01 also highlights the importance of timely enrollment to minimize recall bias. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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150. Corrigendum to “oral and injectable contraceptive use and HIV acquisition risk among women in four African countries: a secondary analysis of data from a microbicide trial” [Contraception 2016; 93 (1): 25–31]
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Balkus, Jennifer E., primary, Brown, Elizabeth R., additional, Hillier, Sharon L., additional, Coletti, Anne, additional, Ramjee, Gita, additional, Mgodi, Nyaradzo, additional, Makanani, Bonus, additional, Reid, Cheri, additional, Martinson, Francis, additional, Soto-Torres, Lydia, additional, Abdool Karim, Salim S., additional, and Chirenje, Zvavahera M., additional
- Published
- 2016
- Full Text
- View/download PDF
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