Medicine and Health Sciences Commons^™

Safety, Tolerability, And Pharmacokinetics Of Long-Acting Injectable Cabotegravir In Low-Risk Hiv-Uninfected Individuals: Hptn 077, A Phase 2a Randomized Controlled Trial., Raphael J Landovitz, Sue Li, Beatriz Grinsztejn, Halima Dawood, Albert Y Liu, Manya Magnus, Mina C Hosseinipour, Ravindre Panchia, Leslie Cottle, Gordon Chau, Paul Richardson, Mark A Marzinke, Craig W Hendrix, Susan H Eshleman, Yinfeng Zhang, Elizabeth Tolley, Jeremy Sugarman, Ryan Kofron, Adeola Adeyeye, David Burns, Alex R Rinehart, David Margolis, William R Spreen, Myron S Cohen, Marybeth Mccauley, Joseph J Eron

Epidemiology Faculty Publications

BACKGROUND: Cabotegravir (CAB) is a novel strand-transfer integrase inhibitor being developed for HIV treatment and prevention. CAB is formulated both as an immediate-release oral tablet for daily administration and as a long-acting injectable suspension (long-acting CAB [CAB LA]) for intramuscular (IM) administration, which delivers prolonged plasma exposure to the drug after IM injection. HIV Prevention Trials Network study 077 (HPTN 077) evaluated the safety, tolerability, and pharmacokinetics of CAB LA in HIV-uninfected males and females at 8 sites in Brazil, Malawi, South Africa, and the United States.

METHODS AND FINDINGS: HPTN 077 was a double-blind, placebo-controlled phase 2a trial. Healthy …

Conventional Early Infant Diagnosis In Lesotho From Specimen Collection To Results Usage To Manage Patients: Where Are The Bottlenecks?, Appolinaire Tiam, Michelle M Gill, Heather J Hoffman, Anthony Isavwa, Mafusi Mokone, Matokelo Foso, Jeffrey T Safrit, Lynne M Mofenson, Thorkild Tylleskär, Laura Guay

Epidemiology Faculty Publications

INTRODUCTION: Early infant diagnosis is an important step in identifying children infected with HIV during the perinatal period or in utero. Multiple factors contribute to delayed antiretroviral treatment initiation for HIV-infected children, including delays in the early infant HIV diagnosis cascade.

METHODS: We conducted a retrospective study to evaluate early infant diagnosis turnaround times in Lesotho. Trained staff reviewed records of HIV-exposed infants (aged-6-8 weeks) who received an HIV test during 2011. Study sites were drawn from Highlands, Foothills and Lowlands regions of Lesotho. Central laboratory database data were linked to facility and laboratory register information. Turnaround time geometric means …

Depressive And Anxiety Symptoms Predict Sustained Quality Of Life Deficits In Hiv-Positive Ugandan Adults Despite Antiretroviral Therapy: A Prospective Cohort Study., Amara E. Ezeamama, Makhabele N. Woolfork, David Guwatudde, Danstan Bagenda, Yukari C. Manabe, Wafaie W. Fawzi, Mary C. Smith Fawzi

Journal Articles: Epidemiology

The impact of psychosocial status at onset of antiretroviral therapy on changes in quality of life (QOL) and subjectively rated health (SRH) among adults on highly active antiretroviral therapy (HAART) in resource-limited settings is poorly understood. Therefore, we evaluate the association between stigma, anxiety, depression, and social support and change in QOL and SRH in HIV-infected Ugandan adults during an 18-month period.Psychosocial indicators were assessed at enrollment using structured questionnaires. QOL and SRH measures were assessed at months 0, 6, 12, and 18 using the Medical Outcomes Survey-HIV. Linear mixed models determined risk estimated differences in QOL and SRH in …

The Effect Of Standard Dose Multivitamin Supplementation On Disease Progression In Hiv-Infected Adults Initiating Haart: A Randomized Double Blind Placebo-Controlled Trial In Uganda., David Guwatudde, Molin Wang, Amara E. Ezeamama, Danstan Bagenda, Rachel Kyeyune, Henry Wamani, Yukari C. Manabe, Wafaie W. Fawzi

Journal Articles: Epidemiology

BACKGROUND: Efficacy trials investigating the effect of multivitamin (MV) supplementations among patients on Highly Active Antiretroviral Therapy (HAART) have so far been inconclusive. We conducted a randomized, double blind, placebo controlled trial to determine the effect of one recommended daily allowance (RDA) of MV supplementation on disease progression in patients initiating HAART.

METHODS: Eligible subjects were randomized to receive placebo or MV supplementation including vitamins B-complex, C and E. Participants were followed for up to 18 months. Primary endpoints were: change in CD4 cell count, weight and quality of life (QoL). Secondary endpoints were: i) development of a new or …

Striving For Cultural Competence In An Hiv Program: The Transformative Impact Of A Microsystem In A Larger Health Network, Judith N Sabino, Timothy Friel, Lynn Deitrick, Debbie Salas-Lopez

Debbie Salas-Lopez MD, MPH

No abstract provided.

University Students And The Risk Of Hiv And Other Sexually Transmitted Infections In Uganda: The Crane Survey., George W. Rutherford, Andrew Anglemyer, Danstan Bagenda, Michael Muyonga, Christina P. Lindan, Joseph L. Barker, Lisa Johnston, Wolfgang Hladik

Journal Articles: Epidemiology

Adolescents and young adults are at high risk of human immunodeficiency virus (HIV) infection in sub-Saharan Africa. Previous reports have found that university students in Africa comprise a sexually active population, although the prevalence of HIV or sexually transmitted infections (STI) has not been measured. We conducted a cross-sectional survey of students from five large universities in Kampala, Uganda, using respondent-driven sampling. We asked students to complete behavioral questionnaires and provide biological samples to test for HIV, Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum, Trichomonas vaginalis, and bacterial vaginosis. We enrolled 649 students and obtained interpretable data from 640. Around 50% …

Hiv Testing Implementation In Two Urban Cities: Practice, Policy, And Perceived Barriers., Camden J Hallmark, Jennifer Skillicorn, Thomas P Giordano, Jessica A Davila, Marlene Mcneese, Nestor Rocha, Avemaria Smith, Stacey Cooper, Amanda D. Castel

Epidemiology Faculty Publications

BACKGROUND: Although funding has supported the scale up of routine, opt-out HIV testing in the US, variance in implementation mechanisms and barriers in high-burden jurisdictions remains unknown.

METHODS: We conducted a survey of health care organizations in Washington, DC and Houston/Harris County to determine number of HIV tests completed in 2011, policy and practices associated with HIV testing, funding mechanisms, and reported barriers to testing in each jurisdiction and to compare results between jurisdictions.

RESULTS: In 2012, 43 Houston and 35 DC HIV-testing organizations participated in the survey. Participants represented 85% of Department of Health-supported testers in DC and 90% …

Medication Use And Patients Co-Infected With Human Immunodeficiency Virus And Hepatitis C Virus : Quantifying The Prevalence And Identifying The Predictors Of Clinically Significant Drug-Drug Interactions Associated With Therapy Containing First Generation Non-Structural 3a Serine Protease Inhibitors, Nimish Patel

Legacy Theses & Dissertations (2009 - 2024)

This dissertation enhances our understanding of clinically significant drug-drug interactions (CSDDIs) and contraindicated drug interactions among patients with human immunodeficiency virus (HIV) and hepatitis C virus (HCV) coinfection before and after the addition of HCV therapy including first generation non-structural (NS) 3A serine protease inhibitors. This is important to understand because the clinical sequelae of untreated chronic HCV infection are devastating yet drug-drug interactions greatly complicate treatment for these patients. The HIV/HCV coinfected population is a population that is particularly vulnerable because they are using a high volume of medications. Specifically, the standard of care for patients with HIV infection …

Men At Risk; A Qualitative Study On Hiv Risk, Gender Identity And Violence Among Men Who Have Sex With Men Who Report High Risk Behavior In Kampala, Uganda., Rachel King, Joseph Barker, Sylvia Nakayiwa, David Katuntu, George Lubwama, Danstan Bagenda, Tim Lane, Alex Opio, Wolfgang Hladik

Journal Articles: Epidemiology

In Uganda, men who have sex with men (MSM) are at high risk for HIV. Between May 2008 and February 2009 in Kampala, Uganda, we used respondent driven sampling (RDS) to recruit 295 MSM≥18 years who reported having had sex with another man in the preceding three months. The parent study conducted HIV and STI testing and collected demographic and HIV-related behavioral data through audio computer-assisted self-administered interviews. We conducted a nested qualitative sub-study with 16 men purposively sampled from among the survey participants based on responses to behavioral variables indicating higher risk for HIV infection. Sub-study participants were interviewed …

Molecular Epidemiology Of Early And Acute Hiv Type 1 Infections In The United States Navy And Marine Corps, 2005–2010, Richard A. Heipertz, Eric Sanders-Buell, Gustavo Kijak, Shana Howell, Michelle Lazzaro, Linda L. Jagodzinski, John Eggleston, Sheila Peel, Jennifer Malia, Adam Armstrong, Nelson L. Michael, Jerome H. Kim, Robert J. O'Connell, Paul T. Scott, David Brett-Major, Sodsai Tovanabutra

Journal Articles: Epidemiology

The U.S. military represents a unique population within the human immunodeficiency virus 1 (HIV-1) pandemic. The last comprehensive study of HIV-1 in members of the U.S. Navy and Marine Corps (Sea Services) was completed in 2000, before large-scale combat operations were taking place. Here, we present molecular characterization of HIV-1 from 40 Sea Services personnel who were identified during their seroconversion window and initially classified as HIV-1 negative during screening. Protease/reverse transcriptase (pro/rt) and envelope (env) sequences were obtained from each member of the cohort. Phylogenetic analyses were carried out on these regions to determine relatedness within the cohort and …

Multivitamin Supplementation In Hiv Infected Adults Initiating Antiretroviral Therapy In Uganda: The Protocol For A Randomized Double Blinded Placebo Controlled Efficacy Trial., David Guwatudde, Amara E. Ezeamama, Danstan Bagenda, Rachel Kyeyune, Fred Wabwire-Mangen, Henry Wamani, Ferdinand Mugusi, Donna Spiegelman, Molin Wang, Yukari C. Manabe, Wafaie W. Fawzi

Journal Articles: Epidemiology

BACKGROUND: Use of multivitamin supplements during the pre-HAART era has been found to reduce viral load, enhance immune response, and generally improve clinical outcomes among HIV-infected adults. However, immune reconstitution is incomplete and significant mortality and opportunistic infections occur in spite of HAART. There is insufficient research information on whether multivitamin supplementation may be beneficial as adjunct therapy for HIV-infected individuals taking HAART. We propose to evaluate the efficacy of a single recommended daily allowance (RDA) of micronutrients (including vitamins B-complex, C, and E) in slowing disease progression among HIV-infected adults receiving HAART in Uganda.

METHODS/DESIGN: We are using a …

Epidemiology Of Contemporary Seroincident Hiv Infection In The Navy And Marine Corps, David Brett-Major, Shilpa Hakre, Neal A. Naito, Adam Armstrong, Eric A. Bower, Nelson L. Michael, Paul T. Scott

Journal Articles: Epidemiology

Human Immunodeficiency Virus (HIV) infection continues at a steady rate among U.S. Sailors and Marines. This study provides the first service-specific description of HIV infection demographics. All Sailors and Marines identified as HIV infected between January 2005 and August 2010 were included. The project compared personnel and epidemiologic data, and tested reposed sera in the Department of Defense Serum Repository. This group comprised 410 Sailors and 86 Marines, predominantly men. HIV infected Marines were more likely to be foreign born than their Navy counterparts, 42% versus 10%, p < 0.001. Approximately half of the patients had deployed including to the wars in Iraq or Afghanistan. Nearly half of each group was infected by the age of 25. Similar to the U.S. epidemic, Black race was over-represented. Unlike national rates, Hispanic Sailors and Marines were not over-represented. Demographics were distinct for those of specific occupational specialties. Certain ship classes carried lower incidences. Clustering of HIV infection risk occurred around deployment. The Navy and Marine Corps have different patterns of HIV infection, which may merit distinct approaches to prevention. The Navy may have unique targets for prevention efforts to include pipeline training and first assignment as well as particular occupational environments.

A Pilot Online Survey Assessing Risk Factors For Hiv Acquisition In The Navy And Marine Corps, 2005-2010, Shilpa Hakre, Adam W. Armstrong, Robert J. O'Connell, Nelson L. Michael, Paul T. Scott, David Brett-Major

Journal Articles: Epidemiology

The Department of Defense policy Don't Ask, Don't Tell (DADT) ended in September, 2011. The Navy Bloodborne Infection Management Center conducted a post-DADT pilot survey of HIV seroconverters identified when the DADT policy was in effect. Sailors and Marines newly diagnosed as HIV positive from 2005 to 2010 were invited to participate in an online survey. A structured questionnaire elicited risk information about the 3-year period before HIV diagnosis. Respondents reported engaging commonly in same sex sexual activity, having concurrent partners, and poor condom use for anal sex. In this first post-DADT repeal report of self-reported behaviors, male-to-male sexual contact …

Medical Encounter Characteristics Of Hiv Seroconverters In The Us Army And Air Force, 2000–2004, Shilpa Hakre, David Brett-Major, Darrell E. Singer, Robert J. O'Connell, Warren B. Sateren, Jose L. Sanchez, Brian K. Agan, Nelson L. Michael, Paul T. Scott

Journal Articles: Epidemiology

BACKGROUND AND METHODS: Active duty US Army and Air Force military personnel undergo mandatory biennial HIV antibody screening. We compared pre- and post-HIV seroconversion health status by conducting a case-control study, which evaluated all medical encounters and sociodemographic factors among incident HIV seroconverters and HIV-negative controls from June 2000 through February 2004.

RESULTS: A total of 274 HIV seroconverters and 6205 HIV-negative personnel were included. In multivariate analysis restricted to male personnel (cases = 261, controls = 5801), single marital status (adjusted odds ratio [AOR] = 14.37), clinical indicators or symptoms within four years of HIV diagnosis (AOR = 6.22), …

Distribution Of Health Care Expenditures For Hiv-Infected Patients, Ray Y. Chen, Neil A. Accortt, Andrew O. Westfall, Michael J. Mugavero, James L. Raper, Gretchen A. Cloud, Beth K. Stone, Jerome Carter, Stephanie Call, Maria Pisu, Jeroan J. Allison, Michael S. Saag

Jeroan J. Allison

BACKGROUND: Health care expenditures for persons infected with human immunodeficiency virus (HIV) in the United State determined on the basis of actual health care use have not been reported in the era of highly active antiretroviral therapy.

METHODS: Patients receiving primary care at the University of Alabama at Birmingham HIV clinic were included in the study. All encounters (except emergency room visits) that occurred within the University of Alabama at Birmingham Hospital System from 1 March 2000 to 1 March 2001 were analyzed. Medication expenditures were determined on the basis of 2001 average wholesale price. Hospitalization expenditures were determined on …

Trends In Aids-Defining And Non-Aids-Defining Malignancies Among Hiv-Infected Patients: 1989-2002, Roger Bedimo, Ray Y. Chen, Neil A. Accortt, James L. Raper, Carol Linn, Jeroan J. Allison, John Dubay, Michael S. Saag, Craig J. Hoesley

Jeroan J. Allison

In a comparison of rates of acquired immunodeficiency syndrome (AIDS)-defining malignancies (ADMs) for 1989-1996 versus 1997-2002, we found a decrease in ADMs (rate ratio, 0.31; P<.0001) and a significant increase in non-AIDS-defining malignancies (non-ADMs; rate ratio, 10.87; P<.0002). The mean CD4 cell count was lower among patients with ADMs than among those with non-ADMs. A longer duration of survival during highly active antiretroviral therapy might explain the increasing incidence of non-ADMs.

Growth, Immune And Viral Responses In Hiv Infected African Children Receiving Highly Active Antiretroviral Therapy: A Prospective Cohort Study., Philippa M. Musoke, Peter Mudiope, Linda N. Barlow-Mosha, Patrick Ajuna, Danstan Bagenda, Michael M. Mubiru, Thorkild Tylleskar, Mary G. Fowler

Journal Articles: Epidemiology

BACKGROUND: Scale up of paediatric antiretroviral therapy in resource limited settings continues despite limited access to routine laboratory monitoring. We documented the weight and height responses in HIV infected Ugandan children on highly active antiretroviral therapy and determined clinical factors associated with successful treatment outcomes.

METHODS: A prospective cohort of HIV infected children were initiated on HAART and followed for 48 weeks. Body mass index for age z scores(BAZ), weight and height-for-age z scores (WAZ & HAZ) were calculated: CD4 cell % and HIV-1 RNA were measured at baseline and every 12 weeks. Treatment outcomes were classified according to; both …

Associations Between Water-Treatment Methods And Diarrhoea In Hiv-Positive Individuals, J. N. S. Eisenberg, T. J. Wade, A. Hubbard, D. I. Abrams, R. J. Leiser, S. Charles, M. Vu, S. Saha, C. C. Wright, Deborah A. Levy, P. Jensen, J. M. Colford

Journal Articles: Epidemiology

This manuscript extends our previously published work (based on data from one clinic) on the association between three drinking water-treatment modalities (boiling, filtering, and bottling) and diarrhoeal disease in HIV-positive persons by incorporating data from two additional clinics collected in the following year. We conducted a cross-sectional survey of drinking water patterns, medication usage, and episodes of diarrhoea among HIV-positive persons attending clinics associated with the San Francisco Community Consortium. We present combined results from our previously published work in one clinic (n = 226) with data from these two additional clinics (n = 458). In this combined analysis we …

Risk Factors In Hiv-Associated Diarrhoeal Disease: The Role Of Drinking Water, Medication And Immune Status, J. N. S. Eisenberg, T. J. Wade, S. Charles, M. Vu, A. Hubbard, C. C. Wright, Deborah A. Levy, P. Jensen, J. M. Colford

Journal Articles: Epidemiology

In a cross-sectional survey of 226 HIV-infected men, we examined the occurrence of diarrhoea and its relationship to drinking water consumption patterns, risk behaviours, immune status and medication use. Diarrhoea was reported by 47% of the respondents. Neither drinking boiled nor filtered water was significantly associated with diarrhoea (OR = 0.5 [0.2, 1.6], 1.2 [0.6, 2.5] respectively), whereas those that drank bottled water were at risk for diarrhoea (OR = 3.0 [1.1, 7.8]). Overall, 47% always or often used at least one water treatment. Of the 37% who were very concerned about drinking water, 62% had diarrhoea, 70% always or …

Sulfa Or Sulfone Prophylaxis And Geographic Region Predict Mutations In The Pneumocystis Carinii Dihydropteroate Synthase Gene, Laurence Huang, Charles B. Beard, Jennifer Creasman, Deborah A. Levy, Jeffrey S. Duchin, Sherline Lee, Norman Pieniazek, Jane L. Carter, Carlos Del Rio, David Rimland, Thomas R. Navin

Journal Articles: Epidemiology

To determine factors associated with mutations in the Pneumocystis carinii dihydropteroate synthase (DHPS) gene, a prospective study of human immunodeficiency virus (HIV)-infected patients with confirmed P. carinii pneumonia was conducted in Atlanta, Seattle, and San Francisco. Clinical information was obtained from patient interview and chart abstraction. DHPS genotype was determined from DNA sequencing. Overall, 76 (68.5%) of 111 patients had a mutant DHPS genotype, including 22 (81.5%) of 27 patients from San Francisco. In multivariate analysis, sulfa or sulfone prophylaxis and study site were independent predictors of a mutant genotype. Fourteen (53.8%) of 26 patients who were newly diagnosed with …