Results from a PrEP Demonstration Project for At-Risk Cisgender Women in the United States

Author(s):  
Jill Blumenthal ◽  
Sonia Jain ◽  
Feng He ◽  
K Rivet Amico ◽  
Ryan Kofron ◽  
...  

Abstract Background Daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is effective for reducing HIV acquisition among cisgender women. We report results from the first United States observational open-label demonstration project of PrEP among at-risk cisgender women. Methods Adherence Enhancement Guided by Individualized Texting and Drug Levels (AEGiS) was a 48-week single-arm open-label demonstration study of daily oral TDF/FTC in cisgender women ≥18 years old at-risk for HIV. Adherence was supported using two-way text messaging and titrated adherence counseling based on rapid-turnaround tenofovir diphosphate concentrations from dried blood spots. Study visits occurred at baseline, and at weeks 4, 12, and quarterly through week 48. Outcomes included TDF/FTC adherence, retention and persistence. Results From June 2016 to October 2018, 136 cisgender women enrolled [mean age 40 (SD 11); 38% non-Hispanic (NH) Black and 19% Latina]. At 48 weeks, 84 (62%) participants were retained and 62 (46%) remained on PrEP. Over one-third (12/31) of those on study but off PrEP throughout study discontinued TDF/FTC due to side effects, and one adverse event led to study discontinuation. Of 120 participants with drug concentrations measured, 67 (56%) had at least one concentration consistent with ≥6 doses/week (d/w); 22 (18%) had consistent ≥6 d/w across all study visits attended. There were no incident HIV infections and 4 incident bacterial STIs. Conclusion Adequate PrEP adherence for protective drug concentrations was not achieved for most study participants. More work needs to be done to fully explicate the reasons for non-adherence and low retention in cisgender women.

2018 ◽  
Author(s):  
Lisa Hightow-Weidman ◽  
Kathryn Muessig ◽  
Eli Rosenberg ◽  
Travis Sanchez ◽  
Sara LeGrand ◽  
...  

BACKGROUND Over a fifth of all new HIV infections in the United States occur among persons aged 13 24 years, with most of these diagnoses occurring among gay and bisexual males (81%). While the epidemic of HIV in the United States has leveled off for many age groups, the annual number of new HIV diagnoses among young men who have sex with men (YMSM; 13-24 years old) remains high. Traditional approaches to continuum improvement for youth have been insufficient, and targeted interventions are urgently needed for young people at risk for or infected with HIV. Interventions delivered through mHealth technology represent a promising approach for improving outcomes in this population. Mobile phones have nearly reached saturation among youth, making mobile technology a particularly promising tool for reaching this population. OBJECTIVE The University of North Carolina/Emory Center for Innovative Technology (iTech) is a National Institutes of Health cooperative agreement as part of the Adolescent Medicine Trials Network for HIV/AIDS Interventions. iTech aims to impact the HIV epidemic by conducting innovative, interdisciplinary research on technology-based interventions across the HIV prevention and care continuum for adolescents and young adults in the United States, particularly YMSM, by providing the following: (1) Evaluation of novel approaches to identifying youth with undiagnosed HIV infections; (2) evaluation of multilevel, combination prevention approaches, particularly relevant to gender- and sexual-minority youth facing co-occurring health risks; (3) evaluation of uptake of and adherence to biomedical prevention modalities; and 4) evaluation of interventions designed to promote or optimize engagement in care and antiretroviral therapy adherence in HIV-positive youth, to optimize viral load suppression. METHODS iTech brings together multidisciplinary experts in the fields of adolescent HIV treatment and prevention, development and evaluation of technology-based interventions, HIV surveillance and epidemiology, and intervention design and evaluation. This initiative will support 8 efficacy trials and 2 exploratory projects, each led by 2 principal investigators. Taken together, the studies address all of the key steps of the HIV prevention and care continuum for youth in the United States. Each proposal uses technology in a scientifically rigorous and innovative way to access, engage, and impact at-risk or infected youth. Nine iTech subject recruitment venues are spread across 8 US cities. Three cores (management, analytic, and technology) support all iTech activities and form the research network’s infrastructure, facilitating all aspects of study implementation and evaluation. RESULTS Formative work has already begun on many of the above-mentioned iTech trials. We expect the first randomized controlled trials to begin in mid-2018. Additional details can be found in the individual intervention protocol papers in this issue. CONCLUSIONS Through its comprehensive research portfolio, iTech aims to effectively advance HIV prevention and care for youth through technology-based, youth-relevant interventions that maximize adaptability and sustainability.


2000 ◽  
Vol 181 (2) ◽  
pp. 463-469 ◽  
Author(s):  
Patrick S. Sullivan ◽  
Ann N. Do ◽  
Dennis Ellenberger ◽  
Chou‐Pong Pau ◽  
Sindy Paul ◽  
...  

10.2196/10365 ◽  
2018 ◽  
Vol 7 (8) ◽  
pp. e10365 ◽  
Author(s):  
Lisa B Hightow-Weidman ◽  
Kathryn Muessig ◽  
Eli Rosenberg ◽  
Travis Sanchez ◽  
Sara LeGrand ◽  
...  

BackgroundOver a fifth of all new HIV infections in the United States occur among persons aged 13 24 years, with most of these diagnoses occurring among gay and bisexual males (81%). While the epidemic of HIV in the United States has leveled off for many age groups, the annual number of new HIV diagnoses among young men who have sex with men (YMSM; 13-24 years old) remains high. Traditional approaches to continuum improvement for youth have been insufficient, and targeted interventions are urgently needed for young people at risk for or infected with HIV. Interventions delivered through mobile health technology represent a promising approach for improving outcomes in this population. Mobile phones have nearly reached saturation among youth, making mobile technology a particularly promising tool for reaching this population.ObjectiveThe University of North Carolina/Emory Center for Innovative Technology (iTech) is a National Institutes of Health cooperative agreement as part of the Adolescent Medicine Trials Network for HIV/AIDS Interventions. iTech aims to impact the HIV epidemic by conducting innovative, interdisciplinary research on technology-based interventions across the HIV prevention and care continuum for adolescents and young adults in the United States, particularly YMSM, by providing the following: (1) evaluation of novel approaches to identifying youth with undiagnosed HIV infections; (2) evaluation of multilevel, combination prevention approaches, particularly relevant to gender- and sexual-minority youth facing co-occurring health risks; (3) evaluation of uptake of and adherence to biomedical prevention modalities; and 4) evaluation of interventions designed to promote or optimize engagement in care and antiretroviral therapy adherence in HIV-positive youth, to optimize viral load suppression.MethodsiTech brings together multidisciplinary experts in the fields of adolescent HIV treatment and prevention, development and evaluation of technology-based interventions, HIV surveillance and epidemiology, and intervention design and evaluation. This initiative will support 8 efficacy trials and 2 exploratory projects, each led by 2 principal investigators. Taken together, the studies address all of the key steps of the HIV prevention and care continuum for youth in the United States. Each proposal uses technology in a scientifically rigorous and innovative way to access, engage, and impact at-risk or infected youth. Nine iTech subject recruitment venues are spread across 8 US cities. Three cores (management, analytic, and technology) support all iTech activities and form the research network’s infrastructure, facilitating all aspects of study implementation and evaluation.ResultsFormative work has already begun on many of the above-mentioned iTech trials. We expect the first randomized controlled trials to begin in mid-2018. Additional details can be found in the individual intervention protocol papers in this issue.ConclusionsThrough its comprehensive research portfolio, iTech aims to effectively advance HIV prevention and care for youth through technology-based, youth-relevant interventions that maximize adaptability and sustainability.Registered Report IdentifierRR1-10.2196/10365


2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 772-773
Author(s):  
Rose Ann DiMaria-Ghalili ◽  
Connie Bales ◽  
Julie Locher

Abstract Food insecurity is an under-recognized geriatric syndrome that has extensive implications in the overall health and well-being of older adults. Understanding the impact of food insecurity in older adults is a first step in identifying at-risk populations and provides a framework for potential interventions in both hospital and community-based settings. This symposium will provide an overview of current prevalence rates of food insecurity using large population-based datasets. We will present a summary indicator that expands measurement to include the functional and social support limitations (e.g., community disability, social isolation, frailty, and being homebound), which disproportionately impact older adults, and in turn their rate and experience of food insecurity and inadequate food access. We will illustrate using an example of at-risk seniors the association between sarcopenia, the age-related loss of muscle mass and function, with rates of food security in the United States. The translational aspect of the symposium will then focus on identification of psychosocial and environmental risk factors including food insecurity in older veterans preparing for surgery within the Veterans Affairs Perioperative Optimization of Senior Health clinic. Gaining insights into the importance of food insecurity will lay the foundation for an intervention for food insecurity in the deep south. Our discussant will provide an overview of the implications of these results from a public health standpoint. By highlighting the importance of food insecurity, such data can potentially become a framework to allow policy makers to expand nutritional programs as a line of defense against hunger in this high-risk population.


2018 ◽  
Vol 133 (2_suppl) ◽  
pp. 18S-27S ◽  
Author(s):  
Kim M. Williams ◽  
Raekiela D. Taylor ◽  
Thomas Painter ◽  
William L. Jeffries ◽  
Cynthia Prather ◽  
...  

Author(s):  
Pallavi Dubey ◽  
Sireesha Y. Reddy ◽  
Luis Alvarado ◽  
Sharron L. Manuel ◽  
Alok K. Dwivedi

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