Needed: A Life Course Perspective on Maintaining Pre-exposure Prophylaxis Use.
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ABSTRACT:
SUBMITTER: Siegler AJ
PROVIDER: S-EPMC7850543 | biostudies-literature | 2021 Feb
REPOSITORIES: biostudies-literature
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Needed: A Life Course Perspective on Maintaining Pre-exposure Prophylaxis Use.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20210201 3
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Project description:ObjectivesThe objective was to perform a survey-based service evaluation of our telephone PrEP clinic (Tele-PrEP), which was instituted during the COVID-19 pandemic, to inform future service delivery.MethodsWe administered parallel, web-based, anonymous surveys to PrEP-users who had a Tele-PrEP appointment between 13.11.2020 and 17.12.2020 and all healthcare professionals (HCPs) conducting Tele-PrEP clinics. We used descriptive statistics to summarise demographic and qualitative data, and thematically categorised free text responses using the Framework for a Systems Approach to Healthcare Delivery.Results62/117 (53%) PrEP-users and 8/9 (89%) HCPs completed the surveys. Tele-PrEP was rated 'excellent' or 'good' by 61/62 (98%) PrEP-users. All HCPs felt that Tele-PrEP allowed them to assess patients safely and confidently. 10/62 (16%) PrEP-users and 1 (11%) HCP expressed a preference for face-to-face care. Using the Framework for a Systems Approach to Healthcare Delivery we identified key areas important to respondents who highlighted the rapid changes as a result of COVID-19, which required an increase in dedicated resources. HCPs valued teamwork, support/supervision and convenience in achieving quality care for the patient, who in turn, valued convenient, holistic and individualised management to meet their sexual healthcare needs.ConclusionTele-PrEP is feasible and acceptable. While most respondents rated the service highly, others identified a need/preference for face-to-face appointments.
| S-EPMC9189322 | biostudies-literature
Project description:When taken consistently, pre-exposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) with once daily tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) has been shown to safely reduce the incidence of HIV infection in high-risk individuals by more than 90%. Yet, according to the Centers for Disease Control and Prevention, there were about 2.1 million new cases of HIV reported worldwide in 2015. Undoubtedly, there is significant room for improvement to prevent the transmission of HIV. Research to date has been heavily focused on the high-risk men who have sex with men (MSM) population, yet, many women worldwide remain at high risk of HIV transmission. PrEP offers women a protection method that is discrete, does not require partner consent, and may be compatible with both contraception or conception as desired. However, women often remain under-represented in HIV prevention literature and are reported to have lower real-world uptake in comparison to men. Furthermore, clinical trials that do focus on the female population demonstrate mixed efficacy results that highlight the adherence challenges in this population. It is essential to identify factors that contribute to PrEP non-adherence as well as barriers to preventative treatment. This review will discuss the clinical evidence behind PrEP in women, current barriers to use afflicting this population, pharmacotherapy considerations for the female patient, alternative and future agents, and the current real-world application of PrEP.
| S-EPMC5595773 | biostudies-other
Project description:Few studies of pre-exposure prophylaxis (PrEP) to prevent HIV infection have focused on drug users. Between February to September 2013, we asked 351 opiate injectors entering detoxification treatment about HIV risk, knowledge about PrEP, and willingness to use a once daily PrEP pill under one of two randomly assigned effectiveness scenarios-40 % (low) or 90 % (high) effective in reducing HIV risk. Participants were 70 % male and 87 % non-Hispanic White. Only 7 % had heard of a drug to reduce HIV risk, yet once informed, 47 % would be willing to take such a pill [35 % of those in the low effectiveness scenario and 58 % in the high group (p < 0.001)]. Higher perceived HIV risk was associated with greater willingness to take medication. Increasing knowledge of PrEP and the rate of HIV reduction-effectiveness promised will influence its use among targeted high-risk drug users.
| S-EPMC4127116 | biostudies-literature
Project description:PurposeThe number of individuals who have started a regimen for HIV pre-exposure prophylaxis (PrEP) in the United States is not well characterized but has been on the rise since 2012. This analysis assesses the distribution of PrEP use nationally and among subgroups.MethodsA validated algorithm quantifying tenofovir disoproxil fumarate/emtricitabine for PrEP in the United States was applied to a national prescription database to determine the quarterly prevalence of PrEP use. HIV diagnoses from 2016 were used as an epidemiological proxy for PrEP need. The PrEP-to-need ratio (PnR) was defined as the number of PrEP users divided by new HIV diagnoses.ResultsA total of 70,395 individuals used PrEP in the fourth quarter of 2017: 67,166 males and 3229 females. Nationally, prevalence of PrEP use was 26/100,000 (range across states per 100,000 [RAS/100k]: 4-73) and the PnR was 1.8 (RAS: 0.5-6.6). Prevalence of PrEP use among males and females, respectively, was 50/100,000 and 2/100,000 (RAS/100k: 7-143 and 0.3-7) and PnR was 2.1 and 0.4 (RAS: 0.6-7.1 and 0.1-4.0). Prevalence of PrEP use was lowest among individuals aged less than or equal to 24 and more than or equal to 55 years (15/100,000 and 6/100,000, RAS/100k: 1-45 and 0.4-14), with PnR 0.9 and 1.5 (RAS: 0.2-5.6 and 0.3-7.0). The Northeast had the highest PnR (3.3); the South had the lowest (1.0). States with Medicaid expansion had more than double the PnR than states without expansion.ConclusionsAvailable data suggest that females, individuals aged less than or equal to 24 years and residents of the South had lower levels of PrEP use relative to epidemic need. These results are ecological, and misclassification may attenuate results. PnR is useful for future assessments of HIV prevention strategy uptake.
| S-EPMC6286209 | biostudies-literature
Project description:Rectal pre-exposure prophylaxis (PrEP) will be a critical component of HIV prevention products due to the prevalence of unprotected receptive anal intercourse among men who have sex with men and heterosexual couples. Given the biological considerations of this compartment and the complexity of HIV infection, design of a successful rectal microbicide product faces a number of challenges. Important information is being compiled to begin to address deficits in knowledge toward design of rectal PrEP products for men and women. Aspects of formulation development and preclinical and clinical evaluation of rectal products studied to date are summarized in this review. This article is based on a presentation at the "Product Development Workshop 2013: HIV and Multipurpose Prevention Technologies," held in Arlington, Virginia on February 21-22, 2013. It forms part of a special supplement to Antiviral Research.
| S-EPMC3896093 | biostudies-literature
Project description:Pre-exposure prophylaxis (PrEP) has emerged as a promising strategy for preventing the transmission of HIV. Although only one formulation is currently approved for PrEP, research into both new compounds and new delivery systems for PrEP regimens offer intriguing challenges from the perspective of pharmacokinetic and pharmacodynamic modeling. This review aims to provide an overview the current modeling landscape for HIV PrEP, focused on PK/PD and QSP models relating to antiretroviral agents. Both current PrEP treatments and new compounds that show promise as PrEP agents are highlighted, as well as models of uncommon administration routes, predictions based on models of mechanism of action and viral dynamics, and issues related to adherence to therapy. The spread of human immunodeficiency virus (HIV) remains one of the foremost global health concerns. In the absence of a vaccine, other prophylactic strategies have been developed to prevent HIV transmission. One approach, known as pre-exposure prophylaxis (PrEP), allows HIV-negative individuals who are at high risk of exposure to the virus, be it through an HIV-positive sexual partner or through the shared use of drug injection equipment, to substantially reduce the risk of developing an HIV infection. PrEP is a relatively recent approach to combating the HIV epidemic, with the only currently approved treatment being Truvada, a daily oral antiretroviral (ARV) therapy initially indicated in the treatment of active HIV-1 infections, but approved for HIV PrEP in 2012. Although PrEP therapy has consistently demonstrated high efficacy in preventing HIV infection, this efficacy is dependent on patient adherence to the prescribed treatment regimen. This can present a significant problem in low- and middle-income countries, which may lack the infrastructure to provide sufficient access to PrEP medication to maintain daily dosing regimens. Furthermore, while the conventional approach has generally been to advocate for continuous administration akin to regimens used for viral suppression in infected patients, there has been some discussion of whether a better treatment paradigm might be to push for PrEP therapy primarily during those known periods of heightened exposure risk, while relying on post-exposure prophylaxis regimens to prevent infection after unanticipated exposures during low-risk periods. These considerations have led to a push for the development of long-duration and on-demand PrEP formulations, including subdermal and subcutaneous implants, slow-release intramuscular depot injections, vaginal and rectal antimicrobial gels, and intravaginal rings and dissolving films. PrEP therapy is a quickly evolving field, with a variety of antiretroviral compounds and formulations under investigation. This review aims to report on notable drugs and formulations from a pharmacokinetic/pharmacodynamic (PK/PD) modeling perspective. Given the nature of PrEP as a preventive therapy designed for long-term use, clinical trials for PrEP therapies can last for months or even years, particularly in the case of long-duration formulations. Furthermore, in contrast to antiretroviral trials in infected patients, pharmacodynamic endpoints in PrEP therapies are difficult to quantify, as the primary endpoint for efficacy is generally the rate of seroconversion. Computational modeling approaches offer flexible and powerful tools to provide insight into drug behavior in clinical settings, and can ultimately reduce the time, expense, and patient burden incurred in the development of PrEP therapies.
| S-EPMC7005100 | biostudies-literature
Project description:Human immunodeficiency virus (HIV) infection continues to disproportionately affect vulnerable populations in Canada; particularly men who have sex with men (MSM). Novel HIV prevention strategies have recently expanded from the use of non-occupational post-exposure prophylaxis (nPEP) after high risk exposures to the use of pre-exposure prophylaxis (PrEP) in which individuals reduce risk of HIV infection through use of combination antiretrovirals taken prior to risk exposure. With approval of tenofovir/emtricitabine (TDF/FTC) for use as PrEP only in early 2016, and with limited public funding to date, uptake in Canada is in its preliminary stages. These biomedical prevention strategies have proven efficacy for MSM, and they may have potential for other at-risk populations. With generic formulations of TDF/FTC now available in Canada, there is an opportunity for widespread implementation. Expanding knowledge of health care providers across Canada on how best to assess, refer for or prescribe and monitor PrEP will contribute to the current efforts to reach the global goal of eliminating new HIV infections.
| S-EPMC5937069 | biostudies-literature
Project description:Purpose: In Argentina, transgender women face a disproportionately high prevalence of HIV infection (34%). Although not currently approved in Argentina, pre-exposure prophylaxis (PrEP) may offer a potential effective HIV prevention tool for this population. In this study, we assessed the willingness to use PrEP among transgender women in Argentina. Methods: Data were drawn from a nationwide cross-sectional survey conducted among transgender women in 2013. Using multivariable logistic regression, we assessed the prevalence of and factors associated with willingness to use PrEP among transgender women with negative or unknown HIV status. Results: This study included 337 transgender women (278 HIV negative and 59 with unknown HIV status), most of whom had a history of sex work involvement (81.8%). Overall, 301 (89.3%) expressed willingness to use PrEP. In a multivariable analysis, having casual sexual partners was positively associated with willingness to use PrEP (adjusted odds ratio [AOR]=4.26, 95% confidence interval [CI] 1.73-10.51), while discrimination by healthcare workers was negatively associated (AOR=0.33, 95% CI 0.12-0.88). Conclusion: We found high levels of willingness to use PrEP among transgender women in Argentina, suggesting that there is high perception of HIV risk in this population. However, discrimination by healthcare workers was a strong negative correlate of willingness to use PrEP, suggesting that multilevel interventions that address gender-based stigma in healthcare settings will be critical for the success of PrEP as an HIV prevention strategy in this population.
| S-EPMC5367484 | biostudies-other
Project description:As pre-exposure prophylaxis (PrEP) effectiveness is strongly linked to adherence, we sought to determine if certain self-report measures could be used to inform objective PrEP adherence. We studied participants from the TAPIR study (a multicenter randomized study of daily text messages to support adherence to PrEP In At-Risk), a 48-week randomized controlled trial of HIV-uninfected men who have sex with men (MSM) randomized to receive text message to support adherence versus standard of care. Self-reported medication adherence was assessed using several validated measures modified for PrEP. Objective PrEP adherence was determined through dried blood spot (DBS) measurement of intracellular tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP). A summary of adherence was estimated using responses to the seven adherence items at weeks 12 and 48 using confirmatory factor analysis. Correlations between self-report questions and drug concentrations were estimated with Pearson's correlations for continuous outcomes and point-biserial correlations for dichotomous outcomes. Receiver operating characteristic (ROC) analyses were conducted to assess the performance of self-report measures in predicting protective or perfect TFV-DP concentrations. Of the 369 participants who completed week 12 or 48 visits, the mean age was 35 (standard deviation 9 years), with 79% White, 12% Black, and 29% Hispanic. Correlations between self-report measures of adherence (both individual items and the adherence factor) and quantifiable FTC-TP and continuous TFV-DP concentrations showed that all self-report measures were significantly associated with these objective measures. Compared to a summary measure of self-reported adherence, the 4-week percent taken question medication recall was the only self-report item similarly or more strongly associated with recent adherence and long-term protective and perfect adherence at weeks 12 and 48. ROC analysis also showed that 4-week percent taken question had a reasonable AUC (0.798 at week 12 and 0.758 at week 48) in predicting protective TFV-DP concentrations. All single-item self-report questions assessing PrEP adherence were significantly associated with biomarker quantification, with the 4-week percent taken question performing best. Therefore, in the absence of drug concentration measurements, a 4-week self-report percent taken question may be a good single-item measure of PrEP adherence.
| S-EPMC6624646 | biostudies-literature
Project description:Approximately 1.1 million individuals in the United States are living with HIV/AIDS. HIV disproportionately affects young, black men who have sex with men (YBMSM). Recent biomedical advances, including the use of antiretroviral therapy as pre-exposure prophylaxis (PrEP), hold promise for preventing HIV infections. However, PrEP uptake remains slow among those most at-risk. To develop and test an intervention to address HIV disparities in YBMSM, we conducted qualitative interviews with 29 YBMSM from Jackson, Mississippi, to learn more about their views of PrEP. Twenty-nine PrEP-eligible YBMSM were enrolled and participated in either semistructured interviews or focus groups. They were asked about PrEP use, messaging, and promotion. Data were coded based on an iteratively developed coding scheme and entered into NVivo to facilitate thematic analysis. Our analysis identified the following three main themes: (1) the role of setting, context, and stigma in health care, (2) targeted PrEP messaging is further stigmatizing, and (3) recommendations for PrEP messaging and care. YBMSM in our sample felt highly stigmatized in their current environment and felt that PrEP messaging targeting YBMSM only enhanced their sense of marginalization. They concluded that broad and inclusive messaging would be just as relevant and cause less stigma. Our findings were somewhat surprising, as several prior studies benefited from using targeted materials to engage YBMSM in HIV prevention and PrEP uptake. The study's location may explain this difference in findings, which suggests the importance of considering local conditions and opinions when developing interventions for HIV prevention among minority populations.
| S-EPMC6839422 | biostudies-literature