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Rectal pre-exposure prophylaxis (PrEP).

ABSTRACT: 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.

SUBMITTER: Rohan LC

PROVIDER: S-EPMC3896093 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

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Rectal pre-exposure prophylaxis (PrEP).

Rohan Lisa C LC Yang Haitao H Wang Lin L

Antiviral research 20131101

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 ...[more]

PMID: 24188705

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HIV pre-exposure prophylaxis (PrEP)--a quantitative ethics appraisal.

Project description:BACKGROUND:There is now strong evidence that preventive oral antiretroviral therapy can moderately reduce likelihood of HIV infection. This concept is called HIV pre-exposure prophylaxis (PrEP). Premature closures of some previous PrEP clinical trials, secondary to ethical concerns, did not stop research. We aimed to appraise the extent of ethics considerations reporting in PrEP study documents. METHODS:We conducted a systematic quantitative ethics appraisal, grounded in PrEP literature and using eight principles proposed by Ezechiel Emanuel. We developed an a priori checklist of 101 evidence-based ethics items. We obtained protocols for eleven of nineteen clinical controlled studies identified. Two reviewers independently appraised study documents against the checklist. Ethics appraisal was synthesized using adjusted percentages of items reported. RESULTS:On average, 58% of the 101 ethics items were mentioned or addressed in documents, with variations noted both across studies and across principles. Considerations pertaining to social value were least reported (43% of checklist items, on average) whereas considerations related to informed consent and favorable risk-benefit ratio were most reported (75% of checklist items, on average). DISCUSSION:Some PrEP studies reportedly address more ethics considerations than others but, overall, ethics considerations reporting could be much improved. While this review does not allow us to comment on the actual execution of HIV PrEP trials, it is a reminder that optimism generated by potentially effective interventions should not overshadow the importance of ethics in research design and development. Improving ethics reporting might improve the perceived value of PrEP research and subsequent data.

| S-EPMC3151244 | biostudies-literature

Daily HIV pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate-emtricitabine reduced Streptococcus and increased Erysipelotrichaceae in rectal microbiota.

Project description:Daily PrEP is highly effective at preventing HIV-1 acquisition, but risks of long-term tenofovir disoproxil fumarate plus emtricitabine (TDF-FTC) include renal decline and bone mineral density decrease in addition to initial gastrointestinal side effects. We investigated the impact of TDF-FTC on the enteric microbiome using rectal swabs collected from healthy MSM before PrEP initiation and after 48 to 72 weeks of adherent PrEP use. The V4 region of the 16S ribosomal RNA gene sequencing showed that Streptococcus was significantly reduced from 12.0% to 1.2% (p = 0.036) and Erysipelotrichaceae family was significantly increased from 0.79% to 3.3% (p = 0.028) after 48-72 weeks of daily PrEP. Catenibacterium mitsuokai, Holdemanella biformis and Turicibacter sanguinis were increased within the Erysipelotrichaceae family and Streptococcus agalactiae, Streptococcus oralis, Streptococcus mitis were reduced. These changes were not associated with host factors including PrEP duration, age, race, tenofovir diphosphate blood level, any drug use and drug abuse, suggesting that the observed microbiome shifts were likely induced by daily PrEP use. Long-term PrEP resulted in increases of Catenibacterium mitsuokai and Holdemanella biformis, which have been associated with gut microbiome dysbiosis. Our observations can aid in characterizing PrEP's side effects, which is likely to improve PrEP adherence, and thus HIV-1 prevention.

| S-EPMC6185988 | biostudies-literature

Attitude towards antiretroviral Pre-Exposure Prophylaxis (PrEP) prescription among HIV specialists.

Project description:BackgroundTo investigate perceptions and attitude to prescribe Pre-Exposure Prophylaxis (PrEP) among HIV specialists.MethodsA questionnaire developed through a Focus Group and literature review was administered to a convenience sample of HIV specialists during educational courses in two Regions and an online survey in February-May 2012. Participants were classified as having a positive or negative attitude according to their willingness to prescribe PrEP. Demographic and working information, experience with HIV-infected patients, information and provision of antiretrovirals to uninfected persons, self-reported knowledge, perceptions and concerns regarding PrEP were assessed. The association between a different attitude towards PrEP prescription and selected characteristics was assessed through univariate and multivariate regression analysis.ResultsOf 311 specialists, 70% would prescribe PrEP, mainly to serodiscordant partners (64%) but also to people at ongoing, high risk of HIV infection (56%); 66% advocated public support of costs. A negative attitude towards PrEP was significantly associated with lack of provision of information on, and prescription of, antiretroviral post-exposure prophylaxis; specialists with a negative attitude believed behavioural interventions to be more effective than PrEP and were more concerned about toxicity. Overall, 90% of specialists disagreed regarding a lack of time for engaging in prevention counselling and PrEP monitoring; 79% would welcome formal guidelines, while those with a negative attitude did not consider this advisable.ConclusionsAlthough conflicting attitudes appear evident, most specialists seem to be willing, with guidance from normative bodies, to promote PrEP within multiple prevention strategies among vulnerable populations. More scientific evidence regarding effectiveness could overcome resistance.

| S-EPMC3658955 | biostudies-literature

PrEP (Pre-Exposure Prophylaxis) Education for Clinicians: Caring for an MSM Patient.

Project description:Introduction:Gaps exist in educational materials addressing LGBTQ patient care and LGBTQ health. One such area is prescribing HIV pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM). PrEP awareness, familiarity, and comfort in prescribing are very important in the rollout and success of PrEP as a preventative measure. Our needs assessments showed a lack of familiarity and comfort among clinicians/medical students in prescribing PrEP. Furthermore, studies have shown that since its launch as an effective prevention method of HIV transmission, PrEP has not been widely prescribed to at-risk populations. Educating clinicians about PrEP may increase its use among high-risk MSM populations and reduce the incidence of HIV infections. Methods:For medical students, we developed a didactic presentation and video recording discussing (1) a brief history of HIV prevention, (2) indications for PrEP prescription, (3) medical testing for PrEP onboarding, (4) common PrEP side effects, and (5) appropriate follow-up and testing for PrEP maintenance and discontinuation. We also developed a videotaped clinical encounter demonstrating communication skills used in PrEP counseling. Pre- and postworkshop surveys assessed participants' PrEP attitudes and knowledge. Results:All 43 survey respondents were second- through fourth-year medical students. Pre- and postpresentation evaluation of questions assessing comfort demonstrated a statistically significant improvement in level of comfort with understanding when to prescribe PrEP and in level of knowledge in prescribing PrEP. Discussion:Workshop participants acknowledged their training gaps in PrEP prescribing and acquired knowledge and comfort with prescribing PrEP for at-risk populations.

| S-EPMC7336890 | biostudies-literature

Oral Pre-Exposure Prophylaxis (PrEP) for HIV Prevention in Adolescents and Young Adults.

Project description:Purpose of review:To review the literature about oral pre-exposure prophylaxis (PrEP) for HIV prevention, with specific focus on adolescents. Recent findings:Use of PrEP reduces new HIV infections among men who have sex with men, heterosexuals, and people who inject drugs. One combination antiretroviral medication is approved for PrEP in the U.S. for adults. Limited data suggest that PrEP is safe for use in youth, although declines in adherence to PrEP over time suggest the need for adherence interventions specifically targeting youth. Safety concerns related to PrEP include potential negative impacts on bone density and renal function, as well as potential increases in riskier sexual behaviors. The U.S. Public Health Service has published guidelines for PrEP use in adults. Summary:Current data suggest that PrEP use is safe in adolescents; however, further research is needed on the potential impact of long-term PrEP use on bone density and kidney function.

| S-EPMC6192052 | biostudies-literature

Developing Educational Animations on HIV Pre-exposure Prophylaxis (PrEP) for Women: Qualitative Study.

Project description:BackgroundDespite experiencing the second-highest rate of HIV incidence in the United States, pre-exposure prophylaxis (PrEP) use remains low among Black women due, in part, to a lack of patients' awareness and providers' knowledge.ObjectiveOur goal was to design animated educational tools informed by patients and women's health providers to address these barriers, specifically for women at risk for HIV.MethodsTwo animation storyboards about PrEP for women were created by academic stakeholders (eg, HIV clinical experts, educators, and HIV peer counselors), one for patients and one for providers. Four focus groups with community members from Baltimore, Maryland and four with women's health providers (eg, obstetrician/gynecologists, midwives, nurse practitioners, and peer counselors) at an academic center were conducted to discuss the storyboards. Transcripts were analyzed using conventional content analysis, and themes were incorporated into the final versions of the animations.ResultsAcademic stakeholders and 30 focus group participants (n=16 female community members and n=14 women's health providers) described important themes regarding PrEP. The themes most commonly discussed about the patient animation were understandability of side effects, HIV risk factors, messaging, PrEP access, and use confidence. Provider animation themes were indications for PrEP, side effects, and prescribing confidence.ConclusionsWe created two PrEP animations focused on women. Stakeholder feedback highlighted the importance of ensuring the understandability and applicability of PrEP educational materials while including necessary information to facilitate use or prescribing confidence. Both community members and women's health providers reported greater use confidence after viewing the animations.

| S-EPMC9308066 | biostudies-literature

Student Education About Pre-exposure Prophylaxis (PrEP) Varies Between Regions of the United States.

Project description:BackgroundDaily, oral pre-exposure prophylaxis (PrEP) is an effective and safe prevention strategy for people at risk for HIV. However, prescription of PrEP has been limited for patients at the highest risk. Disparities in PrEP prescription are pronounced among racial and gender minority patients. A significant body of literature indicates that practicing healthcare providers have little awareness and knowledge of PrEP. Very little work has investigated the education about PrEP among health professionals in training.ObjectiveThe objective of this study was to compare health professions students' awareness of PrEP and education about PrEP between regions of the US, and to determine if correlations between regional HIV incidence and PrEP use were present.DesignSurvey study.ParticipantsA cross-sectional sample of health professions students (N = 1859) representing future prescribers (MD, DO, PA), pharmacists, and nurses in the US.Key resultsOverall, 83.4% of students were aware of PrEP, but only 62.2% of fourth-year students indicated they had been taught about PrEP at any time during their training. Education about PrEP was most comprehensive in the Northeastern US, the area with the highest PrEP to need ratio (4.7). In all regions, transgender patients and heterosexual men and women were least likely to be presented in education as PrEP candidates, and men who have sex with men were the most frequently presented.ConclusionsThere are marked differences in education regarding PrEP both between academic programs and regions of the USA.

| S-EPMC7573046 | biostudies-literature

Midwest pharmacists' familiarity, experience, and willingness to provide pre-exposure prophylaxis (PrEP) for HIV.

Project description:IntroductionPharmacist provision of pre-exposure prophylaxis (PrEP) through collaborative practice agreements with physicians could expand access to people at risk for HIV. We characterized pharmacists' familiarity with and willingness to provide PrEP services in Nebraska and Iowa.MethodsAn invitation to complete an 18-question survey was emailed to 1,140 pharmacists in Nebraska and Iowa in June and July of 2016. Descriptive analyses and Pearson chi-square tests were used to determine to what extent demographics, familiarity and experience were associated with respondent willingness to provide PrEP. Wilcoxon rank-sum tests compared ages and years of experience between groups of respondents.ResultsOne hundred forty pharmacists (12.3%) responded. Less than half were familiar with the use of PrEP (42%) or the CDC guidelines for its use (25%). Respondents who were older (p = .015) and in practice longer (p = .005) were less likely to be familiar with PrEP. Overall, 54% indicated they were fairly or very likely to provide PrEP services as part of a collaborative practice agreement and after additional training. While familiarity with PrEP use or guidelines did not affect respondents' willingness to provide PrEP, respondents were more likely to provide PrEP with prior experience counseling HIV-infected patients on antiretroviral therapy (OR 2.43; p = 0.023) or PrEP (OR 4.67; p = 0.013), and with prior HIV-related continuing education (OR 2.77; p = 0.032).ConclusionsPharmacist respondents in Nebraska and Iowa had limited familiarity and experience with PrEP, but most indicated willingness to provide PrEP through collaborative practice agreements after additional training. Provision of PrEP-focused continuing education may lead to increased willingness to participate in PrEP programs.

| S-EPMC6235377 | biostudies-literature

In vitro exposure of leukocytes to HIV pre-exposure prophylaxis (PrEP) decreases mitochondrial function and alters gene expression profiles.

Project description:The use of antiretroviral therapy (ART) as pre-exposure prophylaxis (PrEP) is an effective strategy for preventing HIV acquisition. The cellular consequences of PrEP exposure, however, have not been sufficiently explored to determine potential effects on health in individuals without HIV. Peripheral blood mononuclear cells (PBMCs) from people without HIV were exposed to tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC) overnight. Mitochondrial mass and function were measured by flow cytometry and Agilent XFp analyzer. Monocyte-derived macrophages (MDMs) were differentiated in 20% autologous serum for 5 days in the presence or absence of TDF or FTC, and surface markers, lipid uptake, and efferocytosis were measured by flow cytometry. MDM gene expression was measured using RNAseq. Serum lipids were measured using mass spectrometry. PBMCs exposed to TDF or FTC had decreased maximal oxygen consumption rate (OCR) and reduced mitochondrial mass. Exposure to PrEP also increased reactive oxygen species (ROS) production from monocyte subsets. Compared to MDMs cultured in medium alone, cells differentiated in the presence of TDF (829 genes) or FTC (888) genes had significant changes in gene expression. Further, PrEP-exposed MDMs had decreased mitochondrial mass, and displayed increased lipid uptake and reduced efferocytosis. Plasma biomarkers and lipid levels were also altered in vivo in individuals receiving a PrEP regimen. Exposure of leukocytes to TDF or FTC resulted in decreased mitochondrial function, and altered functional and transcriptional profiles. These findings may have important implications for the metabolic and immunologic consequences of PrEP in populations at risk for HIV acquisition.

2021-10-01 | GSE159339 | GEO

Interest in Switching to On-Demand HIV Pre-Exposure Prophylaxis (PrEP) Among Australian Users of Daily PrEP: An Online Survey.

Project description:We surveyed 970 PrEPX study participants to evaluate interest in switching from daily to on-demand PrEP in a study setting. Interested respondents (n = 469, 48%) more commonly reported PrEP cessation (adjusted odds ratio [aOR], 3.0; P < .001), difficulty with adherence (aOR, 1.6; P = .029), infrequent sex (aOR, 3.7; P < .001), and toxicity concerns (aOR, 2.7; P < .001).

| S-EPMC6612821 | biostudies-literature

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