Structural, Dosing, and Risk Change Factors Affecting Discontinuation of Pre-exposure Prophylaxis (PrEP) in a Large Urban Clinic.
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SUBMITTER: Shover CL
PROVIDER: S-EPMC7886279 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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: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
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
Project description:BackgroundHeterosexual men in South Africa are a large key population to exposure to HIV, yet preferences for HIV pre-exposure prophylaxis (PrEP) among this population have not, to date, been investigated in the literature. This paper aims to explore HIV prevention preferences among heterosexual men in urban South Africa, as well as to examine the demand and characteristics of men who favour long-acting injectable (LAI) PrEP over condoms and oral PrEP.MethodsData were collected among 178 self-reported HIV-negative heterosexual men, who were given example products and information before being asked which they preferred. Multivariate logistic regression was used to analyse which characteristics were associated with product choice.Results48% (n = 85) of participants preferred LAI PrEP, while 33% (n = 58) and 20% (n = 35) chose oral PrEP and condoms respectively. Having children (marginal effect = 0.22; 95% CI [0.01, 0.44]) or having higher risk attitude scores (marginal effect = 0.03; 95% CI [0.01, 0.06]) was significantly associated with a choice of LAI PrEP, while those who had unprotected anal intercourse (marginal effect = - 0.42; 95% CI [- 0.57, - 0.27]) and those who were concerned with protection against other sexually transmitted infections over HIV (marginal effect = - 0.42; 95% CI [- 0.60, - 0.24]) appeared less likely to prefer LAI PrEP.ConclusionsThe results suggested a relatively high demand and theoretical acceptability for LAI PrEP among heterosexual men in urban South Africa, but there appeared to be fewer distinct predictors for the willingness to use LAI PrEP compared to studies conducted among gay and bisexual men and women. Nevertheless, the findings contribute to the mapping of the demand and determinants of heterosexual men's preferences for novel antiretroviral-based prevention in sub-Saharan Africa, and the data could aid in the differentiated design of future HIV prevention strategies using LAI PrEP in conjunction with other methods.
| S-EPMC6657137 | biostudies-literature
Project description:When used appropriately, pre-exposure prophylaxis (PrEP) substantially reduces the risk of HIV acquisition. Early implementation outcomes often suggest poor PrEP adherence and persistence; however, this intervention is time-limited and the need for PrEP fluctuates as risk behaviours change. In this Viewpoint we examine the current guidelines and early programmatic outcomes after starting, stopping, and restarting PrEP, and we review the implications of PrEP in relation to HIV testing algorithms. Guidelines suggest to discontinue PrEP when a person is no longer at risk for HIV, but effectively implementing this strategy requires support tools to make the decision of stopping and restarting PrEP that considers the complex relationship between risk perceptions and risk behaviours. Safely discontinuing PrEP also requires greater understanding of the daily dosing duration that is needed to protect the person after their last HIV exposure. Additionally, clear strategies are needed to re-engage a person as their HIV exposure risk changes over time.
| S-EPMC7541752 | biostudies-literature
Project description:IntroductionPre-exposure prophylaxis (PrEP) is an effective tool to reduce HIV transmission. The primary objective of this study was to assess awareness of PrEP by individuals living with HIV (HIV+) and acceptance of its use for their HIV negative (HIV-) partners.MethodsA cross sectional survey was conducted among individuals living with HIV who received care at an urban HIV clinic between January 2013 and June 2013. The survey examined knowledge, attitudes, and acceptability of PrEP, and perception of transmission risk of HIV. Chi-Square test and Fisher's Exact test were used to compare proportions.ResultsAmong 206 subjects living with HIV, 15.3% (32) had heard of PrEP. Men who have sex with men (MSM) were more likely to be aware of PrEP than all others (p = 0.003). Once educated about PrEP those who believed PrEP would reduce their partner's risk for HIV were more likely to recommend PrEP to their partner (p<0.001). 92% of all respondents said they would be "extremely likely/likely" to discuss PrEP use with their provider. Of 159 subjects whose main partner was HIV-, MSM (p = 0.007), male participants (p = 0.044), and those who were consistently taking meds (p = 0.049) were more likely to be aware of PrEP. Those who perceived they were at risk of transmitting HIV (p<0.001) and those who were consistently taking meds (0.049) were more likely to agree that PrEP could reduce the risk of HIV to their partners.ConclusionThis study illustrates a low awareness of PrEP but once educated the willingness of a cohort of individuals living with HIV to recommend PrEP to their partners. Our findings demonstrate the importance of providers informing their patients living with HIV about PrEP, as these persons are an underutilized link to support the uptake of PrEP by their HIV- partners.
| S-EPMC4749230 | biostudies-literature
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
Project description:To date, there are no established scales to assess PrEP stigma among youth. We validated the Youth PrEP Stigma Scale within the Adolescent Trials Network P3 study (2019-2021). Data from sexual and gender minority youth (16-24 years) who were prescribed PrEP across nine domestic sites were evaluated (N = 235). Descriptive statistics, exploratory factor analysis, and correlation coefficients are reported. Results yielded a three-factor solution (PrEP Disapproval by Others, Enacted PrEP Stigma, and PrEP User Stereotypes) with strong factor loadings and Cronbach's alphas ranging from 0.83 to 0.90, suggesting excellent internal consistency. Correlations between this Scale, anticipated HIV stigma, perceived HIV risk, and disclosure of sexual identity were significant, indicating potential for robust application. Given the persistence of HIV infections among youth, stigma as a barrier to prevention, and expansion of PrEP modalities, the Youth PrEP Stigma Scale could enhance intervention and mechanistic research among youth at elevated risk for HIV acquisition.
| S-EPMC9968821 | biostudies-literature
Project description:Cabotegravir is an integrase strand transfer inhibitor (INSTI) for HIV treatment and prevention. Cabotegravir-based long-acting pre-exposure prophylaxis (PrEP) presents an emerging paradigm for infectious disease control. In this scheme, a combination of a high efficacy and low solubility of anti-infection drugs permits the establishment of a pharmaceutical firewall in HIV-vulnerable groups over a long period. Although the structure-activity-relationship (SAR) of cabotegravir as an INSTI is known, the structural determinants of its low solubility have not been identified. In this work, we have integrated multiple experimental and computational methods, namely X-ray diffraction, solid-state NMR (SSNMR) spectroscopy, solution NMR spectroscopy, automated fragmentation (AF)-QM/MM and density functional theory (DFT) calculations, to address this question. The molecular organization of cabotegravir in crystal lattice has been determined. The combination of very-fast magic-angle-sample-spinning (VF MAS) SSNMR and solution NMR, as supported by AF-QM/MM and DFT calculations, permits the identification of structural factors that contribute to the low aqueous solubility of cabotegravir. Our study reveals the multitasking nature of pharmacophores in cabotegravir, which controls the drug solubility and, meanwhile, the biological activity. By unraveling these function-defining molecular features, our work could inspire further development of long-acting HIV PrEP drugs.
| S-EPMC10819392 | biostudies-literature
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