Suboptimal awareness and comprehension of published preexposure prophylaxis efficacy results among physicians in Massachusetts

In 2010, the centre for the AIDS Programme of Research in South Africa (CAPRISA)004 and iPrEx trials (microbicide gel containing tenofovir and oral pill containing tenofovir–emtricitabine, respectively) demonstrated that antiretroviral preexposure prophylaxis (PrEP) reduced the risk of HIV acquisition among high-risk individuals. To determine the facilitators and barriers to PrEP provision by health-care providers, we conducted an online, quantitative survey of Massachusetts-area physicians following the publication of the CAPRISA and iPrEx results. We assessed awareness and comprehension of efficacy data, prescribing experience, and anticipated provision of oral and topical PrEP among physicians, as well as demographic and behavioral factors associated with PrEP awareness and prescribing intentions. The majority of HIV specialists and generalist physicians were aware of data from these PrEP trials and able to correctly interpret the results, however, correct interpretation of findings tended to vary according to specialty (i.e., HIV specialists had greater awareness than generalists). In addition, provider concerns regarding PrEP efficacy and safety, as well its ability to divert funds from other HIV prevention resources, were associated with decreased intentions to prescribe both oral and topical PrEP. Findings suggest that a substantial proportion of physicians who may have contact with at-risk individuals may benefit from interventions that provide accurate data on the risks and benefits of PrEP in order to facilitate effective PrEP discussions with their patients. Future studies to develop and test interventions aimed at health-care providers should be prioritized to optimize implementation of PrEP in clinical settings.     

Oral preexposure anti-HIV prophylaxis for high-risk U.S. populations: current considerations in light of new findings

This article reviews the status of current research evaluating oral preexposure prophylaxis (PrEP) for prevention of HIV infection in high-risk populations. In animal model studies, the use of antiretrovirals has been shown to be effective in preventing HIV acquisition. Early-phase PrEP studies have established safety in humans. Currently, more than 20,000 men and women will soon be enrolled in studies of oral or topical chemoprophylaxis, testing a variety of drug delivery methods including tenofovir disoproxil fumarate (TDF) gel applied vaginally or rectally, as well as oral PrEP using TDF by itself or coformulated with emtricitabine (FTC). The largest global PrEP trial in men who have sex with men (MSM), known as iPrEx has demonstrated that oral chemoprophylaxis can decrease HIV incidence in this population. Although TDF/FTC PrEP was generally well tolerated, side effects such as nausea, as well as mild and reversible renal abnormalities were increased among the men who received active medication, suggesting that PrEP users will need ongoing PrEP clinical monitoring. The prophylactic benefits of TDF/FTC were substantially attenuated by nonadherence, indicating that effective PrEP implementation programs will need to focus on this behavioral variable, in addition to safer sex counseling. This article considers biological, policy, and practical implications of large-scale oral PrEP implementation.     

Perceptions among Dutch men who have sex with men and their willingness to use rectal microbicides and oral pre-exposure prophylaxis to reduce HIV risk – a preliminary study

Oral pre-exposure prophylaxis (PrEP) with antiretroviral (ARV) tablets and topical PrEP or microbicides containing ARV drugs could help to reduce HIV incidence. These methods hold promise for men who have sex with men (MSM) who are at higher risk of acquiring HIV. This mixed-methods study in the Netherlands explored perceptions of MSM and their willingness to use oral PrEP and rectal microbicides (RM) if made available. Recruited through social media (Facebook and Twitter), 108 MSM completed online questionnaires. Seven of them consented to discuss the survey results in semi-structured interviews. Survey participants preferred a RM that could be applied before and after anal intercourse (60.8%) to daily oral PrEP (20.3%). This preference was based on anticipated user friendliness, hypothetically fewer expected adverse events, and perceptions that RM would be less likely to be confused with ARVs for treatment. Those who preferred oral PrEP had stronger beliefs in the effectiveness of pills, perceived its use as easy, and viewed not requiring sexual partner awareness as advantages. No predictive factors were found for the choice of one prevention method over the other. Although Dutch MSM perceive both oral and topical PrEP positively, many barriers exist to the introduction of these products in the Netherlands. These include lack of regulatory approval of oral PrEP, no proven efficacy as yet for RM, and strong HIV stigma within the MSM population. In-depth qualitative research is needed to further explore the perceptions of MSM to inform implementation of programmes should these HIV prevention methods become available.     

Primary Care Physicians’ Willingness to Prescribe HIV Pre-exposure Prophylaxis for People who Inject Drugs

Pre-exposure prophylaxis for HIV (PrEP) is recommended for people who inject drugs (PWID). Despite their central role in disease prevention, willingness to prescribe PrEP to PWID among primary care physicians (PCPs) is largely understudied. We conducted an online survey (April–May 2015) of members of a society for academic general internists regarding PrEP. Among 250 respondents, 74% (n = 185) of PCPs reported high willingness to prescribe PrEP to PWID. PCPs were more likely to report high willingness to prescribe PrEP to all other HIV risk groups (p’s < 0.03 for all pair comparisons). Compared with PCPs delivering care to more HIV-infected clinic patients, PCPs delivering care to fewer HIV-infected patients were more likely to report low willingness to prescribe PrEP to PWID (Odds Ratio [95% CI] = 6.38 [1.48–27.47]). PCP and practice characteristics were not otherwise associated with low willingness to prescribe PrEP to PWID. Interventions to improve PCPs’ willingness to prescribe PrEP to PWID are needed.     

Knowledge and acceptability of alternative HIV prevention bio-medical products among MSM who bareback

Condom use is the best available strategy to prevent HIV infection during sexual intercourse. However, since many people choose not to use condoms in circumstances in which HIV risk exists, alternatives to condom use for HIV prevention are needed. Currently there are several alternative bio-medical HIV-prevention products in different stages of development: microbicides, vaccines, post-exposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP). Seventy-two men who have sex with men (MSM) who took part in a study on Internet use and intentional condomless anal intercourse were asked about these four products during a semi-structured interview. The questions explored knowledge and acceptability of all the products and willingness to participate in microbicide and vaccine trials. Qualitative analysis of the data suggests that these men had virtually no knowledge of PrEP, very limited knowledge of microbicides, some information about PEP and considerably more knowledge about vaccines. Reactions towards the products were generally positive except for PrEP, for which reactions were polarized as either enthusiastic or negative. With the exception of PrEP, many men expressed willingness to use the products in the future. Most men would be willing to participate in trials for microbicides and vaccines if given basic reassurances. Concerns over negative side effects and preoccupation with possible infection were some of the motives given for non-willingness to participate in a vaccine trial. These results should inform the development of future trials of biomedical prevention products.     

Acceptability of microbicidal vaginal rings and oral pre-exposure prophylaxis for HIV prevention among female sex workers in a high-prevalence US city

Biomedical HIV prevention tools including oral pre-exposure prophylaxis (PrEP) and vaginal microbicidal rings hold unique value for high-risk women who may have limited capacity for condom negotiation, including the key populations of sex workers and drug users. Commercial sex is a PrEP indicator in CDC guidelines, yet little is known about female sex workers’ (FSWs) knowledge of and attitudes toward PrEP or the recently developed monthly vaginal microbicide rings. We describe knowledge and attitudes toward PrEP and microbicide rings in a sample of 60 mostly drug-using FSWs in Baltimore, Maryland, a high HIV-prevalence US city. Just 33% had heard of PrEP, but 65% were interested in taking daily oral PrEP and 76% were interested in a microbicide vaginal ring; 87% were interested in at least one of the two methods. Results suggest method mix will be important as biomedical tools for HIV prophylaxis are implemented and scaled up in this population, as 12% were interested in PrEP but not vaginal rings, while 19% were interested in vaginal rings but not in PrEP. Self-efficacy for daily oral adherence was high (79%) and 78% were interested in using PrEP even if condoms were still necessary. Women who had experienced recent client-perpetrated violence were significantly more interested in PrEP (86% vs 53%, p?=?0.009) and microbicidal rings (91% vs 65%, p?=?0.028) than women who had not recently experienced violence. No differences were observed by demographics nor HIV risk behaviors, suggesting broad potential interest in daily PrEP and monthly-use vaginal microbicides in this high-risk population.     

HIV providers’ likelihood to prescribe pre-exposure prophylaxis (PrEP) for HIV prevention differs by patient type: a short report

Pre-exposure prophylaxis (PrEP), the antiretroviral treatment regimen for HIV-negative people at high risk of acquiring HIV, has demonstrated efficacy across clinical trials in several patient populations. The Centers for Disease Control (CDC) have released detailed guidelines to aid providers in prescribing PrEP for their high-risk patients, including men who have sex with men (MSM), high-risk heterosexuals, and injection drug users (IDUs). Given that much attention in PrEP has focused on MSM patients, the present study used an online survey to assess factors involved in HIV care providers’ (n?=?363) decisions about prescribing PrEP, along with their willingness to prescribe PrEP to patients from various risk populations (e.g., MSM, heterosexuals, IDUs). The efficacy of PrEP was an important factor in providers' decisions about prescribing PrEP, as were considerations about patients’ adherence to the regimen, regular follow-up for care, and medication costs. This survey's findings also suggest that providers’ willingness to prescribe PrEP varies by patient group, with providers most willing to initiate the regimen with MSM who have an HIV-positive partner, and least willing to prescribe to high-risk heterosexuals or IDUs. In the context of the current CDC recommendations for PrEP that include MSM, heterosexuals, and IDUs, examining providers’ rationales for and barriers against supporting this HIV prevention strategy across patient groups merits further attention.     

PrEP Awareness,Familiarity, Comfort,and Prescribing Experience among US Primary Care Providers and HIV Specialists

HIV pre-exposure prophylaxis (PrEP) was FDA approved in 2012, but uptake remains low. To characterize what would facilitate health care providers’ increased PrEP prescribing, we conducted a 10-city, online survey of 525 primary care providers (PCPs) and HIV providers (HIVPs) to assess awareness, knowledge, and experience with prescribing PrEP; and, comfort with and barriers to PrEP-related activities. Fewer PCPs than HIVPs had heard of PrEP (76 vs 98%), felt familiar with prescribing PrEP (28 vs. 76%), or had prescribed it (17 vs. 64%). PCPs were less comfortable than HIVPs with PrEP-related activities such as discussing sexual activities (75 vs. 94%), testing for acute HIV (83 vs. 98%), or delivering a new HIV diagnosis (80 vs. 95%). PCPs most frequently identified limited knowledge about PrEP and concerns about insurance coverage as prescribing barriers. PCPs and HIVPs differ in needs that will facilitate their PrEP prescribing. Efforts to increase PrEP uptake will require interventions to increase the knowledge, comfort, and skills of providers to prescribe PrEP.     

Willingness of Clinicians to Integrate Microbicides into HIV Prevention Practices in Southern Africa

The first vaginal microbicide was recently proven effective in clinical trials. We assessed the willingness of clinicians to integrate microbicides into HIV prevention practices in Southern Africa, where women face elevated HIV risks. We conducted in-depth interviews (n?=?60) and nationally representative surveys (n?=?1,444) in South Africa and Zimbabwe with nurses and physicians. Over half of clinicians (58%) were aware of microbicides, with physicians far more likely than nurses to be familiar. Clinicians, including those in rural areas, were generally willing to discuss microbicides, a female-initiated method less effective than the condom, particularly when condom use was unlikely (70%). Fewer would include microbicides while counseling adolescents (51%). Most clinicians (85%) thought their patients would use microbicides; greater clinician familiarity with microbicides was significant for support. Training for both nurses and physicians prior to introduction is critical, so they have sufficient knowledge and skills to offer a microbicide upon availability.     

Sexual risk behaviors and acceptability of HIV pre-exposure prophylaxis among HIV-negative gay and bisexual men in serodiscordant relationships: a mixed methods study

The objective of this mixed methods study was to examine current sexual risk behaviors, acceptability and potential adoption of pre-exposure prophylaxis (PrEP) for HIV prevention, and sexual behavior intentions with PrEP adoption among HIV-negative gay and bisexual men (GBM) in HIV serodiscordant relationships. A multiracial/ethnic sample of 25 HIV-negative GBM in serodiscordant relationships completed a qualitative interview and a brief interviewer-administered survey. A modified grounded theory approach was used to identify key themes relating to acceptability and future adoption of PrEP. Participants reported engaging in sexual risk behaviors that place them at risk for HIV infection. Participants also reported a high level of acceptability for PrEP and willingness to adopt PrEP for HIV prevention. Qualitative themes explaining future PrEP adoption included: (1) the opportunity to engage in sex using a noncondom HIV prevention method, (2) protection from HIV infection, and (3) less anxiety when engaging in sex with an HIV-positive partner. Associated with the future adoption of PrEP, a majority (64%) of participants indicated the likelihood for an increase in sexual risk behaviors and a majority (60%) of participants also indicated the likelihood for a decrease or abandonment of condom use, both of which are in contrast to the findings from the large iPrEx study. These findings suggest that the use of PrEP by HIV-negative GBM in serodiscordant relationships carries with it the potential for risk compensation. The findings suggest that PrEP only be offered as part of a comprehensive HIV prevention strategy that includes ongoing risk reduction counseling in the delivery of PrEP to help moderate risk compensation.     

Knowledge,Stereotyped Beliefs and Attitudes Around HIV Chemoprophylaxis in Two High HIV Prevalence Neighborhoods in New York City

HIV chemoprophylaxis (PrEP/PEP) has emerged as a transformative prevention tool to reduce infection rates and decrease disease burden. However, uptake is low, and efficacy depends upon adherence. To maximize impact, potential barriers to uptake and adherence must be identified and understood. Using univariate and logistic regression analytic methods, we assessed associations among potential barriers to uptake and adherence, including HIV chemoprophylaxis knowledge, negative stereotyped beliefs about people who use it and negative attitudes towards HIV chemoprophylaxis use by relatives among 583 residents of two high HIV prevalence neighborhoods in New York City. About a quarter of respondents knew about HIV chemoprophylaxis and over 50 % endorsed negative stereotyped beliefs about users; yet, approximately two-thirds had positive attitudes toward its use among a male or female relative. Young age, having lesbian or gay friends/family members and low levels of homophobia were associated with not endorsing negative stereotyped beliefs. Negative stereotyped beliefs were not associated with negative attitudes toward HIV chemoprophylaxis use among relatives. Implications for PrEP dissemination are discussed.     

Willingness to Use HIV Pre-Exposure Prophylaxis Among Opiate Users

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.     

Perceived HIV risk,actual sexual HIV risk and willingness to take pre-exposure prophylaxis among men who have sex with men in Toronto,Canada

Pre-exposure prophylaxis (PrEP) reduces HIV acquisition. Our goal was to determine the willingness of men who have sex with men (MSM) to take PrEP given perceived and actual HIV risk. HIV-negative MSM were recruited from September 2010 to June 2012 and asked about PrEP willingness and perceived HIV risk. Actual sexual HIV risk was measured by three condom-use components generated through principal components analysis. General HIV risk was measured using the HIV Incidence Risk Index for MSM (HIRI-MSM). Model 1 measured PrEP willingness given perceived and actual sexual HIV risk. Model 2 included actual HIV sexual risk, perceived HIV risk and general HIV risk. Model 3 removed actual sexual HIV risk. We recruited 150 HIV-negative MSM. About 55% were willing to take PrEP. Reasons for PrEP unwillingness were: low perceived risk (64%), side-effect concerns (44%), daily pill burden (16%) and efficacy concerns (4%). Model 1: MSM with high compared to low actual sexual HIV risk were more willing to use PrEP (OR 27.11, 95% CI 1.33–554.43) after adjusting for perceived risk, which was not significantly associated with PrEP willingness (OR 4.79, 95% CI 0.72–31.96). Model 2: MSM with high compared to low actual sexual HIV risk were more willing to use PrEP (OR 29.85, 95% CI 1.39–640.53) after adjusting for perceived and general HIV risk, neither of which was significantly associated with PrEP willingness (OR 5.07, 95% CI 0.73–35.09) and (OR 1.58, 95% CI 0.37–6.79), respectively. Model 3: After removing actual sexual HIV risk, MSM with high compared to low perceived risk were more willing to use PrEP (OR 6.85, 95% CI 1.23–38.05), and the HIRI-MSM general risk index was not associated with PrEP willingness (OR 1.87, 95% CI 0.54–6.54). Therefore, actual sexual HIV risk was the best predictor of PrEP willingness and general HIV risk did not inform PrEP willingness.     

Effects of Messaging About Multiple Biomedical and Behavioral HIV Prevention Methods on Intentions to use Among US MSM: Results of an Experimental Messaging Study

Combining multiple biomedical and behavioral HIV prevention approaches is a priority for at-risk populations such as men who have sex with men (MSM), and it is essential to understand how receiving messages about multiple approaches impacts attitudes and intentions for their use. We examined whether receiving combinations of different HIV prevention messages produced differences in perceived benefits and costs of condom use, and in intentions to use condoms and biomedical prevention approaches. MSM (N = 803) were recruited online and were randomly assigned to view informational messages about one, two, or four of the following prevention options: pre-exposure prophylaxis (PrEP), non-occupational post-exposure prophylaxis (nPEP), rectal microbicides, and condoms. The number of HIV prevention messages did not produce differential attitudes and intentions regarding condoms, nor did it produce changes in attitudes towards unprotected sex. Receiving multiple messages was associated with greater intentions to use PrEP and nPEP, but not rectal microbicides.     

Awareness and Acceptability of Pre-exposure HIV Prophylaxis Among Men Who have Sex with Men in Baltimore

This paper assessed characteristics associated with awareness of and willingness to take pre-exposure prophylaxis (PrEP) among Baltimore men who have sex with men (MSM). We used data from BESURE-MSM3, a venue-based cross-sectional HIV surveillance study conducted among MSM in 2011. Multivariate regression was used to identify characteristics associated with PrEP knowledge and acceptability among 399 participants. Eleven percent had heard of PrEP, 48% would be willing to use PrEP, and none had previously used it. In multivariable analysis, black race and perceived discrimination against those with HIV were significantly associated with decreased awareness, and those who perceived higher HIV discrimination reported higher acceptability of PrEP. Our findings indicate a need for further education about the potential utility of PrEP in addition to other prevention methods among MSM. HIV prevention efforts should address the link between discrimination and potential PrEP use, especially among men of color.     

Supporting Study Product Use and Accuracy in Self-Report in the iPrEx Study: Next Step Counseling and Neutral Assessment

The recent successes of biomedical HIV prevention approaches have sparked considerable debate over the scalability, feasibility, and acceptability of pre-exposure prophylaxis (PrEP) as a widespread prevention strategy for men who have sex with men and trans-gender. Anticipated difficulties with PrEP adherence and concerns about resources required to best support it have tempered enthusiasm of PrEP demonstration projects and roll-out. While no evidence-based approach for supporting PrEP use is presently available, a number of approaches have been developed in the context of double-blind, randomized, placebo-controlled trials of PrEP that can provide guidance in moving forward with real world support of open label PrEP use. We present the development, implementation and evaluation of feasibility and acceptability of next-step counseling (NSC) and neutral assessment (NA), the adherence support and promotion of accurate reporting approaches used in the late phases of the iPrEx study. Evaluation of the approach from the perspective of implementers of over 15,000 NSC sessions in seven different countries with almost 2,000 iPrEx participants provided support for NSC, its brevity (averaging ~14 min per follow-up session) and overall acceptability and feasibility. NA also was generally well supported, with a majority of study staff believing this approach was feasible and acceptable; however, lower acceptability for certain aspects of NA was noted amongst staff reporting NA was different from their previous interview approach. Quantitative and qualitative data gathered from implementers were used to make modifications for supporting PrEP use in the open-label extension of iPrEx.     

Pre-exposure prophylaxis--one more tool for HIV prevention

The 30 years of the human immunodeficiency virus (HIV) epidemic have been marked by many triumphs. Today, thanks to life-saving anti-retroviral medications, patients are living longer than ever. However, despite scientific advances in the field of HIV treatment, HIV prevention has had less success. Despite efforts on several fronts, the number of new HIV diagnoses each year in the United States is unchanged. In this review, we will give a brief overview of the ups and downs of the field of HIV prevention, focusing on pre-exposure prophylaxis (PrEP). CAPRISA 004, iPrEx, FEMPREP, the VOICE trial and HPTN 052, among other prevention trials, are discussed. The CAPRISA 004 and iPrEx studies suggest optimism regarding the use of PrEP for those at risk for HIV infection, but the recent early termination of FEM-PREP and of one arm of VOICE has led to tempered enthusiasm. Many questions remain: Who should get PrEP? How long is it safe to take PrEP? What role will adherence play, and will there be problems with acquired resistance to the drugs with larger numbers using it daily? What is the best method of administering PrEP? Pre-exposure prophylaxis alone is unlikely to be the magic bullet- instead, this strategy will likely need to be part of a broader test-and-treat effort, ongoing education, treatment of sexually transmitted infections, and condom use.     

Differences in awareness of and willingness to use pre-exposure prophylaxis and anticipated condom use among serodiscordant couples in Taiwan

Pre-exposure prophylaxis (PrEP) has proven to be effective in reducing the risk of HIV transmission in uninfected individuals who engaged in sexual activity with HIV-infected partners. Serodiscordant couples are the key targets of PrEP implementation. The study aimed to compare awareness of and willingness to use PrEP and anticipated condom use among 112 HIV-serodiscordant couples: 32 heterosexuals couples, 70 men who have sex with men (MSM) couples, and 10 people who inject drugs (PWID) couples. A cross-sectional study was conducted in an AIDS designated hospital in Taiwan. The PrEP survey for discordant couples included questions on awareness of non-occupational post-exposure prophylaxis (nPEP) and PrEP, attitudes toward PrEP, anticipated condom use if using PrEP, and sexual behaviors. Overall, 46.2% were aware of PrEP, only 33% were willing to take PrEP, and 44.6% would continue condom use if they were taking PrEP. Among the three key populations, MSM couples had the highest awareness of and willingness to use PrEP. Awareness of and willingness to use PrEP did not differ by HIV status, with moderate agreement (Cohen’s Kappa coefficient: 0.56) between HIV-serodiscordant partners. Both HIV-serodiscordant partners’ willingness to use PrEP was significantly associated with being MSM (adjusted odds ratio (AOR), 4.28 [1.28–14.30], p?=?0.018), previous receipt of nPEP (AOR, 6.98 [1.23–39.65], p?=?0.028), anticipated condom use (AOR, 0.14 [0.05–0.41], p?p?=?0.05). Policy makers need to consider the differences among key populations to scale up PrEP implementation. More efforts should be focused on improving awareness of and willingness to use PrEP among heterosexual and PWID serodiscordant couples to scale up PrEP implementation in Taiwan.     

Pre-exposure prophylaxis and antiretroviral resistance: HIV prevention at a cost?

Pre-exposure prophylaxis (PrEP), the use of antiretrovirals (ARVs) by human immunodeficiency virus (HIV)-uninfected individuals to prevent acquisition of the virus during high-risk sexual encounters, enjoyed its first 2 major successes with the Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 and the Pre-Exposure Prophylaxis Initiative (iPrEx). These successes were buoyed by additional positive results from the TDF2 and Partners PrEP trials. Although no seroconverters in either arm of CAPRISA developed resistance to tenofovir, 2 participants in iPrEx with undetected, seronegative acute HIV infection were randomized to receive daily oral tenofovir-emtricitabine and resistance to emtricitabine was later discovered in both men. A similar case in the TDF2 study resulted in resistance to both ARVs. These cases prompted us to examine existing literature on the nature of resistance mutations elicited by ARVs used for PrEP. Here, we discuss the impact of signature mutations selected by PrEP, how rapidly these emerge with daily ARV exposure, and the individual-level and public health consequences of ARV resistance.