Lilianna Angel Reyes

PrEP's success should not be measured by quantity but by quality. The basic level of health care accessibility should allow people high-quality health care provided by premiere providers and frontline staff.

Access Means More Than Co-Pays: PrEP Success for Transgender Women of Color

Preston Mitchum

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It's time that patients, providers, pharmaceutical companies and the public health community have honest and difficult conversations about condoms, PrEP and bodily pleasure.

PrEP and Pleasure: We Need More Holistic Sexual Health Conversations

Howard Grossman, M.D.

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PrEP has been nothing short of revolutionary in changing the landscape of HIV prevention. What has been less discussed are the enormous secondary benefits that have followed the introduction of PrEP.

The Overlooked Secondary Benefits of PrEP

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Critics have been warning since the concept of oral PrEP was in its infancy that it would lead to major increases in condomless sex among users and a corresponding dramatic spike in STIs. So far, the data has been inconclusive.

What's Up With PrEP and STIs?

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Terri Wilder, M.S.W.

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Could a provider's personal beliefs about condom use affect their willingness to prescribe PrEP? One study surveyed U.S. medical students and found bias in terms of willingness to offer PrEP based on clinical situations.

Condoms and the Double Standard in Prescribing PrEP

Warren Tong

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PrEP (pre-exposure prophylaxis) is highly effective at preventing HIV, but uptake has been slow around the world. We asked providers and community leaders what they thought needed to happen for PrEP to reach everybody who needs it.

What Needs to Happen for PrEP to Reach All Who Need It?

Rubén Cabrera has vitals checked by nurse

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Demetre Daskalakis 900x600

Demetre Daskalakis (left) and Rubén Cabrera 900x600

Pre-exposure prophylaxis (PrEP) provides nearly 100% protection from HIV infection -- and it's also a powerful incentive to affirming primary care, as described by Demetre Daskalakis, M.D., M.P.H, and his patient Rubén Cabrera.

PrEP: More Than an HIV Prevention Tool

PrEP for HIV Prevention: You and Your Patient

"There is something very unique about the relationship between a PrEP provider and their patient." --Demetre Daskalakis, M.D.

Bridging the Gap: PrEP for HIV Prevention -- You and Your Patient

Bridging the Gap: HIV PrEP

Identification of clients at highest risk of acquiring human immunodeficiency virus (HIV) is a critical component to PrEP implementation. CDC published clinical practice guidelines for identifying individuals as PrEP candidates in 2014 and developed a risk-screening tool:

One of the key components of PrEP (pre-exposure prophylaxis) rollout is identifying those who are at highest risk of HIV. The CDC (U.S. Centers for Disease Control and Prevention) has clinical guidelines for identifying PrEP candidates and developed a risk-screening tool. One study examined how accurate these current guidelines and risk-screening tools are among a group of young Black men who have sex with men. Terri Wilder, M.S.W., spoke with study author John Schneider, M.D., M.P.H., at CROI 2017, in Seattle.

You can also read the [study abstract](http://www.croiconference.org/sessions/prep-guidelines-have-limited-accuracy-identifying-young-msm-prior-seroconversion) and view the [study poster](http://www.croiconference.org/sites/default/files/posters-2017/969_Schneider.pdf).

__Terri Wilder:__ Can you take our readers through your study, telling us about the background, objective methods, your analysis and, of course, your conclusions?

__John Schneider, M.D., M.P.H.:__ Sure. We started a cohort study in 2012 that was focused on young black gay and bisexual men in Chicago. We started in 2012 because that's when pre-exposure prophylaxis [PrEP] really started being implemented. We followed this cohort over time. We were really interested in how the different guidelines -- the Centers for Disease Control and Prevention [CDC] guidelines, the HIRI Risk Index guidelines and Gilead indications -- would predict whether someone seroconverted or not. And so, [cohort members] were followed over time. They were asked a bunch of questions relative to the guidelines. This was a sample of 612 individuals at baseline.

What we found was very interesting. First of all, all of the traditional risk factors -- you know, things like having an anal/rectal sexually transmitted infection, having a sexual relationship with an HIV-positive male partner -- all these sorts of things did not predict seroconversion. The only thing that predicted seroconversion in this cohort was having a partner 10 or more years older than you.

The CDC clinical practice guidelines missed about half of the seroconversions. There were 33 seroconversions, and half of those people would not have been eligible for PrEP according to the CDC guidelines.

Now, you know, more of them were eligible with the HIRI guidelines and the Gilead guidelines, but then those guidelines also identified more people that would not seroconvert, so the specificity would go down. We found that the HIRI guidelines was probably the best, but it still had limitations.

In some, the implications of this are really that if a general provider who doesn't do a lot of PrEP care, or doesn't know about the epidemic, opens up some guidelines, they may have different implications for the clients that they're serving. They may miss some who need it, and they may give it to some who don't need it. We might want to think about guidelines that are not based on risk behaviors but more on network prevalence of HIV.

__TW:__ Can you talk a little bit more about the HIRI Risk Index that may have missed a little something? Is there something that maybe needed to be added to that from your analysis?

__JS:__ I think it did really well. The reason why it did well is because it really, for younger guys, it really increased the index. The age piece was important. In young black gay and bisexual men being 16 to 29 is an important age group. That wasn't included in some of the other indices.

What can be added to it? It's doing pretty good at capturing who, at predicting who, would have a seroconversion if they weren't on PrEP. Not as good as Gilead, but Gilead had very permissive guidelines. For the 15% that were missed, I can't tell you off the top of my head what would capture them. It's clearly not any of the classic variables that people look at.

__TW:__ When you think about guidelines, there's the CDC guidelines, there are some states that have their own guidelines -- for example, the New York State Department of Health AIDS Institute has its own PrEP guidance -- if we're going to get to a place where we're offering and getting folks on PrEP who really need to be on it, what do you think would be a strategy to think about, in addition to guidelines or guidance?

__JS:__ Well, I think a lot of good public health messaging campaigns, whether that's online, whether that's traditional posters, billboards; that sort of thing. In Chicago, we have the PrEP for Love campaign; it's a sex-positive campaign. People can call in and learn more about PrEP. We basically start most people on PrEP and then decide later on whether they should stop PrEP.

Not enough people are talking about: How do you stop PrEP? But it's hard for clinicians. The question I think we have to face is whether this is going to be something that every doc in their clinic is going to offer, or whether people have to have specialized training and understanding about what it means to be a good PrEP provider.

Its intent was to be in every primary care setting. I think that's noble. But in actuality it takes a lot of experience to work with the populations that need it most.

__TW:__ In terms of clinical education, in terms of training medical providers -- whether an M.D., a nurse practitioner, a physician assistant -- I wonder if you can speak to whether there is room for knowing your epidemic as part of a strategy to identifying folks for PrEP?

__JS:__ Yeah. It's knowing your epidemic. But you could be in a specific geographic location and have people that come from outside of that geographic location. And even within the geographic location, there are just so many strata of people -- by race, age, ethnicity -- that it's hard to pull up an AIDS view map and say, well, this neighborhood has a lot of HIV, so we should give it.

Sure. It's crude. So, you could follow that. But it's not -- it's going to still miss some, and it's still going to give people PrEP who don't need it.

__TW:__ In terms of social networking, looking at that, can you speak to that, as well?

__JS:__ Yeah. I'm obsessed with networks. Yeah.

__TW:__ OK. Tell me about your obsession.

__JS:__ Networks drive everything. Sure, there's behaviors; but the real drivers of HIV are network phenomena. So, we don't know enough about who we're exposed to. Classically, in this community, for example, young black gay and bisexual men have fewer sex partners. They use drugs less than their white men who have sex with men counterparts. Yet, they have higher rates of HIV. And so it's a network phenomenon. It's the surrounding seroprevalence in the patterns of mixing.

If we can have network data, which is hard to get, then this is easy. In fact, in the Gilead recommendations, all these risk factors were in the network members. You know, if your network member has gone to jail, if your network member is using a lot of drugs -- that's more predictive of one's own probability of getting infected. So, you know, for whatever that's worth. It's just hard to get. That's why people use these proxies, such as, behavioral -- you know, "Do you use condoms?" "How many partners do you have?" Things like that.

__TW:__ Great. Very interesting. Thank you so much.

*This transcript has been lightly edited for clarity.*

Terri Wilder, M.S.W., spoke with John Schneider, M.D., M.P.H., author of a study  that examined how accurate current guidelines for identifying PrEP candidates and risk-screening tools are among a group of young Black men who have sex with men.

John Schneider

John Schneider, M.D., M.P.H.

Are Current PrEP Guidelines and HIV Risk-Screening Tools Accurate?

Are Current PrEP Guidelines and HIV Risk-Screening Tools Accurate Enough?

Pre-exposure prophylaxis (PrEP) remains an underutilized method of HIV prevention, with growing evidence that the most important barriers to wider use do not lie with patients but with health care professionals, who act as gatekeepers and conduits to this prescription medicine.

Some health care providers may have concerns or misgivings about PrEP, including fears that some PrEP users may increase their sexual risk-taking behavior because they feel less susceptible to HIV while taking PrEP. This may be referred to as "risk compensation" or "behavioral disinhibition" and refers to individuals using condoms less often, having more sexual partners, or otherwise having riskier behavior while taking PrEP. No study has identified a consistent pattern of risk compensation in PrEP users, although it may describe the behavior of a minority of PrEP users.

How do other health care providers manage and think about this issue? Sarah Calabrese, Ph.D., and colleagues conducted in-depth interviews with 18 "early adopter" PrEP providers in order to find out. Most were infectious disease or HIV specialists, working in university-affiliated medical centers or hospitals, in the northeast or the south of the United States. Key findings were published in the [April 2017 issue of AIDS Patient Care and STDs](http://online.liebertpub.com/doi/abs/10.1089/apc.2017.0002).

Most interviewees' role as a provider was to support patients in making informed choices about their sexual health. The providers emphasized the benefits of using condoms together with PrEP (particularly in relation to sexually transmitted infections), but recognized that patients may not always follow these recommendations. Some providers valued a patient-centered approach to care, in which they aimed to support each client "at the space that they are in," as one provider put it.

Another interviewee explained a more situational-based approach: "When I talk about whether taking PrEP may change people's behavior... as a provider it's not my business. My job, as a provider, is making sure that I use the methods that I have available to minimize negative outcomes. So I spend less time into trying to change people in society, but to give them information so they can make better decisions when they are in x, y, z situations."

Some providers recognized their knowledge of patients' sexual behaviors is incomplete because, as one put it, "there's always this thing about seeing a doctor and saying the right thing in front of them." And many felt that patients had insights into their own sexual behavior that health care providers inevitably lacked. Many providers felt that, in general, "people know what's best for themselves" and so patients must be actively involved in making choices about their own health.

Many of the providers interviewed were skeptical that "risk compensation" would offset the protective benefit of PrEP, and it may not in fact be a new behavior in response to PrEP. "I don't think people really change their behaviors. The people who are not using condoms with PrEP never used condoms without PrEP," one interviewee explained, summarizing the feeling that it would not be possible for some patients' behaviors to become any riskier.

Several providers also expressed confidence that even if patients did increase their risk behavior, the high level of protection against HIV that PrEP affords would more than offset that increase. One noted that the best evidence for the efficacy of condoms during vaginal sex is around 80%, but that people who adhere to PrEP have close to 100% protection.

"So now you have this medication you can take every day that appears, possibly, certainly as effective, if not more effective, than condoms. So there's no way that I would ever not give PrEP out to someone, even if their condom use went to zero."

The providers also felt that PrEP-related risk compensation was unduly stigmatized by health care professionals and in wider society. "You should just view it like you view treating high cholesterol," one provider said. "You know, sometimes people who are taking statin drugs might eat steaks now and then because they feel like they can 'cause they're on this drug ... "

Others drew parallels with family planning: Women using hormonal contraception often stop using condoms. Appropriately, that behavior is not stigmatized, providers said. But they shared multiple anecdotes of their patients being discouraged when initially seeking PrEP from other providers. 

"The biggest clinical challenges for me have been supply side," one health care professional shared. "What I mean by that is primary care doctors or primary care providers or even other HIV specialists who are not supportive of PrEP use, and shaming patients."

Some believe that prescribing PrEP is a professional obligation when it was clinically indicated. To withhold PrEP due to concerns about changes in a patient's condom use or partner numbers would constitute an imposition of the provider's personal values and preferences rather than an evidence-based clinical decision.

Finally, several interviewees said that their own thinking and attitudes had evolved, from initial ambivalence to greater acceptance of PrEP and PrEP-related behavior change. The researchers hope that sharing their insights will help other health care providers develop their own thinking on this issue.

Roger Pebody

PrEP remains an underutilized method of HIV prevention, with growing evidence that the most important barriers to wider use do not lie with patients but with health care professionals.

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Managing Risk Compensation in PrEP Users

How Can Providers Deal With Concerns About Risk Compensation in PrEP Users?

Many men who have sex with men (MSM) who cited low HIV risk as a reason for not wanting to start pre-exposure prophylaxis (PrEP) actually had key HIV risk factors, according to results of a cross-sectional survey analysis presented at IDWeek 2016. Compared with white MSM, black MSM were more likely to consider PrEP only if it were free.

The CDC [estimates](http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6446a4.htm) that almost a half-million MSM in the United States are candidates for PrEP. Emory University researchers who conducted the survey study noted that Atlanta ranks seventh on the list of most new HIV diagnoses in the United States, and MSM account for 76% of those diagnoses. They hypothesized that reasons for starting or declining PrEP may differ between black and white MSM because of disparities between those groups in HIV incidence, sociodemographic factors, and health care access.

To test that hypothesis, the investigators conducted a [cross-sectional analysis](https://idsa.confex.com/idsa/2016/webprogram/Paper56837.html) of 482 HIV-negative MSM enrolled in the Emory-based InvolveMENt PrEP study. From February 2012 through April 2013, participants completed a survey on willingness to take PrEP and motivators and barriers to using PrEP. Most men, 82%, took the survey just before FDA approval of daily tenofovir/emtricitabine (Truvada) PrEP.

Among the 219 black men and 263 white men, blacks included a higher proportion of 18- to 25-year olds (55% versus 34%, *P* = .004), a higher proportion with less than a college education (65% versus 41%, *P* = .0004), a higher proportion without health insurance (43% versus 23%, *P* < .0001), a higher proportion without a primary care visit in the past year (40% versus 24%, *P* < .0001) and a lower proportion reporting substance use (28% versus 50%, *P* < .0001). A higher proportion of black than white MSM got diagnosed with a sexually transmitted infection (STI) during follow-up (38% versus 19%, *P* < .0001), but a lower proportion of black men had condomless anal intercourse in the past 12 months (65% versus 76%, *P* = .007).

Nearly identical proportions of black and white men (44.8% and 44.5%) expressed a willingness to use PrEP. Multivariate logistic regression analysis identified only one factor that independently predicted willingness to use PrEP -- having condom-free anal sex in the past 12 months (adjusted odds ratio 1.7, 95% confidence interval 1.1 to 2.6). Insurance status, HIV/STI incidence and number of anal sex partners in the past 12 months were not associated with PrEP willingness in this analysis.

White MSM were more likely than black MSM to say they would consider PrEP if a doctor recommended it (45% versus 22%, *P* = .002) or if a counselor or other health care worker recommended it (39% versus 21%, *P* = .012). Whites differed from blacks in four reasons explaining unwillingness to start PrEP: not being sexually active (8% versus 17%, *P* = .017), partner HIV-negative (33% versus 11%, *P* < .0001), not wanting to take a pill every day (42% versus 29%, *P* = .038) and not wanting to go to doctor every three months (25% versus 7%, *P* = .0003).

Among 137 men who listed "low risk behavior" as a reason for unwillingness to start PrEP, 77 (56%) actually had high risk indicated by condomless anal sex in the last 12 months, while 39 (28.5%) had a new STI during study follow-up. Overall, most men said they would consider PrEP if it cost less than $50 per month. But a higher proportion of black than white men (26% versus 18%, *P* = .03) said they would use PrEP only if it were free.

Because of the discordance between perceived and actual HIV risk in this study group, the Emory investigators recommended "formal population-specific risk assessment tools which combine risk behavior assessment with local epidemiologic risk ... to identify high-risk men who may benefit from PrEP."

Mark Mascolini

Many men who have sex with men who cited low HIV risk as a reason for not wanting to start PrEP actually had key HIV risk factors, according to results of a cross-sectional survey analysis.

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Perceived and Actual HIV Risk Behaviors Differ in MSM Surveyed on PrEP

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