Juan Michael Porter II

Staff Writer

on a date-iStock-992048664

Open conversations between care providers and Black women are vitally important in order to empower women with information about HIV and how to protect their health.

Real Talk at SYNChronicity 2020: Black Women Are Essential to Eliminating HIV

Chase Alston

telehealth-iStock-1224542353

Washington, D.C. area community organizations and clinics have moved a lot of prevention efforts online, but much is missing without in-person contact.

Getting PrEP to Those Who Need It During COVID-19 Has Presented New Challenges

Terri Wilder, M.S.W.

Zeda Rosenberg and Manju Chatani

Two experts discuss the history of the ring, how it works, and when it may come to the United States.

A Vaginal Ring to Prevent HIV Was Given a Positive Opinion by a European Drug Regulator. Here’s What You Need to Know About It.

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If you’re a provider in or outside the state, you’ll want to read these new guidelines.

To Increase Access to HIV Post-Exposure Prophylaxis, New York State Updated Its Guidelines for Clinicians

injectable-iStock-97503451

Richard Jefferys of Treatment Action Group discusses the pipeline for new modalities being explored for treatment, PrEP, vaccine, and cure.

What Are the New HIV Treatment and Prevention Drugs Under Development in 2020?

Lynne Mofenson

This researcher has some ideas about what we need to do to address the problem.

After Years of Decline, Perinatal HIV Transmission Has Hit a Plateau. Why?

cisgender woman prescription-iStock-183431557

Two researchers discuss their analysis of Philadelphia FIGHT’s HIV pre-exposure prophylaxis (PrEP) program for cisgender women.

Evaluating PrEP Uptake and Adherence in Cisgender Women—and What to Do About It

Larry Buhl

drive thru testing-GettyImages-1225090483

Some advocates support it but want to ensure protections against criminalization. 

Could COVID-19 Contact Tracing Also Help End HIV? These Researchers Think So.

PrEP prescription-iStock-1169001422

Home HIV and STI testing is now being endorsed by the Centers for Disease Control and Prevention to start or continue pre-exposure prophylaxis (PrEP).

CDC Issues New Guidance for Easier PrEP Access During COVID-19

Akilah Wise, Ph.D.

African American couple-iStock-1128717752

Researchers say the “bisexual bridge” theory creates stigma and biphobia.

Increased HIV Testing and Treatment for Black Bisexual Men May Have Played a Role in HIV Drop in Black Women. But Has the Stigma Gone Away?

A new U.S. study reinforces that on-demand pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy for those who don’t want the more common daily dosing. In the study, published last week in the journal *Clinical Infectious Diseases*, researchers followed 279 male Kaiser Permanente patients in San Francisco for three months of 2-1-1 dosing. They found that none of the patients contracted HIV during the study period, and few reported missed doses.
 
PrEP 2-1-1 involves taking a double dose of emtricitabine/tenofovir disoproxil fumarate (Truvada) between two and 24 hours before anticipated sex, one dose 24 hours after the initial double dose, and a final dose 24 hours after that.

Carlo Hojilla, Ph.D., RN, a research fellow with the Kaiser Permanente Northern California Division of Research and one of the authors of the study, told TheBody that 2-1-1 dosing, when used as directed, is safe and effective at preventing HIV, and a “good strategy for those reluctant to take a daily dose.”

The Kaiser study provides one of the first major sets of data that demonstrate the effectiveness of 2-1-1 dosing from the United States. Recent studies from France and the Netherlands have also shown that 2-1-1—PrEP taken before and after sex—works at preventing HIV for men who have sex with men, regardless of the frequency of sex.

Clients in the Kaiser study who were already on daily PrEP were told about PrEP 2-1-1 and given an opportunity to switch; those starting PrEP could choose between the on-demand or daily regimen. Three-quarters had previously used PrEP, including 11 men who had used the 2-1-1 regimen before Kaiser started offering it and six who had used other nondaily schedules, such as taking PrEP only when on vacation. All but six of the men who were prescribed on-demand PrEP completed their three-month follow-up visit. Of these, 51% exclusively used the 2-1-1 regimen during that period, 19% switched to a daily dose, 15% used a combination of daily and 2-1-1, and 3% never started PrEP. 

Approximately 14% of the men reported challenges using the 2-1-1 regimen, including forgetting the dosing regimen, not planning for sex in advance, and side effects. Twenty men discontinued PrEP due to loss of health insurance, reduced sexual risk, or side effects.

Among the 181 men who used the 2-1-1 regimen exclusively or in combination with daily dosing, only 4% reported missing a dose of Truvada the last time they had sex. On average, they used one course of PrEP 2-1-1—or four pills—during a month. “Our results did show a low number of challenges with 2-1-1, and those who did have challenges switched over to daily PrEP,” Hojilla said.

Hojilla admitted that the study has some limitations: It’s not clear what sexual activities or sexual positions the study participants engaged in, which could make a difference in their risk of HIV. Gauging precise reasons for adherence issues was also difficult. “The question was phrased, ‘Did you miss any doses?’” Hojilla said; “5.9% said that they did, or they had trouble remembering when to take a dose, but that’s a pretty low number.” Hojilla added that no subjects initiated PEP (post-exposure prophylaxis), suggesting nobody who skipped a dose had engaged in risk exposure.

Kaiser San Francisco started offering 2-1-1 PrEP in February 2019. The San Francisco AIDS Foundation’s Magnet sexual health service at Strut began offering 2-1-1 a month later. The World Health Organization and the International Antiviral Society-USA have endorsed on-demand PrEP for men who have sex with men, but the U.S. Food and Drug Administration has not approved the regimen, mainly because it has not yet been studied in cisgender (non-transgender) women or transgender men. Study results for cisgender men only apply to Truvada, not emtricitabine/tenofovir alafenamide (Descovy), which was approved last year as an alternative daily PrEP option.

There is no data on how many U.S. medical professionals are prescribing PrEP 2-1-1, but Hyman Scott, M.D., M.P.H., medical director for clinical research at Bridge HIV in the San Francisco Department of Public Health, said few providers feel empowered to counsel for 2-1-1 and therefore only prescribe Truvada or Descovy for daily use, if they prescribe it at all.
 
“Counseling is more complex for 2-1-1,” Scott said. “And we are still working on expanding daily PrEP now, eight years after [Truvada] approval, and we’re continuing to encourage and expand that.”
 
Scott noted that people go back and forth between 2-1-1 and daily PrEP, depending on their sexual needs, regardless of what their providers say.
 
Hojilla agrees that often patients are savvier than their doctors about dosing, and that some will adopt alternate regimens, including T’s and S’s, which is four days a week, on Tuesdays, Thursdays, Saturdays, and Sundays, or vacation dosing. “What’s needed are some clear regulatory guidelines for intermittent PrEP use. There’s still a hesitation for doctors to prescribe, and a lack of guidance is a barrier to implementation,” Hojilla said.

The Centers for Disease Control and Prevention has estimated that more than a million people in the U.S. could benefit from PrEP. But since its introduction in 2012, prescriptions have lagged far behind the need, especially for the most vulnerable populations, including Black and Latinx men and transgender women. Globally, PrEP use is lagging too: It’s estimated that PrEP use is one-tenth of the World Health Organization’s goal of 3 million PrEP users by 2020.

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Kaiser Permanente’s 2-1-1 pre-exposure prophylaxis (PrEP) program shows event-driven dosing works.

New Study Shows Effectiveness of On-Demand PrEP

- “On-Demand PrEP Is Great. Now, What About Women?” TheBodyPro. August 30, 2018. [thebodypro.com/article/on-demand-prep-is-great-now-what-about-women](http://www.thebodypro.com/article/on-demand-prep-is-great-now-what-about-women)  
- “Early Adopters of Event-Driven Human Immunodeficiency Virus Pre-Exposure Prophylaxis in a Large Healthcare System in San Francisco,” *Clinical Infectious Diseases*. June 4, 2020. [doi:10.1093/cid/ciaa474](https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciaa474/5850905?redirectedFrom=fulltext) 
- “Sexual Behaviour and Incidence of HIV and Sexually Transmitted Infections among Men Who Have Sex with Men Using Daily and Event-Driven Pre-Exposure Prophylaxis in AMPrEP: 2 Year Results from a Demonstration Study,” *The Lancet HIV*. June 6, 2019. [doi:10.1016/s2352-3018(19)30136-5](https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(19)30136-5/fulltext) 
- “PrEP Before and After Sex Worked as Well as Daily PrEP in Preventing HIV, New Study Finds,” TheBodyPro. July 30, 2018. [thebodypro.com/article/on-demand-prep-vs-daily-hiv-prevention-prevenir](http://www.thebodypro.com/article/on-demand-prep-vs-daily-hiv-prevention-prevenir) 
- “Estimates of Adults with Indications for HIV Pre-Exposure Prophylaxis by Jurisdiction, Transmission Risk Group, and Race/Ethnicity, United States, 2015,” *Annals of Epidemiology*. May 18, 2018. [doi:10.1016/j.annepidem.2018.05.003](https://www.sciencedirect.com/science/article/abs/pii/S1047279717310694?via%3Dihub) 

HIV Prevention

illustration of mixed-status couples from 'PrEP and HIV Prevention: A Quick Primer on a Hot Topic'

News, analysis, research, and key information for health care providers on HIV epidemiology, testing, and transmission.

Spotlight Center: HIV Prevention Today

  
After years of programs focusing on prevention for positives, we've learned that treatment is in fact the best prevention option for people who are HIV positive. In fact, treatment works so well that people who successfully achieve viral suppression are not at risk of passing the virus on to their partners, even without using condoms or other barrier methods.

While over the last decade the science was quickly mounting evidence that this was true, it took a push from people living with HIV to begin making public health and medicine shift clinical guidelines, policies, and program priorities to address this reality. Due to [community pressure and activism](https://www.preventionaccess.org/undetectable), the language that physicians, scientists, and public health bodies use to describe the potential for HIV transmission when a person has an undetectable viral load is now much clearer.

The slogan "Undetectable = Untransmittable" (U=U) is simple and easy to grasp. Moreover, as Anthony S. Fauci, M.D., the director of the National Institute of Allergy and Infectious Diseases (NIAID), has said, "[The science really does verify and validate U=U](https://www.youtube.com/watch?v=LffrIfipgwc&feature=youtu.be)."

U=U expresses the fact that people living with HIV who take antiretroviral medications daily as prescribed and who maintain a durable undetectable viral load do not transmit HIV to their sexual partners. When a person has had an undetectable viral load for at least six months and maintains good adherence, there is effectively no risk that he or she will sexually transmit the virus.

  

Talking About U=U
-----------------

Language matters. When speaking with people living with HIV, their sexual partners, and the wider community, it is important to describe these facts in a way that inspires confidence and does not promote unnecessary doubts or fear.

For example, it is scientifically accurate to say that the risk of transmission in these circumstances is "negligible." However, this can sometimes be misinterpreted to suggest that a risk still needs to be taken into account or remains of practical significance.

It is preferable to use terminology that is less likely to be misunderstood. For example the Centers for Disease Control and Prevention (CDC) [uses the phrase](https://www.cdc.gov/hiv/library/dcl/dcl/092717.html) "effectively no risk" and states that effective antiretroviral therapy "prevents sexual HIV transmission." Others say that those with a durable undetectable viral load "do not transmit," "cannot transmit," or "will not transmit" HIV.

  

The Science Behind U=U
----------------------

Data showing the relationship between an HIV-positive person's viral load and their HIV-negative partner's risk of acquiring HIV have been available for almost two decades. [A key study, from a Ugandan cohort](http://www.nejm.org/doi/full/10.1056/NEJM200003303421303), was published in the _New England Journal of Medicine_ in 2000.

However, the key evidence supporting U=U comes from three international research studies published since 2011. Each one recruited couples in which one partner was living with HIV and the other was not. Between them, [HPTN 052](/article/hptn-052-no-partner-infections-with-viral-suppress), [PARTNER](/article/zero-no-linked-hiv-transmissions-in-partner-study-), and [Opposites Attract](/article/no-hiv-transmissions-between-gay-couples-when-vira) recruited over 3,000 couples. During the latter two studies, couples reported engaging in more than 74,000 episodes of condomless vaginal or anal intercourse.

Between these three studies, not a single HIV transmission was observed from an HIV-positive partner who had a durable undetectable viral load to an HIV-negative partner.

Although it had been hypothesized that transmission would be more likely during anal sex than vaginal sex, or if one of the partners had a sexually transmitted infection, in fact, the number of linked HIV transmissions was zero in each of these circumstances.

Some HIV transmissions did, however, occur in the first few months of a person taking antiretroviral therapy in the HPTN 052 study, before his or her viral load was durably suppressed. Individuals can, therefore, be advised to use other prevention methods if their viral load has not been undetectable for at least six months. A number of HIV-negative study participants also acquired HIV from outside their main relationships, with viral strains that were different from those of their primary partners. People who are in a relationship with a person living with undetectable HIV may need counseling on prevention with other sexual partners.

Have a look at "Key U=U Studies," below, to find out more about these studies.

It is notable that since the data from HPTN 052, PARTNER, and Opposites Attract have been released, there have been no case reports of HIV transmission from a person with HIV who had an undetectable viral load. Given the high level of public and scientific interest in this topic, it might be expected than any suspected cases would be investigated and published.

Summing up, there isn't any evidence that sexual HIV transmission occurs when a person's viral load is durably undetectable.

  

Factsheets and Overviews
------------------------

[**HIV Undetectable = Untransmittable (U=U): Information for Providers**](/content/80817/hiv-undetectable--untransmittable-uu-information-f.html) (February 12, 2018)  
_From the New York City Department of Health and Mental Hygiene_  
Provides key facts about U=U and suggestions for counseling patients.

[**The Evidence for U=U: Why Negligible Risk Is Zero Risk**](/content/80301/the-evidence-for-uu-why-negligible-risk-is-zero-ri.html) (August 10, 2017)  
_In_ HIV Treatment Bulletin_, from HIV i-Base_  
While the dramatic impact of antiretroviral treatment (ART) on reducing HIV transmission has been known for a long time, it is new to say that ART stops transmission completely. This article provides a thorough review of key studies from the past 20 years.

  

News & Opinion
--------------

[**Pregnancy and Infant Feeding: Can We Say U=U About the Risk of Passing HIV to an Infant?**](/content/80820/pregnancy-and-infant-feeding-can-we-say-uu-about-t.html) (February 14, 2018)  
_In_ Prevention in Focus: Spotlight on Programming and Research_, from Canadian AIDS Treatment Information Exchange_  
Can an undetectable viral load eliminate the risk of passing HIV to an infant? This article examines what we know about the risk of passing HIV through pregnancy, childbirth, and infant feeding.

[**What Should We Do About Persistent Low-Level Viremia?**](/content/80505/what-should-we-do-about-persistent-low-level-virem.html) (October 10, 2017)  
_From Journal Watch_  
Paul E. Sax, M.D., answers a question about a patient with a persistently low viral load, of around 70-100 copies/mL. Does "undetectable = uninfectious" still count?

[**CDC Corrects Misleading HIV Conception Guidance, Responding to Community Pressure**](/content/80323/cdc-corrects-misleading-hiv-conception-guidance-re.html) (August 17, 2017)  
_From TheBodyPRO_  
The CDC is finally up-to-date with its HIV-affected conception guidance. It now quotes data from HIV trials showing that treatment alone can prevent HIV transmission when couples with mixed HIV status desire to have a baby.

[**Swaziland Dramatically Reduces HIV Incidence Through Test-and-Treat Programs**](/content/80232/swaziland-dramatically-reduces-hiv-incidence-throu.html) (August 1, 2017)  
_From TheBodyPRO_  
The Kingdom of Swaziland has dramatically reduced the number of new HIV infections thanks to a massively expanded testing-and-treatment program, as reported at the 9th International AIDS Society Conference on HIV Science (IAS 2017).

[**Viral Loads Becoming Undetectable in More People Across the United States**](/content/79873/viral-loads-becoming-undetectable-in-more-people-a.html) (May 4, 2017)  
_From the Center for AIDS Information & Advocacy_  
Among HIV-positive people in care in the U.S., the proportion reaching an undetectable viral load rose steadily from 2009 through 2013. Women, blacks, Latinx, and younger people were less likely to have an undetectable viral load.

[**HIV Researchers Reassert Treatment Is Prevention**](/content/79495/hiv-researchers-reassert-treatment-is-prevention.html) (March 8, 2017)  
_From TheBodyPRO_  
In an interview at the 24th Conference on Retroviruses and Opportunistic Infections, (CROI 2017), Fred Schaich spoke with Deborah Donnell and Matthew Golden about how getting people onto HIV treatment also prevents the spread of the virus.

[**HIV Undetectable Does Equal Uninfectious: The Swiss Statement and the Vindication of Pietro Vernazza**](/content/78550/hiv-undetectable-does-equal-uninfectious-the-swiss.html) (October 7, 2016)  
_From TheBody_  
In 2008, the "Swiss Statement" clearly stated that people with an undetectable viral load cannot pass on HIV. This is the story of how the Swiss Statement went from policy pariah to documented fact.

[**The Undetectable Problem: Dating, Sex, and Criminalization (Part 2)**](/content/78494/the-undetectable-problem-dating-sex-and-criminaliz.html) (September 30, 2016)  
_From TheBodyPRO_  
Expressing the author's concern that with increased focus on getting everyone seropositive to undetectable, we are creating a larger divide between people with access to care and bodily stability and those without.

[**Treatment as Prevention Could Nearly Eliminate HIV in MSM, Danish Study Predicts**](/content/78393/treatment-as-prevention-could-nearly-eliminate-hiv.html) (September 16, 2016)  
_From TheBodyPRO_  
Antiretroviral treatment as prevention in Denmark could nearly eliminate the HIV epidemic among men who have sex with men, according to predictions of a Bayesian back-calculation model.

[**HIV Transmission Risk Remains During First 6 Months of Treatment**](/content/75595/hiv-transmission-risk-remains-during-first-6-month.html) (March 12, 2015)  
_From TheBodyPRO_  
A study from Uganda shows that in the first six months of antiretroviral therapy, a residual risk of sexual transmission exists of about 2% per year.

[**Minimal Risk of Sexual HIV Transmission for Heterosexual Couples When the HIV-Positive Partner Has an Undetectable Viral Load**](/content/70469/minimal-risk-of-sexual-hiv-transmission-for-hetero.html) (January/February 2013)  
_In_ HIV Treatment Bulletin_, from HIV i-Base_  
A systematic review of publications reporting on rates of HIV transmission between heterosexual couples where the HIV-positive partner has an undetectable viral load on ART revealed minimum risk of transmission.

  

Key U=U Studies
---------------

[**No HIV Transmissions in Couples With Positive Partner Undetectable on Treatment**](/content/78862/no-hiv-transmissions-in-couples-with-positive-part.html) (November 23, 2016)  
_From TheBodyPRO_  
Results from the PARTNER study, as reported in _JAMA_.

[**Negligible Risk: Updated Results From Two Studies Continue to Show That Antiretroviral Treatment and an Undetectable Viral Load Is a Highly Effective HIV Prevention Strategy**](/content/78315/negligible-risk-updated-results-from-two-studies-c.html) (September 6, 2016)  
_In_ CATIE News_, from Canadian AIDS Treatment Information Exchange_  
Final results from HPTN 052, as reported in the _New England Journal of Medicine_, and results from the PARTNER study, as reported in _JAMA_.

[**Early HIV Treatment Lowers Transmission Risk by Up to 93%: HPTN 052 Final Results**](/content/78131/early-hiv-treatment-lowers-transmission-risk-by-up.html) (August 10, 2016)  
_From TheBodyPRO_  
Final results from HPTN 052, as reported at the 21st International AIDS Conference (AIDS 2016).

[**Zero: No Linked HIV Transmissions in PARTNER Study After Couples Had Sex 58,000 Times Without Condoms**](/content/77903/zero-no-linked-hiv-transmissions-in-partner-study-.html) (July 12, 2016)  
_From HIV i-Base_  
Results from the PARTNER study, as reported in _JAMA_.

[**HPTN 052: No HIV Transmissions on Effective Antiretroviral Therapy but Only Limited Data on Viral Failure and Drug Resistance**](/content/76263/hptn-052-no-hiv-transmissions-on-effective-antiret.html) (August 1, 2015)  
_In_ HIV Treatment Bulletin_, from HIV i-Base_  
Results from HPTN 052, as reported at IAS 2015.

[**HPTN 052: No Partner Infections With Viral Suppression**](/content/76169/hptn-052-no-partner-infections-with-viral-suppress.html) (July 21, 2015)  
_From_ BETA  
Results from HPTN 052, as reported at IAS 2015.

[**No HIV Transmissions Between Gay Couples When Viral Load Is Undetectable: Preliminary Results**](/content/75652/no-hiv-transmissions-between-gay-couples-when-vira.html) (March 24, 2015)  
_In_ HIV Treatment Bulletin_, from HIV i-Base_  
Interim results from [Opposites Attract](http://www.aidsmap.com/International-study-of-gay-couples-reports-no-transmissions-from-an-HIV-positive-partner-on-treatment/page/3159177/), as reported at CROI 2015.

[**Real-World Antiretroviral Therapy as Prevention: A Top HIV Clinical Development of 2014**](/content/75285/real-world-antiretroviral-therapy-as-prevention-a-.html) (December 15, 2014)  
_From TheBodyPRO_  
Results from the PARTNER study, as reported at CROI 2014.

[**Insight Into HIV Transmission Risk When the Viral Load Is Undetectable and No Condom Is Used**](/content/74305/insight-into-hiv-transmission-risk-when-the-viral-.html) (April 10, 2014)  
_In_ CATIE News_, from Canadian AIDS Treatment Information Exchange_  
Results from the PARTNER study, as reported at CROI 2014.

[**Zero HIV Infections Seen Through Condomless Sex When HIV-Positive Partner Is on Effective Treatment**](/content/73978/zero-hiv-infections-seen-through-condomless-sex-wh.html) (March 4, 2014)  
_From TheBodyPRO_  
Results from the PARTNER study, as reported at CROI 2014.

[**Early Treatment Reduces HIV Transmission in Heterosexual Serodiscordant Couples**](/content/68659/early-treatment-reduces-hiv-transmission-in-hetero.html) (Fall 2011)  
_In_ Prevention in Focus: Spotlight on Programming and Research_, from Canadian AIDS Treatment Information Exchange_  
Results from HPTN 052, as reported at IAS 2011.

[**Treatment Is Prevention: ARV Treatment in HPTN-052 Reduces Transmission by at Least 96%: Single Transmission in Treatment Arm Occurred Prior to Viral Suppression**](/content/63683/treatment-is-prevention-arv-treatment-in-hptn-052-.html) (July/August 2011)  
_In_ HIV Treatment Bulletin_, from HIV i-Base_  
Results from HPTN 052, as reported at IAS 2011.

Roger Pebody

U=U t-shirt

Featured image for U=U: What HIV Providers Should Know

Due to community pressure and activism, the language that physicians, scientists, and public health bodies use to describe the potential for HIV transmission when a person has an undetectable viral load is now much clearer....

Due to community pressure and activism, the language that physicians, scientists, and public health bodies use to describe the potential for HIV transmission when a person has an undetectable viral load is now much clearer.

U=U: What HIV Providers Should Know

This assessment tool, created primarily for HIV medication prescribers and health care providers in the United States, will help you determine whether HIV pre-exposure prophylaxis (PrEP) is an optimal fit for your patients or clients. 

This tool is free of advertiser influence; it was produced by the editorial team of TheBodyPRO and is periodically reviewed by a rotating panel of respected HIV care providers and community advocates. The tool was last updated in March 2018.

physician discussing/consulting with patient 300x300

Is PrEP -- the HIV prevention pill -- a good fit for your patient or client? Take the assessment.

Is HIV PrEP Right for Your Patient or Client?

Have you taken both a sexual history and a drug use history from your patient?

In the past six months, with how many different people has your patient engaged in receptive or insertive intercourse?

In the past six months, has your patient consistently used condoms when engaging in receptive or insertive intercourse?

In the past six months, has your patient had condomless, receptive or insertive intercourse with a person whose HIV status is 1) unknown with certainty or 2) known to be HIV positive with a detectable viral load?

In the past six months, has your patient been diagnosed with a bacterial sexually transmitted infection (such as chlamydia, syphilis or gonorrhea)?

In the past six months, has your patient exchanged insertive or receptive intercourse for money, food, shelter, alcohol or drugs?

Has your patient used methamphetamines during receptive or insertive intercourse at any time within the past six months?

In the past six months, has your patient injected drugs using needles, syringes, or other drug preparation equipment that have already been used by another person?

In the past six months, has your patient injected 1) illegal drugs or 2) prescription medications for nonmedical reasons, despite recently taking part in a methadone or other medication-based drug treatment program?

Has your patient tested HIV negative in the past week?

Within the past four weeks, has your patient exhibited any possible signs or symptoms of acute (primary) HIV infection?

Has your patient recently tested negative for hepatitis B virus infection?

Your responses to the assessment you just completed yielded no clear indications that your patient is currently at substantial risk of acquiring HIV. Although PrEP may still be worth considering for this patient, it is not strongly recommended.

That said, if your patient has expressed an interest in PrEP regardless of specific risk factors, the subject is worth further discussion. [Read this article on TheBodyPRO.com](http://www.thebodypro.com/content/80117/yes-to-prep-a-prescribers-next-steps.html){target="_blank"} for more information regarding next steps in discussing, and potentially prescribing, PrEP to your patient.

PrEP's Benefits for Your Patient or Client Are Unclear

One or more of your responses to the questions in this brief assessment suggest that your patient may be at risk for acquiring HIV, thus making it worthwhile for them to strongly consider taking PrEP.

[Read this article on TheBodyPRO.com](http://www.thebodypro.com/content/80117/yes-to-prep-a-prescribers-next-steps.html){target="_blank"} for more information regarding next steps in discussing, and potentially prescribing, PrEP to your patient.

PrEP Should Be Considered for Your Patient or Client

Your responses to the questions in this assessment suggest that, regardless of whether your patient may benefit from PrEP, there are clinical considerations -- e.g., lack of a recent HIV-negative test result, possible symptoms of acute HIV infection, or relatively low creatinine clearance -- that could make it unwise for them to begin PrEP at this particular time. As you and your patient/client seek to address and resolve those considerations, you may want to ensure they are aware of additional HIV prevention methods.

[Read this article from TheBodyPRO.com](http://www.thebodypro.com/content/79818/current-hiv-prevention-methods.html){target="_blank"} outlining the current armamentareum of HIV prevention methods.

Use Caution Before Moving Forward With PrEP

Is PrEP -- the HIV prevention pill -- a good fit for your patient or client?

Assessment Tool: Is HIV PrEP Right for Your Patient or Client?

As the U.S. enters the worst of the COVID-19 health crisis, brick-and-mortar medical practices are learning how to quickly shift non-essential appointments online. These practices are relying on telehealth to minimize in-person interactions, and the theory is, even if labs are required, eliminating person-to-person interaction in the office can help prevent the spread of COVID-19. But in many cases, the learning curve for clinics and doctor’s offices is steep. Moving pre-exposure prophylaxis (PrEP) appointments to a virtual space is somewhat easier than doing the same with ongoing HIV management—and some practitioners have been doing it for a while.
 
Philip Chan, M.D., an infectious disease physician at the Rhode Island Department of Health, said his practices, a hospital-based clinic and community clinic, have been “very proactive” in moving to telehealth for non-essential visits.
 
“PrEP aligns well with telemed, because most [patients] don’t have symptoms and don’t need an exam,” Chan told TheBodyPro. “Our community clinic was able to ramp up fast, thanks to a savvy office manager. But there are lots of logistics, and we’ve had endless discussions about billing.
 
“For people with HIV, there can be additional considerations when moving to a virtual space for appointments,” Chan added. “There are two groups of people with HIV, those who are doing well and undetectable, who can safely use telemed. And there are those who struggle, and we worry about them most. But there are varying degrees of essential [appointments] even for patients who are struggling.”
 
Even some PrEP patients may need a little extra attention, according to Jason Farley, Ph.D., M.P.H., RN, a professor at the Johns Hopkins University School of Nursing and director of the REACH Initiative.
 
“What I’m concerned about is, are we all moving supportive services to the virtual space?” Farley told TheBodyPro. “It’s hard to tell, because this [pandemic] happened so quickly.”
 
Farley also expressed concern about those who are in poverty and don’t have the same access to technology. “For places that serve more patients in poverty, like federally qualified health centers, they’re going to have to work even harder to make sure their patients are virally suppressed,” he said.
 
[In a joint webinar](https://aahivm.webex.com/recordingservice/sites/aahivm/recording/563de6b641924da0b3f9cb0eb6604be2) between the Association of Nurses in AIDS Care and American Academy of HIV Medicine on HIV care during the COVID-19 crisis, Farley presented an escalation matrix for adherence using electronic HIV-related checkups. In tier one, all patients get standardized information through email, electronic health record blasts, and robocalls. Tier two, patients with long-term viral suppression, get automatic refills by the pharmacy for a 90-day supply of meds. Tier three, patients with a viral load of fewer than 20 copies/mL but who are vulnerable to non-adherence, need at least weekly contact and added virtual support. Tier four, those with changing viral suppression, need more frequent contact, via texts and phone calls, and need pill boxes shipped when possible.  
 
Will Giordano-Perez, M.D., clinical assistant professor of family medicine with the Warren Alpert Medical School of Brown University, said that so far, telehealth has been mostly an upside for his clinic. “Prior to COVID-19, we were doing monthly phone check-ins with my adolescent patients who are on PrEP or HIV positive, understanding that monthly contact has been shown to increase medication adherence and in-person follow-up.” 
 
Now, follow-up visits for all patients, including for PrEP, are offered by telephone, and prescriptions are filled for 90 days rather than 30, though the clinic remains open for STD testing and treatment, Giordano-Perez said.
 
“Our no-show rate for telephonic visits is about 5%, with almost everyone answering and participating in their follow-up visits now that they are being done over the phone,” he said. “Our in-person no-show rate was previously about 20%. We have known for quite some time now that for our patients on PrEP, HIV-positive patients, and even our patients on [medication-assisted treatment for substance use], that telehealth visits would be much more patient-friendly and that we would increase adherence. The issue is that we weren’t being reimbursed for telehealth visits, so they weren’t being offered.”
 
## Learning to Innovate, Quickly
 
On the cusp of the widespread COVID-19 outbreak in late February, [TheBodyPro](https://www.thebodypro.com/article/digital-platforms-improve-patients-prep-access-adherence) compared four telehealth apps that could be used for accessing PrEP. In recent weeks, these platforms have seen a significant increase in customers, and in some cases brick-and-mortar health care facilities are teaming up with the app providers rather than building their own telehealth infrastructure from scratch, quickly. 

John Huckaby, CEO of AIDS Foundation Houston (AFH), told TheBodyPro that AFH had to innovate linkage to care during the COVID-19 crisis—but, fortunately, they had already been using a PrEP telehealth app, [Mistr](http://heymistr.com/AFH). “We have seen the traffic to the [Mistr] site increase dramatically, and our patient registrations and also those receiving PrEP prescriptions have doubled in two months. Accessing PrEP fully online was conceived for convenience and privacy, but we find that in the age of COVID-19, it offers an additional benefit of not having to leave home to access PrEP.” AFH also created a PrEP care hotline, 832-AFH-PREP, for information about accessing PrEP through Mistr, and is engaging Houstonians on social media, dating apps, and their [web site](https://www.aidshelp.org/) about Mistr. AHF is also preparing to launch a new electronic health record system, E-Clinical Works, that will have an integrated, secure app for video appointments with their clinical team.

“We are also launching Zoom Health this week, to enable us to better communicate with all of our PrEP care patients during the COVID-19 crisis, and we believe that one outcome of the pandemic will be greater use and acceptance of telemedicine going forward,” Huckaby said.
Christopher Hall, M.D., a senior medical advisor to the telehealth app [Nurx](https://www.nurx.com), agreed that more people will find telemed apps an acceptable alternative to brick-and-mortar medical outlets, even after the COVID-19 crisis wanes.

“We see this [crisis] as a tipping point for digital health and telehealth,” Hall told TheBodyPro. “I think this could be the new normal for nonessential medical visits.”

But it’s hard for many brick and mortars to set up their own telehealth apps overnight, Hall added. “They can do video connections, but that’s a limited one-off interaction. Digital health providers can give even more—for example, home lab tests and results you can see on the app.”

Chan agreed that telehealth apps could become more routine for nonessential appointments, and that brick-and-mortar health facilities need to look into innovative approaches to make sure they’re usable and accessible by all patients.
 
“For example, could we provide the technologies, like schools give computers to students who need them? Could we lend a smartphone to patients? We could, but the clinical world is still getting up to speed with the infrastructure [for telemed visits] and isn’t yet thinking about that.”


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Many providers are quickly moving PrEP and treatment services to telemedicine platforms due to COVID-19.