The PEP Program

What is the Program?

The PEP Program is a unique service offered by Clinique médicale l’Actuel that administers PEP to people who believe that they may have been exposed to HIV within the past 72 hours. It is one of the only programs in Canada that offers PEP as HIV prevention for people who may have come in contact with HIV through risky sex or drug use (as opposed to occupational exposure, such as in a health-care setting). The PEP Program also offers STI, HIV and hepatitis B and C testing and counselling, as well as safer-sex education to all clients who come to the clinic to inquire about PEP after engaging in risky behaviour.

The program is based on a philosophy of universal access through which PEP should be accessible to anyone who needs it. The immediate goal of the program is to increase knowledge of and ensure appropriate use of PEP in the gay community; the ultimate goal is to reduce HIV seroconversions among gay men. While the services offered by the clinic are available to everyone, this program specifically targets gay and bisexual men in Montreal, given their increased risk of HIV.

What is PEP?

Post-exposure prophylaxis (PEP) is the administration of antiretroviral treatment in an attempt to prevent HIV infection immediately following exposure to the virus. PEP is currently the only method of preventing HIV infection after a person has been exposed.

PEP:

has the potential to stop someone from becoming infected with HIV after exposure to the virus
involves the person who has possibly been exposed taking specific anti-HIV drugs every day for 28 days
must be started as soon as possible – up to a maximum of 72 hours but ideally within 24 hours – after exposure to HIV
has side effects
is highly promising but not guaranteed to work

While different studies have identified that PEP may be effective at preventing HIV infection, PEP doesn’t work every time. It is more likely to fail if it’s not taken properly or not started early enough. In addition, a person can be infected with HIV while taking PEP if they are exposed to the virus again, which makes education on safer sex important.

PEP is most commonly offered to health-care providers in workplace settings after “occupational exposure” (i.e., when a health-care provider has been exposed to HIV through a needle-stick injury) and to victims of sexual assault.

Exposure to HIV through unprotected sex or injection drug use is called “non-occupational exposure.” People exposed to HIV through non-occupational routes are less likely to know about PEP and to have access to PEP to help them reduce their chances of becoming infected with the virus. Ethical and policy issues related to PEP access can sometimes be quite complex.

To learn more about PEP, see Other Useful Resources.

Why Was the Program Developed?

In Canada, HIV continues to have a tremendous impact on gay men and other men who have sex with men. The Public Health Association of Canada estimated that 51% of all people living with HIV in 2008 were men who have sex with men, and 44% of all new infections in 2008 were attributed to sex between men. While certainly not all gay men and other MSM participate in risky sex, some men are at considerable risk of HIV and STIs through unprotected anal sex (including instances of condoms breaking) with partners of unknown or positive serostatus.

L’Actuel has firsthand knowledge of the HIV and STI rates among gay men in Montreal. The medical clinic has been operating for more than 25 years in the gay village and serves a predominately GLBTQ population.

Three key factors led to the clinic implementing a PEP service:

Many of the gay men presenting at the clinic had recently been exposed to HIV.
The clinic was aware that PEP was widely accepted as a form of HIV prevention for exposures to HIV in occupational settings and in cases of sexual assault.
The clinic came upon guidelines for the use of PEP for non-occupational exposure to HIV (e.g., exposure to HIV through consensual sex) developed in the United States.

Since Canada currently has no national guidelines for non-occupational exposure, the clinic used the U.S. guidelines and information from research and practice to inform the implementation of its PEP program.

See Other Useful Resources for more information.

How Does the Program Work?

Location

The PEP service is administered in a sexual health clinic that also provides HIV, STI and hepatitis B and C testing, treatment, counselling and support.

Engagement and recruitment

To increase awareness of PEP and The PEP Program and to encourage people to use it, Clinique médicale l’Actuel relies heavily on word of mouth. The clinic runs an ongoing poster campaign in the gay community in Montreal. Posters are placed in kiosks throughout the gay village as well as in saunas (bathhouses) and bars. In addition, the program is promoted on the clinic website and in local gay publications. Posters are also placed in the clinic waiting room, which has proven to be effective in increasing inquiries about PEP.

The PEP Program promotional posters include information in plain language on:

What PEP is
How it works
Who is eligible to receive it

The posters also include a call to action targeting people who think they are at risk, telling them to hurry to the clinic if they’ve had a sexual encounter that may have put them at risk.

Who uses the PEP program?

PEP may be effective in preventing HIV in people who’ve been exposed to the virus in the last 72 hours, regardless of their sex or gender, socio-economic background or sexual orientation. Nevertheless, l’Actuel’s promotional messaging is primarily displayed in places frequented by gay men and targets men who identify as gay men. Clientele from outside this context (e.g., young gay men who are not “out” or gay men in remote settings with few gay-positive resources, women from visible minority communities, injection drug users, etc.) are very likely to present distinct challenges for engagement as well as PEP adherence.

If the program is adapted to serve another community, care should be taken to ensure that the program is sufficiently adapted to ensure that the specific needs and risk factor(s) of the new target group are addressed to maximize client’s engagement and adherence to the 28-day PEP regimen. For example, some communities might require more one-on-one support to adhere to the medication than l’Actuel clients generally do.

PEP users at l’Actuel

1. Most are gay men.

77% of the 1,139 people who participated in the PEP program between 2001 and 2009 are gay men. This percentage confirms that the program’s targeted messaging is working. Meanwhile, the participation of people from outside the targeted group (10% heterosexual men and 13% women) demonstrates an opportunity for expanded outreach to other communities.

2. Over half are university educated.

52% of the people who have participated in the PEP program have completed a university degree.

3. They are of all different ages.

The age of participants in the PEP program ranges from 15 to 76, with an average age of 34.

4. Half claim that intoxication was a factor in their risk-taking.

47% of PEP users were intoxicated when their possible exposure to HIV took place. Promoting the PEP program in gay bars may be effective for engaging gay men; however, a different target clientele may have different triggers for risk, requiring a different approach for engagement.

5. The vast majority had a risky sexual encounter.

95% of the clients reported that they may have become exposed to HIV during risky sexual activity. Other clientele may have become exposed through injection drug use, requiring different language in both program promotion and HIV prevention messaging.

6. Most are not repeat PEP users.

80% of the people who take PEP at the clinic take it only one time. Only 6% take PEP more than two times. Those in the latter group tend to be managing problematic drug or alcohol use or mental health concerns. Administering the program to another community may or may not produce a different pattern of repeat PEP users.

The Program

Screening a person who wishes to participate in The PEP program includes four steps:

Assessing an individual’s risk of HIV infection
Providing pre-PEP support and education
Administering PEP and offering treatment support
Offering post-PEP testing, counselling and education

Step 1: Initial assessment for the risk of HIV infection

A nurse meets confidentially with each client who visits the clinic to participate in The PEP Program to determine if he/she is in need of PEP based on three criteria:

The individual is, to the best of his/her knowledge, currently HIV negative.
The individual has potentially been exposed to HIV through a high-risk activity.
The exposure has taken place within the previous 72 hours.

During this initial meeting, the nurse determines whether or not the client fulfils each criteria based on their responses to guided questions. If a client is determined to have only a minimal risk for having been exposed to HIV (e.g., he/she has engaged in protected sex only), the person will be not be given access to PEP, but are offered information on HIV and STI transmission, risk factors and safer behaviour. The client is also offered vaccinations, such as hepatitis A and B, and testing for syphilis, hepatitis A, B and C, gonorrhea and chlamydia.

If the nurse determines that the person is eligible for PEP, they will move on to Step 2.

Step 2: Second assessment, pre-PEP support and education

The physician who can prescribe PEP meets with the client to:

Assess his/her eligibility for PEP
Explain the pros and cons of PEP (i.e., its potential efficacy and side effects)
Provide safer-sex counselling and HIV transmission information
Promote the use of safer sex during as well as after PEP
Administer STI and HIV testing
Administer blood tests for liver and kidney function to ensure that the client is able to take PEP medications

The physician explains that the HIV test may not show a positive result if exposure occurred within the past two months (also known as the “window period”).

If the client is eligible for PEP, the physician will explain the treatment, potential side effects and importance of adhering to the full 28-day prescription. The physician will also explain that additional exposure to HIV during PEP treatment may reduce the treatment’s efficacy, so safer behaviours such as continued use of condoms during sex are essential. The physician will emphasize that even if adherence is perfect and no additional exposures occur there is still no guarantee that infection will be prevented.

The PEP Challenge

Taking antiretroviral medication is no walk in the park. While PEP can reduce the odds of becoming infected with HIV, it is still a serious regimen of powerful medication. For his or her own well-being, the client must completely understand the health implications of taking PEP and the need for fully adhering to the 28-day treatment regimen.

Common side effects of PEP include headaches, bloating, diarrhea, nausea and vomiting. Of the more than 1,000 people who have participated in The PEP Program at Clinique médicale l’Actuel, 68% have reported experiencing side effects.

Adherence is central to the success of PEP. Adherence means that the client takes medication every day for the full duration of the 28-day PEP regimen. Poor or non-adherence means the client either does not take PEP as prescribed or stops using PEP before the four-week period is over. This can reduce the effectiveness of PEP and lead to HIV infection.

Step 3: Administering PEP

A person who is determined to use PEP and who understands the implications of taking PEP will be given a written prescription to be presented at a pharmacy for the 28-day regimen of antiretroviral medications. Currently, the clinic uses Kaletra and Truvada because they cause fewer side effects than other available drugs. See Other Useful Resources for more information on antiretroviral medication.

The cost of the medication is either covered by private insurance (if the patient has insurance) or the Quebec provincial drug plan, which covers the majority of the prescription costs. Most provincial health plans in Canada do not cover PEP medications for non-occupational exposure to HIV.

Support during treatment: Patients are encouraged to follow up with the clinic during the 28-day treatment if they want to discuss side effects and challenges to adherence. The clinic does not contact them.

Step 4: Follow up – HIV testing, counselling and education after the completion of PEP

After the completion of the treatment, the client must return to the clinic for follow-up HIV testing to determine if they have seroconverted. Follow-up visits also include counselling, safer-sex education and support, including, when relevant, referrals to addiction and mental health services.

The client will return to the clinic two times for HIV testing:

One month after the first visit (just after the completion of the treatment)
Three months after finishing the treatment

If they test positive, they are referred to a physician within the clinic to discuss how to proceed with their care.

Required Resources

Human resources

A physician trained in prescribing and monitoring adherence to medication
Nurses trained in HIV and STI testing, counselling and risk assessment

Given that clients present themselves at the clinic after recent risky sex or drug use, it is very important that doctors and nurses administering the program are committed to providing harm reduction services with a nonjudgmental attitude. Currently, the nurses and physician at l’Actuel each spend about 10-15 hours per week working with clients who present themselves to the clinic as candidates for PEP treatment.

Service providers in community organizations who wish to implement a PEP program may consider partnering with a local clinic to assist in administering PEP.

Material resources

HIV and STI testing materials
Campaign materials to support word-of-mouth promotion of the service

Financial resources

The cost of the service is wrapped up into the overall operating cost of the clinic. It is considered a low-cost service because the medication is almost entirely covered by the Quebec health plan, with the exception of the $80.25 co-payment, which is paid for by the client (a “co-payment” is the amount paid by a medically insured person each time a medical service is accessed). In the event that a client is covered instead by private insurance, the client cost is usually 20% of the medication’s $1,750 total cost, or $350.

Challenges

Capacity to respond to the need for PEP: The 72-hour window period for PEP requires that staff respond quickly to any inquiry. This can be a challenge if staff resources are limited.
Lack of awareness of PEP: Some communities at risk for HIV are not aware that PEP is available to them. This can be a challenge when attempting to engage certain groups to seek out PEP.
Cost of PEP: The cost associated with treatment can be a major barrier to individuals accessing PEP. In Quebec, if a person is not insured for medical treatments, they can access provincial funds to cover the cost of PEP. This is not the case in other provinces.

Evaluation

According to l’Actuel, the response from the community has been overwhelmingly positive. The following data was collected by the clinic between 2001 and 2009:

More than 1,139 people contacted the clinic regarding PEP.
After consultations with clinic staff, 931 people were prescribed PEP.
Of treated clients, 68% complained of side effects.
Of treated clients, six (0.6%) seroconverted.

The effectiveness of PEP, in terms of how many HIV infections it prevents, is difficult to determine because multiple factors are at play with PEP (such as whether or not the client was actually exposed to HIV, whether exposure would have led to infection without PEP, whether or not the client was adherent to treatment, whether the client received the treatment within 72 or 24 hours, etc.).

Nevertheless, in 2008, Quebec Health and Social Services reported that approximately 1.3% of MSM contract HIV each year, which is more than double the rate of seroconversion in participants who were prescribed PEP in The PEP Program. Though there is insufficient evidence to draw a direct correlation between this data and the data from The PEP Program, they do show promise for future research.

After consulting the six individuals who seroconverted in The PEP Program, it was determined that though they presented themselves to the clinic within 72 hours of the activity which they believed may have exposed them to HIV, there was a strong probability that they were also exposed to HIV at least once more outside of the 72-hour window period. Therefore, infection may have been caused by an earlier exposure for which PEP was not accessed.

The l’Actuel staff rarely see clients who are interested in taking PEP but who turn out to be either at low risk for having been exposed to HIV or who present themselves to the clinic after the 72-hour window period has elapsed. This response suggests that the promotional campaign is being well received and understood.

In addition to preventing seroconversion among the target clientele, The PEP Program provides an opportunity for people who believe they have recently been exposed to HIV to speak with a health-care professional about their level of risk for exposure to HIV as well as their options for preventing infection, a benefit of the program that extends even to those who do not qualify for PEP. All participants in the program were able to take advantage of this service, regardless of whether or not they were prescribed treatment.

Lessons Learned

The timing of receiving PEP is crucial: While PEP can be administered up to 72 hours after a person’s potential exposure to HIV, it’s best to administer it within 24 hours.
Targeted messaging and the use of word of mouth, posting flyers at community venues and advertising in community publications are good ways to promote a PEP program and increase awareness about PEP.
Inquiries into PEP increase on Mondays after people have engaged in using drugs and/or having high-risk sex over the weekend.
Adherence to PEP can be a challenge; clients must be fully briefed on the pros and cons of PEP prior to initiating treatment.
PEP programs offered to this target population did not attract repeat users and did not lead to abuse or inappropriate use of the service.
Offering PEP in context of integrated STI, HIV, HCV testing and counselling can be an effective way to promote prevention and education.

Contact Information

For more information, please contact:

Clinique médicale l'Actuel
http://www.cliniquelactuel.com/