Summary

Cabenuva is the name given to an injectable formulation that combines the two anti-HIV drugs cabotegravir and rilpivirine (Edurant). Cabotegravir belongs to a group or class of drugs called integrase inhibitors. Rilpivirine belongs to a group of drugs called non-nucleoside reverse transcriptase inhibitors (“non-nukes”).

Cabenuva is a treatment option if you are already on successful HIV treatment and the amount of HIV in your blood is less than 50 copies/mL or “undetectable”.

Before starting Cabenuva injections, the two anti-HIV drugs in Cabenuva are taken in pill form once daily together with food for one month. These pills are called Vocabria (containing cabotegravir) and Edurant (containing rilpivirine). If Vocabria + Edurant continue to suppress the amount of HIV in your blood and you can tolerate them, your doctor will switch you to Cabenuva (the injectable formulations of these drugs). You will get two injections of Cabenuva into the buttocks, once a month for two consecutive months. After this, you may continue with monthly injections or switch to injections every two months depending on what you and your doctor have decided.

The pills (Vocabria + Edurant) and the injections of Cabenuva are generally well-tolerated. Common side effects from Cabenuva include temporary pain at the injection site, lack of energy and headache.

How do the drugs in Cabenuva work?

Cabotegravir works by interfering with the integrase enzyme and rilpivirine works by interfering with the reverse transcriptase enzyme. Both these enzymes are needed by HIV to make copies of itself. Using these drugs greatly reduces HIV’s ability to infect cells and make copies of itself.

How do people with HIV use Cabenuva?

When starting the new treatment, the two pills Vocabria + Edurant are first taken daily as an oral replacement for your previous treatment. These pills are taken with a meal. Prior to changing treatment to the combination of Vocabria + Edurant, your viral load should be less than 50 copies/mL or “undetectable”. The combination of Vocabria + Edurant pills is a complete treatment but its use is temporary – usually for a month. The main purpose of initiating the temporary oral formulations of these drugs is to ensure that you can tolerate them and to maintain your viral suppression. At the end of this time, as long as your viral load is still suppressed and you are not having side effects, your doctor will change your treatment to Cabenuva, the injectable version of these anti-HIV drugs. Cabenuva consists of two injections, one into each buttock, initially once a month for two consecutive months. After this, you can get Cabenuva injected on one of two schedules: every month or every two months, as decided by you and your doctor.

Cabenuva is considered a complete treatment for people with HIV.

For more information about HIV treatment, see CATIE’s Your Guide to HIV Treatment.

For many people with HIV, the use of ART (HIV treatment or antiretroviral therapy) has increased their CD4+ cell counts and decreased the amount of HIV in their blood (viral load). These beneficial effects help to greatly reduce the risk of developing a life-threatening infection or an AIDS-related cancer. Vocabria, Edurant or Cabenuva or any other treatment regimen (ART) is not a cure for HIV. It is therefore important that you see your doctor for checkups and lab tests on a regular basis.

Evidence shows that HIV-positive people who are on ART, engaged in care, and have an ongoing undetectable viral load are substantially less likely to transmit HIV to others, be it through sex, when sharing equipment to use drugs or during pregnancy and birth. In fact, the evidence for sexual transmission shows that people on ART who maintain an undetectable viral load do not pass HIV to their sexual partners. For further information see the CATIE fact sheet HIV treatment and an undetectable viral load to prevent HIV transmission. However, it may still be a good idea to use condoms because they can reduce your risk for getting and passing on other sexually transmitted infections.

Warnings

Anxiety and depression

Although not common in clinical trials, a small proportion of people who took either Vocabria + Edurant (pills) or Cabenuva (injections) developed irritability, anxiety, depression and/or negative thoughts. Anxiety and depression are relatively common in HIV-positive people (regardless of whether they are on treatment or the type of treatment that they take). If you are taking either Vocabria + Edurant (pills) or Cabenuva (injections) and think that you may have developed anxiety or depression, speak to your doctor right away. Your doctor can help determine if you have anxiety or depression and if there is any relationship between them and the medicines that you are taking.

 Symptoms of anxiety and depression can include the following:

• becoming easily upset or angry
• feeling fearful
• excessive worry
• difficulty falling asleep or staying asleep, or waking up prematurely
• unexpected feelings of sadness
• recurrent nightmares
• prolonged feelings of sadness, anger or depression
• feeling hopeless
• loss of pleasure in everyday activities
• unexpectedly feeling tired or experiencing a lack of energy
• strange thoughts

If you have any of these feelings, contact your doctor or nurse right away.

If you have thoughts of harming yourself or others, dial 911 right away.

Liver health

A small proportion of people who have taken cabotegravir (in Vocabria and Cabenuva) have developed liver inflammation. This was detected with blood tests. These tests found higher than normal levels of liver enzymes.

A small proportion of people who have taken rilpivirine (in Edurant and Cabenuva) have also developed elevated levels of liver enzymes in their blood.

These problems with elevated liver enzyme levels with cabotegravir and rilpivirine have occurred both in HIV-positive people without any history of liver problems, and in HIV-positive people who have pre-existing liver issues, such as co-infection with hepatitis B virus or hepatitis C virus.

The manufacturer recommends that people taking these drugs undergo regular tests to monitor the health of their liver.

Immediate reactions after injection

Cabenuva is meant to be injected deep into muscle. It is released slowly and for a prolonged period (a couple of months) after injection into muscle. When it is not injected into muscle, some short-term problems can occur. There have been reports of rare cases of reactions occurring within minutes after an injection of rilpivirine (in Cabenuva). These reactions included the following:

• problems breathing
• agitation
• abdominal cramps
• flushing of the skin
• sweating
• numbness of the mouth
• feeling lightheaded or faint

Tell your doctor or nurse right away if you have any of these symptoms soon after an injection of Cabenuva. These problems should start to clear after a few minutes. The manufacturer of Cabenuva suggests that these problems have occurred when Cabenuva is accidentally and partially injected into a vein rather than deep into muscle tissue.

Skin and hypersensitivity reactions

Over the past decade, there have been reports of skin and hypersensitivity reactions with integrase inhibitors and with rilpivirine (in Edurant). Symptoms of hypersensitivity reactions can include severe rash or rash with a fever, together with lack of energy and painful muscles or joints. There have not been reports of skin and hypersensitivity reactions to the integrase inhibitor cabotegravir (in Cabenuva and Vocabria). However, users of either Vocabria + Edurant (pills) or Cabenuva (injections) should remain vigilant about these potential side effects.

In clinical trials with Edurant-containing regimens, some severe cases of hypersensitivity with additional symptoms occurred, such as peeling of the skin, blisters on the lips, swollen eyes and face, stomach cramps and difficulty breathing. If symptoms suggestive of hypersensitivity occur, see your doctor or nurse immediately or go to the emergency room of your nearest hospital or medical centre.

Pregnancy

Neither Vocabria + Edurant (pills) nor Cabenuva (injections) have been studied in pregnant women. The manufacturer recommends that these combinations of drugs “should not be used in pregnant women unless the potential benefits outweigh the potential risks to the fetus.”

Age

Neither Vocabria + Edurant (pills) nor Cabenuva (injections) have been tested in people younger than 18 years. This combination of drugs has also not been tested in large numbers of people who are 65 years or older so its effectiveness and safety in these populations is not known.

Hepatitis B virus

Cabenuva cannot protect you from hepatitis B virus. Check with your healthcare provider to find out if you have been vaccinated against hepatitis B and whether it is still effective. If you have not been vaccinated against hepatitis B, talk to your healthcare provider about getting vaccinated. If you have hepatitis B, ask about your treatment options.

Side effects

General

In clinical trials, Vocabria + Edurant (pills) and Cabenuva (injections) were well tolerated, generally safe and effective. However, as with any treatment, there were side effects but these were uncommon and included the following:

• fever or feeling hot
• lack of energy or feeling weak
• headache
• muscle pain

Note that the HIV-positive people who are typically enrolled in pivotal clinical trials of HIV treatments, including either Vocabria + Edurant (pills) or Cabenuva (injection), are generally young and healthy. Once a drug is approved and more widely available, it gets used by populations who are not usually in pivotal clinical trials. These people may be older and may have other health issues—such as cardiovascular disease, liver injury, kidney injury, type 2 diabetes, anxiety, depression, and substance use—that require medications or that cause symptoms. As a result, their experience of side effects may be different from those reported in pivotal clinical trials.

Injection site reactions

There will be some discomfort and pain from the injections of Cabenuva. In clinical trials, the vast majority of cases where such side effects occurred were of mild or moderate intensity. Also, these side effects usually resolve in a day or two. However, if pain and discomfort at the injection site persist, speak to your nurse or doctor.

Weight gain

Research suggests that some people with the following features or characteristics tend to gain weight when on ART:

• women
• people of African, Black or Caribbean descent
• people whose CD4+ cell count fell below the 200 cell/mm³ level at some point in the past

However, some HIV-positive people without these features can also gain weight. The cause of increased weight in HIV-positive people is not clear because studies suggest that HIV-negative people of the same age and gender are also generally gaining weight even though they are not taking ART.

An increase of one or two kilograms in weight over the course of one year is normal when initiating ART and is what has been reported in clinical trials of Vocabria + Edurant (pills) and Cabenuva (injection). However, should you gain more than this amount of weight, speak to your nurse or doctor so that your weight gain can be assessed. Doctors and nurses also take into account a person’s waist size and/or body mass index (BMI) – this is a number derived by dividing their height by the square of their weight. If your nurse or doctor has found that your BMI is increasing and is outside what is considered healthy then they will investigate possible causes for an increase in weight.

There may be one or more reasons that your BMI is increasing, including the following:

Physical activity – Are you getting enough daily physical activity, including walking and climbing stairs? If not, can you begin a program of exercise? Speak to your nurse or doctor about what kind of exercise is right for you.

Sleeping problems – Rest and sleep quality are sometimes overlooked aspects of health. A large observational study in HIV-negative people found that people who have sleeping problems tend to gain weight. If you are unexpectedly gaining weight, speak to your doctor or nurse to rule out any sleep problems.

Emotional and mental health – Are there factors in your life that can affect how you respond to stressful events? For instance, when stressed, some people eat more fat and carbohydrate-rich foods as a source of comfort. Repeated engagement in excessive intake of carbohydrates and fatty foods can lead to weight gain over time. Depression can affect appetite—some people gain weight, others lose weight. If you notice weight gain along with changes in your mood, speak to your doctor or nurse.

Metabolic conditions, hormones and arthritis

Some conditions and life-stages are associated with weight gain, including the following:

• diabetes
• problems with the thyroid gland and its hormones
• being post-menopausal
• arthritis

Diet

Not everyone follows a diet that is informed by dietary guidelines. If you have access to subsidized dietary counselling (sometimes this is provided in large hospitals and clinics), you may benefit from consulting a registered dietitian. Registered dietitians can assess the quality and quantity of meals, and if necessary, provide helpful advice about making healthy changes.

Substance use

Alcohol contains calories. Is excess consumption of alcohol an issue for you? Excess consumption of alcoholic beverages could suggest unaddressed mental health and emotional issues.

Prescription medicines

Some prescription medicines (for conditions other than HIV) have the potential to cause changes in weight, particularly increased weight.  It can be useful to speak to a pharmacist about all the medicines that you are taking to see if any are associated with changes in weight. You can then discuss any medicines that your pharmacist has identified with your doctor.

Bear in mind

While this list covers some potential causes of weight gain in HIV-positive people, it is not exhaustive.

Uncommon symptoms

The following symptoms were generally uncommon (occurring in 3% or fewer participants) in clinical trials of Vocabria + Edurant (pills) or Cabenuva (injections). With the exception of muscle/bone pain it is not clear if these symptoms were caused by these drugs, the underlying disease process or something else:

• muscle soreness and/or bone pain
• nausea
• difficulty falling asleep and/or staying asleep; feeling sleepy during the daytime
• dizziness
• rash

Drug interactions

Some drugs (including prescribed and over-the-counter), herbs and supplements can interfere with the absorption and/or effectiveness of either Vocabria + Edurant (pills) or Cabenuva (injections). Such interference is called a drug interaction. Some drugs or herbs and supplements can reduce the levels of the medicines in Vocabria + Edurant or Cabenuva in your blood. This can make Vocabria + Edurant or Cabenuva less effective and lead to treatment failure, reducing your future treatment options. Other drugs can raise the levels of medicines in Vocabria + Edurant or Cabenuva in your blood, resulting in enhanced side effects or new side effects. Therefore it is important to disclose to your doctor, nurse and pharmacist all the supplements, drugs, and herbs you are taking.

This factsheet is not comprehensive and only lists some of the potential and actual drug interactions with the pills Vocabria and Edurant and with the injectable formulation Cabenuva. Speak to your pharmacist to find out more about drug interactions with Vocabria, Edurant or Cabenuva.

Drug interactions with Vocabria

People taking Vocabria should not use the following drugs:

• Antiseizure drugs – carbamazepine, oxcarbazepine, phenobarbital, and phenytoin.
• Antibiotics for TB (tuberculosis) or Mycobacterium complex – rifampin and rifapentine should not be used by people taking Vocabria.
• Other antibiotics – clarithromycin, erythromycin or telithromycin. The manufacturer of Vocabria, ViiV, recommends that where possible, doctors should consider alternative antibiotics such as azithromycin.

Acid-reducing agents, laxatives, metal supplements and buffered medicines

ViiV recommends that acid-reducing agents and similar drugs/metal supplements/buffered medicines should be taken “at least two hours before or four hours after taking Vocabria.” Examples of acid-reducing agents include:

• Alka-Seltzer
• Calcium and/or magnesium supplements
• Gaviscon (tablets and syrup)
• Maalox (liquid and tablets)
• Milk of Magnesia
• Pepto-Bismol and Pepto Bismol Children’s
• Rolaids
• Tums
• Zantac (ranitidine), Tagamet (cimetidine)

Drug interactions with Edurant

Rilpivirine (in Edurant and Cabenuva) interacts with many medicines. Always speak to your pharmacist about its potential to interact with over the counter or prescription drugs. Here are a few more interactions with rilpivirine (this list is not exhaustive):

• Antifungal agents – azole antifungal drugs such as fluconazole (Diflucan), itraconazole (Sporanox), posaconazole (Spirafil) and voriconazole (Vfend) can all increase levels of rilpivirine in the blood. This increase in rilpivirine levels may affect the health of the heart. Also, rilpivirine can reduce the concentration of these drugs in the blood leading to new or recurring fungal infections. Therefore, the manufacturer of rilpivirine recommends that azole antifungal drugs be used “cautiously” in people who are taking rilpivirine.
• Herbs – St. John’s wort or the active ingredients – hypericin or hyperforin; this herb or substances in St. John’s wort has the potential to reduce levels of rilpivirine in the blood and increase the risk of treatment failure.
• Methadone – the manufacturer states that no dose adjustment of methadone is needed when starting therapy with Edurant. However, it encourages doctors to monitor people who use methadone as the dose of this drug may need adjustment in the future.

Drug interactions with Cabenuva

ViiV recommends that the following drugs and herbs should not be used by people who take Cabenuva:

• anti-seizure drugs – carbamazepine, oxcarbazepine, phenobarbital or phenytoin
• antibiotics – rifabutin, rifampin or rifapentine
• steroids – more than one dose of dexamethasone (oral or intravenous)
• herbs – St. John’s wort or the active ingredients – hypericin or hyperforin

Methadone

No interaction is expected between methadone and Cabenuva. However, ViiV cautions that doctors monitor people who are taking methadone as its dose may need to be adjusted.

Resistance and cross-resistance

Over time, as new copies of HIV are made in the body, the virus changes its structure. These changes, called mutations, can cause HIV to resist the effects of anti-HIV drugs, which means those drugs will no longer work for you. ViiV states that Vocabria and Cabenuva should not be used in people with “known or suspected resistance to cabotegravir or rilpivirine.”

To reduce the risk of developing drug resistance, all anti-HIV drugs should be taken exactly as prescribed and directed. If doses are delayed, missed or not taken as prescribed, the level of medicines inside Vocabria + Edurant (pills) or Cabenuva (injections) in the blood may fall too low. If this happens, the HIV in your body can become resistant to the medication. If you find you are having problems taking your medications as directed, speak to your doctor, nurse or pharmacist about this. They can find ways to help you.

When HIV becomes resistant to one drug in a class, it sometimes becomes resistant to other drugs in that class. This is called cross-resistance. Feel free to talk with your doctor about your current and future treatment options. To help you decide what these future options might be, at some point your doctor can have a small sample of your blood analyzed to test for resistance.

Dosage

The dosing, formulation, schedule and administration of injectable therapy can seem complex at first. The drugs need to be injected deep into muscular tissue in the buttocks and need to be injected by a health care professional.

Below is a brief outline of how people are switched to first the oral formulations of cabotegravir and rilpivirine and then the injectable formulations. Speak to your doctor or nurse about dosing and other concerns you may have about Cabenuva.

First patients are given oral therapy (pill formulations of the drugs that will eventually be injected) and then if there are no problems, about a month later they are switched to injectable therapy.

The dose of oral therapy is one tablet of Vocabria and one tablet of Edurant, taken together, once daily with a meal. ViiV notes that a protein shake is not equivalent to a meal in this case. Edurant requires fat in food to ensure its absorption.

If these drugs continue to suppress HIV and you can tolerate them, doctors proceed to the next phase which involves regular injections of Cabenuva and cessation of Vocabria and Edurant.

The doses and schedule of Cabenuva will vary depending on whether you and your doctor have decided that you will receive the injections once a month or every two months. Your doctor or clinic nurse will inject the drugs or refer you to a nurse who will do so. If a nurse will be injecting the drugs, note that your doctor will continue to provide your overall care so regular doctor visits and lab tests are important.

Speak to your nurse or doctor about your schedule of visits to get future injections. If you cannot attend your next appointment for an injection, let your doctor or nurse know right away. ViiV indicates that there is some flexibility about the timing of injections by up to seven days. However, repeatedly missing appointments for injections may increase the risk of that HIV can develop resistance to Cabenuva.  

Missed doses of Vocabria + Edurant

If you miss a dose of Vocabria or Edurant pills, ViiV advises to take a dose as soon as you remember. The company further states, “if your next dose is due within 12 hours, skip the dose you missed and take the next one at your usual time. Then continue your treatment as before. Don’t take a double dose to make up for the missed dose.”

Changing your regimen

If you want to stop taking Vocabria + Edurant (pills) or Cabenuva (injections) first speak to your doctor or nurse. They can listen to your reasons for quitting and either advise you about resolving the issues you have raised or help you find a new regimen. According to ViiV, small amounts of rilpivirine and cabotegravir will remain in your body for “up to 12 months or longer” after you stop getting injections. It is therefore important that you adhere to your new regimen so that your viral load stays suppressed and your HIV does not become resistant to Cabenuva or other treatments.

Bear in mind

Cabenuva is not for everyone. There are risks and benefits with every combination of ART. Leading HIV treatment guidelines in the U.S. have stated that Cabenuva can be considered for use in the following people with HIV whose viral loads have been suppressed for at least three months and meet the following criteria:

• have no pre-existing resistance to cabotegravir or rilpivirine
• have never experienced virological failure
• do not have active hepatitis B virus (HBV) infection (unless also receiving an oral HBV active regimen), 
• are not pregnant and are not planning on becoming pregnant
• are not receiving medications with significant drug interactions with either the oral or injectable forms of medicines used with this therapy

If you are thinking about changing your regimen from pills to injectable formulations, speak with your doctor or nurse to find out if these medicines are right for you.

Availability

Vocabria, Edurant and Cabenuva are licensed in Canada. Cabenuva is meant to replace the current HIV treatment in people whose viral loads are less than 50 copies/mL (“undetectable”). Your doctor or pharmacist can tell you more about the availability and coverage of Cabenuva in your region. CATIE’s online module Federal, Provincial and Territorial Drug Access Programs also contains information about Canadian drug coverage.

References

1. Vocabria cabotegravir tablets and Cabenuva extended release injectable suspension (cabotegravir and rilpivirine). Product Monograph. 26 March, 2021
2. Edurant (rilpivirine) tablets. Product Monograph. 4 March, 2019.
3. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. 03 June, 2021. Available at https://clinicalinfo.hiv.gov/sites/default/files/inline-files/AdultandAdolescentGL.pdf.

Author(s): Hosein SR

Published: 2021

Vancouver, B.C.
2020

The Molson Overdose Prevention Site (OPS) in Vancouver co-locates a supervised consumption service, a drug-checking service, a service for injectable opioid agonist treatment and a hydromorphone tablet distribution program. The hydromorphone tablet distribution program is a safe supply program that provides a regulated alternative for people at high risk of overdose from the fentanyl-contaminated, illicit opioid supply. Factors that facilitate engagement in the safe supply program include its low-threshold model, co-location within the OPS and the flexibility and choice that the program offers to participants. Barriers to engagement include the OPS’ limited operating hours, dosage restrictions, wait times to access the OPS and clients’ potential discomfort in accessing an OPS. Overall, the program has been well received by participants and provides learnings that can inform the implementation of other safe supply and harm reduction programs in Canada.

Program description

The hydromorphone tablet distribution program is located at the Molson OPS in the Downtown Eastside of Vancouver, Canada. The program was started in 2019 by the Portland Hotel Society (PHS), a housing and social service agency that operates the Molson OPS. The goal of this safe supply program is to provide a regulated alternative to illicit opioids to decrease the risk of overdose.

The Molson OPS is a provincially sanctioned harm reduction site. In addition to the hydromorphone distribution program, the Molson OPS offers a supervised consumption service, a drug-checking service (to determine what is present in a sample of drugs) and a service for injectable opioid agonist treatment (provided via an adjacent PHS clinic). The Molson OPS is considered an especially low-threshold model as it allows for the sharing of drugs and peer-assisted injection.

The program is delivered by the PHS primary care clinic, which is linked to the OPS. It serves people who are at high risk of fatal overdose and not currently enrolled in or interested in drug treatment programs such as opioid agonist therapy. Program participants access the program via the OPS, during operating hours (1:30 p.m. to 10:30 p.m. daily). The hydromorphone tablets are dispensed to program participants by nurses through a sliding window that connects the OPS to a nursing station on the other side. Participants are allowed to pause their involvement in the program at any time and return without having to be put back on the waitlist.

Participants are enrolled in the program through PHS clinic primary care physicians, who also visit the OPS twice per week. Participants are prescribed a weekly amount up to 80 milligrams per day. Participants can receive up to two eight-milligram tablets at a time and can come back for additional dosages up to five times per day, with a minimum one-hour waiting period in between.

To avoid diversion of tablets into the illicit market, participants are supervised while consuming the tablets onsite (whether they take them orally, snort them or inject them). However, since April 2020, “take-home” doses have been permitted under emergency COVID-19 pandemic prescribing guidelines in British Columbia. A small subset of participants receive an injectable, liquid hydromorphone formulation instead of tablets because of personal preference, including participants who have transitioned from an injectable opioid agonist treatment program.

As of February 2020, 69 participants were enrolled in the program.

Results

This study was a combination of interviews with 42 program participants and ethnographic observation at the OPS throughout 2019. The goal was to identify key barriers and facilitators to participant engagement with the hydromorphone tablet program.

The study found that key facilitators to program engagement included the following:

• Having access to a reliable, regular source of opioids enables participants to exert more control over their drug use, greatly reduces their fear of overdose and reduces their involvement in illicit behaviours to purchase drugs on the street.
• The program is located in the Molson OPS, a central, low-threshold, safe space where many participants were already accessing other harm reduction services.
• Participants are offered flexibility and choice in how to use the program, including varied consumption methods (e.g., oral, intranasal, injection) and flexibility in terms of when and how often to access the program.

The study found that key barriers to program engagement included the following:

• The limited operating hours of the program, particularly in the morning, when withdrawal may begin, meant many participants reverted to illicit opioid sources outside of program hours. (However, this issue may be less significant now that take-home doses are available).
• Co-location with the OPS meant potentially long wait times for people to access the program, especially during peak hours.
• The hourly-dose limits also meant participants could not receive their full daily dose without returning several times throughout the day. Very few participants received the maximum of five daily doses.
• The OPS, which participants must enter to access the program, may also be a triggering or uncomfortable environment for individuals who are attempting to reduce their drug use, or for those who did not use supervised consumption services before joining the program.
• There were complaints about lower potency and difficulty injecting a generic brand of the hydromorphone tablets that was used for a period when the brand-name hydromorphone tablets were unavailable.

What does this mean for service providers?

This study demonstrated a number of key facilitators and barriers for engaging users of the hydromorphone tablet distribution program. This information can be applied to the planning and delivery of other safe supply programs and, more generally, other low-threshold harm reduction programs. In particular, the co-location with other services and the flexibility of the program creates a lower threshold approach, especially for those who are most marginalized.

A number of barriers were also directly or indirectly tied to individual, social and structural factors such as housing, mobility and poverty. The intersection of these factors should be taken into account when designing and implementing other safe supply and overdose prevention programs.

Despite this, the study shows that safe supply programs can be a feasible public health intervention to address the overdose crisis. Although barriers exist, these can be addressed via considerations of how the program is delivered.  The authors noted that overall, the program was very well received among program participants. Taking into account high enrolment numbers and long waitlists, they expressed the need for scale-up of safe supply programs.

Related resources

keepSIX Supervised Consumption Service (CATIE)

Hepatitis C Treatment Program at Moss Park Consumption and Treatment Service (CATIE)

Harm reduction in action: Supervised consumption services and overdose prevention sites (CATIE)

References

1. Ivsins A, Boyd J, Mayer S et al. Barriers and facilitators to a novel low-barrier hydromorphone distribution program in Vancouver, Canada: a qualitative study. Drug and Alcohol Dependence. 2020 Sep 15: 108202.
2. Olding M, Ivsins A, Mayer S et al. A low-barrier and comprehensive community-based harm-reduction site in Vancouver, Canada. Public Health Practice. 2020; 110(6): 833-5.

 

Newfoundland and Labrador and Alberta, Canada
2020

A point-of-care (POC) HIV testing pilot program took place in two Canadian provinces, Newfoundland and Labrador and Alberta, to increase access to HIV testing and provide linkage to care. The program used pharmacists in four community pharmacies to provide HIV POC testing, including pre- and post-test counselling. Three-quarters of the people who were tested were at moderate to high risk for HIV and 27% were first-time testers. Pharmacies were found to be an acceptable venue for HIV POC testing by both pharmacists and clients; pharmacists felt prepared to provide testing and confident in doing so, and clients indicated that they felt comfortable receiving testing from pharmacists. Almost all clients (99%) who participated in a study of the pilot program indicated that HIV POC testing should be routinely offered in pharmacies.

Program description

Advisory committees were created in Alberta and Newfoundland to assist with the design of the pilot program. Committees consisted of a variety of stakeholders including public health officials, policy-makers, pharmacists, healthcare workers with experience providing care for people with HIV and individuals with lived experience.

The program provided free HIV POC testing using pharmacists in four community-based pharmacies in both urban and rural locations in Alberta and Newfoundland. The program was promoted through newspapers, social media (e.g., Grindr) and posters displayed in communities, as well as through organizations that serve populations that may be at risk for HIV. Clients could request an HIV POC test at one of the four sites by making an appointment or by visiting during scheduled drop-in testing hours.

At least one pharmacist at each pharmacy received training to participate in the program, which included training on consent and pre- and post-test counselling, as well as on how to administer the HIV POC test and interpret results. Pharmacists were provided with information on where to link clients if the HIV POC test was reactive, including support services in their area.

Participating pharmacies had a private room where clients and pharmacists met for testing and pre- and post-test counselling. The INSTI HIV-1/HIV-2 rapid antibody test (which requires a finger-prick blood sample) was used. Results were available within one minute; they were interpreted by the pharmacists and then shared with the client. Pharmacists completed pre- and post-test counselling, which included providing information on testing for other sexually transmitted and blood-borne infections.

If the test was reactive, the pharmacist provided the clients with a requisition for blood work to complete confirmatory tests, in addition to providing counselling and referral to additional supports. Confirmatory test results were sent to a designated physician or nurse practitioner, according to the linkage plan established in each province.

Results

A study of the pilot program (i.e., the APPROACH study) looked at the feasibility and acceptability of a pharmacist-provided HIV POC testing program and used a mixed-methods design. The study took place between February and September 2017. Clients were asked to complete two questionnaires (i.e., one before and one after testing) and were also invited to take part in a telephone semi-structured interview about their testing experience. Pharmacists’ perspectives were obtained through focus groups where they were asked to share information about the training and supports provided, as well as their thoughts on the scalability and sustainability of the program.

A total of 123 tests were conducted (10% in rural communities), with one reactive test. The person with the reactive test was linked to confirmatory testing and then successfully linked with the provincial HIV program within 72 hours of the HIV POC test. Additionally:

• Pharmacists spent an average of 30 minutes completing the testing process, including pre- and post-test counselling.
• 27% of clients indicated that this was their first HIV test. Of these, 69% were at moderate to high risk of undiagnosed HIV infection.
• 75% of participants were at moderate to very high risk of HIV infection¹ (47% self-identified as men who have sex with men, 7% had previously exchanged sex for money or drugs and 5% had a history of intravenous drug use).

Results from client questionnaires indicated that:

• clients felt comfortable getting tested at the pharmacy and had a high degree of confidence in the pharmacist’s ability to complete the test
• clients pursued pharmacy testing because of their ability to receive an immediate result and because testing took place in a private room
• 99% of clients indicated that HIV testing should be routinely offered through pharmacies
• 78% of clients indicated that they would pay for an HIV POC test at a pharmacy

Results from focus groups with pharmacists indicated that pharmacists felt that:

• the training provided prepared them well for the program
• a key element of the program was a clear linkage to care plan established by the advisory committee
• it would be important to have multiple pharmacists trained to perform the testing to increase accessibility
• lack of remuneration was a major challenge to the scale-up and sustainability of the program
• HIV POC testing was part of their professional role and identity

What does this mean for service providers?

Service providers should consider ways to move HIV POC testing into community locations where it might be possible for service providers to reach more people for testing and eliminate barriers experienced by potential testers (e.g., concerns over privacy and discretion). Pharmacies provide a way to normalize the testing experience in an environment that is familiar to people. Pharmacists who participated in this study indicated that providing HIV POC testing aligns with what they see as their professional role and identity.

Service providers looking to create a similar program should consider the workflow changes in the pharmacy required to implement it (e.g., support staff, documentation of results and follow- up plans). Consideration will also need to be given to the remuneration of pharmacists for providing the testing service, as well as the need to have adequate staffing so that a trained pharmacist can be available and provide greater flexibility for clients in terms of drop-in hours. Service providers should also ensure that an adequate linkage to care plan is in place for clients who have a reactive POC test. The quality assurance of the testing process and the standards of practice related to pharmacists’ ability to perform HIV POC testing in each province/territory should also be considered when developing a program.

Related resources

Task-shifting in HIV testing services

Rapid point-of-care HIV testing: a review of the evidence

Reference

Kelly DV, Kielly J, Hughes C et al. Expanding access to HIV testing through Canadian community pharmacies: findings from the APPROACH study. BMC Public Health. 2020;20:639.

1. HIV risk was based on the Denver HIV Risk Score using information gathered from the first participant questionnaire. A score of 30 points or higher indicated an increased risk of undiagnosed HIV and that someone should be offered routine HIV testing.

Ontario, Canada
2020

Black PRAISE (Pastors Raising Awareness and Insight of Stigma through Engagement) is an HIV-related knowledge and stigma awareness raising program focused on bringing information on HIV to Black congregations in Ontario, Canada. The program brought resources in the form of a booklet, a sermon and a short film to congregation members to strengthen congregants’ critical awareness of HIV-related issues in Black communities. In the quantitative component of a study that evaluated the program, Black PRAISE was associated with increased HIV knowledge and reduced HIV stigma among congregants who received the intervention.¹ In the qualitative component of the study, congregants expressed appreciation for Black PRAISE even though it challenged some of their beliefs and ideas about HIV and people who are affected.²

Program description¹

Black PRAISE aimed to increase HIV-related knowledge and decrease HIV-related stigma in Black churches. The program used a congregation-based approach and strived to prompt people to critically appraise their individual beliefs and knowledge related to HIV and HIV stigma. The program also aimed to build the capacity of churches to address critical health issues among Black communities.

A community-based participatory approach that engaged pastors and congregation members was used to develop Black PRAISE. The program took place in six Black churches in Ontario (Toronto, Mississauga, Ottawa) that were identified through community consultation. Pastors/leaders at each of the churches were men of Caribbean or African background.

User-friendly information related to HIV among Black communities was developed for the program, in the form of a booklet, a sermon and a short film. The components of the intervention were sequenced over time and addressed multiple issues related to stigma. The following resources addressed HIV-related knowledge and stigma to promote critical awareness:

• Booklet: A booklet addressed fear of HIV by conveying information about how HIV is transmitted and tested for and how it can be prevented in Black communities. The booklet also addressed issues of equity, justice and the social determinants of health and provided research data on how HIV disproportionately affects Black communities and specific information on HIV programs for Black communities in Ontario.
• Sermon: A sermon on love, compassion and social justice was delivered by pastors to their congregations. The sermon referenced biblical teachings related to reducing stigma and used anecdotes about experiences of stigma in church settings. Through these anecdotes, the sermon provided an audience for the voices of people living with HIV.
• Film: An 8-minute film featured Black Canadians discussing HIV stigma and how the church could help to reduce stigma. The film also illustrated how HIV stigma is layered with other dimensions of social oppression such as racism, sexism and heterosexism and showed the diversity of Black populations directly affected by HIV. The film was shown during church services.

The resources were distributed and/or presented to congregation members during their regular Saturday or Sunday service on an agreed schedule.

Results

A study of the program took place from October 2016 to March 2017 and evaluated changes in HIV-related knowledge and stigma at baseline, immediately after the intervention and at a 3-month follow-up using  surveys. Although the intervention was provided to anyone who attended the Saturday or Sunday service where the resources (i.e., booklet, sermon, film) were shared, only congregants who identified as African, Caribbean or Black were eligible to participate in the surveys. Knowledge of HIV and HIV stigma were assessed using separate validated tools.¹

A total of 173 study participants completed the baseline survey and at least one of the surveys after the intervention. Participants identified predominantly as Caribbean (54%) or Black (52%), female (74%), heterosexual (98%) and foreign born (68%). Additionally, 48% indicated that they had tested for HIV at least once and 95% indicated that they were HIV-negative or had never been diagnosed with HIV. Approximately 47% of participants indicated that they were exposed to one component of the intervention and 38% that they were exposed to all three components. The study investigators found that:¹

• There was a significant increase in HIV knowledge when baseline HIV knowledge was compared with HIV knowledge immediately after the intervention and at the 3-month follow-up.
• In an analysis of participants who reported high levels of stigma at baseline (i.e., people whose stigma scores exceeded the mean for the group), stigma decreased significantly after the intervention.
• Participants exposed to all three components of the intervention had a significant reduction in their stigma score compared with those exposed to just one or two components.

A qualitative study on the Black PRAISE program was completed between June and August 2017. It included 18 interviews with congregants and pastors to understand their experience with the program. Generally, participants’ experience with the program was positive. Some congregants shared that addressing stigma in a faith-based context led to a dilemma for them (i.e., viewing behaviours that may have exposed someone to HIV through the moral lens of their religion). The study suggested that successful interventions should support critical reflection of the underlying implicit assumptions and beliefs that motivate faith organizations, researchers and public health decision-makers. Moreover, this process of critical reflection should be ongoing to ensure longevity of similar interventions.²

What does this mean for service providers?

Service providers could consider inviting Black faith communities to play a more active role in their work, to engage African, Black and Caribbean populations in responding to HIV. Using a community-based participatory approach for program and resource development could help to ensure that resources are relevant to the populations that programs are targeting, in addition to helping elicit support from participating church leaders and congregants. Service providers should also consider using multiple resources that address a variety of issues that contribute to HIV stigma (e.g., individual beliefs, systemic conditions) when engaging community members in these critical awareness-building efforts. Phase 2 of Black PRAISE will engage a larger and more diverse group of Black churches across Ontario, using a more streamlined process that churches can use to administer the program.

Related resources

Operation Hairspray (CATIE)

Many Men, Many Voices (3MV) (CATIE)

Health Promotion Case Management Program (CATIE)

References

1. Husbands W, Kerr J, Calzavara L et al. Black PRAISE: engaging Black congregations to strengthen critical awareness of HIV affecting Black Canadian communities. Health Promotion International. 2020.  https://doi.org/10.1093/heapro/daaa057 
2. Husbands H, Nakamwa J, Tharao W et al. Love, judgement and HIV: congregants’ perspectives on an intervention for Black churches to promote critical awareness of HIV affecting Black Canadians. Journal of Racial and Ethnic Health Disparities. 2020. https://doi.org/10.1007/s40615-020-00808-5