Session 1: HIV Prevention
Pre Exposure Prophylaxis (PrEP)
The MoHCC has included pre-exposure prophylaxis (PrEP) in the HIV treatment guidelines since 2015. This section will provide you with information on PrEP so that you will be able to know why PrEP is given, which clients should receive it, how to prescribe it, and how to manage clients on it.
Learning Objectives
By the end of this section, you should be able to:
- Define what PrEP is and differentiate PrEP from PEP and ART.
- Describe PrEP as part of combination HIV prevention.
- Identify people at risk and at substantial risk for HIV infection; including key populations (KP).
- Conduct HIV risk assessment for PrEP.
- Describe when and how to prescribe PrEP.
- Follow up and monitor clients on PrEP.
- Conduct adherence counselling.
- Manage PrEP side effects and adverse events.
- Describe when to stop PrEP.
Learning Activities
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PrEP Introduction (5 min)
Ruvo is a 20-year-old second-year student at the University of Zimbabwe studying laboratory science. She also volunteers at a local orphanage. Ruvo has met many HIV-positive children at the orphanage and has learned a lot about HIV through the volunteer work that she does. Ruvo is in a long-distance relationship with Joseph, who is currently studying in the U.K. She knows he is not faithful, but hopes that they will eventually marry when he returns to Zimbabwe after he graduates. In the meantime she occasionally dates other men and still sees Joseph when he is home on holidays. She recently attended a health talk at school about HIV and learned about PrEP. Ruvo decided that she is a good candidate for PrEP considering she and Joseph both have multiple partners, and last year Joseph had an STI.
Women are at greater risk of HIV during adolescence and into their 20s. PrEP is a prevention strategy that can allow for young women to be empowered and lower their risk of HIV infection.
Defining PrEP
PrEP is defined by WHO as the use of antiretroviral drugs before HIV exposure by people who are not infected with HIV to prevent the acquisition of HIV.
WHO recommends that PrEP should be offered as an additional prevention choice for people at substantial risk of HIV infection as part of a combination of prevention approaches that include
- HIV testing services (HTS)
- Male and female condoms and lubricants
- ART for HIV-positive partners among sero-discordant couples
- Voluntary medical male circumcision (VMMC)
- STI prevention and management
PrEP has been included in the Zimbabwe combination prevention strategy and is being implemented in a phased approach.
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Combination HIV Prevention (5 min)
Combination HIV prevention refers to the combination of structural, behavioural, and biomedical interventions aimed at reducing new HIV infections. Tap on each tab below to learn more about each type of intervention.
Structural interventions
Structural interventions aim to address social, economic, political, environmental, cultural, organizational, community, legal, and policy factors that influence vulnerability and predispose different groups of people to HIV infection.
Behavioural interventions
Behavioral interventions support behaviour change to reduce the risk of HIV infection.
Biomedical interventions
Biomedical interventions are tools, commodities, or mechanisms that lower infectiousness of people with HIV or susceptibility of HIV-negative people to HIV. Biomedical interventions use antiretroviral drugs for HIV prevention, including PrEP and PEP.
We will focus on biomedical interventions, specifically the use of ARV for pre-exposure prophylaxis (PrEP).
PrEP is taken as dual therapy (TDF+FTC or 3TC) daily during periods of risk and does not have to be taken for life. If taken alone, PrEP may reduce the risk of HIV infection by 90% with excellent adherence. However, PrEP works best as part of other HIV prevention measures and does not protect against STIs or pregnancy.
Population groups that may be at higher risk of infection may include:
- Female and male sex workers
- Sero-discordant couples (the HIV-sero-negative partners)
- Adolescent girls and young women
- Pregnant women in relationships with men of unknown status
- High-risk men (MSM, prisoners, long-distance truck drivers)
- Transgender people
PrEP should be offered at all facilities, and, where available, through mobile outreach.
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What Is PrEP? (10 min)
PrEP is the use of ARV drugs by HIV-uninfected persons to prevent the acquisition of HIV before exposure to HIV.
ART vs PrEP
What’s the difference between ART and PrEP? ART is taken by people with HIV to remain healthy and prevent transmission. PrEP is taken by people who are not infected with HIV and who are healthy to prevent acquisition of infection. ART is a lifelong regimen; PrEP is taken only during periods of high HIV risk.
Why Is PrEP Needed?
PrEP provides an additional prevention intervention to be used with existing interventions (such as condoms). It is not meant to replace or be a substitute for existing interventions.
Tap on the tabs to see the similarities and differences between Pre-Exposure Prophylaxis (PrEP) and Post-Exposure Prophylaxis (PEP)?
Similarities
- Used by HIV uninfected persons
- Use ARVs to prevent HIV acquisition
- Available from a clinical provider by prescription
- Effective when taken correctly and consistently
Differences
- PrEP is started before potential exposure and PEP is taken after exposure
- PEP is taken for 28 days. PrEP requires ongoing use as long as HIV risk exists.
PrEP can protect the uninfected partner in a sero-discordant relationship when the HIV-infected partner is either not on antiretroviral therapy (ART) or has not yet achieved viral suppression. ART that suppresses viral load is highly effective for preventing transmission to others. Still, PrEP may provide additional protection to sero-discordant couples in a number of situations as indicated below:
- The partner with HIV has been taking ART for less than six months. ART may take up to six months to suppress viral load; in studies of sero-discordant couples, PrEP has provided a useful bridge to full viral suppression during this time.
- The uninfected partner has doubts about the effectiveness of the partner’s treatment or has other partners besides the HIV-positive partner on treatment.
- There have been gaps in the partner’s treatment adherence or the couple is not communicating openly about treatment adherence and viral load test results.
Unlike a patient on lifelong ART, a client may be discontinued from PrEP when they are no longer at substantial risk of HIV infection.
Frequently Asked Questions
Tap on the questions below to read the answers to a few frequently asked questions about PrEP.
Will PrEP users engage in riskier behaviours? Will PrEP encourage people to use condoms less often or to have more sexual partners ?
There was no evidence of people engaging in riskier behaviours in clinical trials. The PROUD study showed that for participants who were at high risk before initiating PrEP, sexual behaviour remained unchanged regardless of whether participants received PrEP.
McCormack, Sheena et al. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. The Lancet , Volume 387 , Issue 10013 , 53 - 60Will PrEP lead to more HIV drug resistance (HIVDR)?
- HIVDR in PrEP users was rare in clinical trials. It occurred mostly in cases where the person had undiagnosed HIV infection at the time of starting PrEP. When adherence to PrEP is high and HIV seroconversion does not occur, HIVDR will not occur.
- If adherence is suboptimal and HIV infection occurs while on PrEP, there can be a risk of HIVDR.
- Optimal adherence to PrEP is crucial. Health providers must support clients on PrEP, monitor adherence, teach users to recognize signs/symptoms of acute HIV infection.
Does PrEP protect against other STI?
- Only condoms protect against STI and pregnancy. PrEP protects against HIV and herpes simplex virus type 2 in heterosexual populations.
- PrEP does not protect against syphilis, gonorrhoea, chlamydia, or human papilloma virus (HPV).
- PrEP should be provided within a package of other prevention services, including STI screening and management, risk reduction counselling, condoms, and contraceptives.
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Knowledge Check (5 min)
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Indications for PrEP (10 min)
Oral PrEP should be made available to all individuals who are HIV uninfected and are at substantial risk of HIV infection after individual risk assessment. The following are indications for PrEP by history over the past six months:
- HIV negative and sexual partner with HIV who has not been on effective therapy for the preceding six months or
- HIV negative and sexually active in a high HIV prevalence population
and any of the following:
- Vaginal or anal intercourse without condoms with more than one partner, or
- A sexual partner with one or more HIV risk factors, or
- A history of an STI by lab testing or self-report or syndromic STI treatment, or
- Any use of post-exposure prophylaxis (PEP), or
- Requesting PrEP
The first two indication must be met before the other indications can be considered. However, individuals belonging to certain population groups may be at higher risk of HIV infection than others and should be offered PrEP. These include:
- Female and male sex workers
- Sero-discordant couples (the HIV sero-negative partner)
- Adolescent girls and young women
- Pregnant women in relationships with men of unknown status
- High-risk men (MSMs, prisoners, long distance truck drivers)
- Transgender people
Individual risk assessment should be made based on various behavioural factors and other factors to assess vulnerability.
PrEP is contradicted when one of the following is present
- HIV positive status
- Unknown HIV status (no client should receive PrEP if they are not tested for HIV)
- Allergy to any medicine in the PrEP regimen
- Unwilling/unable to adhere to daily PrEP
- Known renal impairment
- Estimated creatinine clearance <60 cc/min (if known)
PrEP for Pregnant Women
A desire to be pregnant can be associated with an increased risk of HIV infection. HIV-negative women in sero-discordant relationships are at risk of acquiring HIV infection when trying to get pregnant. In sero-discordant couples, the infected partner should be initiated on ART and virologically suppressed, ideally for six months, before any attempts to conceive.
Acquisition of HIV infection in pregnancy or during the breastfeeding period is associated with peak viremia and increased risk of HIV transmission to the baby. As such women at risk of new infections (sero-discordant couples) and/or pregnant women in relationships with men of unknown status should be provided with PrEP during pregnancy and breastfeeding. PrEP can be stopped when the risk of HIV transmission to mother and baby decreases.
PrEP benefits for women at high risk of HIV acquisition appear to outweigh any risks observed to date. The WHO recommends continuing PrEP during pregnancy and breastfeeding for women at substantial risk of HIV.
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HIV Risk Assessment and Screening (5 min)
The screening questions will help identify potential PrEP users nd should not be used to ration or exclude people from accessing PrEP. People who ask for PrEP are likely to have made this choice based on a careful assessment of their own personal circumstances, risk, and desire for additional HIV prevention and should therefore not be excluded on the basis of these questions.
Tap on each tab below to learn about which questions to ask when screening. Any “yes” answer should prompt a discussion of the risks and benefits of PrEP.
General Screening Questions
In the past six months,
- Has the client had sex with more than one person?
- Has the client had sex without a condom?
- Has the client had sex with anyone whose HIV status you do not know?
- Are any of the client’s sexual partners at risk of HIV?
- Does the client have sex with a person who has HIV?
- Has the client received a new diagnosis of a sexually transmitted infection?
- Does the client desire to be pregnant?
- Has the client used or wanted to use PEP or PrEP for sexual exposure to HIV?
Additional Questions
Are there aspects of the client’s situation that may indicate higher risk for HIV? Has the client…
- Started having sex with a new partner?
- Ended a long-term relationship and are looking for a new partner?
- Received money, housing, food or gifts in exchange for sex?
- Been forced to have sex against your will?
- Been physically assaulted, including assault by a sexual partner?
- Injected drugs or hormones using shared equipment?
- Used recreational or psychoactive drugs?
- Been forced to leave your home (especially if due to sexual orientation or violence)?
- Moved to a new place (possibly having a higher prevalence of HIV exposure)?
- Lost a source of income (such that you may need to exchange sex for shelter, food, or income)?
- Left school earlier than planned?
Any “yes” answer may indicate situations that confer increased vulnerability to HIV and help to identify someone who may benefit from PrEP. In addition, any sign of intimate partner violence, controlling behaviour, or anger or fear in response to questions about HIV treatment should prompt discussion about PrEP as a way to control risk for HIV.
Questions for People with a New Partner
For people who have a sex partner with HIV, the following questions will help to ascertain whether that person might benefit from PrEP:
- Is your partner taking antiretroviral therapy (ART) for HIV?
- Has your partner been on ART for more than 6 months?
- At least once a month, do you discuss whether your partner is taking therapy daily?
- If you know, when was your partner’s last HIV viral load test? What was the result?
- Do you use condoms every time you have sex?
Any “no” answer to any of the above questions including a desire to be pregnant with a HIV positive partner may indicate increased risk for HIV infection.
Any “no” answer to any of the above questions including a desire to be pregnant with a HIV positive partner may indicate increased risk for HIV infection.
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Ruling Out Current HIV Infection (5 min)
Before starting PrEP it is important to rule out HIV infection. If a client is started on PrEP while being HIV positive, this will lead to dual therapy, increasing the chances of HIV drug resistance. Hence, no client should be started on PrEP if they are infected with HIV or their HIV status is unknown.
The following activities should be done before PrEP is initiated:
- Conduct a rapid HIV test to rule out existing HIV infection, preferably on the same day that PrEP is being started.
- Take a complete history and full physical examination to rule out any signs or symptoms of an acute viral syndrome, including a flu-like illness. If the client has any of these symptoms, consider the possibility that acute HIV infection could be the cause. In such circumstances testing for HIV RNA or antigen is helpful, if such tests are available. Alternatively, PrEP can be deferred for four weeks, after which the person would be tested again. This allows time for seroconversion to be detected.
- Blood creatinine should be measured before starting PrEP and every six months after PrEP is started. Blood creatinine is mandatory in people with comorbid conditions that can affect renal function, such as diabetes mellitus and uncontrolled hypertension.
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Prescribing PrEP (5 min)
PrEP should be administered by medical doctors and nurses trained in ARV management. When a client is starting PrEP, be sure to do the following procedures.
Investigation/intervention Rationale Mandatory HIV test - Assessment of HIV infection status
- Symptom checklist for possible acute HIV infection
Brief counselling - To assess whether the client is at substantial risk for HIV
- To discuss prevention needs and provide condoms and lubricants
- To discuss desire for PrEP and willingness to take PrEP
- To develop a plan for effective PrEP use, sexual and reproductive health
- Assess fertility intentions and offer contraception or safer conception counselling.
- Assess intimate partner violence and gender based violence
- Assess substance use and mental health issues
Other STI screening To diagnose and treat STI Where available Pregnancy testing - To guide antenatal care, contraceptive and safer conception counselling, and to assess risk of maternal to child transmission.
Pregnancy is not a contraindication for PrEP use.
Serum creatinine To identify pre-existing estimated creatinine clearance less than 60 ml/min. Hepatitis B surface antigen (HBsAg) To identify undiagnosed current hepatitis B (HBV) infection Hepatitis B surface antibody If negative, consider vaccination against hepatitis B. Hepatitis C antibody If positive, consider HCV treatment. Rapid syphilis test To diagnose and treat syphilis infection The following table provides details on PrEP medication, their doses, and frequency.
Medicine Dosage Duration Preferred regimen Tenofovir (TDF (300 mg) plus Emtricitabine (FTC) (200 mg) Fixed dose combination one tablet once a day Period of substantial risk Alternative regimen TDF (300 mg) plus 3TC (300 mg) Fixed dose combination one tablet once a day Period of substantive risk Period to Effectiveness
If there is risk via anal sex, four days of daily dosing with oral PrEP is needed to reach adequate anal/rectal tissue levels for effectiveness.
If there is risk via vaginal sex, seven days of daily dosing with oral PrEP is needed to achieve protective vaginal tissue levels. During this period, other protective precautions must be used, such as abstinence or condoms.
PrEP medications should be continued for 28 days after the last potential HIV exposure in those wanting to cycle off PrEP.
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Knowledge Check (5 min)
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PrEP Follow-Up Procedures (5 min)
Ruvo, the 20-year-old student, has now been on PrEP for three months. When you initially met with her, you provided counselling and reviewed the risks and benefits of PrEP. She had done her own research and already made the choice after considering her risk factors and lifestyle. She returns for a follow-up HIV test as scheduled and has tested HIV negative.
Tap on each tab to learn about what each follow-up visit should include. Unless otherwise noted, all of these activities are mandatory.
Every visit
- Address medicine side effects
- Counselling regarding:
- Effective PrEP use (adherence)
- Prevention of sexually transmitted infections
- Issues related to mental health
- Intimate partner violence
- Substance use
- Recognition of symptoms of sexually transmitted infections and management
- HIV risk assessment
Every three months
Confirmation of HIV negative status
Every six months
Where available: Estimated creatinine clearance. Consider more frequently if there is a history of conditions affecting kidneys. Consider less frequently if age is less than 45, baseline estimated creatinine clearance is greater than 90 mL/min, and weight is greater than 55 kg.
Every 12 months
Where available: Hepatitis C antibody. Consider testing MSM every 12 months. Incident HCV infections have been reported among PrEP users who deny injection drug use.
As needed
Provide STI screening, condoms, contraception or safer conception services
After initiating PrEP the client should be reviewed after one month to monitor adherence and side effects, and to refill medicines and seen every three months thereafter. You may dispense a one-month supply at the first visit and then a three to four month’s supply at subsequent visits. Note: When a client is on PrEP, HIV testing should be performed every three months.
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PrEP Adherence and Counselling (10 min)
Adherence to drug(s) means that an individual takes prescribed medications correctly and consistently. This means taking the drugs:
- In the correct dose
- At a consistent frequency (number of times per day)
- At a consistent time of day
TDF/FTC for PrEP provides 92-99% reduction in HIV risk for HIV-negative individuals who take the pills every day as directed. If a daily dose is missed, the level of HIV protection may decrease.
According to data analysis from the iPrEx study, the effectiveness of PrEP is:
Source: Grant RM et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. New Engl Jour Med 363(27):2587-2599, 2010- Seven PrEP pills per week: 99% effective
- Four PrEP pills per week: 96% effective
- Two PrEP pills per week: 76% effective
Counselling
Counselling for PrEP places emphasis on reducing risk in a sustainable way rather than eliminating it entirely at once. It recognizes that behaviour change is not easy and human beings are not perfect. Counselling must focus on the identification of “small wins” and more achievable “next steps” in reducing risk and making pill taking easier.
Supporting a PrEP client to take pills should be honest, direct, and non-judgemental. The key to pill-taking counselling is establishing an open and honest relationship. You must recognise that taking a daily pill for an otherwise healthy person may require coaching, but it is highly achievable. The following are examples of good counselling messages given to a client starting or on PrEP.
- “You’ve decided to use PrEP as a way to protect yourself and that's great.”
- “Pill taking isn’t easy and takes some practice, especially if you aren’t used to taking pills.”
- “It's okay to not be perfect at taking your pills. But remember, for PrEP to work you have to take your pills regularly.”
- “I’m here to help by working with you to figure out a way to make taking your pills easier, so that you get the most protection you can.”
You should take the following steps to support PrEP client on effective pill taking:
- Assess how pill-taking is going for PrEP client
- Positively affirm client to support provider/client relationship
- Identify a motivator to support effective pill-taking
- Provide PrEP education regarding effective use and effectiveness of PrEP
- Identify barriers to effective use
- Provide realistic strategies to address barriers
- Discuss use of other HIV prevention measures that are relevant to the situation
- Make a realistic and achievable plan to increase or sustain use
Tips for supporting pill-taking
The following tips can be used to enhance pill-taking among clients taking ART.
- Schedule medication taking time to correspond with the patient’s daily routine activities
- Use reminders, like cell phone, alarms, beepers, calendars
- Use of pillboxes
- Join an on-line support group, such as Facebook: PrEP Rethinking HIV Prevention
- Review disclosure issues to identify those who can support the patient’s intentions to take their pills or barriers to pill-taking due to lack of disclosure/privacy at home
- Use alternative methods of communication: SMS, social networking, mobile applications
- Collect additional contact information for each patient
- Integrate mobile services and outreach into existing services
- Enhance peer support strategies, such as the use of clubs
- Provide alternative clinic hours, if possible
- Provide patients in advance with referral partners in the event that they migrate, or provide with additional stock/prescription
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PrEP Side Effects (5 min)
TDF / FTC for PrEP is generally safe and well tolerated. While most people on PrEP report experiencing no side effects, some side effects were reported in clinical trials. Participants in the iPrEx study reported side effects that fall into four main categories (ordered here as most to least common):
- Nausea: 9% of those who received TDF / FTC reported nausea in the first month, compared with 5% of those who received placebo.
- Headaches: 4.5% of participants who received TDF / FTC reported headaches, compared with 3.3% of those who received placebo.
- Weight loss: 2.2% of those who received TDF / FTC reported unintentional weight loss of more than 5%, compared with 1.1% of placebo users
- Small increases in serum creatinine: TDF / FTC is known to cause small increases in serum creatinine, a naturally occurring molecule filtered by the kidneys. In this study, 0.3% of those who received TDF / FTC experienced mild increases in serum creatinine that persisted until the next test. Creatinine levels went back down once these participants stopped taking PrEP. Four of the five participants restarted PrEP without recurrence of the creatinine increase. Investigators monitored kidney function throughout the study and found no serious problems.
Such side effects are usually mild and resolve without stopping PrEP. Typically, these symptoms start in the first few days or weeks of PrEP use and usually last just a few days. These side effects almost resolve after a month of use.
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Knowledge Check (5 min)
For the following activities, list whether it is reviewed every visit, every three months, or other.
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Key Points (5 min)
- PrEP is the use of ARV drugs by people who are not infected with HIV to prevent the acquisition of HIV before exposure to HIV
- PrEP is not meant to replace existing interventions, instead it complements them
- PrEP is safe to use
- PrEP policy is broad to ensure equitable access and to avoid stigmatizing individuals, groups or the product
- Before commencing a client on PrEP HIV test, symptom check for acute HIV infection and screening for STIs and HIV risk is mandatory
- PrEP may be discontinued when risk of HIV infection is no longer substantial
- Client monitoring and follow up is critical from 1 month after initiation
- Clients on PrEP should be retested for HIV every 3 months
- Provide ongoing counselling on medicine adherence
- Conduct risk assessment at every visit
- PrEP can be discontinued when:
- Client has sero converted (tested HIV positive)
- risk of HIV acquisition is reduced
- When client develops severe side effects or risks outweigh benefits
- In sero discordance where HIV positive partner has achieved viral suppression