PrEP-Training Slides For Providers

Pre-Exposure Prophylaxis (PrEP)
Training for
HTS Providers
in Clinical Settings in Ethiopia

Introductions
Take a minute (and only one, please!) to tell us:

• Your name
• The name of your organization
• Your position there
2
Ground Rules
• Be punctual.
• Keep client stories confidential.
• Respect differing opinions.
• Be an active participant in all training activities.
• Stick to our agreement on cellphone use.
• Ask questions—ask, ask, ask.
• Let others finish speaking before responding
or commenting.
3
PrEP-Specific Competencies
After completing this training, participants will be able to:
• Identify candidates eligible for PrEP.
• Assess individual risk for HIV.
• Educate and counsel PrEP candidates and users.
• Assess medical eligibility for PrEP.
• Prescribe PrEP.
• Conduct clinical and laboratory assessments during follow-up visits.
• Determine how PrEP monitoring and evaluation tools may be
used locally.
• Provide adherence education, counseling, and support to
PrEP candidates and users.
4
Training Overview
1 Introduction to
Combination HIV
Prevention
2 PrEP Basics
Demand Creation
3
PrEP Screening and Eligibility
4
5
Training Overview
(continued)
Initial and Follow-Up PrEP Visits

Managing PrEP Side Effects,
5 Seroconversion, and Stigma
6 PrEP Monitoring and Evaluation Tools
6
Introduction to
Combination HIV
Prevention
9/22/2018
Training on Oral PrEP
Rationale: Insufficient Progress on Prevention
Number of new HIV infections, global, 1990–2017 and 2020 target
UNAIDS 2018
8
Local Epidemiology of HIV/AIDS
• Most new infections are happening amongst Key and Vulnerable Populations
(HIV negative FSWs and HIV negative partners of Sero – discordant couples),
making these the populations appropriate targets for PrEP.
• In Ethiopia, adult new HIV infection in 2016 was reported to be 9800 annually.
• HIV prevalence among Female Sex Workers (FSW) is estimated to be 23%
– (Ranging from 14% in Hawassa town to 32% in Mekelle & Bahardar town
respectively (EPHI 2014).
• HIV prevalence among Sero-discordant partners is estimated to be 5.1% (FHAPCO
2017)
9
National response: Towards Epidemic Control
• In the past two decades, Ethiopia has been successful1:

 In reducing HIV prevalence rate from 3.3 % in 2000 to 0.9 %
in 2017
 In decreasing AIDS related deaths from 83,000 deaths in 2000
to 15,600 in 2017
• The Federal Democratic Republic of Ethiopia (FDRE) is

committed to:
 Reducing new adult HIV infections by 50% by 2020 and ending
10
1. UNAIDS, Gap Report 2016.; 2 Ethiopian HIV Prevention roadmap 2018 - 2020,
HIV Prevention Roadmap in Ethiopia
• The HIV prevention roadmap is built around six prevention pillars. The six HIV
Prevention Pillars adopted by Ethiopia include the following:
1 2 3 4 5 6
Addressing Adolescent Addressing the Key Promotion and Conducting Voluntary Offering Pre - Providing STIs
girls, young women and Priority Provision of medical male Exposure Prophylaxis Prevention and
(AGYW) & their male Population Groups Condoms circumcision (VMMC) Control related
partners
(PrEP) Services
Pillar – 5: Offering PrEP and related services for population groups at substantial risk of
acquiring HIV infection and experiencing high levels of HIV incidence particularly for HIV
Negative Female Sex Workers and HIV Negative Partner (s) of Sero- Discordant couples.
11
HIV prevalence and size estimates of key and
priority population in Ethiopia
Female Sex workers

Size: 120,000
HIV prevalence: 23%
(EPHI 2014)
Prisoners:
Size: 85,000
HIV prevalence: 4.2%
(UNODC 2014)
Widowed & Divorced
PLHIV and Partners Size: 640,000
Size: 769,600 HIV prevalence
HIV prevalence among Widowed: 10.9%
partners: 5.1% Divorced: 3.6%
(FHAPCO 2017) (EDHS 2016)
Distance drivers
Size: 15,000
(EPHI 2014)
Mobile & resident workers in
hot spot areas
Size: 1,000,000
(FHAPCO 2017)
12
Rationale for the PrEP Implementation in Ethiopia?
• There are already several effective HIV prevention interventions (e.g. condoms, risk reduction).
– HIV incidence among key and vulnerable populations remains high (e.g. Female Sex
Workers (FSWs), Sero – discordant couples).1
– Ethiopia has committed to reducing new adult HIV infections by 50% by 2020 and ending
AIDS as a public health threat by 2030.
– Has been clearly reflected in the Country’s Growth and Transformation Plan II (2015 ‐2020)
where one of the major indicators is reduction of HIV incidence rate from 0.03% to 0.01 %.
– In the past two decades, the success was in reducing HIV prevalence rate from 3.3 in 2000 to
0.9 in 2017 and AIDS related deaths from 83,000 deaths in 2000 to 15,600 in 2017
• PrEP provides an additional prevention intervention to be used together with existing
interventions (e.g. condoms).
– Considered as one of the Combination HIV Prevention pillars set by the Ethiopian
Prevention roadmap.
– PrEP is not meant to replace or be a substitute for existing interventions
13
(continued)
• The overarching targets set by the Ethiopian HIV Prevention Road map for 2020 are:
– Reducing adult new HIV infection by 50% from 2016 baseline to reach 4,590
– Reach 90% of adolescent girls and young women in high burden areas, key and
priority population with combination HIV prevention.
– Distribute 200,000,000 condoms per year ( 50% to key population groups)
• Six Pillars set and one of these is the implementation of PrEP for Key and vulnerable
population as a component of the Combination HIV Prevention.
• PrEP provides an additional prevention intervention to be used together with existing

interventions (e.g. condoms).
• PrEP is not meant to replace or be a substitute for existing interventions.
HIV prevention remains as important as ever!!!

14
(continued)
• PrEP task force group (sub technical

group) established at FMOH.
• PrEP was included in the National
Comprehensive HIV prevention Care and
Treatment Guidelines
• PrEP pilot program lunched in September
29, 2018 at Hilton Hotel
• PrEP Implementation manual developed
in September 2018 and revised in
December 2019.
• 9 public health facilities and 6 Drop-in
center site selected from Addis Ababa,
Oromia, Amhara, Tigray & Gambella
regions for PrEP pilot Implementation at
national level.
• PrEP pilot implementation has been
validated for national scale up in June
2019. 15
Combination HIV Prevention
• Different people have different HIV prevention needs.
• HIV prevention needs change over a lifetime.
• Combination prevention is a mix of biomedical, behavioral, and

structural interventions that decrease risk of HIV acquisition.
• Greater impact may come from combining approaches than

from using single interventions alone.
• An important additional prevention tool is provided by PrEP:

using antiretroviral drugs (ARVs) for prevention.
16
(continued)
• Integration of different intervention is cost-effective

• Antiretroviral drugs (ARVs) used as PrEP should have to be
considered as an important additional combination HIV
prevention intervention.
• The use of ARVs for HIV prevention is well established;

We have been using ARVs to prevent :
– mother-to-child transmission of HIV (PMTCT)
– for post-exposure prophylaxis (PEP) for many years.
– Recently PrEP considered as an important additional combination HIV prevention
intervention.
17
Combination HIV Prevention
Structural Behavioral Bio – medical
•Policies • Education • HIV testing (why? For

•Laws • Counselling whom?)
• Condoms
•Regulatory environment • Stigma reduction
• VMMC
•Work environment • Risk reduction • PMTCT
•Culture • Adherence • Screening, diagnosis and
•Cash transfers interventions
(economic strengthening)
+ + management of STI
• ARV
• Antiretroviral therapy
for prevention (ART)
• Pre-Exposure
Prophylaxis (PrEP)
• Post-Exposure
Prophylaxis (PEP)
Module 1
1 PrEP Basics
19
Module 1 Learning Objectives
After completing Module 1, participants will be able to:
• Define PrEP.
• Differentiate PrEP from post-exposure prophylaxis (PEP)

and antiretroviral therapy (ART).
• Describe the need for PrEP.
• Identify people at risk and people at substantial risk

for HIV infection.
• Identify key & priority populations (KP & PP) for PrEP in Ethiopia
context.
20
Module 1 Learning Objectives
(continued)
• Explain the relationship between PrEP effectiveness and

adherence.
• State the key reasons why PrEP is needed.
• Specify the PrEP regimens approved by the FMoH Ethiopia.
• Identify concerns regarding PrEP implementation.
• Explain the risks and benefits of PrEP.
21
Questions
• What is pre-exposure prophylaxis (PrEP)?

• What is Post-exposure prophylaxis PEP?
• What are some similarities and
differences between PrEP and PEP?
22
Pre-Exposure Prophylaxis
PrEP is the use of ARVs by people who are HIV

negative to prevent the acquisition of HIV before
exposure to the virus.
Pre • Before
• Activity that can lead to HIV
Exposure
infection
Prophylaxis • Prevention
23
Post-Exposure Prophylaxis
PEP is short-term antiretroviral treatment to

reduce the likelihood of HIV infection after potential
exposure, either occupationally or nonoccupationally
—for instance, through sexual intercourse.
Post • After
Exposure • Activity that can lead to HIV infection
Prophylaxis • Prevention
24
Comparing PrEP and PEP
What is the same?

Both are used by HIV-negative persons.
Both use ARVs to prevent HIV acquisition.
Both are available from clinical providers by prescription.
Both are effective when taken correctly and consistently.
What is different?
PrEP is started before potential exposure. PEP is taken after exposure.
PEP is taken for 28 days only. PrEP requires ongoing use as long as
HIV risk exists.
25
Why We need PrEP?
• Even if there are already several effective HIV prevention

interventions (e.g. condoms, risk reduction, …).
– PrEP provides an additional prevention intervention to
be used together with existing interventions (e.g.
condoms, HIV testing..).
– Considered as one of the Combination HIV Prevention
pillars set by the Ethiopian Prevention roadmap1
– PrEP is not meant to replace or be a substitute for
existing interventions
– PrEP is safe
– PrEP is cost effective
1. UNAIDS, Gap Report 2016.; Ethiopian HIV Prevention roadmap 2018 - 26

2020,
Question
• Who do you think are the Key

Populations (KPs) or other
populations targeted for PrEP in the
Ethiopian context?
27
KP and PP Target groups for PrEP
• THE KP AND PP GROUPS

– Ethiopia defined KP and PP groups taking local epidemiology in to
consideration.
– KPs include Female sex workers (FSW) and Prisoners,
– PPs include widowed, separated or divorced individuals; Distance
Drivers; PLHIV and their partners; People working at hot spot areas
(Mobile and resident).
– Both KP and PP have high/substantial risk of acquiring HIV
infection, have limited access to services and some face stigma and
discrimination.
– Substantial risk of HIV - defined by the WHO as HIV incidence > 3
per 100 person–years in the absence of PrEP.
• The target groups for PrEP in Ethiopia are:
• KP:HIV Negative Female Sex Workers (FSWs)
• PP:HIV Negative partners of sero – discordant couples 28
Evidence PrEP Works
• PrEP efficacy was measured in:

– 11 randomized control trials (RCT) comparing PrEP with placebo.
– 3 RCTs comparing PrEP with no PrEP (e.g. delayed PrEP or ‘no
pill’).
– 3 observational studies.
• PrEP was found to be effective in reducing HIV acquisition.

– PrEP was most effective in studies with high adherence, where HIV infection
risk was reduced by 70% .
– Quantifiable drug in plasma increased the efficacy estimates to 74%
–92%.
Fonner VA, Dalglish SL, Kennedy CE, et al. Effectiveness and safety of oral HIV pre-exposure prophylaxis (PrEP) for all populations:
A systematic review and meta-analysis. Aids. May 5 2016.
29
Evidence PrEP Works
• PrEP can protect the HIV – uninfected partner in heterosexual sero -

discordant relationship with an HIV – infected partner if:
• The partner with HIV has been taking ART for less than six months.
– ART takes three 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 is not confident of the partner’s adherence to
treatment or has other sexual partners besides the HIV-infected partner
on treatment.
• There is knowledge of gaps in treatment adherence by the HIV-
infected partner or the couple is not communicating openly about
treatment adherence and viral load test results.
Fonner VA, Dalglish SL, Kennedy CE, et al. Effectiveness and safety of oral HIV pre-exposure prophylaxis (PrEP) for all
populations: A systematic review and meta-analysis. Aids. May 5 2016. 30
Effectiveness and Adherence in Trials of Oral and Topical
Tenofovir – Based Prevention
31
PrEP Efficacy Depends
on Adherence
• Taken as prescribed, PrEP works! Both ART and PrEP must be
taken correctly and consistently.
• Highest PrEP effectiveness was in trials with PrEP use of more than
70% (risk ratio = 0.30, 95% confidence interval: 0.21–0.45,
P<0.001) compared with placebo).*
• Referring to the previous line graph on “Effectiveness and
Adherence in Trials of Oral and Topical Tenofovir-Based
Prevention” , the higher the percentage of participant samples with
detectable PrEP drug levels, the greater the efficacy.
*Fonner VA, Dalglish SL, Kennedy CE, et al. Effectiveness and safety of oral HIV pre-exposure prophylaxis (PrEP) for all populations: A systematic review
and meta-analysis. AIDS 2016(30):1973-1983. doi:10.1097/QAD.0000000000001145.
32
Question
• How would you define adherence?
33
Defining Adherence
Adherence to drugs means that an individual is taking
prescribed medications correctly and consistently. It involves
taking the correct drug in the correct dose:
• With consistent frequency (the same number
of times per day).
• At a consistent time of day.
Adherence with follow-up means that clients attend all scheduled
clinic visits and observe all required protocols, including:
• Clinic and lab assessments.
• Prescription refills.
34
http://www.prepwatch.org/about-prep/research/#ongoingResearch 35
Global Progress of PrEP
• 2012: FDA approval in the United States
• 2015: WHO recommendation
• 2016: Southern African guidelines on PrEP

for persons at risk, including adolescents
• 2018: Adolescents included in PrEP

recommendations
in the United States
• Regulatory approval in dozens of countries
• Access through programs and research in

several other countries
36
PrEP Initiations by Country (April 2018)
> 25,000
10,000-25,000
5,000-10,000
1,500-5,000
500-1,500
< 500
No Data
PrEP Available (No Data)
Source: AVAC Global PrEP Initiation Tracker 2018 Training on Oral PrEP 37
PrEP Initiations by Country (April 2018)
> 25,000
10,000-25,000
5,000-10,000
1,500-5,000
500-1,500
< 500
No Data
PrEP Available (No Data)
Source: AVAC Global PrEP Initiation Tracker Training on Oral PrEP 38

2018
Summary
When taken
CORRECTLY and
CONSISTENTLY—
PrEP Works!
39
Recommended Regimen
• In Ethiopia, the available recommended PrEP regimens
include:
– TDF / 3TC, 1 Tablet to be taken orally daily
40
Concerns about PrEP
Is
PrEP
safe?
41
PrEP Side Effects: Reports from
RCTs
Approximately 10% of participants in randomized controlled
trials (RCTs) trials experienced side effects:
•They were mild.
•They usually did not persist beyond the first month.
Side effects may include:
• Gastrointestinal (GI) side effects: nausea, vomiting,
abdominal pain.
•Creatinine elevation: typically reversible.
•Loss of bone mineral density: recovers after stopping PrEP.
42
Will PrEP Users Engage in
More Risk Behaviors?
Will PrEP Encourage People to Use Condoms Less Often
or to Have More Sexual Partners (i.e., “Risk Compensation”)?
• There was no evidence of this in clinical trials, where participants

received regular counseling, screening, and access to condoms
• Evidence from real-world PrEP implementation shows declines in
self-reported condom use and increases in STI diagnoses among
some PrEP users.
• Combination prevention should include quality counseling and
access to condoms.
43
Will PrEP Lead to More
HIV Drug Resistance?
• Drug resistance (HIVDR) in PrEP users was rare in clinical
trials.
• HIVDR occurred mostly in cases where the person had
undiagnosed HIV infection when starting PrEP.
• HIVDR will not occur when adherence to PrEP is high and
HIV seroconversion does not occur.
• There can be risk of HIVDR if adherence is suboptimal and
HIV infection occurs while the individual is on PrEP.
• Optimal PrEP adherence is crucial.
• Health providers must support and monitor adherence and
teach PrEP users to recognize signs and symptoms of AHI.
44
HIV Drug Resistance (HIVDR)
9/22/2018 Training on Oral PrEP 45

Questions
• Does PrEP protect against other STIs?

• What can people do to protect
themselves against STIs while they are taking PrEP?
• What should the package of prevention services
include?
46
Does PrEP Protect Against
Other STIs?
• PrEP does not protect against syphilis, gonorrhea, chlamydia, or human
papilloma virus (HPV).
• Only condoms protect against STIs and pregnancy.
• PrEP protects against HIV.
• PrEP also provides modest protection against herpes simplex virus type
2 in heterosexual populations.
• PrEP should be provided within a package of prevention services,

including STI screening and management, risk reduction counseling,
condoms, and contraceptives.
47
Module 1 Summary
What We Know about PrEP
• PrEP can be used by HIV-negative persons to reduce the risk of
HIV acquisition.
• Daily oral PrEP with TDF-containing regimens is currently
recommended.
• PrEP should be taken as an additional prevention intervention.
• PrEP is effective if taken correctly and consistently.
• PrEP can be used by for those who have HIV substantial risk of
HIV Negative FSWs and HIV Negative Sero-discordant couples.
• PrEP is safe and has minimal side effects.
48
Module – 2:
Demand Creation
9/22/2018
Brainstorming
– How do you promote PrEP service among
target populations?
• HIV negative FSWs?
• Sero-discordant couples?
Training on Oral PrEP 50

PrEP Demand Creation
• Importance of demand creation
– To increasing awareness about PrEP, and generate demand and access
– PrEP service uptake is generally low if not supported by strong
demand creation activity
• To promote service for HIV negative FSWs:

– Communication materials including brochures and posters
– Peer educators/Peer navigators, who are oriented on PrEP will
facilitate the recruitment of eligible clients who are at high risk of
acquiring HIV.
– Discussing PrEP on SBCC sessions
– Testimony from initial PrEP users

PrEP Demand Creation
• For HIV negative partners of sero - discordant
couples:
– adherence case managers and service providers should
identify those couples with continuous risk from patients
currently taking treatment,
– discordant couples, who are at continuous risk will be
recruited.
– The selection of eligible beneficiaries will also be done
through using the existing index case register and line-
listing HIV negative partners
– sero – discordant couples, could be contacted and offered
evaluation for PrEP eligibility.

demand creation strategies
• What other demand creation strategies could
be used locally?

Demand creations
• One to One counseling

• Group health education/counseling
• Communication materials including brochures and
posters
• Testimony from initial PrEP users
• Educate KPs during outreaches KP activities
• Promote PrEP availability to clients.
Module – 3:
PrEP Screening &
Eligibility
9/22/2018
Module – 3: Learning Objectives
After completing Module 3, participants will be able to:

• List the eligibility criteria for PrEP.
• Use the standard medical screening form for PrEP
eligibility and substantial risk.
• Discuss exclusion criteria and contraindications for
PrEP.
• Explain how to evaluate for and exclude acute HIV
infection.

WHO Recommendation for PrEP
• Substantial HIV risk (provisionally defined as

HIV incidence > 3 per 100 person–years in the
absence of PrEP)
• Offer as an additional prevention choice
• Provide PrEP as part of combination HIV
prevention approaches
– Condoms
– Harm / risk reduction
– HIV testing and links to ART
• Give PrEP with comprehensive support
– Adherence counselling
– Legal and social support
– Mental health and emotional support
– Contraception and reproductive health
services

Questions
• Who should receive PrEP?
• What are the eligibility criteria for initiating PrEP?

Target Populations for PrEP (Ethiopian Context)
• The following Key & Priority populations should be

offered PrEP (Ethiopian Context):
– HIV Negative Female Sex Workers (KPs)
– HIV Negative partners of Sero - Discordant couples
(PPs)

Eligibility Criteria for FSWs (Ethiopia)
• FSW Client who:

 HIV negative using a rapid antibody test as per the
National HIV testing algorithm on the day of PrEP
initiation
 No suspicion of acute HIV infection
 Self- identifying FSWs.
 No contraindications to PrEP medicines (TDF/3TC)

Eligibility Criteria for Partners of Sero - discordant Couples
• Partner of a Sero – Discordant Couple who:

 HIV negative using a rapid antibody test as per the National HIV testing
algorithm on the day of PrEP initiation
 No suspicion of acute HIV infection
 Substantial risk of HIV infection (any ONE of the following in the past six
months):
o Has a known HIV positive sexual partner(s) who is not on ART or
o On ART less than six months, or not yet achieved viral suppression or
 No contraindications to PrEP medicines (TDF/3TC)

Screening visit: What is required before PrEP?
HIV test negative

Clinical screening for acute • Blood Creatinine level check
HIV infection • Pregnancy test
HIV risk assessment using a
• STI Screening and
screening tool
Treatment
Adherence counselling
• Hepatitis – B test

Additional considerations
• f a client is positive for Hepatitis – B infection,
referrals should be facilitated/made to Health Facilities
offering management for Hepatitis B infection.
• Young adults may benefit from more frequent
appointments e.g. monthly visits, as they commonly
have lower adherence rates.
• Adherence is a significant modifier of PrEP
effectiveness and PrEP can be started and stopped as a
person moves through “seasons of risk”.
• Offer immediate ART if a PrEP user sero - converts.
The PrEP Screening Tool
• Used to conduct screening of the clients

• Helps to conduct preliminary identification of those who
are going to be eligible
– Refer to the tool and have a discussion later on

Screening visit
Screening  PrEP initiation  One month follow - up  maintenance visits
Educate on risks and benefits of PrEP
Assess risk and eligibility
Conduct HCT /Check Creatinine/Test HBV and Pregnancy /Screen

and Treat STI s
Provide Contraception / condoms
Arrange for a follow – up

Before initiating PrEP
1. Conduct a rapid HIV test to rule out existing HIV infection

2. Take a complete medical history and full physical examination to
rule out any signs or symptoms of an acute HIV infection
3. Perform HBsAg test if available(Other wise not mandatory)

4. Measure blood creatinine before starting PrEP and at every 6
months after PrEP where available. If not assess signs and
symptoms of renal impairment

Before initiating PrEP
• Contraindications must be ruled out before starting PrEP, these

include:
 HIV positive status
 Unknown HIV status
 Allergy to any medicine in the PrEP regimen
 Unwilling/unable to adhere to daily PrEP
 Known renal impairment
 Estimated creatinine clearance <60 cc/min

Example Screening Questions
Consider PrEP if a client answers yes to any of the following

questions:
“In the past six months,”:
• “Have you had sex with one or more than one sexual
partner?”
• “Have you had sex without a condom?”
• “Have you had sex with people whose HIV status you do not
know?”
• “Are any of your partners at risk of HIV?”
• “Have you had sex with a person who has HIV?”

Additional issues to ask FSWs about:
“Are there aspects of your situation that may indicate higher risk for
HIV?
Have you…”:
• “been forced to have sex against your will?”
• “been physically assaulted, including assault by a sex
partner?”
• “taken PEP to prevent HIV infection?”
• “had a sexually transmitted infection (STI)?”
• “used recreational drugs or alcohol?”
• “do you have plans to move within the next 3 months?”
Please note:……

For a person who has a partner with HIV:
The following questions will help to ascertain whether that person

would be a good candidate for PrEP;
• “Is your partner taking ART for HIV?”
• “Has your partner been on ART for more than six months?”
• “Do you discuss your partner’s adherence to HIV treatment every
month?”
• “Do you know your partner’s last viral load? What was the
result? And when was it done?
• “Are you and your partner consistently using condoms?”

Screening for Substantial Risk
• Screening questions should be framed in terms of

people’s behavior and should refer to a six month time
period.
• It is important for PrEP providers to be sensitive,
inclusive, non-judgmental, and supportive.
NOTE
• Be careful not to develop a screening process that might
discourage PrEP use.

Exclude HIV Infection before starting PrEP
• PrEP is a prevention intervention for people who are HIV

uninfected.
• All persons at substantial risk for HIV and who may be eligible for
PrEP should be offered HIV testing prior to PrEP initiation
• HIV testing must be done using national guidelines and
algorithms.
– Use rapid HIV tests at point of care.
– Promptly link clients who test HIV positive to HIV treatment
and care services.

Pregnancy and PrEP
• HIV – negative women in sero – discordant relationships are at

risk when trying to get pregnant.
• PrEP benefits for women at high risk of HIV acquisition appear to

outweigh any risks observed to date.
• WHO recommends continuing PrEP during pregnancy and

breastfeeding for women at substantial risk of HIV.

PrEP use during Pregnancy
• TDF is safe in pregnant and breastfeeding women, however,

evidence comes from studies of HIV infected women on ART.1
• PrEP benefits for women at high risk of HIV acquisition appear

to outweigh any risks observed to date.

74
Sero – Discordant Couples
PrEP can protect the HIV uninfected partner in a heterosexual

serodiscordant relationship with an HIV-infected partner if:
• The partner with HIV has been taking ART for less than six months.
– ART takes three to six months to suppress viral load.
– In studies of serodiscordant couples, PrEP has provided a
useful bridge to full viral suppression during this time.
• The uninfected partner is not confident of the partner’s adherence to

treatment or has other sexual partners besides the HIV-infected partner
on treatment.
• There is awareness of gaps in treatment adherence by HIV – infected
partner or the couple is not communicating openly about treatment
adherence and viral load test results.
Medications used for PrEP
• The preferred and alternative • Preferred Medication (as per

regimens for PrEP consist of the Ethiopian national
ARVs that are already in use. guideline)
– TDF (300 mg) plus 3TC
• Doctors and nurses may offer (300 mg)
PrEP – Fixed Dose Combination
– 1 tablet to be taken orally
daily
– Duration of intake:
Through out the period of
substantive risk

Duration of PrEP
Recommended:
• Daily dosing in the period of substantial risk
– PrEP reaches maximum effectiveness after 7 doses.
– Full protection may occur after 7 daily doses
• Unlike a patient on lifelong ART, a PrEP client may be discontinued
from PrEP when they are no longer at substantial risk of HIV
infection
• PrEP medications should be continued for 28 days after the last
potential HIV exposure in those wanting to cycle off PrEP

Question
• What is Acute HIV Infection (AHI)?

Acute HIV Infection
• Acute HIV infection (AHI) is the early phase of HIV disease that is
characterized by an initial burst of viremia.
• AHI infection develops within two to four weeks after someone is infected
with HIV.
• Approximately 40% to 90% of patients with AHI will experience “flu-like”
symptoms.
– These symptoms are not specific to HIV, they occur in many other viral
infections.
– Remember that some patients with AHI can be asymptomatic.
• The figure on the next slide depicts some of the presenting signs and symptoms
of AHI.
• Do NOT start PrEP in clients with suspected AHI.

Source: Medical gallery of Mikael Häggström 2014

Diagnosis of Acute HIV Infection
• During AHI, antibodies might be absent or be below level of

detection.
– Serological testing using rapid test might be negative.
• PrEP should be deferred for four weeks if AHI is suspected.

– Repeat HIV serological test after four weeks to reassess
eligibility.

Creatinine & Estimated Creatinine Clearance
• TDF can be associated with a small decrease in estimated

creatinine clearance (eGFR) early during PrEP use and usually
this does not progress.
• PrEP is not indicated if eGFR* is < 60ml/min.
*eGFR: estimated glomerular filtration rate using Cockroft-Gault

equation:
Estimated CrCl = [140-age (years)] x weight (kg) x f where f=1.23

for men and 1.04 for women Serum creatinine (μmol/L)

Online Cockcroft-Gault Calculator
http://reference.medscape.com/calculator/creatinine-clearance-cockcroft-gault
Willingness to Use PrEP as Prescribed
• Clients should not be coerced into using PrEP.
• Clients should be given information and supported to make an

informed choice.
The final decision should come from the client!

PrEP Screening Tool / Form
• Use of a standard form can ensure that screening is done

in a consistent manner and is well documented.
• Please refer to the tool the PrEP) Screening for

Substantial Risk and Eligibility for use to record key
elements in the sexual history needed to screen for PrEP
eligibility.

PrEP Screening Form for Substantial Risk and Eligibility (By FMoH)
PrEP Screening Form for Substantial Risk and Eligibility (By FMoH)
1. Facility Information
Health Facility / DIC Name: _________________________
Region:_________________________Zone:____________________Woreda/Town :________________________
Date the form completed (dd/mm/yy) __ __ /__ __ /__ __
Name of service provider completed the form
__________________________________________
Unit eligibility assessment done: ART clinic □ PMTCT □ DIC PrEP provision unit: ART clinic □ PMTCT □ DIC
2. Client Information
First Name Father’s Name Grandfather’s Name
Address Telephone:
Region: (in case of FSW include bar or street of work)
Woreda:
House Number:
MRN/UIC: Referred for PrEP evaluation by:
3. Client Demographics
Sex Male Female

Age _______ Enter number of years

PrEP Screening Form for Substantial Risk and Eligibility
4. Screening for Substantial Risk for HIV infection

Clients are considered at substantial risk if they
belong to any of the two categories below:
Question prompts for providers:
Do you trade sex for money or other material goods?

1)Self Identifying FSW
Have you been sexually active in the last six months?
2) If they report having a sexual partner in the last Is your partner HIV infected? Note for FSWs check if she knows the HIV status of her
six months who is HIV positive AND who has not Baluka/boyfriend?.
been on effective* HIV treatment Is he/she on ART?
*If partner has been on ART for less than six months, How long has your partner been on ART?
or has inconsistent or unknown adherence, or has Is your partner adherent to ART?
unsuppressed viral load What was the last viral load result?

5. PrEP Eligibility
Clients are eligible if they fulfill ALL the
criteria below:
Date client tested: ___/___/____ (dd/mm/yy)
HIV-negative Date client received test results: ___/___/____
Test result: □ Negative □ Positive* (*Refer to HIV medical care)
At substantial risk of HIV At least one item/risk in Box #4 above is ticked: □ #1 □ #2 □ Both
Has no signs/symptoms of acute HIV
See Box #6 below to confirm no recent exposure to HIV
infection
Has creatinine clearance (eGFR) >60
eGFR Result:_________ Date:_________
ml/min* (if available)
HBsAg negative* HBsAg Result:_________ Date:_________
Meets other eligibility criteria Has no allergies or contraindications to TDF/3TC,
If all above boxes in this section are ticked, offer PrEP.*
*If creatinine test are not available, may start PrEP if there is no suspicion for renal disease
6. Recent Exposure to HIV. Ask, “In the last 2 weeks”…

Have you had sex without a condom with someone living with HIV who is
Yes** No Don’t know
not on treatment?
Have you had a “cold” or “flu” or a sore throat, runny nose, or fever? Yes** No Don’t know
**If ONLY reporting sex without a condom, within the last 72 hours and is a survivor of GBV, refer for post-exposure prophylaxis (PEP) as part of
comprehensive GBV services.
**If reporting BOTH sex without a condom and flu-like symptoms, an acute HIV infection might be suspected.
 In this case, do NOT offer PrEP or PEP and repeat HIV testing after four weeks to determine if client has acute HIV infection.
Clinical Scenario for Discussion
Mulu is a 22 year-old woman who presented to the clinic because she is interested in
starting PrEP. She reports using condoms sometimes during sex with her HIV-positive
male partner. Her partner is healthy and has been on ART for 3 months. Their last
unprotected intercourse was last week. Mulu is in good health, taking no medications,
and her rapid HIV antibody test today is negative.
• Please turn to the person beside you and over the next few minutes discuss the
following:
– Is Mulu a candidate for PrEP?
– If so, what are the considerations?
• Refer to and use the sample PrEP Screening for Substantial Risk and Eligibility
tool.

Clinical Scenario for Discussion
Marie is an 18 year - old woman who presented at the clinic because she felt sick
and became afraid that she might have HIV.
She reluctantly explained that, during the past year, she was having sex for money
or gift in order to support her two children.
Some of her partners used condom and others had not. She didn’t know if her
partners had HIV.
Marie reported that she was feeling down and sick for the past few weeks. Her
rapid HIV antibody test conducted today turned out to be negative.
• Is Marie a candidate for PrEP?

• If so, why?
• What other information would you need in order to determine eligibility?

Module – 3: Summary: PrEP Eligibility and Screening
• Health Care Providers should inform and counsel potential PrEP users and
conduct an individualized risk assessment.
• PrEP should be considered for HIV Negative FSWs and HIV negative partners
of sero – discordant couples.
• Eligibility for PrEP includes:

– At substantial risk of HIV infection
– HIV seronegative
– No suspicion of acute HIV infection
– No contra-indications to ARVs used in PrEP regimen
• The standard screening forms should have to be used to document eligibility

Module – 4:
Initial and Follow – Up
PrEP Visits, Managing
PrEP Side Effects,
Seroconversion & Stigma
9/22/2018
Module - 4: Learning Objectives
By the end of Module – 4, participants will be able to:
• Specify the steps for the initial PrEP visit.

• Demonstrate knowledge of national HTS guidelines and local algorithms for
HIV testing
• Describe the rationale and content for brief counseling during the initial/first
PrEP visit.
• Specify the steps for follow-up PrEP visits.
• Describe the rationale and content for follow – up counseling at each visit.
• Explain how to manage creatinine elevation.
• List additional causes of creatinine elevation.
• Explain how to manage sero - conversion.
• Develop strategies to minimize PrEP stigma.

Investigations / Interventions
Investigations Duration of Interventions and Purpose
Confirmation of HIV negative test status Every 3 months; consider also testing at the first month
Address side-effects Every visit.
Brief adherence counselling Every visit.
Estimated creatinine clearance Every 6 months. Consider more frequently if there is a
history of conditions affecting the kidney, such as diabetes
or hypertension.
Screening for sexually transmitted infection To diagnose and treat STI (syndromic or diagnostic STI
(STI) testing, depending on local guidelines). Should have to be
conducted at every visit.
Counseling To assess adherence and provide counselling regarding
effective PrEP use (adherence),
To assess whether the client is still at substantial risk of
HIV.
To discuss prevention needs and provide condoms
To assess fertility intentions and offer contraception or

safer conception counselling.
To assess intimate partner violence and gender based
violence.
To assess substance use and mental health issues.
Initial PrEP Counselling
• Initial counseling should focus on:

– Increasing awareness of PrEP as a choice.
– Helping the clients to decide whether PrEP is right for them.
– Preparing individuals for starting PrEP.
– Explaining of how PrEP works.
– Providing basic recommendations.
– The importance of adherence and follow-up visits.
– Potential PrEP side effects.
– Recognizing symptoms of acute HIV infection.
– Building a specific adherence plan for PrEP.
– Discussing sexual health and risk reduction measures.

Initial PrEP counseling (cont’d)
• Assess client’s understanding that the protection provided by PrEP

is not 100%.
• Explain need for repeat clinic visits and repeat blood tests.
• Additional information for women:
– PrEP does not affect the efficacy of hormonal contraceptives.
– PrEP does not protect against pregnancy.
– PrEP can be continued during pregnancy and breastfeeding.

PrEP Counselling
During the counseling session :
“Assess client understanding that the protection provided

by PrEP is not complete, and does not prevent other STIs
or unwanted pregnancies, and therefore PrEP should be
used as part of a package of HIV combination prevention
services [including condoms, contraception, risk reduction
counseling and STI management].”
(Source: From the Southern African Clinician Society Guidelines for Provision of
PrEP)

Key Initial Visit Counseling Messages: PrEP Efficacy
PrEP works when taken regularly
PrEP reaches maximum effectiveness after seven daily doses.
PrEP does not prevent most sexually transmitted infections other than HIV.
Condoms used with every act of sexual intercourse provides some protection
against many of these infections.
PrEP does not prevent pregnancy. Use effective contraception unless you want
pregnancy.
PrEP is safe.

Key Initial Visit Counseling Messages: Supporting Adherence
Taking PrEP each day is easiest if you make taking the tablets a daily habit,
linked to something else that you do every day without failure.
If you forget to take a tablet, take it as soon as you remember.
PrEP tablets can be taken any time of day, with food or without food.
PrEP is safe and effective even if you are taking hormonal contraceptives, sex
hormones or non-prescription drugs.
• Drinking alcohol will not affect the safety or effectiveness of PrEP. But
drinking alcohol could make you forget to take the PrEP tablets.

Think_Pair_Share_10 minutes
• What are some common reasons for poor adherence?
• What can providers do to promote and support

adherence?

Common Reasons for Poor
Adherence to PrEP
Individual Factors Medication Factors Structural Factors
• Forgetting doses • Adverse events / Side • Distance to health
• Being away from home effects services
• Changes in daily routines • Access to Public Health
• Depression or other illness Facilities (like
including mental health convenient working
• Limited understanding of hours)
treatment benefits
•
• Long waiting hours to
Lack of interest or desire to
take the medicines receive care and obtain
• Substance (“Khat Ebulis” refills
or ) or alcohol use • Burden of direct and
• Absence of supportive indirect costs of care
environment (Direct like
• Fear of stigma and transportation cost and
discrimination work related issues as
indirect costs)

Understanding Voluntary VS. Involuntary / Non – Adherence
Voluntary Non – Adherence Involuntary Non – Adherence

(intentionally by a client) (not intentionally by a client)
• Not convinced that PrEP is needed • Forgot to take pill

• Does not believe PrEP works or is • Forgot to refill prescription
working • Has competing priorities (e.g.
• Does not like taking pills employment, child care)
• Has experienced side-effects • Has difficulty with personal organization
• Has experienced stigma while taking and scheduling
PrEP • Affected by depression or other mental
illness

Adherence: Lessons from ART Programs
• Health Care Providers can positively influence adherence by:

– Facilitating accurate knowledge and understanding of medication benefıts
and requirements.
– Preparing for and managing side-effects.
– Monitoring of adherence.
– Identifying social support.
– Encouraging medication optimism.
– Building self-effıcacy for adherence.
– Developing a routine daily schedule in which to integrate regular dosing.
– Maintaining two way communication with PrEP users.

Approaches to PrEP Medication Adherence Support
Support Issue: Health Care Provider’s Options

Educating to create • Briefly explain or provide materials about:
adequate and accurate o Indications for medication.
knowledge on PrEP
o The anticipated risks and benefits of taking medication.
o How to take it (one pill per day).
o What to do if one or more doses are missed.
• Assess for misinformation.
Preparing for and • Educate about what side effects to expect, for how long, and how to manage
managing side effects
them.
• Educate about the signs and symptoms of acute HIV infection and how to
obtain prompt evaluation and care.
Fostering self – efficacy • Foster discussion of personal perception of HIV risks.
• Recommend or provide medication-adherence tools:
o Pill boxes
o Phone apps, SMS reminder services (if available)
Creating routine daily • Discuss how to integrate daily dose with other daily events and what to do
schedule
when away from home.

Approaches to PrEP Medication Adherence Support (Cont’d)
Support Issue Health Care Provider’s Options

Providing • Regularly assess adherence.
support
• Ask for a patient self-report.
• Complete the prescription/visit record.
• Use new technologies (text reminders if available).
• Offer allied clinical support services (e.g.. pharmacist).
Fostering Social • Discuss privacy issues for PrEP user.
Support
• Offer to meet with partners or family members if they are supportive.
Addressing • Consider screening for depression or substance-abuse problems.
Mental health
and substance • Provide or refer to indicated mental health or substance-abuse treatment and
abuse related relapse-prevention services.
issues • Encourage clients to take medication before / after the use of substances
Addressing • Consider additional medication-adherence support for:
population o Adolescents.
challenges o People with unstable housing..
o Others with specific stressors that may interfere with medication adherence.

Adherence Assessments
• Ask about adherence at each visit:

– Encourage the PrEP user to self-report in order to understand what they
believe about their adherence.
– Ask about adherence over the last seven days (short recall )
– Ask about any missed doses over the last month
– Avoid judgment to encourage a realistic and honest description.
• Additional methods to monitor adherence:

– Pharmacy refill history
– Pill – count

Peer Workers for PrEP
• Outreach workers, including lay or peer workers, are uniquely able
to engage people who may benefit from PrEP but do not routinely
access health care.
• Lay and peer workers can provide nonjudgmental, respectful

support.
• Peers with PrEP experience can be effective role models.
• PrEP services that include lay providers from KP groups can help
reduce client concerns about stigma and increase PrEP uptake.

Role of Peers in Promoting PrEP
• Peers play an important role in promoting PrEP,
delivering accurate messaging, and supporting
adherence.
• Peer workers are an effective “first line” in

introducing PrEP to clients at community events
and outreach activities and in clinic waiting rooms.
• Include peers in PrEP discussions and trainings.

Provider Checklist for Initial PrEP visit
 HIV testing (using algorithm in national guideline)
 Exclude acute HIV infection
o Ask about last potential exposure to HIV
o Ask/look for ‘flu-like’ symptoms/signs
 Screen for substantial HIV risk
 Serum creatinine (if available)
 Hepatitis B surface antigen (HBsAg)
 STI screening
o Use syndromic approach
 Pregnancy test
o Ask about last menstrual period(perform pregnancy test if needed)
 Conduct risk reduction counselling
o Clients will be referred based on specific needs i.e. social support, harm reduction,
GBV programs etc
 Provide information on PrEP and conduct adherence counseling
 Provide Condom
 Provide (or refer to) reproductive health services (as needed)
 Schedule next appointment (provide appointment card )
109
Clinical Scenario for Role Play
Helen is a 20 years old FSW and wanted to be put on PrEP since she was informed
about it by her peers who started taking it.
She reported that she had multiple sexual partners who used to force her not to use
condoms and used to give her more money for not using condoms during such
encounters.
She reported that she had history of recurrent vaginal discharge and was managed at
a local pharmacy two months ago.
She had the habit of forgetting on taking medications prescribed at different
occasions. She reported that she likes to take alcohol every time.
How do you manage this case?

PrEP Follow – Up Visits
• Clients on PrEP require regular visits with the Health

Care Provider.
• Outside regular monitoring visits, clients should also
consult if they have severe adverse events or
signs/symptoms of AHI.

Follow – up Schedule for clients on PrEP
• HIV negative FSWs • HIV negative partners of

– At initiation: provide a supply sero – discordant couples
for 1 month
– At initiation: provide a
– At one – month: repeat HIV
test, provide 1 – month supply for 1 month
supply, and for the first 3 – – At one – month: repeat
months, appoint monthly for HIV test and provide 3
close adherence support and
months supply
provision of other prevention
packages. – Every 3 – months: repeat
– At three – months: repeat HIV HIV test and provide 3
test and provide 3 – months months supply
supply

Suggested Procedures during Follow – Up PrEP Visits
Intervention Schedule Following PrEP initiation

Confirmation of HIV - • Every three months
negative status
Address side-effects • Every visit
Brief adherence • Every visit

counseling
Estimated creatinine • At least every six months, or more frequently if there is a
clearance history of conditions affecting the kidney, such as diabetes or
hypertension
• Provide STI screening, condoms, contraception as needed.
• Counselling regarding symptoms of acute HIV infection, and to come back as soon as
possible for evaluation if these symptoms occur.
Repeat HIV Testing
• Repeat HIV testing is needed to inform decisions on whether to continue or

discontinue PrEP.
• Repeat HIV testing (using national guidelines):
– One month after starting PrEP.
– Every three months thereafter.
• Remember the limitation of serological tests during AHI in the window period
(time from HIV infection to detection of antibodies), and also that exposure to
ARVs can decrease sensitivity of serological tests.
Stop PrEP if Acute HIV infection is suspected!

Follow – Up PrEP Counselling
• Follow – up counseling should focus on:

– Checking in on the current context of sexual health.
– The patient’s desire to remain on and assessment of continued risk of PrEP.
– Facilitators & barriers to PrEP use.
– Additional non – PrEP related sexual health protection strategies (condoms,
etc.).
– Emphasize the need for taking it daily.
– What to do if a dose is missed.
– Common adherence strategies.
– Reasons for ongoing monitoring while on PrEP.
– How to recognize symptoms of acute HIV infection.
– Side-effects & their management.
– How to safely discontinue and restart PrEP as appropriate.

•HIV testing (using algorithm in national guideline)
•Exclude acute HIV infection
Ask about last potential exposure to HIV
Ask/look for ‘flu-like’ symptoms/signs
•Screen for substantial HIV risk
•Serum creatinine (if available)
•Hepatitis B surface antigen (HBsAg)
•STI screening
Use syndromic approach
•Pregnancy test
Schedule
Ask about last menstrual period(perform next appointment
pregnancy (provide appointment card)
test if needed)
•Conduct risk reduction counselling
Clients will be referred based on specific needs i.e. social support, harm reduction, GBV programs
If client using PrEP testsinformation
•Provide positive foron
HIV, stop
PrEP andPrEP and link
conduct promptly
adherence to treatment
counseling
and care
•Provide services
Condom for immediate initiation of ART
•Provide (or refer to) reproductive health services (as needed)
116
• HIV testing (using algorithm in national guideline)

• Exclude acute HIV infection
– Ask about last potential exposure to HIV
– Ask/look for ‘flu-like’ symptoms/signs
• Screen for substantial HIV risk
• Serum creatinine (if available)
• Hepatitis B surface antigen (HBsAg)
• STI screening
– Use syndromic approach
• Pregnancy test
– Ask about last menstrual period(perform pregnancy test if needed)
• Conduct risk reduction counselling
– Clients will be referred based on specific needs i.e. social support, harm reduction,
GBV programs etc
• Provide information on PrEP and conduct adherence counseling
• Provide Condom
• Provide (or refer to) reproductive health services (as needed)
• Training
9/22/2018
Schedule next appointment (provide appointment card)
on Oral PrEP 117
PrEP Discontinuation
Starting PrEP Does Not Mean Staying on PrEP for Life
• People often move in and out of substantial risk for HIV.
• Education and support for safe stops and restarts of PrEP use are essential.
• A variety of life changes may prompt a person to stop PrEP, including:
 A partner with HIV achieves viral suppression on ART.

 A relationship becomes mutually monogamous.
 Sex work or injection drug use stops.
 Other risks change.
• Clients who decide to stop PrEP should:

 Contact their health care providers.
 Continue to take PrEP for 28 days after their last potential exposure to HIV.
99
Clinical Case Scenario for Discussion
Helen is a 25 years old FSW and has been on PrEP (TDF/3TC) for the last nine
months.
At her follow – up visit, she is in good health and her repeat HIV test is negative.
She decided to stop sex work and reported recently of starting a monogamous
relationship with a partner who tested HIV negative last year and feels that she
might no longer need PrEP.
How would you manage this case?

Managing PrEP Side Effects,
Seroconversion & Stigma

Monitoring Creatinine Elevation
• Approximately 1 in every 200 PrEP users may develop an elevation of

serum creatinine.
– Defined as a 50% increase above baseline or an elevation above
the normal range.
– Reminder: Renal impairment is defined as having an estimated
creatinine clearance of < 60 ml/min (Check it form the Ethiopian ART
Guideline, Page 69 )
• Creatinine elevations have usually reversed after stopping PrEP.
• It is important to monitor transient creatinine elevation and for signs of
chronic or severe renal insufficiency

Question
• How would you manage increase in creatinine

clearance?

Managing Creatinine Elevation
• Discontinue PrEP if creatinine elevation is confirmed on a
separate specimen and if estimated creatinine clearance decreases
to < 60 ml/min (Check!).
– The test has to be repeated immediately / ASAP after the first
result for confirmation and discontinuation of PrEP
– Contact the client when the result for the test from the second
specimen comes back elevated.
– If no contact information, use other options like involvement of
case managers, peer navigators
• After PrEP is stopped, creatinine test can be done every month for
three months, and PrEP could be restarted after three month if
eGFR returns to > 60 ml/min.

Managing Creatinine Elevation
• Referrals should be made for management of additional causes

and management of creatinine elevations should be considered if:
– Creatinine elevations are more than 3x the baseline.
– Renal function or creatinine elevations do not return to normal
levels within three months after stopping PrEP.
– Creatinine elevations progress at one month or more after
stopping PrEP.
• Common causes of chronic or severe renal insufficiency include:
diabetes mellitus, uncontrolled systemic hypertension, hepatitis C
infection, liver failure, and pre-eclampsia during pregnancy.

Sero – Conversion on PrEP
• PrEP works when taken correctly and consistently as prescribed.

In clinical trials, the level of protection was strongly correlated
with adherence.
• HIV sero – conversion after prescribing PrEP can occur if PrEP is

not used correctly or consistently, or if HIV infection was
undiagnosed at the time of PrEP initiation.
• Part of counseling should include information to help PrEP users

recognize signs/symptoms of AHI, which should prompt a clinic
visit without delay.

Question
• How would you manage seroconversion while your

clients is on PrEP?

Managing Sero – conversion
• If a person using PrEP tests positive for HIV, PrEP should be

stopped immediately and the person referred for prompt
initiation of HIV treatment.
• Transitions from PrEP to HIV treatment without a gap avoid the

risk of resurgence in viral load, immunological injury, and
secondary transmissions.

PrEP “Special Situations”
Situation Recommendation /Follow – Up
Hormonal • PrEP does not affect the efficacy of hormonal

Contraception contraceptives and hormonal contraceptives do not
affect PrEP efficacy.
Pregnancy • PrEP may be continued during breastfeeding in

and women who are at substantial risk for HIV
breastfeeding acquisition.

Minimizing PrEP Stigma
• Confidentiality is essential in PrEP services.
• People may face stigma if their PrEP use becomes known.
• PrEP use can exacerbate stigma if others mistakenly consider PrEP use to be
evidence of irresponsible behavior or mistakenly think that PrEP is HIV treatment.
– Such stigma will decrease PrEP uptake and adherence among people who would
otherwise benefit from it.
Presenting PrEP to your communities as a responsible choice

that protects both partners will increase the impact of PrEP,
prevents more HIV infections, and can help reduce stigma.

Question
• What strategies can you think of to minimize PrEP

stigma?
– Discuss with participants

Module – 4: Summary
• Prescribe PrEP as part of HIV combination prevention strategy.

• Confirm for a negative HIV test on the day of PrEP initiation.
• Ensure there are no contra-indications to PrEP.
• Ensure clients have correct information about PrEP.
• Develop an adherence support plan with the client and monitor adherence
at each visit.
• Conduct risk-reduction counseling at each visit.
• PrEP users should be informed about how to recognize signs and
symptoms of acute HIV infection.
• If person using PrEP tests positive for HIV, stop PrEP immediately and
start ART as soon as possible, without a gap after PrEP is discontinued.
• If confirmation of positive HIV test result is delayed for more than a few
hours, transition to fully suppressive ART (three ARVs as per national
treatment guidelines) Training on Oral PrEP 132
Module – 5:
PrEP Monitoring
& Evaluation
Tools
9/22/2018
Module – 5: Learning Objectives
• By the end of Module – 5, participants will be able to:

• Correctly complete MOH approved PrEP Monitoring and
Evaluation tools (Screening Log, PrEP Facility Record, and PrEP
Client Register)
• Use the Provider Checklist for Substantial Risk during PrEP follow-
up visits.
• Correctly complete the PrEP Monthly Summary Report Form

PrEP Monitoring & Evaluation Tools
• Refer below the PrEP M&E tools. We will review and practice using these in
this session
• PrEP Screening for Substantial Risk and Eligibility Assessment tool
• PrEP Facility Record
• PrEP client register
• PrEP Seroconversion Tracker
• PrEP reporting template
• Others
• Begin to think and discuss about how these M & E tools can be used within
your Facility.

PrEP Screening Form for Substantial Risk and Eligibility (By MoH)
1. Facility Information
Health Facility / DIC Name: Region:
Facility code: Zone:
Woreda:
Date of initial client visit Person Completing Form:
(dd/mm/yy) __ __ /__ __ /__ __ Unite eligibility assessment done:
□ ART clinic □ PMTCT □ DIC
2. Client Information
First Name Father’s Name Grandfather’s Name
Address Telephone:
Region: (in case of FSW include bar or street of work)
Woreda:
House Number:
MRN/UIC: Referred for PrEP evaluation by:
3. Client Demographics
Sex Male Female

Age _______ Enter number of years

4. Screening for Substantial Risk for HIV infection

Clients are considered at substantial risk if they
belong to any of the two categories below:
Do you trade sex for money or other material goods?

1)Self Identifying FSW
Have you been sexually active in the last six months?
2) If they report having a sexual partner in the last Is your partner HIV infected? Note for FSWs check if she knows the HIV status of her
six months who is HIV positive AND who has not Baluka/boyfriend?.
been on effective* HIV treatment Is he/she on ART?
*If partner has been on ART for less than six months, How long has your partner been on ART?
or has inconsistent or unknown adherence, or has Is your partner adherent to ART?
unsuppressed viral load What was the last viral load result?

5. PrEP Eligibility
Clients are eligible if they fulfill ALL the
criteria below:
Date client tested: ___/___/____ (dd/mm/yy)
HIV-negative Date client received test results: ___/___/____
Test result: □ Negative □ Positive* (*Refer to HIV medical care)
At substantial risk of HIV At least one item/risk in Box #4 above is ticked: □ #1 □ #2 □ Both
Has no signs/symptoms of acute HIV
See Box #6 below to confirm no recent exposure to HIV
infection
Has creatinine clearance (eGFR) >60
eGFR Result:_________ Date:_________
ml/min* (if available)
HBsAg negative* HBsAg Result:_________ Date:_________
Meets other eligibility criteria Has no allergies or contraindications to TDF/3TC,
If all above boxes in this section are ticked, offer PrEP.*
*If creatinine and/or HBsAg test are not available, may start PrEP if there is no suspicion for renal disease
6. Recent Exposure to HIV. Ask, “In the last 2 weeks”…

Have you had sex without a condom with someone living with HIV who is
Yes** No Don’t know
not on treatment?
Have you had a “cold” or “flu” or a sore throat, runny nose, or fever? Yes** No Don’t know
**If ONLY reporting sex without a condom, within the last 72 hours and is a survivor of GBV, refer for post-exposure prophylaxis (PEP) as part of
comprehensive GBV services.
**If reporting BOTH sex without a condom and flu-like symptoms, an acute HIV infection might be suspected.
 In this case, do NOT offer PrEP or PEP and repeat HIV testing after four weeks to determine if client has acute HIV infection.
PrEP Facility Record
Facility Information
Health facility Name__________ Region__________________ PrEP provision site
Facility Code________________ Woreda_________________ ART Clinic______
Town___________________ PMTCT________
KP Clinic________
DIC_______
Data of initial client visit: ___/_____/______ Name of provider filling the form
________________________
Demographics
Client Name First Name Middle Name Last Name
__________ ____________ _________
Current Region Telephone Number:
Address Woreda For FSW include bar or street of
Town work
HN
Trainer distributes hard copy of the facility record to discuss with participants
PrEP Facility Record
(continued)
• This form is completed after the initial PrEP screening, for
clients who agree to start PrEP.
• The provider must ask questions of the client in order to
complete some sections of the form.
• Other sections are completed using test results and
information obtained during PrEP screening.
• Source to complete this form: Complete this form with the
client and consult the PrEP Screening for Substantial Risk
and Eligibility form.
• PrEP Follow-Up Visits section of this form will be
completed at each follow-up visit.
• Let us review the form section by section.
1
S.NO
2
Date
PrEP s tarted
MRN/ UIC
3
4
Father's and
Name
PrEP Register
Grandfather's name
5
years)
Age (In
6
/ F)
Sex (M
( )
7
s ero -
t couples
discordan
T a r g e t P o p u l a ti o n
8 F S Wü) (
9 T e l e p h o n e # / HWN oo r #e d/ a / K e b e le
R e s u l t : ( P oDs a. t/e H I V
10
N e g .) te ste d
1 1D a t e C l i e n t R e c e i v e d R e s u l t
1 2 C r e a ti n i n e ( e G F R )
STI
(Y/N)
13 STI Syndrom e
PrEP Client Register
screening
Initial visit Status
Tes t
(P/N)
14
Res ult
done
B Tes t
(HBs Ag)
Hepatitis
Preg nancy
15 te st r e s u lt
FP method
(P /N /N A )/
(s ee codes )
1 6N u m b e r o f t a b l e t s ( T D F , 3 T C )
17
Vis it date
PrEP Client Register
(continued)
• As each new client starts PrEP, the relevant
information is added to this register, and the
client’s follow-up visits are recorded.
• Source document to complete this form: Use
the PrEP Facility Record.
Question
• If a client is overdue for a return visit and the
outcome is not recorded (e.g., died, lost to
follow-up, or transferred out), what should you
do?
Seroconversion Tracker
Age sex T Dat Pr Last Last AHI Acute HIV Lin ART Re
a e EP PrEP PrEP sysm HIV positive ked Uniq m
r Last ini follo refill ptom sympto diagnosis to ue ar
g HIV tiat w up provide (yes/ ms(see date HI num k
et Neg ed visit d date No) code) V ber
dat date
ativ car
e
e e(Y
test es/
No)
Importance of the Seroconversion
Tracker
• The tracker is completed during follow-up visits for PrEP

clients who seroconvert to HIV positive.
• Source documents to complete this form: PrEP Client Register
and ART records.
• Refer to the variable and code definitions as needed when
completing the tracker.
• The tracker will help ensure appropriate linking and follow-up
of clients diagnosed with HIV and can facilitate reporting of
seroconversions for surveillance.
PrEP Reporting Template

HIV testing & PrEP Monthly Report Form
Facility/DIC:
__________________________________________
Date:
________________________________________________
Period start date:
____________________________________
PrEP REPORTING (FROM PREP REGISTER)
AGE (YEARS) 15-19 20-24 25-29 30-34 35-39 40-44 45-49 50+
Total
FS FS FS FS FS FS FS FS
Catagories W DC W DC W DC W DC W DC W DC W DC W DC
FS
SEX F MF F M F F M F F M F F M F F M F F M F F M F W DC
Oral PrEP screening
Number of clients undergoing
PrEP risk assessment
Number of clients assessed to
be at high risk of HIV infection
Number clients eligible for and
offered PrEP
Number of clients initiated on
PrEP and on their 6th month on
PrEP
Fear of stigma and
discrimination
PrEP Reporting Template
(Continued)
• This form is used to collect and track data on
monthly bases.
• Source to complete this document: Use the
PrEP Client Register.
Module 5 Summary
• Tracking PrEP screening data can inform increased
outreach and education efforts and IEC materials.
THANK YOU!!!

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Pre-Exposure Prophylaxis (PrEP)

in Clinical Settings in Ethiopia

Take a minute (and only one, please!) to tell us:

Initial and Follow-Up PrEP Visits

6 PrEP Monitoring and Evaluation Tools

Number of new HIV infections, global, 1990–2017 and 2020 target

• In the past two decades, Ethiopia has been successful1:

• The Federal Democratic Republic of Ethiopia (FDRE) is

Female Sex workers

• PrEP provides an additional prevention intervention to be used together with existing

• PrEP is not meant to replace or be a substitute for existing interventions.

HIV prevention remains as important as ever!!!

• PrEP task force group (sub technical

• HIV prevention needs change over a lifetime.

• Combination prevention is a mix of biomedical, behavioral, and

• Greater impact may come from combining approaches than

• An important additional prevention tool is provided by PrEP:

• Integration of different intervention is cost-effective

• The use of ARVs for HIV prevention is well established;

Structural Behavioral Bio – medical

•Policies • Education • HIV testing (why? For

• Differentiate PrEP from post-exposure prophylaxis (PEP)

• Describe the need for PrEP.

• Identify people at risk and people at substantial risk

• Explain the relationship between PrEP effectiveness and

• State the key reasons why PrEP is needed.

• Specify the PrEP regimens approved by the FMoH Ethiopia.

• Identify concerns regarding PrEP implementation.

• Explain the risks and benefits of PrEP.

• What is pre-exposure prophylaxis (PrEP)?

PrEP is the use of ARVs by people who are HIV

PEP is short-term antiretroviral treatment to

Exposure • Activity that can lead to HIV infection

What is the same?

• Even if there are already several effective HIV prevention

1. UNAIDS, Gap Report 2016.; Ethiopian HIV Prevention roadmap 2018 - 26

• Who do you think are the Key

• THE KP AND PP GROUPS

• PrEP efficacy was measured in:

• PrEP was found to be effective in reducing HIV acquisition.

• PrEP can protect the HIV – uninfected partner in heterosexual sero -

• How would you define adherence?

• 2015: WHO recommendation

• 2016: Southern African guidelines on PrEP

• 2018: Adolescents included in PrEP

• Regulatory approval in dozens of countries

• Access through programs and research in

Source: AVAC Global PrEP Initiation Tracker Training on Oral PrEP 38

– TDF / 3TC, 1 Tablet to be taken orally daily

• There was no evidence of this in clinical trials, where participants

9/22/2018 Training on Oral PrEP 45

• Does PrEP protect against other STIs?

• Only condoms protect against STIs and pregnancy.

• PrEP protects against HIV.

• PrEP should be provided within a package of prevention services,

Training on Oral PrEP 50

• To promote service for HIV negative FSWs:

Training on Oral PrEP 51