Oral Daily PrEP Eligibility Criteria
* Risk-based creatinine clearance (CrCl) evaluation, using
estimated glomerular filtration rate (eGFR) calculation.
Kidney Function Monitoring During Oral PrEP
Initiation
Does the individual have any
NO known kidney-related co- YES
morbidities (e.g., diabetes or
hypertension)?
What age is the
individual?
Evaluate CrCl on
<30 30+ ce within 1-3
years years months after
oral PrEP initiati
on
CrCl evaluation
optional
CrCl = creatinine clearance
Calculate using estimated glomerular filtration rate (eGFR) equation:
Estimated CrCl = [140-age (years)] x weight (kg) x f
where f=1.23 for men and 1.04 for women / [72 x serum creatinine (μmol/L)]
Kidney Function Monitoring During Oral PrEP
Follow-up Visits
Does the individual have any
known kidney-related co- YES
morbidities (e.g., diabetes or
hypertension)?
NO
What age is the individual?
<50 years 50+ years
Evaluate CrCl
every 6 months
What age is the NO Was a baseline CrCl
individual? estimation done?
30+ years <30 years YE
S
≥90ml/min <90ml/min
Evaluate CrCl
CrCl once optional CrCl = creatinine clearance
Calculate using estimated glomerular filtration rate (eGFR) equation:
Estimated CrCl = [140-age (years)] x weight (kg) x f
where f=1.23 for men and 1.04 for women / [72 x serum creatinine (μmol/L)]
Recommendations for Starting and Stopping Oral PrEP
For individuals assigned
For individuals assigned male sex at female sex at birth or
birth + not taking gender-affirming individuals taking gender-
hormones + sexual HIV exposure only. affirming hormones or
parenteral HIV exposure.
Starting oral PrEP Starting oral PrEP
Start with 2 pills 2-24h before sexual Start 7 consecutive days
exposure before exposure
Stopping oral PrEP Stopping oral PrEP
Stop after 2 days Stop after 7 days
post-exposure post-exposure
Groups Included Groups included
• Cisgender men • Cisgender women
• Transgender women and non-
binary individuals assigned male at birth • Transgender women and non-
NOT taking gender-affirming hormones. binary individuals assigned male at
birth taking gender-
affirming hormones
• Transgender men and non-binary
individuals assigned female at
birth
• Individuals with HIV exposure
Recommendations on Starting and Stopping Oral PrEP
Mal What sex was the Female
individual assigned
e
at birth?
HIV exposure through YE Start 7 consecutive
injecting practices? S days before exposure
and stop after 7 days
N post-exposure
O
Taking gender-
affirming hormone YES
therapy?
N
O
Start with 2 pills 2-24h
before sexual exposure
and stop after 2 days
post-exposure
Oral PrEP Dosing
Oral Daily PrEP Initiation Visit: Essential Procedures
Procedure Rationale
HIV test using national algorithm or • Assess HIV infection status
assisted HIV self-test
Acute HIV infection symptom • Assess for acute HIV infection
checklist
Ask about last potential HIV exposure • If last exposure <72 hours
prior, post-exposure
prophylaxis (PEP) may be more
appropriate before transitioning to
PrEP
Determine age and assess for • Determine whether a serum
medical co-morbidities that may creatinine test is indicated to
impair renal function (e.g., diabetes, calculate creatinine clearance
hypertension) (CrCl)
PrEP initiation counseling • Assess substantial risk for HIV
• Assess HIV prevention needs and
educate about options
• Discuss desire for PrEP and
willingness to take PrEP
• Plan for effective PrEP use and
sexual and reproductive health
Oral Daily PrEP Initiation Visit: Essential Procedures
Procedure Rationale
Gender based violence (GBV) screening • Linkage to other services eg (PrEP, PEP,
psycho-therapy etc)
Sexually transmitted infection (STI) screening • Diagnose and treat STIs
• Syndromic or diagnostic STI testing, depending
on local guidelines
• Rapid plasma regain (RPR)testing
Pregnancy testing • Ascertain pregnancy status and link to FP/MCH
services if necessary
Oral Daily PrEP Initiation Visit: Suggested Procedures
Procedure Rationale
Hepatitis B surface antigen (HBsAg)testing • Identify undiagnosed hepatitis B virus (HBV)
infection
• Identify those eligible for HBV vaccination
Hepatitis C antibody testing • Identify undiagnosed hepatitis C virus (HCV)
infection; determine if eligible for HCV
treatment
Rapid plasma regain (RPR)testing • Diagnose and treat syphilis infection
Clinical Pathway for Oral Daily PrEP Initiation
Perform rapid HIV test or HIV
Confirm HIV
Negative self-test per national
1 Status guidelines
Link people found to be living
with HIV to care and
treatment
Screen for
Substantial Assesss for PrEP eligibility
2 Risk for HIV according to national
guidelines
Informed choice counseling
PrEP about available PrEP options
3 Counseling Shared decision making to
start oral daily PrEP
No evidence of acute HIV
Establish
Eligibility for infection
4 Oral Daily Willingness to use oral daily
PrEP as prescribed
PrEP
Low risk for or no evidence of
kidney function impairment
Counseling on adherence,
risk reduction, side effects
5 Initiate PrEP
and acute HIV infection
symptoms
Key Initial Visit Counseling Messaging for Daily Oral PrEP
Oral PrEP works when taken regularly!
Oral PrEP prevents HIV infection and is effective for everyone when taken every day.
PrEP does not prevent STIs other than HIV.
Using condoms 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.
Oral PrEP side effects usually go away within the first month.
Gastrointestinal side effects (e.g., nausea, diarrhea, stomach pain) can occur, but usually go away over
time.
Make taking oral PrEP a daily habit.
Taking oral PrEP each day is easiest if you link taking the pills to a daily habit, something else you do
daily without fail (e.g., brushing your teeth).
If you forget to take a pill or miss a dose, take it as soon as you remember.
For example, if you usually take PrEP in the morning but realize at 10pm one night that you forgot, it is
okay to take your pill then and resume your usual schedule the following morning.
PrEP pills can be taken any time of day, with or without food.
Counseling Messaging for Starting and Stopping Oral
PrEP
For individuals assigned male sex at birth For individuals assigned female
+ not taking gender-affirming hormones + sex at birth or individuals taking
sexual HIV exposure only. gender-affirming hormones or
parenteral HIV exposure.
Starting oral PrEP Starting oral PrEP
Start PrEP with two pills (loading Start PrEP with one dose every day
dose) taken between 2 and 24 hours for 7 consecutive days to achieve
before you expect to have sex. protective levels in your body.
Ideally, this loading dose should be Alternative HIV prevention methods
taken closer to 24 hours before your should be used during this time.
potential sexual exposure.
Stopping oral PrEP Stopping oral PrEP
If you would like to stop taking oral If you would like to stop taking oral
PrEP, continue to take one dose every PrEP, continue taking one dose every
day until 2 days after the day of your day and stop 7 days after your last
last potential sexual exposure. potential exposure to HIV.
Oral PrEP Follow-Up Visit Procedures
Schedule Following PrEP
Intervention
Initiation
• At one month follow-up
Confirmation of HIV negative status
• Every 3 months
Review the client’s HIV risk • Every visit
Address side effects • Every visit
Brief adherence evaluation and
• Every visit
counseling
Determine need for creatinine
• Every visit
clearance evaluation
Screening for hepatitis B and C virus • Once within 3 months of
(optional) initiation
Counsel on starting/continuation/re-
starting stopping PrEP, acute HIV
symptoms and advise to come back • Every visit
as soon as possible for evaluation if
symptoms occur
Provide STI screening, condoms and
contraception
• Every visit, and as needed
Mental health, GBV and pregnancy
Discussion Prompts for Daily Oral PrEP Follow-Up Visits
Open-ended questions Strategies to help with
about adherence PrEP adherence
• How has it been for you to take PrEP? • Use a pillbox , pill bag
• What side effects have you had, if any? • Take the pill at the same time every day
• What or who helps you remember to take • Link PrEP to daily routine or event like
your pill? brushing teeth or eating breakfast
• What challenges do you experience in • Take PrEP pills with other daily medicines
taking the pills? When are you more
likely to forget? • Use reminder alarms, text messages, or
a calendar
• What are your concerns about missing
PrEP pills? • Have more support from your partner, a
family member, or a friend
• What have been your experiences with
missing PrEP doses? • Have a back-up supply of pills in a bag or
purse
• What helps or might help you to take
your pills regularly? • Carry extra pills in case routines are
disrupted, e.g., stay out overnight, go on
holiday
