December 2020

NATIONAL GUIDELINES FOR THE

PROVISION OF ORAL PRE-EXPOSURE
PROPHYLAXIS FOR INDIVIDUALS AT
SUBSTANTIAL RISK OF HIV IN
MALAWI

1st Edition

Ministry of
Health, Malawi

DEPARTMENT OF HIV AND AIDS

©2020 Ministry of Health and Population, Malawi
Publications of the Ministry of Health enjoy copyright protection in accordance with the
provisions of Protocol 2 of the Universal Copyright Convention. All rights reserved.

The Ministry of Health welcomes requests for permission to reproduce or translate its
publications, in part or in full.

Applications, comments and inquiries should be addressed to the Secretary for Health, P.O.
Box 30377, Lilongwe 3, Malawi. We will be glad to provide the latest information on any
changes made to the text, plans for new editions, and reprints and translations already
available.

An electronic copy of this guideline is available on the website (www.hiv.health.gov.mw) of

the Dept. for HIV and AIDS of the Ministry of Health.

NOTE: The mention of certain manufacturers’ products does not imply they are endorsed or
recommended by the Ministry of Health in preference to others of a similar nature that are
not mentioned.

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Table of Contents
Acknowledgements ....................................................................................... v
Foreword ......................................................................................................vii
Acronyms and Abbreviations .........................................................................ix
1 Background ........................................................................................... 1
Rationale for the PrEP guidelines .................................................................... 2
2 Target Populations ................................................................................. 3
Key Populations .............................................................................................. 3
Vulnerable Population .................................................................................... 3
Sero-discordant Couples ................................................................................. 4
3 Implementation considerations ............................................................. 5
Facility requirements for PrEP Provision .......................................................... 5
Minimum requirements: ................................................................................. 5
3.3 Service delivery clinics/entry Points ............................................................................ 7
4. Getting Started with PrEP....................................................................... 8
4.1 Risk Assessment.............................................................................................. 8
4.2 Rule out Acute HIV infection (AHI)................................................................. 13
4.3 Eligibility criteria for PrEP .............................................................................. 14
5. Key Messages ....................................................................................... 18
5.1 Initial Education and counselling ................................................................... 18
5.2 Risk reduction counselling ............................................................................. 19
5.3 Use of Pre-Exposure Prophylaxis Pills ............................................................ 19
5.4 Prescribing and Dispensing PrEP .................................................................... 20
5.5 Clients follow up visit procedures .................................................................. 20
5.6 Quitting PrEP ................................................................................................ 23
5.7 Restarting PrEP ............................................................................................. 23
6. Management of clients in specific situations ........................................ 24
6.1 Management of creatinine elevation ............................................................. 24
6.2 Management indeterminate (inconclusive) HIV test result during follow-up
visit 24
6.3 Management of a client who seroconvert while on PrEP ............................... 25
6.4 Management of side effects and adverse drug reactions (ADRs) .................... 25
6.5 Classification and management of interruption of PrEP ................................. 26
6.6 Management of clients requesting a transfer out .......................................... 26
6.7 Management of clients transferring in........................................................... 26

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6.8 Re-initiation of PrEP ...................................................................................... 26
6.9 Clients with a hepatitis B infection wanting PrEP ........................................... 26
6.10 PrEP and other drug interactions ................................................................... 27
6.11 Provision of community-based Pre-Exposure Prophylaxis services ................. 28
6.11.1 Demand creation ......................................................................................... 28
6.11.2 Drug refills ................................................................................................... 28
7. Prep and family planning services ........................................................ 29
8. Monitoring and Evaluation ................................................................... 30
8.1 Definitions .................................................................................................... 30
8.2 PrEP Primary Outcomes ................................................................................ 31
8.3 PrEP Adherence Level ................................................................................... 34
8.4 Overview of PrEP M&E Tools/Job Aid ............................................................ 35
8.5 Reporting of registration data ....................................................................... 37
8.6 Reporting of cohort outcomes ....................................................................... 37
8.6.1 Primary follow-up outcome......................................................................... 38
8.6.2 Secondary outcome ..................................................................................... 38
8.6.3 Cumulative cohorts...................................................................................... 38
8.7 Record keeping and filing .............................................................................. 38
8.7.1 Confidentiality of Client records .................................................................. 38
8.7.2 Use of the PrEP registers ............................................................................. 39
8.7.3 Use of Client cards ....................................................................................... 39
8.8 Ensuring adequate data quality ..................................................................... 40
8.9 PrEP Standard Indicators ............................................................................... 40
9. Appendices .......................................................................................... 41

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 Acknowledgements
These Guidelines have been developed through the collaborative effort of many individuals
and organizations under coordination of Department for HIV/AIDS and Viral Hepatitis) of the
Ministry of Health. The Malawi Ministry of Health is grateful to all members of the PrEP
Taskforce for their technical inputs under the leadership of the Director; Rose Kolola
Nyirenda.

The Ministry of Health and National AIDS Commission are indebted to all bilateral and
multilateral development partners, implementing partners, civil society organizations (CSOs),
and local communities who collectively contributed to the write-up and review of this
document. The guidelines have been developed following WHO normative guidance and
other international frameworks that have been adapted to the national context.

The following individuals have made substantive contributions to this guideline:

Alice Maida, CDC Josephine Chinele,

Allan Ahimbisibwe, EGPAF Katie Simon, Baylor Paediatric AIDS
Andreas Jahn, DHAVH / ITECH Initiative
Andrew Gunda, CHAI Louis Banda, FHI360
Andrew Kankhongwe CERA Maria Sanena, PIH
Caroline Ntale, DHAVH / I-TECH James Kachingwe, DHAVH
Carrie Cox, Baylor Paediatric AIDS Martin Maulidi, DHAVH / ITECH
Initiative Maureen Luba, AVAC
Christine Kiruthu Kamamia, Lighthouse Michael Odo, DHAVH / I-TECH
Trust Mike Nyirenda, PIH
Clement Banda, CHAI Paul Nyasulu, DHAVH / TECH
David Chilongozi, FHI360 Prince Mikel LITE
Dunia Chiwala, FHI360 Reuben Mwenda, DHAVH
Dr.Thoko Kalua, DHAVH Rose Nyirenda, DHAVH
Dyson Telela, CHAI Sam Phiri, Lighthouse Trust
Eric Mlanga, USAID Sarah Shaw, CDC
Fatima Zulu, DC Simon Sikwese, Pakachere
Friday Saidi, UNC PROJECT Stanley Ngoma, DHAVH
Godwin Nyirenda,CHAI Sundeep Gupta, PIH
Innocent Zungu, CDC Tamala Mwenifumbo, PSI
Isaac Ihemesah, UNAIDS Harrison Tembo, DHAVH
James Odek, USAID Tiwonge Chimpandule, DHAVH / ITECH
Jean Isaac, CHAI Veena Sampathkumar, EGPAF
Jill Paterson, FHI360 Washington Ozituosauka, DHAVH
Joep van Oosterhout, PIH

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Foreword
Although Malawi has made progress in scaling up antiretroviral treatment and bringing down
HIV prevalence from 14% in 1989 to 9.6% in 2015/16, there has been a slow decline in new
HIV infections. While there has been an estimated 57% reduction of new infections from a
baseline of 56,000 in 2010 to 32,248 in 2020, (Spectrum Estimates; 2020), the country has not
met the UNAIDS fast track target of achieving 75% reduction in new infections by 2020. The
National strategic plan 2020 -2025 aims at reducing new HIV infections from 33,000 in 2019
to 11,000 in 2025.

In order to achieve this ambitious target, there is need to sustain the gains made in achieving
the UNAIDS 90.90.90 treatment targets and scale up comprehensive evidence based HIV
combination prevention approaches targeting those at substantial risk and most affected
geographical areas. In expanding use of oral Pre-exposure Prophylaxis (PrEP), the country has
adopted public health, human rights and people centred approaches, prioritizing universal
health coverage, gender equality, health related rights including accessibility, availability,
acceptability and quality.

Implementation will therefore be undertaken in a phased in approach, prioritizing

facilities/sites based on estimated number of clients at substantial risk, capacity of facility/site
and referral mechanisms, availability of trained and skilled professional health workers,
infrastructure and laboratory capacity/proximity. Public health facilities, CHAM, Drop-in
Centres, Private and NGO facilities will deliver PrEP to allow access to marginalized
populations. Additional sites will be set as demand increases and capacity is strengthened.

Drawing lessons from studies implemented in the region as well implementation research
among Adolescents Girls and Young Women (AGYW) and Female Sex Workers (FSW) in
Malawi, community educators and advocates will be used to increase awareness about PrEP
in their communities and sub populations. Additionally, PrEP services will be integrated within
HIV, Sexual Reproductive Health, maternal & Child Health, Youth friendly Health services, TB
and other clinical care and finally services for key populations.

The document is a guideline to support funders, implementing partners, district health team
leads and service providers in the implementation of PrEP in Malawi. It will also promote
standardization in the delivery of pre exposure prophylaxis services in health care settings. It

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is the view of Ministry that all stakeholders in HIV space will subscribe to government
commitment in supporting implementation of oral pre-exposure prophylaxis as stipulated in
this guideline.

Dr Charles Mwansambo
SECREATRY FOR HEALTH

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 Acronyms and Abbreviations
ADR Adverse drug reaction
AGYW Adolescent girls and young women
AHI Acute HIV infection
ALT Alanine aminotransferase
ANC Antenatal clinic
APRI Aminotransferase and platelet ration index
ART Antiretroviral Therapy
ARV Antiretroviral
AST Aspartate aminotransferase
BBSS Biomedical Behavioural Surveillance Survey
BMI Body mass index
CMS Central Medical Stores
CO Clinical Officer
Cr Cl Creatinine clearance
DIC Drop-in centre
DTG Dolutegravir
EC Expert clients
eGFR Estimated glomerular filtration rate
FBC Full blood count
FTC Emtricitabine
FP Family planning
FSW Female sex worker
HDA HIV diagnostic assistant
HBsAg Hepatitis B surface antigen
HBV Hepatitis B virus
HIV Human immunodeficiency virus
HIVST HIV self-test
HTS HIV Testing Services
DCSA Disease Control Surveillance Assistant
ID Identification
IEC Information, education and communication
MA Medical Assistant
MCH Maternal and Child Health
MDHS Malawi Demographic Health Survey
MO Medical officer
MOH Ministry of Health
MSM Men who have sex with men
MSW Male Sex Workers
NSAIDS Non-steroidal anti-inflammatory drugs
PEP Post-exposure prophylaxis
PLHIV People Living with HIV
PMTCT Prevention of mother to child transmission
POC Point of Care
PrEP Pre-exposure prophylaxis
sCR Serum creatinine

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SOPs Standard Operating Procedures
STI Sexually transmitted infection
TDF Tenofovir disoproxil fumarate
TDF/3TC Fixed dose combination of Tenofovir Disoproxil Fumarate (TDF) plus
Lamivudine (3TC)
VL Viral Load
VMMC Voluntary Male Medical Circumcision
WHO World Health Organization

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1 Background
Oral Pre-exposure prophylaxis of HIV infection refers to the daily use of Antiretroviral drugs
by HIV negative persons to prevent acquisition of HIV. In 2015 World Health Organization
recommended that oral PrEP (containing TDF in combination with emtricitabine) should be
offered as combination prevention for people at substantial risk of HIV infection. WHO further
recommends that PrEP be prioritized in populations or geographic areas with HIV incidence
of more than 3 per 100 person- years or higher for effectiveness, offered within a
comprehensive package of HIV interventions.

Although the annual HIV Incidence among adults 15-64 years was estimated at 0.37% (MPHIA,
2016), Malawi has missed the UNAIDS fast track target of reducing the number of annual
infections by 75% between 2010 and 2020. Latest epidemiological model estimates suggest a
wide gap between the actual number of new HIV infections in 2020 (32,000) and the target
(11,000). The slow decline in new infections has necessitated the need to fast track
implementation of combination prevention interventions among the high-risk populations
such as Female Sex (FSW) workers, Adolescent Girls and Young women AGYW) and other high-
risk groups.

To assess the feasibility, acceptability, and tolerability of PrEP among AGYW and FSW,
demonstration projects were implemented in Lilongwe and Blantyre. The findings would also
inform efficacy of PrEP in real life setting. Findings from the AGYW study reported 5% (17)
pregnancy, 1.4% (5) seroconversion and 12.4% (43) contracting sexually transmitted
infections. The findings raise concern about the actual levels of adherence considering that
participants were incentivised and unmitigated high-risk behaviour even with intensive
adherence to intensive counselling protocols.

Regardless of the findings, high quality evidence strongly recommends use of PrEP by any
person with substantial risk of acquiring HIV infection (WHO 2015). In Malawi program follow
up of key populations has shown repeated HIV negative testing results which prompts the
need for reliable combination prevention interventions such as use of PrEP. With emerging
evidence from trials on use of injectable PrEP, Malawi awaits WHO normative guidance to the
method.

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 Rationale for the PrEP guidelines
 To provide guidance to funders, implementers and service providers
 Standardization of PrEP service delivery Target Population

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2 Target Populations
PrEP will be offered to individuals that are at substantial risk for HIV infection. PrEP services
will be rolled out nationally, and will prioritise the following HIV negative high-risk groups:

 Individuals who buy or sell sex

 Key Populations (FSW, MSW, MSM and Transgender
 Vulnerable Populations such as Adolescent Girls and Young women (AGYW) [15 – 24
years]
 Sexually Transmitted Infections (STI) Clients
 Sero-discordant couples. Offer PrEP if HIV negative woman is pregnant or breast
feeding or the HIV positive sexual partner is;
a. Not on ART
b. On ART <6 month
c. With unsuppressed or high VL
d. Is non adherent to antiretroviral treatment

Key Populations
Key populations are at a high risk of acquiring and transmitting HIV infections. In Malawi, gay
men, men who have sex with men, sex workers, transgenders, people who inject drugs
and prisoners are recognized as populations. They face challenges in accessing
comprehensive quality health services due to stigma, discrimination, and threat of criminal
prosecution.

Key populations are important to the dynamics of HIV transmission. They are also essential
partners in an effective response to the epidemic.

Vulnerable Population
In Malawi, AGYW, migrants, long-distance drivers, displaced populations and men in uniform
are vulnerable populations due to their living conditions which are prone to shifting factors
that would place them at risk of contracting HIV. Vulnerability can be defined as a reduced
ability or complete lack of control to protect oneself and avoid HIV risk.

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 Sero-discordant Couples
Sero-discordancy is where only one partner in an intimate relationship is HIV positive. HIV
treatment with antiretroviral drugs to the infected partner is one way of preventing HIV
transmission as long as there is good adherence and viral suppression. In addition to
Combination HIV Prevention methods, WHO recommends use of PrEP.

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3 Implementation considerations
PrEP implementation should take into consideration public health, human rights and people
centred approaches, prioritizing universal health coverage, gender equality, integration,
health related rights including accessibility, availability, acceptability and quality. PrEP will be
integrated within HIV, Sexual Reproductive Health, maternal & Child Health, Youth friendly
Health services, TB and other clinical care and finally services for key populations.

Facility requirements for PrEP Provision

PrEP will be delivered in health facilities and Drop-in Centres guided by the following:

Minimum requirements:
 Human Resource: Minimum of two licenced health professionals (Medical Officer/
Clinician/Nurse) who are trained in PrEP service provision.
 Infrastructure with adequate space for service delivery.
 With already existing HIV, SRH, services. STI, family planning and ANC clinics will be
used as key service delivery points in public health facilities. Drop-in Centres will be
largely used by key populations.
 Availability of Standard Operating Procedures (SoPs) to aid in service provision.
 Ability to collect laboratory samples and deliver to a functioning laboratory within
8 hours.
 A well secured Pharmacy for storage of pharmaceuticals.
 Availability and utilization of national monitoring and evaluation tools.

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Figure 1 : Staff roles in PrEP service delivery

Staff Roles in PrEP Implementation

Community
HIV Counselling and Testing Service Provider
(HDAs/DCSA) : Screening for HIV substantial risk and PrEP eligibility including
HIV testing before PrEP initiation

Expert Clients : Screening for PrEP eligibility especially in sero-discordant couples

Community Health Volunteers : PrEP sensitization as well as screening clients

at substantial risk for acquiring HIV

Youth Friendly Service Provider/

Peer Educator : Screening potential clients especially the youth at substantial
risk for HIV acquisition

Facility PrEP HDAs/DCSA : Screening for clients at substantial HIV risk and conducting HIV
Entry Points testing before PrEP initiation

PrEP Clinics Trained Providers :Offer PrEP Education

Conduct PrEP Eligibility Assessment
PrEP dispersions
Monitor side effects

Pharmacy
Pharmacy Personnel : Management of drugs, test kits and supplies for PrEP

Lab
Lab Personel : Conducting laboratory tests such as serum creatinine ,
Hepatitis B

3.2 PrEP minimum Package of services

The following minimum package of services must be provided to all clients accessing PrEP:

 Screening for substantial risk of HIV infection (risk assessment)

 HIV testing services and counselling including active index testing, couples testing
 Screening to Rule out Acute HIV Infection
 Risk reduction
 Laboratory tests: Hepatitis B, Serum creatinine clearance, Syphilis, Pregnancy test

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  (Pregnancy screening to guide antenatal care, contraceptive and safer conception
counselling, and to assess risk of mother to child transmission, Pregnancy is not a
contraindication for PrEP use )
 Screening, diagnostic and treatment of STIs
 Screening for non-communicable diseases such as hypertension
 Provision of PrEP drugs
 Condoms and lubricants
 Provision of Contraceptives
 Referral for voluntary male medical circumcision services
 Referral for Gender based violence and mental health services
 Adherence counselling

3.3 Service delivery clinics/entry Points

PrEP will be integrated into several health service delivery entry points as follows:

 HIV testing & Counselling/VCT STI clinic

 Family Planning
 Antenatal Care clinic
 Drop-in Centers (DIC’s) as safe spaces for Key Populations
 Youth Friendly Health Services Clinic
 Gynecology clinic

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 4. Getting Started with PrEP

4.1 Risk Assessment

Risk assessment should be done in all entry points for all the HIV negative clients who are
sexually active. Clients who are eligible for PrEP based on the risk assessment have to undergo
PrEP education. Risk assessment guide is outlined in the Figure 2 below.

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Figure 2: Risk Assessment for PrEP Provision

All
ForClients/Ages
HIV negative clients who are sexually active, assess risk per the following guidelines

HIV Status HIV negative Client

Is your partner HIV positive and not Yes ( 1) No

virally Suppressed ?

Have you had STI in Yes No

the past 6 months?

Do you give or receive monetary Yes No

incentive for sex?
Substantial Risk for HIV Aquistion

Are you a 15-24 year-old woman? Yes No

High (2) Low

AGYW HIV Risk
No Substantial Risk

Offer Combination
Action Discuss PrEP Prevention & Counseling

Notes
(1) PLHIV is not on ART ,
or On ART for less than 6 months
or Is not adherent on ART
or Has high viral load
(2) The AGYW answers yes to both having an older sexual partner (5 years +) AND ever
being pregnant

Table 1: Counselling and education for

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 Table 1: Counselling and education for clients about PrEP

TOPIC KEY MESSAGES

 PrEP is one of several HIV preventions options and, should be used in combination with condoms. PrEP does not
What is PrEP?
protect against other STIs or prevent pregnancy.

 For PrEP to be effective, it must be taken every day and for 28 days after the last exposure. Condoms must be used
PrEP works if taken as
always.
prescribed
 If you miss a dose, you must take PrEP as soon as you remember, and continue to take daily as before.

 You should take PrEP for as long as you are at substantial risk for HIV infection.
PrEP is not for life
 Some clients may have intermittent need for PrEP while others have an ongoing need.

 At least 21 days of PrEP are needed before you achieve maximum protection from HIV.
 You can stop PrEP 28 days after your last exposure if you are no longer at a substantial risk. Ways to lower risk include:
 You are no longer sexually active

Starting and Quitting PrEP  Adopting safer sexual practices, including consistent condom use
 When an HIV-positive partner in a Sero-discordant couple has been on effective ART for six months, has an
undetectable viral load, and remains adherent
 Clients are strongly encouraged to visit the clinic to formally stop PrEP to allow for a final HIV test to confirm HIV status.

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  PrEP can be taken any time of the day, with or without food.
 Taking PrEP each day is easiest if you make taking the tablets a daily habit, linked to something you do every day
Ways to support adherence
without fail. For example, you could take PrEP when you brush your teeth (either in the morning or evening).
 If you forget to take a tablet, take it as soon as you remember, and continue to take it daily as before.
PrEP and alcohol or recreational  There are no PrEP interactions with recreational drugs or alcohol. (Emphasize adherence and pill-taking reminders.)
drugs
 Pregnancy is not a contraindication for PrEP.
 You can use PrEP throughout pregnancy and breastfeeding. (Assess family planning needs and offer as

PrEP, pregnancy, and breast- appropriate.)

feeding  PrEP does not prevent pregnancy.
 (Offer PrEP to pregnant and breastfeeding women at high risk of HIV as a priority after all the risks and
benefits have been explained to the client.)

 PrEP is safe and effective, even when taken with hormonal contraceptives or nonprescription drugs.
PrEP and other drugs

No STI protection other than  PrEP does not prevent any other STIs. Condom used in every act of sexual intercourse provide protection against
HIV many of these infections.

 Approximately ten percent of people experience mild side effects, including:

 Gastrointestinal symptoms (diarrhoea and nausea, decreased appetite, abdominal cramping, and flatulence)
Side effects
 Dizziness
 Headaches

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 Most of those symptoms will disappear within one month. However, your health care provider can help you
manage these side effects. (Symptom management will help clients adhere to PrEP.)
 Major side effects are rare and include renal toxicity, metabolic complications, and decreased bone mineral
density (all of which are reversible upon stopping PrEP). However, recommend against combining PrEP with other
chronic nephrotoxic drugs, including NSAIDs

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 4.2 Rule out Acute HIV infection (AHI)
 For those at substantial risk with a history of recent HIV exposure, rule out acute
HIV infection (AHI). Defer PrEP initiation if client has sign/symptoms of Acute HIV
Infection (AHI).
 Female Sex Workers should be allowed to make an informed decision to start
regardless of AHI.
 If a client has at least one “cold or flu” symptom (See Figure 3) in the past 3 days
and exposure to HIV within the last 3 weeks, then defer PrEP and have client return
in 4 weeks for repeat HIV test and PrEP evaluation. Remember to rule out other
differential diagnoses.
 If client is eligible for PrEP, the client should be referred to the PrEP Service delivery
point at the facility (Linkage).

Figure 3: Acute HIV infection

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 4.3 Eligibility criteria for PrEP
 If you have determined that the client is at substantial risk, and ruled out AHI,
determine if the client is eligible for PrEP, use the following eligibility checklist.

 In circumstances where a healthcare worker cannot determine the risk for HIV
infection for a client who belongs to one of the target groups, but the client demands
PrEP and meets other criteria, the client can still be initiated on PrEP.

ELIGIBILITY CHECKLIST

 Age ≥ 15 years
 HIV-negative test on the day of PrEP initiation using the national HIV testing
algorithm
 Client is at substantial risk of HIV infection
 Not found to have risk of Acute HIV infection
 Client willingness to attend scheduled PrEP visits until 28 days after risk period
 No contraindication to use of TDF and 3TC
 Bodyweight ≥ 30kg
 Estimated glomerular filtration rate (eGFR) ≥60ml/min
 No known renal diseases
 No Diabetes mellitus

 Once you have determined that a client has met the eligibility criteria listed above,
and does not have contraindications for PrEP, the client should undergo further testing
and screening, as outlined in Table 2.

 For most clients, PrEP can be initiated the same day. However, in some scenarios
outlined in table 1 including concern for acute HIV infection or Hepatitis B infection,
PrEP initiation should be deferred.

 All clients who defer initiation should still receive other applicable.

Table 2: PrEP
Initiation
Steps

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Table 2: PrEP Initiation Steps

STEPS PLAN OF ACTION PROVIDER

HIV test  HIV test needs to be performed on the day of PrEP initiation.  HTS counsellor /HDA/ DCSAs
 If HIV positive, refer for ART. Do NOT start PrEP  Nurse
(HIV testing services [HTS] )
 If HIV test is inconclusive, defer PrEP and follow the National algorithm  Clinician/Lab assistants
until a definite HIV test result has been obtained

Counselling  Conduct behaviour risk assessment.  HTS counsellor Nurse

 Discuss combination prevention package and risk reduction, including  Clinician
counselling and demonstration of correct and consistent condom use.  Expert Client (EC) / Peer
 Educate about the benefits and limitations of PrEP, including what to Navigators
do when experiencing side-effects.
 Evaluate client’s eligibility, willingness, and readiness to take PrEP.
 Offer family planning and safer conception counselling, if applicable.

 If risk factors of client require a serum creatinine test resultat initiation  Nurse
Serum creatinine
Draw sample for Creatinine for
defer client until results are received.  MA/ CO / MO
all eligible clients  If no risk factors for renal failure are present, start PrEP and evaluate
Wait for Creatinine clearance creatinine result at the first follow up visit at 1 month
results prior to PrEP initiation
for clients with any of the
following risk factors:
 Age >50

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 Hypertension  Calculate creatinine clearance using the equation below for men and
 Diabetes mellitus
 Body Mass Index (BMI) < women. NOTE: weight, age and sex are requirements for creatinine
18.5 clearance calculations
 Other nephrotoxic
medication  If creatinine clearance < 60 ml/min, refer to Clinician
 Any symptoms or signs
suggestive of renal  If creatinine clearance ≥ 60 ml/min, initiate or continue PrEP.
impairment

 HBsAg is positive – Refer to Viral Hepatitis section before proceeding  Nurse

Hepatitis B surface antigen
All clients need Hepatitis B
with PrEP  CO / MO/ MA
Surface Ag test before  HepB vaccine is recommended for all clients with HBsAg negative  HTS Counsellor/HDA
starting PrEP.
 We expect the majority of the population will be immune as they
Use POC test when possible.
mature
 HBsAg positive: Refer to Hepatitis B program for assessment before
initiating PrEP.

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  No Hepatitis B test kits: Proceed with PrEP. Ensure clients are tested
within 3 months of initiation.

 If syndromic, manage STIs as per STI standard treatment guidelines.  Nurse/ CO/MO/ MA
Syndromic screening for STIs
 All clients must be tested for HIV on the day of initiation regardless of  Nurses
PrEP initiation
a previous negative result.  CO/ MO /MA
 Counsel and provide combination prevention methods including
condoms.
 Offer Emergency Contraception per need
 Assess exclusion criteria for PrEP contraindications. If no
contraindications, provide PrEP for 28 days

 Measure Client’s weight and Height. Calculate BMI. Convert height to  Nurses
Assess Body Mass Index.
meters then use the following formulae: BMI=Kgs/M2. A BMI of less  CO/ MO /MA
than 18.5 denotes weight loss and PrEP should not be offered.

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 5. Key Messages
KEY FACTS

 Be client-driven, based on their needs, resources, and preferences; it is not

prescriptive.
 Recognize that behaviour change is not easy, and human beings are not perfect.
 Focus on the identification of small wins and achievable next steps in reducing
risk and/or making pill-taking easier

5.1 Initial Education and counselling

Education and counselling for clients considering PrEP, or clients already on PrEP, are
important to ensure that drugs are effectively used. PrEP counselling should Include the
messages outlined in Table . Examples of good counselling messages:

“Remember, for PrEP to work, you have to take it every day.”

“Pill-taking isn’t easy and takes some practice, especially if you aren’t
used to taking pills.”

“I’m here to help by working with you to take your pills easier so that you
get the most protection you can.”

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5.2 Risk reduction counselling
 PrEP counselling should include messages about risk reduction.
 Risk reduction counselling is a behavioural intervention that attempts to decrease
an individual’s chances of acquiring HIV and other STIs.
 It includes counselling about HIV prevention, sexual and reproductive health, and
family planning and should be provided at all follow-up visits for PrEP users.
 The main objective of risk reduction counselling is for clients to assess individual
risk and set realistic goals for behaviour change that could reduce their risk of
contracting HIV and other STIs, as well as prevent unintended pregnancies.
 This counselling should be non-prejudicial, and user centred and should be
provided by any trained health care provider
 Health care provider should Explore context of the client’s specific sexual practices
and psychosocial status and help the client recognize any of his or her behaviours
that are associated with higher risks for HIV infection or unintended pregnancy.
Health care providers should also be aware that clients might not always perceive
their own risk or may be in denial about it.
 Identify the sexual health protection needs of the potential PrEP user and reflect
on what his or her main concerns appear to be.
 Strategize with the client about how he or she can manage these concerns or needs
 Agree on which strategies the client is willing to explore and provide guidance on
how to implement them.

5.3 Use of Pre-Exposure Prophylaxis Pills

 PrEP is a pill that should be taken daily before, during, and after periods of
substantial risk of HIV acquisition (Error! Reference source not found.).
 PrEP reaches maximum protection for both men and women at about 3 weeks with
continuous use. It can be stopped 28 days after the last exposure and again started
3 weeks prior to any new risk.

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 FIGURE 1.
Fig 4: PreP Use
PrEP Use

1
DAY
21 DAY
End of
risk 28 DAY

Initiate PrEP PrEP becomes 28 days after

effective last potential
exposure, PrEP
can be
discontinued

5.4 Prescribing and Dispensing PrEP

The recommended ARV regimen for use as PrEP in Malawi is Tenofovir Disoproxil Fumarate
(TDF) 300 mg and Lamivudine (3TC) 300 mg, orally given as a fixed-dose combination. PrEP
must be dispensed together with condoms corresponding to the next appointment.

Table 3: PrEP Regimen

STANDARD ALTERNATIVE
PrEP REGIMEN

≥30Kg TDF/3TC (300mg/300mg) TDF/FTC (300mg/200mg)

DOSE 1 0 1 0

5.5 Clients follow up visit procedures

The standard follow-up visits for PrEP dispersing and client monitoring are one month after
initiation, three months after initiation then every three months. In special situations, PrEP
can be dispensed for 6 months. below shows some of the suggested interventions for client’s
follow-up visit

Table 4: Prep
scheduled
visits and
suggested
procedures

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Table 4: Prep scheduled visits and suggested procedures
Schedule following prep Intervention What to Do
initiation

Every Visit Confirmation of HIV-  Positive Result

negative status  Refer to ART
 Discordant Result
 Stop PrEP for 4 weeks and retest
 Stress on condom use during this period
 AHI
 Stop PrEP for 4 Weeks and retest
 Stress on condom Use during this period
Every Visit Provide risk reduction  Poor adherence
counselling and adherence  Identify possible barriers to good adherence
monitoring  Provide support as appropriate
 Emphasize on the limitation of PrEP if not taken daily
 Discuss and offer other prevention methods
 Good adherence
 Encourage the good adherence
 Issue appropriate supply of PrEP if the client meets all the criteria
Every Visit Address Side Effects  Assess tolerability
 Actively manage side effects and document in the ADR form if available
 Stop PrEP if the side effect is adverse
Every Visit Assess the Contraceptive
 Refer to family planning if client is need of contraceptives
needs

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Every Visit Assess the VMMC need
 Refer to VMMC if male client is not circumcised

Every Visit STI Screening & Treatment  Refer the client to STI treatment if presented with any STI
 Discuss the use of condoms

Standard Scheduled Visit Review of previous

 Stop PrEP if creatinine test result is < 60ml/min
laboratory results

6 months Repeat creatinine

clearance test for clients
with risk factors for kidney  Stop PrEP if creatinine test result is < 60ml/min
disease, thereafter
annually
12 months Repeat creatinine
clearance test for clients
 Stop PrEP if creatinine test result is < 60ml/min
with no risk factors for
kidney disease
Standard Scheduled Visit Provide appropriate refill
 If the client is eligible, refill the client with PrEP
and schedule next visit

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5.6 Quitting PrEP
 Advise clients to inform the service provider when they want to discontinue PrEP.
 The duration of PrEP use may vary, and individuals are likely to start and stop PrEP
depending on their risk assessment at different periods in their lives, including
changes in sexual relationship status, behaviours, and ability to adhere to a PrEP
maintenance program.
 Health care workers should discuss the options of when to discontinue PrEP with their
clients. PrEP can be stopped for the following reasons:
 Positive HIV test
 Client request
 Safety concerns, such as persistent creatinine clearance <60ml/min
 No longer at substantial risk
 Persistent side effects

 Be sure to adequately document the reason for stopping PrEP, and if PrEP is discontinued
at request of the client, do not be judgmental. Remember, PrEP is a personal decision.

 If a client develops Hepatitis B whilst on PrEP, DO NOT STOP PrEP. Refer to Hepatitis
B clinic/service provider/specialist for further review and advise (medication is also
treatment for Hepatitis B and the client can fall ill if treatment is with stopped)

5.7 Restarting PrEP

 Advise clients that an HIV test is required before restarting PrEP.
 All client that were stopped due to decreased eGFR ≤60ml/min, must not be
restarted on PrEP
 When clients re-start PrEP after missing more than seven days, they are treated as
a re-start client.
 Providers should follow normal PrEP initiation procedures.
 If the client missed less than 7 days, renal function tests are not required.
 Enter the client on a new line in the register in a new cohort and indicate that the
client is a re-start.

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 6. Management of clients in specific situations
This section outlines management of clients in specific situations outside of regular client
follow-up.

KEY FACTS

 Approximately 80 percent of creatinine elevations are self-limiting (without

stopping PrEP) and are caused by dehydration, exercise, diet, or may be a false
positive result.
 Comorbid conditions including diabetes mellitus, hypertension, liver failure, or
hepatitis C infection can also cause worsening of kidney function.
 Rule out and manage other causes of worsened kidney function.

6.1 Management of creatinine elevation

Serum creatinine alone is not a very good marker of kidney function. Calculate estimated
creatinine clearance as per Cockcroft-Gault formula as a better measure of kidney function.
In normal kidney function, creatinine clearance is above 60 ml/min.

If the calculated creatinine clearance is < 60 ml/min: Stop PrEP and refer to Clinician
immediately. Never restart PrEP again.

6.2 Management of indeterminate (inconclusive) HIV

test result during follow-up visit
 Discontinue PrEP.
 Repeat rapid HIV antibody test in 4 weeks
 Only after the HIV negative result has been proved, can the client continue with
PrEP.
 Strongly emphasize the importance of condoms use during the period with
inconclusive HIV test results (e.g. new infection is highly infectious).

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 6.3 Management of a client who seroconvert while on
PrEP
 Document seroconversion and possible reason for seroconversion (non-
adherence, stopped taking PrEP, or PrEP failure, i.e., breakthrough infection while
adherent to PrEP)
 Document clearly that client seroconverted on PrEP and that client should be
monitored closely for possible failure.
 ART regimen for seroconversion Clients.

Table 5: Regimens for PrEP Clients after Sero-Conversion

ART STANDARD ALTERNATIVE

REGIMEN
FOR SERO-
CONVERSION On PrEP for Less than 3 Months On PrEP for More than 3 Months
TDF/3TC/DTG
≥30Kg (300mg/300mg/50mg) AZT/3TC+ DTG (300mg/300mg+50mg)
DOSE 1 0 1 1

6.4 Management of side effects and adverse drug

reactions (ADRs)
 Minor side effects are relatively common but are mild and self-limiting and often
do not require discontinuation of PrEP.
 Minor toxicities include nausea and/or vomiting, diarrhoea and/or flatulence,
dizziness, headache, and weight loss.
 Side effects should be managed symptomatically, and counselling should be
provided.
 Major toxicities (including renal toxicity and metabolic complications) associated
with TDF and 3TC are rare in PrEP exposure to date. Consult clinician if these occur.
 Any side effects should be recorded in client records and ADR form, regardless of
severity.
 Complete the national ADR form as per standard operating procedures.
 If PrEP will be discontinued, record the outcome in PrEP register.

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 6.5 Classification and management of interruption of
PrEP
PrEP discontinued: This is a final outcome for the current course of PrEP. If these clients
reinitiate PrEP, they are “restarting” PrEP. Use different PrEP ID in registering the client in the
register and issue a new PrEP card if the client is still HIV negative, still at risk, clinically eligible,
and willing to restart.

6.6 Management of clients requesting a transfer out

If a client wants to move and is motivated to stay on PrEP, inform the client of other
facilities that offer PrEP.
 Record outcome as “Transfer Out” in the PrEP register and client card.
 Update the register and hand over the Client Card to submit at the next facility.

6.7 Management of clients transferring in

 Write transfer-in date and original facility in comment section.
 Use the new facilities’ continuous PrEP serial number
 Continue with routine PrEP follow up schedule
 See M&E section for details

6.8 Re-initiation of PrEP

If a client wants to go back on PrEP after having been off for more than seven days.

 Repeat all procedures conducted at the PrEP initiation visit.

 Hepatitis B screening should only be redone if the previous result was from more
than one year ago.
 See PrEP initiation and follow-up visits

6.9 Clients with a hepatitis B infection wanting PrEP

PrEP is not contraindicated in clients with hepatitis B infection, but the following must be
done;

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  Refer to Hepatitis section to be evaluated for their Hepatitis B infection before
initiating PrEP.

6.10 PrEP and other drug interactions

 ARV drugs used for PrEP (TDF and 3TC) do not have any known interactions with
hormonal Contraceptives
 There are no known interactions between PrEP medicines and alcohol or recreational
drugs.
 However, warning should be given for the combination of PrEP with other chronic
nephrotoxic drugs, including NSAIDs. Advise Clients to reduce the use of NSAIDs.
 If a PrEP user thinks that his or her use of alcohol or other substances is interfering
with taking PrEP regularly, the PrEP provider should discuss possible behaviour
change with the client.
 See 2018 HIV Treatment Guidelines section for further guidance on potential drug
interactions with TDF and 3TC.

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 6.11 Provision of community-based Pre-Exposure
Prophylaxis services
PrEP services will also be available at community level.

6.11.1 Demand creation

Demand creation will be guided the PrEP Communication Strategy which highlights use of
Media, print media, Youth groups, key population led organisations, DCSAs, Peer educators,
Health workers, including Expert Clients to disseminate PrEP messages

6.11.2 Drug refills

 Static clinics will initiate clients on PrEP and dispense initial drugs including refills
at the clinic’s outreach clinic. This will only apply to Key population outreach clinics
 PrEP services can be provided on monthly basis at outreach location to ensure
clients can receive their refills. A three-month schedule will be available to support
refill appointments.
 Services need to be offered at the time of day that accommodates priority
populations
 Monitoring and evaluation tools will be used to document all services offered at
the outreach clinic

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 7. Prep and family planning services
KEY FACTS

 PrEP needs to be provided with other SRHR/FP services in combination HIV

prevention methods.
 Some clients who are at substantial risk of HIV acquisition are also at substantial
risk of unwanted pregnancies.
 Prep should be provided with other family planning services like i.e. Emergency
contraception.
 Clients already on a regular family planning method need adherence
counselling.

 Offer family planning method of emergency contraception in advance to all female

clients as are at substantial risk of pregnancy. Provide ECs together with PrEP.

 Clients may opt for regular family planning methods or emergency contraceptives.
Provide the services together with Prep or refer to family planning section.

 Clients who report unprotected sexual intercourse will be offered emergency

contraceptive pills or intrauterine device. Most clients may benefit from emergency
contraceptives.

 Emergency contraceptives should be taken 24 hours in advance prior to sexual

intercourse, the dose is effective only for 24 hours, and in case she didn’t have
unprotected sex she has to repeat the dose. ECs ca be taken together with PrEP

Emergency Contraceptives that are available for use are as follows:

 Levonorgestrel ECPs (1.5 mg or 0.75mg), 1 pill or 2 pills in a single dose

 Microlut (35-pill pack): contains norgestrel 25 pills at once then followed by 25 pills
12 hours later.
 Microgynon (containing progestin and Oestrogen) 4 pills at once then followed by
4 pills 12 hours later.
.

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 8. Monitoring and Evaluation
KEY FACTS

 The HIV program relies heavily on accurate and timely data for planning,
reporting to donors and for drug procurement and distribution.
 Data analysis and reporting is done from Client cards and clinic registers at most
facilities, but electronic systems for monitoring are used at sites with many
clients.
 Reporting is done quarterly for ART
 Cohort analyses are needed to report outcomes of clients in PrEP follow-up.
Cohort reports look at the current / latest status of all clients enrolled in follow-
up and require a review of all client records to classify primary and secondary
outcomes before data can be aggregated for reporting.
 Reports from facilities are to be completed within 5 working days after the end
of the reporting period.
 PrEP reporting will be further integrated into the regular Health Management
Information System. Quarterly PrEP facility reports will be entered directly into
the District Health Information System at the District Health Offices for national
reporting.

8.1 Definitions
 PrEP site
A facility is counted as PrEP site if they had retained at least one client still taking PrEP at
the end of the reporting period.

 PrEP Eligibility Assessment Outcomes

In addition to the HIV risk assessment that is repeated by the PrEP provider at the PrEP clinic,
all clients that presents at the PrEP clinic are assessed of their eligibility to start PrEP using
the. Not all clients who present for PrEP assessment will proceed to start. Document all clients
who presented for the initial PrEP assessment in this register.

 PrEP eligibility assessment outcomes refers to the outcomes of the PrEP initiation
assessment at the baseline for all clients who present at the PrEP clinic
 Start PrEP: Eligible, ready and received the first tin of ARVs for PrEP.
 Refused: Eligible, no contraindications, but client decided not to start PrEP.

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  Low HIV Risk: Client was advised not to start PrEP based on the low HIV risk
assessment done at the PrEP clinic by the provider.
 Acute HIV Infection: PrEP initiation was suspended because of suspected acute HIV
infection.
 Initial HIV +Result: Positive HIV test result at baseline PrEP assessment.
 Suspected Kidney Failure: PrEP initiation was suspended because of impaired
kidney function (suspected or confirmed).

 PrEP Registration Type

Refers to the client’s status at the time of registration at this PrEP clinic

 First time: Never taken PrEP before – disaggregated by age and sex. Circle the
appropriate sex and age group for clients who initiate PrEP for the first time.
 Transfer in: Received PrEP from another site before and is currently on PrEP or has
interrupted for less than 7 days. Count as Transfer In regardless if the Client brings
his old client card or not (‘official’ or ‘unofficial’ transfer).
 Re-initiation: Received PrEP from another site in the past but has NOT been taking
it for 7 days or more as of the day of registering at this clinic.

8.2 PrEP Primary Outcomes

The following outcomes are applicable for clients in PrEP follow-up See Figure 1 below
summarizing the outcomes.

 Defaulted/Lost to follow-up

Clients are counted as ‘defaulted’ in the cohort report if they have not returned to the clinic
and are not known to have transferred out, stopped (Quit/side-effects) or died. Assign this
outcome 2 months after the client is expected to have run out of PrEP.

 Clients may revert to “retained on PrEP” when the next cohort analysis is done if
they return to the clinic and continue ART.

 Died

Clients are counted as ‘died’ if there is a reliable report about the client’s death. ‘Died’ is used
regardless of any cause for clients who were taking PrEP.

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 HIV Positive

Client Stops PrEP after testing HIV positive during their scheduled follow-up visit HIV testing.
Link the client to start ART.

 Side Effects
Client Stops PrEP after developing significant side effects which are associated with PrEP . The
client might also decide to stop PrEP due to their own reported side effects which might not
be determined by the clinician.

 Low HIV Risk

Client stops PrEP because the HIV risk is no longer considered significant. The client may re-
start PrEP once the HIV risk is considered high.

 Quit

Client decides to stop PrEP although s/he is eligible, has no contraindications and is at
significant HIV risk acquisition.

 Transfer-Out

The client wants to continue to another site. Issue the client card to the client which will be
used by the receiving facility when registering the client as a transfer-in.

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Figure 4: PrEP Follow-up Outcomes

Outcomes- Asses after 2 Months of scheduled visit

Status PrEP Client

Surv/Retention Died Alive LTFU

HIV status Neg Pos Not done

AE Yes No

HIV Risk High Low

Choice Continue Quit*

Where Here Transfer-out

Notes
(*) PrEP clients would choose to stop based on their own risk assessment regardless of Clinicians high or low risk assessment .

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8.3 PrEP Adherence Level
 Reporting of adherence levels is based on a classification of the number of doses
missed at the last visit before the end of the quarter evaluated.
 Clients who are taking 1 tablet per day and who have missed more than 7 tablets
in a month are classified as not adherence.
 Clients who are not adherent should be counselled on the benefits of adhering
since the effectiveness of PrEP depends on the adherence.

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 8.4 Overview of PrEP M&E Tools/Job Aid
The table 4 below summarizes the various M&E tools and job aids for PrEP

Table 6 : PrEP Job/AIDs /Data collection Forms

JOB AID PURPOSE COMMENTS

PrEP risk To identify clients at substantial risk for  Tool can be used by HTS counsellors or other health care workers performing HIV
assessment
acquiring HIV infection testing or post-test counselling to HIV-negative clients.

 The tool can be used to initiate a discussion about individual risk.

 Tool can be used by HTS counsellor or other health care workers performing
counselling on the priority population status

PrEP eligibility To ensure that clients are eligible for

 Tool to be used by clinicians for clients identified as being at substantial risk
assessment PrEP and have no contraindications
for HIV.

 Checklist to ensure that there are no contraindications for PrEP or reasons

to delay PrEP initiation.

PrEP register To monitor PrEP continuation and

 The register captures the registration details of clients who have been
outcomes of all PrEP clients
assessed for PrEP and those that are continuing to receive PrEP

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  Captures the outcome of clients on follow-up

PrEP Client Card To capture baseline details for clients

 Only clients who have been assessed to start PrEP will have a client card
who have started PrEP and document
follow-up visits

PrEP Quarterly To summarize the data elements for

 Complete within five working days of new quarter and submit to DHO
cohort report reporting PrEP key indicators for
monitoring uptake, continuation and
adverse events of PrEP at the facility
level

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8.5 Reporting of registration data
 For all new clients registered, baseline data (such as age at registration, sex,
pregnancy status, clinical stage, etc.) are recorded on Client treatment cards and
copied into the PrEP register.
 These details do not change over time and tallying of these data needs to be done
only once when reporting on new clients registered during the reporting month or
quarter.
 Page summaries in the PrEP registers are filled as soon as each page is full. Count
the number of circled values for each column on the page.
 Quarterly registration reports are obtained by adding the page summaries from
each page in the respective reporting month or quarter.
 Cumulative registration reports are obtained by adding the data from the new
monthly or quarterly registration report to the data from the previous cumulative
registration report.
 Data elements in most sections should add up to the respective total number of
PrEP clients registered.
 Males, non-pregnant females and pregnant females must add up to the total
number registered.
 Age groups must add up to the total number registered.
 PrEP status (first time initiations, re-initiations, and transfer ins) must add up to the
total number registered.

8.6 Reporting of cohort outcomes

 Cohort analyses are needed to measure outcomes of PrEP clients in follow-up.
 In principle, the outcome status of any Client ever registered can change at any
time, unless they have died. Therefore, the records of all clients ever started have
to be reviewed each time a cumulative cohort outcome analysis is done. Current
outcome data cannot be obtained by addition from the previous quarterly outcome
data.

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  Client outcomes are considered as of the last day of the reporting period. Any
events (e.g. death) that happened after that day are ignored in the respective
cohort analysis but will be counted in the next report.

8.6.1 Primary follow-up outcome

 The primary outcome shows if a client has been retained alive in care or if he has
dropped out and why.
 The primary outcome categories must add up to the total clients registered in the
cohort.
and evaluation

8.6.2 Secondary outcome

 Secondary outcomes are the latest treatment details among the PrEP clients
retained PrEP.
 Secondary outcomes are counted directly from the cards of the clients retained in
PrEP, usually by looking at the last visit before the end of the month or quarter
evaluated.
 The secondary outcome categories must add up to the total number of clients
retained on PrEP.

8.6.3 Cumulative cohorts

Cumulative cohort (PrEP): Follow-up status of all PrEP clients ever Started at the respective
clinic. The number of clients with adverse follow-up outcomes (death, default, etc.) inevitably
increases over time. The number of clients retained on PrEP is calculated by subtracting all
clients with adverse follow-up outcomes from the total Client ever registered.

8.7 Record keeping and filing

8.7.1 Confidentiality of Client records
 All PrEP cards and registers are property of the MOH and may only be kept at the
respective facility or at the National Archives.

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  PrEP cards and PrEP registers must be kept in a locked room and are only to be
accessed by clinic staff responsible of providing the respective service and by the
national supervision team. Clients have access to their own Client card.

8.7.2 Use of the PrEP registers

 Keep only one register for the facility
 Each client has only one row in each register: Do not Continue using the same row
for returning transfers and re-starts after default or stop.
 Turn to a new page when starting to register clients in a new quarter. Leave any
unused rows at the bottom of the previous page empty. This is to separate the
quarters when adding page totals.
 Assign continuous registration numbers (by sequence of registration). Take care
not to duplicate registration numbers.
 Continue assigning cumulative registration numbers in PrEP-Register. These
number series are never re-started.

8.7.3 Use of Client cards

 Each client has only one PrEP card at any one time. Attach another Client card once
the old card is full.
 Start another card if the client has come back after default and stops
 Client cards are filed in polythene sleeves in lever arch files, up to 100 cards per
arch file.
 File the cards in ascending order by registration number.
 Prepare separate filing systems for ACTIVE (retained on PrEP) and INACTIVE clients
(Quit, HIV+ Side effects, transferred out, defaulted, or died).
 One arch file can hold approximately 100 cards.
▪ Label the ACTIVE files with PrEP numbers 1-100, 101-200, 201-200, etc.

▪ Label the INACTIVE files with PrEP numbers 1-200, 201-400, 401-600, etc.

o Each time the quarterly cohort analysis is done, update in the PrEP register the
outcome for the client who have dropped out of PrEP (Quit, HIV+ Side effects,

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 transferred out, defaulted or died). Straight after this, move these cards of from
the ACTIVE to the INACTIVE filing system.

8.8 Ensuring adequate data quality

 Use only the standard national reporting forms.
 The clinic’s own reports are checked by the supervision team each quarter from
primary records.
 Copies of the checked reports are kept at the clinic.

8.9 PrEP Standard Indicators

1. Number of individuals who were newly enrolled on oral antiretroviral pre-exposure
prophylaxis (PrEP) to prevent HIV infection in the reporting period
2. Number of individuals, inclusive of those newly enrolled, that received oral
antiretroviral pre-exposure prophylaxis (PrEP) to prevent HIV during the reporting
period
3. Number of clients retained alive on PrEP by the end of the quarter

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 9. Appendices
Figure 5: Entry Point, HIV testing

PrEP Entry Points

HTS/OPD Room STI Clinic/Service DICs Others

 Other Entry point as
 PITCT or VCT clients  Clients who were  AGYW/ABYM seeking described in the
 Clients mobilized from treated for an STI youth friendly services guideline
community  FSW/MSM

Step 1

HIV Counselling and Testing

Cadres
HIV Test
 HSAs
 HDAs
Initial HIV Testing Services for Potential

Captured in the HIV Testing Register

HIV Positive Negative

HIV Risk Assesment

PrEP Clients

Refer to ART
No Risk High Risk

Counsel on
Benefits of PrEP

Offer VMMC and Condoms & Not Interested in

Interested in PrEP
other preventive measure PrEP

Step 2
1st Visit/Initiation
 Discuss with the client if they want to initiate on the same day
 If the site has more than one PrEP Clinic, discuss with the client where they feel comfortable going for first initiations

41 | P a g e
Figure 6: First visit at PrEP clinic and Follow-up Visits

First PrEP Clinic Visit

Special PrEP PrEP @STI

PrEP Clinics room Clinic
PrEP @FP Clinic PrEP @DICs

First Visit PrEP Education

Do not offer
Interested Not Interested
PrEP

Current HIV Status PrEP Eligibility Assessment

Eligible Not Eligible

Kidney Failure Assessment

Assessment Results Suspected Not Suspected

*Book an appointment when

Serum Creatinine* results will be out

CrCl CrCl
Serum results >60 mL/min <60 mL/min

Positive Negative
(Refer to the HepB programme for
HepB results (Refer to the HepB Programme for
treatment Vaccine

Proceed to HIV Testing /

Confirmation Page 1 of 2

See page 2

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First PrEP Clinic Visit / Follow-up Visits @ 1,3,6,9,12,15,18 months

HIV Test/Confirmation

HIV Neg HIV Pos

Wait for 4 weeks

Offer PrEP

AHI
If its first visit

Suspected Not suspected

follow-up
Only in follow-up visits

PrEP Adherence monitoring &

Risk reduction counselling

STI Screening

Contraceptive Needs
Stop Assessment
Family planning

Side Effects

Severe Adverse Mild adverse

No side Effects
Events events

VMMC

Sex Male Female

Non-Circumcised Circumcised Pregnant Non-Pregant

Page 2 of 2

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1st Edition | Ministry of Health | 2020 45 | P a g e