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Table of Contents
Foreword ........................................................................................................................................ iv
Abbreviations & Acronyms ............................................................................................................ v
1.0 Introduction ...................................................................................................................... 1
2.0 Key guidance areas .......................................................................................................... 3
2.1 Target population ............................................................................................................. 3
2.2 PrEP initiation .................................................................................................................. 4
2.3 PrEP follow up in the community. ................................................................................... 4
2.4 Use of Oral PrEP (period of maximum protection and stopping) .................................... 5
2.5 Monitoring kidney function among clients on PrEP ........................................................ 6
2.6 Even Driven oral PrEP ..................................................................................................... 6
2.7 PrEP and Hepatitis ........................................................................................................... 9
3.0 Management of PrEP Commodities in the Community ................................................. 10
3.1 Commodity management at National level .................................................................... 10
3.2 Commodity management at Health Facility level .......................................................... 10
3.3 Commodity management for community outreach level ............................................... 10
4.0 Data management/Monitoring and Evaluation .............................................................. 12
5.0 Considerations for provision of injectable PrEP in implementation science sites ......... 13

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List of Tables
Table 1: Summary of key guidance areas ..................................................................................................................... 2
Table 2: Provision of Oral PrEP Services in the Community ....................................................................................... 5
Table 3: Renal Function Screening ............................................................................................................................... 6
Table 4: Event-Driven PrEP Criteria ............................................................................................................................ 7
Table 5: Commodities to support implementation of PrEP in community ................................................................. 11
Table 6: PrEP M&E and implementation tools .......................................................................................................... 13

List of Figures
Figure 1: Timelines for PrEP Initiation and Refill ........................................................................................................ 4
Figure 2: The dosing of ED-PrEP ................................................................................................................................. 8
Figure 3: Use of ED-PrEP one-time sex or in one day ................................................................................................. 8
Figure 4: Use of ED-PrEP use for sex on multiple consecutive days ........................................................................... 8

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Foreword
Malawi has implemented oral Pre-Exposure Prophylaxis (PrEP) since 2019 after a successful pilot whose
results informed the development of National Guidelines for the Provision of oral Pre-Exposure
Prophylaxis for Individuals at Substantial Risk of HIV in Malawi. Oral PrEP is currently being delivered
in high HIV burden districts through public, private health facilities and Drop-in Centres, and is being
scaled up to the rest of the districts.

The addendum has been developed to provide additional guidance on implementation of oral PrEP within
the sexual reproductive health and child health service delivery points including the community.
Emerging normative guidance by World Health Organization (WHO) on simplified and differentiated
PrEP delivery has been adapted and incorporated in the addendum. The incorporated guidance includes;
provision of PrEP to pregnant and breastfeeding women, revision of duration for Oral- PrEP to reach
maximum protection and duration for clients to stop taking PrEP after last exposure, revision on
conducting kidney function test, provision of Event-Driven PrEP; and screening for Hepatitis B and C
before starting PrEP. The addendum should be used alongside the 2020 National Guidelines for the
Provision of Oral PrEP.

World Health Organization Guidelines (2022) recommend use of long-acting injectable Cabotegravir
(CAB-LA) as safe and highly effective for people at substantial risk of HIV infection. Ministry of Health
in collaboration with key stakeholders will commence delivery on injectable PrEP through
implementation science in Blantyre & Lilongwe in 2023. Findings from the study will inform scale up of
the intervention. Guidance and standard operating procedures for implementation science will be
developed separately for use in the pilot sites.

Dr. Charles Mwansambo

SECRETARY FOR HEALTH

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Abbreviations & Acronyms
AGYW Adolescent Girls and Young women
ABYM Adolescent Boys and Young men
ANC Antenatal Care
ART Antiretroviral Therapy
CAB-LA Long-acting injectable Cabotegravir
CBO Community-Based Organization
CHN Community Health Nurse
CMA Community Midwifery Assistant
CO Clinical Officer
DHAVH Department of HIV, Sexually Transmitted Infections and Viral Hepatitis
DREAMS Determined Resilient Empowered AIDS-Free Mentored and Safe
FP Family Planning
FSW Female Sex Worker
HBV Hepatitis B Virus
HBsAg Hepatitis B Virus surface antigen
HCV Hepatitis C virus
HIV Human Immunodeficiency Virus
HIVST HIV Self-test
HTS HIV Testing Services
DCSA Disease Control Surveillance Assistant
LMIS Logistics Management Information System
MA Medical Assistant
M&E Monitoring and Evaluation
MSM Men who have Sex with Men
MSW Male Sex Workers
NMT Nurse /Midwifery Technician
OPD Outpatients Department
PrEP Pre-Exposure Prophylaxis
SOP Standard Operating Procedure
STI Sexually Transmitted Infection
TG Transgender
WHO World Health Organization
YCBDA Youth Community-Based Distribution Agent

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1.0 Introduction

The Ministry of Health started providing oral PrEP services in Malawi in 2021 after a successful
pilot conducted from 2019 to 2020. Since the start of implementation of the intervention, uptake
has been steadily increasing indicating available demand for the intervention. Furthermore, high
risk populations living in hard-to-reach areas could not access PrEP due to long distances to the
clinics hence the need to establish community models. As a tool for prevention of mother to
child transmission of HIV, PrEP will be expanded to antenatal and breastfeeding women
combined with other prevention tools in addition to family planning clinics.

The emerging issues together with the new WHO 2022 normative guidance on the Differentiated
and Simplified PrEP for Prevention1 have necessitated additional guidance presented in this
addendum. The 2022 addendum provides guidance for the provision of oral PrEP in the
following areas:

i. Delivery of oral PrEP through community models

ii. Event-Driven PrEP
iii. Testing for HIV, Hepatitis B and C for eligible clients at the community and for Event-
Driven PrEP
iv. PrEP and Hepatitis B and C
v. Client monitoring for kidney function among clients on oral PrEP
vi. Supply chain management for PrEP delivery in the community
vii. Considerations for provision of injectable PrEP in implementation science sites

1
Differentiated and simplified pre-exposure prophylaxis for HIV prevention: update to WHO implementation guidance.
Technical Brief. Geneva: World Health Organization; 2022. Licence: CC BY-NC-SA 3.0 IGO.
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 Table 1: Summary of key guidance areas

Issues Old New

Target population - All individuals at substantial - Pregnant and breast-feeding women
risk except pregnant and should be offered PrEP at point of service
breastfeeding women delivery
Expanding access to - Deliver PrEP services in health - Expand delivery and integration within
PrEP for people at facilities and Drop- in centres family planning, antenatal, postnatal,
substantial risk of HIV child health/EPI clinic, integrated
community outreach clinics, health posts
manned by a CMA/CHN, DREAMs girls
clubs, tertiary institutions, youth friendly
health clinics, youth network/clubs

Use of Oral- PrEP - Oral- PrEP reaches maximum -
(period of maximum protection after taking pills
protection and continuously for 21 days
stopping) - Clients willing to stop should
continue taking PrEP till 28
days after the last exposure.
Monitoring Kidney - Conduct Creatinine clearance -
function among clients test for all eligible clients
on Oral PrEP
Screening for hepatitis - Screen all high-risk clients for -
B and C Hepatitis B and C surface
antigen test before starting
PrEP
Event Driven PrEP - No guidance in previous -
guidelines
Oral- PrEP reaches maximum protection
after taking pills continuously for 7 days
- Clients willing to stop should continue
taking PrEP till 7 days after the last
exposure.
Conduct Creatinine clearance test for
individuals 40 years and above with renal
comorbidities within 1 month of starting
oral PrEP and 12-Monthly during follow-
up
Screen all clients for Hepatitis B and C
surface AG test before starting PrEP
Provide Event Driven PrEP to at high-risk
men

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2.0 Key guidance areas
2.1 Target population

The 2020 National guidelines focused on the HIV negative pregnant and breastfeeding woman in
a sero-discordant couple. The addendum recommends offering oral PrEP in all pregnant and
breastfeeding women at substantial risk for HIV.

2.1.1 Expanding access to oral PrEP in family planning, ANC, postnatal, Child
health/EPI clinics
• Oral PrEP services will be expanded through integration with family planning, antenatal,
and postnatal services in wards and clinics and clinics
• Existing Nurses/Midwives shall be trained to deliver integrated HIV/SRH/MNCH
services using an integrated training curriculum (FP, STI treatment, and partner testing
services) with the goal of equipping providers with the comprehensive knowledge and
skills to provide integrated FP and combination HIV prevention services, including PrEP
services.
• FP staff shall promote comprehensive screening for HIV risk and PrEP eligibility
(including HIV testing, HIV risk screening, male partner testing, PrEP provision, and
adherence and safety counseling)
• Coaching and mentoring of health providers shall be implemented quarterly to improve
quality of integrated services
• Existing FP providers will be engaged in ongoing continuous quality improvement to
optimize PrEP delivery.
• All core components of PrEP delivery– including screening for HIV behaviour risk, HIV
testing, dispensing, adherence and risk reduction counselling, assessment of side effects,
provision of PrEP refills, and safety assessments – will be conducted by existing FP
clinic staff as part of the standard of care service package.
• As part of standard of care services, clinics will promote comprehensive provision of
integrated FP services and HIV prevention services, including contraception methods’
use and preferences, promotion of knowledge of partner HIV status, condom provision,
and screening and treatment of STIs.

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 • Determination of eligibility for PrEP, clinical provision of PrEP, and follow-up of clients
who initiate PrEP will be conducted according to the national PrEP guidelines using
MOH tools.
• Clinics will begin PrEP delivery within two weeks of training.

2.1.2 Expanding access to oral PrEP through community health service delivery system.
• Oral PrEP will be delivered through integrated mobile outreach clinics such as Dream
Girls Clubs, Youth NGO/networks and other similar models by trained health workers
such us a General Nurse, CHN, MA, CO and CMA
• Trained CMAs at a health post should deliver integrated HIV/SRH/Maternal Health
services.

2.2 PrEP initiation

The protocol for PrEP initiation will follow the 2020 PrEP National Guidelines. The Figure 1
below illustrates the timelines for initiation, continuation and refill of PrEP in the community.

Figure 1: Timelines for PrEP Initiation and Refill

2.3 PrEP follow up in the community.

• Refill will be done at the site where PrEP was initiated or continue at another site after
formal transfer.
• Client outcome for the visit will be updated in the outreach PrEP register.
• PrEP client card for the outreach client will be kept in the outreach arch lever file at a health
facility.

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The table 2 summarizes how oral PrEP will be provided in the Community.

Table 2: Provision of Oral PrEP Services in the Community

Service / Who to Provide Where to be Provided When
Intervention
Demand CHN, DCSA, NMT, CMA, Health Centre, Health On going
Creation MA, Peer educators, CBO, Post Facility and
Community Leaders Community
Screening and CHN, CO, MA CMA, NMT, Health Centre, Health During Initiation and
Counselling Post Facility and Follow-up
Community
Initiation CHN, CO, MA CMA, NMT, Health Centre, Health First visit
Post Facility and
Community
Follow up and CHN, CO, MA CMA, NMT, Health Centre, Health Based on guidelines
Refill Post Facility and
Community

2.4 Use of Oral PrEP (period of maximum protection and stopping)

The 2020 National guidelines indicated that Oral- PrEP reaches maximum protection after taking
pills continuously for 21 days. Clients willing to stop were advised to continue taking PrEP till
28 days after the last exposure. The new WHO 2022 normative guidance on the Differentiated
and Simplified PrEP for prevention indicates that oral- PrEP reaches maximum protection after
taking pills continuously for 7 days. Clients willing to stop should continue taking PrEP till 7
days after the last exposure.

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2.5 Monitoring kidney function among clients on PrEP
Creatinine Clearance test should be done only to those with risk factors as indicated in the table
3.
Table 3: Renal Function Screening

Risk Factors (any of the following at Intervention

initial or during follow-up)
• Age 40 years plus
• Hypertension
• Diabetes Mellitus
• BMI<18.5kg/m 2
• Routine CrCl needed within 1 months of
starting PrEP and 12 – months during
follow-up

• On nephrotoxic medications*
• Known Creatinine Clearance
(CrCl) < 90ml /min

• No risk factor • Cr CL not needed at baseline and during

follow-up
* Repeated or long-term use: ibuprofen, rifampicin, gentamycin, penicillin, cephalosporins, omeprazole etc

2.6 Even Driven oral PrEP

Event Driven PrEP (ED-PrEP) also called On-Demand PrEP or 2+1+1, is effective in reducing
the likelihood of HIV acquisition during sex for people assigned male at birth, who are not using
gender affirming hormones. Although daily PrEP involves taking medication throughout a period
of potential exposure to HIV, ED-PrEP require taking of oral PrEP for a period as short as three
days and timed to correspond with anticipated sexual encounter. However, ED-PrEP is not
suitable for women and transgender women on female hormone treatment. The table 4
summarizes the eligibility criteria for ED- PrEP.

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Table 4: Event-Driven PrEP Criteria

Eligible for ED-PrEP Not

Noteligible
Eligible
forfor
ED-PrEP
ED-PrEP Not eligible fo
Offer ED-PrEP to all men (men who have • Women and transgender women on
sex with women and men who have sex with female hormone treatment.
men).: • Men and trans and gender diverse
• Find ED-PrEP more convenient people who:
• Have infrequent sex (e.g., less than o Take female hormone treatment.
2 times a week on average) o Use injectable drugs
• Can plan for sex 2 hours in
advance, or who can delay sex at
least for 2hours
• Are not on female hormone
treatment

Note: -The guidance allows men to access ED-PrEP without revealing their sexual orientation.
- Clients on ED-PrEP can be allowed to switch to oral daily PrEP or the other way round

2.6.1 HIV testing in ED-PrEP

• Offer assisted HIVST at facility or community to those clients who are motivated to get
ED-PrEP.
o If Positive refer for conventional testing
o If negative can start on ED PrEP only and advise for conventional testing at three
months.
• Conduct conventional HIV testing at facility or community before the client is initiated
on ED- PrEP.
• Continue every three months according to PrEP testing milestones

2.6.2 Initiating ED-PrEP

Start ED-PrEP using TDF/3TC or TDF/FTC with a loading dose of two pills taken 2–24 hours
before having sex to ensure sufficient drug levels to provide protection. Continue taking one pill
of PrEP at the same time as the loading dose daily until two days after the last potential exposure
(See Figures 1, 2, and 3). This process should be repeated for each period of potential exposure
to HIV. Offer one bottle of 30 tablets and advise on proper storage to maintain drug efficacy for
future use

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Figure 2: The dosing of ED-PrEP

Figure 3: Use of ED-PrEP one-time sex or in one day

Figure 4: Use of ED-PrEP use for sex on multiple consecutive days

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2.6.3 Contraindications for ED-PrEP
All the contraindications to daily PrEP apply to ED-PrEP

2.7 PrEP and Hepatitis

People at high-risk of HIV infection are usually at higher risk of Hepatitis B and C infection.
Therefore, PrEP services will be used as an entry point to identify and screen people with
Hepatitis and link them to care. Testing using Hepatitis B virus surface antigen (HBsAg) and
Hepatitis C virus (HCV) antibody for Hepatitis B and C is recommended before initiating a
client on PrEP.

2.7.1 Hepatitis B
For Patients who test HBsAg positive,

• Refer for enrolment into Viral Hepatitis care.

• Diagnostic follow up.
• and/or tenofovir based lifelong antiviral treatment. (This consistent treatment will also act
as prevention against HIV in high-risk individuals)
• Offer counselling services to all household contacts of persons with Hepatitis B.
• Do not give either Oral daily or ED-PrEP in patients who are HBsAg positive.

For patients who test HBsAg negative,

• Offer either oral daily or ED-PrEP.

• Offer vaccine against Hepatitis B if they have not been vaccinated before (This includes
clients who got vaccinated more than 20 years prior).

2.7.2 Hepatitis C
Hepatitis C infection is not a contraindication for PrEP. Patients who test HCV antibody positive
may be offered both oral daily and ED-PrEP. However, refer the patients for diagnostic follow
up and antiviral treatment against Hepatitis C.

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3.0 Management of PrEP Commodities in the Community

3.1 Commodity management at National level

• Commodities required for PrEP will continuously be incorporated into the existing
national supply chain management system for HIV commodities and managed by
DHAVH.
• Annual national quantification and supply planning will guide stock requirements for the
various commodities and shipment scheduling.
• Stock levels of program commodities will be maintained at a maximum – minimum level
of 9 – 6 months at the Central warehouse.
• Health facilities will be directly restocked from the central warehouse on bi-monthly
interval.
• To determine the quantity of commodities for each facility needs:
- Data will be collected on a quarterly basis through the integrated TB/HIV
supervision
- Data will be entered into the Logistics Management Information System
(LMIS) and will be utilized to determine patient numbers, stock on hand,
consumption, adjustments, and quantity required.

3.2 Commodity management at Health Facility level

• PrEP commodities for all outreach clinics will be ordered from the pharmacy/drug store
using separate Requisition/Issue booklets (RIV) for outreach.
• Stock levels of program commodities will be maintained at a maximum – minimum level
of 4 – 2 months at health facility.

3.3 Commodity management for community outreach level

• After every community outreach activity, commodity returns will be kept at the mother
facility in a secure lockable room/cabinet within the ART clinic.
• Physical counting of supplies must be done every end of week and during handover to a
new team lead to ensure proper accountability.

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• Documentation (stock cards, RIVs, Relocation books, Daily Activity registers (DARs),
etc) for commodities within the health facility and community outreach clinics must be
maintained and accessible by supervisors who support the PrEP/ART program.
• Communication to DHA supply chain should use email (hivdeptlogistics@gmail.com) or
calling the Toll - free lines (5 9 1 9 1 – Airtel & 6882 – TNM) for any commodity related
issues for:
- support and authorization codes for additional supplies from warehouse,
- inter-facility stock transfer,
- disposal of expired/spoiled stocks,
- receipt of damaged or inappropriate stocks,
- serious (suspected) side effects for any medicines.

The Table 5 shows the different commodity groups managed within the Department of
HIV/AIDS to support PrEP implementation.

Table 5: Commodities to support implementation of PrEP in community

No. Commodity group Examples Supply*

• HIV test kits (Determine, Unigold and
SD Bio line)
• Hep B Tests (Determine-Hepatitis B)
1 Screening Tests • Syphilis Tests (Bio line-Syphilis) E
• TDF/3TC 300/300mg
• TDF/FTC 300/200mg
2 ARVs • Cabotegravir E
Laboratory reagents and
3 consumables • Creatinine Test S
Supply*: E = item managed exclusively through HIV Program. S = items supplemented by Diagnostics department for HIV Program

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4.0 Data management/Monitoring and Evaluation

Routine M&E of differentiated PrEP services aims to track uptake, coverage, persistence, and
outcomes of PrEP service delivery for high-risk populations. The national PrEP program also
tracks compliance with SOPs and protocols. It is programmatically challenging to objectively
measure the changing risk levels of PrEP clients over time. This makes it difficult to interpret
PrEP discontinuations as it is usually not known if clients are at continued high risk and therefore
in need of PrEP. The introduction of ED-PrEP makes this even more challenging as it is
impossible to ascertain and predict the number of high-risk events in any given dispensing
interval. Documentation and reporting are therefore limited to the intended use (continuous or
Even-Driven) at the last dispensing visit before the end of the reporting period.

4.1 How to document and report PrEP services

• The same set of M&E and reporting tools is used for PrEP implementation at a health
facility and in the community (PrEP outreach clinics).
• File PrEP client cards in polythene sleeves in dedicated lever arch files.
o Sort cards by clinic registration number
o Separate cards of clients who are no longer retained on PrEP in an “Inactive PrEP
Client File”
• Use one unified PrEP Clinic Register for clients served at the facility and in the
community
• Use separate lever arch files for clients served in outreach clinics (community PrEP)
• Remember to update client outcomes after every visit on both the PrEP Client Card and
the Clinic Register
• Complete the quarterly and cumulative PrEP cohort reports by the end of the first week
of the following quarter
o When compiling quarterly report, combine facility and community PrEP clients in
one single report
• Conduct quarterly mentorship and supervision for the community PrEP delivery points

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Table 6: PrEP M&E and implementation tools

Tool Purpose
PrEP client assessment Identify clients at substantial HIV acquisition risk
form
PrEP client flow chart Elicit risk attributes and determine eligibility
PrEP clinic register Document all clients assessed for PrEP eligibility, their
baseline characteristics, PrEP initiation and primary follow-up
outcome. Source for quarterly registration reporting
PrEP client card Document demographics, risk factors and clinical data for all
clients initiated on PrEP. Document HIV status, renal
function, STI screening, adherence, new dispensing for all
follow-up visits. Source for cumulative outcome reporting.
Adherence SOP Provide standardized client education on prescription, dose
adherence requirements and follow-up schedule
Daily activity register (for Track and account for all rapid test kits used at the service
test kits) delivery point
Requisition and issue Request and track test kits and ARVs from the pharmacy to
voucher the service delivery point

5.0 Considerations for provision of injectable PrEP in implementation science sites

The HIV Prevention Trial Network trial 084 trial demonstrated that injectable, long-acting PrEP
using cabotegravir (CAB-LA) is safe and significantly more effective than oral PrEP. This is
likely due to the more consistent ARV levels that can be achieved with CAB-LA compared with
the suboptimal adherence to daily oral PrEP.

CAB-LA was administered at 2-month intervals in previous trials, but pharmacological studies
are ongoing to determine if it can be given 3 monthly. This would offer significant programmatic
advantages as it would allow for a full alignment with the Depo-Provera injectable contraceptive
schedule. CAB-LA is currently prohibitively expensive, but high-level negotiations are expected
to result in considerable cost reductions that may make CAB-LA cost-effective, considering the
superior efficacy.

In 2023, the MOH will start offering a limited consignment of donated CAB-LA in a sample of
facilities and sub-populations in the context of a formal implementation study. The study will
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examine effective demand generation, optimal delivery channels, clinical outcomes, cost-
effectiveness, and implications for HIV diagnosis and surveillance. The study will also determine
uptake and client choice of the available PrEP options to inform future national scale-up
planning.

In 2023, CAB-LA will therefore only be available at dedicated study facilities for a limited
number of clients. During this phase, CAB-LA may only be given in this and other IRB
approved studies. MOH will issue a formal policy update when CAB-LA has been found suitable
for national scale-up.

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