J.16_Clinical_Implementation_Guide_for_PrEP_Provision_in_Eswatini,_2019.pdf

Clinical Implementation Guide for PrEP Provision in Eswatini

May 2019

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ACKNOWLEDGMENTS

With this document, the Ministry of Health (MOH) issues the first national clinical implementation guidance for PrEP provision in Eswatini. This document has been developed through the collaborative effort of many individuals and organizations. The process—which included a review of documents from the World Health Organization (WHO) and other countries as well as the clinical guidance document used for the PrEP demonstration studies in Eswatini—was led and coordinated by the Ministry of Health through the Eswatini National AIDS Program (ENAP).

The Ministry of Health greatly appreciates the following organizations for their technical and financial support during the development of this document: WHO, U.S. President’s Emergency Plan for AIDS Relief (PEPFAR)/United States Agency for International Development (USAID) and Center for Disease Control (CDC), Joint United Nations Programme on HIV/AIDS (UNAIDS), National Emergency Response Council on HIV and AIDS (NERCHA), Clinton Health Access Initiative (CHAI), FHI 360/LINKAGES, PACT, mothers2mothers (M2M), University Research Co., LLC (URC), International Center for AIDS Care and Treatment Program (ICAP), Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), Population Services International (PSI), Médecins Sans Frontières (MSF), Kwakha Indvodza, HIV Response Coordination, Community Capacity and Communication- Breakthrough ACTION (HC4), Southern Africa HIV and AIDS Information Dissemination Service (SAfAIDS), House of our Pride (HOOP), Health Plus for Men (HP4M), Rock of Hope (RoH), Voice of Our Voices (VOOV), and TransSwati.

We are grateful to the healthcare workers and implementing partners who were involved in the implementation of the PrEP demonstration projects for sharing their experiences and best practices, thus contributing to the revision of this document.

Special compliments go to the core writing team who worked tirelessly to make this a reality.

The team includes Sindy Matse (ENAP), Dr. Mopo Radebe (WHO), Dr. Busi Msimanga (WHO), Dr. Nomthandazo Lukhele (WHO), Dr. Neway Fida (USAID), Laura Muzart (FHI 360/LINKAGES), Anita Hettema (CHAI), Jill M. Peterson (FHI 360), Dr. Rudo Kuwengwa (ENAP) and Dr. Maria Nnambalirwa (EGPAF).

Appreciation is extended to the following individuals who contributed to this guideline:

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MOH

Pholile Maphalala, CMS Thabo Motsa, M&E Voyivoyi Lukhele, HPU

ENAP

Nompilo Dlamini Thembie Dlamini Lenhle Dube Nompilo Gwebu Khanyisile Lukhele Harriet Mamba Dr. Smangele Mthethwa

MOH clinics Senzo Dladla, Khuphuka Clinic Bheki Dlamini, KSII PHU Vuyisile Dlamini, Siphocosini Clinic Thelma Fakudze, Lobamba Clinic Vuyisile Lukhele, Lobamba Clinic Lizwi Makhanya, Mbabane PHU Busi Mamba, Mbabane PHU Thembi Mazibuko, Mbabane PHU Raymond Shabangu, Luyengo Clinic Sannie Sibandze, RFM-Community Sizakele Simelane, Lobamba Clinic

NERCHA

Nsindiso Dlamini Mbuso Mabuza

UNAIDS

Thembisile Dlamini

CDC

Dr. Sikhathele Mazibuko

AIDSFREE

Futhi Dlamini Phinda Dlamini Sibongile Wusumani

CHAI

Bongiwe Dlamini

FHI 360/LINKAGES

Dr. David Chilongozi

FHI 360

Design Lab Suzanne Fischer

HC4

Sibongile Mndzebele Beth Deutsch

HP4M

David Fakudze

HOOP

David Maseko

ICAP

Dr. Altaye Kindane

Kwakha Indvodza Tom Churchyard

M2M Makhosazane Nxumalo Lindiwe Sibiya

MSF

Dr. Bernard Kerschberger Qhubekani Mpala

Pact Mphikeleli Dlamini Nicole Miller

PSI

Alysha Beyer Sandile Ginindza Ngwara Munodawafa Vera Nxumalo

RoH Melusi Simelane

SAfAIDS Sithembile Dlamini

TransSwati Pinty Dludlu

URC

Moyo Nyakallang Zandie Bhila

VOOV

Lungile Khumalo

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FOREWORD

Eswatini has made major strides in its HIV response. Because we have sustained the HIV response over several years, new HIV infections have been reduced by about 44% in five years. Despite these achievements, the epidemic has shifted from what was known traditionally as a generalised epidemic to micro-epidemics affecting different groups, specifically some populations with very high vulnerability to HIV, such as adolescent girls and young women (AGYW), sex workers (SWs), and men.

Different HIV acquisition vulnerability levels, social risk factors, high-risk sexual practices, and limited access to appropriate HIV interventions influence HIV incidence among these populations.

This contextual understanding of the HIV epidemic is critical to developing and implementing effective HIV interventions. In its trajectory toward ending AIDS as a public health threat, the country has introduced pre-exposure prophylaxis (PrEP) in addition to existing HIV prevention interventions.

Expanding access to PrEP can encourage more people to learn about their HIV status, provide an opportunity to discuss individual risks, and increase clients’ understanding of risk—thereby providing more opportunities to expand access to HIV prevention services and, if a person tests positive, to treatment services.

This document has been written to provide healthcare workers with a reference tool for PrEP implementation and to support staff with clinical decision-making related to this new HIV prevention method. The Ministry of Health expects the implementation of these guidelines to help fast-track PrEP scale-up in the country in order to reach epidemic control, and I would therefore like to call upon all actors in the fight against HIV in Eswatini to support successful implementation of these guidelines.

Dr. S. V. Magagula Director of Health Services

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Table of Contents

Acronyms ............................................................................ vi

PrEP Basics

Introduction

PrEP regimen

PrEP use

Definition of terms

Getting started on PrEP

Indications for PrEP

Eligibility criteria for PrEP

Contraindications for PrEP

PrEP minimum package

PrEP initiation and follow-up visits

Community-based PrEP services

1. PrEP initiations and referrals for refills

2. Community outreach provider PrEP initiations and refills

Clients on post-exposure prophylaxis

(PEP)

Clients previously on PrEP coming for re-initiation

Clients with a hepatitis B infection wanting PrEP

Clients with a hepatitis B infection not interested in PrEP

PrEP and other drug interactions

Key counselling messages

Education and counselling

Risk reduction counselling

Client follow-up

Stopping PrEP

Re-starting PrEP

Missed appointments

Management of clients in specific situations ... 15

Management of creatinine elevation

Management of clients with inconclusive HIV test result during follow-up visit

Management of side effects and adverse drug reactions (ADRs)

Management of clients requesting a transfer out

Management of clients transferring in

Documentation and data management

Documentation

PrEP job aids

PrEP data collection tools

Additional indicators to be collected/ tracked and for reporting for community based PrEP initiations

Annex: Algorithm for PrEP initiation

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3TC Lamivudine

ADR Adverse drug reaction

AHI Acute HIV infection

ALT Alanine aminotransferase

ANC Antenatal care

APRI Aminotransferase to platelet ratio index

ART Antiretroviral therapy

ARV Antiretroviral

AST Aspartate aminotransferase

BMI Body mass index

EC Expert client

FP Family planning

HBsAg Hepatitis B surface antigen

HIV Human immunodeficiency virus

HTS HIV testing service

LFT Liver function test

LTFU Lost-to-follow-up

M2M Mothers 2 Mothers

MO Medical officer

PEP Post-exposure prophylaxis

PMTCT Prevention of mother to child transmission of HIV

PO Per os

PrEP Pre-exposure prophylaxis

STI Sexually transmitted infection

TDF Tenofovir disoproxil fumarate

Acronyms

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Introduction Pre-exposure prophylaxis (PrEP) is an efficacious HIV prevention intervention involving the use of antiretroviral (ARV) drugs by people who are not infected with HIV to prevent acquisition of HIV. The World Health Organization has recommended that PrEP be offered to people at substantial risk of HIV infection as part of a combined HIV prevention approach. PrEP should not displace or undermine the use of other effective and well-established HIV combination prevention interventions. This guideline is intended for healthcare workers involved in PrEP service delivery and should be read in conjunction with the Eswatini 2018 HIV Integrated Management Guidelines, the 2017 Eswatini Core Package for HIV Prevention, and the PrEP National Implementation Framework 2019.

PrEP Basics

PrEP regimen The recommended ARV regimen for use as PrEP in Eswatini is Tenofovir (TDF) 300 mg and Lamivudine (3TC) 300 mg, orally given as a fixed-dose combination.

PrEP use PrEP is a pill that should be taken daily before, during, and after periods of substantial risk of HIV acquisition (Figure 1). PrEP becomes effective after seven days of continuous use.

It can be stopped during periods of no risk, but in order for it to be effective it should be taken daily for at least 28 days after the last potential exposure.

FIGURE 1.

PrEP Use

1 7 28

DAY DAY DAY

Initiate PrEP PrEP becomes effective

End of risk

28 days after last potential exposure, PrEP can be discontinued

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Definition of terms

PrEP initiation A client who initiates PrEP for the first time.

PrEP re-start A client who re-starts/re-initiates PrEP after stopping PrEP for at least seven days. A client can re-start PrEP if confirmed HIV negative during a new period of substantial risk.

PrEP continuation A client who continues PrEP without interruption for any period of seven days or more.

PrEP STOP A client who stopped PrEP. Stopping PrEP can be due to a variety of reasons

Missed appointment A client who missed a scheduled follow-up appointment by more than or equal to three days but less then seven days.

PrEP lost-to-follow-up

(LTFU)

A client with no documented STOP code who did not come for a scheduled appointment 7 days or more after the date of the appointment.

Indications for PrEP PrEP is offered to eligible, HIV-negative individuals who are at substantial risk of acquiring HIV infection. The following eight populations will be prioritized:

▶ Adolescent girls and young women (16-24 years)

▶ Pregnant and lactating women

▶ Serodiscordant couples

▶ Sex workers

▶ Men who have sex with men

▶ Clients with sexually transmitted infections (STIs)

▶ Males (30-34 years)

▶ Transgender people

Getting started on PrEP Rx

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The following risk assessment should be used to identify individual risk levels for sexually active clients. Only continue with the following risk assessment questions after determining if the client is sexually active.

Risk Assessment Questions

Risk Conclusion Determine the risk conclusion and offer PrEP to clients at substantial risk.

Yes 1. Did you have sex with: [__] Men [__] Women [__] Both No

Yes

2. Have you had unprotected (condom-less) sex with partners who are

HIV positive or whose HIV status you did not know?

No

Yes 3. Is selling sex part of your regular income? No

Yes 4. Have you had a sexually transmitted infection (STI)? No

Yes 5. Have you had sex under the influence of alcohol and/or drugs? No

Yes 6. For women only: are you currently pregnant or lactating? No

Yes

7. Have you experienced, or do you expect to experience, any situations that you consider to be risky for acquiring HIV?

If yes, specify: __________________________________

No

In the past SIX months:

if yes to any Discuss HIV prevention options, including counseling on the benefits of PrEP.

if no to all The person is not at high risk for HIV discuss HIV prevention as appropriate.

Yes Is the client at substantial risk? No

Yes Did the client accept the PrEP offer? No if yes to both Complete the intra-facility referral tool and continue with the clinical eligibility screening for PrEP.

if no to any Discuss HIV prevention as appropriate.

If yes to substantial risk but no to accepting PrEP offer

Complete the tally section of the intra-facility referral tool in addition to discussing HIV prevention options

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Yes In the past three days, has the client experienced any signs and/or symptoms of acute HIV infection (AHI)?

No

Yes If client experienced signs and symptoms of AHI, has there been exposure to HIV in the previous 14 days?

No

Ruling out acute HIV infection (AHI) if yes to both Defer PrEP and make an appointment for repeat HIV testing in four weeks.

Document appointment date on PrEP client appointment card.

if no to either one Determine if client is eligible for PrEP.

If you have determined the client is at substantial risk, and ruled out AHI, confirm other eligibility criteria.

Eligibility criteria for PrEP ▶ Age ≥ 16 years unless client is a mature minor ≥ 12 years old

▶ HIV-negative test on the day of PrEP initiation using the national HIV testing algorithm

▶ Absence of symptoms indicating AHI in combination with an exposure for HIV in the previous 14 days

▶ Client willingness to attend scheduled PrEP visits until 28 days after risk period

▶ No contraindication to TDF + 3TC

▶ Bodyweight ≥ 40 kg

Intra-facility referral tool To facilitate movement of clients within the facility, the intra-facility referral tool was developed to document that PrEP was offered and to capture priority population(s) of clients.

For this tool it will be key to use the discussions that occurred during the Risk Assessment conversation to fill out this tool.

Please provide this tool to the client to share with the initiating healthcare worker.

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Use the following eligibility checklist to ensure that the client is eligible to initiate PrEP.

In circumstances where a healthcare worker can not determine the risk for HIV infection but the client demands PrEP and meets other criteria, the client can still be initiated on PrEP.

Eligibility checklist prior to PrEP initiation if yes to all Initiate PrEP.

if no to any Client is not eligible for PrEP.

Discuss other HIV prevention options.

Yes 1. Client is ≥16 years (or mature minor >12 years) No

Yes 2. HIV test is nonreactive on PrEP initiation day No Yes 3. Client is at substantial risk for HIV infection No Yes 4. Client is not suspected to have AHI No

Yes 5. Client is ≥ 40 kg No

Yes 6. Client is willing/able to come to follow-up appointments No

Yes

7. Client has no contraindications to TDF or risk factors for abnormal creatinine or recent pre-existing creatinine clearance < 60 ml/min

No

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Contraindications for PrEP PrEP should NOT be provided to people with:

▶ Age less than 16 years unless the client is considered a “mature minor” ≥ 12 years old

▶ HIV-positive test on the day of PrEP initiation using the national HIV testing algorithm

▶ Signs of acute HIV infection (Box 1)

▶ Client unwilling to attend scheduled PrEP visits until 28 days after risk period

▶ Contraindications for TDF + 3TC as described in the national guidelines

▶ A known creatinine clearance less than 60 ml/min

▶ Body weight < 40 kg

PrEP minimum package

The PrEP minimum package of services includes:

▶ HIV testing and counselling

▶ Hepatitis B surface antigen (HBsAg), creatinine clearance monitoring, if applicable

▶ Comprehensive HIV prevention, including risk reduction counselling and condom distribution

▶ Assessment of need for contraceptives and/ or pregnancy testing

▶ STI screening, diagnosis, and treatment

▶ Screening for noncommunicable diseases, such as diabetes mellitus and hypertension

▶ Referral for voluntary medical male circumcision services

▶ Referral for services for gender-based violence or mental health issues identified during counselling

▶ Adherence assessment and counselling, help identify possible barriers to good adherence

PrEP initiation and follow-up visits 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 1.

For most clients, PrEP can be initiated the same day. However, in some scenarios outlined in Table 1, it is recommended to defer PrEP initiation.

For clients reached at the community level follow up should be made within three days of the deferred appointment date by the community outreach provider to ensure linkage. Good practice would include an appointment reminder.

For all clients that defer initiation they should still receive other applicable and available services.

Box 1. Signs and symptoms of AHI

Flu-like symptoms i.e. anorexia, malaise, fever, sweats, sore throat, mouth ulcers, muscle or joint pains, rash, swollen glands and headache or diarrhea

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PREP INITIATION STEPS PLAN OF ACTION PROVIDER

HIV test

(HIV testing services [HTS] guidelines)

HIV test needs to be performed on the day of PrEP initiation.

If positive, client must not be initiated on PrEP, but should be immediately initiated on/referred for ART.

If the test result is inconclusive, defer PrEP and follow the national HIV testing algorithm until a definite HIV test result has been obtained for all clients.

HTS counsellor

Nurse

Medical officer (MO)

Counselling Conduct behavior risk assessment.

Discuss combination HIV prevention package and risk reduction, including counselling and demonstration of correct and consistent condom use.

Educate about the benefits and limitations of PrEP, including what to do when experiencing side effects.

Evaluate client’s eligibility, willingness, and readiness to take PrEP.

Discuss disclosure to partner/family.

Offer family planning and safer conception counselling, if applicable.

HTS counsellor

Nurse

MO

Expert Client (EC)

Mothers 2 Mothers (M2M)

Clients at risk of AHI

If client presents with signs and symptoms of HIV infection and possible exposure to HIV in the previous 14 days

Defer PrEP.

Repeat HTS after four weeks.

If negative, initiate PrEP.

HTS counsellor

Nurse

MO

Table 1. PrEP Initiation

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PREP INITIATION STEPS PLAN OF ACTION PROVIDER

Serum creatinine

A Serum Creatinine test is required prior to initiation for clients with the following risk factors:

• Age >50

• Hypertension

• Diabetes mellitus

• Body Mass Index (BMI) < 18.5

• Other nephrotoxic medication

• Any symptoms or signs suggestive of renal impairment (See Box 2.)

If risk factors of client require a serum creatinine test at initiation defer client until results are received.

Calculate creatinine clearance.

If creatinine clearance < 60 ml/min see management of creatinine elevation (page 15).

If creatinine clearance ≥ 60 ml/min, initiate PrEP.

Nurse

MO

Counsellor/ Phlebotomist

Hepatitis B surface antigen HBsAg negative: Offer hepatitis B vaccination if not previously completed at 0, 1, and 6 months (as per National Hepatitis Guidelines).

HBsAg positive: See section on clients with a hepatitis B infection wanting PrEP (page 10).

Nurse

MO

Counsellor/ Phlebotomist

Syndromic screening for STIs If syndromic, manage STIs as per National STI Treatment Guidelines.

Nurse

MO

Pregnancy testing Determine last menstrual period; do pregnancy test if indicated.

Confirm pregnancy in clients reporting amenorrhea.

(Remember, pregnancy is not a contraindication for PrEP).

Nurse

MO

Counsellor/ Phlebotomist

PrEP initiation Assess exclusion criteria for PrEP contraindications.

If no contraindications, provide PrEP for 28 days

Registered nurse trained on PrEP + IMAI and/or NARTIS

MO

Box 2. Symptoms and Signs suggestive of renal impairment include

Decreased urine output, fluid retention causing swelling of legs, ankles, feet, hands, or face, shortness of breath, excessive drowsiness or fatigue, confusion, nausea and vomiting, general weakness, irregular heartbeat

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Provision of PrEP through the community will be done through approved MOH community outreach providers. Ideally services need to be offered at the time of day that accommodates priority populations (including weekends and after regular business hours). The two approaches to community-based PrEP services are noted below:

1. PrEP initiations and referrals for refills ▶ Client should be willing to be linked to a PrEP-offering facility of their choice.

▶ Initiated client will be entered into the PrEP register, documenting the client as an initiated and transfer out client with the referral serial number and referred facility noted in the notes section.

▶ Complete the national referral tool with the following information:

• PrEP initiation date

• Results of baseline laboratory tests

• Contact information of a healthcare worker that can support any follow up questions.

▶ Provide the client with the national referral tool and an appointment card for the next scheduled visit.

▶ When the client comes for their 1 month visit in the receiving facility; record as a transfer in and the referral serial number and referring organization/clinic should be noted in the notes section.

▶ Follow up with clinic after 3 days of the scheduled 1 month visit to see if client came to the appointment.

▶ If client has attended the scheduled appointment the client has successfully been linked to the clinic.

▶ If the client has not attended the scheduled appointment the client will need continued follow up and documentation of status in the Community Outreach Provider PrEP register (STOP, LTFU, etc).

▶ Utilize a provider specific PrEP register.

▶ PrEP reporting will be done monthly through existing regional reporting structures.

▶ Order PrEP commodities from Central Medical Store (CMS) following MOH policies and procedures.

▶ Ordering, storage and reconciliation of PrEP commodities will be done as part of routine CMS ordering and standard operating procedures.

2. Community outreach provider PrEP initiations and refills

▶ Provide PrEP services monthly at the same outreach location to ensure clients can receive their refills. A three-month schedule will be available to support refill appointments.

▶ Record initiated client in the PrEP register.

▶ Provide the client with an appointment card for the next scheduled visit.

▶ The appointment card should include all relevant information that might be needed for the client who may need to access a healthcare worker due to side effects or other PrEP related issues between visits.

▶ Utilize a PrEP register specific to that provider.

▶ PrEP reporting will be done monthly through existing regional reporting structures.

▶ Order PrEP commodities from CMS following MOH policies and procedures.

▶ Ordering, storage and reconciliation of PrEP commodities will be done as part of routine CMS ordering and standard operating procedures.

Community-based PrEP services

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In the following special scenarios, clients can initiate PrEP with extra considerations and counselling:

Clients on post-exposure prophylaxis (PEP)

▶ If HIV-negative after 28 days of PEP, the client can initiate PrEP. Transition from PEP to PrEP does not need to have an interruption.

Clients previously on PrEP coming for re-initiation

▶ 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 (page 6 and 13).

▶ Enter the client on a new line in the register in the current cohort and indicate that the client is a re-start.

Clients with a hepatitis B infection wanting PrEP

▶ PrEP is not contraindicated in clients with hepatitis B infection; if the HBsAg result is positive, the client can initiate PrEP.

▶ Clients with hepatitis B infection will need monitoring with additional liver function and platelet tests in order to calculate the aminotransferase to platelet ratio index [APRI] score.

▶ Be cautious when stopping PrEP; there is a risk of viral rebound. Check liver function tests when stopping PrEP.

• Consult/refer to medical officer for continued management of hepatitis B infection when stopping PrEP.

▶ Liver function tests should be conducted for clients at baseline, every six months, and when discontinuing PrEP.

Clients with a hepatitis B infection not interested in PrEP

▶ Discuss benefits and limitations of TDF for hepatitis B infection.

▶ Take alanine aminotransferase (ALT), aminotransferase (AST), and platelets to calculate APRI score and assess need for treatment (See pages 107 and 218 of the 2018 Eswatini Integrated HIV Management Guidelines and Eswatini Hepatitis Management Guidelines, respectively.)

▶ Clients with an APRI score greater than 2 should be given treatment for hepatitis B as a priority regardless of their HIV risk.

PrEP and other drug interactions ARV drugs used for PrEP (TDF and 3TC) do not have any known interactions with contraceptive hormones, hormones used for feminization by transgender women, or hormones used for masculinization by transgender men.

There are no known interactions between PrEP medicines and alcohol or recreational drugs.

However, 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 behavior change with the client.

See 2018 Eswatini Integrated HIV Management Guidelines for further guidance on potential drug interactions with TDF and 3TC.

APRI score calculation

AST level

AST upper limit of normal

Platelet count (109/L)

APRI=

x 100( )

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Key counselling messages

Education and counselling Education and counselling for clients considering PrEP, or clients already on PrEP, are important to ensure the drugs’ effective use.

PrEP counselling should:

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

▶ Recognize that behavior 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.

▶ Include the messages outlined in Table 2.

TOPIC KEY MESSAGES

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

PrEP works if taken as prescribed

For PrEP to be effective, it must be taken every day and for 28 days after the last exposure.

If you miss a dose, you must take PrEP as soon as you remember, and continue to take daily as before.

PrEP is not for life You should take PrEP for as long as you are at substantial risk for HIV infection.

Some clients may have intermittent need for PrEP while others have an ongoing need.

Starting and Stopping PrEP Seven 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:

• Adopting safer sexual practices, including consistent condom use

• When an HIV-positive partner in a serodiscordant couple has been on effective ART for six months, has an undetectable viral load, and remains adherent

• Receiving voluntary medical male circumcision

Clients are strongly encouraged to visit the clinic to formally stop PrEP to allow for a final HIV test to confirm HIV status.

Ways to support adherence 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 without fail. For example, you could take PrEP when you brush your teeth (either in the morning or evening).

PrEP and alcohol or recreational drugs

There are no PrEP interactions with recreational drugs or alcohol. (Emphasize adherence and pill-taking reminders.)

Table 2. Counselling and education for clients about PrEP

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TOPIC KEY MESSAGES

PrEP, pregnancy, and breast-feeding

Pregnancy is not a contraindication for PrEP.

You can use PrEP throughout pregnancy and breastfeeding. (Assess family planning needs and offer as appropriate.)

PrEP does not prevent pregnancy.

(Offer PrEP to pregnant women at high risk of HIV as a priority after all the risks and benefits have been explained to the client.)

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

No STI protection other than HIV

PrEP does not prevent any other STIs. Condoms used in every act of sexual intercourse provide protection against many of these infections.

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

• Gastrointestinal symptoms (diarrhea and nausea, decreased appetite, abdominal cramping, and flatulence)

• Dizziness

• Headaches

Most of those symptoms will disappear within one month. However, your healthcare worker 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).

Examples of good counselling messages:

“You’ve decided to use PrEP as a way to protect yourself and that’s great.”

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

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

“I’m here to help by working with you to figure out a way to make taking your pills easier so that you get the most protection you can.”

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, which is most effective when nonprejudicial and client-centred, can be provided by any trained healthcare worker and should:

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▶ Explore the 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. Healthcare workers 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.

AT SCHEDULED FOLLOW-UP VISITS:

• Confirm HIV-negative status (if positive, refer for ART).

• If there are signs or symptoms of AHI at any follow-up visit, continue PrEP while waiting for test results.

• Provide risk reduction counselling.

• Provide adherence assessment and counselling. Identify possible barriers to good adherence.

• If adherence has been good, issue appropriate supply of PrEP medication.

• If adherence has been poor, identify barriers to good adherence and provide support as appropriate. Emphasize the limitations of PrEP if not taken daily and discuss other prevention methods.

• Assess tolerability, side effects, and effective use.

• Actively manage side effects.

• Assess for pregnancy status.

• Assess need for contraceptives.

• Provide STI screening and treatment.

• Review baseline laboratory results (if not done previously).

• Provide appropriate refill. Refills can be provided by Registered Nurse, Medical Officer and Nursing Assistants trained on PrEP.

• Schedule next visit.

Client follow-up

Clients are asked to see a provider for regular follow-up visits one month after initiation, three months after initiation, and then every three months thereafter. Follow up visits can be done by nurse assistants, registered nurses and MOs with support from HTS counsellor, ECs, Phlebotomists and M2Ms. Table 3 outlines the procedures for each of those visits. PrEP follow-up visits (and refills) should be aligned and integrated with any existing services being received at the clinic (e.g. Antenatal care (ANC) or Family Planning (FP)).

Table 3. Client follow up visit procedures

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Stopping 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, behaviors, and ability to adhere to PrEP.

Healthcare 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.

Be sure to:

▶ Explore risks and alternative prevention/risk reduction strategies.

▶ Advise client that an HIV test is required to re-start PrEP.

▶ Remind client that PrEP should be continued for 28 days after the last risky exposure.

▶ Encourage ongoing links to appropriate HIV prevention services and contraceptive services, as well as the use of other HIV prevention strategies, as needed.

▶ See also “Clients with a hepatitis B infection wanting PrEP” (page 10).

Re-starting PrEP Advise clients that, at a minimum, an HIV test is required before re-starting PrEP.

Clients that miss more than seven days are treated as a “re-start”. Providers should follow normal PrEP initiation procedures. Enter the client on a new line in the register in a new cohort and indicate that the client is a re-start.

Indicate if the clients discontinued PrEP for ≤12 months or >12 months.

Missed appointments:

▶ Follow up with clients that have missed their appointment by more than 3 days to discuss ongoing PrEP needs and to encourage a rescheduled appointment.

▶ Any client that missed PrEP for more than 7 days and wants to continue PrEP should be considered a re-strart.

▶ For clients that do not want to continue PrEP follow Stopping PrEP guidance.

IN ADDITION TO THE ABOVE, CONDUCT THE FOLLOWING:

Provide the client with an appointment reminder 48 hours prior to the scheduled appointment. (optional)

At three months:

• Creatinine clearance test, thereafter annually for clients with normal results.

• Bodyweight (in order to calculate the creatinine clearance)

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

Management of creatinine elevation ▶ Approximately 80 percent of creatinine elevations are self-limiting (without stopping PrEP) and are caused by dehydration, exercise, diet, diabetes mellitus, hypertension, liver failure, or hepatitis C virus or may be a false-positive test result. Rule out and manage other causes of elevated creatinine.

▶ Serum creatinine is not a good marker of kidney function. Calculate creatinine clearance as per Cockcroft-Gault formula see Box 3.

▶ If the calculated creatinine clearance is:

• < 50 ml/min: Stop PrEP and refer to MO immediately.

• 50-60 ml/min: Repeat serum creatinine within two weeks. If repeat sample gives creatinine clearance < 60 ml/min, stop PrEP and consult with MO for further investigation and management.

Management of clients with inconclusive HIV test result during follow-up visit

• Discontinue PrEP.

• Follow the National HIV testing algorithm for clients with an inconclusive result.

• Only after a confirmed HIV negative result, 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).

▶ If a client seroconverts 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).

• Offer ART immediately (as per ART guidelines).

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.

These include nausea and/or vomiting, diarrhea 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 MO 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.

Management of clients in specific situations

Box 3. Cockcroft-Gault creatinine clerance formula

(140 – Age) x weight in kg x 1.23 Serum creatinine (in μmol/L)

(140 – Age) x weight in kg x 1.04 Serum creatinine (in μmol/L)

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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.

▶ Complete the national referral tool and include Client Management Information System number, start date, regimen, date of last HIV test, and other laboratory investigations.

▶ Record outcome as “Transfer Out” in the PrEP register and national referral tool.

▶ Put one copy of referral tool in the facility referral file, send one copy to the receiving facility, and give one copy to the client to take to the receiving facility.

Management of clients transferring in ▶ Place copy of MOH referral tool in the facility referral file.

▶ Indicate original PrEP start date in the PrEP register in the current cohort.

▶ Write original facility in comment section.

▶ Continue with routine PrEP follow up schedule

Documentation and data management

Documentation Documentation of PrEP initiation should be done in the PrEP register and the client PrEP appointment card.

PrEP job aids Job aids (Table 4) are available from the MOH to help providers assess PrEP risk and eligibility.

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TOOL PURPOSE COMMENTS

PrEP intra-facility referral tool

To facilitate movement of clients within the facility, to document that PrEP was offered and to capture priority population(s) of clients.

• Who ever conducts the HIV Risk Assessment questions should then note the priority population on the tool.

PrEP register To monitor PrEP continuation and outcomes of all PrEP clients

• Every client initiating, re-starting, transferring in or out on PrEP should be entered in the PrEP register.

• Record clients’ follow-up HIV testing and PrEP status at 1, 3, 6, 9, 12 months.

• Register will be used to complete monthly summary forms.

PrEP monthly summary form To monitor uptake, continuation and adverse events of PrEP at the facility level

• Complete within five working days of new month.

• Submit to Regional Strategic Information Department to provide feedback to the Region and ENAP.

PrEP client appointment card

To remind client of next appointment date

• Write Facility Name and Client ID

• Write current visit date

• Provide relevant notes/comments

• Indicate next visit date

JOB AID PURPOSE COMMENTS

PrEP risk assessment To identify clients at substantial risk for acquiring HIV infection

• Tool can be used by HTS counsellors or other healthcare workers performing HIV 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 healthcare workers performing counselling on the priority population status

PrEP eligibility assessment To ensure that clients are eligible for PrEP and have no contraindications

• Tool to be used by clinicians for clients identified as being at substantial risk for HIV.

• Checklist to ensure that there are no contraindications for PrEP or reasons to delay PrEP initiation.

PrEP data collection tools The tools outlined in Table 5 are required for facilities providing PrEP.

Table 5. PrEP data collection tools

Table 4. PrEP job aids

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Additional indicators to be collected/tracked and for reporting for community based PrEP initiations:

In addition to the indicators that are collected/ tracked and for reporting at the national scale, custom indicators can and should be established to capture the efforts and work completed at the community level to support PrEP uptake and retention for clients that are not continuing PrEP services at the community outreach post initiation.

PrEP_NEW_LINK: Number of clients who were referred and linked to a facility and were initiated on PrEP at the facility level.

PrEP_CURR_LINK: Number of clients who were initiated at the community level and were referred and linked to a facility for subsequent follow up visits.

HIV negative test result

Assess HIV risk profile and offer HIV combination prevention package

Assess PrEP eligibility criteria

Counsel on benefits and limitations of PrEP for clients identified at substantial risk and accepting PrEP offer

Provide 1 month PrEP drugs and book a follow up appointment in 28 days

• Take baseline HBsAg test

• Confirm HIV negative test (if not tested on initiation day)

• Same day PrEP initiation

Client has no risk factors for abnormal kidney function

Client has risk factors for abnormal kidney function

(Age >50, HPT, DM, Low BMI < 18.5, Other nephrotoxic medication, any symptoms or signs suggestive of renal impairment)

Take serum creatinine test

Book a follow up appointment for when creatinine results are expected to be available.

Calculated CrCl ≥ 60 ml/min

Calculated CrCl cl < 60 ml/min

• Do not initiate PrEP

• Discuss and offer other HIV prevention methods

• Repeat serum creatinine test and re-assess in 2-4 weeks

Annex: Algorithm for PrEP initiation