Addendum: INITIATION AND CLINICAL MANAGEMENT OF ORAL PrEP Note: AGYW should follow the same procedures for initiation, follow-up, and maintenance as adults. This has been provided as an optional module. Version: August 2018 Outline of training Module 1: Introduction to oral PrEP PrEP: the basics What is combination prevention? How effective is oral PrEP? What are the differences among PrEP, PEP, and ART? Overview of country-specific guidelines Module 4: Oral PrEP provision for AGYW: getting started Generating demand: reaching AGYW Risk assessments Addressing myths, misconceptions, and fears Factors influencing decisions to initiate or stay on oral PrEP Key issues to discuss with AGYW in relation to PrEP

Module 2: The provision of oral PrEP in the context of AGYW Why oral PrEP for AGYW? Adolescence: a dynamic time of change and transition Providing oral PrEP in the context of adolescent- and youthfriendly services Checking in with ourselves: our personal views and values about AGYW and oral PrEP Unpacking youth-friendly services Module 5: Monitoring, follow-up, and adherence support for AGYW on oral PrEP Promoting adherence and retention for AGYW using oral PrEP Frequently asked questions Module 3: Important factors to consider when providing oral PrEP to AGYW Combination prevention: related services and entry points to PrEP Gathering the evidence: what have we learned about oral PrEP and AGYW? Module 6: Wrapping up Key take-home messages

Resources for providing oral PrEP to AGYW Addendum: Initiation and clinical management of oral PrEP 2 Overview of oral PrEP initiation pathway National HIV Testing Algorithm* Rapid HIV Screening Test HIV Reactive HIV Non-Reactive Rapid HIV Confirmation Test HIV Positive Treatment HIV Negative

HIV Combination Prevention Condoms Oral PrEP Counselling PEP Healthy lifestyles Treatment for STIs Medical male circumcision ART for partners living with HIV 1. 2. 3.

4. Screening Initiation Follow-up Maintenan ce 3 Clinical management a holistic approach Clinical management of oral PrEP needs to be combined with: Clear information about effective use Counselling and ongoing, individualised support need to be provided Concerns and questions need to be addressed A balanced approach to the management of reported side effects 4

Screening visit Screening Oral PrEP initiation One-month follow-up Maintenance visits Educate on risks and benefits of oral PrEP Assess risk and eligibility Screen for HCT/creatinine/HBV/STIs/pregnancy * Provide additional SRH services with a focus on contraception/condoms/lubrication Arrange follow-up 5 Eligibility for oral PrEP* Eligibility criteria include:

# HIV seronegativity No suspicion of acute HIV infection# Substantial risk of HIV infection Creatinine clearance (eGFR) >60mL/min Willingness to use oral PrEP as prescribed Signs of acute HIV infection include rash, fever, chills, headache, fatigue, sore throat, night sweats, loss of appetite, muscle/joint pain, and other symptoms. 6 Required baseline investigations (country-specific)* 7 Oral PrEP initiation Screening Oral PrEP initiation One-month follow-up Maintenance visits HCT

Oral PrEP side effects Acute HIV infection Bone health Effective use of PrEP Eligibility (e.g., labs and CrCl)* HBV vaccination STI treatment Education Follow-up date TDF/FTC for one month Contraception / condoms/ lubricant

8 HIV screening Test for HIV at screening for oral PrEP (4th generation rapid test) Assess for acute HIV infection (signs and symptoms) Suspect acute HIV Delay PrEP initiation (24 weeks) Retest with rapid HIV test after 24 weeks if symptoms have subsided 9 Creatinine and Hepatitis B Creatinine: Hepatitis B: Excretion via glomerular filtration and active tubular secretion Creatinine clearance >60mL/min (CockroftGault) If CrCl <60 mL/min

Oral PrEP is not contraindicated, but viral rebound may occur when PrEP is stopped No oral PrEP Test for HBsAg and HBsAb Provide HBV vaccine if HBsAg -/HBsAb If Hep B+ and on oral PrEP, offer LFT monitoring and referrals Repeat in 2 weeks; if normal, start PrEP If abnormal, refer 10 STI screening and pregnancy STI screening

History Clinical examination if indicated Treat syndromically according to national guidelines Rapid plasma reagin test (RPR) Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) if resources permit Pregnancy Urine pregnancy or beta-hCG blood test must be negative to initiate PrEP No associated increase in overall birth defects Limited data available for oral PrEP in pregnancy In South Africa, in pregnancy, oral PrEP is considered safe (category B) but should not be used as per SAHPRA (previously known as the MCC) national guidelines* 11 Initial oral PrEP counselling Initial counseling should focus on: Increasing awareness of PrEP as a choice Helping the client decide whether oral PrEP is right for her Preparing individuals for starting oral PrEP Explaining how oral PrEP works

Providing basic recommendations Discussing the importance of adherence and follow-up visits Exploring potential barriers to oral PrEP adherence and ways to overcome these Describing potential oral PrEP side effects Recognising symptoms of acute HIV infection Building a specific plan for oral PrEP Discussing sexual health and harm-reduction measures Explaining the need for repeat clinic visits and repeat blood tests Where available, discussing advantages and linking clients to support groups and pill buddies 12 Oral PrEP effectiveness and counselling During the counseling session, assess client understanding that the protection provided by PrEP is not complete, and does not prevent other STIs or unwanted pregnancies, and therefore PrEP should be used as part of a package of HIV prevention services (inclusive of condoms, lubrication, contraception, risk-reduction counselling, and STI management). Oral PrEP provides high levels of protection in people who take their PrEP medicines regularly. Time is needed to build up protective levels of the drug in the blood and other tissues. Ways to lower risk during this period include adopting safer sexual practices, such as not having vaginal or anal intercourse, or using condoms for all vaginal and anal intercourse. Lead-in and stopping times for oral PrEP should be country-specific.* Lead-in time = 20 days in South Africa (7 days according to WHO and other countries).

Oral PrEP should not be stopped until 28 days after last exposure to HIV. 13 One-month follow-up Screening Oral PrEP initiation One-month follow-up Maintenance visits As per PrEP initiation visit PLUS 3 months of TDF/FTC Follow-up Tolerability/side effects Effective use Contraception/ condoms/ lubricant

Management of side effects * Creatinine clearance 14 Oral PrEP follow-up visits Clients on oral PrEP require regular visits with the health care provider. Programs should decide on the optimal frequency of visits for monitoring oral PrEP use. It is suggested to have a follow-up visit: * one month after initiating oral PrEP. thereafter every 3 months. Outside regular monitoring visits, clients should also consult if they have severe adverse events. 15

Follow-up visit procedures Intervention Schedule following oral PrEP initiation Confirm HIV-negative status Every 3 months Address side effects Provide brief adherence counselling Estimate creatinine * Every visit Every visit At least every 6 months, or more frequently if there is a history of conditions affecting the kidney, such as diabetes or hypertension Provide STI screening, condoms, and contraception as needed Counsel clients regarding symptoms of acute HIV infection, and ask them to come back as soon as possible for evaluation if these symptoms occur

16 Follow-up oral PrEP counselling Follow-up counseling should focus on: Checking in on the clients current context of sexual health The clients desire to remain on oral PrEP and assessment of continued risk Facilitators and barriers to PrEP use Additional non-PrEP-related sexual health protection strategies (e.g., condoms) Dosing requirements for highest protection What to do if a dose is missed Common adherence strategies Reasons for ongoing monitoring while on oral PrEP How to recognise symptoms of acute HIV infection Side effects and management of side effects How to safely discontinue and re-start oral PrEP as appropriate 17 Maintenance visits Screening Oral PrEP initiation One-month follow-up Maintenance visits Repeat procedures done at one month

CrCl at 4-month visit, then every every 3 months for the first year and thereafter every 12 months* 6-month STI screen including urine dipstick and rapid syphilis Complete HBV immunisation at 6 months 18 Drug resistance HIV resistance to oral PrEP is rare and has only been seen when oral PrEP is initiated during unrecognised acute HIV infection. HIV drug resistance can be prevented by not initiating or not re-initiating clients on oral PrEP during acute HIV infection. HIV testing should be accompanied by assessment of HIV exposure, symptom screening, and targeted examination and should be done: Every 3 months If a client has symptoms of viral illness Before a client resumes oral PrEP 19

Side effects Most side effects are minor and self-limiting but need to be taken seriously. They may include gastrointestinal symptoms, headache, and malaise, which can be managed symptomatically and through counselling. Renal toxicity and decreased bone mineral density are rare and reversible after oral PrEP is stopped. Reassurance, encouragement, and support are important. 20 Common side effects In stu di bloati es, mild na ng u repor , and head sea, diarrh te e a than 1 d in the firs che were a,

t i effect n 10 peop month by f le. Th s then ewer e s u e sually http:/ /i-bas stopp side /guide ed. s /prep

/prep -and-s ide-eff ects Guidance: Managing side effects Managed symptomatically and through counselling Symptom Nausea (feeling sick) or vomiting Medication Anti-nausea medication Steps to take

Avoid oily or spicy foods Eat dry foods like toast Sip on black tea Drink water with lemon Diarrhoea (running stomach) Antidiarrheal medication Eat very ripe bananas Avoid milk Drink water that contains salt and sugar Headache Pain killers

Drink lots of water Lie down and put a cold wash rag over your face Massage the base of your skull with your thumbs 22 Guidance: managing side effects Managed symptomatically and through counselling Symptom Medication Steps to take Skin rash Anti-histamines

Use a natural soothing cream, calamine lotion or castor oil Eat small meals regularly Eat foods you like even if you are not hungry Avoid foods that do not have any nutritional value Loss of appetite Dizziness Take your pills before you go to sleep and are lying down. Some people who have nightmares prefer to take their pills in the morning, so their sleep

isnt interrupted. Either way you need to talk to your doctor about this Tiredness Go to sleep at the same time every night and get up at the same time every morning Dont drink alcohol HBV management Risk of viral rebound in undiagnosed chronic HBV if oral PrEP stopped Screen for HBsAg and HBsAb HBV vaccination if HBsAg-/HBsAbOral PrEP not contraindicated in HBV infection; requires additional LFT

monitoring Check LFT after stopping oral PrEP in chronic HBV 24 Cycling on and off PrEP* PrEP is not a lifelong drug-taking intervention. People can cycle off PrEP. This is NOT non-adherence. This needs to be taken into account in users who stop and start PrEP according to their periods of risk. Oral PrEP medications should be continued for 28 days after the last potential HIV exposure in those wanting to cycle off oral PrEP. What do we need to consider for AGYW and cycling on and off?

Times for lead-in: Risk via anal sex: need 7 days of daily dosing with oral PrEP to reach adequate anal/rectal tissue levels. Risk via vaginal sex: need 20 days (or according to national or study/protocol guidelines) of daily dosing with oral PrEP to achieve protective vaginal tissue levels. During this period, other protective precautions, such as abstinence or condoms, must be used. 25 Reasons and processes for stopping oral PrEP Reasons to stop oral PrEP: Positive HIV test Request of user Safety concerns (e.g., creatinine clearance <60 mL/min) Risks outweigh benefits

If a client decides to stop oral PrEP: Explore risk and alternative prevention/risk-reduction strategies with her. Advise the client that an HIV test will be required to reinitiate oral PrEP. Oral PrEP needs to be used for 28 days after last exposure to HIV. Oral PrEP in pregnancy: guidelines vary* TDF appears to be safe in pregnant women. However, evidence comes from studies of HIV-infected women on ART. Among HIV-uninfected pregnant women, evidence of TDF safety comes from studies of HBV mono-infected women. PrEP benefits for women at high risk of HIV acquisition appear to outweigh any risks observed to date. WHO recommends continuing oral PrEP during pregnancy and breastfeeding for women at substantial risk of HIV. There is, however, a need for continued surveillance for this population group. Note: South African guidelines do not yet recommend providing oral PrEP during pregnancy and breastfeeding.

27 Acknowledgements This training package was developed by the OPTIONS Consortium. If you adapt the slides, please acknowledge the source: Suggested citation: OPTIONS Provider Training Package: Effective Delivery of Oral Preexposure Prophylaxis for Adolescent Girls and Young Women . OPTIONS Consortium, August 2018. (download date) This program is made possible by the generous assistance from the American people through the U.S. Agency for International Development (USAID) in partnership with PEPFAR under the terms of Cooperative Agreement No. AIDOAA-A-15-00035. The contents do not necessarily reflect the views of USAID or the United States Government. OPTIONS Consortium Partners 28

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