AMPATH Consortium Post-Exposure Prophylaxis (PEP) Protocol for HIV, Hepatitis B and STIs

HIV Exposure: 

Infectious vs Non-Infectious Exposures 

1. Blood, visually bloody body fluids, semen, vaginal secretions, cerebrospinal fluid, peritoneal fluid, pleural fluid, pericardial fluid, synovial fluid, and amniotic fluid are all potentially infectious.
2. Feces, urine, vomitus, nasal secretions, saliva, sputum, sweat, tears, urine are NOT considered to be infectious unless they are visibly bloody.

Needle sticks, lacerations or exposure of non-intact skin (i.e., open wounds, abrasions, chapped skin or areas of dermatitis) 

1. Allow wound to bleed but do not squeeze enough to bruise and do not suck wound
2. Wash the affected area gently with soap and water but do not scrub strongly or use nail brush
3. Inform team leader / supervisor to be evaluated for PEP as soon as exposure occurs (see below)

Mucous Membrane Exposure 

1. Irrigate the affected area (eye, mouth, etc.) with clean water
2. Inform team leader / supervisor to be evaluated for PEP as soon as exposure occurs (see below)

Sexual Exposure 

1. Inform team leader / supervisor to be evaluated for PEP as soon as exposure occurs (see below)

Who to Inform: 

1. The exposed person should immediately contact their Team Leader and/or immediate supervisor
2. If a supervisor other than the Medicine Team Leader is contacted, he/she should then inform either the Medicine Team Leader
3. The Medicine Team Leader will notify the AMPATH Executive Site Director and will discuss the case with long-term faculty with expertise in infectious diseases if needed.
4. In their absence, use the UCSF Clinical Consultation Center for PEP (+1 888 448 4911)
5. The Assistant Director of Education at the IU Center for Global Health will be informed of all details of the incident and be responsible for HIPPA-compliant record keeping.
6. It is the responsibility of the Medicine Team Leader to facilitate the evaluation, treatment and follow-up care for the exposed person, with expert medical consultation from Dr. Adrian Gardner or Dr. Suzanne Goodrich.

Initial Evaluation for HIV PEP: 

Exposed Person 

• Exposed individual should undergo rapid HIV testing immediately after exposure
  • During working hours (M-F, 8AM-5PM) the exposed person should be taken to the AMPATH Voluntary Counseling and Testing (VCT) area where counseling and rapid testing are performed
  • After working hours (nights and weekends), rapid HIV testing should be done by the team leader using the back-up kits stored at IU House
    • The Medicine and Pediatric Team Leader are responsible for ensuring an adequate supply of non-expired back-up HIV testing kits at IU House
• A brief medical history, medication list, and allergies should be obtained from the exposed to ensure no contraindications to ARVs and to tailor the regimen appropriately should there be any potential interactions
• A pregnancy test should be offered to all exposed females. These are kept at IU House.
• ARVs should be started as soon as possible, ideally within 2 hours of exposure, up to 72 hours post-exposure for any of the following exposures listed above.
  • ARVs should be accessed from the Medicine Team Leader’s house
    • ARVs are stored in the IU House Medical Supplies crate kept in Medicine Team Leader’s house and on the bookshelf in the Chandaria Consortium space
    • If no one can access the PEP at IU House, the supply in Chandaria Consortium space on the bookshelf is accessible. It is unlocked during daytime hours and all team leaders and leadership have a key for other times.
    • Back-up ARVs kept at IU House should be obtained from the AMPATH Pharmacy
    • The Medicine and Pediatric Team Leader are responsible for ensuring an adequate supply of non-expired back-up ARVs at IU House
    • The TLs are also responsible for rotating ARVs between IU House and AMPATH pharmacy such that back-up medicines are not allowed to expire and be wasted

Source Patient 

• Rapid HIV testing should be performed on all source patients unless they are known to be HIV positive
  • If source patient is known to be HIV positive (regardless of viral load), and the exposed person is deemed to have an exposure necessitating PEP, then a full course of PEP should be offered
  • Initiation of PEP should not be delayed while awaiting results of HIV testing on the source patient
• If the source patient is HIV positive, further clinical history should be obtained regarding the latest VL and any potential ARV resistance which will guide PEP treatment decisions for the exposed

Clinical Management of HIV PEP: 

Anti-Retroviral Regimen 

• The standard regimen is tenofovir-emtricitabine (Truvada) PLUS dolutegravir
• The regimen should be continued for a full 28 days if the source patient is confirmed positive or status remains unknown
• The full 28-day regimen should be continued even if the source patient is positive but has an undetectable viral load as transmission can still occur
  • If rapid HIV testing on the source patient is negative, and there is no evidence of acute retroviral syndrome, then PEP can be discontinued
  • Expert consultation should be sought for an exposed person who is pregnant or breastfeeding, but initiation of PEP should not be delayed.
• Alternate regimens due to medical contraindications or drug interactions among the exposed, or known source patient resistance patterns, should be tailored on a case-by-case basis under the guidance of Dr. Adrian Gardner, Dr. Suzanne Goodrich, or the UCSF Clinical Consultation Center as detailed above.

Monitoring 

• The exposed person should be given a one-week supply of ARVs at a time, with weekly monitoring visits with the Medicine or Pediatric Team Leader to assess for toxicity.
  • If the exposed person is leaving Kenya within 1 week (i.e., returning to the U.S.) then the full 4-week course should be given along with follow-up instructions
• Blood counts, renal function and liver enzymes should be checked at baseline and 2-week follow-up
  • The Medicine or Pediatric Team Leader should facilitate this testing and retrieval of results at the AMPATH Laboratory
  • Other reliable private labs (e.g., St. Luke’s or Lancet) can be used on the weekends or at the request of the exposed person and the discretion of the Team Leader
  • Awaiting results of baseline laboratory testing should not delay initiation of PEP
• If there any adverse reactions or signs of toxicity, the exposed person should see the Medicine Team Leader immediately and expert consultation from Adrian Gardner or Suzanne Goodrich should be obtained to decide what further monitoring is needed and whether a regimen change is necessary.
• All health information regarding exposed person is kept confidential with the responsible Team Leader and only needed information is disclosed to other personnel (ID specialists, health transport, etc.) as needed for appropriate medical care and follow-up.

Follow-Up 

• The exposed person should have follow-up HIV testing at 6 weeks, 12 weeks and 6 months if the source patient is HIV positive or of unknown status.

Documentation 

• Regardless of the HIV status of the source patient, an email should be written by the Medicine Team Leader, with input from the expert consultants as needed, detailing the following:
  • Demographic details of the exposed
  • Clinical history (PMH, medications, allergies) of the exposed
  • Clinical history of the source patient
  • Date, time and nature of exposure
  • Initial HIV testing results of the exposed
  • Pregnancy status of the exposed (if female)
  • Baseline laboratory results
  • ARV regimen selected, date and time of initiation
  • When PEP was discontinued, and for what reason.
  • Clinical status of exposed at monitoring visits, including laboratory monitoring results
  • Recommendations for future follow-up and testing
  • Contact information of clinician(s) managing PEP in Kenya for follow-up provider in North America.
• The email detailing the above should be sent to Jenny Baenziger, MD from an IU email to her IU email. Internal IU emails are HIPPA-compliant. Jenny Baenziger, MD will file the report in a HIPPA-compliant location. No personally identifying details of the incident will be reported, and no reports will be made except in aggregate.
• A copy of the email should be given to the exposed person to take back home for follow-up care

Sexual Exposure PEP 

• Follow Evaluation, Management, Monitoring and Documentation procedures as outlined above for HIV PEP.
• Consider use of MTRH Rape Crisis Center if sexual assault took place, provide counseling and pursue legal channels if warranted on a case by case basis.
• Emergency contraceptives (“Plan B”) are available for pick-up at the Eldochem pharmacy and for pick-up or delivery at Anchor Pharmacy and should be taken within 72 hours of the sexual contact. Ask for the pill called “T2” or the “emergency pill” at the pharmacy. These are packaged as 2 pills, both should be taken at once
  • Pregnancy testing should be offered
  • Provide empiric treatment for STIs
  • Ceftriaxone 250mg IM or cefixime 400mg PO once
  • Azithromycin 1g PO once or Doxycycline 100mg PO BID for 7 days
  • Benzathine Penicillin 2.4mu IM

Hepatitis B PEP 

• Follow Evaluation, Management, Monitoring and Documentation procedures as outlined above for HIV PEP
• The assumption is that all AMPATH consortium trainees here in a clinical capacity will be immunized against Hepatitis B as that is required for all health care workers in the United States
  • Confirm Hepatitis B immunization status of the exposed person
    • Contact the trainee’s institutional lead to confidentially request immunization records of the exposed person
  • If the exposed person has not received the full Hepatitis B vaccine series, or their status remains unknown, then the following should be done:
    • The source patient should be tested for Hepatitis B with the HBsAg.  If the source patient is HBsAg positive, or unknown, then the exposed should:
      • Receive 1 dose of HBIG (Hepatitis B Immune Globulin) 0.06ml/kg IM
      • This can be sourced from Nairobi at a cost of $184 per dose
      • One dose of the Hepatitis B vaccine as soon as possible after exposure
      • Complete the Hepatitis B vaccine series according to the standard schedule

Cost 

• All costs of PEP will be paid for by the exposed person
  • Individuals are responsible for following up with their own insurance companies for reimbursement.   AMPATH consortium care providers involved in the case can provide documentation and support as needed by the individual and insurance company
  • Fees will be waived on a case by case basis if there are financial barriers
  • Initiation of PEP will not be delayed due to financial considerations

References: 

Updated US Public Health Service Guidelines for the Management of Occupational Exposures to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis. Infect Control Hosp Epidemiol 2013;34(9):875-892

CDC Guidance for Evaluating Health-Care Personnel for Hepatitis B Virus Protection and for Administering Postexposure Management.  MMWR.  December 20, 2013 / 62(RR10);1-19

“WHO recommends dolutegravir as preferred HIV treatment option in all populations.” https://www.who.int/news-room/detail/22-07-2019-who-recommends-dolutegravir-as-preferred-hiv-treatment-option-in-all-populations