1. GUIDELINES FOR HIV POST-EXPOSURE PROPHYLAXIS FOLLOWING SEXUAL ASSAULT
Developed by the New York State Department of Health, AIDS Institute and Rape Crisis

2. Rationale for Sexual Assault PEP Guidelines
HIV may be transmitted through mucous membrane exposure to infected semen or blood during sexual assault
Risk is parallel to occupational exposure through mucous membrane contact
Trauma and STDs enhance HIV transmission
Other probability of infection through sexual exposure, although it varies greatly, appears to be lower than than that of infection through other routes of exposure.

3. Rationale for Sexual Assault PEP Guidelines
Prophylaxis may prevent HIV transmission
Occupational exposure case-control study
Animal data
Perinatal prophylaxis data
Develop consistent standards of clinical practice

4. Parallels to Occupational Exposure
Point source exposure
Non-voluntary exposure
Overall HIV transmission is low

5. Parallels to Occupational Exposure
Risk of exposure is quantifiable if assailant is known to be HIV infected:
per contact transmission probability ranges from
The presence of reproductive tract infections is strongly associated with susceptibility to HIV. The prevalence of genital ulcer disease (chancroid, syphillis, or herpes) is associated with an increased relative risk of HIV infection, ranging from 1.5 to 7.0 in both men and women,
Gonorrhea, chlamydia and trichomonas infections are associated with an increase of 60% to 340% in HIV prevalence in men and women. Bacterial vaginosis and genital ulcer disease may have potentiating effects on the incidence of HIV infection.
Measurement of HIV in genital secretions indicates that HIV infectiousness may be greater in the presence of concurrent reproductive tract infections.

6. Risk of HIV Transmission For Specific Sexual Acts
Estimates of limited available statistics are:
-Unprotected receptive anal intercourse: 8/1,000-32/1,000
-Receptive vaginal intercourse: /10,000-15/10,000
-Insertive vaginal intercourse /10,000-9/10,000
-Insertive anal intercourse /10,000*
There are no risk/episode estimates for oral sex
Mastro, T and de Vincent: Probabilities of sexual HIV-1 Transmission AIDS 1996, 10 (suppl A):S75-82
*Smith, D. The Use of Post-Exposure Therapy to Prevent Non-Occupational Transmission of HIV. CDC Presentation, 1998

7. Parallels to Occupational Exposure
Exposure risk depends on viral load in ejaculate or blood, and nature of exposure
Risk is increased significantly with trauma to mucosal tissue

8. Development of Practice Guidelines: Strengths
Parallels to occupational exposure
Consensus of panel including clinical experts, rape crisis counselors and advocates (NYSCASA)
Benefits of PEP would outweigh potential harm

9. Development of Practice Guidelines: Limitations
No specific scientific evidence to support efficacy
No prospective controlled studies

10. Questions Addressed By The Medical Criteria Committee
Under what circumstances, if any, would rape survivors benefit from HIV PEP?
What is the appropriate timing for initiation of PEP? Is there a time after which PEP would not be indicated or advisable?
Which drugs should be used for prophylaxis?

11. Questions Addressed By The Medical Criteria Committee
How long should therapy be continued?
What is the most reliable diagnostic test for detecting infection?
What other infectious diseases could be prevented through prophylactic treatment following sexual assault?

12. Eligibility Criteria For PEP
Direct contact of vagina, mouth or anus with semen or blood of perpetrator
Tissue damage or presence of blood at site of assault, with or without physical injury

13. Recommendations: Timing of Sexual Assault PEP
Access to prompt treatment in ER or equivalent health care setting with appropriate medical resources
Careful examination of the survivor may be necessary to ascertain whether one of the above factors is present. Studies have shown that genital trauma occurs in nearly two-thirds of rape survivors with anal trauma in slightly over half.
Women who have been anally assaulted often show manifestations of genital trauma. Absence of visible trauma does not indicate that that rape did not occur.
Microabrasions are common; appearance of manifestations may be delayed. Oral trauma may also occur with rape and should be assessed using the same criteria for vaginal or anal assault.

14. Recommendations: Timing of Sexual Assault PEP
PEP should be offered as soon as possible following exposure, preferably within 24 hours
No prophylaxis should be offered beyond 36 hours from exposure

15. Assessment of Survivor
History
Emotional status
Physical exam
HIV status
Readiness for treatment

16. Assessment of Survivor
History:
duration of time since assault
nature of assault
cognitive functioning

17. Assessment of Survivor: Physical Exam
Oral swab should be obtained immediately upon presentation and prior to any oral intake

18. Assessment of the Survivor
Emotional status:
trauma following assault
readiness to consider possible HIV infection immediately following sexual assault
decision-making ability
Support systems:
psychosocial
clinical
education

19. Considering The HIV Status Of The Perpetrator
Recommendations for initiating HIV PEP should not be based on the likelihood of HIV infection in the assailant
If the HIV status is confirmed, it should guide PEP recommendations

20. Initiation of Therapy
The perceived seroprevalence of HIV in a particular geographic location where the assault occurred should not influence the decision to recommend HIV PEP

21. Initiation of Therapy Discussion should include:
potential benefits of prophylaxis
possibility of side effects
nature/duration of treatment and monitoring
importance of adherence/drug resistance
assessment of survivor’s willingness and readiness to begin PEP
Evidence shows the need to begin PEP within hours of exposure. The provider is in the delicate position of deciding how strongly to advise the survivor to initiate the regimen, balancing readiness with the knowledge that the most efficacious intervention must occur promptly.
If the decision to defer recommending PEP is made initially, the follow-up visit to consider PEP should occur within 24 hours

22. Initiation of Therapy If the survivor is pregnant:
full discussion of benefits and risks of PEP for both maternal and fetal health should occur
therapy with certain antiretroviral agents during the first trimester may be associated with fetal toxicity
advise not to breast-feed until a definitive diagnosis has been made
Antiretroviral therapy risks and benefits should be weighed against those of the mother.
Therapy during the later stages of pregnancy may confer additional benefit to prevent perinatal transmission if HIV infection has been transmitted

23. PEP Initiation Regimen recommended: -zidovudine (300 mg BID)
-lamivudine (150 mg BID) nelfinavir (750 mg TID) or -indinavir (800 mg TID)
FOUR WEEK THERAPY

24. PEP Initiation The provider should:
educate the patient about the clinical signs and symptoms of primary HIV infection
instruct him or her to seek immediate medical care from an HIV specialist should they occur
review information the next day whether or not PEP is initiated
review risk reduction

25. PEP Initiation
Practitioners who recommend PEP for sexual assault survivors should ensure that patients have the following:
appropriate arrangements for follow-up care
referral to, or treatment in consultation with an HIV Specialist
monitoring of antiretroviral treatment
repeat diagnostic HIV testing

26. PEP Initiation
In the case of an indeterminate HIV test or in the setting of symptoms suggestive of primary HIV infection (unless the patient is confirmed to be HIV negative), the clinician should continue PEP until a definitive diagnosis is established.

27. PEP Initiation
For patients without insurance or refusing to use insurance, or ineligible for special payment programs, the treating institution has the ethical responsibility for ensuring a timely, uninterrupted supply of medications

28. HIV Testing of Survivor
In New York State, an ELISA test with a confirmatory Western Blot antibody test must be performed in order to confer a diagnosis of HIV infection

29. HIV Testing of Survivor
Baseline HIV serologic testing to be obtained prior to PEP initiation
PEP should be started immediately after serologic testing
Refusal to undergo baseline testing should not preclude initiation of therapy
Confidential HIV testing should be provided by the treating physician

30. HIV Testing of Survivor
Physician performing the test is responsible for:
communicating HIV test result, especially when a primary care physician is unavailable
transferring the results to the treating physician upon agreement from survivor
coordinating treatment with an HIV Specialist

31. HIV Testing of Survivor
Repeat HIV serologic testing should be performed at:
4 weeks
12 weeks
6 months
1 year after assault

32. Rape Crisis Counselors
Should be an active participant in the discussion about prophylaxis management:
critical in providing comfort, assistance and information about the benefits and risks of prophylaxis
convey importance of adherence
facilitate referrals
coordinate consultation with HIV Specialist
Rape crisis counselor is usually a community volunteer:
-is not an employee of the hospital or representative of DOH.
-role in the decision-making process depends solely on the acceptance of the survivor.
-to the extent that this continuing role can be encouraged through the coordinated input of the treating clinician, it should be pursued.
-the rape crisis counselor can become the crucial link between the survivor and the clinician, thus facilitating follow-up care for the survivor.

33. Follow-up Care
Survivors of sexual assault should also be tested for the following:
hepatitis B (vaccine & HBIG should be given)
sexually transmitted diseases : bacterial vaginosis, trichomoniasis, chlamydia, gonorrhea and syphilis (treatment should be given, as appropriate)

34. Follow-up Care Follow-up visit within 24 hrs to review:
PEP regimen
adherence
follow-up care
If prophylaxis was not initiated:
possible initiation of PEP after 24 hours
alternatives

35. Follow-up Care
Management of PEP includes referral to an HIV Specialist
If an HIV Specialist is not in the community, the local primary care provider should consult an HIV Specialist

36. Follow-up Care: Role of The ER Or Urgent Care Clinician
Communicating information to survivor’s primary care provider or designee
Patients without a primary care physician should be referred to HIV Specialists or Centers of Excellence

37. Follow-up Care: Role of Rape Crisis Counselor
Plan for follow-up care should be discussed with rape crisis counselor or outreach worker
Potential continuing contact with survivor
Counselor support will likely enhance:
adherence to prophylaxis
expeditious handling of medical problems
continuity of care

38. Special Considerations
Cost:
Insurance
Crime Victims Board
No mechanism for payment

39. Special Considerations
Drug toxicity
High cost of medications

40. Special Considerations
Education:
Clinicians
Emergency Room Staff
Rape Crisis Counselors
Criminal Justice system
Consumers

41. Institution Responsibility
Ensuring PEP is immediately available
Policy and procedure to ensure efficient and prompt management of PEP for sexual assault
Education of Staff

42. Acknowledgements New York State Department Of Health:
HIV Medical Care Criteria Committee
Rape Crisis Program
New York State Coalition Against Sexual Assault
The New York Hospital of Queens Clinical Education Initiative:
Christine A. Williams, RN, MPH
David S. Rubin, MD