PEP for Victims of Sexual Assault

PEP for Victims of Sexual Assault

Introduction

Medical Care Criteria Committee, October 2014

OF NOTE

The preferred PEP regimen for sexual assault is the same as that for other types of non-occupational exposures and occupational exposures: Tenofovir 300 mg PO daily + Emtricitabine 200 mg PO daily Plus Raltegravir 400 mg PO twice daily or Dolutegravir 50 mg PO daily

See PEP for Non-Occupational Exposure to HIV (nPEP) Guideline for regimen considerations when the source is known to be HIV-infected, dose adjustments for patients with renal insufficiency, drug-drug interactions, and recommended alternative regimens.

RECOMMENDATION
Introduction
  • Victims of sexual assault should be treated in an emergency department or equivalent healthcare setting where all appropriate medical resources are available as needed. (A3)

Although infrequent, cases of HIV transmission following sexual assault have been described [Murphy et al. 1989; Myles et al. 2000]. This guideline addresses the unique considerations involved in evaluation, counseling, and support for HIV exposures resulting from sexual assault.

References

Murphy S, Kitchen V, Harris JR, et al. Rape and subsequent seroconversion to HIV. BMJ 1989;299:718. [PubMed]

Myles JE, Hirozawa A, Katz MH, et al. Postexposure prophylaxis for HIV after sexual assault. JAMA 2000;284:1516-1518. [PubMed]

Assessment

Medical Care Criteria Committee, October 2014

RECOMMENDATIONS
Assessment
  • When deciding whether to recommend the initiation of PEP following sexual assault, the clinician should assess and carefully weigh the following factors: (A3)
    • Whether or not a significant exposure has occurred during the assault
    • Knowledge of the HIV status of the alleged assailant
    • Whether the victim is ready and willing to complete the PEP regimen
  • The clinician’s decision to recommend PEP should not be influenced by the geographic location of the assault. (A2)
Degree of Risk Based on Type of Exposure
  • Clinicians should recommend HIV PEP to victims when significant exposure may have occurred, as defined by direct contact of the vagina, penis, anus, or mouth with the semen, vaginal fluids, or blood of the alleged assailant, with or without physical injury, tissue damage, or presence of blood at the site of the assault. (A2)
  • PEP should also be offered in cases when broken skin or mucous membranes of the victim have been in contact with blood, semen, or vaginal fluids from the alleged assailant. Similarly, PEP should be offered in cases of bites that result in visible blood. (A2)
Considering the HIV Status of the Alleged Assailant
  • Unless the identity and HIV status of the alleged assailant have been clearly established to assist with the decision-making, PEP should be promptly initiated and should not be delayed while awaiting test results from the alleged assailant. (A2)
  • Even when the alleged assailant is known to be HIV-infected, the decision to recommend PEP should be based on the nature of the exposure and the victim’s ability to complete the regimen. (A3)
  • If PEP has been initiated and HIV screening tests from the alleged assailant are found to be negative, including rapid test and 3rd- or 4th-generation EIA or HIV RNA assay,* then PEP should be discontinued. Decisions to discontinue PEP should be made in consultation with a clinician experienced in HIV PEP. (B3)

*Testing protocols for alleged assailants are dependent on whether the test results will affect the victim’s completion of PEP (see Defendant Testing Guidance).

Although the seroprevalence of HIV in different New York communities may vary, the HIV status of an individual who has been accused of perpetrating a sexual assault remains unknown until that individual has been tested. It is also important to consider that HIV prevalence in sexual assailants may be higher than that in the general population [Rich et al. 2002]. In the acute setting of sexual assault, the decision to recommend prophylaxis should not be based on the geographic location of the assault but rather on the nature of the exposure during the assault, the readiness of the victim to initiate and adhere to the prophylactic regimen, and the HIV status of the alleged assailant, if known.

Degree of Risk Based on Type of Exposure

Studies of sexual assault show a large range for the incidence of anogenital trauma following assault (20%-85%) [Grossin et al. 2003; Riggs et al. 2000; Sugar et al. 2004; Jones et al. 2003]. The absence of visible trauma does not indicate that an assault did not occur; microabrasions and bruising are common and the appearance of these manifestations following sexual assault may be delayed. Oral trauma may also occur during sexual assault with potential exposure to blood, semen, or vaginal fluids from the alleged assailant, which would carry a potential risk for HIV exposure. Bites or trauma may be inflicted during an assault and are indications for prophylaxis if there is the possibility of contact with blood, semen, or vaginal fluids from the alleged assailant.

Considering the HIV Status of the Alleged Assailant

As of November 1, 2007, New York State Criminal Procedure Law § 210.16 requires testing of criminal defendants indicted for certain felony sex offenses for HIV, upon the request of the victim. For guidance on defendant testing, please visit NYS Court-Ordered HIV Testing of Defendants. Information regarding interpretation of HIV tests, can be found in the CDC’s Recommended Laboratory HIV Testing Algorithm for Serum or Plasma Specimens.

In most instances, the HIV status of the alleged assailant will not be known and cannot be available in sufficient time to influence the decision to initiate PEP. If the HIV status of the alleged assailant is established and confirmed, that knowledge should be used in decisions to initiate or continue PEP, as well as to assist in choosing the PEP regimen if viral resistance data are available.

When the victim knows the alleged assailant personally, assumptions about HIV status or risk should have limited influence on the decision to initiate prophylaxis. Familiarity with the alleged assailant may influence the victim’s perception of risk, which will influence his/her decision to accept PEP. Because HIV risk behaviors and status may be hidden from close friends and family, decisions based on familiarity with the alleged assailant should be made cautiously. It is not possible to know whether an alleged assailant has HIV infection solely on the basis of risk behaviors. Categorical judgments should not be made on the basis of perceived risk. The decision to offer prophylaxis should be based on whether significant exposure has occurred during the assault rather than on the risk behavior of the alleged assailant.

If the alleged assailant has been confirmed to be HIV-infected, HIV-specific information about the source person, including his/her viral load, ART medication history, and history of antiretroviral drug resistance should be obtained to assist in selection of a PEP regimen [Beltrami et al. 2003]. Consultation with a provider with experience with ART is especially recommended when the source person is known to harbor drug-resistant HIV because an alternate PEP regimen may be more effective. However, initiation of the first dose of PEP should not be delayed while awaiting this information.

References

Beltrami EM, Cheingsong R, Heneine WM, et al. Antiretroviral drug resistance in human immunodeficiency virus-infected source patients for occupational exposures to healthcare workers. Infect Control Hosp Epidemiol 2003;24:724-730. [PubMed]

Grossin C, Sibille I, Lorin de la Grandmaison G, et al. Analysis of 418 cases of sexual assault. Forensic Sci Int 2003;131:125-130. [PubMed]

Jones JS, Rossman L, Hartman M, et al. Anogenital injuries in adolescents after consensual sexual intercourse. Acad Emerg Med 2003;10:1378-1383. [PubMed]

Rich JD, Macalino G, Merchant RC, et al. HIV seroprevalence of adult males incarcerated for a sexual offense in Rhode Island, 1994-1999. JAMA 2002;288:164-165. [PubMed]

Riggs N, Houry D, Long G, et al. Analysis of 1,076 cases of sexual assault. Ann Emerg Med 2000;35:358-362. [PubMed]

Sugar NF, Fine DN, Eckert LO. Physical injury after sexual assault: Findings of a large case series. Am J Obstet Gynecol 2004;190:71-76. [PubMed]

Recommending PEP

Medical Care Criteria Committee, updated May 2018

RECOMMENDATIONS
Initiating PEP
  • PEP should be initiated as soon as possible after exposure, ideally within 2 hours. (A2) Decisions regarding initiation of PEP beyond 36 hours post exposure should be made on a case-by-case basis with the realization that diminished efficacy is a consequence of delay in the timing of initiation. (A3)
  • The recommendation for PEP should be communicated simply and clearly to the patient, considering his/her emotional state and ability to comprehend the nature of antiretroviral treatment. (A3)
  • If a sexual assault victim is too distraught to engage in a discussion about PEP or make a decision about whether to initiate prophylaxis at the initial assessment, the clinician should offer a starter pack of medication and make arrangements for a follow-up appointment within 24 hours to further discuss the indications for PEP. (A3)
  • If a sexual assault victim decides to initiate treatment, a follow-up visit should be scheduled within 24 hours to review the decision, evaluate initial drug tolerability, reinforce the need for adherence to the regimen, and arrange for follow-up care. (A3) In New York State, hospitals providing treatment to victims of sexual assault must provide or arrange for an appointment for medical follow-up related to PEP and other care as appropriate.
  • Discussions regarding initiation of PEP should include the following: (A3)
    • Potential benefit, unproven efficacy, and potential toxicity of PEP
    • Duration of PEP regimen
    • Importance of adherence to the treatment regimen to prevent PEP failure or the development of drug resistance should infection occur
    • Need to reduce risk and prevent exposure to others
    • Clinical and laboratory monitoring and follow-up schedule
    • Signs and symptoms of acute HIV infection
NEW YORK STATE LAW

Because evidence indicates the need to begin prophylaxis within hours after an exposure, the clinician is in the position of deciding how strongly to advise the victim to initiate the regimen. This requires the clinician to balance the victim’s readiness with the knowledge that the most efficacious intervention should occur promptly. If a patient is too distraught to engage in discussion, he/she should be encouraged to take a single dose of PEP, and then revisit the issue the following day. The risk of taking one dose is likely to be minimal, and the efficacy that would be lost if delayed a whole day may be salvaged. However, if the victim decides to defer making a decision at the time of the initial intervention, then the follow-up visit to consider PEP should occur within 24 hours of the exposure to ensure that PEP is started within 36 hours of exposure. If the victim is pregnant, a full discussion of the benefits and risks of prophylaxis for both maternal and fetal health should occur. Preliminary results from an ongoing observational study reported increased risk of neural tube defects in babies born to mothers were taking dolutegravir (DTG)-based antiretroviral (ARV) drug regimens at the time of conception [AIDSinfo 2018; FDA 2018]. For exposed individuals who are or could become pregnant, or who are not using effective contraception, DTG-containing regimens should be avoided until more data are available. If there are no alternatives for DTG for those of childbearing age, clinicians should strongly advise the use of effective contraception and should obtain a pregnancy test before initiating treatment (see NYSDOH AI: PEP for Non-Occupational Exposure to HIV (nPEP) Guideline > nPEP for HIV-Exposed Women Who Are Pregnant or Breastfeeding for drugs to avoid in exposed individuals who are pregnant or breastfeeding).

Payment Methods for PEP Following Sexual Assault

PEP PAYMENT METHODS
Various payment methods for PEP are available for victims of sexual assault, including Medicaid, Medicare, or the NYS Office of Victim Services (OVS). If the individual has prescription drug coverage, third-party reimbursement may cover nPEP, depending on the plan’s prescription drug policy. In cases where the medication-dispensing facility does not receive reimbursement for these services, such expenses may be included in their annual Institutional Cost Report as part of indigent care costs. Timely initiation of medication is crucial to the success of nPEP, and amendments to New York State Public Health Law, Chapter 39, Section 2805-i, effective November 27, 2012, require hospitals providing treatment to victims of sexual assault to have 7-day starter packs available on-site.

Provider reimbursement under the OVS Forensic Rape Exam Direct Reimbursement Program is intended to cover the forensic examiner’s services, including pharmaceuticals related to a sexual assault forensic examination. This reimbursement may include the cost of the initial 7-day starter pack of nPEP if the provider determines a risk of exposure. Claim forms for reimbursement under the Direct Reimbursement Program can be found in each Sexual Offense Evidence Collection Kit and can also be downloaded from the OVS website.

Documentation of a visit to a medical facility that provides a forensic physical examination satisfies the OVS reporting requirement, thereby providing victims who are either unwilling or unable to report the crime to the police the opportunity to file a regular compensation claim. Victims of sexual assault may also contact a Rape Crisis Center or Victim Advocate Program in their county or region for assistance in filing regular compensation claims with OVS, particularly when an emergency award is needed from the OVS (see below). Many of these agencies have 24-hour hotlines. For more information and for a list of Victim Advocate Programs and other resources, consult the OVS website.

The OVS has an “emergency award” procedure in addition to its normal compensation process to ensure continued availability of PEP for sexual assault victims beyond the initial 7-day starter pack supply. The process for requesting an emergency award is as follows:

  • Claimant files a regular claim application with the OVS, indicating that medication for HIV post-exposure prophylaxis is necessary and requests an emergency award
  • OVS makes an expedited determination for the purposes of the emergency award
  • If the OVS determines it can grant an emergency award, then OVS directly reimburses pharmacy providers on behalf of the claimant.
References

AIDSinfo. Statement on Potential Safety Signal in Infants Born to Women Taking Dolutegravir from the HHS Antiretroviral Guideline Panels. 2018 May 18. https://aidsinfo.nih.gov/news/2094/statement-on-potential-safety-signal-in-infants-born-to-women-taking-dolutegravir [accessed 2018 May 23]

U.S. Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq). 2018 May 18. https://www.fda.gov/Drugs/DrugSafety/ucm608112.htm [accessed 2018 May 23]

HIV Testing

Medical Care Criteria Committee, October 2014

RECOMMENDATIONS
HIV Testing of the HIV-Exposed Victim
  • Clinicians should perform baseline rapid HIV testing of the victim. PEP should be initiated without waiting for the results of the HIV test. (A3)
  • Refusal to undergo baseline testing should not preclude initiation of PEP. (A3)

Baseline HIV testing of the victim identifies individuals who were already infected with HIV at the time of presentation. This allows decisions to be made regarding the initiation of ART to treat established HIV infection rather than PEP to prevent it (see NYSDOH AI: When to Initiate ART Guideline). However, the PEP regimen should not be discontinued until the positive result is repeated with a supplementary assay.

If the victim prefers not to undergo HIV testing in the emergency department setting, a referral should be arranged to obtain HIV testing the next day. If excess blood is remaining from blood specimens obtained in the emergency department for other reasons, it may be used for HIV testing later, but only if informed consent has been obtained. A potential consequence of initiating PEP without baseline HIV testing in the context of sexual assault is the inability to subsequently establish that the assault resulted in HIV transmission, should the victim later test positive for HIV.

The emergency department provider should obtain the HIV test; however, with agreement of all parties, this responsibility may be transferred to the treating provider or primary care provider. If the victim is being treated with PEP, this responsibility should be coordinated with the treating provider, who may need to discuss long-term treatment options with the victim should he/she seroconvert. If the victim is not under the care of a primary care clinician, the emergency department provider who has obtained the test is responsible for ensuring that the result is promptly communicated to the victim.

KEY POINT
  • A negative baseline HIV test only demonstrates that the victim was not previously infected with HIV before the exposure occurred; the baseline HIV test cannot determine whether the victim was infected as a result of the assault for which he/she is presenting.

STIs Other Than HIV and Emergency Contraception

Medical Care Criteria Committee, October 2014

RECOMMENDATION
PEP for STIs Other Than HIV
  • For sexual assault victims, clinicians should offer prophylactic medication to prevent gonococcal and chlamydial infections. Routine baseline testing for STIs is not recommended in cases of sexual assault. (A3)
Pregnancy Testing 
  • Clinicians should obtain baseline pregnancy testing for sexual assault victims who are of childbearing age. (A2)
Emergency Contraception
  • Emergency contraception should be discussed and offered to individuals who could become pregnant as a result of the assault. (A2)

In cases of sexual assault, all patients are offered prophylactic medication to prevent gonorrhea and chlamydia infection given the high rates of infection after assault [Reynolds et al. 2000]. Trichomoniasis and bacterial vaginosis can be diagnosed or excluded in the emergency department if microscopy is available; otherwise empiric treatment should be administered. Routine testing for gonorrhea, chlamydia, and syphilis is not recommended at the initial exam in the setting of sexual assault because results of that testing would determine whether the patient had an STI prior to the assault. This information can be used to bias a jury against a victim in court [NYSDOH 2008].

Emergency Contraception

Emergency contraception for patients who could become pregnant should be initiated within 72 hours of the exposure to be effective; optimally, pregnancy prophylaxis should be initiated within 12 hours of the exposure. The following websites offer more information about the use of emergency contraception:

References

New York State Department of Health (NYSDOH). Protocol for the Acute Care of the Adult Patient Reporting Sexual Assault, revised 10/08.

Reynolds MW, Peipert JF, Collins B. Epidemiologic issues of sexually transmitted diseases in sexual assault victims. Obstet Gynecol Surv 2000;55:51-57. [PubMed]

Role of the Rape Crisis Advocate and Sexual Assault Examiner

Medical Care Criteria Committee, October 2014

RECOMMENDATION
Planning for Follow-Up
  • The plan for follow-up care should be discussed with the rape crisis advocate or an outreach worker who will be working with the victim following the victim’s departure from the emergency department or equivalent healthcare setting. (A3)

New York State Public Health Law 2805-i requires that hospitals providing treatment to victims of sexual assault advise the victim of the availability of services provided by the local rape crisis or victim assistance organization and secure such services as requested by the patient. The primary role of the rape crisis advocate is to provide the victim with emotional support, advocacy, information, counseling, and accompaniment services, and to facilitate informed decision-making at a time when the victim may be in crisis. Advocates do not provide health care or collect evidence; they can, however, enhance the efforts of healthcare staff through the provision of information regarding medical and legal options.

The initial response a victim of rape or sexual assault receives when seeking health care or reporting the crime has a profound influence on that individual’s subsequent recovery. The use of healthcare practitioners known as Sexual Assault Forensic Examiners (SAFE) has helped improve the care that victims receive. The NYSDOH certifies all appropriately qualified individuals as SAFEs. A SAFE is a specially trained registered nurse, nurse practitioner, physician, or physician’s assistant.

Public Health Law requires that all SAFE Centers of Excellence have a SAFE either available on-site or on-call within 60 minutes of the victim’s arriving at the hospital, except under exigent circumstances [New York State Public Health Law 2001]. In New York State, the standard of care for rape and sexual assault victims presenting at healthcare settings is comprised of comprehensive and high-quality medical care, collection of forensic evidence, and respectful and sensitive treatment. The NYSDOH recommends the use of SAFEs in all hospitals to assist in meeting this standard. The SAFE should be an active participant in the discussion regarding the initiation of HIV PEP. SAFEs help to ensure the best medical, legal, and psychological outcomes for the adult victim of sexual assault and provide compassionate emotional support. They are trained to provide care to victims of sexual assault and to collect and preserve forensic evidence to support prosecution, if the victim decides to report the crime to law enforcement.

The treating clinician, preferably a SAFE, should coordinate care to encourage medical follow-up and adherence to PEP. The rape crisis advocate may become the crucial link between the victim and the provider, clarifying communication and facilitating follow-up care for the victim. When the victim does not have a primary care provider or has difficulty arranging access to a clinician experienced in HIV PEP, this link becomes especially important. Support from the advocate will increase the likelihood that the individual will adhere to the PEP regimen and that the primary care provider, PEP prescriber, or SAFE will be notified of medical problems. The advocate can also ensure that problems are addressed expeditiously as they arise.

See NYSDOH Sexual Assault Forensic Examiner (SAFE) Program for more information about the SAFE programs in New York State. For information about rape crisis services, see NYSDOH Rape Crisis and Sexual Violence Prevention Program

RESOURCE: RAPE CRISIS AND SEXUAL ASSAULT VIOLENCE PREVENTION PROGRAM

The Rape Crisis and Sexual Violence Prevention Program is the only New York State agency-sponsored program that focuses on sexual assault prevention and treatment for survivors of sexual assault. Located within the Bureau of Women’s Health, the Rape Crisis and Sexual Violence Program’s mission is to support activities to prevent sexual assault and to ensure that services are available, accessible, and appropriate for sexual assault survivors.

The Rape Crisis and Sexual Violence Prevention Program is committed to improving New York State’s response to sexual assault survivors through advocacy, policy development, and coordination and oversight of a statewide network of rape crisis service providers. Technical assistance on sexual assault issues is provided within the NYSDOH, with other State agencies, healthcare facilities, and professional organizations.

The Rape Crisis and Sexual Violence Program is available at: www.health.ny.gov/prevention/sexual_violence/

Reference

New York State Public Health Law, Article 28 – § 2805-i. Treatment of sexual offense victims and maintenance of evidence in a sexual offense. February 2001.

Appendix: Sexual Assault Forensic Examiner (SAFE) Program

December 2018

In 2001, the Sexual Assault Reform Act significantly expanded the New York State (NYS) Department of Health’s (DOH) role in addressing sexual assault by establishing the Sexual Assault Forensic Examiner (SAFE) Program. Under the SAFE Program, the DOH is responsible for establishing standards to certify three distinct program components: sexual assault forensic examiners, hospitals, and training sites. The goals of the SAFE Program are to:

  • Ensure sexual assault victims are provided with competent, compassionate, and prompt medical care.
  • Provide the most advanced technology for collection and preservation of DNA and forensic evidence.
  • Increase the successful prosecution of sex offenders when victims choose to report the crime to law enforcement.

New York Sexual Assault Forensic Examiners (NYSAFE)

A sexual assault medical forensic examination can be performed by any registered nurse, nurse practitioner, physician’s assistant, or physician in any NYS hospital emergency department. In NYS, an increasing number of hospitals are utilizing sexual assault nurse examiners (SANEs) or sexual assault forensic examiners (SAFEs) who have been trained to perform a sexual assault medical forensic examination using a victim-centered approach.

To become an NYSAFE, applicants must:

  • Be licensed in NYS as a nurse, nurse practitioner, physician’s assistant, or physician.
  • Have at least 1 year of full-time post-graduate clinical experience.
  • Complete a 40-hour didactic and clinical training program conducted by a DOH- or International Association of Forensic Nurses-approved SAFE training program.
  • Complete a competency-based preceptorship.
  • Complete and provide documentation of 15 hours of continuing education in the field of forensic science for recertification every 3 years.

SAFE Designated Hospitals Programs

DOH-designated SAFE Hospital Programs provide specialized care to sexual assault patients by utilizing NYSAFEs who are on call 24 hours per day. NYSAFE programs are required to make available a private room with access to a shower for forensic examination services, establish an organized program with a designated program coordinator, and participate on an interdisciplinary task force. All SAFE Hospital Programs report de-identified quarterly data to DOH on sexual assault victims seen in the emergency department.

Qualifying hospitals licensed under Article 28 of the Public Health Law seeking SAFE designation can apply to DOH at any time. Once approved, a provider agreement with DOH obligates all hospitals to provide services consistent with SAFE Program requirements (10 New York Codes, Rules, and Regulations § 722).

DOH-Certified SAFE Training Sites

DOH-certified SAFE Training Sites are essential for any DOH-designated Hospital Program to establish a cohort of medical professionals who are prepared to conduct sexual assault medical forensic examinations, collect and preserve evidence, and provide testimony in the prosecution of sexual assault cases. To meet the minimum demonstrable standards and requirements and obtain a DOH certificate of qualifications, practitioners must typically complete a 40-hour didactic and clinical training course provided by the hospital program.

Visit NYSDOH Sexual Assault Forensic Examiner Program for more information, or contact:

New York State Department of Health
Bureau of Women, Infant and Adolescent Health – SAFE Program
Corning Tower, Rm. 821
ESP, Albany NY 12237
518-474-0535
Email:  rcprpt@health.ny.gov

All Recommendations

Medical Care Criteria Committee, October 2014

Dolutegravir (DTG) Safety Statement, updated March 20, 2019

On December 7, 2018, the DHHS Guidelines Panel issued an update to its prior statement in response to preliminary results from a study that reported increased risk of NTD in babies born to mothers taking DTG-based ART at the time of conception. 

Updated data are pending and expected to be released in 2019. Until that time, the Panel’s conservative, interim recommendations remain that DTG-containing regimens should be avoided in the first trimester of pregnancy or in any HIV-exposed individual who may become pregnant. If there are no alternatives to use of DTG for individuals of child-bearing potential, then clinicians should strongly advise the use of effective contraception and should obtain a pregnancy test before initiating treatment.

For pregnant women already taking DTG who present to care in the first trimester of pregnancy, patient-centered counseling should address the risks and benefits of continuing DTG or switching regimens and include the following information:

  • The importance of accurate gestational dating as neural tube development is complete by 28 days post-conception or 6 weeks after the first day of the last menstrual period.
  • NTD may have already occurred, and the added risk in the remaining weeks of the first trimester may be slight.
  • A background risk of NTD ranging from 0.05% to 01% exists for all pregnancy regardless of HIV status or antiretroviral treatment.
  • Changing ART regimens in pregnancy is often associated with viral rebound that may increase the risk of perinatal HIV transmission.

DTG remains a preferred agent for use in women after the first trimester of pregnancy. Individuals who continue use of DTG after delivery should be counseled regarding possible risk in future pregnancies and should be offered effective, ongoing contraception options.  

For more information, see: DHHS Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States

ALL RECOMMENDATIONS: PEP FOR VICTIMS OF SEXUAL ASSAULT GUIDELINE
Introduction
  • Victims of sexual assault should be treated in an emergency department or equivalent healthcare setting where all appropriate medical resources are available as needed. (A3)
Assessment
  • When deciding whether to recommend the initiation of PEP following sexual assault, the clinician should assess and carefully weigh the following factors: (A3)
    • Whether or not a significant exposure has occurred during the assault
    • Knowledge of the HIV status of the alleged assailant
    • Whether the victim is ready and willing to complete the PEP regimen
  • The clinician’s decision to recommend PEP should not be influenced by the geographic location of the assault. (A2)
Degree of Risk Based on Type of Exposure
  • Clinicians should recommend HIV PEP to victims when significant exposure may have occurred, as defined by direct contact of the vagina, penis, anus, or mouth with the semen, vaginal fluids, or blood of the alleged assailant, with or without physical injury, tissue damage, or presence of blood at the site of the assault. (A2)
  • PEP should also be offered in cases when broken skin or mucous membranes of the victim have been in contact with blood, semen, or vaginal fluids from the alleged assailant. Similarly, PEP should be offered in cases of bites that result in visible blood. (A2)
Considering the HIV Status of the Alleged Assailant
  • Unless the identity and HIV status of the alleged assailant have been clearly established to assist with the decision-making, PEP should be promptly initiated and should not be delayed while awaiting test results from the alleged assailant. (A2)
  • Even when the alleged assailant is known to be HIV-infected, the decision to recommend PEP should be based on the nature of the exposure and the victim’s ability to complete the regimen. (A3)
  • If PEP has been initiated and HIV screening tests from the alleged assailant are found to be negative, including rapid test and 3rd- or 4th-generation EIA or HIV RNA assay,* then PEP should be discontinued. Decisions to discontinue PEP should be made in consultation with a clinician experienced in HIV PEP. (B3)

*Testing protocols for alleged assailants are dependent on whether the test results will affect the victim’s completion of PEP (see Defendant Testing Guidance).

Initiating PEP
  • PEP should be initiated as soon as possible after exposure, ideally within 2 hours. (A2) Decisions regarding initiation of PEP beyond 36 hours post exposure should be made on a case-by-case basis with the realization that diminished efficacy is a consequence of delay in the timing of initiation. (A3)
  • The recommendation for PEP should be communicated simply and clearly to the patient, considering his/her emotional state and ability to comprehend the nature of antiretroviral treatment. (A3)
  • If a sexual assault victim is too distraught to engage in a discussion about PEP or make a decision about whether to initiate prophylaxis at the initial assessment, the clinician should offer a starter pack of medication and make arrangements for a follow-up appointment within 24 hours to further discuss the indications for PEP. (A3)
  • If a sexual assault victim decides to initiate treatment, a follow-up visit should be scheduled within 24 hours to review the decision, evaluate initial drug tolerability, reinforce the need for adherence to the regimen, and arrange for follow-up care. (A3) In New York State, hospitals providing treatment to victims of sexual assault must provide or arrange for an appointment for medical follow-up related to PEP and other care as appropriate.
  • Discussions regarding initiation of PEP should include the following: (A3)
    • Potential benefit, unproven efficacy, and potential toxicity of PEP
    • Duration of PEP regimen
    • Importance of adherence to the treatment regimen to prevent PEP failure or the development of drug resistance should infection occur
    • Need to reduce risk and prevent exposure to others
    • Clinical and laboratory monitoring and follow-up schedule
    • Signs and symptoms of acute HIV infection
HIV Testing of the HIV-Exposed Victim
  • Clinicians should perform baseline rapid HIV testing of the victim. PEP should be initiated without waiting for the results of the HIV test. (A3)
  • Refusal to undergo baseline testing should not preclude initiation of PEP. (A3)
PEP for STIs Other Than HIV
  • For sexual assault victims, clinicians should offer prophylactic medication to prevent gonococcal and chlamydial infections. Routine baseline testing for STIs is not recommended in cases of sexual assault. (A3)
Pregnancy Testing 
  • Clinicians should obtain baseline pregnancy testing for sexual assault victims who are of childbearing age. (A2)
Emergency Contraception
  • Emergency contraception should be discussed and offered to individuals who could become pregnant as a result of the assault. (A2)
Planning for Follow-Up
  • The plan for follow-up care should be discussed with the rape crisis advocate or an outreach worker who will be working with the victim following the victim’s departure from the emergency department or equivalent healthcare setting. (A3)