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HIV - PROPHYLAXIS FOLLOWING SEXUAL ASSAULT
RECOMMENDATIONS FOR THE STATE OF CALIFORNIA

Prepared by: Urban Community Health of the San Francisco Department of Public Health and The California HIV PEP after Sexual Assault Task Force in conjunction with The California State Office of AIDS

For further information and reprints contact:
Joshua D. Bamberger, MD,
MPH Medical Director, Urban Community Health San Francisco Department of Public Health
101 Grove St., Rm. 407
San Francisco,
CA 94102

Tel: 415-554-2664
Fax: 415-554-2770
E-mail: josh_bamberger@dph.sf.ca.us

Preface
Beginning in October 1997, the San Francisco Department of Public Health, in conjunction with the University of California, San Francisco Division of AIDS, began offering HIV postexposure prophylaxis (PEP) following non-occupational exposure as part of an NIH funded feasibility study. In preparing to offer anti-retroviral therapy and counseling to individuals potentially exposed to HIV following sexual exposure, we were concerned that individuals would attempt to access this service following non-consensual sexual exposure. The non-occupational PEP study was not structured to handle the specific needs of assault survivors. The counseling protocol that we developed for our non-occupational PEP study focused on helping individuals develop skills that would reduce their risk of exposure to HIV. The counseling protocol was not designed to offer the essential post-traumatic and recovery counseling that serves as the cornerstone of medical care for survivors of sexual assault. In order to provide the same level of medical care to survivors of sexual assault as to people potentially exposed to HIV following consensual sex, we trained the Sexual Assault Nurse Examiners (SANEs) of the San Francisco Rape Treatment Center to provide pre- and post-HIV test counseling and HIV PEP to all survivors of sexual assault in San Francisco. Between October 1998 and April 2000, over 200 rape survivors were offered HIV PEP in San Francisco with approximately one third initiating anti-retroviral medications. During that same period of time, we received numerous calls from around the state of California from medical providers and from sexual assault survivors requesting information about HIV PEP after sexual assault. It quickly became clear that each local jurisdiction in California had developed unique policies for PEP after sexual assault.

The California legislature has enacted a series of laws mandating each county to develop protocols providing medical care for survivors of sexual assault. However, the medical services offered vary greatly from county to county. This disparity in services often created challenges for those of us answering calls on the PEP counseling line. Survivors and practitioners who called from San Francisco or Los Angeles were able to access PEP services. However, people who were assaulted in more rural counties did not have access to this service. This disparity in service created an inequity that had little logic and was not based on science but on resources available in local jurisdictions. In an attempt to rectify this disparity in care for survivors of sexual assault in California, the San Francisco Department of Public Health applied for funding support from the State Office of AIDS through the California HIV Planning Group (CHPG) to develop California State Guidelines for HIV PEP after sexual assault. Prior to embarking upon the task to develop statewide guidelines for PEP after sexual assault, we surveyed each county to determine the local policy on PEP after sexual assault. In addition, we collaborated with the Alameda County Sexual Assault Response Team that had collected data on the rate of HIV among convicted sex offenders. We then collected background material from published articles on HIV PEP after occupational exposure and after non-occupational exposure. Particularly, we relied upon the New York State AIDS Institute's document "HIV Prophylaxis Following Sexual Assault: Guidelines for Adults and Adolescents." Finally, upon completion of the background research we assembled a panel of experts, described below, to establish California guidelines. The experts were drawn from a variety of backgrounds and they were expected to be knowledgeable about the issues involved in PEP after sexual assault. The advisory panel met over a one day period. The findings of that meeting are presented below in the form of California guidelines for PEP after sexual assault. The Guidelines below were developed with the goal of providing information and support to providers of sexual assault treatment in California so that HIV PEP can be integrated into the medical care offered to sexual assault survivors throughout the State. These guidelines are intended to be presented to the CHPG Emerging Issues Committee for approval and distribution to providers of post-sexual assault treatment. Joshua Bamberger, MD, MPH August 7, 2000 Medical Director, Urban Community Health San Francisco Department of Public Health

Introduction
In 1998, two out of every 1000 individuals in the United States were raped and 9,777 cases of forcible rape were reported in the State of California. The rate of forcible rape per 100,000 individuals in the State of California was 29.2. The rate ranged from 15.1 in Marin County to 55.8 in Shasta County. The State of California requires every county to provide counseling and medical services for survivors of sexual assault. Most counties utilize volunteer lay advocates to assist survivors with recovery from the trauma of sexual assault and to advocate for survivors negotiating the medical system. Medical care routinely involves screening and testing for sexually transmitted diseases such as gonorrhea, chlamydia and syphilis, as well as collection of forensic evidence. Most survivors choose to initiate criminal proceedings and to file a police report. However, medical services following sexual assault are available whether or not the survivor chooses to involve the criminal justice system. Following sexual assault, among the survivor's primary concerns is the possibility of exposure to sexually transmitted diseases (STDs) from the assailant. In California, because each county maintains autonomy over much of the structure and content of their rape treatment, care providers in each county respond differently to survivors' concerns regarding STDs. One of the major concerns of survivors following the assault is exposure to human immunodeficiency virus (HIV). Despite the fact that HIV transmission is a major concern of survivors, rape treatment providers in California inconsistently offer HIV risk assessment information and counseling for survivors of sexual assault. In San Francisco, a program established in 1997 offering PEP following consensual sexual exposure began receiving requests for PEP in cases in of sexual assault. Thus, while programs were in place that offered PEP to individuals potentially exposed to HIV from either occupational exposure or consensual sexual exposure, no program existed in the State of California that uniformly and routinely offered PEP to survivors of sexual assault. Like occupational exposures, sexual assault exposures occur generally as isolated incidents, unlikely to recur. Because sexual assault is so common in our society, a statewide protocol ensuring quick access to PEP was needed.

Background
Offering Post-Exposure Prophylaxis (PEP) with antiretroviral (ART) medication is the standard of care after occupational exposure to HIV. Since a program began in San Francisco in 1997, the Centers for Disease Control and Prevention have acknowledged that PEP may be offered as a part of post-sexual assault treatment. New York State Health Department has developed recommendations that all survivors of sexual assault be tested for HIV and recommended HIV PEP, despite the unproven efficacy of HIV PEP after sexual exposure. A survey of the 58 counties in California conducted in early 2000 reveals that PEP is not offered after sexual assault in approximately two-thirds of the counties in California. In counties that do offer PEP following sexual assault, policies vary greatly. In 3% of the counties, PEP is routinely offered. In 16% of the counties PEP is offered in cases in which the examiner finds evidence of high risk of exposure. In an additional 7% of the counties, PEP is offered in both high risk situations and when the sexual assault survivor requests PEP. In another 7% of the counties, multiple facilities provided sexual assault services and the PEP policies of each provider differ. The great disparity in availability of PEP in California is due mostly to the lack of information and guidance available to treatment providers. In response to the great variance in policy surrounding offering PEP following sexual assault and to providers' frustration at the lack of guidance in this area, the California State Office of AIDS funded the creation an advisory panel (the "advisory panel") which worked to create statewide standards. The advisory panel (see Appendix A), comprised of HIV specialists, sexual assault treatment providers, AIDS program coordinators, and a representative from a survivor advocacy group, convened on April 10, 2000. The advisory panel created a set of standards based upon current medical knowledge. Though cost and other implementation issues are important factors in the ability to offer PEP throughout the State, the panel was directed to focus on developing medical and counseling standards of HIV PEP after sexual assault. The panel also provided examples of funding and implementation strategies utilized by various county sexual assault treatment providers but recommended that each county develops protocols to address implementation specific to the resources available. A sub-committee of the advisory panel (see Appendix A), comprised of medical HIV experts, established recommendations regarding medications and accompanying safety labs.

Organization of HIV PEP after Sexual Assault Recommendations
The recommendations below are organized in a manner based upon the New York State Guidelines. Each section begins with a simple recommendation that is then followed by the rationale behind that recommendation. The goal of this organizational strategy it to provide a quick guide for individuals providing medical care following sexual assault as well as a comprehensive document supporting the recommendations of the advisory committee.

Offering HIV Prophylaxis Following Sexual Assault In California
Recommendation Regarding Timing: In cases where PEP is appropriate, PEP should be offered as soon as possible to the survivor. In no case should PEP be offered after 72 hours following the assault. It is biologically possible that PEP medications taken soon after exposure to HIV can prevent HIV infection. There is limited evidence available to suggest that antiretroviral medications are efficacious when taken prophylactically. In particular, one study of PEP following occupational exposure to HIV showed an 81% reduction in risk of seroconversion when medications were started, on average, 4 hours after exposure. Animal studies suggest that PEP is most beneficial when taken within 1-2 hours of exposure to HIV. While the animal studies show that PEP is not likely to be effective when initiated later than 24-36 hours following the exposure, and not effective after 72 hours there is no definitive answer as to the interval during which PEP may be beneficial in humans. The advisory panel recommends offering PEP to survivors presenting within 72 hours after the assault. The CDC's Hospital Infections Director has recommended that PEP be initiated within 72 hours for individuals with recent sexual exposure to HIV and the San Francisco's non-occupational PEP service uses 72 hours as its cut-off. In the sexual assault context, given the delay that commonly occurs between assault and medical treatment, the advisory panel recommends setting the cut-off for treatment initiation at the outermost acceptable limit. For individuals that seek out medical care more than 72 hours following the potential exposure to HIV, the advisory group recommends that providers offer HIV antibody testing as well as pre- and post-test counseling. Follow-up testing and counseling is recommended at 8 and 14 weeks. If a survivor tests HIV antibody positive on follow-up testing, appropriate referral to an HIV specialist should be expedited to potentially initiate early intervention treatment. Follow-up testing could be offered as part of primary care follow-up or at a local confidential or anonymous testing site.

Recommendation Regarding Age of Survivor: An individual must be 12 years of age or older in order to be eligible to receive PEP using the following recommendations. A pediatric HIV specialist should be consulted when a child younger than 12 presents with possible exposure to HIV from a sexual assault. Medical providers treat individuals 12 years of age and older for STDs such as gonorrhea, chlamydia and syphilis. The advisory panel recommends that the same age be used as a cut-off for PEP treatment. For individuals less than 12 years old who have potentially been exposed to HIV, a pediatric HIV specialist should be consulted in determining whether treatment with PEP is indicated. For children younger than 12 years old, his or her parent(s) or legal guardian(s) should be contacted and included in the discussion whether to initiate PEP.

Recommendations Regarding Consideration of Act(s) of Assault: When deciding whether to offer PEP, categorize the act of assault into 1 of 3 categories: 1) acts with measurable risk of HIV transmission; 2) acts with possible risk of HIV transmission, or 3) acts with no risk of HIV transmission. Not all acts of assault warrant PEP. Based upon the best available epidemiological data, the risk of contracting HIV from one act of unprotected consensual anal sex with a known HIV positive partner is approximately 0.3 - 5%. The risk of contracting HIV from one act of unprotected consensual vaginal sex with an HIV positive partner is approximately 0.1%. Some acts of assault, however, carry no risk of HIV transmission and, therefore, do not warrant PEP. When deciding whether to offer PEP, categorize the act of assault into 1 of 3 categories: 1. Acts with measurable risk of HIV transmission, including anal penetration, vaginal penetration and injection with a contaminated needle; or 2. Acts with possible risk of HIV transmission, including oral penetration with ejaculation, unknown act, contact with other mucous membrane, victim biting assailant, and assailant with bloody mouth biting victim; or 3. Acts with no risk of HIV transmission, including kissing, digital or object penetration of vagina, mouth or anus, and ejaculation on intact skin.

Recommendations Regarding Consideration of Assailant's HIV Status: As a part of the determination of whether to offer PEP to a survivor, it is necessary to consider the assailant's history. The assailant's HIV status can be divided into 3 categories: 1) known HIV positive assailant; 2) assailant with known or suspected risk factors; and 3) unknown assailant or an assailant with unknown risk factors. Past or present intravenous drug users, commercialcommunity sex workers, men who have sex with men, individuals with multiple sex partners, and individuals with either prior convictions for sexual assault or prior prison incarceration all fall into the high risk category. Because HIV is rarely transmitted by sexual assault in the United States, information concerning potential increased risk of transmission is useful when considered in conjunction with the type of assault and other risk factors. Although the decision whether to initiate PEP cannot be made by solely considering the perpetrators status, the more information known about the details of the assault, the better known the risk of HIV transmission.

Recommendations Regarding Consideration of Other Factors: When deciding whether to offer PEP, consider if any of the following factors were present during the assault: presence of blood; survivor or assailant with a sexual transmitted disease with inflammation such as gonorrhea, chlamydia, herpes, syphilis, bacterial vaginosis, trichomoniasis, etc.; significant trauma to survivor; ejaculation by assailant; multiple assailants or multiple penetrations by assailant(s). The specific circumstances of each assault influence the likelihood of HIV transmission following the assault. The presence of the above factors creates an environment of higher risk of contracting HIV for the survivor. Each additional factor present raises the risk of HIV transmission.

Rationale Behind Recommendations and Language Used.
The literature concerning PEP following occupational exposure, as well as the CDC's recommendations for PEP following occupational exposure, take into account the many details of the exposure. Specifically, the CDC recommendations consider the type of bodily fluid involved in the exposure as well as the route and severity of the exposure. The CDC recommendations also consider the source of the possible exposure and make different recommendations depending on whether the source patient is known to be HIV positive, HIV negative or of unknown serostatus. The CDC suggests that PEP decisions be individualized so as to account for various risk scenarios. The advisory panel bases the recommendations for PEP following sexual assault upon the CDC's recommendations for PEP following occupational exposure, specifically the idea of basing each decision to offer PEP upon the details of each assault. The decision to offer PEP will depend upon the type of assault, the assailant's status and other risks present. The advisory panel's recommendations distinguish between "recommending" PEP and "offering" PEP to survivors. In cases with no apparent risk of HIV transmission, the advisory panel recommends that medical providers not offer PEP to survivors. In these cases, PEP medications have side effects whose harm can outweigh any potential benefit to the survivor. By offering PEP, rather than recommending PEP, to survivors in situations with low but possible risk of HIV transmission, medical providers allow survivors some autonomy over their medical treatment. When the medical provider offers or recommends PEP, the provider should clearly explain the possible benefits and side effects of taking the medications. The provider should also explain the lack of definitive answers regarding the medications' efficacy in preventing HIV transmission. It is plausible that the survivor will not be able to process the information or make a truly informed decision in the stressful post-assault period. Given the short time period following the assault during which the advisory panel recommends starting PEP medications, when a survivor is unable to decide whether to initiate PEP, the provider should encourage the survivor to begin the medications immediately. The survivor may discontinue the medications at any time. It is important to consider PEP medications as one important part of the larger post-assault treatment program. Specialized counseling is another critical aspect of the post-assault treatment.

Quick Guide to Offering HIV PEP

1. Has less than 72 hours passed since the assault occurred?
a. If no, do not offer PEP but recommend baseline and follow-up HIV antibody testing.
b. If yes, continue risk analysis.

2. Is survivor 12 years of age or older?
a. If yes, continue risk analysis.
b. If no, consult pediatric HIV specialist (who must be identified in advance).

3. What is the risk of HIV transmission from the assault?
a. Was the assault one with measurable risk of HIV transmission, such as an assault with anal penetration, vaginal penetration or injection?
b. Was the assault one with possible risk of HIV transmission, such as oral penetration with ejaculation, an assault involving other mucous membranes (eg eyes), an unknown assault, an assault in which the survivor bit the assailant or the assailant with a bloody mouth bit the survivor?
c. Was the assault one with no risk of HIV transmission, such as kissing, object or digital penetration, ejaculation on intact skin or an assault in which a condom was used?
d. What other risk factors were present in the assault, including presence of blood, survivor or perpetrator with STD, significant trauma to survivor; ejaculation by assailant; or multiple penetrations of the survivor?

4. Is the assailant's HIV status known?
a. If known HIV negative, do not offer PEP.
b. If known HIV positive,
* Recommend PEP if assault with measurable risk of HIV transmission has occurred.
* Recommend PEP if assault with possible risk of HIV transmission has occurred and at least one additional risk co-factor was present in assault.
* Offer PEP if assault with possible risk of HIV transmission has occurred with no additional risk co-factors present. * Do not offer PEP for exposures carrying no risk.

5. Does the assailant engage in behaviors that put him/her at risk for contracting HIV?
High risk groups include men who have sex with men, past or present injection drug users, commercial sex workers, individuals with multiple sex partners, individuals with prior convictions for sexual assault, and individuals with a history of prison incarceration.
a. If known or suspected risk factors exist,
* Recommend PEP if assault with measurable risk of HIV transmission has occurred.
* Recommend PEP if assault with possible risk of HIV transmission has occurred and more than one additional risk co-factor was present in assault. * Recommend or offer PEP if assault with possible risk of HIV has occurred and only one additional risk co-factor was present in assault. * Offer PEP if assault with possible risk of HIV transmission has occurred with no additional risk co-factors present. * Do not offer PEP for exposures carrying no risk. b. If assailant is not known and/or if assailant's risk factors are unknown, * Offer PEP if assault with measurable risk of HIV transmission has occurred. * Offer PEP if assault with possible risk of HIV transmission has occurred and more than one additional risk co-factor was present in assault. * Offer PEP if assault with possible risk of HIV has occurred and only one additional risk co-factor was present in assault. * Offer or do not offer PEP if assault with possible risk of HIV transmission has occurred with no additional risk co-factors present. * Do not offer PEP for exposures carrying no risk. Offering PEP After Sexual Assault Act Source Known HIV+ Known or Suspected Risk Factors Unknown Risk Factors or Unknown Assailant Measurable Risk R R O Possible Risk + more than 1 co-factor R R O Possible risk + 1 co-factor R R/O O Possible risk + 0 co-factors O O O/N No risk N N N Key R = Recommend O = Offer N = Do Not Offer Other Considerations Recommendations Regarding Structuring PEP Program Each California county provides rape treatment services at specified hospital(s) (see Appendix B). Given the great diversity in county communities and populations, the structure and hierarchy of post-sexual assault treatment providers vary from county to county. Some counties, particularly the more densely populated counties, employ a dedicated group of Sexual Assault Nurse Examiners (SANE) to conduct the forensic exams. In other counties, Emergency Department Physicians conduct the forensic exams and provide the initial treatment following the assault. When implementing the PEP Following Sexual Assault Program, each counties should identify existing resources in the county, both personnel and monetary. The recommendations do not seek to create one single acceptable structure for post-rape treatment, but rather, to list recommended components of the HIV prevention aspect of the program. Recommendations Regarding Antiretroviral Medications Offered In the vast majority of cases of sexual assault, the HIV status of the assailant is unknown. In this situation, the advisory committee recommends that after a thorough discussion of the possible risks and benefits of PEP, survivors be offered two antiretroviral medications in combination to be given for 28 days of treatment. This recommendation follows the CDC's recommendation for PEP following occupational exposure. The only published study of efficacy of PEP is in the occupational setting and the medication offered was zidovudine alone for 28 days. Since the time of that study, the rate of zidovudine resistance in the community of HIV infected people has risen significantly. Therefore, if PEP is elected, the advisory committee recommends the use of zidovudine in combination with another antiretroviral such as lamivudine. The advisory committee does not routinely recommend the use of a third antiretroviral such as a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor, although there are circumstances where such agents may be indicated. The simplest regimen that meets the goals of providing two nucleoside analog anti-retrovirals, one of which is zidovudine, is zidovudine (300mg) in combination with lamivudine (150mg) in a combination pill (Combivir) to be taken twice a day for 28 days. Dosing of Combivir is twice a day rather than every twelve hours and can be taken with or without food though if it is taken with food it can reduce some of the gastrointestinal side effects. Alternative combinations include lamivudine plus stavudine (40 mg stavudine twice a day for a person weighing >/= 60 kg; 20 mg twice a day for a person weighing < 60 kg; 150 mg lamivudine twice a day for body weight >/= 50 kg, 2mg/kg of body weight twice a day for <50 kg). When the assailant is known to be HIV positive and known to be anti-retroviral experienced, PEP decisions should be made in consultation with an expert in HIV resistance. In principle, a regimen should be offered that provides at least two anti-retrovirals to which the assailant's virus is least likely to be resistant, based on the assailant's antiretroviral treatment and viral load history. In addition, if the assailant is known to be presently taking antiretrovirals and known to have a detectable HIV RNA, three anti-retrovirals (the addition of a protease inhibitor plus/minus a non-nucleoside reverse transcriptase inhibitor) should be offered to the survivor with the regimen tailored to having the greatest theoretical likelihood of being beneficial. Such decisions should not be made without expert consultation. In the majority of cases, if PEP medications are elected, zidovudine (300mg)/lamivudine (150mg) in combination (Combivir) taken twice a day for 28 days is the recommended PEP medication regimen following sexual assault. The California HIV Planning Group wished to emphasize that triple combination therapy is the standard of care for people infected with HIV and the double therapy in this situation is acceptable because it is used to reduce the likelihood of transmission following exposure to HIV not to treat established infection. Survivors who choose to initiate medications should be counseled about the importance of adequate adherence to antiretrovirals. Survivors should be counseled that nausea, fatigue and headache are common side effects of zidovudine/lamivudine. Most side effects result from the zidovudine component of the regimen. Zidovudine can be changed to stavudine if side effects are intolerable. Survivors should seek out care with an identified follow-up provider if these side effects are debilitating rather than discontinue medications prior to completion of the regimen. Only a limited amount of antiretroviral medications should be dispensed/prescribed initially to ensure that the survivor who initiates medications returns to receive HIV antibody results as soon as the antibody results are available. As most hospitals in California can process HIV antibody results in one week, the advisory committee recommends that only 10 days of antiretroviral pills be dispensed initially with the remainder of the 28 days of medications being prescribed/dispensed upon follow-up. Limiting the number of antiretroviral doses dispensed also encourages survivors to return to discuss side effects and adherence with a trained provider and provides opportunity for further post sexual assault counseling. If the unique circumstances of the sexual assault preclude follow-up at the facility where treatment is initiated, the provider of sexual assault treatment should make every effort to identify an appropriate provider to participate in both the counseling and medical follow-up.

Recommendations for Laboratory Examinations
The advisory committee recommends that, other than a baseline HIV antibody test and routine post-sexual assault testing and treatment, no additional laboratory examinations be offered routinely to sexual assault survivors who choose to initiate PEP. After experience among 401 HIV negative individuals who enrolled in a study of PEP after consensual sexual exposure to HIV, very few developed laboratory abnormalities during the course of treatment. In addition, those that did develop anemia or liver enzyme elevations had their laboratory values return to baseline following discontinuation of the medications. A careful medical history should be obtained prior to initiation of HIV PEP. Baseline safety laboratories may be indicated in those with significant medical histories, certain concomitant medications, or current symptoms of systemic illness. The main toxicities of zidovudine are anemia, neutropenia and transaminitis. Stavudine can cause pancreatitis or peripheral neuropathy. Lamivudine is almost never associated with toxicity. If alternative agents are chosen, the provider should ensure they know the drug toxicities and interactions and determine if any baseline labs should be drawn on a case-by-case basis. For people that do develop fatigue, jaundice, anorexia or other potential side effects of antiretroviral medications, they should be appropriately evaluated by experienced providers at the time the symptoms develop. The advisory committee does recommend that all people who initiate PEP medications have a baseline HIV antibody test at the initial post-assault evaluation or soon thereafter. It is much more likely that a sexual assault survivor will be HIV positive from exposures occurring prior to the assault than they will seroconvert from the assault. Therefore, providers of sexual assault treatment must be trained to provide pre and post-test counseling. If the survivor is unable or unwilling to provide adequate consent to be tested for HIV, an HIV test should be offered as soon as possible after the initial encounter. However, initiating PEP medications should not be delayed by pre-test counseling or a survivors reluctance to submit to an HIV antibody test. All survivors of sexual assault who initiate PEP medications should have an HIV antibody test at the time of the initial evaluation. However, initiating PEP medications should not be predicated upon obtaining an HIV antibody test If a survivor is found to have a positive HIV antibody test, PEP medications should be discontinued and the survivor should be referred to an HIV medical specialist for evaluation. Do not continue two-drug therapy in a survivor with a positive antibody test result. Goals related to HIV Issues during Survivor's Initial

Meeting with Treatment Team
While a great deal of information will be exchanged at the initial contact between the assault survivor and the treatment team, the goals of the initial meeting remain well-defined.
1. Assessing the survivor's risk of HIV exposure from the assault.
2. Assisting the survivor to make an informed decision whether to have a baseline HIV antibody test and take the PEP medications.
3. If the survivor opts to take the medications, assisting the individual to begin taking the medications as soon as possible.
4. Assuring that appropriate instructions are provided on dosing, adherence, and side effect management.
5. Arranging for follow-up treatment.

Recommendations for Composition of Treatment Team
The advisory panel recommends providing the survivor with certain helpful information at the survivor's initial presentation following the assault. One individual need not provide each aspect of the information provided. When an individual presents for treatment following an assault, the advisory panel recommends that the treatment team include:
1. An individual able to use the above algorithm to evaluate the risk of HIV transmission given the specific assault details;
2. An individual with prescription-writing ability;
3. An individual who understands, and is able to explain, the risks and benefits of taking anti-HIV medications;
4. An individual who is able to explain the potential short- and long-term side effects of the medications;
5. A consultant who is available for unusual exposure histories and medication recommendations when the assailant's ARV history is known; and
6. An individual who can offer pre- and post- HIV test counseling.

Recommendation for Inclusion of a Rape Crisis Counselor in the Treatment Team
A rape counselor should be present during the entire initial examination and treatment of the assault survivor. The counselor's primary role should be comforting, assisting, providing information to, and advocating for the survivor. The counselor may or may not be someone who is a public health worker. The advisory committee recommends that the counselor be someone outside the public health system who can help coordinate care and assist in decision-making. The counselor can serve as a link between the survivor and other follow-up services.

Recommendations for Treatment Team Training
Any training program to be offered to post-rape treatment teams concerning HIV prophylaxis should include the following:
1. understanding the structure of the advisory panel's protocols;
2. understanding the science behind PEP;
3. understanding the limitations regarding PEP efficacy
4. understanding risks and modes of HIV transmission;
5. understanding the psychological burdens on the survivor and incorporating that understanding into pre and post-test HIV antibody testing;
6. understanding the risks and benefits of HIV medications;
7. understanding the legal issues behind HIV testing of the assailant;
8. understanding symptom management of the medication's potential side effects; and
9. familiarity with agencies to refer survivor to for follow-up medical care and counseling.

Recommendations Regarding Timing of PEP Medications
It is the advisory panel's recommendation that HIV PEP medication be given priority and not be delayed by other medications. When determined desirable, HIV PEP medications should be started as soon as possible following a possible exposure to HIV and should not be started after 72 hours following the assault. The advisory panel recognizes that survivors have numerous concerns following an assault. Medical providers often prescribe numerous medications after the assault, including medications to prevent the transmission of various sexually-transmitted diseases, medication to prevent pregnancy and medication to prevent nausea caused by all of the medications. Furthermore, if the survivor is too overwhelmed by the situation and is therefore unable to make a decision regarding initiating PEP medications, the provider should urge the survivor to initiate the medications. The survivor may stop taking the medications if she/he later decides not to continue with the medications.

Recommendations Regarding Follow-up Care
Follow-up care should be provided by a single designated medical provider. This provider will offer medical care and referrals and will receive and explain HIV test results.

Recommendations for Testing and Treatment of other Sexually Transmitted Diseases
While prevention of HIV transmission is the primary concern of the advisory panel, the panel recommends prophylactic treatment of other sexually transmitted diseases following sexual assault. The survivor should be tested for bacterial vaginosis, trichomoniaisis, chlamydia, gonorrhea, and syphilis. The panel recommends administration of the Hepatitis B vaccine to the survivor following the assault.

Recommendations Regarding Cost of HIV Medications
Recognizing that cost of PEP medications have prevented county rape treatment programs from prescribing HIV PEP medications in the past, the panel recommends that each county seek out the most individually appropriate method of procuring and paying for the medications. Options for sources of payment include county health departments, private donations, Victim Witness, law enforcement, and the survivor's private insurance.

Recommendations Regarding Legal Issues
1. Each county should establish a mechanism for providing HIV PEP outside of the legal system. A survivor should not be denied PEP medications if he/she does not wish to pursue legal avenues after the assault and/or does not desire a forensic examination
2. County sexual assault providers and health departments should work with district attorneys in order to establish a system of testing individuals charged with sexual assault for HIV as soon as possible after the assault. In exchange for agreeing to be tested, alleged assailants test results should not be used for any purpose other than determining the survivor's need for PEP medication. The results should not be made available to prosecuting attorneys.

Recommendations Regarding Implementation of PEP after Sexual Assault Program
1. County Level.
A Registry has been established by the CDC to collect data on non-occupational PEP use. Counties should work with the CDC PEP Rregistry in order to further our understanding of the efficacy of PEP following sexual assault. For more information about participation in the Registry, contact xx. Verbal informed consent is required through most IRBs. These issues need to be addressed prior to participation in the registry. For information about the PEP Registry call (877)HIV-1PEP or consult www.hivpepregistry.com.

2. State Level.
The advisory panel recommends that the State of California Office of AIDS establish a technical support program, including a hotline with ready access to expert information about sexual assault and HIV. This program should also offer comprehensive central or on-site training to county rape treatment programs.

Appendix A: Advisory Panel Members Joshua D. Bamberger, M.D., M.P.H.
* Medical Director, Office of Urban Community Health San Francisco Department of Public Health Assistant Clinical Professor, Department of Family and Community Medicine University of California, San Francisco San Francisco, California David Bangsberg. M.D., M.P.H.
* Assistant Professor of Medicine Director of Epidemiology and Prevention Interventions Center Division of Infectious Diseases and The Positive Health Program San Francisco General Hospital/University of California, San Francisco San Francisco, California S. Lynne Bennett, RNP-C Women's Health Care Nurse Practitioner Humboldt County Sexual Assault Response Team Eureka, California Andy Handler, M.A. Senior Health Educator HIV Education and Prevention Programs Monterey County Health Department Monterey, California Hillary Larkin, P.A.-C Medical Director, Sexual Assault Response Team Department of Emergency Medicine Highland Hospital Oakland, California David K. Martin, B.S.N, P.H.N. AIDS Program Coordinator Kern County Department of Public Health Bakersfield, California Victoria L. Ritter, R.N., M.B.A. Manager, Emergency Department University of California Davis, Medical Center Chair, Sexual Assault Advisory Council Sacramento, California Michelle Roland, M.D.
* Assistant Professor of Medicine UCSF Positive Health Program San Francisco General Hospital San Francisco, California Karen Striplin, RN Nurse Manager John C. Fremont District Hospital Mariposa, CA 95338
( * denotes member of medical sub-committee)

Appendix B:
Post-sexual Assault Treatment Providers in California

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