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What is the role of disclosure assistance services in HIV prevention?

why assistance for disclosure?

After more than 20 years of the HIV epidemic, with advances in treatment and increases in understanding and acceptance of HIV, getting an HIV+ diagnosis still can be a traumatic experience. HIV+ persons must come to terms with their own infection and be concerned with possible infection in past and future partners. Talking to partners about HIV is especially hard because even though it is a manageable disease, HIV still is not curable. Disclosure assistance services (also known as partner counseling and referral services or PCRS) are an array of voluntary and confidential services available to persons living with HIV and their exposed sex and/or needle-sharing partner(s). Disclosure assistance is cost effective and can play a critical role in identifying those individuals most at risk for HIV infection, and linking those who are infected to early medical care and treatment.^1,2,3 Most HIV+ persons make the decision to disclose or not disclose to their partners on their own. But HIV+ persons may want support for telling their partners about HIV, whether by encouragement for self-disclosure or by having someone who is well-trained carefully and confidentially notify a partner for them. In one study, persons who received disclosure assistance were over three times more likely to have informed a partner of their risk.⁴ In the past few years, HIV counseling and testing programs across the US have shifted their emphasis from testing anyone, to finding and testing persons at greatest risk for HIV infection.⁵ At general HIV testing sites, around 1% of clients tested are found to be HIV+, whereas 8-39% of clients tested through disclosure assistance are found to be HIV+.²

what is disclosure assistance?

Often, disclosure assistance or PCRS mistakenly has been seen as only provider disclosure, but there are three forms of assistance: Self disclosure–The client chooses to notify a partner him/herself. The disclosure assistance provider guides and prepares the client before disclosure. Currently, most HIV+ persons choose this method. Dual disclosure–The client chooses to notify a partner in the presence of a provider. The provider supports the client during disclosure and acts as a resource for the partner. This method is rarely chosen and requires highly skilled providers. Provider disclosure (anonymous third party)–The client prefers a professional to notify a partner, and gives his/her provider identifying and locating information for partner(s). Most often, providers give this info to Disease Intervention Specialists (DIS) who then locate and notify the named partners, keeping client identity strictly confidential. This method is chosen less often, yet it is the only one with client anonymity. For the partners of an HIV+ client, disclosure assistance services can include: being notified of exposure to HIV, HIV prevention counseling, HIV testing options, referrals for HIV medical evaluation if positive and referrals for other social or medical services.⁶

how does it work?

Disclosure assistance services are first offered when a person receives a positive HIV test result. It is not a one-time only service, but should be offered as clients’ risk circumstances and needs change. The main element is helping HIV+ persons tell their sexual and/or needle-sharing partners about possible HIV exposure. The quality and use of disclosure assistance services can vary widely. Services differ from state to state: some have legal mandates to provide it, some offer it through HIV, STD or combined HIV/STD programs, and states can receive referrals from clinicians, health departments or testing sites.⁷ Services can be provided by HIV service agencies, health departments and most clinics and hospitals. Most service agencies can provide coaching and support for self or dual disclosure and gather partner identifying and locating information which is forwarded to DIS staff. Most notification of partners has been done by DIS at local health departments because they have the capacity, expertise, trained staff and protection from liability. Good provider disclosure depends on DIS staff who are properly trained and have enough experience and knowledge of the populations they serve. DIS staff should be evaluated regularly to assure quality and be provided with support and ongoing training.⁶

what are the concerns?

Public health messages have traditionally urged disclosure to all sexual and drug using partners. In reality, disclosure is complex and difficult. Some HIV+ persons may fear that disclosure will bring partner or familial rejection, limit sexual opportunities, reduce access to drugs of addiction or increase risk for physical and sexual violence. Because of this, some HIV+ persons choose not to disclose. Programs need to accept that not disclosing is a valid option. Many HIV service agencies and testing and counseling sites routinely offer self disclosure and dual disclosure, working with HIV+ clients by preparing and supporting them to disclose to partners on their own. Although provider disclosure services have been used for many years with other STDs, there is a wide variety in rates of acceptance of provider disclosure in HIV: in North Carolina, 87% of newly diagnosed HIV+ persons accepted provider disclosure,⁸ in Florida 63.1%,⁹ Los Angeles, CA 60%,¹⁰ New York State 32.9%,¹² Seattle, WA 32% and among anonymous testers in San Francisco, CA 3.1%.¹³ In Los Angeles, the most common reasons for refusal were: already notified partner (23.4%), not being ready to disclose (15.3%), being abstinent (15%) and having an anonymous partner (11%).¹⁰ Disclosing HIV status to partners can be scary, but also can be empowering. In one study, HIV+ injection drug users who disclosed their status found increased social support and intimacy with partners, reaffirmation of their sense of self and the chance to share experiences and feelings with sexual partners. Another study of HIV+ persons and their partners who received disclosure assistance found that emotional abuse and physical violence decreased significantly after notification.¹⁵

what’s being done?

Florida utilizes trained DISs to deliver disclosure assistance for all reported new HIV infections. In 2004, 63.1% of all newly infected HIV+ persons accepted provider disclosure, identifying 4,460 sex or needle-sharing partners. Among those, 21.8% had previously tested HIV+. Of the 2,518 persons notified, 84.2% agreed to counseling and testing and 11.5% were HIV+.⁹ The Massachusetts Department of Public Health piloted a client-centered model of disclosure assistance that is integrated into the client’s routine prevention, care and support services. The program required significant changes to the standard model of DIS provider disclosure, building close relationships between service providers and DIS to better support clients’ disclosure needs while protecting confidentiality.¹⁶ California instituted a voluntary disclosure assistance program that includes counseling and preparing HIV+ persons for self disclosure; anonymous third party provider notification; counseling, testing and referrals for notified partners; and training and technical assistance to providers in public and private medical sites. About one-third of patients opted for provider disclosure and 85% referred partners. Of the partners located, 56% tested for HIV and half had never tested before. Overall, 18% of partners tested HIV+.⁴

what needs to be done?

New HIV testing technologies can be useful with disclosure assistance services. Improved rapid testing is a potential invaluable tool for offering HIV tests in the field to notified partners. Nucleic acid amplification testing (NAAT) can determine acute infections, that is, new HIV infections that do not show up during the window period of other HIV tests. Combining these testing strategies with disclosure assistance can help identify newly infected persons and provide immediate counseling, support and referrals to medical or social services as needed.¹⁷ Disclosure assistance services, and particularly provider disclosure, may need extensive changes from the traditional DIS model in order to work well and be accepted within HIV services. Health departments could forge closer ties between their STD and HIV programs and with outside service agencies. HIV staff also can be trained to be DIS providers to broaden access to and comfort with disclosure services. Disclosure assistance services should be made available not only upon HIV diagnosis, but on an ongoing basis as HIV+ persons’ circumstances and needs change. It is not the role of providers to decide if a client will need or want disclosure assistance, but to offer clients support and choices, whether or not a client chooses to disclose. Prepared by Fern Orenstein MEd, CA STD Control Branch, Prevention Training Center

Says who?

1. Landis SE, Schoenbach VJ, Weber DJ, et al. Results of a randomized trial of partner notification in cases of HIV infection in North Carolina. New England Journal of Medicine. 1992;326: 101-106. 2. Golden MR. Editorial: HIV partner notification, a neglected prevention intervention. Sexually Transmitted Diseases. 2002;29:472-475. 3. Varghese B, Peterman TA, Holtgrave DR. Cost-effectiveness of counseling and testing and partner notification: a decision analysis. AIDS. 1999;13:1745-1751. 4. Eckert V. Utilization of voluntary HIV partner counseling and referral services. California Office of AIDS & STD Control Branch. Presented at the Statewide PCRS Conference, May 2004. 5. Centers for Disease Control and Prevention. Advancing HIV Prevention: New Strategies for a Changing Epidemic – US, 2003. Morbidity and Mortality Weekly Report. 2003:52;329-332.http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5215a1.htm (accessed April 2006). 6. HIV partner counseling and referral services guidance. Centers for Disease Control and Prevention. 1998. https://www.cdc.gov/hiv/guidelines/partners.html 7. Aldridge C, Randall L. Implementing partner counseling and referral services programs. Presented at the National HIV Prevention Conference, Atlanta, GA. 2005. Abst #TO-057. 8. Centers for Disease Control and Prevention. Partner counseling and referral services to identify persons with undiagnosed HIV–North Carolina, 2001. Morbidity and Mortality Weekly Report. 2003;52:1181-1184.http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5248a4.htm (accessed April 2006). 9. George D. Partner counseling and referral services (PCRS): the Florida experience. Presented at the National HIV Prevention Conference, Atlanta, GA. 2005. Abst #M3-B1605. 10. Aynalem G, Hawkins K, Smith LV, et al. Who and why? Partner counseling and referral service refusal: implication for HIV infection prevention in Los Angeles. Presented at the National HIV Prevention Conference, Atlanta, GA. 2005. Abst #MP-036. 11. Birkhead G. HIV partner counseling and referral services in New York state. Presented at the National HIV Prevention Conference, Atlanta, GA. 2005. Abst #M3-B1603. 12. Golden MR. Partner notification: where do we stand and outstanding barriers. Presented at the National HIV Prevention Conference, Atlanta, GA. 2005. Abst #T3-D1302. 13. Schwarcz S, McFarland W, Delgado V, et al. Partner notification for persons recently infected with HIV: experience in San Francisco. Journal of Acquired Immune Deficiency Syndrome. 2001;28:403-404. 14. Parsons JT, Vanora J, Missildine W, et al. Positive and negative consequences of HIV disclosure among seropositive injection drug users. AIDS Education and Prevention. 2004;16:459-475. 15. Kissinger PJ, Niccolai LM, Magnus M, et al. Partner notification for HIV and syphilis: effects on sexual behaviors and relationship stability. Sexually Transmitted Diseases. 2003;30:75-82. 16. Cranston K. Planning for HIV partner counseling and referral services in the third decade. Presented at the National HIV Prevention Conference, Atlanta, GA. 2005. Abst #T3-D1301. 17. Pilcher CD, Fiscus SA, Nguyen TQ, et al. Detection of acute infections during HIV testing in North Carolina. New England Journal of Medicine. 2005;352:1873-1883.

September 2005. Fact Sheet #53ER Reproduction of this text is encouraged; however, copies may not be sold, and the Center for AIDS Prevention Studies at the University of California San Franciso should be cited as the source of this information. For additional copies of this and other HIV Prevention Fact Sheets, please call the National Prevention Information Network at 800/458-5231. Comments and questions about this Fact Sheet may be e-mailed to [email protected]. ©Sepetmber 2005, University of California

What Is the Role of Counseling and Testing in HIV Prevention?

why is C&T important?

HIV counseling and testing (C&T) is an important part of a continuum of HIV prevention and treatment services. C&T is one of the main times when a comprehensive individual risk assessment is taken, making it the best opportunity for accurate referrals to more intensive services. C&T is also one of the primary entry points into prevention and other services. C&T uses short, client-centered counseling that can be effective in increasing condom use and preventing sexually transmitted diseases (STDs).¹ Knowing one’s HIV status, whether HIV- or HIV+, is key to preventing the spread of HIV and accessing counseling and medical care. It is estimated that one-fourth of all HIV+ persons in the US do not know they’re infected.² A survey of young men who have sex with men (MSM), found that 14% of young Black MSM were HIV+. Among those, 93% were unaware of their infection, and 71% reported it was unlikely they were HIV+.³ Recently, the Centers for Disease Control and Prevention (CDC) announced an initiative aimed at expanding C&T in the US.⁴ Their Strategic Plan for 2005 strives to decrease by 50% the number of people who don’t know their HIV status.⁵ If this goal is met by 2010, an estimated 130,000 new HIV infections may be prevented, saving over $18 billion.⁶

how is C&T done?

C&T has three distinct components: risk assessment and counseling before the blood or oral sample is taken, testing of the sample, and counseling and referral with the test results.⁷ C&T can be confidential-a person’s name is recorded with the test results-or anonymous-no name is recorded with the test. Publicly funded HIV C&T takes place in testing centers, community health clinics, community-based organizations, outreach programs, mobile vans, STD and family planning clinics and local health departments, among other venues. Although public health workers are trained in C&T procedures, most HIV testing in the US occurs in private doctors’ offices. Many people prefer being tested as part of a routine check-up, instead of public health sites. However, testing in private venues does not offer anonymity, and patients who get tested as part of routine medical care may not receive adequate counseling or referrals.⁸ Other venues also test for HIV, such as emergency rooms, jails/prisons, military recruitment sites and Job Corps. HIV testing in the US is mandatory to get some insurance and medical benefits, apply for some jobs, join the military, give blood or enter the US as an immigrant. HIV testing is compulsory for federal prison inmates and sex offenders in some states.

what about rapid testing?

The standard testing method for the past 20 years has been a needle blood draw. In the past 10 years, a mouth swab (OraSure) that tests cells from inside the cheek has also been available. Results are sent to a lab for the ELISA test and a Western Blot to confirm an initially positive result, with an average wait of 1-2 weeks between sample collection and the provision of results. With this method, many persons don’t return for their test results, and nationally 31% of persons who test HIV+ don’t return to find out their results.⁴ Rapid testing is now available with a finger stick (OraQuick). With this method, results are known in 20 minutes, eliminating the need for a return visit for results. However, if a client’s tests is reactive, he receives a preliminary positive result. A second blood test (needle draw or OraSure) is required to confirm the result with a standard Western Blot. Final confirmation still takes 1-2 weeks. National data indicate that with rapid testing, 95% of clients who received a preliminary positive result returned for their confirmatory results.⁹ Rapid testing will change the way C&T is conducted, although clients can still opt to get their results later. Because the client needs to wait for 20 minutes for the results, the counselor takes the blood early in the session and has a “captive audience” for risk assessment and counseling. Test counselors can conduct the blood test themselves, or a separate staff person can do the finger stick and read results. Counseling with rapid testing can be more intense and client-focused due to the immediacy of getting results. It is hoped that rapid testing will dramatically increase the number of persons who know their results.

what makes good C&T?

Good C&T depends on counselors who are properly trained and have enough experience. Counselors must protect the confidentiality of client information, obtain informed consent before testing and provide effective counseling services and appropriate referrals. Counselors should establish relationships with key service agencies to make sure the referrals they give clients reflect their needs, priorities, culture, age, sexual orientation and language. C&T counselors should be evaluated regularly to assure quality and be provided with support and ongoing training.⁷ With rapid testing, counselors need different training as they can be both the counselor and the lab. Rapid testing requires stable temperatures, adequate lighting, and careful attention to detail. Also, rapid testing is not rapid counseling. Counselors need to work closely with clients to develop a reasonable risk reduction step and to make sure their clients are actually ready to receive the test results. It is also important to obtain a second blood sample for confirmation if a client tests positive.¹⁰

what’s being done?

The Department of Public Health (DPH) in Florida made a deliberate effort to improve their C&T services and increase the number of people who know they are HIV+. State funded testing sites targeted venues with high-risk persons, including CBOs, prisons/jails and outreach settings. They also began using OraSure for testing in the field. In 2002, the DPH reported a 2% seropositive rate for blood draws and 3.2% for OraSure. In jails they found a 3.6% seropositive rate. They also used partner counseling and referral services (PCRS) and in 2002, 80% of HIV+ people gave names of partners, 64% of partners were located and counseled, and 13% of partners who tested were HIV+.¹¹ In Minneapolis, MN, rapid testing was offered at a variety of agencies serving primarily African American clients. Venues included drug treatment programs, homeless shelters, teen clinics, sex offender groups and halfway houses. Almost all (99.7%) of clients received their test results and counseling, and 95% reported they would rather have a finger stick than a blood draw.¹² Wisconsin’s AIDS/HIV Program wanted to increase the number of high-risk persons accessing testing. In the early 90s, tests jumped from 6000 per year to between 20,000-30,000. The number of high-risk persons tested, however, remained the same while seroprevalence rates dropped from 3.5% to 0.5%. In the late 90s, the program shifted its philosophy from one of public education to case finding. Publicly funded sites were reduced from 126 to 55 serving the greatest percentage of high-risk persons and persons of color. In one year, the seroprevalence rate improved to .75%, the number of low-risk persons tested decreased 42%, high-risk persons tested increased 6%, and testing among persons of color improved 18%.¹³

what is the future of C&T?

As rapid testing becomes more widely used, it is hoped that the number of people not returning for their test results will decrease. Rapid testing can allow for more targeted outreach to communities and persons at risk, as C&T occurs in venues that are more accessible and acceptable. Rapid testing should be implemented carefully to allow time for agencies to gain experience and clients to understand the new testing process. Greater efforts may be necessary to refer clients to effective services. Behavior change is a slow and difficult process, and many persons make changes incrementally. Linkages to other services and follow-up with clients may substantially increase the impact of the initial counseling. While training and quality assurance has traditionally centered on counseling in C&T, referrals may be the weakest part and need most improvement. Simply increasing the number of persons who know they are HIV+ will not slow the HIV epidemic sufficiently. As more persons in the US discover their HIV status, it is crucial to ensure that more prevention, social and treatment services are available both to HIV+ and HIV- persons. In addition to primary HIV prevention interventions, these should include access to quality drug and alcohol treatment, housing and employment services, STD testing and treatment, syringe exchange programs, quality medical care and adherence support to insure effective use of AIDS medications. Prepared by Steven R. Truax, PhD*, Pamela DeCarlo** *California State Office of AIDS, **CAPS

Says who?

1. Kamb ML, Fishbein M, Douglas JM,et al. Efficacy of risk-reduction counseling to prevent human immunodeficiency virus and sexually transmitted diseases. Journal of the American Medical Association. 1998;280:1161-1167. 2. Fleming P, Byers RH, Sweeney PA, et al. HIV prevalence in the United States, 2000. Presented at the 9th Conference on Retroviruses and Opportunistic Infections, Seattle, WA; February 24-28, 2002. 3. Centers for Disease Control and Prevention. Unrecognized HIV infection, risk behaviors and perceptions of risk among young black men who have sex with men – six US cities, 1994-1998. Morbidity and Mortality Weekly Reports. 2002;33:733-736. 4. Centers for Disease Control and Prevention. Advancing HIV Prevention: New Strategies for a Changing Epidemic – US, 2003. Morbidity and Mortality Weekly reports. 2003:52;329-332. https://pubmed.ncbi.nlm.nih.gov/12733863/  5. Centers for Disease Control and Prevention. HIV Prevention Strategic Plan Through 2005. www.cdc.gov/hiv/partners/ psp.htm 6. Holtgrave DR, Pinkerton SD. Economic implications of failure to reduce incident HIV infections by 50% by 2005 in the United States. Journal of Acquired Immune Deficiency Syndromes. 2003;33:171-174. 7. Centers for Disease Control and Prevention. Revised Guidelines for HIV Counseling, Testing, and Referral. Morbidity and Mortality Weekly Reports. 2001;50. 8. Haidet P, Stone DA, Taylor WC, et al. When risk is low: primary care physicians’ counseling about HIV prevention. Patient Education and Counseling. 2002;46:21-29. 9. Kassler WJ, Dillon BA, Haley C, et al. On-site, rapid HIV testing with same-day results and counseling. AIDS. 1997;11:1045-1051. 10. Fournier J, Morris P. Speed bumps and roadblocks on the road to rapid testing: a look at the integration of HIV rapid testing in an agency and community. Presented at the US Conference on AIDS, New Orleans, LA, 2003. 11. Liberti T. Florida’s HIV counseling, testing and referral program. Presented at the US Conference on AIDS, New Orleans, LA, 2003. 12. Keenan PA. HIV outreach in the African American community using OraQuick rapid testing. Presented at the National HIV Prevention Conference, Atlanta, GA. 2003. 13. Stodola J. Restructuring Wisconsin’s HIV CTR program: targeting CTR services. Presented at the US Conference on AIDS, New Orleans, LA, 2003.

January 2004. Fact Sheet #3ER Special thanks to the following reviewers of this Fact Sheet: Jena Adams, Barbara Adler, Chris Aldridge, Teri Dowling, Barbara Gerbert, Paul Haidet, Sydney Harvey, Willi McFarland, Patrick Keenan, Kathryn Phillips, Jim Stodola, Brenda Storey, Ed Wolf.

Reproduction of this text is encouraged; however, copies may not be sold, and the Center for AIDS Prevention Studies at the University of California San Franciso should be cited as the source of this information. For additional copies of this and other HIV Prevention Fact Sheets, please call the National Prevention Information Network at 800/458-5231. Comments and questions about this Fact Sheet may be e-mailed to [email protected]. © January 2004, University of California

Is Mother-to-Child HIV Transmission Preventable?

Prepared by Sarah A. Gutin, MPH* *CAPS, Community Health Systems- School of Nursing, UCSF Fact Sheet #34ER – September 2015 Special thanks to the following reviewers of this Fact Sheet: Yvette Cuca, Carol Dawson Rose, Shannon Weber In 2012, there were 2.3 million new HIV infections globally [1]. A large proportion of people newly diagnosed with HIV worldwide are in their reproductive years and these men and women are likely to want children in the future [2-4]. Addressing the sexual and reproductive health and rights of this population is critical to addressing the spread of HIV because HIV infection in childbearing women is the main cause of HIV infection in children [5]. Treatment for those who are already infected is also central to stopping the spread of HIV to infants and to uninfected sexual partners.

How does transmission occur?

Perinatal transmission of HIV, also called vertical transmission, occurs when HIV is passed from an HIV-positive woman to her baby during pregnancy, labor and delivery or breastfeeding. For an HIV-positive woman not taking HIV medications, the chance of passing the virus to her child ranges from about 15 to 45% during pregnancy, labor and delivery. If she breastfeeds her infant, there is an additional 35 to 40% chance of transmission [6].

Is the risk of perinatal transmission always the same?

No. Global societal and economic inequities create a wide gap between women in developing nations and women in developed nations with regard to HIV prevention, voluntary counseling and testing and access to drugs which treat HIV infection and can prevent perinatal transmission. Developed countries- In many developed countries, pediatric HIV has been virtually eliminated [7]. In the US in 1994, the Public Health Service recommended HIV counseling and voluntary testing and AZT therapy for all pregnant women after the clinical trial known as “076” showed that AZT reduced rates of MTCT by two-thirds. Since then, a combination of interventions that includes treatment with ART to control the virus and make it undetectable, cesarean delivery, and avoidance of breastfeeding has helped further reduce perinatal transmission in the US, from an estimated 1,500 cases in 1992 to an estimated 162 perinatal infections in 2010 [8]. Although the estimated number of perinatal HIV infections in the US continues to decline, women of color, especially black/African American women are disproportionately affected by HIV infection and as a result, perinatal HIV infection is highest among blacks/African Americans (63%), followed by Hispanics/Latinas (22%) [8]. Although effective interventions have led to a significant reduction in the number of perinatal infections in the US, perinatal transmission still occurs. To close the final gap, the CDC has proposed a new framework to eliminate mother-to-child HIV transmission (EMCT) in the US [8]. This framework focuses on key areas including: comprehensive reproductive health care (that includes both family planning (FP) and preconception care) and comprehensive case-finding of pregnancies in HIV-infected women that is conducted through comprehensive clinical care and case management services for women and infants; case review and community action; continuous quality research in prevention and long-term monitoring of HIV-exposed infants; and thorough data reporting for HIV surveillance at the state and local health department levels [8 9]. Developing countries- Unfortunately, perinatal transmission of HIV continues to plague many developing countries despite recent prevention acceleration. In 2008, an estimated 1.4 million pregnant women in low and middle-income countries were living with HIV, of whom about 90% were in sub-Saharan African countries [7]. In 2012, UNAIDS reported that approximately 210,000 children became HIV infected [1].

Can perinatal transmission of HIV be reduced?

Yes. Perinatal transmission encompasses a variety of highly effective interventions that have huge potential to improve maternal and child health. Advances in treatment and new classes of drugs have provided the opportunity to greatly reduce rates of perinatal transmission worldwide. Also, perinatal transmission can be reduced by preventing unintended pregnancies. Preventing unintended pregnancies is one of the most effective ways to prevent HIV infection in infants and stop spread of the epidemic to children [10]. For that reason, preventing unintended pregnancies among women living with HIV and offering family planning to delay, space or end childbearing is one of the four WHO pillars in the comprehensive approach to preventing perinatal transmission [7]. However, we have still not addressed the root cause of perinatal transmission, mainly heterosexual HIV transmission. The best way to prevent perinatal HIV transmission is to prevent HIV transmission in the mother and father. In order to reduce perinatal transmission, all pregnant women should have access to free or low-cost prenatal care and voluntary HIV testing and counseling. If a pregnant woman is HIV-positive, she should have access to lifelong ART to treat HIV and improve her own health and to decrease the chances of HIV infection in her infant. In June 2013, the WHO published updated guidelines on the diagnosis of HIV, the care of people living with HIV(PLHIV) and the use of ART for treating and preventing HIV infection [1]. In the US, the Department of Health and Human Services recommends that all HIV-infected pregnant women should be given ART during pregnancy to prevent perinatal transmission of HIV, regardless of whether ART is indicated for the woman’s own health [11]. Perinatal transmission can be reduced to less than 2% if a woman is on ART, has a low or undetectable viral load, follows the recommended treatment regimen and does not breastfeed [7 8]. Careful management during labor and delivery can also help reduce perinatal transmission, for example by avoiding unnecessary instrumentation and not prematurely rupturing membranes [12]. Also, although universal prenatal HIV testing is the standard in the US, if prenatal care has not been provided, the patient has HIV, or her HIV status is undocumented, it is critical for hospitals to determine a laboring patient’s HIV status upon admission. Even without the use of ART during the pregnancy, the use of ART during labor and for the infant can reduce the risk of perinatal transmission to between 6 to 13% [13]. It is therefore recommended that rapid HIV testing be performed in Labor and Delivery units on pregnant women with no HIV test during their pregnancy or with risk factors for infection since their last test [14]. In developing countries, perinatal transmission has been a priority since 1998, following the success of short-course zidovudine and single-dose nevirapine clinical trials [7]. In recent years, single-dose nevirapine as the primary antiretroviral medicine option for HIV-positive pregnant women to prevent transmission to their infants has been phased out, in favor of more effective and simplified triple ART regimens [1]. The WHO now recommends that all pregnant and breastfeeding women with HIV, regardless of CD4 count or clinical stage, should initiate a triple ART regimen which should be maintained for the duration of perinatal transmission risk, which includes pregnancy, delivery and throughout the breastfeeding period (this is known as Option B). In countries were more than one percent of the population has HIV (these are known as generalized epidemics) and where there is often limited access to tests that indicate the severity of HIV illness (such as CD4 testing), limited partner testing, long duration of breastfeeding and high rates of fertility, the WHO recommends that women meeting treatment eligibility criteria should continue lifelong ART (this strategy is referred to as Option B+) [12]. There are many benefits to lifelong treatment for all pregnant and breastfeeding women and these include increased coverage of those needing ART for their own health, a reduction in the number of women stopping and starting ART during repeat pregnancies, early protection against perinatal transmission in future pregnancies, reduced risk of infecting a partner who is HIV-negative and decreased risk of medication failure or the development of resistance [12]. The ultimate goal is to find the most effective and sustainable regimens for HIV treatment and the prevention of perinatal transmission worldwide. Economics, politics, poor infrastructure, access to healthcare and medications, stigma and cultural norms all pose significant challenges to providing this standard of care everywhere and not all PLHIV have equal access to treatment.

What are the barriers to the prevention of perinatal transmission?

Pregnant women face many difficult decisions, including decisions around HIV testing, treatment options and infant feeding. Understanding the barriers that women face and addressing barriers at various levels can help in realizing the full potential of prevention of perinatal transmission programs. A recent review article found that barriers to the prevention of perinatal transmission often fell into three broad categories that included the individual, their partners and community, and health systems [15]. At the individual level, studies suggest that a lower maternal education level, younger maternal age, and poor knowledge of HIV transmission and ART are associated with not receiving and/or not taking ART in order to treat and prevent the spread of HIV [15]. Additionally, a woman’s male partner(s), extended family, greater community and health care setting all influence her decision and ability to take advantage of prevention of perinatal transmission programs. Many qualitative studies have found that stigma regarding HIV status and fear of disclosure to partners and family members is a major barrier to the uptake of perinatal prevention interventions [15]. Women living with HIV also continue to report that stigma and discrimination, especially in health care settings, continue to be a barrier to accessing adequate information and services [1]. In various studies, PLHIV have reported negative staff attitudes and this has been cited as a barrier to returning to facilities for care [15]. In developing countries, health systems issues are also a barrier to greater prevention uptake. Key barriers that have been identified include a shortage of trained clinic staff, high patient volumes, long wait times, and brief and poor counseling sessions [15]. In addition, a lack of access or shortages of medications, including ART, as well as stock-outs of HIV test kits and condoms have been reported. Poor access to healthcare overall (long distances to facilities) and poor integration of services also contributes to low ART uptake.

What about breastfeeding?

Breastfeeding is usually the healthiest choice for both infants and mothers. However, HIV transmission can occur during breastfeeding, with chances of transmission increasing the longer the infant is breastfed. In the countries with the highest perinatal HIV rates, it is estimated that more than half of the children newly infected with HIV acquire it during the breastfeeding period [1]. However, the risk of transmitting HIV to infants through breastfeeding is low in the presence of ART [12]. Therefore, providing ART to mothers throughout the breastfeeding period is a critical step needed to further reduce rates of perinatal transmission [1]. It is recommended that HIV-positive mothers do not breastfeed when formula feeding is safe, well accepted and readily available. In the US, both the Centers for Disease Control and Prevention and the American Academy of Pediatrics recommends that HIV-infected women refrain from breastfeeding regardless of their ART status to avoid postnatal transmission of HIV to their infants through breast milk [16 17]. However, formula feeding requires clean water for mixing formula. Many women in developing countries do not have access to clean water or sanitation and cannot afford formula, and therefore cannot avoid breastfeeding. In developing countries where breastfeeding is the norm, formula feeding may also alert a woman’s family or community that she is HIV-positive, which may result in stigma or other negative repercussions. Therefore, the WHO recommends that when breastfeeding is unavoidable, mothers should take ART while breastfeeding and that infants should receive 6 weeks of prophylaxis with once-daily nevirapine [12]. The WHO further recommends that mothers known to be infected with HIV (and whose infants are HIV uninfected or of unknown status) should exclusively breastfeed for the first 6 months of life, introducing appropriate complementary foods thereafter, and continue breastfeeding for the first 12 months of life. It is recommended that breastfeeding should only stop when a nutritionally adequate and safe diet without breast-milk can be provided [12]. Access to ARVs during this extended breastfeeding period is critical [12].

What’s being done?

Primary prevention of HIV among men and women of childbearing age: Various tools are now available to prevent HIV infections in men and women of childbearing age. Pre-exposure prophylaxis (PrEP), which is a special course of HIV treatment that aims to prevent people from becoming infected with HIV, has been found to protect against HIV-1 infection in heterosexual men and women and reduce HIV transmission by 67 to 75% [18 19]. PrEP is intended for people at-risk of becoming infected with HIV, for example in the case of couples where one partner is HIV-positive and the other is HIV-negative. In countries with generalized HIV epidemics, voluntary medical male circumcision for HIV-negative male partners in relationships with a positive partner has been shown to reduce the risk of HIV-acquisition in men by between 38% to 66% [20]. Using ART to decrease the chance of HIV transmission, a concept known as treatment as prevention, has also recently been found to be very efficacious, with studies in heterosexual populations showing that adherence to ART is very effective at preventing transmission of HIV to HIV-negative partners [21-23]. Couples-testing with treatment for infected partners in discordant partnerships is also a promising approach. Integrating couples counseling and partner testing into routine clinic and community services can increase the number of couples in which the status of both partners is known and can help identifying sero-discordant couples [24]. Preventing unintended pregnancies and Safer Conception Options: Preventing unintended pregnancies among women living with HIV (WLHIV) is a powerful prevention strategy. One study found that even modest reductions in the numbers of pregnancies among WLHIV could avert HIV-positive births at the same rates as the use of ART for PMTCT [25]. One targeted approach to strengthening FP programs is to integrate FP within HIV services. In Kenya, a recent cluster-randomized trial tried to determine whether integrating FP services into HIV care was associated with increased use of more effective contraceptive methods such as sterilization, IUDs, implants, injectables and oral contraceptives. Women seen at integrated sites were significantly more likely to use more effective methods of FP at the end of the study [26]. This makes the case for integrating FP within HIV care. Reducing the unmet need for FP will reduce new HIV infections among children and improve overall maternal and infant health. For HIV-positive or serodiscordant couples who would like to have children, there are many options available to make conception safer. When offering preconception care, HIV-positive couples will have specific needs, many of which can be addressed during their routine HIV care. When offering preconception counseling for HIV-positive women, the CDC recommends that health care providers should discuss a variety of topics, including: reproductive options and actively assessing women’s pregnancy intentions on an ongoing basis; Counseling on safe sexual practices that prevent HIV transmission to sexual partners, protect women from acquiring sexually transmitted diseases, and reduce the potential to acquire more virulent or resistant strains of HIV; Using ART to attain a stable, maximally suppressed maternal viral load prior to conception to decrease the risk of perinatal transmission and of HIV transmission to an uninfected partner; and encouraging sexual partners to receive counseling and HIV testing and, if infected, to seek appropriate HIV care[11]. For couples who want to conceive, in which one or both are HIV-positive, the positive partner should be on ART and have achieved maximal suppression of HIV infection. ART for the positive partner may not be fully protective against sexual transmission of HIV and so the administration of PrEP for the HIV-negative partner may offer an additional tool to reduce the risk of transmission. For discordant couples, when the positive partner is a woman, the safest conception option is artificial insemination. In discordant couples where the positive partner is male, the safest conception option is the use of donor sperm from an HIV-uninfected male with artificial insemination. When the use of donor sperm is unacceptable, the use of sperm preparation techniques together with either intrauterine insemination or in vitro fertilization is an option [11]. Preventing HIV transmission from WLHIV to infants: Increasing access to ART for WLHIV is critical to saving the lives of women and their children. The number of pregnant WLHIV receiving ART for their own health has increased from 25% in 2009 to 60% in 2012 [1]. One of the greatest success stories has been in Malawi where a policy of providing lifelong ART to all pregnant and breastfeeding women (irrespective of CD4 count or clinical status– a strategy referred to as Option B+) was enacted in 2011. Since then, Malawi increased the estimated coverage of women in need of ART from 13% in 2009 to 86% in 2012. The implementation of Option B+ has resulted in a 748% increase in the number of pregnant and breastfeeding women starting ART, from 1,257 in the second quarter of 2011 to 10,663 in the third quarter of 2012 [27]. As a result of Option B+, the perinatal transmission rate for women on ART is expected to be reduced, from approximately 40% without intervention to less than 5%. By decentralizing treatment services and offering lifelong HIV treatment to all pregnant and breastfeeding women, Malawi has been able to increase ART coverage both during pregnancy and the breastfeeding period [1]. Providing treatment, care and support to WLHIV and their children and families: Increasing access to ART for pregnant women living with HIV for their own health is critical to saving the lives of women and their children. Even developing countries, which at first lagged behind in reducing the number of children newly infected with HIV, have made great gains in recent years. In 2013, UNAIDS reported that in 7 high burden countries where access to treatment has increased, the rates of HIV transmission to children has fallen by 50% or more [1].

What still needs to be done?

HIV is a preventable disease. Perinatal transmission is best prevented by effective, accessible and sustainable HIV prevention, access to HIV testing, early diagnosis and linkage to treatment programs for women, men and their children, access to family planning and abortion services to prevent unintended pregnancies, and access to an ongoing supply of ARVs to improve the health of women and their children. Structural interventions are also needed that increase access to health centers, improve health care infrastructure, provide food supplementation, and HIV treatments. Women are the key to the HIV response and the number of women acquiring HIV has to be reduced. All women have a right to be treated for HIV infection, not simply because they are bearing a child. All women living with HIV who are eligible for ART need to have access to it. Unfortunately, too many women are still lost along the prevention cascade and never get the care or treatment they need and deserve. Providing women with access to high quality healthcare for themselves and their families, whether they are HIV-positive or not, is imperative.

Says who? 1. UNAIDS. AIDS by the numbers. Geneva, Switzerland, 2013. 2. Kanniappan S, Jeyapaul MJ, Kalyanwala S. Desire for motherhood: exploring HIV-positive women’s desires, intentions and decision-making in attaining motherhood. AIDS care 2008;20(6):625-30 doi: 10.1080/09540120701660361[published Online First: Epub Date]|. 3. Beyeza-Kashesya J, Kaharuza F, Mirembe F, et al. The dilemma of safe sex and having children: challenges facing HIV sero-discordant couples in Uganda. African health sciences 2009;9(1):2-12 4. Cooper D, Moodley J, Zweigenthal V, et al. Fertility intentions and reproductive health care needs of people living with HIV in Cape Town, South Africa: implications for integrating reproductive health and HIV care services. AIDS and behavior 2009;13 Suppl 1:38-46 doi: 10.1007/s10461-009-9550-1[published Online First: Epub Date]|. 5. UNAIDS. We Can Prevent mothers fom dying and babies from becoming infected with HIV. Geneva, Switzerland, 2010. 6. De Cock KM, Fowler MG, Mercier E, et al. Prevention of mother-to-child HIV transmission in resource-poor countries: translating research into policy and practice. JAMA : the journal of the American Medical Association 2000;283(9):1175-82 7. WHO. PMTCT Strategic Vision 2010-2015: Preventing mother-to-child transmission of HIV to reach the UNGASS and Millenium Development Goals. Geneva, Switzerland, 2010. 8. CDC. HIV Among Pregnant Women, Infants, and Children in the United States. Atlanta, 2012. 9. Nesheim S, Taylor A, Lampe MA, et al. A framework for elimination of perinatal transmission of HIV in the United States. Pediatrics 2012;130(4):738-44 doi: 10.1542/peds.2012-0194[published Online First: Epub Date]|. 10. Nakayiwa S, Abang B, Packel L, et al. Desire for children and pregnancy risk behavior among HIV-infected men and women in Uganda. AIDS and behavior 2006;10(4 Suppl):S95-104 doi: 10.1007/s10461-006-9126-2[published Online First: Epub Date]|. 11. Department of Health and Human Services Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. 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. In: Bureau HA, ed. Washington, DC, 2014. 12. WHO. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: Recommendations for a public health approach. Geneva, Switzerland, 2013. 13. Kourtis AP, Lee FK, Abrams EJ, et al. Mother-to-child transmission of HIV-1: timing and implications for prevention. The Lancet infectious diseases 2006;6(11):726-32 doi: 10.1016/S1473-3099(06)70629-6[published Online First: Epub Date]|. 14. Branson BM, Handsfield HH, Lampe MA, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports / Centers for Disease Control 2006;55(RR-14):1-17; quiz CE1-4 15. Gourlay A, Birdthistle I, Mburu G, et al. Barriers and facilitating factors to the uptake of antiretroviral drugs for prevention of mother-to-child transmission of HIV in sub-Saharan Africa: a systematic review. Journal of the International AIDS Society 2013;16(1):18588 doi: 10.7448/IAS.16.1.18588[published Online First: Epub Date]|. 16. American Academy of Pediatrics Committee on Pediatric A. HIV testing and prophylaxis to prevent mother-to-child transmission in the United States. Pediatrics 2008;122(5):1127-34 doi: 10.1542/peds.2008-2175[published Online First: Epub Date]|. 17. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. 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. Secondary 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.  18. Celum C, Baeten JM. Tenofovir-based pre-exposure prophylaxis for HIV prevention: evolving evidence. Current opinion in infectious diseases 2012;25(1):51-7 doi: 10.1097/QCO.0b013e32834ef5ef[published Online First: Epub Date]|. 19. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. The New England journal of medicine 2012;367(5):399-410 doi: 10.1056/NEJMoa1108524[published Online First: Epub Date]|. 20. Siegfried N, Muller M, Deeks JJ, et al. Male circumcision for prevention of heterosexual acquisition of HIV in men. The Cochrane database of systematic reviews 2009(2):CD003362 doi: 10.1002/14651858.CD003362.pub2[published Online First: Epub Date]|. 21. Donnell D, Baeten JM, Kiarie J, et al. Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: a prospective cohort analysis. Lancet 2010;375(9731):2092-8 doi: 10.1016/S0140-6736(10)60705-2[published Online First: Epub Date]|. 22. Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. The New England journal of medicine 2010;363(27):2587-99 doi: 10.1056/NEJMoa1011205[published Online First: Epub Date]|. 23. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. The New England journal of medicine 2011;365(6):493-505 doi: 10.1056/NEJMoa1105243[published Online First: Epub Date]|. 24. Medley A, Baggaley R, Bachanas P, et al. Maximizing the impact of HIV prevention efforts: Interventions for couples. AIDS care 2013 doi: 10.1080/09540121.2013.793269[published Online First: Epub Date]|. 25. Sweat MD, O’Reilly KR, Schmid GP, et al. Cost-effectiveness of nevirapine to prevent mother-to-child HIV transmission in eight African countries. Aids 2004;18(12):1661-71 26. Grossman D, Onono M, Newmann SJ, et al. Integration of family planning services into HIV care and treatment in Kenya: a cluster-randomized trial. Aids 2013;27 Suppl 1:S77-85 doi: 10.1097/QAD.0000000000000035[published Online First: Epub Date]|. 27. Centers for Disease Control and Prevention. Impact of an innovative approach to prevent mother-to-child transmission of HIV–Malawi, July 2011-September 2012. MMWR. Morbidity and mortality weekly report 2013;62(8):148-51

What Is Post-Exposure Prevention (PEP)?

Why PEP now?

There is still no cure for AIDS. Prevention remains the most effective way to halt the epidemic. The best way to avoid HIV infection is to avoid exposure in the first place through sexual abstinence, having only uninfected sex partners, consistent condom use, injection drug use abstinence, and consistent use of sterile injection equipment.¹ However, recently we have learned a lot about treating HIV and understanding the progression of HIV disease. Protease inhibitors used in combination with other HIV drugs have been extremely effective in reducing the levels of HIV in the blood and restoring health to many patients.² For HIV-uninfected persons who are exposed to HIV, there may be a window of opportunity in the first few hours or days after exposure in which these highly active drugs may prevent HIV infection. A study of health care workers showed that treatment with AZT after needlestick exposure to HIV-infected blood reduced the odds of HIV infection by 81%.^3,4 The study was not designed to test the efficacy of AZT for post-exposure treatment and has some limitations. Following consultations, the findings from this study and other data led the Centers for Disease Control and Prevention (CDC) to recommend post-exposure prevention (more commonly known as post-exposure treatment, post-exposure prophylaxis or PEP) for some health care workers who are accidentally exposed to HIV-infected body fluids. Since PEP is recommended for health care workers, it is only logical that PEP be considered for people exposed to HIV through sex or injection drug use, especially since these are more common sources of HIV infection.

What are components of PEP?

There are no federal recommendations governing PEP for sexual or injection drug use exposure although the CDC is currently studying the matter. Many physicians and clinics across the country currently offer PEP in widely varying forms.⁵ Most forms of PEP involve providing one or several anti-HIV drugs within 72 hours of possible exposure. These drugs are then taken for a 4-6-week period. Before PEP is implemented, a thorough risk assessment should be conducted to determine a patient’s level and frequency of risk-taking, as well as the HIV status of the patient’s partner. Patients should be informed of the potential side effects and difficulty taking the drugs and should be assisted to develop strategies to successfully take the drugs as prescribed. Partner notification and counseling can be part of a PEP program. One of the potential advantages of PEP is the opportunity to reach and counsel people at high risk for HIV. PEP programs should include a behavioral counseling component to help patients develop skills for avoiding future exposure to HIV and to deal with the fear of becoming infected. Referrals to HIV prevention, substance abuse, medical, mental health and housing programs should also be included to help patients address important risk factors.⁶ Unprotected sexual intercourse can result not only in HIV infection, but in other sexually transmitted diseases (STDs) and unintended pregnancy. PEP programs should offer testing and treatment for other STDs and testing for pregnancy. STD infection has been shown to increase the risk of HIV transmission 2- to 5-fold, and treating STDs is an effective HIV prevention intervention.⁷

Does PEP work?

No one knows for sure. The idea of providing potent anti-HIV drugs to prevent infection makes sense biologically, but some people believe the study of health care workers and AZT is not definitive, and there have been no studies on PEP for sexual or injection exposure. The potency of the new anti-HIV drugs, however, is a compelling, if unproven, reason to offer PEP treatment after exposure to a life threatening disease.⁸

What are disadvantages of PEP?

One of the biggest fears about PEP is that people will return to unsafe sexual and drug using practices if they believe that PEP will prevent them from becoming infected. There is some evidence that treatment advances, including PEP, may be leading to increasing incidence of unsafe sex in the US.⁹ For example, rates of gonorrhea among men who have sex with men have recently increased for the first time since the early 1980s.¹⁰ Another fear is that misuse of PEP drug therapies may cause a person to develop a resistant strain of HIV. If PEP drug therapy is unsuccessful and a person does develop a drug-resistant virus, the new anti-HIV drugs may not be as effective for treating that person. This can occur not only with PEP, but with any combination therapy treatment. PEP regimens can be both complicated and prohibitively expensive to follow. PEP drugs need to be taken at specific times of the day on a regular schedule. About one-third of the health care workers who received PEP never finished the regimen because of difficulty taking the drugs. Side effects of the drugs can be severe and debilitating, and long-term effects are still unknown. A typical dosage for four weeks can cost $600-1,000 including the medicine, blood tests and clinic visits. Prescribing PEP can be a complicated decision for clinicians, and should be done on an individual basis. Many believe that a person with single case of unprotected sexual- or needle-related exposure to an HIV+ partner would be a good candidate for PEP. However, many people worry that providing PEP repeatedly to a person with ongoing high-risk behavior may cause disinhibition for unsafe sex and could also be toxic.

What programs exist?

San Francisco, CA has recently implemented a project to determine the safety and feasibility of PEP. The study offers intensive behavioral counseling, HIV testing and anti-HIV medication to persons who have been exposed within the last 72 hours. The project will not look at the effectiveness of PEP; rather it will look at whether participants comply with treatments, if there are significant side effects, and if clients change their risk behavior following the exposure.¹¹ Internationally, many countries are moving ahead with PEP. In France, the Secretary of State for Health announced in August that PEP would be made available to all accidental exposures to HIV, whether occupational, sexual or injection. In London, England, PEP is available through clinics and private physicians. In British Columbia, Canada, PEP is available in emergency rooms for patients with possible exposure.

How can PEP help?

PEP can help strengthen HIV prevention strategies by serving as a bridge between prevention and treatment, similar to STD prevention. Traditional STD prevention includes education, testing, early treatment, counseling, partner notification and follow-up. In San Francisco, one PEP program is located in an STD clinic. Many people have advocated the integration of HIV and STD strategies. PEP is a step in that direction. No one expects PEP to be 100% effective. No prevention tool is 100% effective for any medical condition, whether it be HIV, unwanted pregnancy or cancer. The best prevention effort requires a “myriad of imperfect, cumulatively effective”¹² interventions. A comprehensive HIV prevention strategy uses many elements to protect as many people at risk for HIV as possible. PEP offers the opportunity to expand the range of prevention activities, thereby expanding the possibility of saving lives.

Says who?

1. Centers for Disease Control and Prevention. Backgrounder: CDC-sponsored external consultants meeting on post-exposure therapy (PET) for non-occupational exposures to HIV. Fact sheet prepared by the CDC. July 1997. 2. Deeks SG, Smith M, Holodniy M, et al. HIV-1 protease inhibitors: a review for clinicians . Journal of the American Medical Association. 1997;277:145-153. 3. Centers for Disease Control and Prevention. Case-control study of HIV seroconversion in health-care workers after percutaneous exposures to HIV-infected blood-France, United Kingdom, and United States, January 1988-August 1994 . Morbidity and Mortality Weekly Report. 1995;44:929-933. 4. Cardo DM, Culver DH, Ciesielski CA, et al. A case-control study of HIV seroconversion in health care workers after percutaneous exposure . New England Journal of Medicine. 1997;337:1485-1490. 5. Zuger A. `Morning after’ treatment for AIDS. The New York Times. June 10, 1997. 6. Katz MH, Gerberding JL. Postexposure treatment of people exposed to the human immunodeficiency virus through sexual contact or injection-drug use . New England Journal of Medicine. 1997;336:1097-1100. 7. Wasserheit JN. Epidemiological synergy. Interrelationships between human immunodeficiency virus infection and other sexually transmitted diseases . Sexually Transmitted Diseases. 1992;19:61-77. 8. Henderson DK. Postexposure treatment of HIV-taking some risks for safety’s sake . New England Journals of Medicine. 1997;337:1542. 9. Dilley JW, Woods WJ, McFarland W. Are advances in treatment changing views about high-risk sex? (letter) . New England Journal of Medicine. 1997;337:501-502. 10. Centers for Disease Control and Prevention. Gonorrhea among men who have sex with men-selected sexually transmitted diseases clinics, 1993-1996 . Morbidity and Mortality Weekly Report. 1997;46:889-892. 11. Perlman D. Morning-after HIV experiment starts in SF. San Francisco Chronicle. October 14, 1997. 12. Cates W. Contraception, unintended pregnancies, and sexually transmitted diseases: why isn’t a simple solution possible? American Journal of Epidemiology. 1996;143:311-318.

Prepared by Pamela DeCarlo*, Thomas J. Coates, PhD* *CAPS, UCSF December 1997. Fact Sheet #32E

Reproduction of this text is encouraged; however, copies may not be sold, and the Center for AIDS Prevention Studies at the University of California San Franciso should be cited as the source of this information. For additional copies of this and other HIV Prevention Fact Sheets, please call the National AIDS Clearinghouse at 800/458-5231. Comments and questions about this Fact Sheet may be e-mailed to [email protected]. © December 1997, University of California

What is pre-exposure prophylaxis (PrEP) and is it effective in preventing HIV?

Prepared by Stephanie Cohen, MD & Al Liu, MD; SF DPH | Gabriel R. Galindo DrPH; CAPS

What is PrEP?

PrEP stands for pre-exposure prophylaxis and it is a promising biomedical HIV intervention. It is an approach to prevention where HIV-negative people take HIV drugs in order to prevent HIV infection. PrEP is started before possible exposure to HIV, and is taken on an ongoing basis.  PrEP is not a vaccine, and it is different from post-exposure prophylaxis (PEP), where the medication is started soon after exposure to HIV, and continued for 28 days only. Taking a medication before exposure has been shown to be effective in preventing other infectious diseases. Likewise, providing antiretroviral therapy to pregnant women and their infants has been used effectively for many years to prevent mother-to-child transmission of HIV [¹]. PrEP can be in the form of a pill taken by mouth, known as “oral PrEP”.[^2,3,4 ] In clinical trials PrEP has been provided in combination with other HIV prevention interventions, such as condom distribution, behavioral counseling, HIV testing, and screening of other sexually transmitted infections (STIs).

Why is PrEP important?

Globally there are 2.6 million new HIV infections each year, and in the US, there are an estimated 56,000 new HIV infections annually.[⁵] While risk reduction counseling, condoms, male circumcision and other methods have been shown to reduce HIV infections, by themselves they are not enough, and new approaches to HIV prevention are urgently needed – especially for men who have sex with men (MSM) and transgender women, the groups who disproportionately bear the greatest HIV burden in the US [⁶].

What drugs are currently being tested for PrEP?

Recently completed and ongoing studies of oral PrEP have tested the HIV drug tenofovir (also known as Viread®) alone or in combination with emtricitabine.   The combination of tenofovir and emtricitabine is known as Truvada®. These medications were chosen because they only have to be taken once daily, they have few side effects, they don’t interact with most other medications, and they have been shown to be safe and effective in animal studies of PrEP.  Different topical formulations are currently being studied in clinical trials and other forms of topical PrEP, including a vaginal ring and a gel formulated for rectal use, are also under development.[⁷]

How effective is PrEP in preventing HIV infection?

For MSM and transgender women, the iPrEx study results, released in November 2010, demonstrated for the first time that daily oral Truvada®  is effective for HIV prevention.[²] The iPrEx study enrolled nearly 2500 MSM (1.2% of participants were transgendered women) participants from 6 countries, and included two cities in the US. All participants received frequent HIV testing, risk reduction counseling, condoms and lubricants, and screening and treatment for STIs. Half of the participants were randomly assigned to receive Truvada®, and the other half a placebo. The participants who received Truvada® had 44% fewer HIV infections than the participants who received the placebo. This means that PrEP prevented almost half of the infections that would have occurred if the medication was not provided. The protective effect of PrEP was even higher for those who were able to take the drug more consistently, including those who had evidence of Truvada® in their blood. The effectiveness of PrEP in other populations, such as heterosexual men and women, and injection drug users, is currently unknown as clinical trials have had mixed results. Still, there are several ongoing studies happening around the world in these populations, and those results will further enhance our understanding of PrEP’s efficacy [^9,10]. For detailed information on PrEP trials occurring globally, click here for a table of ongoing and planned studies [¹¹], and here for a PrEP trials timeline [¹²].

Is PrEP safe?

The iPrEx trial found that Truvada® was safe and generally well-tolerated by participants in the study. There were a few mild side effects related to Truvada®, such as nausea, which were infrequent and decreased with time. While a small amount of bone loss was seen in men receiving PrEP, a finding commonly seen in HIV-positive individuals starting similar antiretroviral treatment regimens, these changes had no apparent negative health impact.  Drug resistance was not seen among those who became HIV-infected during the iPrex study. Still, HIV testing and medical evaluation before starting, and while using PrEP, are important to prevent resistance and to monitor side effects on an individual level. Like the iPrex study, there were also no significant safety concerns raised in the trials of PrEP that have been conducted among heterosexual men and women. However, it is important to note that the follow-up in these studies was relatively short. Therefore, evaluating the longer-term safety of oral PrEP is important and will require further investigation in ongoing studies. Additional research is also needed to determine how frequently people taking PrEP will need to be seen by a health care provider and how often they will need to have laboratory monitoring, including HIV testing and monitoring of kidney function.

What are current recommendations for PrEP?

In January 2011, the Centers for Disease Control and Prevention (CDC) issued interim guidance on the use of PrEP for HIV prevention in MSM.[¹³] The CDC emphasizes that:

• PrEP should only be considered for MSM at high risk for HIV infection (and not other populations until additional data are available).
• PrEP should only be used in individuals with negative HIV antibody test(s) confirmed immediately prior to starting PrEP.  If symptoms of recent HIV infection are present, PrEP should be deferred and testing for acute HIV infection should be performed.
• PrEP should never be seen as the first line of defense against HIV. PrEP should be delivered as a part of a comprehensive prevention package that includes risk-reduction and adherence counseling, encouragement of condom use, and diagnosis and treatment of STIs.
• PrEP should be taken daily. Only the regimen tested in iPrEx (daily Truvada®) should be used, and not other antiretroviral medications or other dosing regimens (such as intermittent or occasional use).
• PrEP should be obtained and used in close collaboration with healthcare providers to monitor side effects, adherence, safety, and risk behaviors at regular intervals.

Individuals taking PrEP should undergo regular HIV testing and should stop taking PrEP if they test HIV-positive. Those interested in PrEP should discuss this with their physicians and should not use PrEP on their own. Comprehensive guidelines for PrEP use will be developed by the United States Public Health Service through expert consultation and community input.

What are the next steps for PrEP?

In July 2012 the U.S. Food and Drug Administration approved Truvada® to reduce the risk of HIV infection in uninfected individuals who are at high risk and who may engage in sexual activity with HIV-infected partners. Recognizing that no infectious disease has ever been eliminated through medications alone, we need to carefully consider how to best use this tool in combination with other prevention strategies to make the largest impact on HIV/AIDS in the US and worldwide. In the iPrEx, Partners PrEP and TDF-2 studies, PrEP was shown to be partially effective when used in combination with regular HIV testing, condoms and other proven prevention methods, like individual risk reduction counseling.  Combination prevention approaches that integrate biomedical, behavioral and structural components are necessary to optimize HIV prevention efforts.[¹⁴] As such, the effectiveness of PrEP depends not just on the effectiveness and safety of the drugs, but also on several other implementation factors, including good adherence to the drug, maintaining safer sex behaviors, and access to clinical and social support services. Interventions and programs that help HIV-negative individuals access PrEP, take the pills on a regular schedule, manage potential side effects, undergo regular HIV testing, and maintain safer sex and drug-using practices are key to maximizing PrEP’s effectiveness and acceptance.[^15,16] Additional studies, community-wide discussions, and advocacy work are underway to try to address and assess many of these important considerations.

Says Who?

1. WHO. Guidance on global scale-up of the prevention of mother-to-child-transmission of HIV: Towards universal access for women, infants and young children and eliminating HIV and AIDS among children. The Interagency Task Team on Prevention of HIV Infection in Pregnant Women, Mothers and Their Children, 2007.
2. Grant RM, Lama JR, Anderson PL, et al. Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men. NEJM 2010;363(27):2587-99. Epub 2010 Nov 23.
3. Abdool Karim Q, Abdool Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 2010;329:1168-74.
4. Centers for Disease Control and Prevention. CDC Trials: Pre-Exposure Prophylaxis for HIV Prevention.   https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf
5. Hall HI, Song R, Rhodes P, et al. Estimation of HIV incidence in the United States. JAMA 2008;300(5):520-9
6. Centers for Disease Control and Prevention. Estimates of new HIV infections in the United States. CDC. Available at: https://www.cdc.gov/hiv/statistics/overview/index.html
7. Stone A, Harrison PF.  Microbicides – Ways Forward. Alliance for Microbicide Development: Silver Spring, MD, USA. 2010.
8. Buchbinder SP, Liu A. Pre-exposure prophylaxis and the promise of combination prevention approaches. AIDS and Behavior. 2011:15,S1:72-79.
9. Peterson L, Taylor D, Roddy R, et al. Tenofovir disoproxil fumarate for prevention of HIV infection in women: a phase 2, double-blind, randomized, placebo-controlled trial. PLoS Clin Trials 2007;2:e27.
10. Grohskopf L, Gvetadze R, Pathak S, et al. Preliminary analysis of biomedical data from the phase II clinical safety trial of tenofovir disoproxil fumarate (TDF) for HIV-1 pre-exposure prophylaxis (PrEP) among U.S. men who have sex with men (MSM). Abstract no. FRLBC102, International AIDS Society 2010, Vienna.
11. AIDS Vaccine Advocacy Coalition. (2012, April). Ongoing and planned pre-exposure prophylaxis (PREP) trials.    https://www.avac.org/prevention-option/prep
12. AIDS Vaccine Advocacy Coalition. (2011, May). Oral and topical PrEP trials timeline. https://www.avac.org/prevention-option/prep 
13. Smith DK, Grant RM, Weidle PJ, et al. Interim guidance: preexposure prophylaxis for the prevention of HIV infection in men who have sex with men. Morbidity and Mortality Weekly Report. 2011;60:65-68.
14. Centers for Disease Control and Prevention. Pre-exposure prophylaxis (PrEP) for HIV prevention: Promoting safe and effective use in the United States  https://www.cdc.gov/hiv/effective-interventions/prevent/prep/index.html
15. Underhill K, Operario D, Skeer MR, et al. Packaging PrEP to prevent HIV: An integrated framework to plan for pre-exposure prophylaxis implementation in clinical practice. JAIDS.2010;55:8-13.
16. 16. Underhill K, Operario D, Mimiaga MJ, Skeer MR, Mayer KH. Implementation Science of Pre-exposure Prophylaxis: Preparing for Public Use. Curr HIV/AIDS Rep 2010;7:210-9.

Fact Sheet 19, October 2012 Prepared by Stephanie Cohen, MD & Al Liu, MD; SF DPH | Gabriel R. Galindo DrPH; CAPS Special thanks to the following reviewers of this Fact Sheet: David Abbott, Tom Aloisi, Susan Buchbinder, Katerina Christopoulos, Chris Collins, Jen Hect, Quarrasha Abdool Karim, Delia Molloy, Stephen Morin, Don Operario, Kristen Underhill and Dana Van Gorder.

Reproduction of this text is encouraged; however, copies may not be sold, and the Center for AIDS Prevention Studies at the University of California San Francisco should be cited as the source of this information. For additional copies of this and other HIV Prevention Fact Sheets, please call the National Prevention Information Network at 800/458-5231. Comments and questions about this Fact Sheet may be e-mailed to [email protected]. © July 2012, University of California