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Kimberly A. Workowski, M.D.
William C. Levine, M.D., M.Sc.
The material in this report was prepared for publication by the National Center for HIV, STD, and TB Prevention, Harold W. Jaffe, M.D., Acting Director; and the Division of Sexually Transmitted Diseases Prevention, Harold W. Jaffe, M.D., Acting Director.
These guidelines for the treatment of patients who have sexually transmitted diseases (STDs) were developed by the Centers for Disease Control and Prevention (CDC) after consultation with a group of professionals knowledgeable in the field of STDs who met in Atlanta on September 26--28, 2000. The information in this report updates the 1998 Guidelines for Treatment of Sexually Transmitted Diseases (MMWR 1998;47[No. RR-1]). Included in these updated guidelines are new alternative regimens for scabies, bacterial vaginosis, early syphilis, and granuloma inguinale; an expanded section on the diagnosis of genital herpes (including type-specific serologic tests); new recommendations for treatment of recurrent genital herpes among persons infected with human immunodeficiency virus (HIV); a revised approach to the management of victims of sexual assault; expanded regimens for the treatment of urethral meatal warts; and inclusion of hepatitis C as a sexually transmitted infection. In addition, these guidelines emphasize education and counseling for persons infected with human papillomavirus, clarify the diagnostic evaluation of congenital syphilis, and present information regarding the emergence of quinolone-resistant Neisseria gonorrhoeae and implications for treatment. Recommendations also are provided for vaccine-preventable STDs, including hepatitis A and hepatitis B.
Physicians and other health-care providers play a critical role in preventing and treating sexually transmitted diseases (STDs). These recommendations for the treatment of STDs are intended to assist with that effort. Although these guidelines emphasize treatment, prevention strategies and diagnostic recommendations also are discussed.
This report was produced through a multi-stage process. Beginning in 2000, CDC personnel and professionals knowledgeable in the field of STDs systematically reviewed literature (i.e., published abstracts and peer-reviewed journal articles) concerning each of the major STDs, focusing on information that had become available since publication of the 1998 Guidelines for Treatment of Sexually Transmitted Diseases (1). Background papers were written and tables of evidence constructed summarizing the type of study (e.g., randomized controlled trial or case series), study population and setting, treatments or other interventions, outcome measures assessed, reported findings, and weaknesses and biases in study design and analysis. A draft document was developed on the basis of the reviews.
In September 2000, CDC staff members and invited consultants assembled in Atlanta for a 3-day meeting to present the key questions regarding STD treatment that emerged from the literature reviews and the information available to answer those questions. When relevant, the questions focused on four principal outcomes of STD therapy for each individual disease: a) microbiologic cure, b) alleviation of signs and symptoms, c) prevention of sequelae, and d) prevention of transmission. Cost-effectiveness and other advantages (e.g., single-dose formulations and directly observed therapy [DOT]) of specific regimens also were discussed. The consultants then assessed whether the questions identified were relevant, ranked them in order of priority, and attempted to arrive at answers using the available evidence. In addition, the consultants evaluated the quality of evidence supporting the answers on the basis of the number, type, and quality of the studies.
In several areas, the process diverged from that previously described. The sections concerning adolescents and hepatitis A, B, and C infections were developed by other CDC staff members knowledgeable in this field. The recommendations for STD screening during pregnancy were developed after CDC staff reviewed the published recommendations from other knowledgeable groups. The sections concerning early human immunodeficiency virus (HIV) infection are a compilation of recommendations developed by CDC staff members knowledgeable in the field of HIV infection. The sections on hepatitis B virus (HBV) (2) and hepatitis A virus (HAV) (3) infections are based on previously published recommendations of the Advisory Committee on Immunization Practices (ACIP).
Throughout this report, the evidence used as the basis for specific recommendations is discussed briefly. More comprehensive, annotated discussions of such evidence will appear in background papers that will be published in a supplement issue of the journal Clinical Infectious Diseases. When more than one therapeutic regimen is recommended, the sequence is alphabetized unless the choices for therapy are prioritized based on efficacy, convenience, or cost. For STDs with more than one recommended regimen, almost all regimens have similar efficacy and similar rates of intolerance or toxicity unless otherwise specified.
These recommendations were developed in consultation with public- and private-sector professionals knowledgeable in the treatment of patients with STDs. They are applicable to various patient-care settings, including family planning clinics, private physicians' offices, managed care organizations, and other primary-care facilities. When using these guidelines, the disease prevalence and other characteristics of the medical practice setting should be considered. These recommendations should be regarded as a source of clinical guidance and not as standards or inflexible rules. These guidelines focus on the treatment and counseling of individual patients and do not address other community services and interventions that are important in STD/HIV prevention.
The prevention and control of STDs is based on the following five major concepts: a) education and counseling of persons at risk on ways to adopt safer sexual behavior; b) identification of asymptomatically infected persons and of symptomatic persons unlikely to seek diagnostic and treatment services; c) effective diagnosis and treatment of infected persons; d) evaluation, treatment, and counseling of sex partners of persons who are infected with an STD; and e) preexposure vaccination of persons at risk for vaccine-preventable STDs. Although this report focuses mainly on the clinical aspects of STD control, primary prevention of STDs begins with changing the sexual behaviors that place persons at risk for infection. Moreover, because STD control activities reduce the likelihood of transmission to sex partners, treatment of infected persons constitutes primary prevention of spread within the community.
Clinicians have a unique opportunity to provide education and counseling to their patients. As part of the clinical interview, health-care providers can obtain sexual histories from their patients. Guidance in obtaining a sexual history is available in Contraceptive Technology, 17th edition (4).
Prevention messages should be tailored to the patient, with consideration given to the patient's specific risk factors for STDs. Messages should include a description of specific actions that the patient can take to avoid acquiring or transmitting STDs (e.g., abstinence from sexual activity if STD-related symptoms develop).
If risk factors are identified, providers should encourage patients to adopt safer sexual behaviors. Counseling skills (e.g., respect, compassion, and a nonjudgmental attitude) are essential to the effective delivery of prevention messages. Techniques that can be effective in facilitating rapport with the patient include using open-ended questions, using understandable language, and reassuring the patient that treatment will be provided regardless of circumstances unique to individual patients (including ability to pay, citizenship or immigration status, language spoken, or lifestyle).
Many patients seeking treatment or screening for STDs expect evaluation for all common STDs; all patients should be specifically informed if testing for a common STD (e.g., genital herpes and human papillomavirus [HPV]) is not performed.
The most reliable way to avoid transmission of STDs is to abstain from sexual intercourse (i.e., oral, vaginal, or anal sex) or to be in a long-term, mutually monogamous relationship with an uninfected partner. Counseling that encourages abstinence from sexual intercourse is crucial for persons who are being treated for an STD or whose partners are undergoing treatment and for persons who wish to avoid the possible consequences of sexual intercourse (e.g., STD/HIV and unintended pregnancy). A more comprehensive discussion of abstinence and the range of sexual expression is available in Contraceptive Technology, 17th edition (4).
Preexposure vaccination is one of the most effective methods for preventing transmission of certain STDs. For example, because hepatitis B virus infection frequently is sexually transmitted, hepatitis B vaccination is recommended for all unvaccinated persons being evaluated for an STD. In addition, hepatitis A vaccine is currently licensed and is recommended for men who have sex with men (MSM) and illegal drug users (both injection and non-injection). Vaccine trials for other STDs are being conducted, and additional vaccines may become available in the next several years.
When used consistently and correctly, male latex condoms are effective in preventing the sexual transmission of HIV infection and can reduce the risk for other STDs (i.e., gonorrhea, chlamydia, and trichomonas). However, because condoms do not cover all exposed areas, they are likely to be more effective in preventing infections transmitted by fluids from mucosal surfaces (e.g., gonorrhea, chlamydia, trichomoniasis, and HIV) than in preventing those transmitted by skin-to-skin contact (e.g., herpes simplex virus [HSV], HPV, syphilis, and chancroid). Condoms are regulated as medical devices and are subject to random sampling and testing by the Food and Drug Administration (FDA). Each latex condom manufactured in the United States is tested electronically for holes before packaging. Rates of condom breakage during sexual intercourse and withdrawal are low in the United States (i.e., approximately two broken condoms per 100 condoms used). Condom failure usually results from inconsistent or incorrect use rather than condom breakage.
Male condoms made of materials other than latex are available in the United States. Although they have had higher breakage and slippage rates when compared with latex condoms, the pregnancy rates among women whose partners use these condoms are similar. Non-latex condoms (i.e., those made of polyurethane or other synthetic material) can be substituted for persons with latex allergy.
Patients should be advised that condoms must be used consistently and correctly to be highly effective in preventing STDs. Patients should be instructed in the correct use of condoms. The following recommendations ensure the proper use of male condoms.
Laboratory studies indicate that the female condom (Reality™), which consists of a lubricated polyurethane sheath with a ring on each end that is inserted into the vagina, is an effective mechanical barrier to viruses, including HIV (5). With the exception of one investigation of recurrent trichomoniasis, no clinical studies have been completed to evaluate the efficacy of female condoms in providing protection from STDs, including HIV. If used consistently and correctly, the female condom may substantially reduce the risk for STDs. When a male condom cannot be used properly, sex partners should consider using a female condom.
Vaginal Spermicides, Sponges, and Diaphragms
Recent evidence has indicated that vaginal spermicides containing nonoxynol-9 (N-9) are not effective in preventing cervical gonorrhea, chlamydia, or HIV infection (6). Thus, spermicides alone are not recommended for STD/HIV prevention. Frequent use of spermicides containing N-9 has been associated with genital lesions, which may be associated with an increased risk of HIV transmission. The vaginal contraceptive sponge appears to protect against cervical gonorrhea and chlamydia, but its use increases the risk for candidiasis. In case-control and cross-sectional studies, diaphragm use has been demonstrated to protect against cervical gonorrhea, chlamydia, and trichomoniasis; however, no cohort studies have been conducted (7). Neither vaginal sponges nor diaphragms should be relied on to protect women against HIV infection. The role of spermicides, sponges, and diaphragms for preventing transmission of HIV to men has not been evaluated. Diaphragm and spermicide use has been associated with an increased risk of bacterial urinary tract infection in women.
Condoms and N-9 Vaginal Spermicides
Condoms lubricated with spermicides are no more effective than other lubricated condoms in protecting against the transmission of HIV and other STDs. Distribution of previously purchased condoms lubricated with N-9 spermicide should continue provided the condoms have not passed their expiration date. However, purchase of any additional condoms lubricated with the spermicide N-9 is not recommended because spermicide-coated condoms cost more, have a shorter shelf-life than other lubricated condoms, and have been associated with urinary tract infection in young women.
Rectal Use of N-9 Spermicides
Recent data indicate that N-9 may increase the risk for HIV transmission during vaginal intercourse (6). Although similar studies have not been conducted among men who use N-9 spermicide during anal intercourse with other men, N-9 can damage the cells lining the rectum, thus providing a portal of entry for HIV and other sexually transmissible agents. Therefore, N-9 should not be used as a microbicide or lubricant during anal intercourse.
Nonbarrier Contraception, Surgical Sterilization, and Hysterectomy
Women who are not at risk for pregnancy might incorrectly perceive themselves to be at no risk for STDs, including HIV infection. Contraceptive methods that are not mechanical or chemical barriers offer no protection against HIV or other STDs. Women who use hormonal contraception (e.g., oral contraceptives, Norplant™, and Depo-Provera™), have intrauterine devices (IUDs), have been surgically sterilized, or have had hysterectomies should be counseled regarding the use of condoms and the risk for STDs, including HIV infection.
Interactive counseling approaches directed at a patient's personal risk, the situations in which risk occurs, and use of goal-setting strategies are effective in STD prevention (8). One such approach --- "client-centered" HIV prevention counseling --- involves two sessions, each lasting 15--20 minutes, and has been recommended for STD clinic patients who receive HIV testing. In addition to prevention counseling, certain videos and large group presentations that provide explicit information about how to use condoms correctly have been effective in reducing the occurrence of additional STDs among persons at high risk, including STD clinic patients and adolescents. Results from randomized controlled trials demonstrate that compared with traditional approaches to providing information, certain brief risk reduction counseling approaches can reduce the occurrence of new sexually transmitted infections by 25%--40% among STD clinic patients (9).
Interactive counseling strategies can be effectively used by most health-care providers, regardless of educational background or demographic profile. High-quality counseling is best ensured when clinicians are provided basic training in prevention counseling methods and skills building approaches, periodic supervisor observation of counseling with immediate feedback to counselors, periodic counselor and/or patient satisfaction evaluations, and regularly scheduled meetings of counselors and supervisors to discuss difficult situations. Prevention counseling is believed to be more effective if provided in a non-judgmental manner appropriate to the patient's culture, language, sex, sexual orientation, age, and developmental level.
Partner notification, once referred to as "contact tracing" but more recently included in the broader category of partner services, is the process of learning from persons with STDs about their sexual partners and helping to arrange for evaluation and treatment of those partners. Providers can furnish this service directly or with assistance from state and local health departments. The intensity of services and the specific conditions for which such services are offered by health agencies vary from area to area. Such services usually are accompanied by health counseling and may include referral of patients and their partners for other services.
Many persons benefit from partner notification; thus, providers should encourage their patients to make partners aware of potential STD risk and urge them to seek diagnosis and treatment, regardless of assistance from local health agencies. However, whether the process of partner notification effectively decreases exposure to STDs from a person's sexual environment or whether it changes the incidence and prevalence of disease is uncertain. The paucity of supporting evidence regarding the consequences of partner notification has spurred the exploration of alternative approaches. One such approach is to place partner notification in the larger context of the sexual and social networks in which people are exposed to STDs. The underlying hypotheses are that networks have an influence on disease transmission that is independent of personal behaviors, that network structure is related directly to prevalence and to underlying disease transmission dynamics, and that network approaches provide a more powerful tool for identifying exposed persons and other persons at risk. A second such approach for which supporting data are being collected is the use of patient delivered therapy for treatment of contacts and others at risk, a technique that can considerably expand the role of practitioners in the control of STDs. The combination of these approaches has the potential to provide both an intervention and its evaluative tool.
These approaches have not yet been sufficiently assessed to warrant definitive recommendations. However, practitioners and public health professionals should be aware of the current potential use of these nontraditional modalities in the prevention and control of STDs.
The accurate identification and timely reporting of STDs are integral components of successful disease control efforts. Timely reporting is important for assessing morbidity trends, targeting limited resources, and assisting local health authorities in identifying sex partners who may be infected. STD/HIV and acquired immunodeficiency syndrome (AIDS) cases should be reported in accordance with local statutory requirements.
Syphilis, gonorrhea, chlamydia, and AIDS are reportable diseases in every state. HIV infection and chancroid are reportable in many states. The requirements for reporting other STDs differ by state, and clinicians should be familiar with local reporting requirements. Reporting can be provider- and/or laboratory-based. Clinicians who are unsure of local reporting requirements should seek advice from local health departments or state STD programs.
STD and HIV reports are kept strictly confidential. In most jurisdictions, such reports are protected by statute from subpoena. Before public health representatives conduct a follow-up of a positive STD-test result, they should consult the patient's health-care provider to verify the diagnosis and treatment.
Intrauterine or perinatally transmitted STDs can have severely debilitating effects on pregnant women, their partners, and their fetuses. All pregnant women and their sex partners should be asked about STDs, counseled about the possibility of perinatal infections, and ensured access to treatment, if needed.
Recommended Screening Tests
Other STD-related concerns are as follows.
For a more detailed discussion of these guidelines, as well as infections not transmitted sexually, refer to the following references: Guide to Clinical Preventive Services (10), Guidelines for Perinatal Care (11), American College of Obstetricians and Gynecologists (ACOG) Educational Bulletin: Antimicrobial Therapy for Obstetric Patients (12), ACOG Committee Opinion: Primary and Preventive Care: Periodic Assessments (13), Recommendations for the Prevention and Management of Chlamydia trachomatis Infections (14), Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States through Universal Childhood Vaccination --- Recommendations of the Immunization Practices Advisory Committee (ACIP) (2), Mother-to-infant transmission of hepatitis C virus (15), Hepatitis C: Screening in pregnancy (16), American College of Obstetricians and Gynecologists (ACOG) Educational Bulletin: Viral hepatitis in pregnancy (17), Human Immunodeficiency Virus Screening: Joint statement of the AAP and ACOG (18), Preventing Perinatal Transmission of HIV (19), and the Revised Public Health Service Recommendations for HIV Screening of Pregnant Women (20).
These sources are not entirely consistent in their recommendations. The Guide to Clinical Preventive Services recommends screening of patients at high risk for chlamydia, but indicates that the optimal timing for screening is uncertain. The Guidelines for Perinatal Care recommend that pregnant women at high risk for chlamydia be screened for infection during the first prenatal-care visit and during the third trimester. Recommendations to screen pregnant women for STDs are based on disease severity and sequelae, prevalence in the population, costs, medicolegal considerations (e.g., state laws), and other factors. The screening recommendations in this report are more extensive (i.e., if followed, more women will be screened for more STDs than would be screened by following other recommendations) and are compatible with other CDC guidelines.
Health professionals who provide care for adolescents should be aware of several issues that relate specifically to persons within this age group. The rates of many STDs are highest among adolescents. For example, the reported rates of chlamydia and gonorrhea are highest among females aged 15--19 years, and young adults are also at highest risk for HPV infection. In addition, surveillance data indicate that 9% of adolescents who have acute HBV infection either have had sexual contact with a chronically infected person or with multiple sex partners or report their sexual preference as homosexual. As part of a comprehensive strategy to eliminate HBV transmission in the United States, ACIP has recommended that all children be administered hepatitis B vaccine (2).
Younger adolescents (i.e., persons aged <15 years) who are sexually active are at particular risk for infection. Adolescents at especially high risk for STDs include youth in detention facilities, STD clinic patients, male homosexuals, and injection-drug users. Adolescents are at greater risk for STDs because they frequently have unprotected intercourse, are biologically more susceptible to infection, are engaged in partnerships often of limited duration, and face multiple obstacles to utilization of health care. Several of these issues can be addressed by clinicians who provide services to adolescents. Clinicians can address the lack of knowledge and awareness about the risks and consequences of STDs and offer guidance, constituting true primary prevention, to help adolescents develop healthy sexual behaviors and thus prevent the establishment of patterns of behavior that can undermine sexual health.
With a few exceptions, all adolescents in the United States can consent to the confidential diagnosis and treatment of STDs. Medical care for STDs can be provided to adolescents without parental consent or knowledge. Furthermore, in many states adolescents can consent to HIV counseling and testing. Consent laws for vaccination of adolescents differ by state. Several states consider provision of vaccine similar to treatment of STDs and provide vaccination services without parental consent. Health-care providers should acknowledge the importance of confidentiality for adolescents and should strive to follow policies that comply with state laws to ensure the confidentiality of STD-related services.
Despite the prevalence of STDs among adolescents, providers frequently fail to inquire about sexual behavior, assess risk for STDs, counsel about risk reduction, and screen for asymptomatic infection during clinical encounters. When addressing these sensitive areas with young people, the style and content of counseling and health education should be adapted for adolescents. Discussions should be appropriate for the patient's developmental level and should identify risky behaviors (e.g., sex and drug-use behaviors). Careful counseling and thorough discussions are particularly important for adolescents who may not acknowledge that they engage in high-risk behaviors. Care and counseling should be direct and nonjudgmental.
Management of children who have STDs requires close cooperation between clinicians, laboratorians, and child-protection authorities. Investigations, when indicated, should be initiated promptly. Some diseases (e.g., gonorrhea, syphilis, and chlamydia), if acquired after the neonatal period, are almost 100% indicative of sexual contact. For other diseases (e.g., HPV infection and vaginitis), the association with sexual contact is not as clear (see Sexual Assault and STDs).
Some MSM are at high risk for HIV infection and other viral and bacterial STDs. Although the frequency of unsafe sexual practices and reported rates of bacterial STDs and incident HIV infection has declined substantially in MSM during the last several decades, increased rates of infectious syphilis, gonorrhea, and chlamydial infection, largely among HIV-infected MSM, have been recently reported in many cities in the United States and other industrialized countries. Preliminary data also indicate higher frequencies of unsafe sex and suggest that the incidence of HIV infection may be rising among MSM in some cities. The underlying behavioral changes likely are related to effects of improved HIV/AIDS therapy on quality of life and survival, "safer sex burnout," and in some cities, adverse trends in substance abuse.
Clinicians should assess sexual risk for all male patients, which includes routinely inquiring about the sex of patients' sex partners. MSM, including those with HIV infection, should routinely undergo straightforward, nonjudgmental STD/HIV risk assessment and client-centered prevention counseling to reduce the likelihood of acquisition or transmission of HIV and other STDs. In addition, screening for STDs should be considered for many MSM. The following screening recommendations are based on preliminary data; these tests should be performed at least annually for sexually active MSM:
In addition, vaccination against hepatitis is the most effective means of preventing sexual transmission of hepatitis A and B. Prevaccination serologic testing may be cost-effective in MSM, among whom the prevalence of hepatitis A and B infection is likely to be high.
More frequent STD screening (e.g., at 3--6-month intervals) may be indicated for MSM at highest risk (e.g., those who acknowledge having multiple anonymous partners or having sex in conjunction with illicit drug use and patients whose sex partners participate in these activities). Screening tests usually are indicated regardless of a patient's history of consistent use of condoms for insertive or receptive anal intercourse. Providers also should be knowledgeable about the common manifestations of symptomatic STDs in MSM (e.g., urethral discharge, dysuria, anorectal symptoms [such as pain, pruritis, discharge, and bleeding], genital or anorectal ulcers, other mucocutaneous lesions, lymphadenopathy, and skin rash). If these symptoms are present, providers should perform appropriate diagnostic tests.
Infection with HIV produces a spectrum of disease that progresses from a clinically latent or asymptomatic state to AIDS as a late manifestation. The pace of disease progression varies. In untreated patients, the time between infection with HIV and the development of AIDS ranges from a few months to as long as 17 years (median: 10 years). Most adults and adolescents infected with HIV remain symptom-free for extended periods, but viral replication is active during all stages of infection, increasing substantially as the immune system deteriorates. In the absence of treatment, AIDS eventually develops in almost all HIV-infected persons; in one study of HIV-infected adults, AIDS developed in 87% within 17 years of infection. Additional cases are expected to occur among those who have remained AIDS-free for longer periods of time.
Greater awareness among both patients and health-care providers of the risk factors associated with HIV transmission has led to increased testing for HIV and earlier diagnosis of the infection, often before symptoms develop. Prompt diagnosis of HIV infection is important for several reasons. Treatments are available that slow the decline of immune system function; use of these therapies has been associated with substantial declines in HIV-associated morbidity and mortality in recent years. HIV-infected persons who have altered immune function are at increased risk for infections for which preventive measures are available (e.g., Pneumocystis carinii pneumonia [PCP], toxoplasmic encephalitis [TE], disseminated Mycobacterium avium complex [MAC] disease, tuberculosis [TB], and bacterial pneumonia). Because of its effect on the immune system, HIV affects the diagnosis, evaluation, treatment, and follow-up of many other diseases and may affect the efficacy of antimicrobial therapy for some STDs. Finally, the early diagnosis of HIV enables health-care providers to counsel such patients, refer them to various support services, and help prevent HIV transmission to others.
Proper management of HIV infection involves a complex array of behavioral, psychosocial, and medical services. Although some of these services may be available in the STD treatment facility, many services are often unavailable in this setting. Therefore, referral to a health-care provider or facility experienced in caring for HIV-infected patients is advised. Staff in STD treatment facilities should be knowledgeable about the options for referral available in their communities. While in STD treatment facilities, HIV-infected patients should be educated about HIV infection and the various options for available support services and HIV care.
Because multiple, complex services are required for management of HIV infection, detailed information (particularly regarding medical care) is beyond the scope of this section and can be found elsewhere (8,21). This report provides information regarding diagnostic testing for HIV infection, counseling patients who have HIV infection, and referral of patients to support services (including medical care). Information also is provided regarding the management of sex partners, because such services can and should be provided in STD treatment facilities. In addition, the topics of HIV infection during pregnancy and in infants and children are addressed.
Testing for HIV is recommended and should be offered to all persons who seek evaluation and treatment for STDs. Counseling before and after testing (i.e., pretest and posttest counseling) is an integral part of the testing procedure (see HIV Prevention Counseling). Informed consent must be obtained before an HIV test is performed. Some states require written consent.
HIV infection usually is diagnosed by tests for antibodies against HIV-1 and HIV-2 (HIV-1/2). Antibody testing begins with a sensitive screening test (e.g., the enzyme immunoassay [EIA]). Reactive screening tests must be confirmed by supplemental test (e.g., the Western blot [WB]) or an immunofluorescence assay (IFA). If confirmed by a supplemental test, a positive antibody test result indicates that a person is infected with HIV and is capable of transmitting the virus to others. HIV antibody is detectable in at least 95% of patients within 3 months after infection. Although a negative antibody test result usually indicates that a person is not infected, antibody tests cannot exclude recent infection.
Most HIV infections in the United States are caused by HIV-1; <100 cases of HIV-2 infection have been documented (22). However, HIV-2 infection should be suspected in persons who have epidemiologic risk factors for HIV-2. Examples of these risk factors include persons with sex partners from West Africa (where HIV-2 is endemic), those with sex partners known to be infected with HIV-2, and persons who received a blood transfusion or a non-sterile injection in a West African country. HIV-2 testing is also indicated when clinical evidence of HIV exists but tests for antibodies to HIV-1 are not positive, or when HIV-1 Western blot results include the unusual indeterminate pattern of gag plus pol bands in the absence of env bands (22).
Health-care providers should be knowledgeable about the symptoms and signs of acute retroviral syndrome, which is characterized by fever, malaise, lymphadenopathy, and skin rash. This syndrome frequently occurs in the first few weeks after HIV infection, before antibody test results become positive. Suspicion of acute retroviral syndrome should prompt nucleic acid testing (HIV plasma RNA [i.e., viral load]) to detect the presence of HIV, although this test is not approved for diagnostic purposes; a positive test should be confirmed by another HIV test. Current guidelines suggest that persons with recently acquired HIV infection might benefit from antiretroviral drugs, and such patients may be candidates for clinical trials (23,24). Therefore, patients with acute HIV infection should be referred immediately to an HIV clinical care provider.
Detection of HIV infection should prompt efforts to reduce the risk behavior that resulted in HIV infection and could result in transmission of HIV to others. Early counseling and education are particularly important for persons with recently acquired infection, because HIV plasma RNA levels are characteristically high during this phase of infection and likely constitute a risk factor for HIV transmission.
The following are specific recommendations for diagnostic testing for HIV infection.
Patients can be expected to be distressed when first informed of a positive HIV test result. Such patients face several major adaptive challenges, including a) accepting the possibility of a shortened life span, b) coping with others' reactions to a stigmatizing illness, c) developing and adopting strategies for maintaining physical and emotional health, and d) initiating changes in behavior to prevent HIV transmission to others. Many patients also require assistance with making reproductive choices, gaining access to health services, and confronting possible employment or housing discrimination. Therefore, in addition to medical care, behavioral and psychosocial services are an integral part of health care for HIV-infected patients. Such services should be available on site or through referral when HIV infection is diagnosed. A comprehensive discussion of specific recommendations is available in the Guidelines for HIV Counseling, Testing, and Referral (8).
Practice settings for offering HIV care differ depending on local resources and needs. Primary-care providers and outpatient facilities must ensure that appropriate resources are available for each patient to avoid fragmentation of care. Although a single source that is capable of providing comprehensive care for all stages of HIV infection is preferred, the limited availability of such resources often results in the need to coordinate care among medical and social service providers in different locations. Providers should avoid long delays between diagnosis of HIV infection and access to additional medical and psychosocial services.
Recently identified HIV infection may not have been recently acquired. Persons newly diagnosed with HIV may be at any stage of infection. Therefore, health-care providers should be alert for symptoms or signs that suggest advanced HIV infection (e.g., fever, weight loss, diarrhea, cough, shortness of breath, and oral candidiasis). The presence of any of these symptoms should prompt urgent referral for medical care. Similarly, providers should be alert for signs of psychologic distress and be prepared to refer patients accordingly.
Diagnosis of HIV infection reinforces the need to counsel patients regarding high risk behaviors, because the consequences of such behaviors include the risk for acquiring additional STDs and for transmitting HIV (and other STDs) to other persons. Such attention to behaviors in HIV-infected persons is consistent with national strategies for HIV prevention (25). Providers should be able to refer patients for prevention counseling and risk reduction support concerning high risk behaviors (e.g., substance abuse and high risk sexual behavior).
HIV-infected patients in the STD treatment setting should be educated about what to expect as they enter medical care for HIV infection. In non-emergent situations, the initial evaluation of HIV-positive patients usually includes a) a detailed medical history, including sexual and substance-abuse history, previous STDs, and specific HIV-related symptoms or diagnoses; b) a physical examination (including a gynecologic examination for women); c) testing for N. gonorrhoeae and C. trachomatis (and for women, a Pap test and wet mount examination of vaginal secretions); d) complete blood and platelet counts and blood chemistry profile; e) toxoplasma antibody test; f) tests for hepatitis B, C, and for MSM, hepatitis A; g) syphilis serology; h) a CD4+ T-lymphocyte analysis and determination of HIV plasma RNA (i.e., HIV viral load); i) a tuberculin skin test (TST) (sometimes referred to as a purified protein derivative [PPD]); j) a urinalysis; and k) a chest radiograph (21).
In subsequent visits, once the results of laboratory and skin tests are available, the patient may be offered antiretroviral therapy (23,24), if indicated, as well as specific medications to reduce the incidence of opportunistic infections (e.g., PCP, TE, disseminated MAC infection, and TB) (21,26). Hepatitis B vaccination should be offered to patients who lack hepatitis B serologic markers. Hepatitis A vaccination should be given to persons at increased risk for hepatitis A infection (e.g., MSM and illegal drug users) and to patients with chronic hepatitis B or hepatitis C who lack antibodies to hepatitis A. Influenza vaccination should be offered annually, and pneumococcal vaccination should be administered if not given in the previous 5 years (21).
Providers must be alert to the possibility of new or recurrent STDs and treat such conditions aggressively. Occurrence of an STD in an HIV-infected person is an indication of high-risk behavior and should prompt referral for counseling. Because many STDs are asymptomatic, routine screening for curable STDs (e.g., syphilis, gonorrhea, and chlamydia) should be performed at least yearly for sexually active persons. More frequent screening may be appropriate depending on individual risk behaviors, the local epidemiology of STDs, and whether incident STDs are detected by screening or by the presence of symptoms.
Patients should receive, or be referred for, a thorough psychosocial evaluation, including ascertainment of behavioral factors indicating risk for transmitting HIV. Patients may require referral for specific behavioral intervention (e.g., a substance abuse program), for mental health disorders (e.g., depression), or for emotional distress. They may require assistance with securing and maintaining employment and housing. Women should be counseled or appropriately referred regarding reproductive choices and contraceptive options. Patients with multiple psychosocial problems may be candidates for prevention case management (27).
The following are specific recommendations for counseling and referral.
Clinicians evaluating HIV-infected persons should collect information to determine whether any partners should be notified about possible exposure to HIV (8). When referring to persons who are infected with HIV, the term "partner" includes not only sex partners but also injection-drug users who share syringes or other injection equipment. The rationale for partner notification is that the early diagnosis and treatment of HIV infection in these partners possibly reduces morbidity and provides the opportunity to encourage risk-reducing behaviors. Partner notification for HIV infection must be confidential and depends on the voluntary cooperation of the patient.
Two complementary notification processes, patient referral and provider referral, can be used to identify partners. With patient referral, patients directly inform their partners of their exposure to HIV infection. With provider referral, trained health department personnel locate partners on the basis of the names, descriptions, and addresses provided by the patient. During the notification process, the confidentiality of patients is protected; their names are not revealed to partners who are notified. Many state health departments provide assistance, if requested, with provider-referral partner notification.
The following are specific recommendations for implementing partner-notification procedures.
Voluntary counseling and HIV testing should be offered routinely to all pregnant women as early in pregnancy as possible (20). For women who decline these services, providers should continue to strongly encourage testing and to address concerns that pose obstacles to testing. Providing pregnant women with counseling and testing is particularly important not only to maintain the health of the patient, but also because interventions (antiretroviral and obstetrical) are available that can reduce perinatal transmission of HIV.
Once identified as being HIV-infected, pregnant women should be informed specifically about the risk for perinatal infection. Current evidence indicates that, in the absence of antiretroviral and other interventions, 15%--25% of infants born to HIV-infected mothers will become infected with HIV; such evidence also indicates that an additional 12%--14% are infected during breastfeeding in resource-limited settings where HIV-infected women breastfeed their infants into the second year of life (28). However, the risk of HIV transmission can be reduced substantially to <2% through antiretroviral regimens and obstetrical interventions (i.e., AZT or nevirapine and elective c-section at 38 weeks of pregnancy) and by avoiding breastfeeding (29). Pregnant women who are HIV-infected should be counseled about their options (either on-site or by referral), given appropriate antenatal treatment, and (for women living in the United States, where infant formula is readily available and can be safely prepared) advised not to breastfeed their infants.
HIV Infection Among Infants and Children
Diagnosis of HIV infection in a pregnant woman indicates the need to consider whether additional children are infected. Infants and young children with HIV infection differ from adults and adolescents with respect to the diagnosis, clinical presentation, and management of HIV disease. For example, because maternal HIV antibody passes through the placenta, antibody tests for HIV are expected to be positive in the sera of both infected and uninfected infants born to seropositive mothers. A definitive determination of HIV infection for an infant aged <18 months should be based on laboratory evidence of HIV in blood or tissues by culture, nucleic acid, or antigen detection. Management of infants, children, and adolescents who are known or suspected to be infected with HIV requires referral to physicians familiar with the manifestations and treatment of pediatric HIV infection (21,30).
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