Essential Components of SAFE
The 5 SAFE steps are as follows: (1) Increase the number of HIV-infected persons who know their serostatus. (2) Increase the use of health care and preventive services. (3) Increase high-quality care and treatment. (4) Increase adherence to therapy by individuals with HIV. (5) Increase the number of individuals with HIV who adopt and sustain HIV-STD risk reduction behavior.
There are both medical and public health benefits to increasing knowledge of HIV status as early after infection as possible.
Medical benefits of HIV diagnosis. Individuals who have early knowledge of their HIV infection can benefit from prophylaxis for opportunistic infections; treatment of STDs, substance abuse, and mental health conditions; access to social services; and, when appropriate, use of combination antiretroviral therapy (ART).5 Prophylaxis of opportunistic infections has been important in reducing HIV-related morbidity;6 treatment of STDs can reduce the risk of HIV transmission; treatment of substance abuse and mental health problems can reduce HIV risk behavior.7 It is ART, though, that has had the most dramatic effect on morbidity and mortality. HIV-infected individuals in care are now living longer than before the advent of highly active antiretroviral agents,8 and one study suggests that some HIV-infected individuals receiving ART may have a normal life expectancy.9 AIDS is no longer 1 of the 15 leading causes of death in the United States.10 Quality of life for individuals with HIV has improved substantially, although the drugs' side effects can be troublesome and even life threatening. Recent information about side effects has resulted in a recommendation to delay the initiation of ART.5
Public health benefits of HIV diagnosis. Although 70% of individuals with HIV remain sexually active after they learn they are infected,11,12 it is clear that when people know they are HIV infected, they are significantly more likely to take steps to protect their partners than when they were unaware of their infection.12-15 It is probable, then, that a high proportion of HIV infections are being transmitted by people unaware of their HIV status. The only data that address this issue directly are from the Options Project in San Francisco, where 15 of 39 newly infected people were infected by individuals who did not know their serostatus (F. Hecht, written communication, February 1, 2001).
Another important public health reason for considering people with HIV as a priority population for HIV prevention programs is that ART may reduce infectiousness. If low viral load is associated with a lower risk of transmission and if antiretroviral drugs reduce viral load, then antiretroviral drugs may reduce transmission. High plasma viral load is an important risk factor for all modes of HIV transmission.16-22 In 2 studies in Africa, the risk of heterosexual transmission increased approximately 2.5-fold for every 10-fold increase in plasma viral load.23,24 Several studies have demonstrated a correlation between plasma HIV RNA and concentration of HIV RNA in semen and cervicovaginal secretions.25-28 ART reduces both plasma and genital fluid viral load; persons with the greatest decline in plasma HIV RNA concentration are most likely to show undetectable genital fluid HIV RNA.26-28 Although cell-associated virus is frequently present when seminal HIV RNA is undetectable,29 animal model data suggest that transmission by cell-associated virus may be less efficient than transmission by cell-free virus.30,31 The reduction of HIV transmission through the use of antiretroviral treatment is most clearly seen in the reduction of mother-to-child transmission.32-35 All of these data suggest that ART probably reduces the infectiousness of HIV during sexual and drug-using exposures, although the evidence is still indirect. The spread of a sexually transmitted agent in a population is related to the rate of partner change, the agent's transmissibility, and the duration of infectiousness.36 By lowering viral load, ART can potentially reduce the duration as well as the degree of infectiousness and therefore reduce HIV transmission at the population level, provided that partner change, condom use, and sexual practices remain unchanged.
Because of these individual and public health benefits of HIV diagnoses, the CDC is giving additional emphasis to encouraging those at high risk for infection to seek testing and is expanding access to voluntary testing as a part of SAFE (Table 2). The CDC is piloting a media campaign called "Know Now" to encourage testing through raising individual awareness of the benefits of knowing HIV status among risk populations in high-prevalence, geographically circumscribed areas. This campaign is using marketing strategies and multiple forms of media to address motivation for and psychologic barriers to testing.37 Such media campaigns are also targeting stigma associated with testing and a diagnosis of HIV infection.
Table 2—Examples of Essential Components of Centers for Disease Control and Prevention Programs Focusing on Individuals With HIV
- Increase number of HIV-infected persons who know their serostatus.
Create campaigns to emphasize benefits of early diagnosis of HIV.
Educate to reduce fear of knowledge of serostatus.
Create campaigns to diminish discrimination against HIV-infected persons.
Create campaigns to reduce stigma associated with HIV infection.
Train providers of high-risk persons on benefits and strategies of early HIV diagnosis.
Create campaigns to encourage voluntary HIV testing.
Continue to support anonymous testing.
Make testing venues more responsive to client needs.
Facilitate use of rapid tests.
Increase voluntary testing in health care facilities.
Increase voluntary testing of pregnant women.
Increase voluntary testing in prisons and jails.
Increase voluntary testing among sex and needle-sharing partners of HIV-infected persons.
Increase availability of home collection kits and testing through outreach programs.
- Increase use of services.
Increase links between prevention and care programs.
Improve access to HIV/AIDS care through community-based organizations.
Upon discharge, link prisoners to care and prevention services.
Increase proportion of pregnant women receiving antenatal care.
- Increase quality care and treatment.
Increase proportion of HIV-infected pregnant women receiving ART.
Educate health care workers and HIV-infected persons about HIV/AIDS treatment.
Monitor and evaluate quality of HIV/AIDS care.
Institute surveillance for effectiveness and side effects of ART.
- Increase adherence to therapy by individuals with HIV.
Evaluate and implement strategies for increasing adherence, including directly observed therapy.
Monitor adherence to therapy.
Monitor antiretroviral drug resistance.
- Increase number of individuals with HIV who adopt and sustain HIV–STD risk reduction behavior.
Increase availability of prevention services for individuals with HIV (e.g., counseling, prevention case management, peer opinion leader, small-group interventions).
Develop, implement, and evaluate specific risk reduction strategies for individuals with HIV.
Monitor behaviors and outcomes in individuals with HIV.
Teach health care providers to perform HIV and STD risk assessment for their HIV-positive patients.
Increase STD screening, diagnosis, and treatment for individuals with HIV.
Increase delivery of prevention messages to HIV-positive patients by health care workers.
Provide adequate and appropriate substance abuse treatment.
An important method for making HIV testing more accessible is use of simple, rapid tests. These can be performed without laboratory support and offer the possibility of providing preliminary results within minutes after blood or oral secretions are collected. No such tests are currently available in the United States, although they are available in most other parts of the world. Studies have shown that when used in combination, rapid tests can provide results equal in predictive value to Western blot-based testing strategies.38 When available in the United States, they will provide opportunities to dramatically increase the availability of HIV testing in a variety of settings and thus increase the number of people who know their HIV status.39 Simple, rapid tests can be used for outreach by community-based organizations at social events such as community health fairs or gay pride festivals, or at bars, clubs, or street corners where large numbers of people at risk for HIV infection may congregate. In addition, rapid tests can be used for routine voluntary testing in emergency rooms or other medical settings where HIV prevalence may be elevated. Routinely offering HIV tests to all patients aged 15 to 54 years in high-HIV-prevalence acute care hospital settings,40 and in other high-prevalence settings such as drug detoxification units and STD clinics, should increase the number of people who are aware of their serostatus. Through revised guidelines for HIV counseling and testing, the CDC is encouraging the routine offering of voluntary HIV testing in medical settings where large numbers of HIV-infected people may seek care for non-HIV-related illnesses.41 Expansion of voluntary HIV testing is also needed in nonmedical facilities such as correctional institutions where HIV-infected injection drug users are likely to be found.
Although three quarters of individuals with HIV seek medical care within 6 months of learning of their HIV infection,42 some individuals, for a variety of personal, social, economic, or other reasons, delay seeking services for up to 5 years.13,43 Data are limited on the use of prevention services by individuals with HIV. Better information is also needed on the performance of current referral systems. While the CDC will work with its partners to improve its programs that link people from publicly funded HIV testing settings to care and prevention services,44 providers in other settings in which testing occurs will need to develop feasible links to care and prevention service providers. State and local health departments and community-based organizations can create better links between prevention and care programs, increasing access to both. Case management related to clinical care and social services or prevention case management (case management with risk reduction counseling)45 can also increase use of both care and prevention services.
In 1996, one third to two thirds of individuals with HIV were not receiving appropriate HIV/AIDS care, either because they were unaware that they were infected with HIV or because care services had not been accessed or delivered.46 While the Health Resources Services Administration (HRSA) and the Health Care Financing Administration (HCFA) are the leading federal agencies in providing support for HIV care, the CDC will continue to be a part of Public Health Service efforts to continually update guidelines for optimal ART5 and for prophylaxis of opportunistic infection.6 In addition to HIV and AIDS surveillance, the CDC is developing population-based studies to monitor the quality, use, and impact of care.
Toxicity, poor adherence to HIV treatment regimens, and pharmacologic problems such as poor drug absorption can cause failure to achieve viral suppression and development of drug resistance. Patients' failure to adhere to the complicated dosage requirements of ART may be the most important reason for these negative outcomes of treatment.47,48 In addition, drug-resistant viruses can be transmitted to uninfected individuals.49,50 Improving therapeutic adherence can reduce the frequency of drug resistance, but it will not eliminate it.
The CDC, in collaboration with other federal agencies, is conducting research on more effective interventions to increase adherence, including evaluating the feasibility of directly observed therapy. Directly observed therapy for tuberculosis has been feasible with simpler regimens of fixed duration,51 but because adherence to ART regimens is so important, trials of directly observed therapy for HIV are needed even if treatment regimens remain complex and of long-term—possibly lifetime—duration.5
Many individuals with HIV feel healthier when undergoing ART than they did before such treatments became available. In addition, the impression that HIV is a treatable chronic disease, and that ART reduces infectiousness, may be leading to increases in risk behavior among HIV-infected individuals and those at highest risk for HIV infection.52 In a number of cities in the United States, increasing rates of gonorrhea among men who have sex with men suggest that unsafe sexual behavior may be reemerging in this community.53 While most individuals who learn that they are infected reduce their risk behavior, a considerable fraction continue to have unprotected sex.54 In a recent outbreak of primary and secondary syphilis in King County, Washington, among men who have sex with men, nearly three quarters of whom were HIV infected.55
In 1997, a National Institutes of Health consensus conference on HIV prevention interventions called for increased research to identify interventions to support infected individuals in adopting and sustaining risk reduction behavior,56 and several studies have been subsequently initiated by the National Institute of Mental Health and by the CDC. The CDC will strongly encourage health departments, HIV prevention community planning groups, and community-based organizations to include people with HIV among priority populations for prevention programs. In addition, simple risk assessment tools are needed for physicians to assess the risk behavior of their HIV-infected patients and to provide referral for those needing prevention interventions. Preliminary information suggests that even when they are enrolled in primary care, sexually active individuals with HIV are not receiving adequate HIV prevention counseling or adequate diagnosis and treatment of other STDs.57 The CDC is collaborating with the Infectious Diseases Society of America and federal agencies to develop recommendations for prevention activities in care settings. With the vast majority of prescriptions for ART being written by a few thousand physicians across the country, it is feasible to offer training to these caregivers to recognize ongoing risk behavior and refer people appropriately for prevention services. Because many individuals with HIV are already in publicly financed systems of care,46 the CDC will work closely with HCFA and HRSA to increase prevention services in those settings. However, new resources are needed to increase the availability to all individuals with HIV infection of current prevention services, such as risk reduction counseling, peer group support, peer-based prevention case management, STD treatment, substance abuse treatment, and mental health services.
Some mathematical models suggest that much HIV transmission occurs from individuals who are recently infected and whose plasma viral loads are therefore high.58 If preventing transmission from such individuals is essential for controlling the epidemic, partner counseling and referral services are crucial, because, in combination with serologic methods that detect recently acquired HIV infection, they enable the identification of persons with early HIV infection.59 Using such methods for rapid assessment of sexual or injection-drug-use networks can lead to the interruption of chains of active transmission by helping network members adopt and sustain risk reduction behavior.