Medical News
by Bill Valenti MD

Access to Experimental HIV Treatments:  Ethnic and Racial Disparities
 
A nationwide study sponsored by the Agency for Healthcare Research and Quality (AHRQ), shows that black and Hispanic HIV patients are only about half as likely as non-Hispanic whites to participate in clinical trials of new HIV medications.  Together, blacks and Hispanics comprise roughly 48 percent of the HIV patient population -- 33 percent and 15 percent, respectively.  The study also found that women, regardless of race or ethnicity, are no less likely than men to participate in HIV drug studies.

Interviews were conducted of a nationally representative sample of HIV patients between 1996 and 1998, led by a team of researchers from the VA Healthcare System and the University of California, SanDiego.  The investigators found that, overall, 14 percent of the patients participated in an HIV medication trial.  In addition, 24 percent of the patients overall received experimental treatments at some time through a trial or early access programs that make promising new HIV drugs available to patients before the drugs' final approval by the US Food and Drug Administration.  During the study period, several potent new anti-retroviral medications were being tested.

About 10 percent of the black patients and 11 percent of Hispanic patients participated in a clinical trial, compared with 18 percent of non-Hispanic white patients.  Black patient participation in trials did not increase during the study period, and these patients were more likely to drop out of the trial, according to the investigators.

According to the lead investigator, Allen L. Gifford, M.D, black and Hispanic patients' limited attempts to obtain experimental HIV medications may reflect lack of awareness of clinical trials in minority communities, as well as suspicion and mistrust of trials and researchers.  Black patients were less than half as likely as white non-Hispanic patients to try to obtain an experimental HIV medication.

"Our findings suggest that to boost minority participation in trials, we must look critically at structural barriers such as research-entry criteria, enrollment and tracking procedures, and study center operations, as well as clinical researchers' attitudes and practices," said Dr. Gifford.

Other factors contributing to a reduced likelihood of participation in a clinical trial were having less than a high school education, being in a commercial HMO, and receiving primary care 8 miles or more from where the clinical trial was held.

Gifford, AL, Cunningham, WE, Heslin, KC et al. Participation in Research and Access to Experimental Treatments for HIV-Infected Patients," New England Journal of Medicine 2002; 346:1373- 82

New HIV Testing Recommendations for Men Who Have Sex with Men

Men who have sex with men (MSM) should get tested at least once a year for HIV, the government said in a new recommendation aimed at heading off a feared surge of new HIV infections.

The new guidelines from the Centers for Disease Control and Prevention (CDC) marked the first time the government has made such a firm recommendation. Previous guidelines from CDC have been less specific, urging doctors to "recommend HIV tests for patients whose behavior might put them at risk for infection."  But recent studies have shown that gay and bisexual men, possibly lulled into complacency by Highly Active Antiretroviral Therapy (HAART) that have helped people with HIV/ AIDS live longer, are having more unprotected sex.

Rates of syphilis and gonorrhea have increased among gay and bisexual men in many US cities, and health officials are concerned that those diseases are a warning that new HIV infections in MSM are also on the increase. (See Richard Ferri's discussion of syphilis in this edition of NuMedX).

The new guidelines recommend annual screening for HIV, chlamydia, syphilis and gonorrhea for gay and bisexual men, plus vaccination  against hepatitis A and B. Some men in high-risk groups may need to be screened more often, the CDC said. "There has been an increase in awareness of the level of risk behavior of men who have sex with men," said the CDC's Dr. Stuart Berman. "There really haven't been recommendations before."

The guidelines also urge providers of HIV care to ask their male patients about the gender of their sex partners -  a question experts say physicians are sometimes hesitant to ask. "It's important for them to provide educational messages about what's important in terms of safe sex behavior," said CDC lead author Dr. Kimberly Workowski. "A lot of times providers have reticence in asking their patients these questions."

The guidelines also update previous recommendations for chlamydia screening in women. (See below).

Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines 2002.  Morbidiy and Mortality Weekly Report.  2002 (May 10); 51: RR-6.

Also available on the internet: http://www.cdc.gov/std

Revised Recommendations for Chlamydia Screening in Women

Chlamydia is the most commonly reported infectious disease in the United States; 702,093 cases were reported in 2000.

Chlamydia screening now is advised annually for sexually active adolescent women (19 years old and under) and young adult women (20- to 24 years-old). Even without symptoms, screening is recommended, as well as screening older women with a risk factor for chlamydia (a new partner or multiple sexual partners).

Another new recommendation is that all women with chlamydial infections be rescreened three to four months after treatment is completed.

This is the first time CDC has recommended rescreening in the management of chlamydia. Chlamydia is concentrated among female adolescents. In the United States, millions of cases go unrecognized. Reinfection with chlamydial infection is a key risk factor for pelvic inflammatory disease (PID). PID can damage the fallopian tubes, uterus and ovaries, and cause chronic pelvic pain. One in five women with PID also become infertile. Moreover, women infected with chlamydia are up to five times more likely to become infected with HIV, if exposed.

Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines 2002.  Morbidiy and Mortality Weekly Report.  2002 (May 10); 51: RR-6.1-80.

Also available on the internet: http://www.cdc.gov/std
 
HIV Reporting and Partner Notification:  New York State
 
New York State implemented its HIV Reporting and Partner Notification law effective on June 1, 2000.  Prior to the change in the law, only diagnosed cases of AIDS were reportable to the State Health Department. Due to the length of time between initial infection with HIV and the development of AIDS, presumably due to Highly Active Antiretroviral Therapy (HAART) and earlier diagnosis, data limited to diagnosed AIDS cases did not provide the State with an accurate picture of the current incidence of HIV/AIDS. In addition, while partner information is voluntary, State and local public health staff are now better able to respond to information from individuals who need assistance in notifying partners, according to the health department.  This is thought to increase the likelihood that persons who may have been exposed to HIV can be advised to seek HIV testing, and get treatment if they are infected.

Of the 16,866 HIV tests and AIDS cases reported by laboratories and medical providers and confirmed by State surveillance staff between June 1, 2000 and December 31, 2000, 2,817 (17%) were initial HIV diagnoses, 9,036 (53%) were cases of initial HIV illness and 5,013 (30%) were initial AIDS diagnoses. A total of 12,144 cases, or 72 percent, were New York City residents, while 4,722 cases (28%) were from counties outside of New York City.

The addition of HIV reporting tripled the number of cases that would have been reported under the previous AIDS case reporting system. Along with allowing health officials to more accurately determine the magnitude of HIV infection and identify populations at risk-providing better information to meet HIV prevention and care needs-successful implementation of the new system will assist the State in receiving future federal funding.

HIV Reporting and Partner Notification is thought to have public health implications.  Of the 3,564 Medical Provider Reports of HIV and AIDS submitted between June 1 and December 31, 2000, 3,230 (91%) were newly diagnosed infections or cases prioritized for voluntary partner notification assistance. In total, 1,383 partners of HIV infected persons were notified or are in the process of being notified of their possible exposure to HIV. This number of documented partner notifications is more than four times greater than the number of partner notifications documented in 1998, prior to implementation of the new law.

While this program is in the early stages of data gathering and review, the newly diagnosed HIV cases appear to differ from that of AIDS cases, providing more precise information to meet the HIV prevention and care needs of infected persons in New York State, according to the health department. Preliminary findings indicate that among newly diagnosed HIV cases, there is a greater proportion of females, younger persons, and African Americans, than among AIDS cases.

HIV reporting has funding implications as well.  In 2005, the basis for the formula used to award federal Ryan White CARE Act funds to the states is expected to change from AIDS cases to HIV cases. An HIV reporting system allows us to document the full extent of HIV/AIDS in our state, and to access additional federal dollars to support New York's comprehensive continuum of services.

New York is the 35th state to implement name-based reporting for HIV and it is expected that most, if not all, of the remaining states will follow.
 
See the New York State Health Department's web site: http://www.health.state.ny.us/nysdoh/commish/2002/partner.htm

Centers for Disease Control and Prevention. Guidelines for National Human Immunodeficiency Virus Case Surveillance, Including Monitoring for Human Immunodeficiency Virus Infection and Acquired Immunodeficiency Syndrome. Morbidiy and Mortality Weekly Report. 1999 (December 10);  48 (RR13): 1-28.