Participants in Mid-1990s CDC STD Study Just Now Gaining Access to Herpes Test Results
Officials at the New Jersey Department of Health and Senior Services have criticized the CDC for delaying herpes test result notification for Newark participants in an STD study that began in 1993, the Newark Star-Ledger reports. More than 1,200 New Jersey residents were tested between 1993 and 1997 for herpes as part of the CDC-sponsored " Project Respect" -- a national study evaluating the effects of HIV prevention counseling on reducing high-risk behavior and the number of new STD infections -- but the agency only yesterday sent out letters informing participants that they can receive the test results for the first time. In addition to Newark, Baltimore, Denver, San Francisco and Long Beach, Calif., served as study sites. According to New Jersey health officials, the CDC should have informed the participants of their test results as soon as it finished them, instead of up to eight years later. "It's conceivable that a person who was infected could have unknowingly passed the disease on to someone else," Eddy Bresnitz, epidemiologist for the state Department of Health and Senior Services, said. However, the CDC said that the initial herpes test it used "proved unreliable," causing it to delay passing on test results to participants until it could re-test collected samples and conduct "further analysis." As a result, three of the five federally funded STD clinics that took part in the study changed their consent forms telling volunteers that results of the herpes test would not be available. However, the Newark clinic, along with the clinic in Denver, decided to keep the old consent forms that promised volunteers results of the herpes test in "about six months or longer." CDC spokesperson Kathryn Bina said, "It's not that the CDC had test results on hand since 1997," adding that the CDC did not know how to interpret the tests because "[p]eople who tested positive in one test turned up negative in the next." After being notified in July 2001 that the test results were available, the New Jersey health department's Institutional Review Board sent a letter in August to the CDC outlining "complaints" about the delay in notification. At the IRB's recommendation, the CDC reported the situation to the U.S. Office for Human Research Protections for investigation. Study participants will be offered new herpes tests and a phone number to call for additional information (Campbell, Newark Star-Ledger, 3/28).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.