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TRENTON
-Approximately 900 Newark residents who participated in a federal
Centers for Disease Control and Prevention (CDC) research study
in the 1990's were mailed letters by the CDC this week informing
them that test results for herpes simplex virus (HSV) are now available.
More than 400 study participants tested positive for the virus.
The
individuals being contacted were participants in a five-city, five-state
study called Project RESPECT, conducted between 1993 and 1996, to
examine the effectiveness of prevention approaches among sexually
transmitted disease (STD) clinic participants.
Study
participants were tested for numerous STDs and given their results
throughout the study period. Early in the study, however, the reliability
of the herpes test available at the time was questioned, according
to the CDC. Three cities decided to amend their participant consent
forms and dropped HSV notification. Project managers in Newark and
Denver did not change their consent forms after deciding that study
participants in their jurisdictions would be told their HSV test
results even though reliable results would not be available for
six months or more. When the Newark project manager informed the
New Jersey Department of Health and Senior Services (DHSS) in the
fall of 1996 that the study had ended, the CDC had not yet completed
the HSV tests.
In
October 1997, the CDC completed its tests for HSV on all specimens
received from the five cities but failed to realize at the time
that the consent forms used in two of those cities - Newark and
Denver - required that participants be notified of their results.
The CDC first informed the DHSS of this issue in June 2001. As a
result, the DHSS and the CDC jointly developed a plan for notifying
former study participants.
CDC
personnel were assigned to New Jersey to create a database from
Project RESPECT records. That database was completed in December
2001. The agencies developed a notification letter, protocol and
counseling guidelines, and the department assigned a trained individual
to inform and counsel former study participants regarding their
test results.
The
CDC's Institutional Review Board recently approved the notification
protocol that will be followed by staff of the DHSS STD program
and staff in the Newark Department of Health and Human Services.
Former participants who respond to the outreach will be given their
test results; provided information on HSV; offered an exam and viral
culture for those with symptoms; offered a new, more specific herpes
test upon request; and offered testing for their sexual partners.
The
DHSS has notified the U.S. Department of Health and Human Services'
Office for Human Research Protection (OHRP) of its concerns related
to the research conducted by the CDC. The CDC is making a similar
referral to the OHRP.
In
addition to the CDC notification letter, the DHSS will send follow-up
letters next week to further inform study patients that their test
results are available through the Newark Department of Health and
Human Services and to provide them additional contact options for
more information.
"We
will make a concerted effort to reach every study participant to
provide them with accurate information and appropriate counseling
and evaluation," said Clifton R. Lacy, M.D., Acting Commissioner
of the New Jersey Health and Senior Services.
Project
RESPECT study participants with questions or concerns should contact
the Newark Department of Health and Human Services' STD Program
at 973-648-2572 or 2227, the CDC at 800-584-8814, or the DHSS at
609-588-7526.
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