RESPECT-2 is a research study that compares different
forms of HIV testing and risk-reduction counseling in clients at sexually
transmitted disease (STD) clinics in the United States (U.S.). The purpose
of the study is to look for ways to provide HIV testing and counseling
that are more effective at reducing clients' risk of becoming infected
with sexually transmitted infections (STIs), than the best known methods
used now. The study looks at whether providing a rapid HIV test, the
result of the test, and all counseling in one clinic visit, is as effective
at preventing STIs as having a standard HIV test, with the result and
the second counseling session given 1 to 2 weeks after the test. It
also looks at whether having an additional counseling session 6 months
after an HIV test reduces a client's risk of becoming infected with
STIs in the next 6 months. The cost-effectiveness of different HIV testing
and counseling approaches are also being compared.
Enrollment for the RESPECT-2 study began in February
1999 and ended in December 2000. All study visits will be completed
by March 2002. The study is still in progress and results will not be
available until all phases of the study have been completed (late 2002).
RESPECT-2 is named after a previous study,
RESPECT, because it is building on the knowledge gained in the Project
RESPECTstudy. Also, the study methods used in RESPECT-2 are similar
to Project RESPECT, and all 3 study sites where the RESPECT-2 study
is being done were also study sites in Project RESPECT.
Project RESPECT showed that STD clinic clients
who have an HIV test and 2 counseling sessions 1 to 2 weeks apart, have
fewer STIs during the next year than those who are tested for HIV and
given educational messages alone (without counseling). However, many
of those who are tested for HIV in STD clinics do not receive the full
benefit of risk-reduction counseling because they do not come back for
the HIV test result and second counseling session.
In 1992, a rapid HIV test was licensed by the
Food and Drug Administration in the United States (U.S.). This test
provides an HIV result in less than half an hour. It is now possible
for STD clinic clients to have an HIV test, be given the result, and
have 2 counseling sessions (before and after the HIV test), all in one
clinic visit. Unlike many other countries, rapid HIV testing, with the
result given the same visit, is not yet widely used in STD clinics in
the U.S. In most STD clinics, clients tested for HIV have to come back
to the clinic for the HIV result and a second counseling session.
It is expected that several other rapid HIV tests
will be licensed in the U.S. soon, and that rapid HIV testing will become
widely used in U.S. STD clinics, and in other places that provide HIV
are using this window of opportunity, before rapid HIV testing becomes
widely used, to test whether good-quality risk-reduction counseling
given in one clinic visit is as effective at preventing STIs and reducing
risky behavior as the same type of counseling given over 2 successive
In the Project RESPECT study, counseling was effective
at reducing a person's risk of STIs in the 6 months after HIV testing
and counseling, but the impact of the counseling was not apparent beyond
6 months. The RESPECT-2 investigators are going one step further by
testing whether giving clients an extra counseling session 6 months
after an HIV test (without doing another HIV test) is effective at making
the benefits of HIV testing and counseling last longer.
The RESPECT-2 study is a randomized controlled
trial (RCT). Study participants were recruited in 3 publicly-funded
STD clinics in Long Beach, California; Denver, Colorado; and Newark,
New Jersey. Clients who attended one of the 3 study clinics for a check-up
for STDs between February 1999 and December 2000 were invited to participate
in the study, if eligible. Participants had to be 15 to 39 years of
age when they were enrolled in the study, and had to be willing to come
back for 4 study visits over the next year. About 3,300 participants
were enrolled in the study, of whom almost half were female.
Participants were given a confidential HIV test
during the first clinic visit and tested for STDs. Two types of HIV
tests were used: the standard HIV test, and a rapid HIV test. Half of
the participants were randomly selected (by chance) to be tested for
HIV with the rapid test and given the result the same visit. The other
half were tested for HIV using the standard HIV test for that clinic,
and were asked to return 1 to 2 weeks later for the result. During the
first visit, participants also completed a questionnaire about their
STD history, recent sexual partners, and recent sexual behavior.
All participants were given risk-reduction counseling
during the first visit, and when given the HIV result. Those who were
tested using the rapid HIV test were given 2 counseling sessions during
the first visit, and those who were tested using the standard test were
given 2 counseling sessions 1 to 2 weeks apart. The type of counseling
given was the same in both groups. However, the timing of the second
counseling session was different. For more details about the counseling
methods used, see Counseling Methods.
Participants who were HIV-positive (about 1% of
those enrolled) were referred to appropriate services for further care,
and did not continue with follow-up. The rest were asked to stay in
the study for 1 year and to come back for a study visit every 3 months,
for a total of 4 more visits.
Half the participants in each group were randomly
selected (by chance) to receive an additional risk-reduction counseling
session during the 6-month study visit. At this session, the client's
original risk-reduction plan was reviewed, and the client and counselor
developed a new risk-reduction plan, taking into account the client's
success and difficulties at carrying out the original plan.
As of November 2001, 9 out of 10 of participants
have reached the end of the follow-up period. The rest still have one
or more study visits left. During each study visit, participants are
tested for common STIs (gonorrhea, chlamydia, and trichomoniasis) and
treated if any of these infections are detected. At the final visit,
one year after enrolling in the study, participants are retested for
HIV and syphilis infection. Participants are asked to complete a questionnaire
during each study visit, similar to the questionnaire completed at the
first visit. Questionnaires are being completed by computer, instead
of face-to-face interviews. This is known as Computer-Assisted Self-Interview,
When the information from the study is analyzed,
the number of STIs that are detected in each group during the study
period will be compared, in order to measure the relative effectiveness
of each testing and counseling combination. Risk behavior in each group
will also be compared.
All counseling in this study follows the principles
of prevention counseling recommended by the CDC.
The CDC recommendations are based on the latest scientific research
on what has been shown to be effective. Counseling is tailored to each
individual client. This includes an assessment of each client's risk
behaviors and circumstances. Counselors work with each client to develop
realistic goals for reducing personal risk, and to decide on a small
step to take to reduce the client's risk of HIV infection. Counselors
also help clients plan how to go about carrying out this risk-reduction
step, and how to get around barriers that might stand in the way.
Further details are given under