November 2001

Purpose

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.

Timeframe

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).

Background

RESPECT-2 is named after a previous study, Project 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 testing. The RESPECT-2 investigators 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 clinic visits.

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.

Study Methods

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, or CASI.

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.

Counseling Methods

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 Counseling.