HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S.

An estimated 56,300 Americans are newly infected with HIV every year. In addition, of the
more than one million Americans living with HIV, approximately one-fifth do not know they
are infected. Identifying these individuals is among the biggest challenges for HIV
prevention in the United States. Early diagnosis of such individuals, combined with
prevention counseling and provision of health care, could decrease the spread of HIV and
improve the survival of HIV-infected persons.

The recent introduction of rapid HIV testing offers a critical public health screening
approach for facilitating earlier diagnoses of HIV infection. Rapid tests permit a sensitive
and specific, fast, simple, minimally invasive, and cost-effective method to screen for HIV.

Project Aware expands on the CDC's Project RESPECT-2 study that was an expansion of the
RESPECT study (a randomized controlled trial conducted in STD clinics in the mid-1990s
before the advent of highly active antiretroviral therapy and before the advent of rapid
testing). Project RESPECT demonstrated that a 2-session, client centered counseling session
based on behavioral theory with HIV testing was superior to a program with HIV testing and
information only. This project showed that the counseling arm had significant reduction of
STIs compared to those in the information arm. However, RESPECT did not include men who have
sex with men (who account for 53% of all new HIV infections in the U.S.) and did not examine
the cost effectiveness of the intervention. RESPECT-2 did include MSM, but it only compared
a 1-session counseling session with rapid testing to 2-session counseling with traditional
testing and did not address the question of whether counseling and testing is more effective
than testing alone.

Project Aware combines the RESPECT-2 counseling approach by adapting the HIV Rapid Testing
and Counseling in Drug Abuse Treatment Study (CTN 0032), a NIDA-sponsored randomized
controlled clinical trial being conducted in the NIDA Clinical Trials Network (CTN) to
sexually transmitted disease (STD) clinics to provide important and timely data on the
effect of counseling in high-risk populations tested in health care settings. In this
adaptation of CTN 0032, we will assess the relative effectiveness of (1) on-site HIV rapid
testing with brief, participant-tailored prevention counseling vs. (2) on-site HIV rapid
testing with information only (as recommended in the CDC guidelines). Secondary outcomes
are reduction of sexual risk behaviors, substance use during sex (i.e., being under the
influence during sex) and cost and cost effectiveness of counseling and testing.
Participants (approximately 5,000 from 9 STD clinics) will be assessed for STIs, HIV testing
history and sexual and drug use risk behaviors at baseline and at 6-months follow-up. The
battery of STI tests will screen for Neisseria gonorrhea (GC), Chlamydia trachomatis (CT),
Trichomonas vaginalis, Herpes Simplex 2 (HSV-2) and Treponema pallidum (syphilis). HIV test
results that yield a reactive result will receive a confirmatory HIV blood test that day,
with results delivered 5-10 days later. All participants will be randomized into one of two
arms: Group 1- HIV testing and brief, client-centered counseling or Group 2- HIV testing and
information only. Group 1 will receive a rapid HIV test with brief prevention counseling
that addresses risk reduction based on an evidence-based counseling approach (RESPECT-2
counseling), while Group 2 will receive a rapid HIV test with information only.

The primary outcome will be analyzed using logistic regression for the binary outcome, new
diagnoses of STIs (Yes/No). The logistic regression analysis will predict 6-month STI
incidence as a function of randomization group controlling for the baseline incidence of
STI. ANCOVA will be used for the secondary continuous outcomes, number of sexual risk
behaviors and number of sexual episodes involving substance use. Costs will be compared
based on study records supplemented by site-level data collection. Primary analyses will be
performed under intent-to-treat (ITT) criteria.