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A Randomized Controlled Trial

Mary L. Kamb, MD, MPH; Martin Fishbein, PhD; John M. Douglas, Jr, MD; Fen Rhodes, PhD; Judy Rogers, MS; Gail Bolan, MD; Jonathan Zenilman, MD; Tamara Hoxworth, PhD; C. Kevin Malotte, DrPH; Michael Iatesta, MA; Charlotte Kent, MPH; Andrew Lentz, MPA; Sandra Graziano, PhD; Robert H. Byers, PhD; Thomas A. Peterman, MD, MSc; for the Project RESPECT Study Group

JAMA. 1998;280:1161-1167.

Context.— The efficacy of counseling to prevent infection with the human immunodeficiency virus (HIV) and other sexually transmitted diseases (STDs) has not been definitively shown.

Objective.— To compare the effects of 2 interactive HIV/STD counseling interventions with didactic prevention messages typical of current practice.

Design.— Multicenter randomized controlled trial (Project RESPECT), with participants assigned to 1 of 3 individual face-to-face interventions.

Setting.— Five public STD clinics (Baltimore, Md; Denver, Colo; Long Beach, Calif; Newark, NJ; and San Francisco, Calif) between July 1993 and September 1996.

Participants.— A total of 5758 heterosexual, HIV-negative patients aged 14 years or older who came for STD examinations.

Interventions.— Arm 1 received enhanced counseling, 4 interactive theory-based sessions. Arm 2 received brief counseling, 2 interactive risk-reduction sessions. Arms 3 and 4 each received 2 brief didactic messages typical of current care. Arms 1, 2, and 3 were actively followed up after enrollment with questionnaires at 3, 6, 9, and 12 months and STD tests at 6 and 12 months. An intent-to-treat analysis was used to compare interventions.

Main Outcome Measures.— Self-reported condom use and new diagnoses of STDs (gonorrhea, chlamydia, syphilis, HIV) defined by laboratory tests.

Results.— At the 3- and 6-month follow-up visits, self-reported 100% condom use was higher (P<.05) in both the enhanced counseling and brief counseling arms compared with participants in the didactic messages arm. Through the 6-month interval, 30% fewer participants had new STDs in both the enhanced counseling (7.2%; P = .002) and brief counseling (7.3%;P=.005) arms compared with those in the didactic messages arm (10.4%). Through the 12-month study, 20% fewer participants in each counseling intervention had new STDs compared with those in the didactic messages arm (P = .008). Consistently at each of the 5 study sites, STD incidence was lower in the counseling intervention arms than in the didactic messages intervention arm. Reduction of STD was similar for men and women and greater for adolescents and persons with an STD diagnosed at enrollment.

Conclusions.— Short counseling interventions using personalized risk reduction plans can increase condom use and prevent new STDs. Effective counseling can be conducted even in busy public clinics.

From the Division of HIV/AIDS Prevention (Drs Kamb, Graziano, Byers, and Peterman) and STD Prevention (Dr Fishbein), National Center for HIV, STD, TB Prevention, Centers for Disease Control and Prevention, Atlanta, Ga; Denver Public Health, Denver, Colo (Dr Douglas); Colorado Department of Health and Environment, Denver (Dr Hoxworth); Long Beach Health Department and California State University, Long Beach (Drs Rhodes and Malotte); New Jersey Health Department, Newark STD Clinic (Ms Rogers and Mr Iatesta); San Francisco Health Department, San Francisco, Calif (Dr Bolan and Ms Kent); and Baltimore City Health Department and Johns Hopkins University, Baltimore, Md (Dr Zenilman and Mr Lentz).

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