Efficacy of Risk-Reduction Counseling to Prevent Human Immunodeficiency Virus and Sexually Transmitted Diseases: A Randomized Controlled Trial

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