To test the efficacy and acceptability of a single-session personalized cognitive counseling (PCC) intervention delivered by paraprofessionals during HIV voluntary counseling and testing. HIV-negative men who have sex with men (MSM; n = 336) were randomly allocated to PCC or usual counseling (UC) between October 2002 and September 2004. The primary outcome was the number of episodes of unprotected anal intercourse (UAI) with any nonprimary partner of nonconcordant HIV serostatus in the preceding 90 days, measured at baseline, 6 months, and 12 months. Impact was assessed as "intent to treat" by random-intercept Poisson regression analysis. Acceptability was assessed by a standardized client satisfaction survey. Men receiving PCC and UC reported comparable levels of HIV nonconcordant UAI at baseline (mean episodes: 4.2 vs. 4.8, respectively; P = 0.151). UAI decreased by more than 60% to 1.9 episodes at 6 months in the PCC arm (P < 0.001 vs. baseline) but was unchanged at 4.3 episodes for the UC arm (P = 0.069 vs. baseline). At 6 months, men receiving PCC reported significantly less risk than those receiving UC (P = 0.029 for difference to PCC). Risk reduction in the PCC arm was sustained from 6 to 12 months at 1.9 (P = 0.181), whereas risk significantly decreased in the UC arm to 2.2 during this interval (P < 0.001 vs. 6 months; P = 0.756 vs. PCC at 12 months). Significantly more PCC participants were "very satisfied" with the counseling experience (78.2%) versus UC participants (59.2%) (P = 0.002). Both interventions were effective in reducing high-risk sexual behavior among MSM repeat testers. PCC participants demonstrated significant behavioral change more swiftly and reported a more satisfying counseling experience than UC participants.
