Effect of risk-reduction counseling with rapid HIV testing on risk of acquiring sexually transmitted infections: the AWARE randomized clinical trial

Abstract

Importance: To increase human immunodeficiency virus (HIV) testing rates, many institutions and jurisdictions have revised policies to make the testing process rapid, simple, and routine. A major issue for testing scale-up efforts is the effectiveness of HIV risk-reduction counseling, which has historically been an integral part of the HIV testing process.

Objective: To assess the effect of brief patient-centered risk-reduction counseling at the time of a rapid HIV test on the subsequent acquisition of sexually transmitted infections (STIs).

Design, setting, and participants: From April to December 2010, Project AWARE randomized 5012 patients from 9 sexually transmitted disease (STD) clinics in the United States to receive either brief patient-centered HIV risk-reduction counseling with a rapid HIV test or the rapid HIV test with information only. Participants were assessed for multiple STIs at both baseline and 6-month follow-up.

Interventions: Participants randomized to counseling received individual patient-centered risk-reduction counseling based on an evidence-based model. The core elements included a focus on the patient's specific HIV/STI risk behavior and negotiation of realistic and achievable risk-reduction steps. All participants received a rapid HIV test.

Main outcomes and measures: The prespecified outcome was a composite end point of cumulative incidence of any of the measured STIs over 6 months. All participants were tested for Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum (syphilis), herpes simplex virus 2, and HIV. Women were also tested for Trichomonas vaginalis.

Results: There was no significant difference in 6-month composite STI incidence by study group (adjusted risk ratio, 1.12; 95% CI, 0.94-1.33). There were 250 of 2039 incident cases (12.3%) in the counseling group and 226 of 2032 (11.1%) in the information-only group.

Conclusion and relevance: Risk-reduction counseling in conjunction with a rapid HIV test did not significantly affect STI acquisition among STD clinic patients, suggesting no added benefit from brief patient-centered risk-reduction counseling.

Trial registration: clinicaltrials.gov Identifier: NCT01154296.

Conflict of interest statement

Conflicts of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. All authors, except Drs. Korthuis, Mandler, and Branson, report that their respective institution(s) received grant funds from the study sponsor for their effort on this study. Dr. Golden reports that his institution received grant funds from Cempra Pharmaceuticals, Gen-Probe, and Bio-Rad for his effort on work outside of this study. Ms. Haynes reports receiving support from the study sponsor (via a subcontract with the University of Miami) for travel to meetings for this study. Dr. Korthuis reports that his effort on this project was supported by a NIDA award, 1K23DA019809. Dr. Duffus reports that his institution received grant funds from Gilead for his effort on work outside of this study. Dr. Henn reports that her institution received grant funds from Gilead Sciences (GS-US-299-0102 and GS-US-3370102), GlaxoSmithKline (GSK ING114467), Pfizer (Wyeth6115A1-3017) and the NIH HIV Prevention Trials Network 065 (TLC-Plus) for her effort on work outside of this study. Dr. Bolan reports that his institution received support from the study sponsor for travel to meetings for this study; he receives funds from the Los Angeles Gay & Lesbian Center for his employment and Simply Speaking for lectures on HIV/AIDS; and his institution received grant funds from NIAID, NIDA, California AIDS Research Program, NIMCH/CHIPTS, and Ryan White parts A and C for his work outside of this study. No other disclosures were reported.

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Figure 1

CONSORT FLOW DIAGRAM