2020 Articles

Challenges and opportunities in the science of research to practice: lessons learned from a randomized controlled trial of a sexual risk-reduction intervention for psychiatric patients in a public mental health system

Wainberg, Milton L.; Mann, Claudio G.; Norcini Pala, Andrea; McKinnon, Karen; Pinto, Diana; Pinho, Veronica; Cavalcanti, Maria T.; Leu, Cheng-Shiun; Guimaraes, Mark D.; Mattos, Paulo E.; Hughes, Elizabeth; Palinkas, Lawrence A.; Otto-Salaj, Laura; Remien, Robert H.; Cournos, Francine; PRISSMA Project

Objective: Human immunodeficiency virus (HIV) prevention efficacy trials with psychiatric patients have been conducted in research settings in high-resourced countries, establishing short-term efficacy for reducing sexual risk behavior. None has been implemented within systems of care. In the last decade, overcoming this research-to-practice gap has become a focus of implementation science. This paper describes the first and only HIV Prevention intervention trial for psychiatric patients conducted in real-world outpatient psychiatric settings facilitated by trained clinic-based providers.

Methods: The HIV Prevention intervention, which uses the Information-Motivation-Behavioral Skills model to achieve sexual risk-reduction, was rigorously adapted to the local context and clinic services' needs. Participants from eight clinics were randomized to HIV Prevention or Health Promotion conditions.

Results: HIV Prevention participants showed significant improvement in Information-Motivation-Behavioral domains; in this group, behavioral intentions were associated with significantly fewer unprotected sex occasions, but reduction of unprotected sex occasions was similar in both conditions.

Conclusion: Our trial was conducted before implementation studies became widely funded. Transporting an intervention to a new culture or into real-world practice settings may require adaptations. Our results demonstrate that clear guidelines are needed regarding whether to conduct efficacy, effectiveness, and/or implementation research as the most appropriate next step.

Clinical trial registration: NCT00881699.