Development and feasibility testing of an integrated PTSD and adherence intervention cognitive processing therapy-life steps (CPT-L) to improve HIV outcomes: Trial protocol

• Published in: Contemporary clinical trials communications 2023-06, Vol.33, p.101150, Article 101150
• Main Authors: Lopez, Cristina M., Baker, Nathaniel L., Moreland, Angela D., Bisca, Erin, Wilson, Tayler, Slick, Nathalie, Danielson, Carla Kmett, Eckard, Allison R., Madisetti, Mohan, Resick, Patricia A., Safren, Steven A.
• Format: Article
• Language: English
• ISSN: 2451-8654; 2451-8654
• DOI: 10.1016/j.conctc.2023.101150

Despite high rates of Post-Traumatic Stress Disorder (PTSD) in persons living with HIV (PLWH) and poor HIV-related health outcomes associated with PTSD, an effective evidence-based treatment for PTSD symptoms in PLWH does not exist. Negative reinforcement conceptual models posit that avoidant behavior (hallmark symptom of PTSD) demonstrated by PLWH with co-occurring PTSD can contribute to poor antiretroviral therapy (ART) adherence. However, research evaluating the impact of evidence-based treatment for PTSD among HIV infected populations on HIV outcomes is scarce. The Cognitive Processing Therapy (CPT) protocol is an evidence-based PTSD treatment that may address internalized stigma with targeted modifications and improve ART adherence and subsequent viral suppression through reduction of avoidant coping. This study will be the first pilot open-label randomized control trial (RCT) to test feasibility of an integrated evidence-based PTSD treatment (CPT) with an adherence intervention (Lifesteps) delivered in a Ryan White clinic to improve PTSD symptoms, adherence to ART, and retention in HIV care. Primary aims are to (1) conduct theater testing of the CPT and Lifesteps research protocol and evaluate acceptability (n = 12) and (2) deliver a modified CPT protocol (CPT-Lifesteps, or CPT-L) in 60 PLWH/PTSD exploring impact of CPT-L on PTSD symptoms and HIV outcomes compared to a Lifesteps + Standard of Care condition. This innovative research extends PTSD treatment approaches as a paradigm to reduce barriers to ART adherence. Findings of this innovative study are significant because they support the Undetectable = Untransmittable (UU) campaign and can help prevent the transmission of HIV infection through increased viral suppression.