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In the United States, over 1.2 million people are living with HIV. This disease disproportionately affects men who have sex with men (MSM), people of color, youth and young adults, and transgender individuals. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention method. Barriers exist for both primary care providers (PCPs) to prescribe PrEP and prevent patients from initiating PrEP. This study, MOST: PrEP, follows the multiphase optimization strategy (MOST) framework. The purpose is to identify a multi-level intervention among patients and PCPs to increase PrEP prescriptions in primary care. First, feedback will be obtained from providers and patients via focus groups, then, suggestions related to the context-specific (provider and individual level) factors of intervention component delivery will be incorporated. Subsequently, a rigorous experiment will be conducted using a 24 factorial design focusing on priority populations for PrEP initiation. Provider components include computer-based simulation training and a best practice alert. Patient components include a tailored PrEP educational video and HIV risk assessment. Finally, the facilitators and barriers to implementing the intervention components will be qualitatively examined. In this protocol paper, we describe the one of the first known multilevel MOST optimization trial in healthcare. Intervention components are to be delivered to patients and providers in a large healthcare system, based in an HIV Ending the Epidemic priority jurisdiction. If effective, this multi-level approach could be disseminated to providers and patients in other large healthcare systems to make a significant impact on HIV prevention. [ABSTRACT FROM AUTHOR]

Dental disease continues to be one of the most prevalent chronic diseases in the United States. Although oral self-care behaviors (OSCB), involving systematic twice-a-day tooth brushing, can prevent dental disease, this basic behavior is not sufficiently practiced. Recent advances in digital technology offer tremendous potential for promoting OSCB by delivering Just-In-Time Adaptive Interventions (JITAIs)— interventions that leverage dynamic information about the person's state and context to effectively prompt them to engage in a desired behavior in real-time, real-world settings. However, limited research attention has been given to systematically investigating how to best prompt individuals to engage in OSCB in daily life, and under what conditions prompting would be most beneficial. This paper describes the protocol for a Micro-Randomized Trial (MRT) to inform the development of a JITAI for promoting ideal OSCB, namely, brushing twice daily, for two minutes each time, in all four dental quadrants (i.e., 2x2x4). Sensors within an electric toothbrush (eBrush) will be used to track OSCB and a matching mobile app (Oralytics) will deliver on-demand feedback and educational information. The MRT will micro-randomize participants twice daily (morning and evening) to either (a) a prompt (push notification) containing one of several theoretically grounded engagement strategies or (b) no prompt. The goal is to investigate whether, what type of, and under what conditions prompting increases engagement in ideal OSCB. The results will build the empirical foundation necessary to develop an optimized JITAI that will be evaluated relative to a suitable control in a future randomized controlled trial. [ABSTRACT FROM AUTHOR]

The majority of care for >10 million older adults with dementia (PWD) in the United States depends on at least on 11 million unpaid care partners (CPs). CPs are at greater risk of adverse physical, psychological, and cognitive health outcomes relative to non-caregiving peers. The goal of this paper is to establish the rationale, design, and protocol for a pilot randomized control trial to test the efficacy of the CP-focused intervention, ICECaP: Individualized Coordination and Empowerment for Care Partners of Persons with Dementia. ICECaP involves the assignment of a trained dementia care coordinator to a CP. The care coordinator maintains at least monthly contact with the CP with hybrid delivery (in-person, phone, e-mail, and video calls) and provides individualized support with care coordination for the CP navigating the PWD's care in a complex healthcare system, as well as supportive counseling, psychoeducation, and skills training for the CP. This trial will compare outcomes from baseline to 12-months among CPs who receive ICECaP versus routine care (controls). Outcomes include CP depression, burden, anxiety, and quality of life; CPs' reactions to the behavioral symptoms of dementia; and use of support services for the PWD. This trial will also assess mechanisms of intervention efficacy including changes in CP dementia knowledge, caregiving preparedness, self-efficacy, and optimism. Publication of this intervention protocol will benefit other dementia care teams seeking to support CPs and PWDs. [ABSTRACT FROM AUTHOR]

This paper describes the design and protocol of a pragmatic, randomized trial to evaluate the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Integrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE) is a multicenter, randomized trial conducted at three academic health centers in the southeastern United States. Participants are adults receiving long-term opioid therapy of at least 20 morphine milligram equivalents daily for chronic noncancer pain. Participants were randomized to either the shared decision-making intervention or the motivational interviewing session and cognitive behavioral therapy for chronic pain intervention. All participants also received guideline-concordant care supporting opioid pharmacotherapy. The primary outcome was change from baseline in average daily prescribed opioid dose at 12 months, using prescribing data from electronic health records. Secondary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference and Physical Function at 12 months. This trial evaluates the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Results from this study can guide clinicians, researchers, and policymakers as they seek to reduce opioid prescribing and improve management of chronic pain. ClinicalTrials.gov Identifier: NCT03454555 (https://clinicaltrials.gov/ct2/show/record/NCT03454555). Participant enrollment began on June 26, 2019. [ABSTRACT FROM AUTHOR]