Improving Delivery and Use of HIV Pre-Exposure Prophylaxis in the US: A Systematic Review of Implementation Strategies and Adjunctive Interventions.

Implementation of pre-exposure prophylaxis (PrEP) to prevent HIV transmission is suboptimal in the United States. To date, the literature has focused on identifying determinants of PrEP use, with a lesser focus on developing and testing change methods to improve PrEP implementation. Moreover, the change methods available for improving the uptake and sustained use of PrEP have not been systematically categorized. To summarize the state of the literature, we conducted a systematic review of the implementation strategies used to improve PrEP implementation among delivery systems and providers, as well as the adjunctive interventions used to improve the uptake and persistent adherence to PrEP among patients. Between November 2020 and January 2021, we searched Ovid MEDLINE, PsycINFO, and Web of Science for peer reviewed articles. We identified 44 change methods (18 implementation strategies and 26 adjunctive interventions) across a variety of clinical and community-based service settings. We coded implementation strategies and adjunctive interventions in accordance with established taxonomies and reporting guidelines. Most studies focused on improving patient adherence to PrEP and most conducted pilot trials. Just over one-third of included studies demonstrated a positive effect on outcomes. In order to end the human immunodeficiency virus (HIV) epidemic in the U.S., future, large scale HIV prevention research is needed that develops and evaluates implementation strategies and adjunctive interventions for target populations disproportionately affected by HIV.

Adjunctive interventions: change methods directed at recipients that support uptake and use of health innovations.

BACKGROUND: Implementation science groups change methods into two categories: (1) clinical, behavioral, or biomedical intervention targeting recipient's health outcomes and (2) implementation strategies targeting the delivery system. Differentiating interventions from strategies based on their intended functions is critical to accurately attributing their effects to health or implementation outcomes. However, in coordinating 200+ HIV implementation research projects and conducting systematic reviews, we identified change methods that had characteristics of both interventions and strategies that were inconsistently categorized. To alleviate confusion and improve change method specification, we propose that implementation science should adopt an extant but rarely used term-adjunctive interventions-to classify change methods that are distinct from the common intervention/strategy taxonomy. MAIN TEXT: Adjunctive interventions as change methods that target recipients (e.g., patients, participants) of a health intervention but are designed to increase recipients' motivation, self-efficacy, or capacity for initiating, adhering to, complying with, or engaging with the health intervention over time. In two of our published reviews on implementation of HIV interventions, 25 out of 45 coded change methods fell into this gray area between strategy and intervention. We also noted instances in which the same change method was labelled as the intervention ("the thing"), as an adjunctive intervention, or an implementation strategy in different studies-further muddying the waters. Adjunctive interventions are distinguished from other change methods by their intended targets, desired outcomes, and theory of action and causal processes. Whereas health interventions target recipients and have a direct, causal effect on the health outcome, adjunctive interventions enhance recipients' attitudes and behaviors to engage with the intervention and have an indirect causal link to the health outcome via increasing the probability of recipients' utilization and adherence to the intervention. Adjunctive interventions are incapable of directly producing the health outcome and will themselves require implementation strategies to effectively impact sustained uptake, utilization, and adherence. Case examples, logic modeling, and considerations (e.g., relationship to consumer engagement strategies) for adjunctive intervention research are provided. CONCLUSION: Conceptualizing adjunctive interventions as a separate type of change method will advance implementation research by improving tests of effectiveness, and the specification of mechanisms and outcomes.

Comparing cognitive behavioral therapy and social prescribing in patients with loneliness on long-term opioid therapy to reduce opioid misuse: protocol for a randomized controlled trial.

BACKGROUND: Patients with chronic pain on opioids frequently experience loneliness, which is associated with poorer health outcomes and higher risk for opioid misuse and opioid use disorder. Given that almost half of opioids are prescribed in primary care, a critical need exists for the development and testing of interventions to reduce loneliness in primary care patients at risk for opioid misuse. Cognitive behavioral therapy and social prescribing have been shown to be efficacious in reducing loneliness and improving outcomes in other populations but have not been tested in patients at risk for substance use disorder. The overall objective of our study is to reduce opioid misuse and opioid use disorder by addressing loneliness in patients on long-term opioid therapy in real-world primary care settings. METHODS: We will conduct a 3-arm pragmatic, randomized controlled trial to compare the effectiveness of two group-based, telehealth-delivered interventions with treatment as usual: (1) cognitive behavioral therapy to address maladaptive thought patterns and behaviors around social connection and (2) a social prescribing intervention to connect participants with social opportunities and develop supportive social networks. Our primary outcome is loneliness as measured by the UCLA Loneliness Scale and our dependent secondary outcome is opioid misuse as measured by the Common Opioid Misuse Measure. We will recruit 102 patients on long-term opioid therapy who screen positive for loneliness from 2 health care systems in Washington State. Implementation outcomes will be assessed using the RE-AIM framework. DISCUSSION: Our study is innovative because we are targeting loneliness, an under-addressed but critical social risk factor that may prevent opioid misuse and use disorder in the setting where most patients are receiving their opioid prescriptions for chronic pain. If successful, the project will have a positive impact in reducing loneliness, reducing opioid misuse, improving function and preventing substance use disorder. TRIAL REGISTRATION: NCT06285032, issue date: February 28, 2024, original.

Categorising implementation determinants and strategies within the US HIV implementation literature: a systematic review protocol.

INTRODUCTION: Despite decreased rates of new infections, HIV/AIDS continues to impact certain US populations. In order to achieve the goals laid out in the Ending the HIV Epidemic (EHE) in the US initiative, implementation science is needed to expand the sustained use of effective prevention and treatment interventions, particularly among priority populations at risk for and living with HIV/AIDS. Over 200 HIV-related implementation studies have been funded by the US National Institutes of Health. Therefore, a comprehensive review of the literature identifying implementation determinants (barriers and facilitators) and categorising implementation strategies across the continuum of HIV prevention and care in the USA is appropriate and needed to enhance current knowledge and help achieve the goals laid out in the EHE national strategic plan. METHODS AND ANALYSIS: This systematic review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Between November 2020 and January 2022, a broad database search strategy of Ovid MEDLINE, PsycINFO and Web of Science was conducted to capture implementation-related studies along the HIV prevention and care continuum. Articles were eligible for inclusion if they were: conducted in the USA, published after the year 2000, written in English, related to HIV/AIDS, focused on outcomes related to dissemination and implementation (ie, did not test/evaluate/explore implementation determinants or strategies) and were behavioural studies (ie, not basic science). We plan to conduct three systematic reviews to identify and categorise determinants and strategies associated with three HIV focus areas: pre-exposure prophylaxis, testing/diagnosing and linkage to care, and treatment. Determinants will be coded according to an adapted Consolidated Framework for Implementation Research 2.0. Implementation strategies and outcomes will be categorised in accordance with existing taxonomies and frameworks. ETHICS AND DISSEMINATION: Ethics approval is not applicable. No original data will be collected. Results will be disseminated through peer-reviewed publications, conference presentations and via online tools. PROSPERO REGISTRATION NUMBER: CRD42021233089.

Supporting the Growth of Domestic HIV Implementation Research in the United States Through Coordination, Consultation, and Collaboration: How We Got Here and Where We Are Headed.

BACKGROUND: The Ending the HIV Epidemic (EHE) initiative sets a goal to virtually eliminate new HIV infections in the United States by 2030. The plan is predicated on the fact that tools exist for diagnosis, prevention, and treatment, and the current scientific challenge is how to implement them effectively and with equity. Implementation research (IR) can help identify strategies that support effective implementation of HIV services. SETTING: NIH funded the Implementation Science Coordination Initiative (ISCI) to support rigorous and actionable IR by providing technical assistance to NIH-funded projects and supporting local implementation knowledge becoming generalizable knowledge. METHODS: We describe the formation of ISCI, the services it provided to the HIV field, and data it collected from 147 NIH-funded studies. We also provide an overview of this supplement issue as a dissemination strategy for HIV IR. CONCLUSION: Our ability to reach EHE 2030 goals is strengthened by the knowledge compiled in this supplement, the services of ISCI and connected hubs, and a myriad of investigators and implementation partners collaborating to better understand what is needed to effectively implement the many evidence-based HIV interventions at our disposal.

Profile of the Portfolio of NIH-Funded HIV Implementation Research Projects to Inform Ending the HIV Epidemic Strategies.

BACKGROUND: The US government created an initiative to end the HIV epidemic in the United States by the year 2030 (EHE). This multiagency initiative was structured around four pillars: Prevent, Diagnose, Treat, and Respond to improve HIV programs, resources, and service delivery infrastructure. In support of its research mission, the National Institutes of Health (NIH) has funded implementation research (IR) projects by addressing the four pillars and encouraging investigators to collaborate with local partners and Health and Human Services (HHS) grantees in 57 priority jurisdictions. METHODS: This paper analyzed data from the NIH funded CFAR/ARC supplement projects from 2019 to 2021. The Exploration, Preparation, Implementation, Sustainment (EPIS) framework was used to characterize projects by stage of implementation. RESULTS: The Prevent pillar was most frequently studied, with Pre-Exposure Prophylaxis (PrEP) being the most studied intervention. The most common partners were health departments, community-based organizations (CBOs), and Federally Qualified Health Centers (FQHCs). The Consolidated Framework for Implementation Research (CFIR) framework was the most utilized to investigate implementation determinants, followed by the RE-AIM framework and Proctor model to assess implementation outcomes. CONCLUSION: Monitoring the projects resulting from NIH investments is fundamental to understanding the response to EHE, and achieving these results requires systematic and continuous effort that can support the generalizable implementation knowledge emerging from individual studies. There are some remaining gaps in the project portfolio, including geographical coverage, range of implementation outcomes being measured, and interventions still requiring further research to ensure equitable scale-up of evidence based interventions and achieve EHE goals.

Determinants of Implementation for HIV Pre-exposure Prophylaxis Based on an Updated Consolidated Framework for Implementation Research: A Systematic Review.

BACKGROUND: Delivery and use of HIV pre-exposure prophylaxis (PrEP) are suboptimal in the United States. Previous reviews of barriers and facilitators have not used an implementation science lens, limiting comprehensiveness and the link to implementation strategies. To summarize the state of the science, we systematically reviewed determinants of PrEP implementation using the updated Consolidated Framework for Implementation Research (CFIR 2.0). SETTING: PrEP-eligible communities and delivery settings in the United States. METHODS: In January 2021, we searched Ovid MEDLINE, PsycINFO, and Web of Science for peer-reviewed articles related to HIV/AIDS, interventions, implementation, and determinants or strategies. We identified 286 primary research articles published after 1999 about US-based PrEP implementation. Team members extracted discrete "mentioned" and "measured" determinants, coding each by setting, population, valence, measurement, and CFIR 2.0 construct. RESULTS: We identified 1776 mentioned and 1952 measured determinants from 254 to 239 articles, respectively. Two-thirds of measured determinants were of PrEP use by patients as opposed to delivery by providers. Articles contained few determinants in the inner setting or process domains (ie, related to the delivery context), even among studies of specific settings. Determinants across priority populations also focused on individual patients and providers rather than structural or logistical factors. CONCLUSION: Our findings suggest substantial knowledge in the literature about general patient-level barriers to PrEP use and thus limited need for additional universal studies. Instead, future research should prioritize identifying determinants, especially facilitators, unique to understudied populations and focus on structural and logistical features within current and promising settings (eg, pharmacies) that support integration of PrEP into clinical practice.