A Systematic Review of Implementation Research on Determinants and Strategies of Effective HIV Interventions for Men Who Have Sex with Men in the United States.

Men who have sex with men (MSM) are disproportionately affected by HIV, accounting for two-thirds of HIV cases in the United States despite representing ∼5% of the adult population. Delivery and use of existing and highly effective HIV prevention and treatment strategies remain suboptimal among MSM. To summarize the state of the science, we systematically review implementation determinants and strategies of HIV-related health interventions using implementation science frameworks. Research on implementation barriers has focused predominantly on characteristics of individual recipients (e.g., ethnicity, age, drug use) and less so on deliverers (e.g., nurses, physicians), with little focus on system-level factors. Similarly, most strategies target recipients to influence their uptake and adherence, rather than improving and supporting implementation systems. HIV implementation research is burgeoning; future research is needed to broaden the examination of barriers at the provider and system levels, as well as expand knowledge on how to match strategies to barriers-particularly to address stigma. Collaboration and coordination among federal, state, and local public health agencies; community-based organizations; health care providers; and scientists are important for successful implementation of HIV-related health innovations.

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.

Determinants of Pre-exposure Prophylaxis (PrEP) Implementation in Transgender Populations: A Qualitative Scoping Review.

We conducted a scoping review of contextual factors impeding uptake and adherence to pre-exposure prophylaxis in transgender communities as an in-depth analysis of the transgender population within a previously published systematic review. Using a machine learning screening process, title and abstract screening, and full-text review, the initial systematic review identified 353 articles for analysis. These articles were peer-reviewed, implementation-related studies of PrEP in the U.S. published after 2000. Twenty-two articles were identified in this search as transgender related. An additional eleven articles were identified through citations of these twenty-two articles, resulting in thirty-three articles in the current analysis. These thirty-three articles were qualitatively coded in NVivo using adapted constructs from the Consolidated Framework for Implementation Research as individual codes. Codes were thematically assessed. We point to barriers of implementing PrEP, including lack of intentional dissemination efforts and patience assistance, structural factors, including sex work, racism, and access to gender affirming health care, and lack of provider training. Finally, over 60% of articles lumped cisgender men who have sex with men with trans women. Such articles included sub-samples of transgender individuals that were not representative. We point to areas of growth for the field in this regard.

RESUMEN: En este revisión de alcance, examinamos los factores contextuales que impiden la adopción y el cumplimiento de la profilaxis previa a la exposición en las comunidades transgénero. Este revisión sistemática se formó a partir de una revisión sistemática más grande. Utilizando un proceso de selección de aprendizaje automático, filtración de los titulus y examines, y revision del texto complete, el primer revisión sistemática identificó 353 artículos por el analisis. Estes artículos fueron estudios revisados por pares, relacionados con la implementación de la PrEP en los EE.UU. publicados despues de 2000. Veintidós artículos se identificaron en esta b?squeda como relacionados con personas transgénero. Se identificaron once artículos adicionales a través de citas de estos veintidós artículos, lo que resultó en treinta y tres artículos en el análisis actual. Estos treinta y tres artículos fueron codificados cualitativamente en NVivo utilizando construcciones adaptadas del Marco Consolidado para la Investigación de Implementación (CFIR) como códigos individuales. Los códigos fueron evaluados temáticamente. Señalamos las barreras de la implementación de la PrEP, como la falta de esfuerzos intencionales de difusión y asistencia al paciente, las barreras estructurales como el trabajo sexual, el racism, y el acceso a la salud de afirmación de género, y la falta del entrenamiento de los doctores. Finalmente, más de sesenta por ciento de los artículos tuvieron submuestras de personas transgénero que no eran representativas. Se?alamos áreas de crecimiento para el campo en este sentido.

Addressing Ethical Challenges in US-Based HIV Phylogenetic Research.

In recent years, phylogenetic analysis of HIV sequence data has been used in research studies to investigate transmission patterns between individuals and groups, including analysis of data from HIV prevention clinical trials, in molecular epidemiology, and in public health surveillance programs. Phylogenetic analysis can provide valuable information to inform HIV prevention efforts, but it also has risks, including stigma and marginalization of groups, or potential identification of HIV transmission between individuals. In response to these concerns, an interdisciplinary working group was assembled to address ethical challenges in US-based HIV phylogenetic research. The working group developed recommendations regarding (1) study design; (2) data security, access, and sharing; (3) legal issues; (4) community engagement; and (5) communication and dissemination. The working group also identified areas for future research and scholarship to promote ethical conduct of HIV phylogenetic research.

Landscape of HIV Implementation Research Funded by the National Institutes of Health: A Mapping Review of Project Abstracts.

In 2019, the requisite biomedical and behavioral interventions to eliminate new HIV infections exist. "Ending the HIV Epidemic" now becomes primarily a challenge of will and implementation. This review maps the extent to which implementation research (IR) has been integrated into HIV research by reviewing the recent funding portfolio of the NIH. We searched NIH RePORTER for HIV and IR-related research projects funded from January 2013 to March 2018. The 4629 unique studies identified were screened using machine learning and manual methods. 216 abstracts met the eligibility criteria of HIV and IR. Key study characteristics were then abstracted. NIH currently funds HIV studies that are either formally IR (n = 109) or preparatory for IR (n = 107). Few (13%) projects mentioned a guiding implementation model, theory, or framework, and only 56% of all studies explicitly mentioned measuring an implementation outcome. Considering the study aims along an IR continuum, 18 (8%) studies examined barriers and facilitators, 43 (20%) developed implementation strategies, 46 (21%) piloted strategies, 73 (34%) tested a single strategy, and 35 (16%) compared strategies. A higher proportion of formal IR projects involved established interventions (e.g., integrated services) compared to newer interventions (e.g., pre-exposure prophylaxis). Prioritizing HIV-related IR in NIH and other federal funding opportunity announcements and expanded training in implementation science could have a substantial impact on ending the HIV pandemic. This review serves as a baseline by which to compare funding patterns and the sophistication of IR in HIV research over time.

A Data Visualization and Dissemination Resource to Support HIV Prevention and Care at the Local Level: Analysis and Uses of the AIDSVu Public Data Resource.

BACKGROUND: AIDSVu is a public resource for visualizing HIV surveillance data and other population-based information relevant to HIV prevention, care, policy, and impact assessment. OBJECTIVE: The site, AIDSVu.org, aims to make data about the US HIV epidemic widely available, easily accessible, and locally relevant to inform public health decision making. METHODS: AIDSVu develops visualizations, maps, and downloadable datasets using results from HIV surveillance systems, other population-based sources of information (eg, US Census and national probability surveys), and other data developed specifically for display and dissemination through the website (eg, pre-exposure prophylaxis [PrEP] prescriptions). Other types of content are developed to translate surveillance data into summarized content for diverse audiences using infographic panels, interactive maps, local and state fact sheets, and narrative blog posts. RESULTS: Over 10 years, AIDSVu.org has used an expanded number of data sources and has progressively provided HIV surveillance and related data at finer geographic levels, with current data resources providing HIV prevalence data down to the census tract level in many of the largest US cities. Data are available at the county level in 48 US states and at the ZIP Code level in more than 50 US cities. In 2019, over 500,000 unique users consumed AIDSVu data and resources, and HIV-related data and insights were disseminated through nearly 4,000,000 social media posts. Since AIDSVu's inception, at least 249 peer-reviewed publications have used AIDSVu data for analyses or referenced AIDSVu resources. Data uses have included targeting of HIV testing programs, identifying areas with inequitable PrEP uptake, including maps and data in academic and community grant applications, and strategically selecting locations for new HIV treatment and care facilities to serve high-need areas. CONCLUSIONS: Surveillance data should be actively used to guide and evaluate public health programs; AIDSVu translates high-quality, population-based data about the US HIV epidemic and makes that information available in formats that are not consistently available in surveillance reports. Bringing public health surveillance data to an online resource is a democratization of data, and presenting information about the HIV epidemic in more visual formats allows diverse stakeholders to engage with, understand, and use these important public health data to inform public health decision making.

Considerations for Modernized Criminal HIV Laws and Assessment of Legal Protections Against Release of Identified HIV Surveillance Data for Law Enforcement.

In November 2018, the Centers for Disease Control and Prevention distributed guidance to funded agencies under its Integrated HIV Surveillance and Prevention Programs Initiative to support the implementation of the program's third strategy: HIV transmission cluster investigation and outbreak response efforts. Cluster detection seeks to identify persons infected with HIV (diagnosed and undiagnosed) who are linked to infections in single or related sexual and injection drug networks. Identifying expanding clusters allows public health personnel to intervene directly where active HIV transmissions occur.However, in the context of HIV infection where most US states have enacted criminal exposure laws, these efforts have sparked concerns about the protection of HIV surveillance data from court order or subpoena for law enforcement purposes. The Centers for Disease Control and Prevention calls for funded agencies to evaluate relevant confidentiality laws to ensure that these are sufficient to protect the confidentiality of HIV surveillance data from use by law enforcement.We present four often overlooked factors about the criminalization of HIV exposure and HIV surveillance data protections that should be considered in statutory assessments.

A cross-jurisdictional evaluation of insurance coverage among HIV care patients following the Affordable Care Act.

The impact of the Affordable Care Act (ACA) on HIV care patients, aged 18-64, was evaluated in three jurisdictions with Medicaid expansion (Chicago, New York State, and Washington) and three jurisdictions without Medicaid expansion (Georgia, Texas, and Virginia) using data from the Medical Monitoring Project. Multivariate regression models were used to evaluate insurance status that was reported pre- and post-ACA; self-reported impact of ACA on HIV care was explored with descriptive statistics. The likelihood of having insurance was significantly greater post-ACA compared to pre-ACA in Chicago (aRR = 1.33, 95%CI = 1.20, 1.47), Washington (aRR = 1.15, 95%CI = 1.08, 1.22), and Virginia (aRR = 1.14, 95%CI = 1.00, 1.29). In Washington and Chicago, the likelihood of being Medicaid-insured was greater post-ACA compared to pre-ACA implementation (Chicago: aRR = 1.25, 95%CI = 1.03,1.53; Washington: aRR = 1.66 95% CI = 1.30, 2.13). No other significant differences were observed. Only a subset of HIV care patients (range: 15-35%) reported a change in insurance that would have coincided with the implementation of ACA; and within this subset, a change in medical care costs was the most commonly noted issue. In conclusion, the influence of ACA on insurance coverage and other factors affecting HIV care likely varies by jurisdiction.

Trends in HIV Risk, Testing, and Treatment among MSM in Chicago 2004-2014: Implications for HIV Elimination Planning.

Men who have sex with men (MSM) in the USA continue to have high rates of HIV infection. Increasingly, in addition to behavioral factors, biomedical interventions have been found to play important roles in HIV prevention. In this analysis, we used four waves of cross-sectional data (2004, 2008, 2011, and 2014) from the National HIV Behavioral Surveillance System (NHBS) to examine trends in key behaviors and biomedical interventions among MSM in Chicago (N = 3298). Logistic regression was used to determine changes in behaviors and use of biomedical interventions. Condomless sex increased significantly in waves 3 and 4, compared to wave 1: wave 3 (AOR = 2.07; 95% CI 1.53, 2.78) and wave 4 (AOR = 2.19; 95% CI 1.62, 2.96). Compared to those aged 18-24, older participants were significantly less likely to be routinely tested for HIV: 30-39 (AOR = 0.63; 95% CI 0.48, 0.83), 40-49 (AOR = 0.40; 95% CI 0.29, 0.55), and >50 (AOR = 0.28; 95% CI 0.18, 0.43). Awareness of both post-exposure prophylaxis (PEP)(​AOR = 3.13; 95% CI 1.22, 8.03) and pre-exposure prophylaxis (PrEP)(​AOR = 10.02; 95% CI 2.95, 34.01) increased significantly in wave 4, compared to wave 3. These results suggest a potential increase in HIV rates among men with main and casual partners and should be monitored closely as PrEP becomes more widespread among MSM of all races and ethnicities in Chicago. This study also suggests that further analyses of the barriers to PEP and PreP uptake among high-risk populations are necessary.

Adherence to Centers for Disease Control and Prevention Gonococcal Treatment Guidelines Among Chicago Health Care Providers, 2011-2012.

BACKGROUND: Expansion of antimicrobial resistance in Neisseria gonorrhoeae requires rapid adaptation of treatment guidelines and responsive provider practice. We evaluated patient factors associated with provider adherence to the Centers for Disease Control and Prevention gonococcal treatment recommendations among Chicago providers in 2011 to 2012. METHODS: Laboratory-confirmed cases of uncomplicated urogenital gonorrhea were classified via surveillance data as originating from Chicago Department of Public Health (CDPH) or non-CDPH providers. Recommended treatment was determined according to the Centers for Disease Control and Prevention sexually transmitted disease treatment guidelines: April 2011-July 2012 (period 1) and August-December 2012 (period 2, after August 2012 revision). Multivariable log-binomial regression identified factors associated with recommended treatment over time, stratified by provider type. RESULTS: April 2011 through December 2012, 16,646 laboratory-confirmed gonorrhea cases were identified, of which 9597 (57.7%) had treatment information: 2169 CDPH cases and 7428 non-CDPH cases. Documented recommended treatment increased for CDPH (period 1: 71.3%, period 2: 80.8%; P < 0.01) and non-CDPH providers (period 1: 63.5%, period 2: 68.9%; P < 0.01). Among CDPH cases, statistically significant factors associated with recommended treatment were male sex (adjusted prevalence rate ratio [aPRR], 1.16) white versus black race (aPRR, 0.68), same-day treatment (aPRR, 1.07), and period 2 (aPRR, 1.11). Among non-CDPH cases, statistically significant factors were as follows: male sex (aPRR, 1.10), other versus black race (aPRR, 0.91), same-day treatment (aPRR, 1.31), greater number of within-facility reported cases (aPRRs ranging from 1.22 to 1.41), and at least 50% within-facility missing treatment data (aPRR, 0.84). CONCLUSIONS: Recommended treatment improved over time, yet remains suboptimal. Efforts to reduce variability and improve provider adherence to recommended treatment are urgently needed.

AIDSVu Cities' Progress Toward HIV Care Continuum Goals: Cross-Sectional Study.

BACKGROUND: Public health surveillance data are critical to understanding the current state of the HIV and AIDS epidemics. Surveillance data provide significant insight into patterns within and progress toward achieving targets for each of the steps in the HIV care continuum. Such targets include those outlined in the National HIV/AIDS Strategy (NHAS) goals. If these data are disseminated, they can be used to prioritize certain steps in the continuum, geographic locations, and groups of people. OBJECTIVE: We sought to develop and report indicators of progress toward the NHAS goals for US cities and to characterize progress toward those goals with categorical metrics. METHODS: Health departments used standardized SAS code to calculate care continuum indicators from their HIV surveillance data to ensure comparability across jurisdictions. We report 2018 descriptive statistics for continuum steps (timely diagnosis, linkage to medical care, receipt of medical care, and HIV viral load suppression) for 36 US cities and their progress toward 2020 NHAS goals as of 2018. Indicators are reported categorically as met or surpassed the goal, within 25% of attaining the goal, or further than 25% from achieving the goal. RESULTS: Cities were closest to meeting NHAS goals for timely diagnosis compared to the goals for linkage to care, receipt of care, and viral load suppression, with all cities (n=36, 100%) within 25% of meeting the goal for timely diagnosis. Only 8% (n=3) of cities were >25% from achieving the goal for receipt of care, but 69% (n=25) of cities were >25% from achieving the goal for viral suppression. CONCLUSIONS: Display of progress with graphical indicators enables communication of progress to stakeholders. AIDSVu analyses of HIV surveillance data facilitate cities' ability to benchmark their progress against that of other cities with similar characteristics. By identifying peer cities (eg, cities with analogous populations or similar NHAS goal concerns), the public display of indicators can promote dialogue between cities with comparable challenges and opportunities.

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.

Establishing Evidence Criteria for Implementation Strategies: A Delphi Study for HIV Services.

Background: There are no criteria specifically for evaluating the quality of implementation research and recommend implementation strategies likely to have impact to practitioners. We describe the development and application of the Best Practices Rubric, a set of criteria to evaluate the evidence supporting implementation strategies, in the context of HIV. Methods: We developed the Best Practices Rubric from 2022-2023 in three phases. (1) We purposively selected and recruited by email participants representing a mix of expertise in HIV service delivery, quality improvement, and implementation science. We developed a draft rubric and criteria based on a literature review and key informant interviews. (2) The rubric was then informed and revised through two e-Delphi rounds using a survey delivered online through Qualtrics. The first and second round Delphi surveys consisted of 71 and 52 open and close-ended questions, respectively, asking participants to evaluate, confirm, and make suggestions on different aspects of the rubric. After each survey round, data were analyzed and synthesized as appropriate, and the rubric and criteria were revised. (3) We then applied the rubric to a set of research studies assessing 18 implementation strategies designed to promote the adoption and uptake of pre-exposure prophylaxis, an HIV prevention medication, to assess reliable application of the rubric and criteria. Results: Our initial literature review yielded existing rubrics and criteria for evaluating intervention-level evidence. For a strategy-level rubric, additions emerged from interviews, for example, a need to consider the context and specification of strategies. Revisions were made after both Delphi rounds resulting in the confirmation of five evaluation domains - research design, implementation outcomes, limitations and rigor, strategy specification, and equity - and four evidence levels - best practice, promising practice, more evidence needed, and harmful practices. For most domains, criteria were specified at each evidence level. After an initial pilot round to develop an application process and provide training, we achieved 98% reliability when applying the criteria to 18 implementation strategies. Conclusions: We developed a rubric to evaluate the evidence supporting implementation strategies for HIV services. Although the rubric is specific to HIV, this tool is adaptable for evaluating strategies in other health areas.

Estimating the number of young Black men who have sex with men (YBMSM) on the south side of Chicago: towards HIV elimination within US urban communities.

The rate of HIV infection among young Black men who have sex with men (YBMSM) aged 16-29 is increasing significantly in the United States. Prevention in this population would considerably impact future health-care resources given the need for lifelong antiretrovirals. A YBMSM population estimate is needed to assist HIV prevention program planning. This analysis estimates the number of YBMSM aged 16-29 living on the south side of Chicago (SSC), the Chicago HIV epicenter, as the first step in eliminating HIV in this population. Three methods were utilized to estimate the number of YBMSM in the SSC. First, an indirect approach following the formula a = k/b; where a = the estimated number of YBMSM, k = the average YBMSM HIV prevalence estimate, and b = the YBMSM population-based HIV seropositivity rate. Second, data from the most recent National Survey of Family Growth (NSFG) was used to estimate the proportion of Black men who report having sex with a man. Third, a modified Delphi approach was used, which averaged community expert estimates. The indirect approach yielded an average estimate of 11.7 % YBMSM, the NSFG yielded a 4.2 % (95 % CI 2.28-6.21) estimate, and the modified Delphi approach yielded estimates of 3.0 % (2.3-3.6), 16.8 % (14.5-19.1), and 25 % (22.0-27.0); an average of 14.9 %. The crude average of the three methods was 10.2 %. Applied to SSC, this results to 5,578 YBMSM. The estimate of 5,578 YBMSM represents a group that can be feasibly reached with HIV prevention efforts. Population estimates of those most at risk for HIV will help public health officials allocate resources, offering potential for elimination of new HIV cases.

Predictors of HIV Molecular Cluster Membership and Implications for Partner Services.

Public health surveillance data used in HIV molecular cluster analyses lack contextual information that is available from partner services (PS) data. Integrating these data sources in retrospective analyses can enrich understanding of the risk profile of people in clusters. In this study, HIV molecular clusters were identified and matched to information on partners and other information gleaned at the time of diagnosis, including coinfection with syphilis. We aimed to produce a more complete understanding of molecular cluster membership in Houston, Texas, a city ranking ninth nationally in rate of new HIV diagnoses that may benefit from retrospective matched analyses between molecular and PS data to inform future intervention. Data from PS were matched to molecular HIV records of people newly diagnosed from 2012 to 2018. By conducting analyses in HIV-TRACE (TRAnsmission Cluster Engine) using viral genetic sequences, molecular clusters were detected. Multivariable logistic regression models were used to estimate the association between molecular cluster membership and completion of a PS interview, number of named partners, and syphilis coinfection. Using data from 4,035 people who had a viral genetic sequence and matched PS records, molecular cluster membership was not significantly associated with completion of a PS interview. Among those with sequences who completed a PS interview (n = 3,869), 45.3% (n = 1,753) clustered. Molecular cluster membership was significantly associated with naming 1 or 3+ partners compared with not naming any partners [adjusted odds ratio, aOR: 1.27 (95% confidence interval, CI: 1.08-1.50), p = .003 and aOR: 1.38 (95% CI: 1.06-1.81), p = .02]. Alone, coinfection with syphilis was not significantly associated with molecular cluster membership. Syphilis coinfection was associated with molecular cluster membership when coupled with incarceration [aOR: 1.91 (95% CI: 1.08-3.38), p = .03], a risk for treatment interruption. Enhanced intervention among those with similar profiles, such as people coinfected with other risks, may be warranted.

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.

Keep It Up! 3.0: Study protocol for a type III hybrid implementation-effectiveness cluster-randomized trial.

BACKGROUND: Despite evidence that eHealth approaches can be effective in reducing HIV risk, their implementation requirements for public health scale up are not well established, and effective strategies to bring these programs into practice are still unknown. Keep It Up! (KIU!) is an online program proven to reduce HIV risk among young men who have sex with men (YMSM) and ideal candidate to develop and evaluate novel strategies for implementing eHealth HIV prevention programs. KIU! 3.0 is a Type III Hybrid Effectiveness-Implementation cluster randomized trial designed to 1) compare two strategies for implementing KIU!: community-based organizations (CBO) versus centralized direct-to-consumer (DTC) recruitment; 2) examine the effect of strategies and determinants on variability in implementation success; and 3) develop materials for sustainment of KIU! after the trial concludes. In this article, we describe the approaches used to achieve these aims. METHODS: Using county-level population estimates of YMSM, 66 counties were selected and randomized 2:1 to the CBO and DTC approaches. The RE-AIM model was used to drive outcome measurements, which were collected from CBO staff, YMSM, and technology providers. Mixed-methods research mapped onto the domains of the Consolidated Framework for Implementation Research will examine determinants and their relationship with implementation outcomes. DISCUSSION: In comparing our implementation recruitment models, we are examining two strategies which have shown effectiveness in delivering health technology interventions in the past, yet little is known about their comparative advantages and disadvantages in implementation. The results of the trial will further the understanding of eHealth prevention intervention implementation.

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.

Agent-based model projections for reducing HIV infection among MSM: Prevention and care pathways to end the HIV epidemic in Chicago, Illinois.

Our objective is to improve local decision-making for strategies to end the HIV epidemic using the newly developed Levers of HIV agent-based model (ABM). Agent-based models use computer simulations that incorporate heterogeneity in individual behaviors and interactions, allow emergence of systemic behaviors, and extrapolate into the future. The Levers of HIV model (LHM) uses Chicago neighborhood demographics, data on sex-risk behaviors and sexual networks, and data on the prevention and care cascades, to model local dynamics. It models the impact of changes in local preexposure prophylaxis (PrEP) and antiretroviral treatment (ART) (ie, levers) for meeting Illinois' goal of "Getting to Zero" (GTZ) -reducing by 90% new HIV infections among men who have sex with men (MSM) by 2030. We simulate a 15-year period (2016-2030) for 2304 distinct scenarios based on 6 levers related to HIV treatment and prevention: (1) linkage to PrEP for those testing negative, (2) linkage to ART for those living with HIV, (3) adherence to PrEP, (4) viral suppression by means of ART, (5) PrEP retention, and (6) ART retention. Using tree-based methods, we identify the best scenarios at achieving a 90% HIV infection reduction by 2030. The optimal scenario consisted of the highest levels of ART retention and PrEP adherence, next to highest levels of PrEP retention, and moderate levels of PrEP linkage, achieved 90% reduction by 2030 in 58% of simulations. We used Bayesian posterior predictive distributions based on our simulated results to determine the likelihood of attaining 90% HIV infection reduction using the most recent Chicago Department of Public Health surveillance data and found that projections of the current rate of decline (2016-2019) would not achieve the 90% (p = 0.0006) reduction target for 2030. Our results suggest that increases are needed at all steps of the PrEP cascade, combined with increases in retention in HIV care, to approach 90% reduction in new HIV diagnoses by 2030. These findings show how simulation modeling with local data can guide policy makers to identify and invest in efficient care models to achieve long-term local goals of ending the HIV epidemic.