Network Analysis of Organizations Providing HIV Services in Chicago: Toward an Integrated Response to the HIV Epidemic.

CONTEXT: The public health response to the HIV epidemic has increasingly centered on the uptake of and adherence to biomedical interventions (eg, pre-exposure prophylaxis [PrEP], treatment as prevention [TasP]). Traditionally, various community and health care organizations have worked to address different stages of PrEP or TasP care. OBJECTIVE: To understand the importance of how HIV prevention organizations providing these services interact to provide the comprehensive care needed for successful HIV and PrEP continuum outcomes. DESIGN: Utilizing an Organizational Network Survey, network ties were examined between formal and informal partnerships among community agencies. SETTING: This study examined community agencies in the current HIV prevention system in Chicago. PARTICIPANTS: Seventy-two community agencies across the Chicago metropolitan area. MAIN OUTCOME MEASURES: Using network analysis, this study examined ties between community agencies and assessed perceptions of collaboration and competitiveness in the current HIV prevention system in Chicago. RESULTS: Overall, respondents reported that the current environment of HIV prevention in Chicago was extremely (18.8%), moderately (37.5%), or somewhat collaborative (37.5%) and extremely (68.8%) or moderately competitive (25.0%). The majority of partnerships reported were informal, with less than a quarter being formalized. That said, those who reported formal partnerships reported being satisfied with those relationships. There was a significantly negative association between density and perceived collaboration-grantees experiencing a more collaborative also reported less dense networks. CONCLUSION: These findings indicate that, despite perceived competitiveness, agencies are willing to work together and create a cohesive HIV prevention and treatment system. However, more work should be done to foster an environment that can support the formation of partnerships, to improve a coordinated response to providing HIV care, and sustain mutually beneficial relationships.

Development of the Functional Assessment of Cancer Therapy-Carcinoid Syndrome Symptom Index.

OBJECTIVE: To develop a symptom-focused index to evaluate representative symptoms, treatment side effects, and emotional and functional well-being of patients with carcinoid syndrome (CS). METHODS: The development of the Functional Assessment of Cancer Therapy-Carcinoid Syndrome Symptom Index (FACT-CSI) followed US Food and Drug Administration guidelines for the development of patient-reported outcome (PRO) measures and involved the following: (a) literature review; (b) interviews with 14 CS patients; (c) interviews with 9 clinicians; and (d) instrument development involving input from a range of PRO measure development and CS experts. The resulting draft instrument underwent cognitive interviews with 7 CS patients. RESULTS: Forty-six CS sources were reviewed. Analysis of patient interviews produced 23 patient-reported symptoms. The most frequently endorsed physical symptoms were flushing, diarrhea, abdominal pain, fatigue, and food sensitivity/triggers. Seven priority CS emotional and functional themes were also identified by patients. Expert interviews revealed 12 unique priority symptoms - the most common being diarrhea, flushing, wheezing, edema, abdominal pain/cramping, fatigue, and 8 emotional and functional concerns. Through an iterative process of team and clinical collaborator meetings, data review, item reduction and measure revision, 24 items were selected for the draft symptom index representing symptoms, emotional concerns, global assessment of treatment side effects, and functional well-being. Cognitive interview results demonstrated strong content validity, including positive endorsement of item clarity (>86% across items), symptom relevance (>70% for most items), and overall measure content (86%). CONCLUSIONS: The FACT-CSI is a content-relevant, symptom-focused index reflecting the highest priority and clinically relevant symptoms and concerns of people with CS.

Awareness and Knowledge of Pre-exposure Prophylaxis Among Sexual and Gender Minority Adolescents Assigned Male at Birth in the United States.

Sexual and gender minority (SGM) adolescents assigned male at birth are at increased risk for HIV infection. Pre-exposure prophylaxis (PrEP) is a daily pill taken to prevent HIV, which the United States Food and Drug Administration approved for minors under age 18 years weighing at least 77.5 lb in 2018. A lack of awareness and knowledge of PrEP are barriers to uptake among adults and adolescents, but SGM adolescents' awareness and knowledge about PrEP remain underexplored and no studies have assessed SGM adolescents' informational needs. We collected data on 59 SGM adolescents' (ages 14-18 years) awareness, knowledge, and questions about PrEP in an online survey and six online focus groups. Although a majority of SGM adolescents (83.1%) were aware of PrEP before the study, many wanted more information about side effects and how to navigate potential barriers to PrEP initiation. Findings can inform public health efforts to promote PrEP knowledge and uptake among SGM adolescents.

Transgender Women's Concerns and Preferences on Potential Future Long-Acting Biomedical HIV Prevention Strategies: The Case of Injections and Implanted Medication Delivery Devices (IMDDs).

There are several long-acting biomedical HIV prevention products in the development pipeline, including injections and implanted medication delivery devices (IMDDs). It is critical to understand concerns and preferences on the use of these products in populations that shoulder a disproportionate burden of the HIV epidemic, such as transgender women. This will allow researchers and public health professionals to construct interventions tailored to the needs of these women to promote optimal use of these tools. In studies of other biomedical HIV prevention products (e.g., oral PrEP) it is clear that transgender women have unique concerns related to the use of these strategies. This may have an impact on this group's uptake and sustained use of longacting HIV prevention products. This study conducted four focus groups with N = 18 transgender women in New York City to understand their concerns and preferences on long-acting PrEP injections and IMDDs. Findings showed that participants were overwhelmingly positive about long-acting HIV prevention strategies, though they had some apprehensions. Overall, participants felt that injections and IMDDs could help address adherence challenges, and that transgender-specific needs should be addressed during clinical trials. Also, there were concerns related to injection or IMDD logistics, concerns about injections' or IMDDs' presence in the body, and familiarity with these products affected participants' opinions on them. Findings from this work can be used to inform protocols, measures, materials, and adherence interventions in future initiatives for transgender women using PrEP injections or IMDDs.

Knowledge About Oral PrEP Among Transgender Women in New York City.

This paper grows our understanding about PrEP knowledge in transgender women (TW) to improve PrEP-focused education/outreach. Research took place in New York City. We conducted four focus groups in English or Spanish (N = 18). Discussions focused on participants' perceptions and knowledge of oral PrEP. Most participants knew that PrEP is efficacious and requires consistent use. However, some participants were skeptical of medications; others acknowledged that false assumptions about PrEP exist among TW. Most TW in our focus groups were informed about PrEP through clinics or community-based organizations. Some participants felt that messages about medications were oversimplified, and wanted more information.

Exploring new and existing PrEP modalities among female sex workers and women who inject drugs in a U.S. city.

To address a shortage in research on Pre-Exposure Prophylaxis (PrEP) amongst women at high risk of HIV acquisition, this study explored the attitudes and preferences of female sex workers (FSW) (n = 15) and women who inject drugs (WWID) (n = 16) to existing (e.g., pill) and new (e.g., injection, implant) PrEP modalities, in Baltimore, Maryland, U.S.A. This study reports on seven focus groups conducted between December 2016 and April 2017 and aims to provide new insights into FSW and WWID attitudes and preferences towards three different PrEP delivery methods (i.e., PrEP pill, PrEP implant, PrEP injection). Results draw upon the PrEP care continuum framework and distill existing factors, including lack of control over side effects with new, longer lasting modalities, better privacy with injections, increased adherence with reduced dosing schedules from longer lasting PrEP and new factors such as perceptibility concerns with respect to the PrEP implant relevant to PrEP uptake and adherence among two important overlapping, at-risk populations. The study contributes to a better understanding of barriers and facilitators to uptake and adherence for FSW and WWID around both existing and new PrEP modalities, with implications for future clinical trials and PrEP interventions with at risk-populations.

Empowerment Evaluation: A Case Study of Citywide Implementation within an HIV Prevention Context.

HIV continues to significantly impact the health of communities, particularly affecting racially and ethnically diverse men who have sex with men and transgender women. In response, health departments often fund a number of community organizations to provide each of these subgroups with comprehensive and culturally responsive services. To this point, evaluators have focused on individual interventions, but have largely overlooked the complex environment in which these interventions are implemented, including other programs funded to do similar work. The Evaluation Center was funded by the City of Chicago in 2015 to conduct a city-wide evaluation of all HIV prevention programming. This article will describe our novel approach to adapt the principles and methods of the Empowerment Evaluation approach, to effectively engage with 20 city-funded prevention programs to collect and synthesize multi-site evaluation data, and ultimately build capacity at these organizations to foster a learning-focused community.

Barriers and Facilitators to Oral PrEP Use Among Transgender Women in New York City.

Transgender women may face a disparate risk for HIV/AIDS compared to other groups. In 2012, Truvada was approved for daily use as HIV pre-exposure prophylaxis (PrEP). However, there is a dearth of research about barriers and facilitators to PrEP in transgender women. This paper will shed light on transgender women living in New York City's perceived and actual challenges to using PrEP and potential strategies to overcome them. After completing an initial screening process, four 90-min focus groups were completed with n = 18 transgender women. Participants were asked what they like and dislike about PrEP. Participants identified the following barriers: uncomfortable side effects, difficulty taking pills, stigma, exclusion of transgender women in advertising, and lack of research on transgender women and PrEP. Facilitators included: reducing pill size, increasing the types of available HIV prevention products, and conducting scientific studies to evaluate PrEP in transgender women.

Attrition and HIV Risk Behaviors: A Comparison of Young Men Who Have Sex with Men Recruited from Online and Offline Venues for an Online HIV Prevention Program.

In addition to offline venue-based and time-space sampling, recruitment of young men who have sex with men (YMSM) into HIV surveillance and prevention studies has expanded over time to include Internet-based approaches. Despite broadening recruitment strategies, enrolling racially and ethnically diverse YMSM who are disproportionately impacted by HIV continues to be challenging. Additionally, there is little literature on the impact of recruitment venue on participant characteristics and likelihood to enroll YMSM into online randomized control trials (RCT). This study used data from the multisite RCT, Keep It Up! 2.0, to examine the impact of recruitment venue on participant demographics, behavioral HIV risks, and enrollment. A total of 2984 participants were screened for eligibility from community-based organizations, Facebook, dating apps, and outreach events. There were significant differences by venue in age (χ2[3] = 54.38, p < .001), race/ethnicity (χ2[9] = 110.78, p < .001), sexual orientation (χ2[3] = 7.85, p < .05), relationship status (χ2[6] = 27.71, p < .001), and region of recruitment (χ2[6] = 1480.51, p < .001). There were no significant differences by venue in attrition during the enrollment process. The only difference in attrition was by race/ethnicity. Compared to White participants, eligible Black (OR: 0.35, p < .01) and Latino (OR: 0.46, p < .05) participants were significantly less likely to enroll in the intervention. There were also no significant differences by recruitment venue in sexual risk behaviors among enrolled participants. These findings suggest that recruitment into online HIV interventions from a variety of venues is feasible for diverse YMSM who are at similar risk for HIV infection.

A method to create a standardized generic and condition-specific patient-reported outcome measure for patient care and healthcare improvement.

PURPOSE: Patient-reported outcome measures (PROMs), which are generic or condition-specific, are used for a number of reasons, including clinical care, clinical trials, and in national-level efforts to monitor the quality of health care delivery. Creating PROMs that meet different purposes without overburdening patients, healthcare systems, providers, and data systems is paramount. The objective of this study was to test a generalizable method to incorporate condition-specific issues into generic PROM measures as a first step to producing PROMs that efficiently provide a standardized score. This paper outlines the method and preliminary findings focused on a PROM for osteoarthritis of the knee (OA-K). METHODS: We used a mixed-methods approach and PROMIS® measures to test development of a combined generic and OA-K-specific PROM. Qualitative methods included patient focus groups and provider interviews to identify impacts of OA-K important to patients. We then conducted a thematic analysis and an item gap analysis: identified areas covered by existing generic PROMIS measures, identified "gap" areas not covered, compared gap areas to legacy instruments to verify relevance, and developed new items to address gaps. We then performed cognitive testing on new items and drafted an OA-K-specific instrument based on findings. RESULTS: We identified 52 existing PROMIS items and developed 24 new items across 14 domains. CONCLUSIONS: We developed a process for creating condition-specific instruments that bridge gaps in existing generic measures. If successful, the methodology will create instruments that efficiently gather the patient's perspective while allowing health systems, researchers, and other interested parties to monitor and compare outcomes over time, conditions, and populations.

Exploring Patterns of Awareness and Use of HIV Pre-Exposure Prophylaxis Among Young Men Who Have Sex with Men.

Pre-exposure prophylaxis (PrEP) has shown promise as a safe and effective HIV prevention strategy, but there is limited research on awareness and use among young men who have sex with men (YMSM). Using baseline data from the "Keep It Up! 2.0" randomized control trial, we examined differences in PrEP awareness and use among racially diverse YMSM (N = 759; mean age = 24.2 years). Participants were recruited from study sites in Atlanta, Chicago, and New York City, as well as through national advertising on social media applications. While 67.5 % of participants reported awareness of PrEP, 8.7 % indicated using the medication. Awareness, but not use, varied by demographic variables. PrEP-users had twice as many condomless anal sex partners (ERR = 2.05) and more condomless anal sex acts (ERR = 1.60) than non-users. Future research should aim to improve PrEP awareness and uptake among YMSM and address condom use.

Preferences for Long-Acting Pre-exposure Prophylaxis (PrEP), Daily Oral PrEP, or Condoms for HIV Prevention Among U.S. Men Who Have Sex with Men.

HIV prevention method preferences were evaluated among 512 U.S. men who have sex with men (MSM; median age: 22 years). Approximately 90 % consistently preferred one option across pairwise comparisons of condoms, daily oral pre-exposure prophylaxis (PrEP), and long-acting PrEP delivered via either an injectable or one of two types of PrEP implants differing in visibility. Condoms were most frequently preferred (33.8 %), followed by non-visible implants (21.5 %), and oral PrEP (17.0 %); HIV risk was reported by more choosing implants. In a follow-up question comparing the four PrEP options only, daily oral pills and non-visible implants were most frequently preferred (35.5 and 34.3 %, respectively), followed by injections (25.2 %) and visible implants (4.3 %). An inductive, open-coding approach determined that convenience, duration of protection, and privacy were the most commonly cited reasons for a PrEP method choice, and associated with self-report of HIV risk. Tailoring PrEP product development to privacy and other concerns important to those at highest HIV risk may improve HIV prevention.

Envisioning an America without sexual orientation inequities in adolescent health.

This article explicates a vision for social change throughout multiple levels of society necessary to eliminate sexual orientation health disparities in youths. We utilized the framework of Bronfenbrenner's ecological theory of development, a multisystemic model of development that considers direct and indirect influences of multiple levels of the environment. Within this multisystem model we discuss societal and political influences, educational systems, neighborhoods and communities, romantic relationships, families, and individuals. We stress that continued change toward equity in the treatment of lesbian, gay, and bisexual youths across these levels will break down the barriers for these youths to achieve healthy development on par with their heterosexual peers.

The association between sexual orientation identity and behavior across race/ethnicity, sex, and age in a probability sample of high school students.

OBJECTIVES: We examined the prevalence and associations between behavioral and identity dimensions of sexual orientation among adolescents in the United States, with consideration of differences associated with race/ethnicity, sex, and age. METHODS: We used pooled data from 2005 and 2007 Youth Risk Behavior Surveys to estimate prevalence of sexual orientation variables within demographic sub-groups. We used multilevel logistic regression models to test differences in the association between sexual orientation identity and sexual behavior across groups. RESULTS: There was substantial incongruence between behavioral and identity dimensions of sexual orientation, which varied across sex and race/ethnicity. Whereas girls were more likely to identify as bisexual, boys showed a stronger association between same-sex behavior and a bisexual identity. The pattern of association of age with sexual orientation differed between boys and girls. CONCLUSIONS: Our results highlight demographic differences between 2 sexual orientation dimensions, and their congruence, among 13- to 18-year-old adolescents. Future research is needed to better understand the implications of such differences, particularly in the realm of health and health disparities.

Testing negative means I'm lucky, making good choices, or immune: diverse reactions to HIV test results are associated with risk behaviors.

BACKGROUND: HIV testing may lead to behavioral changes among some individuals, but no scale has been developed to assess potential mechanisms. PURPOSE: We aimed to develop and evaluate the psychometric properties of a scale to measure psychological reactions to the receipt of a negative HIV test and explore the scale's associations with unprotected anal intercourse (UAI). METHODS: Two focus groups were conducted to develop the Inventory of Reactions to Testing HIV Negative, which was subsequently tested on 725 men who have sex with men in the New York City area. RESULTS: Factor analyses confirmed the presence of three subscales-Reinforced Safety, Invulnerability, and Luck. Regression analyses demonstrated that the subscales interacted with HIV testing behavior to influence UAI. CONCLUSIONS: These findings support the notion that there is heterogeneity in how individuals respond to a negative HIV test, with some individuals subsequently being influenced towards increased engagement in HIV risk behaviors.

Intimacy, monogamy, and condom problems drive unprotected sex among young men in serious relationships with other men: a mixed methods dyadic study.

This mixed methods study aimed to examine partner and relationship characteristics associated with HIV risk among young men who have sex with men (YMSM). A sub-sample of YMSM (18-25 years) who were involved in serious relationships with other men were recruited from two on-going longitudinal studies, Project Q2 and Crew450 (N = 20 couples). The mean age of the dyadic sample was 22.5 years (SD = 5.33, range 18-46 years) and participants were racially and ethnically diverse, with the largest percentage of the sample identifying as African American (47.5 %), followed by Hispanic (20 %). Participants completed individual self-report measures using computer-assisted self-interview technology and engaged in couples-based interviews. Mixed methods analyses indicated three global reasons for unprotected sex among YMSM in serious relationships: (1) the desire to achieve emotional intimacy; (2) the perception of being in a monogamous relationship; and (3) the difficulties associated with accessing and/or using condoms. Couples' decision-making processes, including decisions made "in the heat of the moment," have implications for HIV prevention interventions.

Obstacles to Biosimilar Acceptance and Uptake in Oncology: A Review.

Importance: Biosimilar drugs provide cost-effective yet clinically indistinguishable replications of target drugs. During initial development, this class of biologic medicines was expected to revolutionize pharmaceutical markets; however, following US Food and Drug Administration approval of the first biosimilar drug in 2015, the commercialization of biosimilars has been limited. The lack of biosimilar use may be especially salient in oncology, given that biosimilar distribution in this particularly high-cost area of medicine would bring savings on the order of many billions of dollars. Observations: While researchers have focused on salient economic barriers to biosimilar uptake in the US, the present review provides insight regarding noneconomic barriers. This review discusses psychological, attitudinal, and educational factors among both health care professionals and payers in the US that may play a role in slowing biosimilar uptake. More specifically, these factors include a lack of health care professional education, concerns of safety and efficacy, and overly complex product naming systems. Conclusions and Relevance: The pathway to biosimilar use has been obstructed by economic elements as well as attitudinal and psychological factors. For biosimilar drugs to achieve their potential in decreasing treatment costs and thus increasing patient access, it will be essential for both economic and noneconomic factors to be identified and systematically addressed.

Medical Oncologists' Knowledge and Perspectives on the Use of Biosimilars in the United States.

PURPOSE: Despite increasing availability of biosimilar cancer treatments, little is known about oncologists' knowledge and concerns regarding biosimilar use in the United States. We surveyed medical oncologists to examine their knowledge, attitudes, and experience with biosimilars. METHODS: Oncologists recruited via the ASCO Research Survey Pool completed a 29-question survey in 2020 designed with input from clinical and health care system experts and literature review. RESULTS: Of the 269 respondents, most treated patients with biosimilars (n = 236, 88%) and reported that biosimilars were required at their institution (n = 168, 63%). Approximately half (n = 140, 52%) of oncologists correctly responded that biosimilars were not the same as generic medicines. Commonly reported barriers to use of biosimilars included concerns regarding a perceived lack of relevant research (n = 85, 33% reporting quite a bit/very much), the potential for extrapolation (n = 83, 33%), and efficacy limitations (n = 77, 30%). More oncologists from university hospitals (n = 36, 22%) than from community/private hospitals (n = 28, 38%) or private practices (n = 13, 38%) were concerned about biosimilar efficacy. A high proportion of oncologists reported that information on safety (n = 259, 99%) and efficacy (n = 255, 99%) is important when considering whether to use biosimilars. Less than half reported that their institution provided education about biosimilars (n = 108, 40%). CONCLUSION: In this sample of medical oncologists, knowledge about basic features of biosimilars was limited and access to information about biosimilars was insufficient. The present study determined that educational programs on biosimilars for oncologists are needed and identified priorities for such efforts.

Integrating PROMIS Measures in a Treat-to-Target Approach to Standardize Patient-Centered Treatment of Rheumatoid Arthritis.

OBJECTIVE: To evaluate the effect of a patient-centered rheumatoid arthritis (RA) treat-to-target (T2T) disease management approach on patient outcomes and patient satisfaction with care. METHODS: In this longitudinal, observational pilot study, rheumatologists implemented a modified T2T approach that integrated Patient Reported Outcomes Measurement Information System (PROMIS) measures for depression, fatigue, pain interference, physical function, and social function into RA care. Study participants selected 1 PROMIS domain to target treatment and completed quarterly follow-up assessments. Participants were classified as improved if their Clinical Disease Activity Index (CDAI) changed by > 5 points. Change in PROMIS t scores was examined for the group with improved CDAI, and then compared to those with unchanged or worsened CDAI. Satisfaction with care was assessed using multiple measures, including the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-Patient Satisfaction Scale. RESULTS: The analytical sample (n = 119, median age 57 years, 90.8% female) was split between those with CDAI > 10 (n = 63) and CDAI ≤ 10 (n = 53). At 1 year, there was improvement in CDAI by > 5 points in 66% and 13% of individuals with baseline CDAI > 10 and baseline CDAI ≤ 10, respectively. Across all participants, improvement in CDAI by > 5 points correlated with improvements in the 5 PROMIS domains. Satisfaction with RA treatment also increased. CONCLUSION: The integration of PROMIS measures into the T2T approach for RA care was associated with improvements in disease activity, and improvement in disease activity was associated with improvements in PROMIS measures.

Implementation and evaluation of patient navigation in Chicago: Insights on addressing the social determinants of health and integrating HIV prevention and care services.

Patient navigation is a primary element in linkage to HIV pre-exposure prophylaxis (PrEP) care and linkage to or re-engagement in HIV care, depending on the HIV status of the individual. However, there is a dearth of literature describing navigation services in these areas. In the context of Chicago Project PrIDE, this project conducted process and implementation evaluations with eight agencies leading demonstration projects to address these gaps. The evaluation team conducted semi-structured, individual interviews with agency staff (N = 20) assessing navigation implementation and fit, as well as project successes and challenges. Additionally, agency staff collected patient surveys (N = 300) assessing services provided, service quality, and satisfaction. The interview transcripts were coded and analyzed thematically and descriptive analyses were performed on the survey data. Analyses indicated that screening for social determinants of health, providing healthcare engagement guidance, and providing service referrals were frequently cited navigation activities. Most staff members indicated that navigation fits well within their agencies, and that limited staff and clinic capacity were often barriers to navigation. Patient navigation to support engagement in HIV prevention and care services is critical due to the extensive support provided by navigators to address social determinants of health impacting HIV disparity populations.