An Algorithmic Approach to Understanding Osteoarthritic Knee Pain.

Background: Osteoarthritic knee pain is a complex phenomenon, and multiple factors, both within the knee and external to it, can contribute to how the patient perceives pain. We sought to determine how well a deep neural network could predict osteoarthritic knee pain and other symptoms solely from a single radiograph view. Methods: We used data from the Osteoarthritis Initiative, a 10-year observational study of patients with knee osteoarthritis. We paired >50,000 weight-bearing, posteroanterior knee radiographs with corresponding Knee Injury and Osteoarthritis Outcome Score (KOOS) pain, symptoms, and activities of daily living subscores and used them to train a series of deep learning models to predict those scores solely from raw radiographic input. We created regression models for specific score predictions and classification models to predict whether the modeled KOOS subscore exceeded a range of thresholds. Results: The root-mean-square errors were 15.7 for KOOS pain, 13.1 for KOOS symptoms, and 14.2 for KOOS activities of daily living. Modeling was performed to predict whether pain was above or below given pain thresholds, and was able to predict extreme pain (KOOS pain < 40) with an area under the curve (AUC) of 0.78. Notably, the system was also able to correctly predict numerous cases where the Kellgren-Lawrence (KL) grade assigned by the radiologist was 0 but patient pain was high, and cases where the KL grade was 4 but patient pain was low. Conclusions: A deep neural network can be trained to predict the osteoarthritic knee pain that a patient experienced and other symptoms with reasonable accuracy from a single posteroanterior view of the knee, even using low-resolution images. The system can predict pain and dysfunction that the traditional KL grade does not capture. Deep learning applied to raw imaging inputs holds promise for disentangling sources of pain within the knee from aggravating factors external to the knee. Level of Evidence: Diagnostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Functional analysis of Rickettsia monacensis strain humboldt folA dihydrofolate reductase gene via complementation assay.

Nutritive symbiosis between bacteria and ticks is observed across a range of ecological contexts; however, little characterization on the molecular components responsible for this symbiosis has been done. Previous studies in our lab demonstrated that Rickettsia monacensis str. Humboldt (strain Humboldt) can synthesize folate de novo via the folate biosynthesis pathway involving folA, folC, folE, folKP, and ptpS genes. In this study, expression of the strain Humboldt folA gene within a folA mutant Escherichia coli construct was used to functionally characterize the strain Humboldt folA folate gene in vivo. The strain Humboldt folA folate gene was subcloned into a TransBac vector and transformed into a folA mutant E. coli construct. The mutant containing strain Humboldt folA subclone and a pFE604 clone of the knocked-out folA gene was cured of pFE604. Curing of the folA mutant E. coli construct was successful using acridine orange and 43.5 °C incubation temperature. The plasmid curing assay showed curing efficiency of the folA mutant at 100%. Functional complementation was assessed by growth phenotype on minimal media with and without IPTG between strain Humboldt folA and E. coli folA. Large and homogenous wild-type colony growth was observed for both strain Humboldt and E. coli folA on minimal media with 0.1 mM IPTG, wild-type growth for strain Humboldt folA and pin-point growth for E. coli folA on 0.01 mM IPTG, and pin-point growth without IPTG for both strain Humboldt and E. coli folA. This study provides evidence substantiating the in vivo functionality of strain Humboldt folA in producing functional gene products for folate biosynthesis.

Do Patient-Reported Outcomes Reflect Objective Measures of Function? Implications for Total Knee Arthroplasty.

BACKGROUND: Patient-reported outcomes (PROs) are used in research, clinical practice, and by federal reimbursement models to assess outcomes for patients who have knee osteoarthritis (OA) and total knee arthroplasty (TKA). We examined a large cohort of patients to determine if commonly used PROs reflect observed evaluation as measured by standardized functional tests (SFTs). METHODS: We used data from the Osteoarthritis Initiative, a 10-year observational study of knee osteoarthritis patients. Two cohorts were examined: 1) participants who received TKA (n = 281) and 2) participants who have native OA (n = 4,687). The PROs included Western Ontario and McMaster Osteoarthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS), 12-Item Short Form Health Survey (SF-12), and Intermittent and Constant Pain Score (ICOAP). The SFTs included 20 m and 400 meter (m) walks and chair stand pace. Repeated measures correlation coefficients were used to determine the relationship between PROs and SFTs. RESULTS: The PROs and SFTs were not strongly correlated in either cohort. The magnitude of the repeated measures correlation (rrm) between KOOS, WOMAC, SF-12, and ICOAP scores and SFT measurements in native knee OA patients ranged as follows: 400 m walk pace (0.08 to 0.20), chair stand pace (0.05 to 0.12), and 20 m pace (0.02 to 0.21), all with P < .05. In the TKA cohort, values ranged as follows: 400 M walk pace (0.00 to 0.29), chair stand time (0.02 to 0.23), and 20 M pace (0.03 to 0.30). Due to the smaller cohort size, the majority, but not all had P values < .05. CONCLUSION: There is not a strong association between PROs and SFTs among patients who have knee OA or among patients who received a TKA. Therefore, PROs should not be used as a simple proxy for observed evaluation of physical function. Rather, PROs and SFTs are complementary and should be used in combination for a more nuanced and complete characterization of outcome.

Transgender gender-affirming surgery consultation among patients seeking care in the Midwestern United States.

Gender-affirming surgery (GAS) is among the most rapidly growing and expanding subfields in plastic surgery due to increased awareness, decreased stigma, rising demand, and improved access for transgender and gender non-conforming individuals (TGNC). In order to address potential barriers and facilitators in GAS education and training, there is a need to explore the experiences of TGNC individuals. The purpose of this study was to qualitatively explore the factors that influence TGNC patient experiences in surgical consultation for GAS. Targeted recruitment was used to recruit and enroll participants who identified as TGNC and who had undergone consultation with a surgeon to discuss GAS. Semi-structured interviews were used to explore patient experiences with GAS. Recorded audio from these interviews was later transcribed verbatim. Open coding of these transcripts was then performed independently by 3 individual members of the research team using the consensual qualitative coding methods. Fifteen interviews were conducted (transmale, n = 7; transfemale, n = 4; gender non-conforming/non-binary, n = 4). Participants frequently expressed worry and frustration over insurance coverage and exorbitant out-of-pocket expense, whether actual or perceived. Logistical barriers were the most frequently cited category of barriers. The majority of participants made at least 1 reference to relying on others during the process of insurance pre-authorization. The majority of participants described their interactions with surgeons as positive, indicating that they felt comfortable during consultation and that their surgeons ensured their understanding. Our findings provide important insight into this often stressful and challenging process. Ensuring a welcoming, safe, and gender-affirming environment and experience for these individuals is essential. These findings may help to guide future education for medical students, trainees, clinic staff, and surgeons, as well as to direct changes necessary to improve the patient experience in clinics and hospitals for TGNC individuals undergoing consultation for GAS.

An mHealth Intervention to Improve Pre-Exposure Prophylaxis Knowledge Among Young Black Women in Family Planning Clinics: Development and Usability Study.

BACKGROUND: Young Black women between the ages of 18 and 24 years are disproportionately impacted by HIV, yet they have a low self-perception of HIV risk and limited exposure to prevention strategies. Pre-exposure prophylaxis (PrEP) is a safe and effective biomedical HIV prevention strategy for those at risk for HIV infection, but uptake has been slow among cisgender women. Family planning clinics are a primary source of health care access for young women, providing an ideal opportunity to integrate PrEP information and care into existing clinic practices. OBJECTIVE: The aim of this study was to use a multistage, community-engaged process to develop a mobile health app and to evaluate the feasibility and acceptability of the app. METHODS: Using user-centered design, the In the Loop app was developed in collaboration with a community advisory board of young Black women. This study employed a multistage design, which included community-engaged app development, user testing, and evaluation of the app's feasibility and acceptability. A pre- and postdesign was used to assess the impact of the app on PrEP knowledge immediately after app use. Descriptive statistics (eg, mean, SD, and percentage values) were used to describe the sample, and Wilcoxon matched-pairs signed-ranks test was used to detect changes in PrEP knowledge before and immediately after using the app. RESULTS: A total of 50 sexually active, young Black women, aged 18-24 (mean 21, SD 1.9) years, were enrolled in this study. Analysis comparing scores before and immediately after use of the app revealed a significant increase in PrEP content knowledge scores on a 7-item true or false scale (z=-6.04, P<.001). Overall, participants considered the In the Loop app feasible and acceptable to use while waiting for a family planning visit. The majority of participants (n=46, 92%) agreed that they would recommend In the Loop to friends to learn more about PrEP. Participants rated the overall quality of the app 4.3 on a 1-5 scale (1=very poor and 5=very good). Of 50 participants, 40 (80%) agreed that the app was easy to use, and 48 (96%) agreed that they found the information in the app easy to understand. Finally, 40 (80%) agreed that they had enjoyed using the app while waiting for their family planning visit. CONCLUSIONS: Our findings suggest that young Black women waiting for family planning visits found the In the Loop app to be feasible and acceptable. This study demonstrates the value of engaging young Black women in the app design process. As family planning clinics are a primary source of health care access for young women, they provide an ideal setting to integrate PrEP information and care into existing clinic practices. Next steps in the development of the In the Loop app include implementing user-suggested improvements and conducting efficacy testing in a randomized controlled trial to determine the app's impact on PrEP uptake.

Deep Learning and Imaging for the Orthopaedic Surgeon: How Machines "Read" Radiographs.

➤: In the not-so-distant future, orthopaedic surgeons will be exposed to machines that begin to automatically "read" medical imaging studies using a technology called deep learning. ➤: Deep learning has demonstrated remarkable progress in the analysis of medical imaging across a range of modalities that are commonly used in orthopaedics, including radiographs, computed tomographic scans, and magnetic resonance imaging scans. ➤: There is a growing body of evidence showing clinical utility for deep learning in musculoskeletal radiography, as evidenced by studies that use deep learning to achieve an expert or near-expert level of performance for the identification and localization of fractures on radiographs. ➤: Deep learning is currently in the very early stages of entering the clinical setting, involving validation and proof-of-concept studies for automated medical image interpretation. ➤: The success of deep learning in the analysis of medical imaging has been propelling the field forward so rapidly that now is the time for surgeons to pause and understand how this technology works at a conceptual level, before (not after) the technology ends up in front of us and our patients. That is the purpose of this article.

Transgender Care and the COVID-19 Pandemic: Exploring the Initiation and Continuation of Transgender Care In-Person and Through Telehealth.

Gender-affirming care is essential to the health and wellbeing of transgender and nonbinary people. The COVID-19 pandemic has the potential to disrupt transgender care. This study explores transgender care before and during the onset of the pandemic using patient data from 10 family planning clinics in Arkansas, Kansas, Missouri, and Oklahoma. No significant differences were observed in the proportion of transgender care visits pre- or during the pandemic. However, we did find a significantly larger proportion of new transgender patient visits and significantly smaller proportion of established patient visits during the pandemic, with nearly half delivered through telehealth care.

Employment as HIV Prevention: An Employment Support Intervention for Adolescent Men Who Have Sex With Men and Adolescent Transgender Women of Color.

BACKGROUND: The purpose of this study was to adapt and pilot-test an employment support, primary HIV intervention tailored to the needs of adolescent men who have sex with men and adolescent transgender women of color. SETTING: The intervention was implemented in 2 settings: controlled environment (Phase 1) and real-world community-based (Phase 2) setting in Chicago, IL. METHODS: Eighty-seven adolescent men who have sex with men and adolescent transgender women of color ages 16-24 participated in Work2Prevent , a 4-session employment and HIV prevention intervention, designed to increase job-readiness and reduce HIV risk. Intervention sessions consisted of group activities: educational games, roleplaying/modeling behavior, and self-regulation exercises. Participants were assessed at baseline, postintervention, and 8-month (Phase 1) or 3-month follow-up (Phase 2). RESULTS: Participants evaluated Work2Prevent as feasible and acceptable, rating intervention quality, usefulness, and satisfaction highly. Overall, 59.6% (Phase 1) and 85.0% (Phase 2) participants attended 2 or more sessions. At 8 months, Phase 1 participants reported a mean increase of 11.4 hours worked per week. Phase 2 participants reported a mean increase of 5.2 hours worked per week and an increase in job-seeking self-efficacy. Phase 2 participants also reported a decrease in transactional sex work. CONCLUSION: Work2Prevent is one of the first structural primary HIV interventions to specifically focus on adolescent employment readiness. Findings suggest Work2Prevent is feasible and acceptable, improved adolescent employment outcomes, and reduced HIV risk associated with transactional sex work. Our study underscores the need for alternative pathways, such as addressing socioeconomic determinants, to prevent adolescent HIV infection.

Chlamydial Infection Among Adolescents and Young Adults Receiving Sexual and Reproductive Health Care During the COVID-19 Pandemic.

ABSTRACT: The impact of the COVID-19 pandemic on adolescent and young adult chlamydial infection is unknown. Patient testing data were extracted from the electronic health records of 10 family planning clinics. Prepandemic and pandemic comparisons revealed an increase in observed chlamydial infection, with greater positivity among Black/African American female adolescent patients.

Evaluation of Treatment Practices for Urinalyses and Urine Cultures at an Outpatient Multiple Sclerosis Clinic.

BACKGROUND: Patients with multiple sclerosis (MS) experience disease flares that can be precipitated by the presence of infection. Discerning asymptomatic bacteriuria from urinary tract infection (UTI) in patients with MS is complicated by lower urinary tract dysfunction, leading to potentially inappropriate antimicrobial use. In this study the antimicrobial treatment practices for positive urine cultures in patients with MS were evaluated. METHODS: In this single-center, retrospective study, positive cultures in patients with MS were included. The primary outcome was the proportion of patients appropriately treated with or without antimicrobial therapy. Secondary end points included antimicrobial selection and urinalysis positivity. RESULTS: Two hundred thirty-six cultures from 139 patients were evaluated. Treatment was inappropriate in 81 of 201 treated cultures (40%). Frequency, nocturia, dysuria, and foul-smelling urine were reported by patients in 54 (23%), 10 (4%), 25 (11%), and 14 (6%) cultures, respectively. The antimicrobial selected was too broad in spectrum for 35 of 201 (17%). Of those, fluoroquinolones were the agents used in 33 of 35 cases (94%). A urinalysis was sent in 203 cases (86%), with 197 (84%) positive for at least one predefined positivity criteria. CONCLUSIONS: Urinalyses and urine cultures are performed frequently in patients with MS, often independent of symptoms. Patients with MS could be treated for asymptomatic bacteriuria at higher rates than the general population, and traditional urinary symptoms may not be appropriate indicators of infection. Empirical therapy for UTI is frequently used in this population, often resulting in inappropriate and/or too broad of antimicrobial therapy.

Racial and ethnic differences in family planning telehealth use during the onset of the COVID-19 response in Arkansas, Kansas, Missouri, and Oklahoma.

OBJECTIVES: To explore racial/ethnic disparities in family planning telehealth use. STUDY DESIGN: We analyzed telehealth and in-clinic visits (n = 3142) from ten family planning clinics (April 1-July 31, 2020) by race/ethnicity and month. RESULTS: Telehealth comprised 1257/3142 (40.0%) of overall visits. Telehealth was used by 242/765 (31.6%) of Black/African American and 31/106 (29.2%) multiracial patients. Patients with unknown (162/295, 54.9%), White (771/1870, 41.2%), and other (51/106, 48.1%) identities comprised the majority of telehealth visits. CONCLUSIONS: Our study found differences in telehealth use during the COVID-19 pandemic response. IMPLICATIONS: Understanding barriers and facilitators to telehealth is critical to reducing disparities in access.

Police Enforcement of Sex Work Criminalization Laws in an "End Demand" City: The Persistence of Quality-of-Life Policing and Seller Arrests.

The purported goals of commercial sex work criminalization policies in the United States have shifted over the past two decades as local jurisdictions have adopted End Demand reforms. These reforms aim to refocus arrest from individuals who sell sexual services to buyers and facilitators, representing a departure from the quality-of-life, nuisance-focused approach of the late twentieth century. This article presents a case study examining enforcement of commercial sex laws in Chicago, a city that has been heralded as a leader in End Demand reforms. Our case study utilized annualized arrest statistics from 1998 to 2017 and individual arrest reports (n = 575) from 2015 to 2017. Commercial sex arrests by the Chicago Police Department have declined substantially over the past two decades, falling 98.4% from its peak. However, our analysis suggests that sellers of sexual services continue to face the heaviest burden of arrest (80.5%) and officers generally continue to approach commercial sex as a quality-of-life issue. We argue that this divergence between the goals and implementation of End Demand are the result of three institutional factors: street-level bureaucracy, logics of spatial governmentality, and participatory security. Our results suggest that the ideals of End Demand may be incompatible with the institutional realties of urban policing.

COVID-19 Pandemic, Pre-exposure Prophylaxis (PrEP) Care, and HIV/STI Testing Among Patients Receiving Care in Three HIV Epidemic Priority States.

The COVID-19 pandemic has the potential to disrupt HIV prevention services. We conducted an electronic health record analysis of PrEP, HIV, and STI visits at eight sexual health clinics in Arkansas, Missouri, and Oklahoma during the onset of the pandemic (March 1, 2020 to June 30, 2020) and compared the data with pre-pandemic (March 1, 2019 to June 30, 2019) volumes. Our data revealed a significant increase in the proportion of male PrEP visits during the pandemic compared to the pre-pandemic period, with the majority provided via telehealth/telePrEP. Overall, HIV and STI testing significantly decreased during the pandemic period.

RESUMEN: La pandemia del COVID-19 tiene el potencial de interrumpir los servicios de prevención del VIH. Conducimos un análisis electrónico de expedientes de salud sobre visitas para la PrEP, el VIH, e ITS en ocho diferentes clínicas de salud sexual en Arkansas, Misuri y Oklahoma durante el inicio de la pandemia (1 de marzo de 2020 hasta 30 de junio de 2020) y comparamos esos datos con los índices previos a la pandemia (1 de marzo de 2019 hasta 30 de junio de 2019). Nuestros datos revelaron un aumento significativo en la proporción de visitas para la PrEP por personas masculinas durante la pandemia, comparado al periodo previo a la pandemia, con la mayoría de citas conducidas mediante la telemedicina/telePrEP. En general, las pruebas de VIH e ITS disminuyeron significativamente durante el periodo de la pandemia.

Implementation of a Rapid Phenotypic Susceptibility Platform for Gram-Negative Bloodstream Infections With Paired Antimicrobial Stewardship Intervention: Is the Juice Worth the Squeeze?

BACKGROUND: Implementation of the Accelerate PhenoTM Gram-negative platform (RDT) paired with antimicrobial stewardship program (ASP) intervention projects to improve time to institutional-preferred antimicrobial therapy (IPT) for Gram-negative bacilli (GNB) bloodstream infections (BSIs). However, few data describe the impact of discrepant RDT results from standard of care (SOC) methods on antimicrobial prescribing. METHODS: A single-center, pre-/post-intervention study of consecutive, nonduplicate blood cultures for adult inpatients with GNB BSI following combined RDT + ASP intervention was performed. The primary outcome was time to IPT. An a priori definition of IPT was utilized to limit bias and to allow for an assessment of the impact of discrepant RDT results with the SOC reference standard. RESULTS: Five hundred fourteen patients (PRE 264; POST 250) were included. Median time to antimicrobial susceptibility testing (AST) results decreased 29.4 hours (P < .001) post-intervention, and median time to IPT was reduced by 21.2 hours (P < .001). Utilization (days of therapy [DOTs]/1000 days present) of broad-spectrum agents decreased (PRE 655.2 vs POST 585.8; P = .043) and narrow-spectrum beta-lactams increased (69.1 vs 141.7; P < .001). Discrepant results occurred in 69/250 (28%) post-intervention episodes, resulting in incorrect ASP recommendations in 10/69 (14%). No differences in clinical outcomes were observed. CONCLUSIONS: While implementation of a phenotypic RDT + ASP can improve time to IPT, close coordination with Clinical Microbiology and continued ASP follow up are needed to optimize therapy. Although uncommon, the potential for erroneous ASP recommendations to de-escalate to inactive therapy following RDT results warrants further investigation.

Psychosocial Support, Sexual Health, and HIV Risk among Older Men Who Have Sex with Younger Men.

This study examines the extent to which older males are willing to offer psychosocial and sexual health promoting support to their younger male partners, as well as the individual and relationship-level factors associated with this willingness to provide support. In total, 324 men over the age of 45, who currently or previously had younger male sexual partners, completed an anonymous online survey. Results show that participants were most willing to provide emotional support to their younger male partners, followed by health-related encouragement, HIV/STI testing support, and financial support. Of note, HIV positive status and being in a "main partnership" were associated with greater willingness to provide financial support. These results suggest that older men are willing to provide psychosocial and health promotive support to younger male partners, which could be leveraged in targeted interventions to reduce HIV transmission.

A Pragmatic Randomized Controlled Trial to Increase PrEP Uptake for HIV Prevention: 55-Week Results From PrEPChicago.

OBJECTIVES: We tested preliminary efficacy of a peer change agent type I network intervention to increase pre-exposure prophylaxis (PrEP) linkage to care among network members connected to young Black men who have sex with men. DESIGN: Parent study is a pragmatic randomized controlled trial with 110 weeks of total follow-up. Interim midpoint analyses are performed here using participant data before crossover assignment at 55 weeks. METHODS: We randomly assigned 423 participants in Chicago to receive the network intervention, an opinion leader workshop with telephonic booster sessions, versus a time-matched control from 2016 to 2018. The consolidated surrogate outcome was PrEP referral and linkage to clinical care among network members connected to study participants and was collected from independent administrative data. RESULTS: Each study participant in the trial (n = 423) had on average 1822 network contacts who could be eligible for PrEP referral and linkage. During the 55-week observation period, PrEP referral was most likely to occur within 3 days of an intervention session compared to control [odds ratio (OR) 0.07 (0.02-0.013); P = 0.007] resulting in 1-2 referrals of network members per session. Network members with referral or linkage were more likely to be connected to study participants in the intervention arm than the control condition [aOR 1.50 (1.09-2.06); P = 0.012]. CONCLUSIONS: A peer change agent type I network intervention is preliminarily effective at diffusing PrEP through a network of individuals highly susceptible to HIV over 55 weeks. This low-intensity intervention demonstrated network-level impact among populations that have experienced limited PrEP care engagement in the United States.

Work2Prevent, an Employment Intervention Program as HIV Prevention for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 3): Protocol for a Single-Arm Community-Based Trial to Assess Feasibility and Acceptability in a Real-World Setting.

BACKGROUND: In the United States, young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth face elevated rates of HIV infection. However, racial and ethnic disparities in adolescent HIV infection cannot be attributed to individual-level factors alone and are situated within larger social and structural contexts that marginalize and predispose sexual and gender minority youth of color to HIV. Addressing broader ecological factors that drive transmission requires interventions that focus on the distal drivers of HIV infection, including violence exposure, housing, food insecurity, educational attainment, and employment. Given the ways that economic instability may make YMSM, YTW, and GNC youth of color vulnerable to HIV exposure, this study focuses on employment as an HIV prevention intervention. More specifically, the intervention, called Work2Prevent (W2P), targets economic stability through job readiness and employment as a means of preventing behaviors and factors associated with adolescent and young adult HIV, such as transactional sex work and homelessness. The intervention was adapted from iFOUR, an evidence-based employment program for HIV-positive adults in phase 1 of this study, and pilot tested in a university-based setting in phase 2. OBJECTIVE: This paper aims to describe the protocol for the community-based test phase of W2P. The purpose of this phase was to pilot test a tailored, theoretically informed employment intervention program among YMSM, YTW, and GNC youth of color within a lesbian, gay, bisexual, transgender, and queer (LGBTQ) community setting. METHODS: The employment intervention was pilot tested using a single-arm pretest-posttest trial design implemented among a sample of vulnerable YMSM, YTW, and GNC youth of color using services within a community-based LGBTQ center. Assessments will examine intervention feasibility, acceptability, and preliminary estimates of efficacy. RESULTS: Phase 3 of W2P research activities began in May 2019 and was completed in December 2019. Overall, 41 participants were enrolled in the community-based pilot. CONCLUSIONS: This study will assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce vulnerability to HIV when implemented in a community-based setting serving LGBTQ youth of color. Testing the intervention in a community setting is an opportunity to evaluate how recruitment, retention, and other outcomes are impacted by delivery in a venue akin to where this intervention could eventually be used by nonresearchers. If W2P demonstrates feasibility and acceptability, a larger multisite trial implemented in multiple community settings serving YMSM, YTW, and GNC youth of color is planned. TRIAL REGISTRATION: ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18051.

An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 2): Protocol for a Single-Arm Mixed Methods Pilot Test to Assess Feasibility and Acceptability.

BACKGROUND: Young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth of color face substantial economic and health disparities. In particular, HIV risk and infection among these groups remains a significant public health issue. In 2017, 17% of all new HIV diagnoses were attributed to male-to-male sexual contact among adolescents and young adults aged 13 to 24 years. However, such disparities cannot be attributed to individual-level factors alone but rather are situated within larger social and structural contexts that marginalize and predispose YMSM, YTW, and GNC youth of color to increased HIV exposure. Addressing social and structural risk factors requires intervention on distal drivers of HIV risk, including employment and economic stability. The Work2Prevent (W2P) study aims to target economic stability through job readiness and employment as a structural-level intervention for preventing adolescent and young adult HIV among black and Latinx YMSM, YTW, and GNC youth. This study seeks to assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce sexual risk behaviors. OBJECTIVE: The goal of the research is to pilot-test a tailored, theoretically informed employment intervention program among YMSM, YTW, and GNC youth of color. This intervention was adapted from Increased Individual Income and Independence, an existing evidence-based employment program for HIV-positive adults during phase 1 of the W2P study. METHODS: The employment intervention will be pilot-tested among vulnerable YMSM, YTW, and GNC youth of color in a single-arm pre-post trial to assess feasibility, acceptability, and preliminary estimates of efficacy. RESULTS: Research activities began in March 2018 and were completed in November 2019. Overall, 5 participants were enrolled in the pretest and 51 participants were enrolled in the pilot. CONCLUSIONS: Interventions that address the social and structural drivers of HIV exposure and infection are sorely needed in order to successfully bend the curve in the adolescent and young adult HIV epidemic. Employment as prevention has the potential to be a scalable intervention that can be deployed among this group. TRIAL REGISTRATION: ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16401.

An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 1): Protocol for Determining Essential Intervention Components Using Qualitative Interviews and Focus Groups.

BACKGROUND: HIV continues to have a disparate impact on young cisgender men who have sex with men (YMSM), young trans women (YTW), and gender-nonconforming (GNC) youth who are assigned male at birth. Outcomes are generally worse among youth of color. Experiences of discrimination and marginalization often limit educational attainment and may even more directly limit access to gainful employment. Though seemingly distal, these experiences influence young people's proximity to HIV risk by limiting their access to health care and potentially moving them toward sex work as a means of income as well as increased substance use. Work2Prevent (W2P) aims to achieve economic stability through employment as a structural-level intervention for preventing adolescent and young adult HIV infection. The study will pilot-test an effective, theoretically driven employment program (increased individual income and independence [iFOUR]), for HIV-positive adults, and adapt it to the needs of black and Latinx YMSM, YTW, and GNC youth aged 16 to 24 years who are vulnerable to HIV exposure. OBJECTIVE: This paper aimed to describe the protocol for the exploratory phase of W2P. The purpose of this phase was to determine the essential components needed for a structural-level employment intervention aimed at increasing job-seeking self-efficacy and career readiness among black and Latinx YMSM, YTW, and GNC youth aged 16 to 24 years. METHODS: The exploratory phase of the W2P study consisted of in-depth interviews and focus groups with members of the target community as well as brief interviews with lesbian, gay, bisexual, transgender, and queer (LGBTQ)-inclusive employers. The study team will conduct in-depth interviews with up to 12 YMSM and 12 YTW and GNC youth, up to 10 focus groups with a maximum of 40 YMSM and 40 YTW and GNC youth, and up to 40 brief interviews with LGBTQ-inclusive employers. Participants will be recruited through a community-based recruiter, passive recruitment in community spaces and on social media, and active recruitment by research staff in community spaces serving LGBTQ youth. RESULTS: In-depth interviews were conducted with 21 participants, and 7 focus groups were conducted with 46 participants in total. In addition, 19 brief interviews with LGBTQ-inclusive employers were conducted. The analysis of the data is underway. CONCLUSIONS: Preliminary findings from the formative phase of the study will be used to inform the tailoring and refinement of the iFOUR adult-based intervention into the youth-focused W2P intervention curriculum. Perspectives from YMSM, YTW, GNC youth, and LGBTQ-inclusive employers offer a multidimensional view of the barriers and facilitators to adolescent and young adult LGBTQ employment. This information is critical to the development of a culturally appropriate and relevant youth-focused intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16384.