• Early administration of terbutaline in severe pediatric asthma may reduce incidence of acute respiratory failure.

      Doymaz, Sule; Schneider, James; Sagy, Mayer (2014-01-25)
      Background: Severe pediatric asthma, if not immediately and aggressively treated, may progress to acute respiratory failure requiring mechanical ventilation in the pediatric intensive care unit (PICU). Intravenous (IV) terbutaline, a β2 agonist, is dispensed when the initial treatment does not improve the clinical condition. Objective: To investigate the influence of early initiation of IV terbutaline on the incidence of acute respiratory failure requiring mechanical ventilation in severe pediatric asthma. Methods: A retrospective chart review was conducted of 120 subjects (35 patients from an outside hospital emergency department [ED] with late start of terbutaline and 85 patients from the authors' hospital ED with early initiation of IV terbutaline) admitted to the PICU with severe asthma treated with continuous IV terbutaline. Responses to terbutaline treatment and outcomes were evaluated. Results: Patients transported from outlying hospital EDs had shorter pre-PICU mean durations of IV terbutaline than those transferred from the authors' ED (0.69 ± 1.38 and 2.91 ± 2.47 hours, respectively, P = .001). Twenty-one of 35 patients (60%) from outlying EDs required mechanical ventilation compared with 14 of 85 patients (16%) from the authors' ED (P = .001). Durations of pre-PICU terbutaline infusion for patients requiring mechanical ventilation were significantly shorter than those with no such requirement (P = .015). Conclusion: The results of the present study, conducted in the largest number of subjects to date, suggest that early administration of continuous terbutaline in the ED may decrease acute respiratory failure and the need for mechanical respiratory (invasive and noninvasive) support in severe pediatric asthma.
    • Risk factors associated with intracranial hemorrhage in neonates with persistent pulmonary hypertension on ECMO.

      Doymaz, Sule; Zinger, Marcia; Sweberg, Todd (2015-02-11)
      Background: Up to 40% of infants with persistent pulmonary hypertension (PPHN) remains refractory to conventional therapies, and extracorporeal membrane oxygenation (ECMO) is offered as an effective support for this group. However, ECMO is a highly invasive and risky procedure with devastating complications such as intracranial hemorrhage (ICH). In this study, we aimed to determine the risk factors for ICH in infants with PPHN. Methods: A case-control study of patients admitted to the pediatric intensive care unit (PICU) with PPHN requiring ECMO support was conducted. The study was carried out at a 25-bed PICU in large urban tertiary care children's hospital. A total number of 32 subjects were studied. Patients with and without ICH during ECMO were evaluated for activated clotting time (ACT), heparin dosing, platelet count, coagulation profile such as activated partial thromboplastin time (aPTT), prothrombin time (PT), international normalized ratio (INR), fibrinogen level, vital signs including heart rate and mean arterial pressure (MAP), transfusion history, gestational age, and severity of pre-ECMO illness as possible risk factors. Results: Low fibrinogen level (115 ± 13 mg/dl) and low platelet counts (37.4 ± 18.3 Thousand/μl) were associated with higher incidence of ICH (p = 0.009 and p = 0.005, respectively). Elevated MAP (69 ± 4.34 mmHg) was also noticed in ICH patients (p = 0.006). Conclusions: Results demonstrated that low fibrinogen level and low platelet count were associated with ICH in PPHN patients on ECMO. While on ECMO support, maintaining fibrinogen and platelet counts within normal ranges seems crucial to prevent ICH in PPHN patients. This is the first report identifying low fibrinogen level among the risk factors for ICH in infants with PPHN on ECMO support.
    • Structural Model of the Extracellular Assembly of the TCR-CD3 Complex.

      Natarajan, Aswin; Nadarajah, Vidushan; Felsovalyi, Klara; Wang, Wenjuan; Jeyachandran, Vivian R; Wasson, Riley A; Cardozo, Timothy; Bracken, Clay; Krogsgaard, Michelle (2016-03-17)
      Antigen recognition of peptide-major histocompatibility complexes (pMHCs) by T cells, a key step in initiating adaptive immune responses, is performed by the T cell receptor (TCR) bound to CD3 heterodimers. However, the biophysical basis of the transmission of TCR-CD3 extracellular interaction into a productive intracellular signaling sequence remains incomplete. Here we used nuclear magnetic resonance (NMR) spectroscopy combined with mutational analysis and computational docking to derive a structural model of the extracellular TCR-CD3 assembly. In the inactivated state, CD3γε interacts with the helix 3 and helix 4-F strand regions of the TCR Cβ subunit, whereas CD3δε interacts with the F and C strand regions of the TCR Cα subunit in this model, placing the CD3 subunits on opposing sides of the TCR. This work identifies the molecular contacts between the TCR and CD3 subunits, identifying a physical basis for transmitting an activating signal through the complex.
    • Limb Salvage Versus Amputation in Conventional Appendicular Osteosarcoma: a Systematic Review.

      Jauregui, Julio J; Nadarajah, Vidushan; Munn, Joseph; Pivec, Robert; Kapadia, Bhaveen H; Lerman, Daniel M; Maheshwari, Aditya V (2018-01-20)
      The overall survivorship in patients with appendicular osteosarcoma has increased in the past few decades. However, controversies and questions about performing an amputation or a limb salvage procedure still remain. Using three peer-reviewed library databases, a systematic review of the literature was performed to evaluate all studies that have evaluated the outcomes of appendicular osteosarcoma, either with limb salvage or amputation. The mean 5-year overall survivorship was 62% for salvage and 58% for amputation (p > 0.05). At mean 6-year follow-up, the local recurrence rates were 8.2% for salvage and 3.0% for amputation (p > 0.05). Additionally, at mean 6-year follow-up, the rate for metastasis was 33% for salvage and 38% for amputation (p > 0.05). The revision rates were higher with salvage (31 vs. 28%), and there were more complications in the salvage groups (52 vs. 34%; p > 0.05). Despite the heterogeneity of studies available for review, we observed similar survival rates between the two procedures. Although there was no significant statistical difference between rates of recurrence and metastasis, the local recurrence rate and risk of complications were higher for limb salvage as compared to amputation. Cosmetic satisfaction is often higher with limb salvage, whereas long-term expense is higher with amputation. Overall, current literature supports limb salvage procedures when wide surgical margins can be achieved while still retaining a functional limb.
    • Knee dislocation with popliteal artery disruption: A nationwide analysis from 2005 to 2013.

      Naziri, Qais; Beyer, George A; Shah, Neil V; Solow, Maximillian; Hayden, Andrew J; Nadarajah, Vidushan; Ho, Derek; Newman, Jared M; Boylan, Matthew R; Basu, Niladri N; et al. (2018-08-16)
      Objective: Few have compared short-term outcomes following knee dislocations with or without concomitant popliteal artery disruption (PAD). Methods: The Nationwide Inpatient Sample was used to identify 2175 patients admitted for knee dislocation from 2005 to 2013 (concomitant PAD: n = 210/9.7%; without: n = 1965/90.3%). Results: Patients with PAD were younger, more often male, Black and Hispanic, and with Medicaid (all p ≤ 0.013). PADs were associated with 11.0-times higher odds of increased LOS (95%CI, 6.6-18.4) and 2.8-times higher odds of experiencing any complication (95%CI, 2.03-3.92). Female sex was a protective factor against increased LOS, (OR = 0.65; 95%CI, 0.48-0.88). Conclusion: High suspicion index should be maintained for concomitant vascular injuries following knee dislocations.
    • Patients' Use and Perception of Internet-Based Orthopaedic Sports Medicine Resources.

      Koenig, Scott; Nadarajah, Vidushan; Smuda, Michael P; Meredith, Sean; Packer, Jonathan D; Henn, R Frank (2018-09-20)
      Background: Current research is sparse regarding how patients with orthopaedic injuries perceive and use internet-based information resources. Hypothesis: The majority of patients use the internet to research their orthopaedic condition and are receptive to guidance from their provider. Study design: Cross-sectional study. Methods: A total of 213 patients attending a sports medicine clinic on the East Coast of the United States were asked to complete a questionnaire regarding their use of internet-based information. Data from 185 patients were available for analysis. Bivariate and multivariate statistical analyses were used to determine the significance of identified associations. Results: Overall, 54% of patients used the internet to find information about their orthopaedic condition prior to their consultation. A higher percentage of internet users were women (P = .01), were white (P = .03), and had internet access at home (P = .02). Multivariable analysis found home internet access to be the only significant independent factor predictive of patients using internet-based information sources (P < .01). The majority of patients (61%) were neutral toward orthopaedic information found online, and only 32% of patients trusted the orthopaedic information they found online. The majority of patients (83%) reported they would be receptive to providers' guidance on which internet resources to use. Conclusion: Only half of patients use the internet to research their orthopaedic condition. Most patients were either neutral toward or did not trust the internet-based information that they found and may forgo internet sources altogether. To help patients avoid misleading information, sports medicine providers should understand how patients are using the internet and guide patients in selecting high-quality, peer-reviewed sources of information. Doing so allows physicians to proactively educate their patients even after the clinic visit.
    • Transactional Sex, Substance Use, and Sexual Risk: Comparing Pay Direction for an Internet-Based U.S. Sample of Men Who Have Sex with Men.

      Bond, Keosha T; Yoon, Irene S; Houang, Steven T; Downing, Martin J; Grov, Christian; Hirshfield, Sabina (2019-01-03)
      Demographic, behavioral, and structural factors among four mutually exclusive transactional sex categories were assessed in an online sample of 7217 sexually active US men who have sex with men (MSM): (1) No Trade Sex group (87%); (2) Sellers, accepting money or drugs for sex (5%); (3) Buyers, giving money or drugs for sex (6%); and (4) Sellers and Buyers, accepting and giving money or drugs for sex (2%). Separate multivariable logistic regressions compared men who did not report past 60-day transactional sex with men in the three transactional sex groups. Sellers were more likely to report being black or Asian (versus white), low income, a recent STI diagnosis, six or more recent male anal sex partners, and polydrug use. Buyers were more likely to report being older, higher income, urban residence, incarceration history, a recent STI diagnosis, and having non-main sex partners. Sellers and Buyers were more likely to report a higher income, incarceration history, six or more recent male anal sex partners, and polydrug use. Findings suggest that public health policy and HIV prevention harm reduction strategies should address the distinct sexual and behavioral risk patterns among MSM who engage in transactional sex based on payment direction.
    • Pilot feasibility trial of the MyPEEPS mobile app to reduce sexual risk among young men in 4 cities.

      Ignacio, Matt; Garofalo, Robert; Pearson, Cynthia; Kuhns, Lisa M; Bruce, Josh; Scott Batey, D; Radix, Asa; Belkind, Uri; Hidalgo, Marco A; Hirshfield, Sabina; et al. (2019-04-13)
      Objectives: Our study team adapted the MyPEEPS (Male Youth Pursuing Empowerment, Education, and Prevention around Sexuality) curriculum, an evidence-based human immunodeficiency virus (HIV) prevention intervention, from a face-to-face, group-based intervention to an individual-level mobile responsive web-based intervention to improve HIV risk behaviors in very young men, aged 13-18 years. Materials and methods: In adapting the MyPEEPS intervention to mobile app, we used a series of methodologies, including expert panel reviews, weekly team meetings with the software development company, and conducted in-depth interviews with very young men. Following the iterative process, we conducted a 6-week pre-post feasibility pilot trial with 40 young men in Birmingham, AL; Chicago, IL; New York City, NY; and Seattle, WA. Primary outcomes of interest were uptake of the app, accessibility and satisfaction. Results: Across all 4 sites, 62.5% (25/40) of participants completed all modules in the app in an average of 28.85 (SD 21.69) days. Participants who did not attend to the follow-up visit did not complete any of the app modules. Overall participants reported that the app was easy to use, useful and has the potential to improve their sexual health knowledge and behavior and awareness in risky contexts. Participants also highly rated the app, information and interface quality of the app. Discussion: Lessons learned from the pilot included the need for reminder systems and providing anticipatory guidance about Internet connectivity when using the app. These changes will be incorporated into study procedures for our multisite trial. Conclusion: Overall, participants found the app to be highly usable and have the potential to positively improve their sexual risk behavior.
    • Changes in Sleep Quality and Associated Health Outcomes among Gay and Bisexual Men Living with HIV.

      Downing, Martin J; Millar, Brett M; Hirshfield, Sabina (2019-05-02)
      Objectives/Background: Although gay, bisexual, and other men who have sex with men (GBMSM) bear a disproportionate burden of HIV in the U.S., they are underrepresented in HIV-related sleep research. This study sought to (a) investigate changes in self-reported sleep quality among a sample of GBMSM living with HIV during participation in an online sexual risk reduction intervention and (b) examine whether changes in sleep quality predicted later health outcomes.Method/Participants: Men (n = 505) completed measures of sleep quality, psychological distress, condom use self-efficacy, and antiretroviral therapy (ART) adherence. Analyses focused on data obtained from participants as part of the eligibility survey, baseline assessment, and the 9- and 12-month follow-up assessments.Results: Most participants did not report changes in their sleep quality (i.e., 50.1% maintained good sleep quality, 22.8% maintained poor sleep quality) between study screening and 9-month follow-up. Nevertheless, 17.0% indicated improved sleep quality and 10.1% indicated a negative change in sleep quality. Compared to those who maintained good sleep quality during the study, men whose sleep quality declined by 9 months reported significantly greater symptoms of depression and anxiety, as well as lower ART adherence and condom use self-efficacy at 12 months. Similarly, men who maintained poor sleep quality reported greater symptoms of depression and anxiety at 12 months. Men whose sleep quality improved reported better mental health than those with poor or worsening sleep quality.Conclusions: Findings suggest that optimizing sleep health should be prioritized in interventions aimed at improving overall well-being of GBMSM living with HIV.
    • Factors associated with early postoperative survey completion in orthopaedic surgery patients.

      Sajak, Patrick Mj; Aneizi, Ali; Gopinath, Rohan; Nadarajah, Vidushan; Burt, Cameran; Ventimiglia, Dominic; Akabudike, Ngozi; Zhan, Min; Henn, R Frank (2019-07-19)
      Purpose: To determine factors associated with survey compliance 2-weeks postoperatively. Methods: 1269 patients age 17-years and older participating in the Maryland Orthopaedic Registry from August 2015-March 2018 were administered a baseline questionnaire preoperatively and emailed a follow-up questionnaire 10-days postoperatively. Demographics were self-reported and medical records reviewed for relevant medical history. Results: 609 patients (48.0%) completed both the baseline and 2-week surveys. A decreased likelihood of 2-week survey completion was seen in patients who identified as black, smokers, patients without a college education, patients who were unmarried, unemployed, had a lower income, or covered by government-sponsored insurance (p < 0.05). Other preoperative variables significantly associated with decreased likelihood of completion included surgery on the right side, upper extremity surgery, preoperative opioid use, no specific injury leading to surgery, lower preoperative expectations, depression and fatigue symptoms, and worse pain, function, and activity scores (p < 0.05). Multivariable analysis confirmed race, operative extremity, education, insurance status, smoking, activity level, and pain scores were independent predictors of survey completion. Conclusion: Several demographic and preoperative variables are associated with survey completion 2-weeks post-orthopaedic surgery. The results provide insight into patient populations that may be targeted in order to assure higher survey compliance and improve analysis of patient-reported outcomes. Keywords: Orthopaedic surgery; PROMIS; Patient reported outcomes; Survey compliance.
    • Clinical characteristics associated with depression or anxiety among patients presenting for knee surgery.

      La, Ashley; Nadarajah, Vidushan; Jauregui, Julio J; Shield, William P; Medina, Shaun H; Dubina, Andrew G; Meredith, Sean J; Packer, Jonathan D; Henn, R Frank (2019-08-12)
      Background: Preoperative depression and anxiety in patients undergoing surgery have been shown to be associated with increased postoperative complications, decreased functional improvement, and long-term dissatisfaction. The purpose of this prospective study was to measure the relationship between a diagnosis of depression or anxiety and Patient-Reported Outcomes Measurement Information System (PROMIS) domains, as well as determine which preoperative factors are associated with depression or anxiety in patients undergoing knee surgery. We hypothesized that preoperative depression and/or anxiety would be associated with worse preoperative pain, function, and general health status. Methods: Three-hundred and eighty-six patients undergoing knee surgery between 2015 and 2017 were administered health-related quality of life measures preoperatively, and their medical records were reviewed for relevant medical history. A propensity matched analysis was performed to determine clinical factors independently associated with preoperative depression and/or anxiety. Results: The overall study population consisted of 216 males and 170 females, with a mean age of 39.4 ± 16.2 years. From this overall cohort, 43 (11.1%) patients had a positive preoperative diagnosis of depression and/or anxiety. After controlling for covariate imbalances, preoperative depression/anxiety was independently associated with PROMIS Anxiety (p = 0.018), PROMIS Depression (p < 0.019), and Tegner pre-injury (p = 0.013) scores. Regression analysis also determined that preoperative depression/anxiety was independently associated with arthroscopic anterior cruciate ligament reconstruction (ACLR) (p = 0.004), total knee arthroplasty (TKA) (p = 0.019), and uni-compartmental knee arthroplasty (p < 0.05). Conclusion: The results support our hypothesis that preoperative depression/anxiety is associated with worse preoperative pain, function, and general health status. Furthermore, PROMIS Anxiety and Depression tools offer a reliable means of measuring psychological distress in the orthopaedic knee population. Similar to other studies, we also noted psychological comorbidity to be independently associated with ACLR and TKA.
    • Engagement in HIV Care Among New York City Transgender Women of Color: Findings from the Peer-Led, TWEET Intervention, a SPNS Trans Women of Color Initiative

      Hirshfield, S.; Contreras, J.; Luebe, R. Q.; Swartz, J. A.; Scheinmann, R.; Reback, C. J.; Fletcher, J. B.; Kisler, K. A.; Kuhns, L. M.; Molano, L. F. (Springer Science and Business Media LLC, 2019-09-13)
      Transgender women (TW) have higher HIV prevalence rates than cisgender (i.e., non-transgender) women. However, utilization of healthcare for transgender people in the U.S. is low. As part of a multisite initiative to facilitate entry and retention in HIV care for TW of color, we compared health outcomes between participants who became Peer Leaders and those who did not. From 2013 to 2016, 163 New York City, mostly Latina, TW enrolled in the Transgender Women Engagement and Entry to Care Project (TWEET). The TWEET intervention included peer-led, group-based educational sessions called Transgender Leader-Teach Back; 39% completed Peer Leadership requirements. Comparing pre-post change by Peer Leader status, Peer Leaders had a significant decrease in viral load and significant increase in CD4 at the last HIV care visit compared to the first. In multivariable logistic regression, predictors associated with Peer Leadership included having at least some college education, being in a relationship, stable housing, receiving legal assistance for political asylum, and having two or more HIV care visits during the intervention. Findings suggest that, for trans women who have completed at least secondary school education, participating in a peer-led intervention can lead to improved HIV care engagement. Understanding which program components lead to becoming a Peer Leader, and how to better engage non-Peer Leaders, are important next steps.
    • How Prepared Are Pediatric Residents for Pediatric Emergencies: Is Pediatric Advanced Life Support Certification Every 2 Years Adequate?

      Doymaz, Sule; Rizvi, Munaza; Orsi, Marguerite; Giambruno, Clara (2019-09-16)
      Objectives. We assessed pediatric residents' retention of knowledge and clinical skills according to the time since their last American Heart Association Pediatric Advanced Life Support (AHA PALS) certification. Methods. Sixty-four pediatric residents were recruited and divided into 3 groups based on the time since their last PALS certification, as follows: group 1, 0 to 8 months; group 2, 9 to 16 months, and group 3, 17 to 24 months. Residents' knowledge was tested using 10 multiple-choice AHA PALS pretest questions and their clinical skills performance was assessed with simulation mock code scenarios using 2 different AHA PALS checklists, and mean scores were calculated for the 3 groups. Differences in the test scores and overall clinical skill performances among the 3 groups were analyzed using analyses of variance, χ2 tests, and Jonckheere-Terpstra tests. Statistical significance was set at P < .05. Results. The pediatric residents' mean overall clinical skills performance scores declined within the first 8 months after their last AHA PALS certification date and continued to decrease over time (87%, 82.6%, and 77.4% for groups 1, 2, and 3, respectively; P = .048). Residents' multiple-choice test scores declined in all 3 groups, but the scores were not significantly different. Conclusions. Residents' clinical skills performance declined within the first 8 months after PALS certification and continued to decline as the time from the last certification increased. Using mock code simulations and reinforcing AHA PALS guidelines during pediatric residency deserve further evaluation.
    • Preoperative opioid use in patients undergoing shoulder surgery.

      Nadarajah, Vidushan; Meredith, Sean J; Jauregui, Julio J; Smuda, Michael P; Medina, Shaun; Gilotra, Mohit N; Hasan, S Ashfaq; Henn, R Frank (2019-10-17)
      More than one in four patients reported preoperative opioid use. Several health measures, including worse pain, function, and social satisfaction were independently associated with preoperative opioid use. These findings suggest that orthopaedic surgeons need to identify patients using opioids preoperatively in order to effectively establish and execute a plan for pain management, which may include weaning off opioids prior to surgery, managing psychological distress, and optimizing coping strategies.Level of Evidence: III.
    • Stimulant Use and Study Protocol Completion: Assessing the Ability of Men Who Have Sex with Men to Collect Dried Blood Spots for Laboratory Measurement of HIV Viral Load.

      Teran, Richard A; Carrico, Adam W; Horvath, Keith J; Downing, Martin J; Chiasson, Mary Ann; Walters, Suzan M; Hirshfield, Sabina (2019-10-19)
      Stimulant use is associated with higher HIV viral load (VL) and sexual HIV transmission risk among men who have sex with men (MSM) living with HIV. There is little research on willingness of drug users living with HIV to fully participate in studies, especially those involving self-collection of biomarker data. This study presents findings from an at-home dried blood spot collection study measuring laboratory-quantified VL among U.S. HIV-positive MSM who reported high-risk sexual behavior and/or suboptimal antiretroviral therapy (ART) adherence to assess the association between drug-use behavior and (1) ability to complete a study protocol and (2) VL outcomes. Among recruited participants (n = 766), 35% reported stimulant drug use (amphetamines, cocaine, crack, crystal meth, ecstasy, or a combination of stimulant drugs), 39% reported using other drugs (heroin, marijuana, prescription opioids, and others), and 27% reported no drug use in the past 3 months. In all, 61% of enrolled participants completed the study protocol. Stimulant drug users were less likely (ARR 0.84; 95% CI 0.72-0.98) to complete the protocol than other drug users. Furthermore, other drug users were significantly less likely than non-drug users (ARR 0.52; 95% CI 0.28-0.97) to have an HIV VL result ≥ 1500 copies/mL. This study provides important estimates regarding the likelihood of participation in biomedical research activities among HIV-positive MSM with varying drug-use behaviors, showing that it is feasible to conduct such biomedical studies with drug-using MSM who report high-risk sexual behavior and struggle with their ART adherence.
    • Early Sexual Experiences, Mental Health, and Risk Behavior among Black Non-Hispanic and Hispanic / Latino Men Who Have Sex with Men (MSM).

      Downing, Martin J; Benoit, Ellen; Brown, Dominique; Coe, Lauren; Hirshfield, Sabina; Pansulla, Louis; Carballo-Diéguez, Alex (2019-11-07)
      Black and Latino men who have sex with men (MSM) are disproportionately affected by childhood sexual abuse (CSA). Investigating these histories is often confounded by underreporting and varied definitions of abuse. Unrecognized abuse may manifest in unhealthy ways, specifically psychological distress, substance use, and high-risk sexual behaviors. Black and Hispanic/Latino MSM in New York City discussed formative sexual experiences in in-person interviews. Eligible men reported a sexual experience occurring before age 16 with a man or woman 18 or older at the time. Among interviewees (n = 61), men living with HIV were significantly younger at the time of their first sexual experience with a male partner compared to HIV-negative men. Approximately half of interviewees (47.5%) scored at or above the diagnostic cutoff for post-traumatic stress disorder (PTSD). Hispanic/Latino men had increased odds of scoring at or above the diagnostic cutoff for PTSD compared to Black non-Hispanic men. Further, nearly half of interviewees (46%) scored at or above the diagnostic cutoff for harmful drug use or possible drug dependence. Study findings have implications for future research using an indirect approach to uncovering potential sexual abuse during childhood, and associations with adult health outcomes.
    • HIV Prevention Via Mobile Messaging for Men Who Have Sex With Men (M-Cubed): Protocol for a Randomized Controlled Trial.

      Sullivan, Patrick Sean; Zahn, Ryan J; Wiatrek, Sarah; Chandler, Cristian J; Hirshfield, Sabina; Stephenson, Rob; Bauermeister, Jose A; Chiasson, Mary Ann; Downing, Martin J; Gelaude, Deborah J; et al. (2019-11-15)
      Background: Men who have sex with men (MSM) continue to be the predominately impacted risk group in the United States HIV epidemic and are a priority group for risk reduction in national strategic goals for HIV prevention. Modeling studies have demonstrated that a comprehensive package of status-tailored HIV prevention and care interventions have the potential to substantially reduce new infections among MSM. However, uptake of basic prevention services, including HIV testing, sexually transmitted infection (STI) testing, condom distribution, condom-compatible lubricant distribution, and preexposure prophylaxis (PrEP), is suboptimal. Further, stronger public health strategies are needed to promote engagement in HIV care and viral load suppression among MSM living with HIV. Mobile health (mHealth) tools can help inform and encourage MSM regarding HIV prevention, care, and treatment, especially among men who lack access to conventional medical services. This protocol details the design and procedures of a randomized controlled trial (RCT) of a novel mHealth intervention that comprises a comprehensive HIV prevention app and brief, tailored text- and video-based messages that are systematically presented to participants based on the participants' HIV status and level of HIV acquisition risk. Objective: The objective of the RCT was to test the efficacy of the Mobile Messaging for Men (M-Cubed, or M3) app among at least 1200 MSM in Atlanta, Detroit, and New York. The goal was to determine its ability to increase HIV testing (HIV-negative men), STI testing (all men), condom use for anal sex (all men), evaluation for PrEP eligibility, uptake of PrEP (higher risk HIV-negative men), engagement in HIV care (men living with HIV), and uptake of and adherence to antiretroviral medications (men living with HIV). A unique benefit of this approach is the HIV serostatus-inclusiveness of the intervention, which includes both HIV-negative and HIV-positive MSM. Methods: MSM were recruited through online and venue-based approaches in Atlanta, Detroit, and New York City. Men who were eligible and consented were randomized to the intervention (immediate access to the M3 app for a period of three months) or to the waitlist-control (delayed access) group. Outcomes were evaluated immediately postintervention or control period, and again three and six months after the intervention period. Main outcomes will be reported as period prevalence ratios or hazards, depending on the outcome. Where appropriate, serostatus/risk-specific outcomes will be evaluated in relevant subgroups. Men randomized to the control condition were offered the opportunity to use (and evaluate) the M3 app for a three-month period after the final RCT outcome assessment. Results: M3 enrollment began in January 2018 and concluded in November 2018. A total of 1229 MSM were enrolled. Data collection was completed in September 2019. Conclusions: This RCT of the M3 mobile app seeks to determine the effects of an HIV serostatus-inclusive intervention on the use of multiple HIV prevention and care-related outcomes among MSM. A strength of the design is that it incorporates a large sample and broad range of MSM with differing prevention needs in three cities with high prevalence of HIV among MSM. Trial registration: ClinicalTrials.gov NCT03666247; https://clinicaltrials.gov/ct2/show/NCT03666247. International registered report identifier (irrid): DERR1-10.2196/16439.
    • Age- and Race/Ethnicity-Specific Sex Partner Correlates of Condomless Sex in an Online Sample of Hispanic/Latino, Black/African-American, and White Men Who Have Sex with Men.

      Mizuno, Yuko; Borkowf, Craig B; Hirshfield, Sabina; Mustanski, Brian; Sullivan, Patrick S; MacGowan, Robin J (2019-12-16)
      We sought to identify and compare correlates of condomless receptive anal intercourse with HIV-positive or unknown status partners (CRAI) for younger (< 25 years) and older (≥ 25 years) Hispanic/Latino, black/African-American, and white men who have sex with men (MSM). Baseline data from the Evaluation of Rapid HIV Self-Testing among MSM Project (eSTAMP), a randomized controlled trial with MSM (n = 2665, analytical sample size = 2421), were used. Potential correlates included participants' sociodemographic characteristics and HIV status as well as the characteristics of participants' partners. Younger Hispanic/Latino and black men were most likely to report having older sex partners (≥ 50% of partners being at least 5 years older), and having older partners was a significant correlate of CRAI among younger Hispanic/Latino and white men. Regardless of race/ethnicity, not knowing one's HIV status was a significant correlate of CRAI among younger men, whereas having a black sex partner was a significant correlate among older men. HIV prevention initiatives could address these and other correlates specific to race/ethnicity groups to target their prevention resources and messaging.
    • Intersectional Stigma and Multi-Level Barriers to HIV Testing Among Foreign-Born Black Men From the Caribbean.

      Taylor, Tonya N; DeHovitz, Jack; Hirshfield, Sabina (2020-01-10)
      Testing is the entry point into the HIV care continuum that includes linkage to and retention in prevention services, and adherence to prevention strategies, including repeat HIV testing. Despite US policy approaches to expand HIV testing to diverse clinical care and community settings, disparities in HIV testing among Black populations persist. Foreign-born (FB) Black persons from the Caribbean have higher annual rates of HIV diagnosis and a higher percentage of late-stage HIV diagnosis, compared with US-born Black persons; and most HIV infections among FB Blacks are among men. In this article, we provide an overview of HIV testing barriers among FB Black men who engage in HIV risk-taking behaviors (e.g., condomless sex with male and/or female partners of unknown HIV serostatus). Barriers to HIV testing for both FB and US-born Black men, include HIV stigma (anticipated, perceived, internalized), low perceived HIV risk, medical or government mistrust, and perceived low access to testing resources. We examine beliefs about masculinity and gender roles that may perpetuate heteronormative stereotypes associated with perceptions of low HIV risk and barriers to HIV testing. We also discuss the impact of recent immigration policies on accessing HIV testing and treatment services and how intersectional stigmas and structural forms of oppression, such as racism, prejudice against select immigrant groups, and homophobia that may further amplify barriers to HIV testing among FB Black men. Finally, we review comprehensive prevention approaches, and suggest innovative approaches, that may improve the uptake of HIV testing among FB Black men.
    • A randomized controlled efficacy trial of an mHealth HIV prevention intervention for sexual minority young men: MyPEEPS mobile study protocol.

      Kuhns, Lisa M; Garofalo, Robert; Hidalgo, Marco; Hirshfield, Sabina; Pearson, Cynthia; Bruce, Josh; Batey, D Scott; Radix, Asa; Belkind, Uri; Jia, Haomiao; et al. (2020-01-15)
      Background: Young sexual minority men in the United States have a high incidence rate of HIV infection. Early intervention among this group, that is timed to precede or coincide with sexual initiation, is of critical importance to prevent HIV infection. Despite this, there are very few published randomized controlled efficacy trials testing interventions to reduce sexual vulnerability for HIV acquisition among racially/ethnically diverse, very young, sexual minority men (aged ≤18 years). This paper describes the design of a mobile app-based intervention trial to reduce sexual risk for HIV acquisition and promote health protection in this group. Methods: This study is a randomized controlled trial of an mHealth-based HIV prevention intervention, MyPEEPS Mobile, among diverse sexual minority cisgender young men, aged 13-18 years. The mobile intervention was adapted from a prior group-based intervention curriculum with evidence of efficacy, designed to be specific to the risk contexts and realities of young sexual minority men, and to include psychoeducational and skill-building components with interactive games and activities. Participants are recruited locally within four regional hubs (Birmingham, AL, Chicago, IL, New York City, NY, Seattle, WA) and nationwide via the Internet, enrolled in-person or remotely (via videoconference), and randomized (1:1) to either the MyPEEPS Mobile intervention or delayed intervention condition. Post-hoc stratification by age, race/ethnicity, and urban/suburban vs. rural statuses is used to ensure diversity in the sample. The primary outcomes are number of male anal sex partners and frequency of sexual acts with male partners (with and without condoms), sex under the influence of substances, and uptake of pre-and post-exposure prophylaxis, as well as testing for HIV and other sexually transmitted infections at 3-, 6- and 9-month follow-up. Discussion: Behavioral interventions for very young sexual minority men are needed to prevent sexual risk early in their sexual development and maturation. This study will provide evidence to determine feasibility and efficacy of a mobile app-based HIV prevention intervention to reduce sexual risk among this very young group. Trial registration: ClinicalTrials.gov number, NCT03167606, registered May 30, 2017.