A Mixed-Methods Study to Evaluate the Feasibility and Acceptability of Implementing an Electronic Health Record Social Determinants of Health Screening Instrument into Routine Clinical Oncology Practice.

BACKGROUND: Routine screening for social determinants of health (SDOH) in the outpatient oncology setting is uncommon. The primary goal of this study was to prospectively evaluate the feasibility and acceptability of implementing an electronic health record (EHR) SDOH screening instrument into routine, clinical, oncology practice. METHODS: Adult patients with newly diagnosed gastrointestinal cancer presenting to a regional cancer center (November 2020 to July 2021) were eligible. Based on the consolidated framework for implementation research, feasibility measures included screening completion, median clinic visit time, and acceptability by the inter-professional care team and patients as measured by semistructured, qualitative interviews and surveys. Secondary outcomes included SDOH needs identified. RESULTS: Of 137 eligible patients, 112 (81.8%) were screened for SDOH. Demographics of the cohort included: 41.1% black (n = 46), 48.2% rural (n = 54), 4.5% uninsured (n = 5), and 6.3% Medicaid-insured (n = 7) patients. Median visit time was 97 min (95% CI 70-107 min) before and 100 min after implementation (95% CI 75-119 min; p = 0.95). In total, 95.5% (n = 107) reported at least one SDOH need. Clinicians (7/10) reported that SDOH screening was not disruptive and were supportive of ongoing use. Patients (10/10) found the screening acceptable. Screening staff (5/5) reported workflow barriers. Patients and staff also recommended revision of specific instrument questions. CONCLUSIONS: Routine collection of SDOH in an outpatient oncology setting using an EHR instrument is feasible and does not result in increased visit time for patients or clinicians. However, staff perceptions of clinic workflow disruption were reported. Further investigation to determine whether standardized SDOH assessment can improve cancer care delivery and outcomes is ongoing.

Helminth egg derivatives as proregenerative immunotherapies.

The immune system is increasingly recognized as an important regulator of tissue repair. We developed a regenerative immunotherapy from the helminth Schistosoma mansoni soluble egg antigen (SEA) to stimulate production of interleukin (IL)-4 and other type 2-associated cytokines without negative infection-related sequelae. The regenerative SEA (rSEA) applied to a murine muscle injury induced accumulation of IL-4-expressing T helper cells, eosinophils, and regulatory T cells and decreased expression of IL-17A in gamma delta (γδ) T cells, resulting in improved repair and decreased fibrosis. Encapsulation and controlled release of rSEA in a hydrogel further enhanced type 2 immunity and larger volumes of tissue repair. The broad regenerative capacity of rSEA was validated in articular joint and corneal injury models. These results introduce a regenerative immunotherapy approach using natural helminth derivatives.

Clinical trial protocol to evaluate the efficacy of cefixime in the treatment of early syphilis.

BACKGROUND: Syphilis rates have been increasing both in the USA and internationally with incidence higher among men-who-have-sex-with-men and people living with human immunodeficiency virus (HIV) infection. Currently, benzathine penicillin is the recommended treatment for syphilis in all patients. Global shortages and cost increases in benzathine penicillin call for alternative treatment options. This study evaluates the efficacy of oral cefixime for the treatment of early syphilis. METHODS: We are conducting a randomized, multisite, open-label, non-comparative clinical trial in Los Angeles and Oakland, CA. Eligible participants are ≥ 18 years old, with primary, secondary, or early latent syphilis (rapid plasma reagin [RPR] titer ≥ 1:8). Patients with HIV infection must have a viral load ≤ 200 copies/mL and CD4+ T cell count ≥ 350 cells/µL during the past 6 months. Participants are randomized to receive either 2.4 M IU benzathine penicillin G intramuscularly once or cefixime 400 mg orally twice a day for 10 days. Participants return at 3, 6, and 12 months post-treatment for follow-up RPR serological testing. The primary outcome is the proportion of participants who achieve ≥ 4-fold RPR titer decrease at 3 or 6 months post-treatment. DISCUSSION: Clinical trials evaluating the efficacy of alternative antibiotics to penicillin are urgently needed. TRIAL REGISTRATION: Clinicaltrials.gov NCT03660488 . Registered on 4 September 2018.

Stick To It: pilot study results of an intervention using gamification to increase HIV screening among young men who have sex with men in California.

BACKGROUND: In the United States, young men who have sex with men (YMSM) experience a disproportionate burden of HIV and sexually transmitted infections (STIs). Mobile health (mHealth) interventions, including those that incorporate elements of games ("gamification"), have the potential to improve YMSM engagement in desirable sexual health services and behaviors. Gamification leverages theory and tools from behavioral science to motivate people to engage in a behavior in a context of fun. The objective of the study was to determine whether an intervention using gamification is acceptable to YMSM in California and potentially increases repeat HIV screening. METHODS: Eligible YMSM were: (I) 18-26 years, (II) born as and/or self-identified as male, (III) reported male sexual partners, and (IV) lived in a zip code adjacent to one of the two study clinics in Oakland and Hollywood, California. The gamification intervention, Stick To It, had four components: (I) recruitment (clinic-based and online), (II) online enrollment, (III) online activities, and (IV) 'real-world' activities at the clinic. Participants earned points through online activities that could be redeemed for a chance to win prizes during HIV/STI screening and care visits. The primary outcome was intervention acceptability measured with participant engagement data and in-depth interviews. The secondary outcome was the intervention's preliminary effectiveness on repeat HIV screening within 6 months, restricted to the subset of men who provided consent for review of medical records and who had ≥6 months of follow-up. Outcomes were compared to a historical control group of similar YMSM who attended study clinics in the 12 months prior to intervention implementation. RESULTS: Overall, 166 of 313 (53%) eligible YMSM registered. After registration, 93 (56%) participants completed enrollment and 31 (19%) completed ≥1 online activity in the subsequent 6 months. Points were redeemed in clinic by 11% of the 166 users (27% and 5% of those who enrolled in the clinic and online, respectively). Despite moderate engagement, participants provided a positive assessment of the program in interviews, reporting that the inclusion of game elements was motivating. The analysis of repeat HIV testing was assessed among 31 YMSM who consented to medical record review and who had ≥6 months of follow-up. During follow-up, 15 (48%) received ≥2 HIV tests compared to 157 (30%) of a historical comparison group of 517 similar YMSM who lived in the same zip codes and who received care at the same clinics before the intervention (OR =2.15, 95% CI: 1.03-4.47, P=0.04). CONCLUSIONS: Engagement in the intervention was modest, with YMSM who enrolled in a clinic more actively engaged than YMSM who enrolled online. Among the subset of participants recruited in the clinic, repeat HIV screening was higher than a comparison group of similar YMSM attending the same clinic in the prior year.

An Intervention Using Gamification to Increase Human Immunodeficiency Virus and Sexually Transmitted Infection Screening Among Young Men Who Have Sex With Men in California: Rationale and Design of Stick To It.

BACKGROUND: In the United States, young men who have sex with men (YMSM) remain disproportionately affected by human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs). Although routine HIV/STI screening is pivotal to the timely diagnosis of HIV and STIs, initiation of appropriate treatment, and reduced onward disease transmission, repeat screening is underused. Novel interventions that incorporate elements of games, an approach known as gamification, have the potential to increase routinization of HIV/STI screening among YMSM. OBJECTIVE: The study aims to test the hypothesis that an incentive-based intervention that incorporates elements of gamification can increase routine HIV/STI screening among YMSM in California. METHODS: The study consists of a formative research phase to develop the intervention and an implementation phase where the intervention is piloted in a controlled research setting. In the formative research phase, we use an iterative development process to design the intervention, including gathering information about the feasibility, acceptability, and expected effectiveness of potential game elements (eg, points, leaderboards, rewards). These activities include staff interviews, focus group discussions with members of the target population, and team meetings to strategize and develop the intervention. The final intervention is called Stick To It and consists of 3 components: (1) online enrollment, (2) Web-based activities consisting primarily of quizzes and a countdown "timer" to facilitate screening reminders, and (3) in-person activities that occur at 2 sexual health clinics. Participants earn points through the Web-based activities that are then redeemed for chances to win various prizes during clinic visits. The pilot study is a quasi-experimental study with a minimum of 60 intervention group participants recruited at the clinics, at community-based events, and online. We will compare outcomes in the intervention group with a historical control group consisting of individuals meeting the inclusion criteria who attended study clinics in the 12 months prior to intervention implementation. Eligible participants in the pilot study (1) are 18 to 26 years old, (2) were born or identify as male, 3) report male sexual partners, and 4) have a zip code of residence within defined areas in the vicinity of 1 of the 2 implementation sites. The primary outcome is repeat HIV/STI screening within 6 months. RESULTS: This is an ongoing research study with initial results expected in the fourth quarter of 2017. CONCLUSIONS: We will develop and pilot test a gamification intervention to encourage YMSM to be regularly screened for HIV/STIs. The results from this research will provide preliminary evidence about the potential effectiveness of using gamification to amplify health-related behavioral change interventions. Further, the research aims to determine the processes that are essential to developing and implementing future health-related gamification interventions. TRIAL REGISTRATION: Clinicaltrials.gov NCT02946164; https://clinicaltrials.gov/ct2/show/NCT02946164 (Archived by WebCite at http://www.webcitation.org/6ri3G4HwD).

Reaching Suburban Men Who Have Sex With Men for STD and HIV Services Through Online Social Networking Outreach: A Public Health Approach.

BACKGROUND: Technology-enabled approaches may reach suburban and rural men who have sex with men (MSM) who lack physical venues, where they live for sexually transmitted disease (STD)/HIV prevention efforts. We evaluated using Grindr, an all-male social networking platform, for STD/HIV prevention services to MSM by a suburban Public Health department. METHODS: Phase 1 (October 2012-March 2013) focused on acceptability of prevention messages by MSM on Grindr and phase 2 (October 2013-March 2014) Grindr use for implementing testing and linkage-to-care. We compared the number of Public Health encounters with MSM before and after initiation of Grindr use and the proportion of users who remained engaged with Public Health staff after being told they were interacting with a health educator. RESULTS: For a 6-month period before Grindr outreach, Public Health had 60 contacts with MSM. Contacts increased to 305 MSM in phase 1, of which 168/213 (79%) remained engaged. In phase 2, among 903 MSM contacts, 69% remained engaged. Asian and Hispanic MSM were more likely to remain engaged with outreach staff; white men were more likely to be not engaged. No significant difference in age between engaged and nonengaged MSM was seen. CONCLUSIONS: Grindr outreach by Public Health in a suburban county seems acceptable to MSM and leads to a 14-fold increase in MSM reached for counseling and education compared with a traditional outreach period. Further evaluation of technology-enabled approaches for STD/HIV prevention in suburban and rural MSM is warranted.