Implementation of Point of Care Sexually Transmitted Infections Testing in a Community Clinic Setting.

ABSTRACT: The rates of sexually transmitted infections (STIs) in the United States, including chlamydia and gonorrhea, are rising. Point-of-care (POC) testing could increase access to testing and treatment. This evaluation found POC STI testing to be concordant with the results of traditional laboratory testing for 100% of patients who were tested. Ninety-five percent of the patients reported being satisfied with the experience, and 66% preferred it to traditional laboratory testing. The most commonly reported reason for preferring the test was the short amount of time it took to receive results. However, insurance reimbursed less than 30% of what was billed for the POC tests. Low insurance reimbursement rates could be a barrier to implementation long-term financial sustainability of POC STI testing.

PrEPare for Work: A Pilot Randomized Controlled Trial of an Intervention to Optimize HIV PrEP Outcomes Among Male Sex Workers.

HIV pre-exposure prophylaxis (PrEP) use is limited among male sex workers, who are at exceptionally high-risk for HIV infection. We developed a theory-informed, two-pronged intervention ("PrEPare-for-Work") to optimize PrEP initiation and adherence among male sex workers, which was preliminarily evaluated in a two-stage pilot randomized controlled trial of 110 male sex workers in the US Northeast. Individuals randomized to the Stage 1 PrEPare-for-Work Case Management arm were three times as likely as those in the standard of care (SOC) arm to initiate PrEP (RR = 2.95, 95% CI = 1.57-5.57). Participants who initiated PrEP and were randomized to the Stage 2 PrEPare-for-Work Adherence Counseling arm had higher rates of prevention-effective adherence (measured via tenofovir in hair) compared to those in the SOC arm (RR = 1.7, 95% CI 0.64-4.77; 55.6% vs. 28.6%, respectively); though not statistically significant. Given the need and the promise of this pilot RCT, further efficacy testing is warranted and should be prioritized.

RESUMEN: El uso de la profilaxis prexposición (PrEP) para prevenir la adquisición del VIH es limitado entre trabajadores sexuales masculinos, que están en muy alto riesgo de contraerlo. Desarrollamos una intervención de dos partes basada en la teoría para optimizar el inicio y la observancia del tratamiento de la PrEP entre trabajadores sexuales masculinos, que se evaluó preliminarmente en un ensayo piloto controlado y aleatorizado (ECA) de dos fases de 110 trabajadores sexuales masculinos en el noreste de Estados Unidos. Las personas aleatorizadas al grupo de intervención (la primera fase de nuestro programa "PrEPare for Work" ­ la atención individualizada) eran tres veces más probable que las aleatorizadas al grupo control (la norma de atención) a iniciar la PrEP (RR = 2.95, 95% IC = 1.57­5.57). Los participantes que iniciaron la PrEP y se aleatorizaron al grupo de intervención (la segunda fase de "PrEPare for Work" ­ la terapia para aumentar la adherencia al tratamiento) tenían tasas más altas de adherencia al tratamiento (medido por tenofovir en el cabello) que los aleatorizados al grupo control (RR = 1.7, 95% IC 0.64­4.77; 55.6% vs. 28.6%, respectivamente); aunque la diferencia no fue estadísticamente significativa. En vista de la necesidad y el potencial de este ECA piloto, más pruebas de eficacia son necesarias y deben ser priorizadas.

Characterizing HIV Syndemics and the Role of Incarceration Among Men Who have Sex with Men Presenting for Care at a Sexually Transmitted Infections Clinic.

Men who have sex with men (MSM) with a history of incarceration experience unique risk factors for HIV acquisition. The current study examined unique risk factors for HIV among MSM with a history of incarceration presenting to a sexually transmitted infections (STI) clinic. We analyzed self-reported behavioral data from clinical encounters among patients attending the clinic between January 2012 and April 2021. There were 17,221 unique visits, of which 5988 were MSM. Of these, 4.34% (N = 206) were MSM with a history of incarceration. MSM with a history of incarceration were significantly more likely to report a range of behavioral risk factors for HIV, yet also were significantly less likely to perceive themselves at risk for HIV. Future research and practice should develop culturally tailored biobehavioral HIV prevention services and consider embedding these programs within criminal justice settings to better reach this at-risk group.

Statewide evaluation of COVID-19 vaccine hesitancy in Rhode Island.

BACKGROUND: Vaccines are effective in preventing Coronavirus Disease 2019 (COVID-19). Vaccine hesitancy defined as delay of acceptance or refusal of the vaccine is a major barrier to effective implementation. METHODS: Participants were recruited statewide through an English and Spanish social media marketing campaign conducted by a local news station during a one-month period as vaccines were becoming available in Rhode Island (from December 21, 2020 to January 22, 2021). Participants completed an online survey about COVID-19 vaccines and vaccine hesitancy with constructs and items adopted from the Health Belief Model. RESULTS: A total of 2,007 individuals completed the survey. Eight percent (n = 161) reported vaccine hesitancy. The sample had a median age of 58 years (interquartile range [IQR]: 45, 67), were majority female (78%), White (96%), Non-Hispanic (94%), employed (58%), and reported an annual individual income of $50,000 (59%). COVID-19 vaccine hesitancy was associated with attitudes and behaviors related to COVID-19. A one unit increase in concern about COVID-19 was associated with a 69% (Adjusted Odds Ratio: 0.31, 95% CI: 0.26-0.37) decrease in vaccine hesitancy. A one-level increase in the likelihood of getting influenza vaccine was associated with a 55% (AOR: 0.45 95% CI: 0.41-0.50) decrease in vaccine hesitancy. CONCLUSIONS: COVID-19 vaccine hesitancy was relatively low in a state-wide survey in Rhode Island. Future research is needed to better understand and tailor messaging related to vaccine hesitancy.

The Impact of COVID-19 on Sexual Behavior and Psychosocial Functioning in a Clinical Sample of Men who have Sex with Men Using HIV Pre-exposure Prophylaxis.

The purpose of this study was to evaluate the impact of the Coronavirus Disease 2019 (COVID-19) pandemic on sexual behavior, mental health, and substance use among men who have sex with men (MSM) engaged in pre-exposure prophylaxis (PrEP) care. Generalized linear mixed models and logistic mixed-effect models examined change over time for number of sexual partners, mood, and alcohol consumption. From February 29, 2020 to July 31, 2020, 177 MSM actively engaged in PrEP care were evaluated. The median age was 37 [interquartile range (IQR 30, 51]. Patients in the sample were largely representative of the clinic population and identified as White (73.0%), Black/African American (9.2%), and other race (17.2%), and 11.8% identified as Hispanic/Latino ethnicity. Men reported an average of 2.60 fewer sexual partners (95% CI -4.04, -1.40) during the pandemic compared to pre-COVID-19. Rates of depressive symptoms and alcohol use remained stable and few patients reported substance use. The reduced number of sexual partners may be explained by patients' efforts to reduce risk of exposure to COVID-19 and low rates of psychosocial symptoms may be indicative of only the highest functioning patients continuing to engage in care. Reductions in sexual partners may offset reduced engagement in care and help mitigate risk of HIV and other sexually transmitted infections (STIs).

RESUMEN: El propósito de este estudio fue evaluar el impacto que tuvo la pandemia causada por la enfermedad del coronavirus 2019 (COVID-19) en el comportamiento sexual, la salud mental y el uso de sustancias en hombres que tienen sexo con hombres (HSH) que reciben profilaxis previa a la exposición (PrEP). Los modelos lineales mixtos generalizados y los modelos logísticos de efectos mixtos examinaron el cambio a través del tiempo en el número de parejas sexuales, el estado de ánimo y el consumo de alcohol. Desde el 29 de febrero de 2020 hasta el 31 de julio de 2020, se evaluaron 177 HSH que recibían los servicios de la PrEP. La mediana de edad fue de 37 (rango intercuartílico (IQR: 30, 51). Los pacientes de la muestra eran en gran parte representativos de la población de la clínica y se identificaban como Blancos (73.0%), Negros/Afroamericanos (9.2%) y de Otra raza (17.2%) y el 11.8% se identificó de origen Hispano/Latino. Los hombres reportaron un promedio de 2.60 parejas sexuales menos (IC del 95%: -4.04, -1.40) durante la pandemia en comparación con antes de COVID-19. Las tasas de síntomas depresivos y el uso de alcohol se mantuvieron estables y pocos pacientes reportaron uso de sustancias. El número reducido de parejas sexuales puede explicarse por los esfuerzos de los pacientes para reducir su riesgo de exposición al COVID-19 y las bajas tasas de síntomas psicosociales pueden ser indicativos de que solo los pacientes con mayor funcionamiento continúan participando. La reducción en el número de parejas sexuales puede contrarrestar la baja participación en la atención medica de la PrEP y ayudar a mitigar el riesgo de contraer el VIH y otras infecciones de transmisión sexual (ITS).

Loss to Follow-Up and Re-Engagement in HIV Pre-Exposure Prophylaxis Care in the United States, 2013-2019.

Retention in HIV pre-exposure prophylaxis (PrEP) care is critical for effective PrEP implementation. Few studies have reported long-term lost to follow-up (LTFU) and re-engagement in PrEP care in the United States. Medical record data for all cisgender patients presenting to the major Rhode Island PrEP clinic from 2013 to 2019 were included. LTFU was defined as no PrEP follow-up appointment within 98 days. Re-engagement in care was defined as individuals who were ever LTFU and later attended a follow-up appointment. Recurrent event survival analysis was performed to explore factors associated with PrEP retention over time. Of 654 PrEP patients, the median age was 31 years old [interquartile range (IQR): 25, 43]. The majority were male (96%), White (64%), non-Hispanic (82%), and insured (97%). Overall, 72% patients were ever LTFU and 27% of those ever LTFU re-engaged in care. Female patients were 1.37 times [crude hazard ratio (cHR): 1.37; 95% confidence interval (CI): 0.86-2.18] more likely to be LTFU than male patients, and a 1-year increase in age was associated with a 1% lower hazard of being LTFU (cHR: 0.99; CI: 0.98-0.99). Being either heterosexual (aHR: 2.25, 95% (CI): 1.70-2.99] or bisexual (aHR: 2.35, 95% CI: 1.15-4.82) was associated with a higher hazard of loss to follow-up compared with having same-sex partners only. The majority of PrEP users were LTFU, especially at the first 6 months of PrEP initiation. Although a significant number were re-engaged in care, targeted interventions are needed to improve retention in PrEP care. This study characterized the natural projection of loss to follow-up and re-engagement in HIV PrEP care using a longitudinal clinic cohort data and explored associated factors for guiding future interventions to improve retention in PrEP care.

Characterizing the Impact of COVID-19 on Pre-Exposure Prophylaxis (PrEP) Care.

COVID-19 is a public health crisis that has fundamentally altered health care provision. The purpose of this study was to examine the impact of COVID-19 on pre-exposure prophylaxis (PrEP) care. We reviewed all patient records for those who presented for PrEP care at a PrEP program in Providence, Rhode Island from September 1st, 2019 to May 29th, 2020. The number of PrEP encounters decreased but was not significantly different over time (ps > .05). Patients were still able to access PrEP clinical services during the COVID-19 pandemic. Implementing flexible and timely PrEP delivery approaches in this setting likely minimized the disruption of PrEP care during COVID-19.

RESUMEN: COVID-19 es una crisis de salud pública que ha alterado fundamentalmente la prestación de servicios de salud. El propósito de este estudio fue examinar el impacto de COVID-19 en los servicios de la profilaxis preexposición (PrEP). Revisamos todos los registros de pacientes que se presentaron para recibir atención de PrEP en un programa de PrEP en Providence, Rhode Island desde el 1 de septiembre de 2019 hasta el 29 de mayo de 2020. El número de encuentros de PrEP disminuyó pero no fue significativamente diferente con el paso del tiempo (ps > .05). Los pacientes aún pudieron acceder a los servicios clínicos de PrEP durante la pandemia de COVID-19. La implementación de enfoques de entrega de PrEP que eran flexibles y oportunos en este entorno probablemente minimizó la interrupción de la atención médica de la PrEP durante COVID-19.

Seroprevalence of SARS-CoV-2 among Internal Medicine Residents at a Major Academic Medicine Residency Program.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its associated disease (COVID-19) are a significant cause of morbidity and mortality across the United States. Internal medicine (IM) residents are a critical component of the healthcare workforce yet their seroprevalence of SARS-CoV-2 antibodies is largely unknown. The aim of this research was to ascertain the seroprevalences of SARS-CoV-2 among internal medicine residents during the first peak of COVID-19. METHODS: IM residents were enrolled in a surveillance program that included PCR and antibody testing for SARS-CoV-2 in June 2020. Residents also completed a short questionnaire to obtain sociodemographic information and characterize potential workplace exposure to COVID-19. RESULTS: A total of 101 IM residents participated in the study (out of N=162). Of the 101 samples, three (2.9%) tested positive for SARS-CoV-2 antibodies. No residents tested PCR positive for SARS-CoV-2. DISCUSSION: The implementation of COVID-19 patient cohorting and the incorporation of telemedicine to communicate with hospitalized patients into clinical practice early in the pandemic may have prevented the spread of the virus among the surveyed clinical trainees. CONCLUSION: Despite significant engagement with COVID-19 patients, IM residents demonstrated a low rate of SARS-CoV-2 seroprevalence.

Sex Workers and Syndemics: A Population Vulnerable to HIV and COVID-19.

COVID-19 has disproportionately affected vulnerable populations across the U.S. Street-based sex workers are one vulnerable population whose health and impact of COVID-19 have been understudied to date. The goal of this study was to evaluate findings from a community needs assessment with street-based sex workers on impact of COVID-19 on health behaviors and social circumstances. A brief survey was developed at a community-based harm reduction and recovery services organization. Surveys were administered by peer specialists to street-based sex workers during street outreach in April and May 2020. A total of 46 surveys were analyzed. Many individuals reported continuing to do sex work and use substances during the COVID pandemic. Slightly more than a quarter of individuals (n = 13; 28.3%) indicated using personal protective equipment while doing sex work and described challenges to using precautions when working with clients. Individuals had used marijuana (n = 32, 71.1%), cocaine (n = 17, 39.5%), prescription stimulants (n = 9, 21.4%), methamphetamines (n = 5, 11.9%), prescription opioids (n = 12, 27.3%), street opioids (n = 12, 27.3%), sedatives (n = 11, 25.0%), hallucinogens (n = 3, 6.8%), inhalants (n = 3, 7.0%), or some other substance (n = 4, 8.7%) in the past 30 days. About half (48.8%) reported that COVID-19 had a major impact on their lives. This study is among the first to characterize the impact of COVID-19 on street-based sex workers. From a public health standpoint, this group also represents a high-priority population given their vulnerability and close contact with others, which increases the potential for community spread.

Evaluation of the Microbiome in Men Taking Pre-exposure Prophylaxis for HIV Prevention.

Tenofovir-based regimens as pre-exposure prophylaxis (PrEP) are highly effective at preventing HIV infection. The most common side-effect is gastrointestinal (GI) distress which may be associated with changes in the microbiome. Dysbiosis of the microbiome can have numerous health-related consequences. To understand the effect of PrEP on dysbiosis, we evaluated 27 individuals; 14 were taking PrEP for an average of 171 weeks. Sequencing of 16S rRNA was performed using self-collected rectal swabs. Mixed beta diversity testing demonstrated significant differences between PrEP and non-PrEP users with Bray-Curtis and unweighted UniFrac analyses (p = 0.05 and 0.049, respectively). At the genus level, there was a significant reduction in Finegoldia, along with a significant increase in Catenibacterium and Prevotella in PrEP users. Prevotella has been associated with inflammatory pathways, insulin resistance and cardiovascular disease, while Catenibacterium has been associated with morbid obesity and metabolic syndrome. Overall, these results suggest that PrEP may be associated with some degree of microbiome dysbiosis, which may contribute to GI symptoms. Long-term impact of these changes is unknown.

RESUMEN: Los regímenes basados en tenofovir como profilaxis previa a la exposición (PPrE) son muy eficaces en prevenir la infección por VIH. El efecto secundario más común es el malestar gastrointestinal (GI) que puede estar asociado con cambios en el microbioma. La disbiosis del microbioma puede tener numerosas consecuencias relacionadas con la salud. Para comprender el efecto de la PPrE sobre la disbiosis, evaluamos a 27 individuos; 14 de los individuos tomaron PPrE durante un promedio de 171 semanas. La secuenciación del ARNr 16S se realizó utilizando hisopos rectales recolectados por los propios pacientes. Las pruebas beta de diversidad mixta demostraron diferencias significativas entre los usuarios de PPrE y los que no utilizaron PPrE al analizarlos mediente Bray­Curtis y UniFrac no ponderados (p = 0,05 y 0,049, respectivamente). A nivel de género, hubo una reducción significativa de Finegoldia, junto con un aumento significativo de Catenibacterium y Prevotella en usuarios de PPrE. Prevotella se ha asociado con trayectorias inflamatorias, resistencia a insulina y enfermedades cardiovasculares, mientras que Catenibacterium se ha asociado con enfermedades como obesidad mórbida y padecimientos de síndrome metabólico. En general, estos resultados sugieren que la PPrE puede estar asociada con cierto grado de disbiosis del microbioma, lo que puede contribuir a los síntomas gastrointestinales. El impacto a largo plazo de estos cambios se desconoce.

Impact of the COVID-19 Pandemic on Sexually Transmitted Infection Clinic Visits.

Coronavirus disease 2019 is responsible for a global pandemic and has impacted health care accessibility and delivery. Clinic data were reviewed for an STI clinic from September 2019 to May 2020. A significant decrease in rates of STI visits and treatments during the coronavirus disease 2019 pandemic was observed.

Public Health Approaches Toward Eliminating Hepatitis C Virus in Rhode Island.

Hepatitis C Virus (HCV) continues to be a cause of significant morbidity and mortality around the world surpassing HIV, Tuberculosis and Malaria as the leading cause of death by an infectious disease. In the United States, advances in screening, testing and treatment have put the goal set by the World Health Organization (WHO) to HCV elimination within reach. Rhode Island has taken an innovative public health approach to eliminating HCV by improving disease surveillance activities, supporting disease reduction strategies and removing barriers across the continuum of care, particularly for populations that are disproportionately impacted by the disease. Through the coordination of the Rhode Island Hepatitis C Action Coalition, the Rhode Island Department of Health (RIDOH), the Executive Office of Health and Human Services (EOHHS), community organizations, and clinical leaders, important steps have been taken to reduce transmission of the disease and work toward HCV elimination.

Considerations for STI Clinics During the COVID-19 Pandemic.

Coronavirus disease (COVID-19) is responsible for a global pandemic. It is important to balance the need for access to healthcare services, including testing and treatment for sexually transmitted infections. Sexually transmitted infection programs must consider how to use limited resources and implement novel approaches to provide continued access to care.

Evaluation of BioPlex 2200 Syphilis Total With Automated Rapid Plasma Reagin: Experience From a Tertiary Medical Center.

BACKGROUND: Treponema-specific assays are widely adopted in the first step of the reverse algorithm of serologic syphilis screening. The new BioPlex 2200 Syphilis Total and rapid plasma reagin (RPR) test is designed to perform the first 2 steps of the algorithm simultaneously. However, limited data regarding the BioPlex Syphilis Total and RPR in clinical practice exist. METHODS: A total of 293 random samples at a tertiary medical center were tested by BioPlex Syphilis Total and RPR, BioPlex Syphilis IgG, Architect Syphilis TP, and BD Macro-Vue RPR card. Treponema pallidum particle agglutination (TP-PA) assay and clinical chart review were used to resolve discrepancies. Comparisons were performed among treponemal-specific assays and between 2 RPR tests. RESULTS: Good overall agreements (>91%) were achieved between BioPlex Syphilis Total, BioPlex Syphilis IgG, and Architect Syphilis TP. Overall agreement between BioPlex RPR and BD RPR was 86.8% with positive percent agreement of 66.7% and negative percent agreement of 96.3%. There were 37 discordant samples including 30 with BD RPR+/BioPlex RPR- and 7 with BD RPR-/BioPlex RPR+. Negative BioPlex RPR results were observed in samples with reactive BD RPR: 10 (91%) of 11 for BD RPR 1:1, 13 (65%) of 20 for BD RPR 1:2, 6 (35%) of 17 for BD RPR 1:4, and 1 (7%) of 14 for BD RPR 1:8. The discordant samples were predominantly from patients with high-risk of syphilis reinfection and included 9 patients with an early reinfection. CONCLUSIONS: Our results demonstrated that BioPlex Syphilis Total and Architect Syphilis TP performed similarly. The BioPlex RPR missed a small number of early syphilis reinfections, and its implementation should depend on the patient population that the laboratory serves.

Changes in Patient Visits After the Implementation of Insurance Billing at a Sexually Transmitted Diseases Clinic in a Medicaid Expansion State.

BACKGROUND: Medicaid expansion has led to unique opportunities for sexually transmitted disease (STD) clinics to improve the sustainability of services by billing insurance. We evaluated changes in patient visits after the implementation of insurance billing at a STD clinic in a Medicaid expansion state. METHODS: The Rhode Island STD Clinic offered HIV/STD screening services at no cost to patients until October 2016, when insurance billing was implemented. Care for uninsured patients was still provided for free. We compared the clinic visits in the preinsurance period with the postinsurance period using t-tests, Poisson regressions, and a logistic regression. RESULTS: A total of 5560 patients were seen during the preinsurance (n = 2555) and postinsurance (n = 3005) periods. Compared with the preinsurance period, the postinsurance period had a significantly higher average number of patient visits/month (212.9 vs. 250.4, P = 0.0016), including among patients who were black (36.8 vs. 50.3, P = 0.0029), Hispanic/Latino (50.8 vs. 65.8, P = 0.0018), and insured (106.3 vs. 130.1, P = 0.0025). The growth rate of uninsured (+0.10 vs. +4.11, P = 0.0026) and new patients (-4.28 vs. +1.07, P = 0.0007) also increased between the two periods. New patients whose first visit was before the billing change had greater odds (adjusted odds ratio, 2.68, 95% confidence interval, 2.09-3.44; P < 0.0001) of returning compared with new patients whose first visit was after the billing change. CONCLUSIONS: Implementation of insurance billing at a publicly funded STD clinic, with free services provided to uninsured individuals, was associated with a modest increase in patient visits and a decline in patients returning for second visits.

Increasing Syphilis in Rhode Island: Return of an Old Foe.

The number of people diagnosed with syphilis has increased significantly in the United States over the last decade. In Rhode Island, the number of new diagnoses has increased more than four-fold since 2008. Syphilis disproportionately impacts gay, bisexual, and other men who have sex with men (MSM), with those from African American and Hispanic/Latino communities most affected. Given these trends, physicians need to be aware of current prevention, diagnosis, and treatment practices for syphilis, especially when working with populations who are most at risk. [Full article available at http://rimed.org/rimedicaljournal-2019-02.asp].