Pre-exposure Prophylaxis Discontinuation During the COVID-19 Pandemic Among Men Who Have Sex With Men in a Multisite Clinical Cohort in the United States.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic continues to put strain on health systems in the United States, leading to significant shifts in the delivery of routine clinical services, including those offering HIV pre-exposure prophylaxis (PrEP). We aimed to assess whether individuals discontinued PrEP use at higher rates during the COVID-19 pandemic and the extent to which disruptions to usual clinical care were mitigated through telehealth. METHODS: Using data from an ongoing prospective cohort of men who have sex with men (MSM) newly initiating PrEP in 3 mid-sized cities (n = 195), we calculated the rate of first-time discontinuation of PrEP use in the period before the COVID-19 pandemic and during the COVID-19 pandemic and compared these rates using incidence rate ratios (IRRs). Furthermore, we compared the characteristics of patients who discontinued PrEP use during these periods with those who continued to use PrEP during both periods. RESULTS: Rates of PrEP discontinuation before the COVID pandemic and during the COVID-19 pandemic were comparable [4.29 vs. 5.20 discontinuations per 100 person-months; IRR: 1.95; 95% confidence interval (CI): 0.83 to 1.77]. Although no significant differences in the PrEP discontinuation rate were observed in the overall population, the rate of PrEP discontinuation increased by almost 3-fold among participants aged 18-24 year old (IRR: 2.78; 95% CI: 1.48 to 5.23) and by 29% among participants covered by public insurance plans at enrollment (IRR: 1.29; 95% CI: 1.03 to 5.09). Those who continued to use PrEP were more likely to have had a follow-up clinical visit by telehealth in the early months of the pandemic (45% vs. 17%). CONCLUSIONS: In this study, rates of PrEP discontinuation were largely unchanged with the onset of the COVID-19 pandemic. The use of telehealth likely helped retain patients in PrEP care and should continue to be offered in the future.

Perspectives of people living with HIV-1 on implementation of long-acting cabotegravir plus rilpivirine in US healthcare settings: results from the CUSTOMIZE hybrid III implementation-effectiveness study.

INTRODUCTION: The CUSTOMIZE hybrid III implementation-effectiveness study evaluated implementation of once-monthly long-acting (LA) cabotegravir + rilpivirine in diverse US healthcare settings. Here, we report patient participant perspectives after 12 months in CUSTOMIZE. METHODS: CUSTOMIZE was a phase IIIb, 12-month study conducted from July 2019 to October 2020 at eight diverse US HIV clinics that enrolled virologically suppressed people living with HIV-1 (PLHIV) on a stable oral regimen to receive monthly cabotegravir + rilpivirine LA injections after a 1-month oral lead-in. Participants were administered quantitative surveys before injections at months 1 (baseline), 4 and 12. A randomly selected subset of participants was interviewed at baseline and month 12. Data collection at month 12 was completed by October 2020 (during the COVID-19 pandemic). RESULTS: At baseline, 109 and 34 participants completed surveys and interviews, respectively; 87% were male; 35% were Black or African American. All participants who remained in the study at month 12 (n = 102) maintained HIV-1 RNA <50 copies/ml; two participants withdrew due to injection-related reasons. Mean total scores measuring acceptability and appropriateness of cabotegravir + rilpivirine LA were high at baseline (4.5-4.6 out of 5) and month 12 (4.7-4.9). At month 12, 74% of participants reported nothing interfered with receiving LA injections; injection pain or soreness was the most common concern (15%). Time spent in the clinic and coming to the clinic for monthly injections was very or extremely acceptable after 12 months for most participants (93% and 87%, respectively), with 64% reporting having spent ≤30 minutes in the clinic for injection visits. At month 12, 92% of participants preferred LA injections to daily oral tablets (3%); 97% plan to continue LA treatment going forward. In month 12 interviews, 24 (77%) of 31 participants reported the COVID-19 pandemic did not impact their ability to receive treatment. CONCLUSIONS: Once-monthly cabotegravir + rilpivirine LA was highly acceptable among PLHIV who were virologically suppressed on a stable antiretroviral regimen and interested in trying LA therapy, with few participants reporting challenges receiving LA injections. Implementation data from CUSTOMIZE suggest that monthly LA injections provide a convenient and appealing treatment option for PLHIV.

Perspectives of healthcare providers on implementation of long-acting cabotegravir plus rilpivirine in US healthcare settings from a Hybrid III Implementation-effectiveness study (CUSTOMIZE).

INTRODUCTION: CUSTOMIZE evaluated the implementation of long-acting (LA) cabotegravir + rilpivirine, a novel healthcare provider-administered injectable antiretroviral therapy regimen, in diverse US healthcare settings. Findings from staff-study participants (SSPs) through 12 months of implementation are reported. METHODS: CUSTOMIZE was a phase IIIb, 12-month, single-arm, hybrid III implementation-effectiveness study conducted from July 2019 to October 2020 at eight US clinics of five clinic types: private practice (n = 2), federally qualified health centre (n = 2), university (n = 2), AIDS Healthcare Foundation (n = 2) and health maintenance organization (n = 1). Eligible patient participants received monthly cabotegravir + rilpivirine LA injections after a 1-month oral lead-in. At baseline, month 4 and month 12, SSPs (n = 3 each per clinic), including physicians, nurses or injectors, and administrators, completed quantitative surveys and semi-structured interviews to assess implementation outcomes (acceptability, appropriateness and feasibility of intervention measures), programme sustainability and SSP perceptions of, attitudes towards, and expectations for cabotegravir + rilpivirine LA. Month 12 data collection occurred during the COVID-19 pandemic. RESULTS: In surveys, SSPs reported high mean total scores for acceptability, appropriateness and feasibility of cabotegravir + rilpivirine LA implementation at baseline (4.43, 4.52 and 4.38 of 5, respectively) and month 12 (4.45, 4.61 and 4.46 of 5, respectively), regardless of clinic type. At month 12, SSPs were positive about the implementation sustainability (mean Program Sustainability Assessment Tool score, 5.83 out of 7). At baseline, SSPs' top concern was patients' ability to maintain monthly appointments (81%); at month 12, 39% had this concern. The proportion of SSPs reporting patient injection pain or soreness as a barrier was consistent at month 12 versus baseline (48% vs. 46%). Most (78%) SSPs reported optimal implementation of cabotegravir + rilpivirine LA in their clinics was achieved in 1-3 months. In interviews, SSP-reported strategies for successful implementation included teamwork, using a web-based treatment planner and having a designated person to track appointment scheduling. In month 12 interviews, SSP-reported structural changes needed for implementation included changing clinic hours and purchasing refrigerators. CONCLUSIONS: In CUSTOMIZE, cabotegravir + rilpivirine LA was successfully implemented across a range of US healthcare settings. Barriers were mitigated with minor process adjustments.

Projected Effects of Disruptions to Human Immunodeficiency Virus (HIV) Prevention Services During the Coronavirus Disease 2019 Pandemic Among Black/African American Men Who Have Sex With Men in an Ending the HIV Epidemic Priority Jurisdiction.

Background: Disruptions in access to in-person human immunodeficiency virus (HIV) preventive care during the coronavirus disease 2019 (COVID-19) pandemic may have a negative impact on our progress towards the Ending the HIV Epidemic goals in the United States. Methods: We used an agent-based model to simulate HIV transmission among Black/African American men who have sex with men in Mississippi over 5 years to estimate how different reductions in access affected the number of undiagnosed HIV cases, new pre-exposure prophylaxis (PrEP) starts, and HIV incidence. Results: We found that each additional 25% decrease in HIV testing and PrEP initiation was associated with decrease of 20% in the number of cases diagnosed and 23% in the number of new PrEP starts, leading to a 15% increase in HIV incidence from 2020 to 2022. Conclusions: Unmet need for HIV testing and PrEP prescriptions during the COVID-19 pandemic may temporarily increase HIV incidence in the years immediately after the disruption period.

Projected Effects of Disruptions to HIV Prevention Services During the COVID-19 Pandemic Among Black/African American Men Who Have Sex with Men in an Ending the HIV Epidemic Priority Jurisdiction

Disruptions in access to in-person HIV preventive care during the COVID-19 pandemic may have a negative impact on our progress towards the Ending the HIV Epidemic goals in the United States. We used an agent-based model to simulate HIV transmission among Black/African American men who have sex with men (MSM) in Mississippi over five years to estimate how different reductions in access affected the number of undiagnosed HIV cases, new PrEP starts, and HIV incidence. We found that each additional 25% decrease in HIV testing and PrEP initiation was associated with decrease of 20% in the number of cases diagnosed and 23% in the number of new PrEP starts, leading to a 15% increase in HIV incidence from 2020 to 2022. Unmet need for HIV testing and PrEP prescriptions during the COVID-19 pandemic may temporarily increase HIV incidence in the years immediately following the disruption period.

Human Immunodeficiency Virus/Sexually Transmitted Infection Testing Preferences for Young Black Men Who Have Sex With Men in the Southeastern United States: Implications for a Post-COVID-19 Era.

BACKGROUND: Little is known regarding human immunodeficiency virus (HIV)/sexually transmitted infection (STI) testing preferences for location, staffing, and hours of operation among Young Black men who have sex with men (YBMSM) in the Southeastern United States, a population at high risk for HIV/STIs. We used a discrete choice experiment to explore these preferences. METHODS: Young Black men who have sex with men ages 16 to 35 years in Birmingham, AL and Jackson, MS completed online surveys evaluating their preferences (best/worst) for HIV/STI testing locations, staffing, hours, method of results notification, and cost. They also selected preferred combinations of these variables through choice tasks. Results were analyzed using joint best/worst and discrete choice experiment models. RESULTS: Between June 2018 and December 2019, participants in Alabama (n = 54) and Mississippi (n = 159) completed online surveys. Both groups preferred stationary testing locations over mobile testing vans, with the most significant difference favoring STI testing-only clinics in Mississippi and local health departments in Alabama (P < 0.001). Technician-performed tests or self-testing were significantly less preferred compared with clinician-performed testing for both groups (P < 0.0001 and P < 0.0001, respectively). Free testing and phone results notification (versus text) were preferred by both groups. The most desirable combination among all participants was weekday clinician-performed testing at the health department for $5. CONCLUSIONS: Young Black men who have sex with men in the Southeastern United States prefer traditional testing locations staffed by experienced personnel. Combination choices are influenced by services that are low or no cost. More research is needed to inform the best way(s) to provide affordable, high-quality HIV/STI testing services for YBMSM, particularly in the post-COVID-19 era when sexual health care delivery models are evolving toward home-based and remote health-focused strategies.

The persistent and evolving HIV epidemic in American men who have sex with men.

Men who have sex with men (MSM) in the USA were the first population to be identified with AIDS and continue to be at very high risk of HIV acquisition. We did a systematic literature search to identify the factors that explain the reasons for the ongoing epidemic in this population, using a social-ecological perspective. Common features of the HIV epidemic in American MSM include role versatility and biological, individual, and social and structural factors. The high-prevalence networks of some racial and ethnic minority men are further concentrated because of assortative mixing, adverse life experiences (including high rates of incarceration), and avoidant behaviour because of negative interactions with the health-care system. Young MSM have additional risks for HIV because their impulse control is less developed and they are less familiar with serostatus and other risk mitigation discussions. They might benefit from prevention efforts that use digital technologies, which they often use to meet partners and obtain health-related information. Older MSM remain at risk of HIV and are the largest population of US residents with chronic HIV, requiring culturally responsive programmes that address longer-term comorbidities. Transgender MSM are an understudied population, but emerging data suggest that some are at great risk of HIV and require specifically tailored information on HIV prevention. In the current era of pre-exposure prophylaxis and the undetectable equals untransmittable campaign, training of health-care providers to create culturally competent programmes for all MSM is crucial, since the use of antiretrovirals is foundational to optimising HIV care and prevention. Effective control of the HIV epidemic among all American MSM will require scaling up programmes that address their common vulnerabilities, but are sufficiently nuanced to address the specific sociocultural, structural, and behavioural issues of diverse subgroups.

African American Clergy Recommendations to Enhance the Federal Plan to End the HIV Epidemic: A Qualitative Study.

African Americans in the southern United States continue to be disproportionately affected by HIV. Although faith-based organizations (FBOs) play important roles in the social fabric of African American communities, few HIV screening, care, and PrEP promotion efforts harness the power of FBOs. We conducted 11 focus groups among 57 prominent African American clergy from Arkansas, Mississippi, and Alabama. We explored clergy knowledge about the Ending the HIV Epidemic: A Plan for America (EHE); normative recommendations for how clergy can contribute to EHE; and how clergy can enhance the HIV care continua and PrEP. We explored how clergy have responded to the COVID-19 crisis, and lessons learned from pandemic experiences that are relevant for HIV programs. Clergy reported a moral obligation to participate in the response to the HIV epidemic and were willing to support efforts to expand HIV screening, treatment, PrEP and HIV care. Few clergy were familiar with EHE, U = U and TasP. Many suggested developing culturally tailored messages and were willing to lend their voices to social marketing efforts to destigmatize HIV and promote uptake of biomedical interventions. Nearly all clergy believed technical assistance with biomedical HIV prevention and care interventions would enhance their ability to create partnerships with local community health centers. Partnering with FBOs presents important and unique opportunities to reduce HIV disparities. Clergy want to participate in the EHE movement and need federal resources and technical assistance to support their efforts to bridge community activities with biomedical prevention and care programs related to HIV. The COVID-19 pandemic presents opportunities to build important infrastructure related to these goals.

Epidemiology, Clinical Features, and Outcomes of Hospitalized Adults with COVID-19: Early Experience from an Academic Medical Center in Mississippi.

OBJECTIVES: To describe the demographics, clinical characteristics, and outcomes of hospitalized adults with coronavirus disease 2019 (COVID-19) in an academic medical center in the southern United States. METHODS: Retrospective, observational cohort study of all adult patients (18 years and older) consecutively admitted with laboratory-confirmed severe acute respiratory syndrome-coronavirus-2 infection between March 13 and April 25, 2020 at the University of Mississippi Medical Center. All of the patients either survived to hospital discharge or died during hospitalization. Demographics, body mass index, comorbidities, clinical manifestations, and laboratory findings were collected. Patient outcomes (need for invasive mechanical ventilation and in-hospital death) were analyzed. RESULTS: One hundred patients were included, 53% of whom were women. Median age was 59 years (interquartile range 44-70) and 66% were younger than 65. Seventy-five percent identified themselves as Black, despite representing 58% of hospitalized patients at our institution in 2019. Common comorbid conditions included hypertension (68%), obesity (65%), and diabetes mellitus (31%). Frequent clinical manifestations included shortness of breath (76%), cough (75%), and fever (64%). Symptoms were present for a median of 7 days (interquartile range 4-7) on presentation. Twenty-four percent of patients required mechanical ventilation and, overall, 19% died (67% of those requiring mechanical ventilation). Eighty-four percent of those who died were Black. On multivariate analysis, ever smoking (odds ratio [OR] 5.9, 95% confidence interval [CI] 1.2-28.6) and history of diabetes mellitus (OR 5.9, 95% CI 1.5-24.3) were associated with mortality, and those admitted from home were less likely to die (vs outside facility, OR 0.2, 95% CI 0.0-0.7). Neither age, sex, race, body mass index, insurance status, nor rural residence was independently associated with mortality. CONCLUSIONS: Our study adds evidence that Black patients appear to be overrepresented in those hospitalized with and those who die from COVID-19, likely a manifestation of adverse social determinants of health. These findings should help guide preventive interventions targeting groups at higher risk of acquiring and developing severe COVID-19 disease.

Risk for COVID-19 infection and death among Latinos in the United States: examining heterogeneity in transmission dynamics.

PURPOSE: The purpose of this study was to ascertain COVID-19 transmission dynamics among Latino communities nationally. METHODS: We compared predictors of COVID-19 cases and deaths between disproportionally Latino counties (≥17.8% Latino population) and all other counties through May 11, 2020. Adjusted rate ratios (aRRs) were estimated using COVID-19 cases and deaths via zero-inflated binomial regression models. RESULTS: COVID-19 diagnoses rates were greater in Latino counties nationally (90.9 vs. 82.0 per 100,000). In multivariable analysis, COVID-19 cases were greater in Northeastern and Midwestern Latino counties (aRR: 1.42, 95% CI: 1.11-1.84, and aRR: 1.70, 95% CI: 1.57-1.85, respectively). COVID-19 deaths were greater in Midwestern Latino counties (aRR: 1.17, 95% CI: 1.04-1.34). COVID-19 diagnoses were associated with counties with greater monolingual Spanish speakers, employment rates, heart disease deaths, less social distancing, and days since the first reported case. COVID-19 deaths were associated with household occupancy density, air pollution, employment, days since the first reported case, and age (fewer <35 yo). CONCLUSIONS: COVID-19 risks and deaths among Latino populations differ by region. Structural factors place Latino populations and particularly monolingual Spanish speakers at elevated risk for COVID-19 acquisition.