Causal Effects of Stochastic PrEP Interventions on HIV Incidence Among Men Who Have Sex With Men.

Antiretroviral preexposure prophylaxis (PrEP) is highly effective in preventing human immunodeficiency virus (HIV) infection, but uptake has been limited and inequitable. Although interventions to increase PrEP uptake are being evaluated in clinical trials among men who have sex with men (MSM), those trials cannot evaluate effects on HIV incidence. Estimates from observational studies of the causal effects of PrEP-uptake interventions on HIV incidence can inform decisions about intervention scale-up. We used longitudinal electronic health record data from HIV-negative MSM accessing care at Fenway Health, a community health center in Boston, Massachusetts, from January 2012 through February 2018, with 2 years of follow-up. We considered stochastic interventions that increased the chance of initiating PrEP in several high-priority subgroups. We estimated the effects of these interventions on population-level HIV incidence using a novel inverse-probability weighted estimator of the generalized g-formula, adjusting for baseline and time-varying confounders. Our results suggest that even modest increases in PrEP initiation in high-priority subgroups of MSM could meaningfully reduce HIV incidence in the overall population of MSM. Interventions tailored to Black and Latino MSM should be prioritized to maximize equity and impact.

Social and structural factors associated with interest in HIV preexposure prophylaxis among Black women in the United States.

In a nationwide sample of cisgender Black women in the US, we assessed the associations between social and structural factors and interest in using HIV preexposure prophylaxis (PrEP). Among 315 respondents, 62.2% were interested in PrEP if it were provided for free. Positive social norms surrounding PrEP, including injunctive norms (perceived social acceptability of PrEP use) and descriptive norms (perceived commonality of PrEP use), were positively associated with interest in using PrEP. Concerns about HIV infection, recently visiting a health care provider, and comfort discussing PrEP with a provider were also positively associated with interest in using PrEP. Anticipating PrEP disapproval from others was negatively associated with interest in PrEP. Although PrEP can promote autonomy and personal discretion, Black women's PrEP-related decisions occur in a complex social environment. Black women may benefit from interventions to promote positive norms and attitudes surrounding PrEP at the community level and empower them in discussions with their providers about PrEP.

Life and Disability Insurance for People with or at Risk of HIV: Aligning Policy with Evidence.

Antiretroviral medications have substantially improved life expectancy for people with HIV. These medications are also highly effective in preventing HIV acquisition in people who do not have HIV, a strategy known as HIV preexposure prophylaxis (PrEP). Despite these advances, some life and disability insurers continue to deny or limit coverage for people with HIV, and some have even refused to cover people who are using PrEP to protect themselves. These policies unfairly deny people with HIV, PrEP users, and their families the peace of mind and financial protection that can come with life and disability insurance coverage. This article summarizes the current evidence on HIV treatment and prevention, arguing that underwriting decisions by life and disability insurers should not be made based on HIV status or use of PrEP.

Potential impact of doxycycline post-exposure prophylaxis prescribing strategies on incidence of bacterial sexually transmitted infections.

BACKGROUND: Doxycycline post-exposure prophylaxis (doxyPEP) reduces bacterial sexually transmitted infection (STI) incidence in people with HIV (PWH) or using HIV preexposure prophylaxis (PrEP). Given concerns about widespread antibiotic use, we identified doxyPEP prescribing strategies to minimize use while maximizing impact on STIs. METHODS: We used electronic health records of gay and bisexual men (GBM), transgender women, and non-binary people assigned male sex at birth with ≥2 STI tests (chlamydia, gonorrhea, syphilis) at an LGBTQ-focused health center during 2015-2020. We defined 10 hypothetical doxyPEP prescribing strategies based on PrEP use, HIV status, or STI history. We estimated doxyPEP use and STI diagnoses averted in counterfactual scenarios in which people meeting prescribing criteria received doxyPEP, assuming STI rates during use would have been reduced by clinical trial efficacy estimates. RESULTS: Among 10,546 individuals (94% GBM), rate of any STI was 35.9/100 person-years. Prescribing doxyPEP to all individuals would have averted 71% of STI diagnoses (number needed to treat for one year to avert one STI diagnosis, NNT = 3.9); prescribing to PrEP users/PWH (52%/12% of individuals) would have averted 60% of STI diagnoses (NNT = 2.9). Prescribing doxyPEP for 12 months after STI diagnosis would have reduced the proportion using doxyPEP to 38% and averted 39% of STI diagnoses (NNT = 2.4). Prescribing after concurrent or repeated STIs would have maximized efficiency (lowest NNTs) but prevented fewer STIs. CONCLUSIONS: Prescribing doxyPEP to individuals with STIs, particularly concurrent or repeated STIs, could avert a substantial proportion of all STI diagnoses. The most efficient prescribing strategies are based on STI history rather than HIV status or PrEP use.

Development of a Human Immunodeficiency Virus Risk Prediction Model Using Electronic Health Record Data From an Academic Health System in the Southern United States.

BACKGROUND: Human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) is underutilized in the southern United States. Rapid identification of individuals vulnerable to diagnosis of HIV using electronic health record (EHR)-based tools may augment PrEP uptake in the region. METHODS: Using machine learning, we developed EHR-based models to predict incident HIV diagnosis as a surrogate for PrEP candidacy. We included patients from a southern medical system with encounters between October 2014 and August 2016, training the model to predict incident HIV diagnosis between September 2016 and August 2018. We obtained 74 EHR variables as potential predictors. We compared Extreme Gradient Boosting (XGBoost) versus least absolute shrinkage selection operator (LASSO) logistic regression models, and assessed performance, overall and among women, using area under the receiver operating characteristic curve (AUROC) and area under precision recall curve (AUPRC). RESULTS: Of 998 787 eligible patients, 162 had an incident HIV diagnosis, of whom 49 were women. The XGBoost model outperformed the LASSO model for the total cohort, achieving an AUROC of 0.89 and AUPRC of 0.01. The female-only cohort XGBoost model resulted in an AUROC of 0.78 and AUPRC of 0.00025. The most predictive variables for the overall cohort were race, sex, and male partner. The strongest positive predictors for the female-only cohort were history of pelvic inflammatory disease, drug use, and tobacco use. CONCLUSIONS: Our machine-learning models were able to effectively predict incident HIV diagnoses including among women. This study establishes feasibility of using these models to identify persons most suitable for PrEP in the South.

Acceptability and Effectiveness of a One-Hour Healthcare Provider Intervention Integrating HIV Pre-Exposure Prophylaxis and Cultural Competence Training.

Enhanced provider training could improve PrEP access and equity. We conducted a pilot randomized controlled trial comparing (a) a one-hour, group-based provider intervention integrating PrEP and Cultural Competence (PCC) training with (b) a standard HIV continuing medical education session (n = 56). PCC participants favorably rated the intervention and reported increased PrEP knowledge. The PCC intervention increased their confidence performing PrEP-related clinical activities and intention to prescribe PrEP. The percentage of participants discussing PrEP with patients increased marginally in both study conditions. The percentage of participants who prescribed PrEP and self-rated cultural competence did not change in either study condition.

RESUMEN: Una mejor capacitación de los proveedores podría mejorar el acceso y la equidad de la PrEP. Realizamos un ensayo controlado aleatorizado piloto que comparó (a) una intervención grupal de proveedores de una hora que integraba la capacitación en PrEP y competencia cultural (PCC) con (b) una sesión estándar de educación médica continua sobre el VIH (n = 56). Los participantes de PCC calificaron favorablemente la intervención e informaron un mayor conocimiento de la PrEP. La intervención de PCC aumentó su confianza en la realización de actividades clínicas relacionadas con la PrEP y su intención de prescribir la PrEP. El porcentaje de participantes que discutieron la PrEP con los pacientes aumentó marginalmente en ambas condiciones del estudio. El porcentaje de participantes que prescribieron la PrEP y la competencia cultural autoevaluada no cambió en ninguna de las condiciones del estudio.

What Has the Pandemic Revealed about the Shortcomings of Modern Epidemiology? What Can We Fix or Do Better?

In this commentary, we discuss themes that emerged from our symposium about what modern epidemiology as a science may learn from the COVID-19 pandemic. We reflect on the successes and limitations of this discipline from multiple perspectives, including from junior and senior epidemiologists and scientists on the front lines of generating evidence for the COVID-19 pandemic response in Wuhan, China, to Ontario, Canada. These themes include the role of the traditional scientific process in a public health emergency; epidemiologic methods and data that are critical for an effective pandemic response; the interventions that epidemiologists recommended and interventions that we may explore in the future; inequitable impacts of the COVID-19 pandemic contrasted with homogeneity in the epidemiologist workforce; effective and honest communication of uncertainty; trust and collaboration; and the extent to which these themes are currently reflected in our training programs and discipline. We look forward to insights from field epidemiologists directly involved in the ongoing response to the COVID-19 pandemic and further reflection from epidemiologists throughout our discipline.

Hepatitis C coinfection and extrahepatic cancer incidence among people living with HIV.

OBJECTIVES: We assessed the incidence of extrahepatic cancer among people with HIV/HCV coinfection and the potential impact of direct-acting antivirals (DAAs) on extrahepatic cancer risk among people with HIV/HCV coinfection. DESIGN: Our study cohort included adults who initiated HIV care at a CNICS site in the US during 1995-2017, excluding those with previous cancer and without HCV testing. METHODS: We used Cox regression to estimate hazard ratios for extrahepatic cancer incidence among patients with HIV/HCV coinfection compared with those with HIV monoinfection. Standardized morbidity ratio (SMR) weights were used to create a 'pseudopopulation' in which all patients were treated with antiretroviral therapy (ART), and to compare extrahepatic cancer incidence among patients with untreated HIV/HCV coinfection with the incidence that would have been observed if they had been successfully treated for HCV. RESULTS: Of 18 422 adults, 1775 (10%) had HCV RNA and 10 899 (59%) were on ART at baseline. Incidence rates of any extrahepatic cancer among patients with HIV/HCV coinfection and HIV monoinfection were 1027 and 771 per 100 000 person-years, respectively. In SMR-weighted analyses, the risk of any extrahepatic cancer among patients with untreated HCV coinfection at baseline was similar to the risk if they had been successfully treated for HCV. Patients with untreated HCV coinfection at baseline had higher incidence of kidney, lung and inflammation-related cancers than if their HCV had been successfully treated, but these associations were not statistically significant. CONCLUSIONS: We did not find evidence that treating HCV coinfection with DAAs would reduce the incidence of extrahepatic cancers among people with HIV receiving ART.

Preferences for HIV Preexposure Prophylaxis Products Among Black Women in the U.S.

In a nationwide sample of Black women in the U.S., we assessed preferences for HIV preexposure prophylaxis (PrEP) products, including long-acting injectable (LAI) PrEP and once-daily oral PrEP. Among 315 respondents, 32.1% were aware of PrEP and 40.6% were interested in using it; interest increased to 62.2% if PrEP were provided for free. Oral PrEP was the preferred option (51.1%), followed by LAI PrEP (25.7%), vaginal gel (16.5%), and vaginal ring (6.7%). When examining oral and LAI PrEP alone, most (62.7%) preferred oral PrEP. LAI PrEP was more likely to be preferred among respondents with concerns about healthcare costs or PrEP-related stigma, and among those who reported inconsistent condom use and multiple sexual partners. Although most Black women preferred oral PrEP, LAI PrEP may be appealing to a subset with social and structural barriers to PrEP use, such as cost and stigma, and those at increased risk of HIV infection.

Projected HIV and Bacterial Sexually Transmitted Infection Incidence Following COVID-19-Related Sexual Distancing and Clinical Service Interruption.

BACKGROUND: The global COVID-19 pandemic has the potential to indirectly impact transmission dynamics and prevention of HIV and other sexually transmitted infections (STI). It is unknown what combined impact reductions in sexual activity and interruptions in HIV/STI services will have on HIV/STI epidemic trajectories. METHODS: We adapted a model of HIV, gonorrhea, and chlamydia for a population of approximately 103 000 men who have sex with men (MSM) in the Atlanta area. Model scenarios varied the timing, overlap, and relative extent of COVID-19-related sexual distancing and service interruption within 4 service categories (HIV screening, preexposure prophylaxis, antiretroviral therapy, and STI treatment). RESULTS: A 50% relative decrease in sexual partnerships and interruption of all clinical services, both lasting 18 months, would generally offset each other for HIV (total 5-year population impact for Atlanta MSM, -227 cases), but have net protective effect for STIs (-23 800 cases). If distancing lasted only 3 months but service interruption lasted 18 months, the total 5-year population impact would be an additional 890 HIV cases and 57 500 STI cases. CONCLUSIONS: Immediate action to limit the impact of service interruptions is needed to address the indirect effects of the global COVID-19 pandemic on the HIV/STI epidemic.

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Transmission Dynamics Should Inform Policy.

It is generally agreed that striking a balance between resuming economic and social activities and keeping the effective reproductive number (R0) below 1 using nonpharmaceutical interventions is an important goal until and even after effective vaccines become available. Therefore, the need remains to understand how the virus is transmitted in order to identify high-risk environments and activities that disproportionately contribute to its spread so that effective preventative measures could be put in place. Contact tracing and household studies, in particular, provide robust evidence about the parameters of transmission. In this Viewpoint, we discuss the available evidence from large-scale, well-conducted contact-tracing studies from across the world and argue that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission dynamics should inform policy decisions about mitigation strategies for targeted interventions according to the needs of the society by directing attention to the settings, activities, and socioeconomic factors associated with the highest risks of transmission.

Gaps in Sexually Transmitted Infection Screening Among Men who Have Sex with Men in Pre-exposure Prophylaxis (PrEP) Care in the United States.

BACKGROUND: The US Centers for Disease Control and Prevention (CDC) recommends comprehensive sexually transmitted infection (STI) screening every 3-6 months for men who have sex with men (MSM) using human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP). The gaps between these recommendations and clinical practice by region have not been quantified. METHODS: We used survey data collected from the internet-based ARTnet study between 2017 and 2019 on STI screening among MSM across the United States, stratified by current, prior, and never PrEP use. Poisson regression models with robust error variance were used to model factors, including residence in the Southeast, associated with consistent ("always" or "sometimes") exposure site-specific STI screening during PrEP care. RESULTS: Of 3259 HIV-negative MSM, 19% were currently using PrEP, 6% had used PrEP in the past, and 75% had never used PrEP. Among ever PrEP users, 87%, 78%, 57%, and 64% reported consistent screening for STIs by blood sample, urine sample or urethral swab, rectal swab, or pharyngeal swab, respectively, during PrEP care. Compared to PrEP users in all other regions, PrEP users in the Southeast were significantly less likely to be consistently screened for urogenital (adjusted prevalence ratio [aPR], 0.86; 95% confidence interval [CI], .76-.98) and rectal STIs (aPR, 0.76; 95% CI, .62-.93) during PrEP care. CONCLUSIONS: Substantial gaps exist between CDC recommendations for STI screening during PrEP care and current clinical practice, particularly for rectal and pharyngeal exposure sites that can harbor asymptomatic infections and for MSM in Southeast states where the STI burden is substantial.

HIV Preexposure Prophylaxis and Sexual Satisfaction Among Men Who Have Sex With Men.

ABSTRACT: In this large online survey of primarily men who have sex with men, those who used preexposure prophylaxis reported greater sexual satisfaction than did nonusers, including sexual sensations, sexual presence/awareness, and sexual exchange. Person-centered care and messaging may require acknowledging that some people use preexposure prophylaxis for reasons beyond HIV prevention.

Patient-Led Decision-Making for HIV Preexposure Prophylaxis.

PURPOSE OF REVIEW: Shared decision-making is a process that involves bidirectional exchange of information between patients and providers to support patients in making individualized, evidence-based decisions about their healthcare. We review the evidence on patient-led decision-making, a form of shared decision-making that maximizes patient autonomy, as a framework for decisions about HIV preexposure prophylaxis (PrEP). We also assess the likelihood that patient-led decision-making occurs for PrEP and describe interventions to facilitate this process. RECENT FINDINGS: Patient-led decision-making is likely to be uncommon for PrEP, in part because healthcare providers lack knowledge and training about PrEP. Few evidence-based interventions exist to facilitate patient-led decision-making for PrEP. There is a need for rigorously developed interventions to increase knowledge of PrEP among patients and healthcare providers and support patient-led decision-making for PrEP, which will be increasingly important as the range of available PrEP modalities expands.

Early Adopters of Event-driven Human Immunodeficiency Virus Pre-exposure Prophylaxis in a Large Healthcare System in San Francisco.

Among 279 patients within a large healthcare system in San Francisco, event-driven HIV pre-exposure prophylaxis using a 2-1-1 regimen was a desirable alternative to daily dosing. Problems with adherence, planning sex in advance, or side effects were infrequent (13.9%). We found no new HIV infections over 136 person-years of follow-up.

Use of Intrauterine Devices and Risk of Human Immunodeficiency Virus Acquisition Among Insured Women in the United States.

Concerns have been raised about progestin-containing contraceptives and the risk of human immunodeficiency virus (HIV) acquisition. Based on health insurance data from women in the United States with intrauterine device (IUD) insertions during 2011-2018, there was no increased risk of incident HIV diagnosis for levonorgestrel-releasing IUDs versus copper IUDs.

More Screening or More Disease? Gonorrhea Testing and Positivity Patterns Among Men in 3 Large Clinical Practices in Massachusetts, 2010-2017.

BACKGROUND: Gonorrhea diagnosis rates in the United States increased by 75% during 2009-2017, predominantly in men. It is unclear whether the increase among men is being driven by more screening, an increase in the prevalence of disease, or both. We sought to evaluate changes in gonorrhea testing patterns and positivity among men in Massachusetts. METHODS: The analysis included men (aged ≥15 years) who received care during 2010-2017 in 3 clinical practice groups. We calculated annual percentages of men with ≥1 gonorrhea test and men with ≥1 positive result, among men tested. Log-binomial regression models were used to examine trends in these outcomes. We adjusted for clinical and demographic characteristics that may influence the predilection to test and probability of gonorrhea disease. RESULTS: On average, 306 348 men had clinical encounters each year. There was a significant increase in men with ≥1 gonorrhea test from 2010 (3.1%) to 2017 (6.4%; adjusted annual risk ratio, 1.12; 95% confidence interval, 1.12-1.13). There was a significant, albeit lesser, increase in the percentage of tested men with ≥1 positive result (1.0% in 2010 to 1.5% in 2017; adjusted annual risk ratio, 1.07; 95% confidence interval, 1.04-1.09). CONCLUSIONS: We estimated significant increases in the annual percentages of men with ≥1 gonorrhea test and men with ≥1 positive gonorrhea test result between 2010 and 2017. These results suggest that observed increases in gonorrhea rates could be explained by both increases in screening and the prevalence of gonorrhea.