Changes in Body Mass Index Over Time in People With and Without HIV Infection.

Background: Excess weight gain is an important health concern among people with HIV (PWH) on antiretroviral therapy (ART). The extent to which ART contributes to body mass index (BMI) changes is incompletely understood. Methods: We conducted a retrospective study of PWH initiating ART and demographically matched people without HIV (PWoH). Data on baseline BMI (kg/m2; categorized as underweight/normal, overweight, or obese) and ART class (integrase strand transfer inhibitor [INSTI], non-nucleoside reverse transcriptase inhibitor [NNRTI], protease inhibitor [PI]) were obtained from electronic health records. BMI was evaluated longitudinally using piecewise linear splines in mixed effects models by HIV status, baseline BMI, and ART class. Models were adjusted for sociodemographics, comorbidities, and substance use. Results: The study included 8256 PWH and 129 966 PWoH (mean baseline age, 40.9 and 42.2 years, respectively; 88% men). In adjusted models, the average annual change in BMI in the first 2 years after ART initiation was 0.53 for PWH and 0.12 for PWoH (P < .001). BMI increases among PWH were observed for all ART classes: 0.69 for INSTIs, 0.69 for PIs, and 0.40 for NNRTIs vs 0.12 among PWoH. For PWH initiating INSTIs, BMI increases were observed regardless of baseline BMI. Overall BMI changes >2 years after ART initiation were similar by HIV status (0.02 average annual increase for PWH and PWoH). Conclusions: PWH initiating ART gained excess weight in the first 2 years, emphasizing the importance of monitoring weight and cardiometabolic health among ART-treated PWH.

Using Electronic Health Records to Improve HIV Preexposure Prophylaxis Care: A Randomized Trial.

BACKGROUND: Preexposure prophylaxis (PrEP) use remains limited and inequitable, and strategies are needed to improve PrEP provision in primary care. METHODS: We conducted a cluster randomized trial at Kaiser Permanente, San Francisco, to evaluate the effectiveness of a clinical decision support intervention guided by an electronic health record (EHR)-based HIV risk prediction model to improve PrEP provision. Primary care providers (PCPs) were randomized to usual care or intervention, with PCPs who provide care to people with HIV balanced between arms. PCPs in the intervention arm received an EHR-based staff message with prompts to discuss HIV prevention and PrEP before upcoming in-person or video visits with patients whose predicted 3-year HIV risk was above a prespecified threshold. The main study outcome was initiation of PrEP care within 90 days, defined as PrEP discussions, referrals, or prescription fills. RESULTS: One hundred twenty-one PCPs had 5051 appointments with eligible patients (2580 usual care; 2471 intervention). There was a nonsignificant increase in initiation of PrEP care in the intervention arm (6.0% vs 4.5%, HR 1.32, 95% CI: 0.84 to 2.1). There was a significant interaction by HIV provider status, with an intervention HR of 2.59 (95% CI: 1.30 to 5.16) for HIV providers and 0.89 (95% CI: 0.59 to 1.35) for non-HIV providers (P-interaction <0.001). CONCLUSION: An EHR-based intervention guided by an HIV risk prediction model substantially increased initiation of PrEP care among patients of PCPs who also care for people with HIV. Higher-intensity interventions may be needed to improve PrEP provision among PCPs less familiar with PrEP and HIV care.

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.

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.

HIV pre-exposure prophylaxis provision by U.S. health centers in 2021.

OBJECTIVES: The aim of this study was to assess HIV preexposure prophylaxis (PrEP) provision in U.S. health centers. DESIGN: The U.S. Ending the HIV Epidemic (EHE) initiative designated health centers as the main healthcare system through which PrEP scale-up occurs. Health centers offer primary care to over 30 million disproportionately uninsured, racially or ethnically minoritized, and low-income patients. This study is the first to assess PrEP provision across health centers, including characteristics of clinics, patient populations, and policies associated with PrEP prescribing. METHODS: The Health Resources and Services Administration's Uniform Data System contained aggregate data on PrEP prescriptions and patient sociodemographics at health centers from January 1 through December 31, 2021, in 50 U.S. states, the District of Columbia, and eight U.S. territories. We compared patient demographics and availability of Medicaid expansion and PrEP assistance programs at health centers that prescribed vs. those that did not prescribe PrEP. RESULTS: Across 1375 health centers serving 30 193 278 patients, 79 163 patients were prescribed PrEP. Health centers that prescribed any PrEP had higher proportions of sexual, gender, racial, and ethnic minority patient populations compared with health centers that prescribed no PrEP. Compared with health centers that prescribed no PrEP, a higher proportion of health centers that prescribed PrEP were located in designated high-priority jurisdictions of the EHE initiative or states with Medicaid expansion or public PrEP assistance programs. CONCLUSION: Health centers are critical for scaling up PrEP in minoritized populations disproportionately affected by HIV, facilitated through federal and state-level policies. These findings highlight service gaps and inform future interventions to optimize PrEP implementation and support EHE initiative goals.

Fracture Risk and Association With TDF Use Among People With HIV in Large Integrated Health Systems.

BACKGROUND: Greater decline in bone health among people with HIV (PWH) has been documented but fracture risk and the impact of specific antiretroviral therapy (ART) regimens remain unclear. SETTING: Retrospective analyses of electronic health record data from 3 US integrated health care systems. METHODS: Fracture incidence was compared between PWH aged 40 years or older without prior fracture and demographically matched people without HIV (PWoH), stratified by age, sex, and race/ethnicity. Multivariable Cox proportional hazards models were used to estimate fracture risk associated with HIV infection. The association of tenofovir disoproxil fumarate (TDF) use and fracture risk was evaluated in a subset of PWH initiating ART. RESULTS: Incidence of fracture was higher in PWH [13.6/1000 person-years, 95% confidence interval (CI): 13.0 to 14.3, n = 24,308] compared with PWoH (9.5, 95% CI: 9.4 to 9.7, n = 247,313). Compared with PWoH, the adjusted hazard ratio (aHR) for fracture among PWH was 1.24 (95% CI: 1.18 to 1.31). The association between HIV infection and fracture risk increased with age, with the lowest aHR (1.17, 95% CI: 1.10 to 1.25) among those aged 40-49 years and the highest aHR (1.89, 95% CI: 1.30 to 2.76) among those aged 70 years or older. Among PWH initiating ART (n = 6504), TDF was not associated with significant increase in fracture risk compared with non-TDF regimens (aHR: 1.18, 95% CI: 0.89 to 1.58). CONCLUSIONS: Among people aged 40 years or older, HIV infection is associated with increased risk of fractures. Bone health screening from the age of 40 years may be beneficial for PWH. Large cohort studies with longer follow-up are needed to evaluate TDF effect and the potential benefit of early screening.

Doxycycline Postexposure Prophylaxis and Sexually Transmitted Infections.

This JAMA Insights discusses the use of antibiotics for sexually transmitted infection prevention.

Pathways and Intersections: Multifaceted Approaches to Engage Individuals From Underrepresented and Marginalized Communities in HIV Research and Career Development.

BACKGROUND: The underrepresentation of historically marginalized groups in the HIV research workforce is a barrier to reaching national Ending the Epidemic goals. SETTING: The Harvard University Center for AIDS Research (HU CFAR) Diversity Equity and Inclusion Working Group (DEI WG) uses a multifaceted approach to enhance the field's diversity. METHODS: We established a DEI WG to improve the recruitment, inclusion, and retention of underrepresented minorities (URMs) in HIV research. We use community-based, participatory processes to establish and expand education and outreach programs about HIV care and research to better connect the HU CFAR to communities affected by HIV. This article reports on the development of the WG in July 2022, progress in its first year, and future plans. RESULTS: We have built a network of >50 investigators across the university for monthly meetings; partnered with existing research pathway programs for high school, undergraduate, and graduate students, directly supporting 7 new trainees and linking CFAR investigators to additional mentorship opportunities; and created 2-year Scholar Awards for 5 URM investigators in HIV. Planned work includes needs assessments for early-stage investigators to understand factors contributing to inclusion and retention and new pathway and outreach programming being developed with community partner minority-serving institutions. CONCLUSIONS: The HU CFAR DEI WG strives to ensure that individuals from underrepresented, marginalized, and minoritized communities have an opportunity to contribute to HIV research and that research is informed by the needs of the communities affected by the epidemic. An intersectional approach should be incorporated into HIV research pathway initiatives.

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.

Prioritising the values of potential users to promote uptake of HIV pre-exposure prophylaxis.

Benefits of pre-exposure prophylaxis (PrEP) extend beyond HIV risk reduction. Users report a range of physical, emotional, and social effects, including reduced anxiety, increased intimacy, and greater sexual satisfaction. For some people, these benefits are the primary motivation for using PrEP. To successfully engage in shared decision making about HIV prevention methods, clinicians need to be able to discuss all potential risks and benefits of PrEP. These risks and benefits include not only those related to HIV risk reduction and other clinical outcomes, but also those related to experiences and relationships that people value. However, national and international clinical resources on the provision of PrEP do not include user-reported outcomes that are values-based or reflect positive effects on personal, social, or sexual wellbeing. To better integrate the values of potential users into discussions about PrEP, clinician training programmes and clinical guidelines need to be guided by community-driven frameworks and expanded to include user-reported outcomes of PrEP use, including beneficial effects. Achieving PrEP uptake and equity goals will require an approach to PrEP provision that centres the values and desired experiences of potential users, particularly those from populations with the greatest unmet need for PrEP.

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.

Intervention treatment distributions that depend on the observed treatment process and model double robustness in causal survival analysis.

The generalized g-formula can be used to estimate the probability of survival under a sustained treatment strategy. When treatment strategies are deterministic, estimators derived from the so-called efficient influence function (EIF) for the g-formula will be doubly robust to model misspecification. In recent years, several practical applications have motivated estimation of the g-formula under non-deterministic treatment strategies where treatment assignment at each time point depends on the observed treatment process. In this case, EIF-based estimators may or may not be doubly robust. In this paper, we provide sufficient conditions to ensure the existence of doubly robust estimators for intervention treatment distributions that depend on the observed treatment process for point treatment interventions and give a class of intervention treatment distributions dependent on the observed treatment process that guarantee model doubly and multiply robust estimators in longitudinal settings. Motivated by an application to pre-exposure prophylaxis (PrEP) initiation studies, we propose a new treatment intervention dependent on the observed treatment process. We show there exist (1) estimators that are doubly and multiply robust to model misspecification and (2) estimators that when used with machine learning algorithms can attain fast convergence rates for our proposed intervention. Finally, we explore the finite sample performance of our estimators via simulation studies.

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.

Using Health Care Professionals' Perspectives to Refine a Clinical Decision Support Implementation Strategy for Increasing the Prescribing of HIV Preexposure Prophylaxis (PrEP) in Alabama.

Pre-exposure prophylaxis (PrEP) is underused in the southern United States (US), a region with high HIV incidence. Clinical decision support (CDS) tools could increase PrEP prescriptions. We explored barriers to PrEP delivery and views of CDS tools to identify refinements for implementation strategies for PrEP prescribing and PrEP CDS tools. We conducted focus groups with health care providers from two federally qualified health centers in Alabama and analyzed the results using rapid qualitative methods. Barriers to PrEP included providers' lack of training in PrEP, competing priorities and time constraints during clinical visits, concerns about side effects, and intensive workload. We identified refinements to the planned implementation strategies to address the barriers, including training all clinic staff in PrEP and having CDS PrEP alerts in electronic health records sent to all staff. Development and deployment of CDS tools in collaboration with providers has potential to increase PrEP prescribing in high-priority jurisdictions.

Competing health risks associated with the COVID-19 pandemic and early response: A scoping review.

BACKGROUND: COVID-19 has rapidly emerged as a global public health threat with infections recorded in nearly every country. Responses to COVID-19 have varied in intensity and breadth, but generally have included domestic and international travel limitations, closure of non-essential businesses, and repurposing of health services. While these interventions have focused on testing, treatment, and mitigation of COVID-19, there have been reports of interruptions to diagnostic, prevention, and treatment services for other public health threats. OBJECTIVES: We conducted a scoping review to characterize the early impact of COVID-19 on HIV, tuberculosis, malaria, sexual and reproductive health, and malnutrition. METHODS: A scoping literature review was completed using searches of PubMed and preprint servers (medRxiv/bioRxiv) from November 1st, 2019 to October 31st, 2020, using Medical Subject Headings (MeSH) terms related to SARS-CoV-2 or COVID-19 and HIV, tuberculosis, malaria, sexual and reproductive health, and malnutrition. Empiric studies reporting original data collection or mathematical models were included, and available data synthesized by region. Studies were excluded if they were not written in English. RESULTS: A total of 1604 published papers and 205 preprints were retrieved in the search. Overall, 8.0% (129/1604) of published studies and 10.2% (21/205) of preprints met the inclusion criteria and were included in this review: 7.3% (68/931) on HIV, 7.1% (24/339) on tuberculosis, 11.6% (26/224) on malaria, 7.8% (19/183) on sexual and reproductive health, and 9.8% (13/132) on malnutrition. Thematic results were similar across competing health risks, with substantial indirect effects of the COVID-19 pandemic and response on diagnostic, prevention, and treatment services for HIV, tuberculosis, malaria, sexual and reproductive health, and malnutrition. DISCUSSION: COVID-19 emerged in the context of existing public health threats that result in millions of deaths every year. Thus, effectively responding to COVID-19 while minimizing the negative impacts of COVID-19 necessitates innovation and integration of existing programs that are often siloed across health systems. Inequities have been a consistent driver of existing health threats; COVID-19 has worsened disparities, reinforcing the need for programs that address structural risks. The data reviewed here suggest that effective strengthening of health systems should include investment and planning focused on ensuring the continuity of care for both rapidly emergent and existing public health threats.

Correlations between community-level HIV preexposure prophylaxis coverage and individual-level sexual behaviors among United States MSM.

OBJECTIVE: To evaluate if community-level HIV PrEP coverage is correlated with individual sexual behaviors. DESIGN: We used demographic, behavioral, and sexual network data from ARTnet, a 2017-2019 study of United States MSM. METHODS: Multivariable regression models with a Bayesian modeling framework were used to estimate associations between area-level PrEP coverage and seven sexual behavior outcomes [number of total, main, and casual male partners (network degree); count of one-time partnerships; consistent condom use in one-time partnerships; and frequency of casual partnership anal sex (total and condomless)], controlling for individual PrEP use. RESULTS: PrEP coverage ranged from 10.3% (Philadelphia) to 38.9% (San Francisco). Total degree was highest in Miami (1.35) and lowest in Denver (0.78), while the count of one-time partners was highest in San Francisco (11.7/year) and lowest in Detroit (1.5/year). Adjusting for individual PrEP use and demographics, community PrEP coverage correlated with total degree [adjusted incidence rate ratio (aIRR) = 1.73; 95% credible interval (CrI), 0.92-3.44], casual degree (aIRR = 2.05; 95% CrI, 0.90-5.07), and count of one-time partnerships (aIRR = 1.90; 95% CrI, 0.46-8.54). Without adjustment for individual PrEP use, these associations strengthened. There were weaker or no associations with consistent condom use in one-time partnerships (aIRR = 1.68; 95% CrI, 0.86-3.35), main degree (aIRR = 1.21; 95% CrI, 0.48-3.20), and frequency of casual partnership condomless anal sex (aIRR = 0.23; 95% CrI, 0.01-3.60). CONCLUSION: Most correlations between community PrEP coverage and sexual behavior were explained by individual PrEP use. However, some residual associations remained after controlling for individual PrEP use, suggesting that PrEP coverage may partially drive community-level differences in sexual behaviors.