Population-average mediation analysis for zero-inflated count outcomes.

Mediation analysis is an increasingly popular statistical method for explaining causal pathways to inform intervention. While methods have increased, there is still a dearth of robust mediation methods for count outcomes with excess zeroes. Current mediation methods addressing this issue are computationally intensive, biased, or challenging to interpret. To overcome these limitations, we propose a new mediation methodology for zero-inflated count outcomes using the marginalized zero-inflated Poisson (MZIP) model and the counterfactual approach to mediation. This novel work gives population-average mediation effects whose variance can be estimated rapidly via delta method. This methodology is extended to cases with exposure-mediator interactions. We apply this novel methodology to explore if diabetes diagnosis can explain BMI differences in healthcare utilization and test model performance via simulations comparing the proposed MZIP method to existing zero-inflated and Poisson methods. We find that our proposed method minimizes bias and computation time compared to alternative approaches while allowing for straight-forward interpretations.

Re-evaluating the relationship between youth with HIV and BMI in an age of increasing rates of overweight and obese youth.

BACKGROUND: Newer antiretrivirals (ART) have shifted the metabolic experiences of people with HIV (PWH) from those of wasting syndrome to increases in body mass index (BMI). This study sought to examine the relationship between BMI and ART use among youth with HIV (YWH). METHODS: Charts from YWH ages 10-24 with at least two documented BMIs at least 6 months apart between 2017 and 2020 were included (N = 44). Statistical analyses were conducted in SAS 9.4. RESULTS: Clients were predominately African American (66%) males (73%) aged 19-24 years (64%), with men having sex with men (48%) being the most common mode of transmission. YWH on non-integrase inhibitor (INSTI) regimens had greater absolute increases in BMI compared to those on INSTI regimens (p = 0.03). Fourteen percent of clients using INSTI experienced an increase in BMI class from normal to overweight or overweight to obese; no non-INSTI users changed BMI class. Time since diagnosis and BMI change due to weight gain were positively associated (p = 0.03) among behaviorally-acquired YWH. CONCLUSIONS: Increasing BMI and changing BMI classes may be more likely among YWH using INSTI. More longitudinal studies inclusive of diet and exercise profiles are needed to understand the relationship between INSTI and YWH BMI.

The Characteristics of Youth With Missed HIV Visits in Alabama.

Gaps in knowledge remain related to understanding missed human immunodeficiency virus (HIV) visits and youth with HIV (YWH). This study examined data from an Alabama academic HIV clinic with clients aged 16 to 24 years old and found that non virally suppressed and older YWH were associated with missed visits among YWH.

Viral load and sexually transmitted infection testing among youth with HIV in a southern United States clinic.

Background: As compared to their older peers, youth with HIV (YWH) are less likely to attain viral suppression and have higher rates of sexually transmitted infections (STI). In this exploratory study, we examine the relationship between HIV viral suppression, STI testing, and STI diagnosis among YWH receiving care at a clinic in the southern United States.Methods: Data from 933 clinical visits (2017-2020) were aggregated into singular patient records for YWH aged 10-24 years in Alabama (N = 139). Analyses included univariate generalized linear mixed models performed with the PROC GLIMMIX procedure approximating the marginal likelihood by using Laplace's method.Results: Sample median age was 22 years at the index visit. Most YWH were 20-24 years old (69.1%), male (67.6%), and identified as Black (77%); 58.3% were virally unsuppressed at index visit. YWH who identified as White or of other races had 4.79 times higher odds of being virally suppressed as compared to Black YWH (p < .01); STI testing behavior and STI positive diagnosis were associated with lower odds of being virally suppression.Conclusions: Findings suggest that among YWH, receiving STI testing and having an STI diagnosis is associated with a lack of viral suppression, suggesting that extra efforts may be necessary to support YWH who have an STI to attain suppression. Research is needed to examine individual behaviors, structural forces, and clinic features that could impact STI care engagement, specifically among unsuppressed YWH.

Physical activity is associated with adiposity in older adults with HIV in the modern HIV era.

OBJECTIVES: People with HIV (PWH) are aging and are experiencing higher rates of abdominal adiposity. Physical activity is an effective nonpharmacological strategy to reduce adiposity in the general aging population. Yet, the relationship between physical activity and adiposity in people with well controlled HIV is unclear. Our objective was to describe the association between objectively-measured physical activity and abdominal adiposity in PWH. METHODS: As part of the multisite, observational PROSPER-HIV study, virologically suppressed, adult PWH wore an Actigraph accelerometer for 7-10 days and completed duplicate waist and hip circumference measures. Demographic and medical characteristics were abstracted from the CFAR Network of Integrated Clinical Systems dataset. Descriptive statistics and multiple linear regressions were used to analyze the data. RESULTS: On average, our 419 PWH were 58 years of age [interquartile range (IQR): 50, 64], male (77%), Black (54%), and currently taking an integrase inhibitor (78%). PWH completed a mean of 7.06 (±2.74) days of total actigraphy wear time. They took an average of 4905 (3233, 7140) steps per day and engaged in 5.4 h of sedentary time per day. Controlling for age, sex, employment and integrase inhibitor use, the number of steps taken per day was associated with reduced abdominal adiposity ( F  = 3.27; P  < 0.001) and the hours of daily sedentary time was associated with increased abdominal adiposity ( F  = 3.24; P  < 0.001). CONCLUSIONS: Greater physical activity is associated with reduced abdominal adiposity in aging PWH. Future work should investigate how to tailor the amount, type and intensity of physical activity needed to reduce adiposity in PWH taking contemporary HIV medication. REGISTRATION NUMBER: NCT03790501.

Development and implementation of a distributed data network between an academic institution and state health departments to investigate variation in time to HIV viral suppression in the Deep South.

BACKGROUND: Achieving early and sustained viral suppression (VS) following diagnosis of HIV infection is critical to improving outcomes for persons with HIV (PWH). The Deep South of the United States (US) is a region that is disproportionately impacted by the domestic HIV epidemic. Time to VS, defined as time from diagnosis to initial VS, is substantially longer in the South than other regions of the US. We describe the development and implementation of a distributed data network between an academic institution and state health departments to investigate variation in time to VS in the Deep South. METHODS: Representatives of state health departments, the Centers for Disease Control and Prevention (CDC), and the academic partner met to establish core objectives and procedures at the beginning of the project. Importantly, this project used the CDC-developed Enhanced HIV/AIDS Reporting System (eHARS) through a distributed data network model that maintained the confidentiality and integrity of the data. Software programs to build datasets and calculate time to VS were written by the academic partner and shared with each public health partner. To develop spatial elements of the eHARS data, health departments geocoded residential addresses of each newly diagnosed individual in eHARS between 2012-2019, supported by the academic partner. Health departments conducted all analyses within their own systems. Aggregate results were combined across states using meta-analysis techniques. Additionally, we created a synthetic eHARS data set for code development and testing. RESULTS: The collaborative structure and distributed data network have allowed us to refine the study questions and analytic plans to conduct investigations into variation in time to VS for both research and public health practice. Additionally, a synthetic eHARS data set has been created and is publicly available for researchers and public health practitioners. CONCLUSIONS: These efforts have leveraged the practice expertise and surveillance data within state health departments and the analytic and methodologic expertise of the academic partner. This study could serve as an illustrative example of effective collaboration between academic institutions and public health agencies and provides resources to facilitate future use of the US HIV surveillance system for research and public health practice.

A Multicomponent Intervention to Train and Support Family Medicine Providers to Promote Pre-exposure Prophylaxis (PrEP) for Adolescent Girls and Young Women in the Deep South: Protocol for the PrEP-Pro Study.

BACKGROUND: Pre-exposure prophylaxis (PrEP) is a highly effective biomedical prevention intervention and a major strategy for reducing the HIV burden in the United States. However, PrEP provision and uptake remain lower than estimated needs, and in ways that may exacerbate HIV disparities among Black adolescent girls and young women in the southern United States. Data suggest that gaps in provider knowledge of HIV epidemiology and PrEP and skills assessing sexual health practices are important barriers to provision and uptake, with limited evidence-based interventions to address these gaps. OBJECTIVE: This paper describes the "PrEP-Pro" intervention, a multicomponent intervention to train and support family medicine (FM) trainees to promote PrEP for adolescent girls and young women in Alabama. METHODS: The PrEP-Pro intervention comprises 3 main components guided by the Capability-Opportunity-Motivation-Behavior (COM-B) model for behavioral change and the Consolidated Framework for Implementation Research (CFIR): (1) provider HIV epidemiology and PrEP education, (2) sexual history taking, and (3) PrEP Champions. In phase 1, we will work with community advisory boards (providers and clients) and then conduct focus groups with FM trainees to adapt content to train FM residents on HIV epidemiology and PrEP and develop implementation strategies, including provider-facing tools and client-facing educational materials. In phase 2, we will pretest and then pilot-test the initially adapted PrEP-Pro intervention with FM trainees. FM trainees will complete baseline, 3-, and 6-month questionnaires post PrEP-Pro intervention. We will also conduct in-depth interviews (IDIs) with FM pilot participants, adolescent girls and young women who accessed care after the PrEP-Pro pilot, and key stakeholders. The primary outcomes are PrEP-Pro acceptability and feasibility, which would be assessed using validated instruments at months 3 (among pretest participants) and 6 (among pilot participants). Secondary outcomes will also be assessed, including PrEP knowledge, sexual history-taking attitudes and practices, PrEP prescriptions among adolescent girls and young women encounters, and sexually transmitted infections (STIs) and HIV testing among adolescent girls and young women encounters in 6 months. RESULTS: Study results will be disseminated to practices, state health officials, and other key stakeholders to solicit feedback on implementation opportunities and challenges to inform a hybrid effectiveness implementation trial. Our results will also be presented at local and national conferences and submitted to peer-reviewed journals. CONCLUSIONS: As PrEP grows, there is a pressing need to train FM providers and develop appropriate, contextually relevant tools to support PrEP implementation. The PrEP-Pro intervention is a multicomponent intervention to train FM residents across Alabama on sexual history-taking, PrEP provision for adolescent girls and young women, and supporting practice-based PrEP Champions. The PrEP-Pro intervention is anticipated to increase PrEP prescriptions for adolescent girls and young women and expand comprehensive sexual and reproductive health care for adolescent girls and young women in rural and urban Alabama. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/44908.

Geospatial Analysis of Time to Human Immunodeficiency Virus (HIV) Diagnosis and Adult HIV Testing Coverage Highlights Areas for Intervention in the US Southeast.

Background: In the United States (US), 44% of people with human immunodeficiency virus (PWH) live in the Southeastern census region; many PWH remain undiagnosed. Novel strategies to inform testing outreach in rural states with dispersed HIV epidemics are needed. Methods: Alabama state public health HIV testing surveillance data from 2013 to 2017 were used to estimate time from infection to HIV diagnosis using CD4 T-cell depletion modeling, mapped to county. Diagnostic HIV tests performed during 2013-2021 by commercial testing entities were used to estimate HIV tests per 100 000 adults (aged 15-65 years), mapped to client ZIP Code Tabulation Area (ZCTA). We then defined testing "cold spots": those with <10% adults tested plus either (1) within or bordering 1 of the 13 counties with HIV prevalence >400 cases per 100 000 population or (2) within a county with average time to diagnosis greater than the state average to inform testing outreach. Results: Time to HIV diagnosis was a median of 3.7 (interquartile range [IQR], 0-9.2) years across Alabama, with a range of 0.06-12.25 years. Approximately 63% of counties (n = 42) had a longer time to diagnosis compared to national US estimates. Six hundred forty-three ZCTAs tested 17.3% (IQR, 10.3%-25.0%) of the adult population from 2013 to 2017. To prioritize areas for testing outreach, we generated maps to describe 47 areas of HIV-testing cold spots at the ZCTA level. Conclusions: Combining public health surveillance with commercial testing data provides a more nuanced understanding of HIV testing gaps in a state with a rural HIV epidemic and identifies areas to prioritize for testing outreach.

Using publicly available data to identify priority communities for a SARS-CoV-2 testing intervention in a southern U.S. state.

Background: The U.S. Southeast has a high burden of SARS-CoV-2 infections and COVID-19 disease. We used public data sources and community engagement to prioritize county selections for a precision population health intervention to promote a SARS-CoV-2 testing intervention in rural Alabama during October 2020 and March 2021. Methods: We modeled factors associated with county-level SARS-CoV-2 percent positivity using covariates thought to associate with SARS-CoV-2 acquisition risk, disease severity, and risk mitigation practices. Descriptive epidemiologic data were presented to scientific and community advisory boards to prioritize counties for a testing intervention. Results: In October 2020, SARS-CoV-2 percent positivity was not associated with any modeled factors. In March 2021, premature death rate (aRR 1.16, 95% CI 1.07, 1.25), percent Black residents (aRR 1.00, 95% CI 1.00, 1.01), preventable hospitalizations (aRR 1.03, 95% CI 1.00, 1.06), and proportion of smokers (aRR 0.231, 95% CI 0.10, 0.55) were associated with average SARS-CoV-2 percent positivity. We then ranked counties based on percent positivity, case fatality, case rates, and number of testing sites using individual variables and factor scores. Top ranking counties identified through factor analysis and univariate associations were provided to community partners who considered ongoing efforts and strength of community partnerships to promote testing to inform intervention. Conclusions: The dynamic nature of SARS-CoV-2 proved challenging for a modelling approach to inform a precision population health intervention at the county level. Epidemiological data allowed for engagement of community stakeholders implementing testing. As data sources and analytic capacities expand, engaging communities in data interpretation is vital to address diseases locally.

Partnership status and retention in care among cisgender heterosexual newly diagnosed people with HIV: a cohort study.

This study examined the role of partnership status (married, unmarried-partnered, and unpartnered) on retention in care among newly diagnosed (2013-2017), cisgender heterosexual people with HIV in Birmingham, Alabama (n = 152). This study evaluated all scheduled HIV primary care provider visits for two years following diagnosis date. A kept-visit measure was calculated such that, if an individual attended ≥1 visit in each of the four 6-month intervals, they were considered to have high visit constancy. A missed-visit measure was categorized as ≥1 no-show vs. 0 no-show for first and second year after diagnosis. Odds ratios (OR) and 95% confidence intervals (CI) were calculated using logistic regression models. Models were adjusted for confounding sociodemographic and clinical characteristics. The study population was 76% Black, 57% male, median age of 37 years. Overall, 65% had high visit consistency and 34.5% had ≥1 no-show in both years. Compared to unpartnered, married individuals had higher visit constancy [AOR (95% CI): 2.88 (1.02, 8.16)]; no differences were observed among unmarried-partnered individuals. No differences in having ≥1 no-show among partnership status groups were observed for either year. These findings suggest potential success of interventions involving a social confidant in optimizing retention in care among newly diagnosed, heterosexual PWH.

Gaps in sexually transmitted infection screening among youth living with HIV in Alabama.

OBJECTIVE: Gaps in sexually transmitted infection (STI) testing can lead to poor health outcomes due to untreated illness among youth living with HIV (YLHIV). Thus, the objective of this study is to examine STI testing behavior and outcomes among a sample of YLHIV in the southern United States. Clinical records of 139 YLHIV who received HIV care in Alabama (2017-2020) were evaluated for receipt of STI testing (gonorrhea, chlamydia, syphilis), prevalence of positive test results, and factors associated with testing outcomes (933 clinical visits). RESULTS: Nearly 80% of our sample identified as African American, most were 20-24 years, and about 60% reported detectable viral load at first visit during the study period. Just under 60% of cisgender male and transgender female clients reported receipt of at least one STI test, compared to less than 40% of cisgender females. Identifying as a cisgender male and having been diagnosed with HIV related to sex with men were associated with greater likelihood receiving STI testing. Cisgender males reported higher rates of positive syphilis test results than cisgender females; the highest rates of positive STI tests were among transgender females. Results underscore need for providers to promote routine STI testing to YLHIV.

Adapting and pilot testing an HIV and intersectional stigma reducing intervention for Dominican Republic healthcare contexts: Protocol for translational research.

Background: This protocol details the adaptation and pilot testing of the Finding Respect and Ending Stigma around HIV (FRESH) intervention in Dominican Republic. FRESH is a healthcare setting stigma-reduction intervention designed to reduce stigmas affecting people living with HIV (PLHIV), focusing on HIV and intersectional stigmas experienced by sexual and gender minority (SGM) people living with HIV. After the successful adaptation of the FRESH intervention, it will be pilot-tested through the conduct of a pilot stepped wedge cluster randomized controlled trial. Methods: Three aims are included in this study; Aim 1 includes exploratory qualitative assessment, specifically the conduct four focus groups with men who have sex with men (MSM) living with HIV (n = 24-32) and in-depth interviews with transgender women living with HIV to explore their experiences with stigma in clinics (n = 9-12). In-depth interviews will also be held with HIV healthcare workers to elucidate their perceptions and behaviors towards their SGM clients (n = 9-12). In Aim 2, informed by Aim 1 data, we will use the sequential phases of the ADAPT-ITT framework to iteratively adapt the FRESH intervention for the Dominican Republic. In Aim 3, the adapted intervention will be pilot-tested via a cluster stepped wedge randomized controlled trial to assess feasibility and acceptability of the intervention and study protocols. Conclusions: If this pilot trial is successful, next steps will include testing the adapted intervention across Dominican Republic or in similar Spanish-speaking Caribbean nations in a larger trial to assess effectiveness in reducing stigma in clinical settings towards PLHIV.

Trends in diabetes incidence and associated risk factors among people with HIV in the current treatment era.

OBJECTIVE: To examine type 2 diabetes mellitus incidence and associated risk factors among people with HIV (PWH). DESIGN: A retrospective clinical cohort study of PWH at a Southeastern US academic HIV clinic between 2008 and 2018. METHODS: PWH who attended at least two clinic visits were evaluated with demographic and clinical data extracted from the electronic medical record (EMR). Diabetes was defined as: hemoglobin A1C ≥6.5% and/or 2 glucose results >200 mg/dl (at least 30 days apart), diagnosis of diabetes in the EMR, or exposure to diabetes medication. Time to diabetes incidence was computed from the entire clinic population for each year. Multivariable Cox proportional hazard regression models with time-dependent covariates were created to evaluate the independent association between covariates and time to incident diabetes. RESULTS: Among 4113 PWH, we identified 252 incident cases of diabetes. Incidence increased from 1.04 incidents per 1000 person years (PY) in 2008, to 1.55 incidents per 1000 PY in 2018. Body mass index (hazard ratio [HR] 10.5 (6.2, 17.7)), liver disease (HR 1.9 (1.2, 3.1)), steroid exposure (HR 1.5 (1.1, 1.9)), and use of integrase inhibitors (HR 1.5 (1.1, 2.0)) were associated with incident diabetes. Additional associated factors included lower CD4 + cell counts, duration of HIV infection, exposure to nonstatin lipid-lowering therapy, and dyslipidemia. CONCLUSIONS: Rapidly increasing incident diabetes rates among PWH were associated with both traditional and HIV-related associated risk factors, particularly body weight, steroid exposure, and use of Integrase Inhibitors. Notably, several of the risk factors identified are modifiable and can be targeted for intervention.

Prevalence and associations of classic psychedelic-related seizures in a population-based sample.

OBJECTIVES: Previous studies have reported links between classic psychedelic use and seizures, but little remains known about prevalence and potential risk factors of classic psychedelic-related seizures. METHODS: Using a sample representative of the US adult population with regard to sex, age, and ethnicity (N = 2822), this study examined the prevalence and potential risk factors of classic psychedelic-related seizures, in a subsample of respondents who reported lifetime classic psychedelic use (n = 613). RESULTS: Among those who reported lifetime classic psychedelic use, 1.5 % reported classic psychedelic-related seizures, a statistic that comports with the prevalence of epilepsy in the US population. Among those who reported seizures while using a classic psychedelic, almost half reported co-use of antidepressants, mood stabilizers, or opioid replacement therapies at the time of the seizures. Notably, classic psychedelic-related seizures were more commonly reported in certain respondents, especially those with a personal or family history of epilepsy. CONCLUSIONS: These results suggest that classic psychedelic use could increase the risk of seizures in certain populations, particularly those with a personal or family history of epilepsy.

Risk Factors for Incident Hypertension Within 1 Year of Initiating Antiretroviral Therapy Among People with HIV.

Hypertension (HTN) is a common comorbidity among people with HIV and associated with an increased risk for atherosclerotic cardiovascular disease and chronic kidney disease. The relationship of antiretroviral therapy (ART) initiation to incident HTN remains a clinical question. We determined HTN incidence at 48 weeks of follow-up among ART-naive participants without HTN and not taking antihypertensive medications at ART initiation through randomized clinical trials through the AIDS Clinical Trial Group between 1999 and 2011. We assessed the association of baseline characteristics, including randomized ART agents with HTN incidence at 48 weeks using Poisson regression models. Incident HTN was defined as blood pressure ≥130/80 mmHg, or use of antihypertensive medication. Among 2,614 participants, mean age was 37 ± 10 years, 79% male sex, and 36% African American race. After 48 weeks, 839 participants (32%) developed HTN. Receiving a non-nucleoside reverse transcriptase inhibitor (NNRTI) was associated with an increased relative risk (RR) of incident HTN, while the risk was lower for protease inhibitor use. Stavudine and efavirenz were associated with an increased RR of developing HTN, while tenofovir disoproxil fumarate, darunavir/ritonavir, and atazanavir/ritonavir were associated with a decreased risk of developing HTN. Additionally, older age, higher body mass index (BMI), and having hepatitis C were associated with an increased risk for developing HTN, while women and participants with a higher baseline CD4 count were at a decreased risk of developing HTN at 48 weeks. One third of these ART naive participants developed HTN after ART initiation. NNRTIs, notably efavirenz, and stavudine were associated with an increased risk of HTN. Additional factors associated with HTN included traditional factors like older age and higher BMI, and advanced HIV disease (lower CD4 count). (Clinicaltrials.gov: NCT00001137).

mHealth Phone Intervention to Reduce Maternal Deaths and Morbidity in Cameroon: Protocol for Translational Adaptation.

Purpose: The purpose of this NIH-funded protocol is to adapt (Aim 1) and pilot test (Aim 2) an mHealth intervention to improve maternal and child health in Cameroon. We will adapt the 24/7 University of Alabama at Birmingham Medical Information Service via Telephone (MIST) provider support system to mMIST (mobile MIST) for peripheral providers who provide healthcare to pregnant and postpartum women and newborns in Cameroon. Methods: In Aim 1, we apply qualitative and participatory methods (in-depth interviews and focus groups with key stakeholders) to inform the adaptation of mMIST for use in Cameroon. We use the sequential phases of the ADAPT-ITT framework to iteratively adapt mMIST incorporating qualitative findings and tailoring for local contexts. In Aim 2, we test the adapted intervention for feasibility and acceptability in Ndop, Cameroon. Results: This study is ongoing at the time that this protocol is published. Conclusion: The adaptation, refinement, and pilot testing of mMIST will be used to inform a larger-scale stepped wedged cluster randomized controlled effectiveness trial. If successful, this mHealth intervention could be a powerful tool enabling providers in low-resource settings to deliver improved pregnancy care, thereby reducing maternal and fetal deaths.

Association between BMI and periodontitis in women living with or at risk for HIV.

AIMS: Currently, there is no data available assessing the association between body mass index (BMI) and periodontitis among women living with HIV (WLWH). This study aims to investigate this association among WLWH and women at risk for HIV (WRH) in the United States. METHODS AND RESULTS: Data from 351 WLWH and 52 WRH participants from the Women's Interagency HIV Study having pocket depths and clinical periodontal attachment loss assessments in 2003-2004 were included. Multinomial logistic regression analyses in the full sample assessed the relationship between BMI (underweight/normal, overweight, or obese) and periodontitis by severity (mild, moderate, severe), adjusting for study sites, age, education, annual household income, smoking, alcohol consumption, and diabetes. Overall, 75.2% women (76.0% WLWH; 69.0% WRH) had periodontitis. Moreover, 75.0% obese and 75.3% overweight women were affected by periodontitis. In the full sample, adjusted odds ratio (aOR) of having mild, moderate, and severe periodontitis in obese women were: 1.14 (95% confidence interval [CI]: 0.51-2.52), 1.02 (95% CI: 0.46-2.29), and 0.24 (95% CI: 0.06-1.07), respectively, and in overweight women: 0.70 (95% CI: 0.31-1.58), 0.85 (95% CI: 0.38-1.90), and 0.31 (95% CI: 0.08-1.15), respectively. CONCLUSIONS: Even with high prevalence of periodontitis among women with or without HIV infection in this cohort, this study does not provide evidence of an association between BMI and periodontitis.

Partnership status and time to viral suppression and sustained viral suppression among newly diagnosed heterosexual people with HIV.

BACKGROUND: Previous studies examining the role of partnership on HIV care outcomes have primarily focused on the men who have sex with men population in the United States, leaving a gap in the literature on this phenomenon among the heterosexual persons with HIV (PWH). This study examined association between partnership around diagnosis (married, unmarried-partnered, and un-partnered) with time to viral suppression (TVS) and sustained viral suppression (SVS) in newly diagnosed heterosexual PWH from a HIV clinic in Birmingham, Alabama. METHODS: TVS [time to first viral load (VL) <200 copies/ml] was measured using VLs from 12 months following diagnosis using Kaplan-Meier and proportional hazard model for interval censoring (n=153) to calculate hazard ratios (HRs) and 95% confidence intervals (CIs). SVS was measured using VLs for 12 months after first VS using logistic regression model (n=137) to calculate odds ratios (ORs) and 95% CIs. Models were adjusted for confounding demographics and clinical characteristics. RESULTS: The study population comprised of 77% Black, 57% male, and 46% aged 31-49 years; 24% were married, 35% unmarried-partnered, and 41% un-partnered. The median TVS (days) was 57 for married, 73 for unmarried-partnered, and 75 for un-partnered. Compared to un-partnered individuals, unmarried-partnered had similar, whereas married had 69% higher [HR (95% CI): 1.69 (1.02, 2.78)] hazard of TVS. Compared to un-partnered, unmarried-partnered and married individuals had similar odds of achieving SVS. CONCLUSION: Married, newly diagnosed, heterosexual PWH had faster TVS than un-partnered individuals suggesting that intimate partners may help achieve HIV care goals.

Mendelian randomization in the multivariate general linear model framework.

Mendelian randomization (MR) is an application of instrumental variable (IV) methods to observational data in which the IV is a genetic variant. MR methods applicable to the general exponential family of distributions are currently not well characterized. We adapt a general linear model framework to the IV setting and propose a general MR method applicable to any full-rank distribution from the exponential family. Empirical bias and coverage are estimated via simulations. The proposed method is compared to several existing MR methods. Real data analyses are performed using data from the REGARDS study to estimate the potential causal effect of smoking frequency on stroke risk in African Americans. In simulations with binary variates and very weak instruments the proposed method had the lowest median [Q1 , Q3 ] bias (0.10 [-3.68 to 3.62]); compared with 2SPS (0.27 [-3.74 to 4.26]) and the Wald method (-0.69 [-1.72 to 0.35]). Low bias was observed throughout other simulation scenarios; as well as more than 90% coverage for the proposed method. In simulations with count variates, the proposed method performed comparably to 2SPS; the Wald method maintained the most consistent low bias; and 2SRI was biased towards the null. Real data analyses find no evidence for a causal effect of smoking frequency on stroke risk. The proposed MR method has low bias and acceptable coverage across a wide range of distributional scenarios and instrument strengths; and provides a more parsimonious framework for asymptotic hypothesis testing compared to existing two-stage procedures.