Obesity Modifies the Relationship Between Raltegravir and Dolutegravir Hair Concentrations and Body Weight Gain in Women Living with HIV.

Integrase strand-transfer inhibitors (INSTIs) are associated with weight gain in women living with HIV (WLH). Relationships between drug exposure, baseline obesity, and INSTI-associated weight gain remain unclear. Data from 2006 to 2016 were analyzed from virally suppressed WLH enrolled in the Women's Interagency HIV Study, who switched/added an INSTI to antiretroviral therapy: [raltegravir (RAL), dolutegravir (DTG), or elvitegravir (EVG)]. Percent body weight change was calculated from weights obtained a median 6 months pre-INSTI and 14 months post-INSTI initiation. Hair concentrations were measured with validated liquid chromatography-mass spectrometry (MS)/MS assays. Baseline (preswitch) weight status evaluated obese (body mass index, BMI, ≥30 kg/m2) versus nonobese (BMI <30 kg/m2). Mixed models examined the drug hair concentration*baseline obesity status interaction for each INSTI. There were 169 WLH included: 53 (31%) switched to RAL, 72 (43%) to DTG, and 44 (26%) to EVG. Women were median age 47-52 years, predominantly Non-Hispanic Black, median CD4 counts >500 cells/mm3, >75% with undetectable HIV-1 RNA. Over ∼1 year, women experienced median increases in body weight: 1.71% (-1.78, 5.00) with RAL; 2.40% (-2.82, 6.50) with EVG; and 2.48% (-3.60, 7.88) with DTG. Baseline obesity status modified the relationship between hair concentrations and percent weight change for DTG and RAL (p's < 0.05): higher DTG, yet lower RAL concentrations were associated with greater weight gain among nonobese women. Additional pharmacologic assessments are needed to understand the role of drug exposure in INSTI-associated weight gain.

Gut microbiota, circulating inflammatory markers and metabolites, and carotid artery atherosclerosis in HIV infection.

BACKGROUND: Alterations in gut microbiota have been implicated in HIV infection and cardiovascular disease. However, how gut microbial alterations relate to host inflammation and metabolite profiles, and their relationships with atherosclerosis, have not been well-studied, especially in the context of HIV infection. Here, we examined associations of gut microbial species and functional components measured by shotgun metagenomics with carotid artery plaque assessed by B-mode carotid artery ultrasound in 320 women with or at high risk of HIV (65% HIV +) from the Women's Interagency HIV Study. We further integrated plaque-associated microbial features with serum proteomics (74 inflammatory markers measured by the proximity extension assay) and plasma metabolomics (378 metabolites measured by liquid chromatography tandem mass spectrometry) in relation to carotid artery plaque in up to 433 women. RESULTS: Fusobacterium nucleatum, a potentially pathogenic bacteria, was positively associated with carotid artery plaque, while five microbial species (Roseburia hominis, Roseburia inulinivorans, Johnsonella ignava, Odoribacter splanchnicus, Clostridium saccharolyticum) were inversely associated with plaque. Results were consistent between women with and without HIV. Fusobacterium nucleatum was positively associated with several serum proteomic inflammatory markers (e.g., CXCL9), and the other plaque-related species were inversely associated with proteomic inflammatory markers (e.g., CX3CL1). These microbial-associated proteomic inflammatory markers were also positively associated with plaque. Associations between bacterial species (especially Fusobacterium nucleatum) and plaque were attenuated after further adjustment for proteomic inflammatory markers. Plaque-associated species were correlated with several plasma metabolites, including the microbial metabolite imidazole-propionate (ImP), which was positively associated with plaque and several pro-inflammatory markers. Further analysis identified additional bacterial species and bacterial hutH gene (encoding enzyme histidine ammonia-lyase in ImP production) associated with plasma ImP levels. A gut microbiota score based on these ImP-associated species was positively associated with plaque and several pro-inflammatory markers. CONCLUSION: Among women living with or at risk of HIV, we identified several gut bacterial species and a microbial metabolite ImP associated with carotid artery atherosclerosis, which might be related to host immune activation and inflammation. Video Abstract.

Cumulative Human Immunodeficiency Virus (HIV)-1 Viremia Is Associated With Increased Risk of Multimorbidity Among US Women With HIV, 1997-2019.

Background: To evaluate the effect of cumulative human immunodeficiency virus (HIV)-1 viremia on aging-related multimorbidity among women with HIV (WWH), we analyzed data collected prospectively among women who achieved viral suppression after antiretroviral therapy (ART) initiation (1997-2019). Methods: We included WWH with ≥2 plasma HIV-1 viral loads (VL) <200 copies/mL within a 2-year period (baseline) following self-reported ART use. Primary outcome was multimorbidity (≥2 nonacquired immune deficiency syndrome comorbidities [NACM] of 5 total assessed). The trapezoidal rule calculated viremia copy-years (VCY) as area-under-the-VL-curve. Cox proportional hazard models estimated the association of time-updated cumulative VCY with incident multimorbidity and with incidence of each NACM, adjusting for important covariates (eg, age, CD4 count, etc). Results: Eight hundred six WWH contributed 6368 women-years, with median 12 (Q1-Q3, 7-23) VL per participant. At baseline, median age was 39 years, 56% were Black, and median CD4 was 534 cells/mm3. Median time-updated cumulative VCY was 5.4 (Q1-Q3, 4.7-6.9) log10 copy-years/mL. Of 211 (26%) WWH who developed multimorbidity, 162 (77%) had incident hypertension, 133 (63%) had dyslipidemia, 60 (28%) had diabetes, 52 (25%) had cardiovascular disease, and 32 (15%) had kidney disease. Compared with WWH who had time-updated cumulative VCY <5 log10, the adjusted hazard ratio of multimorbidity was 1.99 (95% confidence interval [CI], 1.29-3.08) and 3.78 (95% CI, 2.17-6.58) for those with VCY 5-6.9 and ≥7 log10 copy-years/mL, respectively (P < .0001). Higher time-updated cumulative VCY increased the risk of each NACM. Conclusions: Among ART-treated WWH, greater cumulative viremia increased the risk of multimorbidity and of developing each NACM, and hence this may be a prognostically useful biomarker for NACM risk assessment in this population.

The Effect of Menopausal Status, Age, and Human Immunodeficiency Virus (HIV) on Non-AIDS Comorbidity Burden Among US Women.

Menopause may impact the earlier onset of aging-related comorbidities among women with versus without human immunodeficiency virus (HIV). We found that menopausal status, age, and HIV were independently associated with higher comorbidity burden, and that HIV impacted burden most in the pre-/perimenopausal phases.

Longitudinal determinants of anal intercourse among women with, and without HIV in the United States.

BACKGROUND: Anal intercourse (AI) is not uncommon among U.S. women and, when condomless, confers a far greater likelihood of HIV transmission than condomless vaginal intercourse. We aim to identify determinants preceding AI, among women with, and women without HIV. METHODS: 3708 women living with (73%), and without HIV (27%) participating in the Women's Interagency HIV Study provided sexual behavior and other data at 6-monthly visits over a median of 9 years (1994-2014). We used generalized estimating equation models to examine sociodemographic, structural and behavioral determinants reported in the visit preceding (1) AI, and (2) condomless AI. RESULTS: AI was reported at least once over follow-up by 31% of women without, and 21% with HIV. AI was commonly condomless; reported at 76% and 51% of visits among women living without HIV, and with HIV, respectively. Women reporting AI were more likely to be younger (continuous variable, adjusted odds ratio (aOR) = 0.97, 95% confidence interval (CI):0.96-0.98), Hispanic (aOR = 1.88, CI:1.47-2.41) or White (aOR = 1.62, CI:1.15-2.30) compared to Black, and have at least high school education (aOR = 1.33, CI:1.08-1.65). AI was more likely following the reporting of either (aOR = 1.35, CI:1.10-1.62), or both (aOR = 1.77, CI:1.13-2.82) physical and sexual violence, excessive drinking (aOR = 1.27, CI:1.05-1.66) or any drug use (aOR = 1.34, CI:1.09-1.66), multiple male partners (aOR = 2.64, CI:2.23-3.11), exchange sex (aOR = 3.45, CI:2.53-4.71), one or more female sex partners (aOR = 1.32, CI:1.01-1.75), condomless vaginal intercourse (aOR = 1.80, CI:1.53-2.09), and high depressive symptoms (aOR = 1.23, CI:1.08-1.39). CONCLUSION: AI disproportionally follows periods of violence victimization, substance use, multiple sex partners and depression. Better prevention messaging and biomedical interventions that reduce acquisition or transmission risk are needed, but when AI occurs in the context of violence against women, as our findings indicate, focusing on gender-based violence reduction and immediate treatment to reduce HIV transmission risk is important.

Plasma metabolomic analysis indicates flavonoids and sorbic acid are associated with incident diabetes: A nested case-control study among Women's Interagency HIV Study participants.

INTRODUCTION: Lifestyle improvements are key modifiable risk factors for Type 2 diabetes mellitus (DM) however specific influences of biologically active dietary metabolites remain unclear. Our objective was to compare non-targeted plasma metabolomic profiles of women with versus without confirmed incident DM. We focused on three lipid classes (fatty acyls, prenol lipids, polyketides). MATERIALS AND METHODS: Fifty DM cases and 100 individually matched control participants (80% with human immunodeficiency virus [HIV]) were enrolled in a case-control study nested within the Women's Interagency HIV Study. Stored blood samples (1-2 years prior to DM diagnosis among cases; at the corresponding timepoint among matched controls) were assayed in triplicate for metabolomics. Time-of-flight liquid chromatography mass spectrometry with dual electrospray ionization modes was utilized. We considered 743 metabolomic features in a two-stage feature selection approach with conditional logistic regression models that accounted for matching strata. RESULTS: Seven features differed by DM case status (all false discovery rate-adjusted q<0.05). Three flavonoids (two flavanones, one isoflavone) were respectively associated with lower odds of DM (all q<0.05), and sorbic acid was associated with greater odds of DM (all q<0.05). CONCLUSION: Flavonoids were associated with lower odds of incident DM while sorbic acid was associated with greater odds of incident DM.

Gut Microbiota, Plasma Metabolomic Profiles, and Carotid Artery Atherosclerosis in HIV Infection.

BACKGROUND: Alterations in gut microbiota and blood metabolomic profiles have been implicated in HIV infection and cardiovascular disease. However, it remains unclear whether alterations in gut microbiota may contribute to disrupted host blood metabolomic profiles in relation to atherosclerosis, especially in the context of HIV infection. METHODS: We analyzed cross-sectional associations between gut microbiota features and carotid artery plaque in 361 women with or at high risk of HIV (67% HIV+), and further integrated plaque-associated microbial features with plasma lipidomic/metabolomic profiles. Furthermore, in 737 women and men, we examined prospective associations of baseline gut bacteria-associated lipidomic and metabolomic profiles with incident carotid artery plaque over 7-year follow-up. RESULTS: We found 2 potentially pathogenic bacteria, Fusobacterium and Proteus, were associated with carotid artery plaque; while the beneficial butyrate producer Odoribacter was inversely associated with plaque. Fusobacterium and Proteus were associated with multiple lipids/metabolites which were clustered into 8 modules in network. A module comprised of 9 lysophosphatidylcholines and lysophosphatidylethanolamines and a module comprised of 9 diglycerides were associated with increased risk of carotid artery plaque (risk ratio [95% CI], 1.34 [1.09-1.64] and 1.24 [1.02-1.51] per SD increment, respectively). Functional analyses identified bacterial enzymes in lipid metabolism associated with these plasma lipids. In particular, phospholipase A1 and A2 are the key enzymes in the reactions producing lysophosphatidylcholines and lysophosphatidylethanolamines. CONCLUSIONS: Among individuals with or at high risk of HIV infection, we identified altered gut microbiota and related functional capacities in the lipid metabolism associated with disrupted plasma lipidomic profiles and carotid artery atherosclerosis.

Impacts of Medicaid Expansion on Health Insurance and Coverage Transitions among Women with or at Risk for HIV in the United States.

BACKGROUND: As employment, financial status, and residential location change, people can gain, lose, or switch health insurance coverage, which may affect care access and health. Among Women's Interagency HIV Study participants with HIV and participants at risk for HIV attending semiannual visits at 10 U.S. sites, we examined whether the prevalence of coverage types and rates of coverage changes differed by HIV status and Medicaid expansion in their states of residence. METHODS: Geocoded addresses were merged with dates of Medicaid expansion to indicate, at each visit, whether women lived in Medicaid expansion states. Age-adjusted rate ratios (RRs) and rate differences of self-reported insurance changes were estimated by Poisson regression. RESULTS: From 2008 to 2018, 3,341 women (67% Black, 71% with HIV) contributed 43,329 visits at aged less than 65 years (27% under Medicaid expansion). Women with and women without HIV differed in their proportions of visits at which no coverage (14% vs. 19%; p < .001) and Medicaid enrollment (61% vs. 51%; p < .001) were reported. Women in Medicaid expansion states reported no coverage and Medicaid enrollment at 4% and 69% of visits, respectively, compared with 20% and 53% of visits for those in nonexpansion states. Women with HIV had a lower rate of losing coverage than those without HIV (RR, 0.81; 95% confidence interval [CI], 0.70 to 0.95). Compared with nonexpansion, Medicaid expansion was associated with lower coverage loss (RR, 0.62; 95% CI, 0.53 to 0.72) and greater coverage gain (RR, 2.32; 95% CI, 2.02 to 2.67), with no differences by HIV status. CONCLUSIONS: Both women with HIV and women at high risk for HIV in Medicaid expansion states had lower coverage loss and greater coverage gain; therefore, Medicaid expansion throughout the United States should be expected to stabilize insurance for women and improve downstream health outcomes.

Human Immunodeficiency Virus Is Associated With Elevated FibroScan-Aspartate Aminotransferase (FAST) Score.

BACKGROUND: Whether human immunodeficiency virus (HIV) infection is associated with the development of nonalcoholic steatohepatitis (NASH) remains unclear. The FibroScan-aspartate aminotransferase (FAST) score was developed to identify patients who have histologic NASH with high nonalcoholic fatty liver disease activity score (NAS ≥4) and significant liver fibrosis (≥F2), which has been associated with higher risk of end-stage liver disease. We examined whether HIV infection is associated with elevated FAST score in a large United States (US) cohort. METHODS: Vibration-controlled transient elastography was performed in 1309 women without history of chronic viral hepatitis enrolled from 10 US sites: 928 women with HIV (WWH) and 381 women without HIV (WWOH). We used multivariable logistic regression to evaluate associations of HIV, demographic, lifestyle, and metabolic factors with an elevated (>0.35) FAST score. RESULTS: Median age of WWH and WWOH was 51 years and 48 years, respectively. Most (90%) WWH were on antiretroviral therapy and 72% had undetectable HIV RNA. Prevalence of elevated FAST score was higher among WWH compared to WWOH (6.3% vs 1.8%, respectively; P = .001). On multivariable analysis, HIV infection was associated with 3.7-fold higher odds of elevated FAST score (P = .002), and greater waist circumference (per 10 cm) was associated with 1.7-fold higher odds (P < .001). In analysis limited to WWH, undetectable HIV RNA and current protease inhibitor use were independently associated with lower odds of elevated FAST score. CONCLUSIONS: Our findings suggest that HIV is an independent risk factor for NASH with significant activity and fibrosis. Studies validating FAST score in persons with HIV are warranted.

Multisite prospective Liver Disease and Reproductive Ageing (LIVRA) study in US women living with and without HIV.

PURPOSE: The Liver Disease and Reproductive Ageing (LIVRA) study leverages the infrastructure of the decades-long multicentre prospective Women's Interagency HIV Study (WIHS) to examine the contributions of HIV, hepatitis C virus (HCV) and ageing to liver disease progression in women. PARTICIPANTS: From 2013 to 2018, LIVRA enrolled 1576 participants (77 HCV-seropositive only, 248 HIV/HCV-seropositive, 868 HIV-seropositive only and 383 HIV/HCV-seronegative) who underwent vibration controlled transient elastography (VCTE). A VCTE quality assurance programme was established to ensure consistency and accuracy for longitudinal assessment of steatosis (fatty liver) via the controlled attenuation parameter (CAP) and fibrosis via liver stiffness (LS). Demographic, lifestyle factors, anthropometry, clinical and medication history, host genetics, immune markers and hormone levels were collected as part of the WIHS. FINDINGS TO DATE: At baseline, 737 of 1543 women with CAP measurements had steatosis (CAP ≥248 dB/m) and 375 of 1576 women with LS measurements had significant fibrosis (LS ≥7.1 kPa), yielding a prevalence of 48% and 24%, respectively. On multivariable analysis, waist circumference (WC) and insulin resistance were independently associated with higher CAP (17.8 dB/m per 10 cm (95% CI:16.2 to 19.5) and 1.2 dB/m per doubling (95% CI:0.8 to 1.6), respectively). By contrast, HIV/HCV seropositivity and HCV seropositivity alone were associated with less steatosis compared with HIV/HCV-seronegative women, although the latter did not reach statistical significance (-9.2 dB/m (95% CI:-18.2 to -0.3) and -10.4 dB/m (95% CI: -23.8 to 3.1), respectively). Factors independently associated with higher LS were age (4.4% per 10 years (95% CI: 0.4% to 8.4%)), WC (5.0% per 10 cm (95% CI: 3.3% to 6.6%)), CAP steatosis (0.6% per 10 dB/m (95% CI: 0.1% to 1.0%)), HIV/HCV seropositivity (33% (95% CI: 24% to 44%)) and HCV seropositivity alone (43% (95% CI: 28% to 60%)). Excluding scans that were invalid based on traditional criteria for unreliability did not affect the results. FUTURE PLANS: Enrolled women undergo VCTE at 3-year intervals unless LS is ≥9.5 kPa, indicating advanced fibrosis, in which case VCTE is performed annually. Participants also undergo VCTE every 6 months until 18 months after HCV treatment initiation. Analysis of the data collected will provide insights into the impact of ageing/ovarian function, host genetics, immune function and contemporary HIV and HCV treatments on liver disease progression.

Premature and early menopause among US women with or at risk for HIV.

OBJECTIVE: Little is known about the prevalence and treatment of premature and early menopause among people with HIV. We described premature and early menopause and subsequent hormonal treatment in a longitudinal cohort of women living with or at risk for HIV in the US. METHODS: Data from the Women's Interagency HIV Study between 2008 and 2020 were analyzed to describe premature and early menopause among cohort participants under the age of 51. RESULTS: Of 3,059 eligible women during the study period, 1% (n = 35) underwent premature menopause before age 41, 3% (n = 101) underwent menopause between ages 41 and 46, and 21% (n = 442) underwent menopause between ages 46 and 50, inclusive. Of participants who experienced menopause before age 41, between age 41 and 45, and between ages 46 and 50, 51%, 24%, and 7% (respectively) received either menopausal hormone therapy or hormonal contraception. CONCLUSION: These findings suggest that disparities in receipt of recommended hormone therapy for premature and early menopause may contribute, in part, to evident health disparities, such as cardiovascular disease, osteoporosis, and overall mortality. They also suggest a substantial need for education among people experiencing early menopause and their providers, with the goal of improving access to hormone therapy based on guidelines to address health disparities and minimize future health consequences.

Polypharmacy Is Associated With Falls in Women With and Without HIV.

BACKGROUND: Aging in people with HIV is associated with increased risk of developing synergistic conditions such as neurocognitive impairment, polypharmacy, and falls. We assessed associations between polypharmacy (use of 5 or more non-ART medications), use of neurocognitive adverse effects (NCAE) medications, and odds of falls in women with HIV (WWH) and without HIV (HIV-). METHODS: Self-reported falls and medication use data were contributed semiannually by 1872 (1315 WWH and 557 HIV-) Women's Interagency HIV Study participants between 2014 and 2016. Polypharmacy and NCAE medication use were evaluated separately and jointly in multivariable models to assess their independent contributions to single and multiple falls risk. RESULTS: The proportion of women who reported any fall was similar by HIV status (19%). WWH reported both greater polypharmacy (51% vs. 41%; P < 0.001) and NCAE medication use (44% vs. 37%; P = 0.01) than HIV- women. Polypharmacy conferred elevated odds of single fall [adjusted odds ratio (aOR) 1.67, 95% CI: 1.36 to 2.06; P < 0.001] and multiple falls (aOR 2.31, 95% CI: 1.83 to 2.93; P < 0.001); the results for NCAE medications and falls were similar. Both polypharmacy and number of NCAE medications remained strongly and independently associated with falls in multivariable models adjusted for HIV serostatus, study site, sociodemographics, clinical characteristics, and substance use. CONCLUSIONS: Polypharmacy and NCAE medication use were greater among WWH compared with HIV-, and both were independently and incrementally related to falls. Deprescribing and avoidance of medications with NCAEs may be an important consideration for reducing fall risk among WWH and sociodemographically similar women without HIV.

The Association Between HIV Status, Estradiol, and Sex Hormone Binding Globulin Among Premenopausal Women in the Women's Interagency HIV Study.

Background: Characterizing estradiol among women with HIV may have implications for breast cancer and cardiovascular disease risk but has not been adequately explored. We quantified differences in total (E2), free (FE2) estradiol, and sex hormone binding globulin (SHBG) by HIV and viral suppression status. Methods: Women from a substudy (2003-2006) within the Women's Interagency HIV Study (IRB approved at each participating site) were included if they reported: a period in the last six months, were not pregnant/breastfeeding, no oophorectomy, and no exogenous hormone use in the prior year. Serum was collected on days 2-4 of the menstrual cycle. We assessed differences in biomarkers at 25th, 50th, and 75th percentiles by HIV and viral suppression status using weighted quantile regression. Results: Among 643 women (68% with HIV) median age was 37 years. All E2 percentiles were significantly (p < 0.05) lower in women with suppressed viral load versus women without HIV (4-10 pg/mL). The 25th and 50th percentile of E2 were 4-5 pg/mL lower in women with unsuppressed viral load compared to women without HIV (p < 0.05). The 25th and 50th percentile of SHBG was significantly higher in women with unsuppressed viral load compared to women without HIV (10 and 12 nmol/L, respectively). There were no consistent differences in estradiol or SHBG by suppression status. Conclusions: There were no differences in FE2 but significantly lower E2 and higher SHBG among women with HIV versus without HIV. Further research is merited in a large contemporary sample to clarify the clinical implications of these findings.

Long-Acting Injectable ART and PrEP Among Women in Six Cities Across the United States: A Qualitative Analysis of Who Would Benefit the Most.

Long-acting injectable (LAI) modalities have been developed for ART and PrEP. Women face unique barriers to LAI use yet little research has examined women's perceptions of potential LAI HIV therapy candidates. We conducted 89 in-depth interviews at six Women's Interagency HIV Study (WIHS) sites with women living with HIV (n = 59) and HIV-negative women (n = 30) from 2017 to 2018. Interviews were recorded, transcribed, and analyzed using thematic content analysis. Participants identified specific sub-populations who could most benefit from LAI over daily pills: (1) young people; (2) women with childcare responsibilities; (3) people with adherence-related psychological distress; (4) individuals with multiple sex partners; and (5) people facing structural insecurities such as homelessness. Women are underserved by current HIV care options and their perspectives are imperative to ensure a successful scale-up of LAI PrEP and LAI ART that prioritizes equitable access and benefit for all individuals.

Trends in Bacterial Vaginosis Prevalence in a Cohort of U.S. Women with and at Risk for HIV.

Background: Women with human immunodeficiency virus (HIV) often have bacterial vaginosis (BV). The goal of this analysis was to assess how BV prevalence changed over time and across U.S. regions in enrollment cohorts of the Women's Interagency HIV Study. Methods: In a multisite study, BV was diagnosed retrospectively when pH and two of three other Amsel criteria were met. Prevalence was determined across four recruitment waves: 1994-5, 2001-2, 2011-2, and 2013-5. Generalized estimating equation multivariable logistic regression models assessed changes in visit prevalence across waves after controlling for HIV disease severity and other risks. Results: Among 4,790 women (3,539 with HIV and 1,251 without HIV), BV was diagnosed at 7,870 (12%) of 64,444 visits. Baseline prevalence across enrollment waves was 15.0%-19.2%, but declined in all cohorts, with prevalence in the initial cohort falling to 3.9% in the 1994-5 cohort after up to 21 years of continuous observation. Prevalence varied within U.S. regions. HIV status was not associated with BV. Conclusion: BV prevalence decreased with time in study. Prevalence varied across sites, but was not uniformly increased or decreased in any U.S. region. Clinical Trials.gov identifier: NCT00000797.

Socioeconomic, Psychosocial, and Clinical Factors Associated With Employment in Women With HIV in the United States: A Correlational Study.

ABSTRACT: Employment is a social determinant of health, and women living with HIV (WLWH) are often underemployed. This correlational study examined the socioeconomic, psychosocial, and clinical factors associated with employment among WLWH (n = 1,357) and women at risk for HIV (n = 560). Descriptive and inferential statistics were used to evaluate factors associated with employment status. Employment was associated (p ≤ .05) with better socioeconomic status and quality of life (QOL), less tobacco and substance use, and better physical, psychological, and cognitive health. Among WLWH, employment was associated (p ≤ .05) with improved adherence to HIV care visits and HIV RNA viral suppression. Using multivariable regression modeling, differences were found between WLWH and women at risk for HIV. Among WLWH, household income, QOL, education, and time providing childcare remained associated with employment in adjusted multivariable analyses (R2 = .272, p < .001). A better understanding of the psychosocial and structural factors affecting employment is needed to reduce occupational disparities among WLWH.

Study of Treatment and Reproductive Outcomes Among Reproductive-Age Women With HIV Infection in the Southern United States: Protocol for a Longitudinal Cohort Study.

BACKGROUND: Nearly a quarter of the 1.1 million individuals with HIV in the United States are women. Racial and ethnic minority women in the Southern United States are disproportionately impacted. Reproductive-age women with HIV are prone to poor HIV outcomes but remain underrepresented in HIV research. We will answer contemporary questions related to the health outcomes in this population by enrolling a prospective cohort of reproductive-age women with and without HIV in the Southern United States. OBJECTIVE: The Study of Treatment and Reproductive Outcomes (STAR) will enroll and retain 2000 reproductive-age women with and without HIV. The STAR will leverage the infrastructure of the US-based Multicenter AIDS Cohort Study (MACS)/Women's Interagency HIV Study (WIHS) Combined Cohort Study, comprising the WIHS (a cohort of women with and at risk for HIV, which began in 1993), and the MACS (a cohort of gay and bisexual men with and at risk for HIV, which began in 1984). Although the advancing age of the participants enrolled in the MACS/WIHS Combined Cohort Study provides an opportunity to address the questions related to HIV and aging, the research questions pertinent to the reproductive years must also be addressed. The STAR will conduct high-priority scientific research in key areas with the overall aim of addressing the unique needs of reproductive-age women with HIV. METHODS: The STAR is a prospective, observational cohort study that will be conducted at 6 sites in the United States-Atlanta, Georgia; Birmingham, Alabama; Jackson, Mississippi; Chapel Hill, North Carolina; Miami, Florida; and Washington, District of Columbia. Visits will occur semiannually for 2 years, with additional visits for up to 5 years. At each visit, the participating women will complete a structured interview for collecting key demographic, psychosocial, and clinical variables, and undergo biospecimen collection for laboratory testing and repositing (blood, urine, hair, vaginal, anal, and oral specimens). Pregnant women and infants will undergo additional study assessments. The initial scientific focus of the STAR is to understand the roles of key social determinants of health, depression, reproductive health, and oral health on HIV and pregnancy outcomes across the reproductive life span. RESULTS: Enrollment in the STAR commenced in February 2021 and is ongoing. CONCLUSIONS: Through in-depth, longitudinal data and biospecimen collection, the newly initiated STAR cohort will create a platform to answer scientific questions regarding reproductive-age women with and without HIV. STAR will be uniquely positioned to enable investigators to conduct high-impact research relevant to this population. Building on the legacy of the MACS and WIHS cohorts, the STAR is designed to foster multidisciplinary collaborations to galvanize scientific discoveries to improve the health of reproductive-age women with HIV and ameliorate the effects of the HIV epidemic in this population in the United States.

Poverty, Deprivation, and Mortality Risk Among Women With HIV in the United States.

BACKGROUND: Prior studies suggest neighborhood poverty and deprivation are associated with adverse health outcomes including death, but evidence is limited among persons with HIV, particularly women. We estimated changes in mortality risk from improvement in three measures of area-level socioeconomic context among participants of the Women's Interagency HIV Study. METHODS: Starting in October 2013, we linked geocoded residential census block groups to the 2015 Area Deprivation Index (ADI) and two 2012-2016 American Community Survey poverty variables, categorized into national tertiles. We used parametric g-computation to estimate, through March 2018, impacts on mortality of improving each income or poverty measure by one and two tertiles maximum versus no improvement. RESULTS: Of 1596 women with HIV (median age 49), 91 (5.7%) were lost to follow-up and 83 (5.2%) died. Most women (62%) lived in a block group in the tertile with the highest proportions of individuals with income:poverty <1; 13% lived in areas in the tertile with the lowest proportions. Mortality risk differences comparing a one-tertile improvement (for those in the two highest poverty tertiles) in income:poverty <1 versus no improvement increased over time; the risk difference was -2.2% (95% confidence interval [CI] = -3.7, -0.64) at 4 years. Estimates from family income below poverty level (-1.0%; 95% CI = -2.7, 0.62) and ADI (-1.5%; 95% CI = -2.8, -0.21) exposures were similar. CONCLUSIONS: Consistent results from three distinct measures of area-level socioeconomic environment support the hypothesis that interventions to ameliorate neighborhood poverty or deprivation reduce mortality risk for US women with HIV. See video abstract at, http://links.lww.com/EDE/B863.

Evaluation of the Abbott ARCHITECT HIV Ag/Ab combo assay for determining recent HIV-1 infection.

BACKGROUND: Given the challenges and costs associated with implementing HIV-1 incidence assay testing, there is great interest in evaluating the use of commercial HIV diagnostic tests for determining recent HIV infection. A diagnostic test with the capability of providing reliable data for the determination of recent HIV infection without substantial modifications to the test protocol would have a significant impact on HIV surveillance. The Abbott ARCHITECT HIV Ag/Ab Combo Assay is an antigen/antibody immunoassay, which meets the criteria as the first screening test in the recommended HIV laboratory diagnostic algorithm for the United States. METHODS: In this study, we evaluated the performance characteristics of the ARCHITECT HIV Ag/Ab Combo signal-to-cutoff ratio (S/Co) for determining recent infection, including estimation of the mean duration of recent infection (MDRI) and false recent rate (FRR), and selection of recency cutoffs. RESULTS: The MDRI estimates for the S/Co recency cutoff of 400 is within the 4 to 12 months range recommended for HIV incidence assays, and the FRR rate for this cutoff was 1.5%. Additionally, ARCHITECT Combo S/Co values were compared relative to diagnostic test results from two prior prospective HIV-1 diagnostic studies in order to validate the use of the S/Co for both diagnostic and recency determination. CONCLUSION: Dual-use of the ARCHITECT Combo assay data for diagnostic and incidence purposes would reduce the need for separate HIV incidence testing and allow for monitoring of recent infection for incidence estimation and other public health applications.

Food insecurity and frailty among women with and without HIV in the United States: a cross-sectional analysis.

INTRODUCTION: Frailty is frequently observed among people with HIV, and food insecurity is associated with frailty in the general population. Evidence is scarce on the associations between food insecurity and frailty among women with HIV who may be particularly vulnerable to the impacts of food insecurity. The goal of this study was to assess associations between food insecurity and frailty among women with and without HIV. METHODS: There were 1265 participants from the Women's Interagency HIV Study who participated in frailty assessments in 2017. Frailty was measured using the Fried Frailty Phenotype, and women were subsequently categorized as robust, pre-frail or frail. Food insecurity was assessed using the U.S. Household Food Security Survey Module, with women categorized as having high, marginal, low or very low food security. Multinomial logistic regression models were conducted to examine cross-sectional associations between food insecurity and frailty while adjusting for socio-demographic, behavioural and HIV status covariates. RESULTS AND DISCUSSION: Approximately one-third (31.9%) of the women had marginal, low or very low food security, and the proportions of women who met the criteria for frailty or pre-frailty were 55.6% and 12.4% respectively. In the adjusted model, the relative risk ratio (RRR) of frailty for women with very low food security versus women with high food security was 3.37 (95% CI [1.38 to 8.24], p < 0.01); the corresponding RRR of pre-frailty was 3.63 (95% CI [1.76 to 7.51], p < 0.001). Higher annual household income was associated with lower RRRs of frailty or pre-frailty (p < 0.01). Similarly, older age was associated with more frequent frailty (RRR=1.06, 95% CI [1.03 to 1.09], p < 0.001). HIV serostatus was not significantly associated with either pre-frailty (RRR=0.97, 95% CI [0.71 to 1.31]) or frailty (RRR=0.75, 95% CI [0.48 to 1.16]). CONCLUSIONS: Very low food security was associated with more frequent frailty and pre-frailty among women with and without for HIV. HIV serostatus was not associated with frailty.