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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., Competing Interests: Potential conflicts of interest. A. A. A. reports funding for research provided to their institution from Merck and Gilead; consulting fees paid to the author from Merck and Gilead; a role as a member of the Infectious Diseases Society Board of Directors and as a member of International AIDS Society Governing Council. K. A. reports 3 grants from the National Institutes of Health (NIH) paid to their institution and unrelated to this work; support attending meetings and/or travel in the form of grants paid to their institution from the NIH. M.-C. K. reports support unrelated to this work from the NIH and paid to their institution. S. K. reports support unrelated to this work from the NIH and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Integritas Communications. M. A. F. reports support unrelated to this work from the NHLBI NIH. S. N. reports payments to their institution unrelated to this work from Gilead Sciences and AbbVie Pharmaceuticals; consulting fees paid to the author from Pardes Biosciences, Theratechnologies, and Silverback Therapeutics; participation on an Advisory Board for Vir Biotechnology, a Data Safety and Monitoring Board (DSMB) for Personal Health Insights, Inc, and an Event Adjudication Committee for Bristol-Myers Squibb/PRA; and 2866 stocks with options up to 5500 from Vir Biotechnology. I. O. reports grants or contracts from Merck unrelated to this work for Study 022 and Study 024 and a $4500 payment made to the author for consulting from Accordant (a CVS Caremark Company). F. J. P. reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from ViiV, Gilead, Merck, and Janssen. P. C. T. reports grants or contracts unrelated to this work and paid to their institution from Merck. T. N. T. reports the following grants unrelated to this manuscript: Public Health Solutions (PHS) 21-BHO-364 Building Equity: Intervening Together for Health (BE InTo Health) for Black and/or Hispanic/Latino Older People with HIV (ages 50 and older) (project focuses on geriatric assessments in primary HIV care; sexual health is a minor focus; author is project director) and a PRIDE Special Research Project (SRP) award (R25HL105444-09; G. Jean-Louis, Principal Investigator [PI]) Adapting Cognitive Behavioral Therapy for Menopause-Associated Insomnia (CBT-MI) for Peri- and Post-menopausal Women with HIV (adapt and tailor CBT-MI for women with HIV with complex health needs and pilot test the feasibility of implementing this intervention within a primary HIV care setting; the author is PI). T. N. T. also reports consulting fees as a Qualitative Data Consultant for Dr. Anjali Sharma at Albert Einstein College of Medicine (project focuses on older adults with HIV and sexual health is a focus). All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

BackgroundThe syndemic of HIV, substance use (SU), and mental illness has serious implications for HIV disease progression among women. We described co-utilization of HIV care, SU treatment, and mental health treatment among women with or at risk for HIV.MethodsWe included data from women with or at risk for HIV (n = 2559) enrolled in all 10 sites of the Women's Interagency HIV Study (WIHS) from 2013 to 2020. Current SU was defined as self-reported, non-medical use of drugs in the past year, excluding use of only marijuana. Tobacco and alcohol were assessed separately. We described co-utilization of SU treatment, tobacco and alcohol use treatment, HIV care, and mental health care in the past year among women who were eligible for each service. We compared service utilization by those who did/did not utilize SU treatment using Wald Chi-square tests.ResultsAmong women with current SU (n = 358), 42% reported utilizing SU treatment. Among those with current SU+HIV (n = 224), 84% saw their HIV provider, and 34% saw a mental health provider. Among women with current SU+heavy alcohol use (n = 95), 18% utilized alcohol use treatment; among current SU+tobacco use (n = 276), 8% utilized tobacco use treatment. Women who utilized SU treatment had higher utilization of alcohol use treatment (59% vs. 5%; P

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 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

BackgroundSubstance use (SU) contributes to poor health outcomes, yet limited data exist to inform strategies to optimize SU treatment among persons with human immunodeficiency virus (HIV). We describe SU and SU treatment utilization among women with and without HIV in the Women's Interagency HIV Study (WIHS).MethodsWe included data from women enrolled in WIHS from 2013 to 2020. Current SU was self-reported, nonmedical use of drugs in the past year, excluding use of only marijuana. SU treatment utilization was self-reported use of a drug treatment program in the past year. Multivariable regression models were used to investigate associations between participant characteristics and SU treatment.ResultsAmong 2559 women (1802 women living with HIV [WWH], 757 women without HIV), 14% reported current SU. Among those with current SU (n = 367), 71% reported crack/cocaine followed by 40% reporting opioids, and 42% reported any treatment in the past year. The most common treatments were methadone (64%), Narcotics Anonymous (29%), inpatient programs (28%), and outpatient programs (16%). Among women using opioids (n = 147), 67% reported methadone use in the past year compared to 5% using buprenorphine/naloxone. Multivariable analysis showed lower odds of treatment utilization among WWH with concurrent alcohol or marijuana use. Visiting a psychiatrist/counselor was associated with higher odds of treatment. Among WWH, SU treatment was not associated with HIV-related clinical outcomes.ConclusionsTreatment utilization was high, especially for methadone use. Our results highlight opportunities for accessing SU treatment for WWH, such as the need to prioritize buprenorphine and comprehensive, wraparound services in HIV care settings.

ObjectiveAlterations in glucocorticoid receptor (GCR) function may be a risk factor for cognitive complications among older people with human immunodeficiency virus (HIV). We evaluated whether HIV serostatus and age modify the GCR function-cognition association among women.MethodsEighty women with HIV ( n = 40, 50 years of age [older]) and 80 HIV-uninfected women ( n = 40 older, n = 40 younger) enrolled in the Women's Interagency HIV Study completed a comprehensive neuropsychological test battery. Peripheral blood mononuclear cells collected concurrent with neuropsychological testing were assessed for GCR function. Multivariable linear regression analyses were conducted to examine whether a) HIV serostatus and age were associated with GCR function, and b) GCR function-cognition associations are moderated by HIV serostatus and age adjusting for relevant covariates.ResultsAmong older women, higher baseline FKBP5 expression level was associated with lower attention/working memory performance among women with HIV ( B = 6.4, standard error = 1.7, p = .0003) but not in women without HIV infection ( B = -1.7, standard error = 1.9, p = .37). There were no significant HIV serostatus by age interactions on dexamethasone (DEX)-stimulated expression of the genes regulated by the GCR or lipopolysaccharide-stimulated tumor necrosis factor α levels (with or without DEX stimulation; p values > .13). HIV serostatus was associated with GC target genes PER1 ( p = .006) and DUSP1 ( p = .02), but not TSC22D3 ( p = .32), after DEX stimulation.ConclusionsCollectively, these data suggest that HIV serostatus and age may modify the influence of the GCR, such that the receptor is likely engaged to a similar extent, but the downstream influence of the receptor is altered, potentially through epigenetic modification of target genes.

BackgroundIntegrase strand transfer inhibitors (INSTIs) have been associated with weight gain among women living with HIV. We aimed to investigate the association between INSTIs and change in cardiometabolic risk indicators.SettingRetrospective cohort.MethodsData from 2006 to 2017 were analyzed from women living with HIV enrolled in the longitudinal Women's Interagency HIV Study who were virally controlled on antiretroviral therapy (ART) for ≥5 consecutive semiannual visits. Women who switched/added an INSTI to ART (INSTI group) were compared with women who remained on non-INSTI ART (non-INSTI group). Outcomes included changes in fasting lipids and glucose, hemoglobin A1c (HbA1c), blood pressure (BP), and incident diabetes, hypertension, and insulin resistance. Outcomes were measured 6-12 months before and 6-18 months after INSTI switch/add in the INSTI group with comparable visits in the non-INSTI group. Longitudinal linear regression models compared change over time in each outcome by the study group.ResultsOne thousand one hundred eighteen participants (234 INSTI, 884 non-INSTI) were followed for a median 2.0 (Q1 1.9, Q3 2.0) years. Participants were median age 49 years, 61% Black, and 73% overweight or obese (body mass index ≥25 kg/m). Compared with non-INSTI, the INSTI group experienced greater increases in HbA1c (+0.05 vs. -0.06 mg/dL, P = 0.0318), systolic BP (+3.84 vs. +0.84 mm Hg, P = 0.0191), and diastolic BP (+1.62 vs. -0.14 mm Hg, P = 0.0121), with greatest change in HbA1c among women on INSTIs with ≥5% weight gain.ConclusionsINSTI use was associated with unfavorable changes in HbA1c and systolic and diastolic BP during short-term follow-up. Further research is needed to understand long-term cardiometabolic effects of INSTI use.

ObjectiveHIV is a cardiovascular disease (CVD) risk factor. However, CVD risk is often underestimated in HIV-infected women. C-reactive protein (CRP) may improve CVD prediction in this population. We examined the association of baseline plasma CRP with subclinical CVD in women with and without HIV.DesignRetrospective cohort study.MethodsA total of 572 HIV-infected and 211 HIV-uninfected women enrolled in the Women's Interagency HIV Study underwent serial high-resolution B-mode carotid artery ultrasonography between 2004 and 2013 to assess carotid intima-media thickness (CIMT) and focal carotid artery plaques. We used multivariable linear and logistic regression models to assess the association of baseline high (≥3 mg/l) high-sensitivity (hs) CRP with baseline CIMT and focal plaques, and used multivariable linear and Poisson regression models for the associations of high hsCRP with CIMT change and focal plaque progression. We stratified our analyses by HIV status.ResultsMedian (interquartile range) hsCRP was 2.2 mg/l (0.8-5.3) in HIV-infected, and 3.2 mg/l (0.9-7.7) in HIV-uninfected, women (P = 0.005). There was no statistically significant association of hsCRP with baseline CIMT [adjusted mean difference -3.5 μm (95% confidence interval:-19.0 to 12.1)] or focal plaques [adjusted odds ratio: 1.31 (0.67-2.67)], and no statistically significant association of hsCRP with CIMT change [adjusted mean difference 11.4 μm (-2.3 to 25.1)]. However, hsCRP at least 3 mg/l was positively associated with focal plaque progression in HIV-uninfected [adjusted rate ratio: 5.97 (1.46-24.43)], but not in HIV-infected [adjusted rate ratio: 0.81 (0.47-1.42)] women (P = 0.042 for interaction).ConclusionIn our cohort of women with similar CVD risk factors, higher baseline hsCRP is positively associated with carotid plaque progression in HIV-uninfected, but not HIV-infected, women, suggesting that subclinical CVD pathogenesis may be different HIV-infected women.

Background: The syndemic of HIV, substance use (SU), and mental illness has serious implications for HIV disease progression among women. We described co-utilization of HIV care, SU treatment, and mental health treatment among women with or at risk for HIV. Methods: We included data from women with or at risk for HIV (n = 2559) enrolled in all 10 sites of the Women's Interagency HIV Study (WIHS) from 2013 to 2020. Current SU was defined as self-reported, non-medical use of drugs in the past year, excluding use of only marijuana. Tobacco and alcohol were assessed separately. We described co-utilization of SU treatment, tobacco and alcohol use treatment, HIV care, and mental health care in the past year among women who were eligible for each service. We compared service utilization by those who did/did not utilize SU treatment using Wald Chi-square tests. Results: Among women with current SU (n = 358), 42% reported utilizing SU treatment. Among those with current SU+HIV (n = 224), 84% saw their HIV provider, and 34% saw a mental health provider. Among women with current SU+heavy alcohol use (n = 95), 18% utilized alcohol use treatment; among current SU+tobacco use (n = 276), 8% utilized tobacco use treatment. Women who utilized SU treatment had higher utilization of alcohol use treatment (59% vs. 5%; P <.001) and tobacco use treatment (12% vs. 5%; P =.028). HIV care engagement was high regardless of SU treatment. Conclusions: We found high engagement in SU and HIV care, but low engagement in alcohol and tobacco use treatment. Integrated SU treatment services for women, including tobacco/alcohol treatment and harm reduction, are needed to optimize treatment engagement and HIV care continuum outcomes. [ABSTRACT FROM AUTHOR]

Purpose: We describe the rationale for and design of an innovative, nested, tripartite prospective observational cohort study examining whether relative estrogen insufficiency-induced inflammation amplifies HIV-induced inflammation to cause end organ damage and worsen age-related co-morbidities affecting the neuro-hypothalamic-pituitary-adrenal axis (Brain), skeletal (Bone), and cardiovascular (Heart/vessels) organ systems (BBH Study). Methods: The BBH parent study is the Multicenter AIDS Cohort/Women's Interagency HIV Study Combined Cohort Study (MWCCS) with participants drawn from the Atlanta MWCCS site. BBH will enroll a single cohort of n = 120 women living with HIV and n = 60 HIV-negative women, equally distributed by menopausal status. The innovative multipart nested study design of BBH, which draws on data collected by the parent study, efficiently leverages resources for maximum research impact and requires extensive oversight and management in addition to careful implementation. The presence of strong infrastructure minimized BBH study disruptions due to changes in the parent study and the COVID-19 pandemic. Conclusion: BBH is poised to provide insight into sex and HIV associations with the neuro-hypothalamic-pituitary-adrenal axis, skeletal, and cardiovascular systems despite several major, unexpected challenges. [ABSTRACT FROM AUTHOR]

Background Anal cancer rates have increased, particularly in human immunodeficiency virus (HIV)–infected (HIV+) women. We assessed factors associated with anal precancer in HIV+ and at-risk HIV-negative women from the Atlanta Women's Interagency HIV Study cohort. Methods All participants underwent high-resolution anoscopy and anal cytology and had anal and cervical samples collected. Specimens were tested for 37 human papillomavirus (HPV) types and for FAM19A4 and microRNA124-2 promoter methylation. Binary logistic regression and multivariate analysis were conducted with histologic anal high-grade squamous intraepithelial lesion (A-HSIL) as the dependent variable. Results Seventy-five women were enrolled: 52 (69%) were HIV+ with three-fourths having undetectable viral load; 64 (86%) were black; mean age was 49 ± 8 years. Forty-nine (65%) anal cytology samples were abnormal, and 38 (51%) of anal samples were positive for at least 1 of 13 high-risk HPV (hrHPV) types. Thirteen (18%) anal biopsies identified A-HSIL. Hypermethylation of FAM19A4 and/or microRNA124-2 was found in 69 (95%) anal samples and 19 (26%) cervical samples. In multivariate analyses, the odds of having A-HSIL were >6 times higher in women with anal hrHPV (adjusted odds ratio [aOR], 6.08 [95% confidence interval {CI}, 1.27–29.18], P =.02) and with positive cervical methylation (aOR, 6.49 [95% CI, 1.66–25.35], P =.007), but not significantly higher in women with positive anal methylation. Conclusions Anal hrHPV and promoter hypermethylation in the cervix show promise as biomarkers for anal cancer screening in HIV+ and at-risk HIV-negative women. Greater understanding of gene silencing by promoter hypermethylation in anal carcinogenesis is needed. [ABSTRACT FROM AUTHOR]

Condoms are highly effective for HIV prevention, yet are not currently indicated by the US Food and Drug Administration (FDA) for anal sex. We surveyed a national sample of men who have sex with men to assess whether FDA label indication could affect anticipated condom use, and to determine levels of perceived condom failure for anal sex. We found that 69% of respondents anticipated that a label indication change would increase their likelihood of condom use. Median perceived failure was 15%. We anticipate that these results may aid the FDA in developing standards for a label indication for anal sex. [ABSTRACT FROM AUTHOR]

Highlights • Depressive symptoms associated with elevated baseline expression of Fkbp5 and Nr3c1. • HIV serostatus associated with elevated baseline expression of Fkbp5 and Nr3c1. • Depressive symptoms associated with reduced LPS-induced release of IL-6 and TNF-α. Abstract Chronic inflammation caused by HIV infection may lead to deficient glucocorticoid (GC) signaling predisposing people living with HIV to depression and other psychiatric disorders linked to GC resistance. We hypothesized that comorbid HIV and depressive symptoms in women would synergistically associate with deficits in GC signaling. This cross-sectional study used samples obtained from the Women’s Interagency HIV Study (WIHS). The Centers for Epidemiological Studies (CES-D) was used to define depression in four groups of women from the Women’s Interagency HIV Study (WIHS): 1) HIV-negative, non-depressed (n = 37); 2) HIV-negative, depressed (n = 34); 3) HIV-positive, non-depressed (n = 38); and 4) HIV-positive, depressed (n = 38). To assess changes in GC signaling from peripheral blood mononuclear cells (PBMCs), we examined baseline and dexamethasone (Dex)-stimulated changes in the expression of the GC receptor (GR, gene: Nr3c1) and its negative regulator Fkbp5 via quantitative RT-PCR. GR sensitivity was evaluated in vitro by assessing the Dex inhibition of lipopolysaccharide (LPS)-stimulated IL-6 and TNF-α levels. Depressive symptoms and HIV serostatus were independently associated with elevated baseline expression of Fkbp5 and Nr3c1. Depressive symptoms, but not HIV status, was independently associated with reduced LPS-induced release of IL-6. Counter to predictions, there was no interactive association of depressive symptoms and HIV on any outcome. Comorbid depressive symptoms with HIV infection were associated with a gene expression and cytokine profile similar to that of healthy control women, a finding that may indicate further disruptions in disease adaptation. [ABSTRACT FROM AUTHOR]

Background: Understanding the immune profile of CD4 T cells, the primary targets for HIV, in the female genital tract (FGT) is critical for evaluating and developing effective biomedical HIV prevention strategies in women. However, longitudinal investigation of HIV susceptibility markers expressed by FGT CD4 T cells has been hindered by low cellular yield and risk of sampling-associated trauma. We investigated three minimally invasive FGT sampling methods to characterize and compare CD4 T cell yield and phenotype with the goal of establishing feasible sampling strategies for immune profiling of mucosal CD4 T cells. Methods and results: FGT samples were collected bimonthly from 12 healthy HIV negative women of reproductive age in the following order: 1) Cervicovaginal lavage (CVL), 2) two sequential endocervical flocked swabs (FS), and 3) two sequential endocervical cytobrushes (CB1, CB2). Cells were isolated and phentoyped via flow cytometry. CD4 T cell recovery was highest from each individual CB compared to either CVL or FS (p < 0.0001). The majority of CD4 T cells within the FGT, regardless of sampling method, expressed CCR5 relative to peripheral blood (p < 0.01). Within the CB, CCR5+ CD4 T cells expressed significantly higher levels of α4β7, CD69, and low levels of CD27 relative to CCR5- CD4 T cells (all p < 0.001). We also identified CD4 Treg lineage cells expressing CCR5 among CB samples. Conclusions: Using three different mucosal sampling methods collected longitudinally we demonstrate that CD4 T cells within the FGT express CCR5 and α4β7 and are highly activated, attributes which could act in concert to facilitate HIV acquisition. FS and CB sampling methods can allow for investigation of strategies to reduce HIV target cells in the FGT and could inform the design and interpretation microbicide and vaccine studies in women. [ABSTRACT FROM AUTHOR]

Purpose: HIV pre-exposure prophylaxis (PrEP) is highly efficacious, and yet most individuals indicated for it are not currently using it. To provide guidance for health policymakers, researchers, and community advocates, we developed county-level PrEP use estimates and assessed locality and policy associations.Methods: Using data from a national aggregator, we applied a validated crosswalk procedure to generate county-level estimates of PrEP users in 2018. A multilevel Poisson regression explored associations between PrEP use and (1) state policy variables of Medicaid expansion and state Drug Assistance Programs (PrEP-DAPs) and (2) county-level characteristics from the U.S. Census Bureau. Outcomes were PrEP per population (prevalence) and PrEP-to-need ratio (PnR), defined as the ratio of PrEP users per new HIV diagnosis. Higher levels of PrEP prevalence or PnR indicate more PrEP users relative to the total population or estimated need, respectively.Results: Our 2018 county-level data set included a total of 188,546 PrEP users in the United States. Nationally, PrEP prevalence was 70.3/100,000 population and PnR was 4.9. In an adjusted model, counties with a 5% higher proportion of black residents had 5% lower PnR (rate ratio (RR): 0.95, 95% confidence interval (CI): 0.93, 0.96). Similarly, counties with higher concentration of residents uninsured or living in poverty had lower PnR. Relative to states without Medicaid expansion or PrEP-DAPs, states with only one of those programs had 25% higher PrEP prevalence (RR: 1.25, 95% CI: 1.09, 1.45), and states with both programs had 99% higher PrEP prevalence (RR: 1.99, 95% CI: 1.60, 2.48). There was a significant linear trend across the three policy groups, and similar findings for the relation between PnR and the policy groups.Conclusions: In a data set comprising approximately 80% of PrEP users in the United States, we found that Medicaid expansion and PrEP-DAPs were associated with higher PrEP use in states that adopted those policies, after controlling for potential confounders. Future research should identify which components of PrEP support programs have the most success and how to best promote PrEP among groups most impacted by the epidemic. States should support the admirable health decisions of their residents to get on PrEP by implementing policies that facilitate access. [ABSTRACT FROM AUTHOR]

Background Integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) is recommended first-line HIV treatment. We recently demonstrated increased weight gain associated with INSTI use among women living with HIV (WLH) enrolled in the Women's Interagency HIV Study (WIHS), raising concern for cardiometabolic consequences. We, therefore, evaluated the effects of INSTI use on lipids, insulin resistance, and glycemic control in WLH. Methods Data from 2008 to 2017 were analyzed from WLH enrolled in WIHS. Women who switched to or added an INSTI to ART (SWAD group) were compared with women who remained on non-INSTI ART (STAY group). Outcomes included changes in fasting total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides (TG), and glucose; hemoglobin A1c; and incident insulin resistance (defined as homeostatic model assessment of insulin resistance [HOMA] score ≥2). Outcomes were measured 6–12 months before and 6–18 months after INSTI switch/add in the SWAD group with comparable time points in the STAY group. Linear regression models compared change over time in each outcome by SWAD/STAY group, adjusted for age, race, WIHS site, income, smoking status, statin use, and ART regimen at baseline. Results In total, 881 WIHS participants (182 SWAD and 699 STAY) were followed for a mean 1.8 (±1.1) years. Mean age was 49 (±8.8) years, BMI was 31 (±8.2) kg/m2, and 49% were Black. At baseline, SWAD vs. STAY was more likely to report NNRTI (vs. PI)-based ART and statin use (both P < 0.0001), but all baseline lipid and glucose variables were similar. Compared with STAY, the SWAD group experienced significantly greater decreases in HDL (−2.4 vs. +0.09 mg/dL, P = 0.03) and trended toward greater decreases in TC (−2.6 vs. −2.4 mg/dL, P = 0.07) at follow-up, without significant differences in TG or LDL. The SWAD group had significantly greater increases in A1c (+0.08% vs. −0.05%, P = 0.01) but trended toward lower incidence of insulin resistance (19% vs. 32%, P = 0.05). Conclusion Despite reported increases in weight, INSTI use was associated with only modest changes in lipid measurements and glycemic control during short-term follow-up of WLH compared with non-INSTI ART. Research is needed to elucidate long-term cardiometabolic effects. Disclosures Anandi N. Sheth, MD, MS, Gilead Sciences, Inc.: Research Grant. [ABSTRACT FROM AUTHOR]

Background Age-related non-AIDS comorbidities (NACM) increasingly account for morbidity and mortality in persons living with HIV. The burden of NACM and its association with HIV is poorly described in women. Methods We analyzed data from HIV+ and at-risk HIV− participants who were followed in the Women's Interagency HIV Study (WIHS) after 2009 (when >80% of participants used antiretroviral therapy). The prevalence of each NACM (defined by a combination of self-report, clinical measurements, and laboratory data) and the number of NACM were summarized at a most recent follow-up visit and were compared by age and HIV serostatus using unadjusted linear regression models. Results There were 3232 women (2309 HIV+, 923 HIV–) with a median follow-up of 15.3 years. The median age was 50 years, 65% were black, 38% currently smoked, 71% had ever used illicit drugs, 50% had annual income < $12,000, and median body mass index was 30 kg/m2. HIV+ women had a median CD4 count of 618 cells/mm3 and 66% had HIV viral suppression. Among 10 NACM evaluated, the following were more prevalent in HIV+ vs. HIV– women (all P < 0.01): psychiatric illness (57%/48%), liver disease (45%/26%), hyperlipidemia (40%/35%), bone disease (40%/33%), chronic kidney disease (15%/7%), and non-AIDS cancer (11%/7%). There was little difference in the prevalence of hypertension (66%/64%), lung disease (41%/43%), diabetes (22%/24%), and cardiovascular disease (19%/19%). Mean number of NACM was higher in HIV+ vs. HIV– women (3.6 vs. 3.0, P < 0.0001). Regardless of HIV serostatus, NACM burden significantly increased with age (P < 0.0001). Compared with women aged <40 of the same HIV serostatus, the estimated mean difference in NACM (HIV+/HIV–) for those 40–49, 50–59, ≥60 years was 1.1/0.7, 2.3/2.3, and 3.6/3.2, respectively (P < 0.0001 for all). Within-age-group comparisons revealed significantly greater NACM burden in HIV+ vs. HIV− women aged 40–49 years (P < 0.0001) and ≥60 years (P = 0.003), but not in those aged <40 or 50–59 years (HIV*age interaction P = 0.02) (figure). Conclusion NACM burden was high in both HIV+ and at-risk HIV– women, but higher in HIV+ women overall and in certain age groups. Accumulation of NACM has complex implications for clinical care, medication management, and healthcare screening that must be further examined in this population. Disclosures Anandi N. Sheth, MD, MS, Gilead Sciences, Inc.: Research Grant. [ABSTRACT FROM AUTHOR]

Background: Relatively little is known about the frequency and factors associated with miscarriage among women living with HIV.Objective: The objective of the study was to evaluate factors associated with miscarriage among women enrolled in the Women's Interagency HIV Study.Study Design: We conducted an analysis of longitudinal data collected from Oct. 1, 1994, to Sept. 30, 2017. Women who attended at least 2 Women's Interagency HIV Study visits and reported pregnancy during follow-up were included. Miscarriage was defined as spontaneous loss of pregnancy before 20 weeks of gestation based on self-report assessed at biannual visits. We modeled the association between demographic, behavioral, and clinical covariates and miscarriage (vs live birth) for women overall and stratified by HIV status using mixed-model logistic regression.Results: Similar proportions of women living with and without HIV experienced miscarriage (37% and 39%, respectively, P = .638). In adjusted analyses, smoking tobacco (adjusted odds ratio, 2.0), alcohol use (adjusted odds ratio, 4.0), and marijuana use (adjusted odds ratio, 2.0) were associated with miscarriage. Among women living with HIV, low HIV viral load (<4 log10 copies/mL) (adjusted odds ratio, 0.5) and protease inhibitor (adjusted odds ratio, 0.4) vs the nonuse of combination antiretroviral therapy use were protective against miscarriage.Conclusion: We did not find an increased odds of miscarriage among women living with HIV compared with uninfected women; however, poorly controlled HIV infection was associated with increased miscarriage risk. Higher miscarriage risk among women exposed to tobacco, alcohol, and marijuana highlight potentially modifiable behaviors. Given previous concern about antiretroviral therapy and adverse pregnancy outcomes, the novel protective association between protease inhibitors compared with non-combination antiretroviral therapy and miscarriage in this study is reassuring. [ABSTRACT FROM AUTHOR]

Background Rapid entry programs (REPs) improve time to antiretroviral therapy (ART) initiation (TAI) and time to viral suppression (TVS). We assessed the feasibility and effectiveness of a REP in a large HIV clinic in Atlanta, Georgia, serving a predominately un- or underinsured population. Methods The Rapid Entry and ART in Clinic for HIV (REACH) program was implemented on May 16, 2016. We performed a retrospective cohort study with the main independent variable being period of enrollment: January 1, 2016, through May 15, 2016 (pre-REACH); May 16, 2016, through July 31, 2016 (post-REACH). Included individuals were HIV-infected and new to the clinic with detectable HIV-1 RNA. Six-month follow-up data were collected for each participant. Survival analyses were conducted for TVS. Logistic and linear regression analyses were used to evaluate secondary outcomes: attendance at first clinic visit, viral suppression, TAI, and time to first attended provider visit. Results There were 117 pre-REACH and 90 post-REACH individuals. Median age (interquartile range [IQR]) was 35 (25–45) years, 80% were male, 91% black, 60% men who have sex with men, 57% uninsured, and 44% active substance users. TVS decreased from 77 (62–96) to 57 (41–70) days (P <.0022). Time to first attended provider visit decreased from 17 to 5 days, and TAI from 21 to 7 days (P <.0001), each remaining significant in adjusted models. Conclusions This is the largest rapid entry cohort described in the United States and suggests that rapid entry is feasible and could have a positive impact on HIV transmission at the population level. [ABSTRACT FROM AUTHOR]

Background Gains in life expectancy through optimal control of HIV infection with antiretroviral therapy (ART) may be threatened if other comorbidities, such as diabetes, are not optimally managed. Methods We analyzed cross-sectional data of the Women's Interagency HIV Study (WIHS) from 2001, 2006, and 2015. We estimated the proportions of HIV-positive and HIV-negative women with diabetes who were engaged in care and achieved treatment goals (hemoglobin A1c [A1c] <7.0%, blood pressure [BP] <140/90 mmHg, low-density lipoprotein [LDL] cholesterol <100 mg/dL, not smoking) and viral suppression. Repeated-measures models were used to estimate the adjusted prevalence of achieving each diabetes treatment goal at each time point, by HIV status. Results We included 486 HIV-positive and 258 HIV-negative women with diabetes. In 2001, 91.8% visited a health care provider, 60.7% achieved the A1c target, 70.5% achieved the BP target, 38.5% achieved the LDL cholesterol target, 49.2% were nonsmokers, 23.3% achieved combined ABC targets (A1c, BP, and cholesterol), and 10.9% met combined ABC targets and did not smoke. There were no differences by HIV status, and patterns were similar in 2006 and 2015. Among HIV-positive women, viral suppression increased from 41% in 2001 to 87% in 2015 compared with 8% and 13% achieving the ABC goals and not smoking. Viral suppression was not associated with achievement of diabetes care goals. Conclusions Successful management of HIV is outpacing that of diabetes. Future studies are needed to identify factors associated with gaps in the HIV–diabetes care continuum and design interventions to better integrate effective diabetes management into HIV care. [ABSTRACT FROM AUTHOR]

Background: Little is known about fertility choices and pregnancy outcome rates among HIV-infected women in the current combination antiretroviral treatment era.Objective: We sought to describe trends and factors associated with live-birth and abortion rates among HIV-positive and high-risk HIV-negative women enrolled in the Women's Interagency HIV Study in the United States.Study Design: We analyzed longitudinal data collected from Oct. 1, 1994, through Sept. 30, 2012, through the Women's Interagency HIV Study. Age-adjusted rates per 100 person-years live births and induced abortions were calculated by HIV serostatus over 4 time periods. Poisson mixed effects models containing variables associated with live births and abortions in bivariable analyses (P < .05) generated adjusted incidence rate ratios and 95% confidence intervals.Results: There were 1356 pregnancies among 2414 women. Among HIV-positive women, age-adjusted rates of live birth increased from 1994 through 1997 to 2006 through 2012 (2.85-7.27/100 person-years, P trend < .0001). Age-adjusted rates of abortion in HIV-positive women remained stable over these time periods (4.03-4.29/100 person-years, P trend = .09). Significantly lower live-birth rates occurred among HIV-positive compared to HIV-negative women in 1994 through 1997 and 1997 through 2001, however rates were similar during 2002 through 2005 and 2006 through 2012. Higher CD4+ T cells/mm3 (≥350 adjusted incidence rate ratio, 1.39 [95% CI 1.03-1.89] vs <350) were significantly associated with increased live-birth rates, while combination antiretroviral treatment use (adjusted incidence rate ratio, 1.35 [95% CI 0.99-1.83]) was marginally associated with increased live-birth rates. Younger age, having a prior abortion, condom use, and increased parity were associated with increased abortion rates among both HIV-positive and HIV-negative women. CD4+ T-cell count, combination antiretroviral treatment use, and viral load were not associated with abortion rates.Conclusion: Unlike earlier periods (pre-2001) when live-birth rates were lower among HIV-positive women, rates are now similar to HIV-negative women, potentially due to improved health status and combination antiretroviral treatment. Abortion rates remain unchanged, illuminating a need to improve contraceptive services. [ABSTRACT FROM AUTHOR]

Objective: Chronic inflammation is associated with increased morbidity and mortality for people with HIV (PWH). Psychological stress is an important contributor to this chronic inflammation. We hypothesized that a cognitively based compassion training (CBCT) approach could reduce inflammation and psychological stress in immune nonresponder PWH. Design: An attention-placebo randomized controlled trial design to evaluate the acceptability of CBCT among PWH and its effects on key aspects of stress and immune function compared with an active-attention control group (NCT02395289). Methods: This study was conducted at an HIV clinic in Atlanta, Georgia. Eligible individuals determined by (1) adherence to antiretroviral therapy for at least a year, (2) virologic suppression; and (3) stable CD4+ T-cell counts <350 cells/[mu]L were randomized in a 2:1 ratio to either CBCT or control in 2 study periods: April-May, 2016, and September-December, 2016. Psychological measures and inflammatory biomarkers associated with HIV disease progression (IL-1[beta], TNF-[alpha], sCD14, IL-6, and IL-10) were obtained for all study participants at baseline and at the time of study completion. Results: We found a significant association between CBCT practice time engagement and fold reduction in IL-6 and TNF-[alpha] levels. There was no association between CBCT practice time and other biomarkers markers assessed (IL-1[beta], sCD14, and IL-10). These changes were coincident with significant increases in self-reported psychological well-being and HIV disease acceptance and in benefits for CBCT participants. We also observed fewer instances of virologic failure for those in the CBCT arm compared with controls. Conclusions: CBCT is a novel and feasible nonmedication-based intervention that could reduce inflammation and psychological stress in PWH. [ABSTRACT FROM AUTHOR]

Objective(s): We describe contraception and dual method use among women with HIV initiating antiretroviral therapy (ART) in a U.S. clinical trial and examine associated factors.Study Design: We analyzed data from ART-naïve women aged 45 years and under initiating one of 3 regimens as part of A5257 (May 2009-June 2011) which required that women at risk for pregnancy use contraception. We classified self-reported methods as more effective (Tier 1 [intrauterine device, hysterectomy, permanent contraception] and Tier 2 [hormonal rings, patches, injections, pills]) versus less effective (Tier 3 [condoms alone] and Tier 4 [withdrawal, none]). We used logistic regression models to assess associations with use of (a) more effective, and (b) dual methods (condoms with a more effective method).Results: Of 285 women, majority were Black (59%), had annual income <$20,000 (54%), and had government insurance (68%). The most common contraceptive methods reported at baseline were permanent contraception (37%), male condoms alone (31%), and injectable progestin (8%); 41% and 16% reported Tier 1 and 2 use, respectively; 36% reported dual method use. Use of more effective and dual methods did not change 48 and 96 weeks after ART initiation (p > 0.05). In multivariable analyses, baseline use of more effective and dual methods was associated with age at least 40 years versus 18 to 29 years (odds ratio [OR] 4.46, 95% confidence interval [CI] 2.12, 9.35) and having at least one child (OR 2.31, 95%CI 1.27, 4.20).Conclusions: In women initiating modern ART in a clinical trial, permanent contraception was common, while use of other more effective contraceptive methods was low and did not change after ART initiation. Efforts are needed to improve integration of family planning services for women within the context of HIV clinical trials.Implications: The findings highlight the importance of improving integration of HIV and family planning services, including in the context of clinical trials. [ABSTRACT FROM AUTHOR]