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BACKGROUND Frailty may occur at younger ages among HIV+ populations. We evaluated associations of the frailty status with self-reported single and recurrent falls in the Women's Interagency HIV Study (WIHS). METHODS The frailty status was defined using the Fried Frailty Phenotype (FFP) among 897 HIV+ and 392 HIV- women; median age 53 years. Women were classified as robust (FFP 0), prefrail (FFP 1-2), and frail (FFP 3-5). Stepwise logistic regression models adjusting for the HIV status and study site were fit to evaluate associations of the FFP with self-reported single (1 vs. 0) and recurrent falls (≥2 vs. 0) over the prior 12 months. RESULTS HIV+ women were less likely to be frail (9% vs. 14% vs. P = 0.009), but frequency of falls did not differ by the HIV status. In multivariate analyses, recurrent falls were more common among prefrail [adjusted odds ratio (AOR) 2.23, 95% confidence interval (CI): 1.40 to 3.57, P = 0.0008] and frail (AOR 3.61, 95% CI: 1.90 to 6.89, P < 0.0001) than robust women. Among HIV+ women, single (AOR 2.88, 95% CI: 1.16 to 7.20, P = 0.023) and recurrent falls (AOR 3.50, 95% CI: 1.24 to 9.88, P = 0.018) were more common among those who were frail; recurrent, but not single falls, were more common among prefrail than robust HIV+ women (AOR 2.00, 95% CI: 1.03 to 3.91, P = 0.042). CONCLUSIONS HIV+ women were less likely to be frail. Compared with robust women, prefrail and frail women with and without HIV were more likely to experience single or recurrent falls within a 12-month period. Additional studies are needed to develop interventions that decrease development of frailty and reduce risk of recurrent falls among HIV+ women.

Human Immunodeficiency Virus (HIV) infection remains prevalent among the marginalized and drug using population in the United States. Testing for HIV is an important and cost-effective way to reduce HIV prevalence. Our objective was to determine if there is a difference in the number of HIV testing by injection status among users of illicit drugs and if a person's social network characteristics is a contributing factor. Using a cross-sectional design and negative binomial regression models, we assessed HIV testing behavior of people who use non-injected drugs (PWND) compared to people who use injected drugs (PWID). In an analytic sample of 539 participants, PWND tested for HIV 19% less compared to PWID, PR (95% CI) = 0.81 (0.66, 0.98), p = 0.03. Other contributing factors of testing were education, condomless sex, STIs, heroin use, and participant's sex network. The interaction term between PWND and emotional support in relation to HIV testing was significant, 1.33 (1.03, 1.69), p=0.03. These findings suggest HIV testing behavior differed by injection status, and this relationship may be dependent on emotional support. To exert a greater impact on the HIV epidemic, interventions and policies encouraging HIV testing in PWND, an understudied at-risk sub-population, are warranted.

HIV testing among young Black MSM and transwomen (YBMSM/TW) is the gateway to biomedical HIV prevention or treatment. HIV self-testing (HST) is a method that may increase consistent HIV testing. TRUST, a brief, peer-based behavioral intervention, was designed to increase uptake of consistent (every three months) HST among YBMSM/TW in New York City. To test the efficacy of the intervention, we randomized 200 friend pairs into either the intervention condition (TRUST) or a time and attention control condition. A modified intent-to-treat analysis found that self-reported HST at 3-month follow-up was statistically significantly higher (uOR 2.29; 95% CI 1.15, 4.58) and at 6-month follow-up was marginally statistically significantly higher (uOR 1.94; 95% CI 1.00, 3.75) in the intervention arm as compared with the control arm. There were no statistically significant differences by arm at 9- or 12-month follow-up. TRUST, a culturally-congruent intervention to increase HST among YBMSM/TW, had short-term impact on past-three month HST. Clinical Trials Registration ClinicalTrial.gov NCT04210271.

Purpose To evaluate the association between Medicaid expansion and diabetic dilated eye examinations. Design A retrospective difference in differences (DiD) analysis using individual-level survey response data from January 1, 2009, to December 31, 2017. Participants A total of 52 392 survey responses from 50 states and the District of Columbia between 2009 and 2017. Responders were adults aged 18 to 64 years reporting a previous diagnosis of diabetes and a household income below 138% of the US federal poverty line (FPL). Methods The Centers for Disease Control and Prevention’s Behavioral Risk Factor Surveillance System data were used to identify survey responders who were asked about the presence of dilated eye examinations from years before and after Medicaid expansion implementation. Main Outcome Measures The DiD in proportion of dilated eye examinations among diabetic persons aged 18 to 64 years with household incomes below 138% of the FPL between states that did and did not implement Medicaid expansion. Results Implementation of Medicaid expansion policies was associated with a 1.3% (95% confidence interval [CI], −3.8 to 6.4; P = 0.61), 6.3% (95% CI, 1.3–11.3; P = 0.016), 4.1% (95% CI, −0.8 to 9.0; P = 0.11), and 2.3% (95% CI, −1.6 to 6.2; P = 0.23) increase in the proportion of diabetic persons aged 18 to 64 years with incomes below 138% of the FPL receiving a dilated eye examination within the past year due to Medicaid expansion 1, 2, 3, and 4 cumulative years after expansion, respectively. Conclusions Medicaid expansion policies were significantly associated with an increase in dilated eye examination rates within the first 2 years after implementation. However, this increase did not persist beyond this period, with nonsignificant increases 3 and 4 cumulative years after implementation. Healthcare policymakers should be aware that additional measures beyond expanding insurance coverage may be necessary to increase and sustain the rate of dilated eye examinations among diabetic populations.

BackgroundReproductive tract infections (RTIs) are a major cause of morbidity and mortality, yet RTI testing remains limited in resource-constrained settings. We assessed performance of an existing RTI risk assessment screening tool among women living with HIV (WLHIV) considering intrauterine contraceptive (IUC) use.MethodsWe conducted a cross-sectional analysis among WLHIV screened for participation in an IUC trial in Cape Town, South Africa (NCT01721798). RTI testing included Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis and bacterial vaginosis. Tool scoring was based on five separately scored criteria: (1) age under 25 years, (2) cohabitation with a partner, (3) secondary education, (4) self-reported intermenstrual bleeding and (5) number of current sexual partners and condom use frequency (score 0–5). We assessed tool performance in detecting RTI at 0 vs 1–5, 0–1 vs 2–5 and 0–2 vs 3–5 score thresholds.ResultsOf 303 women, 52% (n=157) reported antiretroviral therapy use and median age was 31 years. The prevalence of any RTI was 38% (gonorrhoea=7%, chlamydia=11%, trichomoniasis=12% and bacterial vaginosis=18%) and 8% of women had multiple RTIs. Overall, 4%, 27% and 69% of women had screening tool scores of 0, 1 or 2+, respectively. At a threshold of at least one scored criterion, the tool demonstrated high sensitivities (95%–97%) but low specificities (3%–4%) for detecting any RTI. Increasing the score threshold and/or inclusion of abnormal vaginal discharge marginally improved specificity.ConclusionThe prevalence of RTIs observed in this population was high, and the screening tool had no discriminatory power to detect prevalent RTIs.

OBJECTIVE To determine whether domain-specific neurocognitive (NC) impairments predict falls in HIV+ compared with HIV- women. DESIGN Cross-sectional data analysis from 825 HIV+ and 392 HIV- women in the Women's Interagency HIV Study with NC testing within 2 years before falls surveys. METHODS NC impairment (T score

This study was conducted among predominately African American/Black women, aged 18-29, in Northeast cities with high HIV prevalence. Demographic, behavioral, and partner characteristics associated with condomless vaginal and anal sex acts with high-risk partners (CVS-HRP and CAS-HRP) and with HIV testing were explored. The high-risk sample was largely recruited online. Of 4972 women screened, 2254 (45.3%) were high-risk for HIV acquisition; 2214 were included. Bivariate and stepwise multivariate logistic regression models were fit. After adjusting for other factors, sex risk behavior did not differ by race and ethnicity. CAS-HRP was associated with believing condoms don't reduce HIV risk and with several high-risk behaviors, including; alcohol use, multiple partners, and sex with men who had sex with men, but, not with HIV testing. Half the sample had condomless sex with partners who never HIV tested and were themselves three times as likely to have never tested. These results point to the ongoing need for effective prevention strategies among at-risk heterosexual women.

Background The only way to systematically screen for self-neglect among older adults is through in-home observations, which are often difficult and unfeasible for healthcare providers. To fill this gap, we need a robust and efficient prognostication tool to better treat and prevent self-neglect among older adults. Objectives To develop a predictive index that can be used to assess risk prognostication of the onset of self-neglect among community-dwelling older populations. Design Two waves of longitudinal data from the Chicago Health and Aging Project (CHAP), collected during 2008 to 2012 with approximately 3-year follow-up intervals. Setting Non-Hispanic black or non-Hispanic white community-dwelling older adults in three adjacent neighborhoods in Chicago, IL. Participants A total of 2885 individuals who were participants of the CHAP study. Measurements The main outcomes are incident self-neglect cases. A total of 86 potential predictors were considered in the domains of sociodemographic and socioeconomic, general well-being, health behavior, medical health, medicine/healthcare, cognitive function, physical well-being, social well-being, and psychological well-being. Results The 3-year self-neglect incidence rate is 241 (8.4%). A 10-item predictive model (with a c-statistic of 0.76) was developed using stepwise selection in multivariable logistical regression models. After corrections of overfitting by validating in 100 bootstrapping samples, the predictive accuracy of the model dropped to 0.71, suggesting at least moderate overfitting. A point-based risk index was developed based on parameter estimates of each predictive factor in the final logistic model. The index has an area under the receiver operating characteristic curve of 0.76. Conclusion The study developed an efficient index with good predictive ability of self-neglect. Further external validation and impact studies are necessary before practitioners can apply this index to determine risk of self-neglect among other community aging populations. J Am Geriatr Soc 68:809-816, 2020.

Background We previously reported lower bone mineral density (BMD) among premenopausal women with HIV (WWH) compared to women without HIV (HIV−). Rate of bone loss may be even greater for WWH during the menopausal transition. Methods Pre-, peri- and postmenopausal women in the Women\'s Interagency HIV Study (WIHS) underwent whole body DXA and central quantitative computed tomography to measure areal BMD (aBMD) and volumetric BMD (vBMD), respectively. Multivariable regression models with covariates associated with low aBMD (T score < −1.0) in univariate analyses (P≤.05) and known risk factors for low BMD assessed contributions of HIV and menopausal stage to the prediction of aBMD. Results Compared to HIV− women, in unadjusted analyses, WWH had 5–9% lower aBMD at the lumbar spine (P=.001), femoral neck (P=.04), total hip (P=.003) and the ultradistal radius (P=.004), and higher osteoporosis prevalence (T score Conclusions HIV infection and menopausal stage were independent predictors of lower BMD, and had an additive effect on lumbar spine and total hip BMD. Additional research is needed to better understand underlying mechanisms by which HIV impacts BMD as women age and transition through menopause, and develop strategies to mitigate osteoporosis and fracture risk in this growing population.

Background Bone mineral density (BMD) loss and fat gain is common in people living with HIV (PLWH), particularly after initiating combination antiretroviral therapy (cART). Given the close metabolic interaction between bone and fat, we tested the hypotheses that changes in bone-derived hormones are associated with fat accumulation and changes in fat-derived hormones are associated with BMD loss following cART initiation. Methods HIV-seropositive subjects (n = 15) initiating fixed dose cART of tenofovir disoproxil fumarate/emtricitabine/efavirenz (TDF/FTC/EFV) underwent dual X-ray absorptiometry (DXA) assessment pre-cART and again 12-months post-cART initiation. DXA-derived measurements included BMD at the lumbar spine, femoral neck, total hip, and trochanter and the trunk and total fat. Serum undercarboxylated osteocalcin (ucOCN), sclerostin, lipocalin-2, leptin, and adiponectin were measured pre and post-cART. Spearman's rank-order correlations assessed the cross-sectional associations between hormones and bone and fat mass pre- and post-cART. Linear regression models adjusting for baseline bone or fat mass assessed the association between hormone change and BMD/fat changes following cART initiation. Results ucOCN (p = 0.04) and lipocalin-2 (p = 0.03) increased post-cART while sclerostin, leptin, and adiponectin remained unchanged. BMD significantly decreased post-cART at all skeletal sites. Trunk and total fat increased post-cART but not significantly, while weight and BMI remained unchanged. In models adjusting for baseline BMD and fat mass, change in ucOCN was negatively associated with change in trunk (p = 0.008) and total fat (p = 0.01) and the change in leptin was positively associated with change in total hip (p = 0.03) and trochanteric BMD (p = 0.02). Conclusion The current study demonstrates bone-fat crosstalk in cART initiating PLWH.

Introduction The Central Africa International epidemiology Database to Evaluate AIDS (CA‐IeDEA) is an open observational cohort study investigating impact, progression and long‐term outcomes of HIV/AIDS among people living with HIV (PLWH) in Burundi, Cameroon, Democratic Republic of Congo (DRC), Republic of Congo (ROC) and Rwanda. We describe trends in demographic, clinical and immunological characteristics as well as antiretroviral therapy (ART) use of patients aged > 15 years entering into HIV care in the participating CA‐IeDEA site. Methods Information on sociodemographic characteristics, height, weight, body mass index (BMI), CD4 cell count, WHO staging and ART status at entry into care from 2004 through 2018 were extracted from clinic records of patients aged > 15 years enrolling in HIV care at participating clinics in Burundi, Cameroon, DRC, ROC and Rwanda. We assessed trends in patient characteristics at enrolment in HIV care including ART initiation within the first 30 days after enrolment in care and calculated proportions, means and medians (interquartile ranges) for the main variables of interest. Results Among 69,176 patients in the CA‐IeDEA cohort, 39% were from Rwanda, 24% from ROC, 18% from Cameroon, 14% from Burundi and 5% from DRC. More women (66%) than men enrolled in care and subsequently initiated ART. Women were also younger than men (32 vs. 38 years, P

Diabetes mellitus (DM) is associated with expansion of proinflammatory lymphocyte subsets. We investigated the relationship of total white blood cell (WBC) count and lymphocyte subsets with incident DM in the Women's Interagency HIV Study (WIHS). Higher CD4 and CD8 T cell counts, lymphocyte count, and total WBC count were associated with incident DM among both women with and without HIV, although the association of CD8 was not statistically significant among women without HIV.

Sex Positive!([+]) is a two-arm, video-based web intervention aimed at reducing condomless anal sex (CAS) with partners of known and unknown serostatus that was delivered online to a racially and ethnically diverse sample of 830 gay, bisexual, and other men who have sex with men living with HIV. Men in each arm received 6 weekly videos after completing a baseline assessment and 4 weekly booster videos following a 6-month assessment. Follow-up assessments were conducted every 3 months for 1 year. At 3-month follow-up, men in the intervention arm reported significantly reduced risk of having unknown serodiscordant CAS partners than men in the control arm (RR 0.60, 95% CI 0.39–0.92), partially supporting study hypotheses. Aside from this finding, similar reductions in sexual risk behaviors were observed in both arms over the study period. There is much to be learned about video-based web interventions in terms of methodological development and intervention delivery, including frequency and duration of intervention components.

Background We describe the timing of human immunodeficiency virus (HIV) diagnosis and antiretroviral treatment (ART) initiation after implementation of universal testing and treatment policies in New York City (NYC). Methods Using NYC population-based HIV registry data for persons with HIV diagnosed from 2012 through 2015 and followed up through June 2017, we examined trends in the proportion with diagnosis soon after HIV infection (ie, with CD4 cell count ≥500/μL or with acute HIV infection) and used Kaplan-Meier plots and proportional hazards regression to examine the timing of ART initiation after diagnosis. Results Among 9987 NYC residents with HIV diagnosed from 2012 to 2015, diagnosis was early in 35%, and 87% started ART by June 2017. The annual proportion of persons with early diagnosis did not increase appreciably (35% in 2012 vs 37% in 2015; P = .08). By 6 months after diagnosis, 62%, 67%, 72% and 77% of persons with HIV diagnosed in 2012, 2013, 2014, or 2015, respectively, had started ART, with median (interquartile range) times to ART initiation of 3.34 (1.34–12.75), 2.62 (1.28–10.13), 2.16 (1.15–7.11), and 2.03 (1.11–5.61) months, respectively. Conclusions Although recommendations for ART initiation on diagnosis are increasingly being implemented, the findings of the current study suggest that immediate treatment initiation is not universal. Continued efforts are needed to expand and better target HIV testing to promote earlier diagnosis.

Objective:To determine associations between frailty and fracture in women with and without HIV infection.Design:Prospective longitudinal cohort study evaluating associations between baseline frailty status and frailty components, with first and second incident fractures.Methods:We evaluated associat

Background Frailty and falls occur commonly and prematurely in HIV-infected populations. Whether frailty in middle-age predicts future falls among HIV-infected women is unknown. Methods We evaluated associations of frailty with single and recurrent falls 10 years later among 729 HIV-infected and 326 uninfected women in the Women's Interagency HIV Study (WIHS) with frailty measured in 2005 and self-reported falls in 2014–2016. Frailty was defined as ≥3 of 5 Fried Frailty Index components: slow gait, reduced grip strength, exhaustion, unintentional weight loss and low physical activity. Stepwise logistic regression models determined odds of single (versus 0) or recurrent falls (≥2 versus 0) during the 2-year period; separate models evaluated frailty components. Results HIV-infected women were older (median 42 versus 39 years; PConclusions Early frailty measurement among middle-aged women with or at-risk for HIV may be a useful tool to assess future fall risk.

The role of advanced practice providers has expanded in the hospital setting. However, little data exist examining the impact of these providers. Our purpose was to determine the effect of adding nurse practitioners in a complementary role on the quality and efficiency of care of hospitalized patients. A retrospective cohort study evaluated adult patients admitted by private physicians (without house staff or non-physician providers) to a general medical-surgical unit in an academic medical center. The admissions department allocated patients as beds became available and nurse practitioners were assigned to patients until their caseload was reached. Outcomes included length of hospital stay, in-hospital mortality, admission costs, 30-day readmissions, transfer to a more intensive care level, and discharge order time. Of the 382 patients included in this study, 263 were assigned to the nurse practitioner group. Hospital mortality was lower in the nurse practitioner group [OR 0.11 (95% CI 0.02&ndash, 0.51)] as was transfer to more intensive care level [OR 0.39 (95% CI 0.20&ndash, 0.75)], however, the nurse practitioner group had longer length of stay (geometric mean = 5.80 days for nurse practitioners, 3.63 days for no nurse practitioners, p &lt, 0.0001) and higher cost per patient (geometric mean = USD 6631 vs. USD 5121, p = 0.005). The results were unchanged when models were adjusted for potential confounders. Adding nurse practitioners can yield improved clinical outcomes (lower hospital mortality and fewer transfers to intensive care), but with a potential economic expense (longer hospital stays and higher costs).

Background Time of day has been associated with variations in certain clinical practices such as cancer screening rates. In this study, we assessed how more general process measures of physician activity, particularly rates of diagnostic test ordering and diagnostic assessments, might be affected by time of day. Methods We conducted a retrospective chart review of 3,342 appointments by 20 attending physicians at five outpatient clinics, matching appointments by physician and comparing the average diagnostic tests ordered and average diagnoses assessed per appointment in the first hour of the day versus the last hour of the day. Statistical analyses used sign tests, two-sample t-tests, Wilcoxon tests, Kruskal Wallis tests, and multivariate linear regression. Results Examining physicians individually, four and six physicians, respectively, had statistically significant first- versus last-hour differences in the number of diagnostic tests ordered and number of diagnoses assessed per patient visit (p ≤ 0.04). As a group, 16 of 20 physicians ordered more tests on average in the first versus last hour (p = 0.012 for equal chance to order more in each time period). Substantial intra-clinic heterogeneity was found in both outcomes for four of five clinics (p < 0.01). Conclusions There is some statistical evidence on an individual and group level to support the presence of time-of-day effects on the number of diagnostic tests ordered per patient visit. These findings suggest that time of day may be a factor influencing fundamental physician behavior and processes. Notably, many physicians exhibited significant variation in the primary outcomes compared to same-specialty peers. Additional work is necessary to clarify temporal and inter-physician variation in the outcomes of interest.

Background Antiretroviral therapy (ART) success has led people to live longer with HIV/AIDS (PLWH) and thus be exposed to increasing risk of cardiovascular diseases (CVD). Hypertension (HTN), the biggest contributor to CVD burden, is a growing concern among PLWH. The current report describes the prevalence and predictors of HTN among PLWH in care in Cameroon. Methods This cross-sectional study included all PLWH aged 20 years and above who received care between 2016 and 2019 at one of the three Central Africa International Epidemiology Databases to Evaluate AIDS (CA-IeDEA) sites in Cameroon (Bamenda, Limbe, and Yaoundé). HTN was defined as blood pressure (BP) ≥140/90 mm Hg or self-reported use of antihypertensive medication. Logistic regressions models examined the relationship between HTN and clinical characteristics, and HIV-related factors. Results Among 9,839 eligible PLWH, 66.2% were women and 25.0% had prevalent HTN [age-standardized prevalence 23.9% (95% CI: 22.2–25.6)], among whom 28 (1.1%) were on BP lowering treatment, and 6 of those (21.4%) were at target BP levels. Median age (47.4 vs. 40.5 years), self-reported duration of HIV infection (5.1 vs 2.8 years years), duration of ART exposure (4.7 vs 2.3 years), and CD4 count (408 vs 359 cell/mm3) were higher in hypertensives than non-hypertensives (all p Conclusion About a quarter of these Cameroonian PLWH had HTN, driven among others by age and adiposity. Appropriate integration of HIV and NCDs services is needed to improve early detection, treatment and control of common comorbid NCD risk factors like hypertension and safeguard cardiovascular health in PLWH.

Background Bone mineral density (BMD) loss and fat accumulation are common in people living with HIV (PLWH). The bone-derived hormone, undercarboxylated osteocalcin (ucOCN) regulates fat metabolism. We investigated the relationship between ucOCN change and body fat change among perimenopausal/postmenopausal HIV-seronegative and HIV-seropositive women on long-term antiretrovirals. Methods Perimenopausal and postmenopausal women enrolled in the Women's Interagency HIV Study (WIHS) MSK sub-study underwent trunk and total fat assessment via dual x-ray absorptiometry (DXA) at study enrollment (index visit) and again two years later. Circulating ucOCN and carboxylated osteocalcin (cOCN) were also measured at the index and two-year visits. The correlation between the two-year change in ucOCN and cOCN and change in trunk and total fat was assessed as a function of HIV-serostatus using linear regression modeling. Multivariate linear regression assessed the association between ucOCN and cOCN change and total and trunk fat change after adjusting for sociodemographic variables. Linear regression models restricted to HIV-seropositive women were performed to examine the contributions of HIV specific factors (index CD4 count, viral load, and cART use) on the associations. Results Increased ucOCN over the two-year follow-up was associated with less trunk and total fat accumulation in models adjusting for HIV-serostatus and participants sociodemographics, while there was no association with cOCN and the fat parameters. None of the HIV-specific factors evaluated influenced the association between ucOCN and fat parameters. Conclusion The current study suggests that increases in ucOCN are associated with decreased fat accumulation in HIV-seronegative and HIV-seropositive postmenopausal women on long-term antiretroviral therapy.

BackgroundTenofovir disoproxil fumarate (TDF) is the antiretroviral drug most commonly associated with renal dysfunction. However, few studies have examined this association in sub-Saharan Africa despite recent scale-up of antiretroviral therapy (ART) to all people living with HIV (Treat All) in this region. We assessed estimated glomerular filtration rate (eGFR) change among HIV infected Rwandan adults following first line TDF-based therapy initiation.MethodsThis prospective, observational study was conducted in 10 Rwandan health centers. Participants were ART-naive adults (≥18 years) living with HIV who initiated TDF-based ART from 1st July 2016 through 30th July 2018. The primary outcome was eGFR change from pre-(within 12 months) to post-TDF initiation (within 6 months).ResultsOf 476 patients with pre- and post-TDF eGFR measurements, 264 (55.5%) were women and mean age was 35.9 years (SD 9.6). Mean pre-TDF eGFR was 92.4 (SD 24.0) and mean post-TDF was 96.0 (SD 21.0) mL/min/1.73m2. Mean pre-to post-TDF change thus increased 3.60 (SD, 26.6) mL/min/1.73m2 (p=0.001).ConclusionWe detected a statistically significant clinically small renal function improvement within 6 months following TDF initiation among 476 ART-naïve patients. This supports continued TDF use for first-line treatment.

BackgroundThe Central Africa International epidemiology Database to Evaluate AIDS (CA-IeDEA) is a prospective study investigating impact, progression and long-term outcomes of HIV/AIDS among people living with HIV (PLWH) in Burundi, Cameroon, Democratic Republic of Congo (DRC), Republic of Congo (ROC) and Rwanda. We described trends in baseline demographic, clinical and immunological characteristics of patients aged >15 years entering into HIV care in the participating CA-IeDEA site and subsequent ART initiation.Materials and MethodsInformation on socio-demographic characteristics, height, weight, body mass index (BMI), CD4 cell count, WHO staging and ART status at entry into care from 2004 to 2018 were extracted from clinic records of patients aged >15 years enrolling in HIV care at participating clinics in Burundi, Cameroon, DRC, ROC and Rwanda. We assessed trends in patient characteristics at enrollment in HIV care and ART initiation at the participating site and calculated proportions, means and medians (interquartile ranges) for the main variables of interest.ResultsAmong 69,176 participants in the CA-IeDEA cohort, 39% % were from Rwanda,, 24% from ROC, 18% from Cameroon, 14% from Burundi and 5% from DRC. More women (66%) than men were enrolled in care and subsequently initiated ART. Women were also younger (32 years) than men (38 years) (p= ConclusionTrends from 2004-2018 in the characteristics of patients participating in the CA-IeDEA cohort highlight improvements over time at entry into care and subsequent ART in all participating sites.

Introduction Aiming to reach UNAIDS 90‐90‐90 targets, nearly all sub‐Saharan African countries have expanded antiretroviral therapy (ART) to all people living with HIV (PLWH) (Treat All). Few published data exist on viral load testing and viral suppression under Treat All in this region. We assessed proportions of patients with available viral load test results and who were virally suppressed, as well as factors associated with viral suppression, among PLWH in 10 Rwandan health centres after Treat All implementation. Methods Cross‐sectional study during 2018 of adults (≥15 years) engaged in HIV care at 10 Rwandan health centres. Outcomes were being on ART (available ART initiation date in the study database, with no ART discontinuation prior to 1 January 2018), retained on ART (≥2 post‐ART health centre visits ≥90 days apart during 2018), available viral load test results (viral load measured in 2018 and available in study database) and virally suppressed (most recent 2018 viral load 49 years (adjusted prevalence ratio (aPR): 0.83, 95% CI 0.76 to 0.90 and those with pre‐ART CD4 counts of

Background Low bone mineral density (BMD) is commonly observed in people living with HIV (PLWH), however the cause for this BMD loss remains unclear. Sclerostin, a bone-derived antagonist to the Wnt/β-catenin-pathway, suppresses bone remodeling and is positively associated with BMD. The goal of the current study was to investigate associations between sclerostin and BMD in a cohort of HIV-seropositive and demographically-matched seronegative women. Methods This cross-sectional analysis used a subset of early postmenopausal women enrolled in the Women's Interagency HIV Study (WIHS). BMD was assessed at the lumbar spine, total hip, femoral neck, and distal and ultradistal radius via dual energy x-ray absorptiometry (DXA). Circulating sclerostin was assessed via commercial ELISAs. Univariate and multivariate linear regression modeling tested associations between sclerostin and BMD after adjusting for a variety of BMD-modifying variables. Results HIV-seropositive women had significantly reduced BMD at all skeletal sites compared to HIV-seronegative women. There was no difference in sclerostin levels according to HIV-serostatus (0.25 vs 0.27 ng/mL in HIV-seronegative and HIV-seropositive, respectively, p = 0.71). Circulating sclerostin was positively associated with BMD at all sites in both univariate and multivariate models adjusting for HIV status, age, BMI, and race, although the coefficients of association were attenuated in HIV-seropositive women. The positive association between sclerostin and BMD among seropositive women remained statistically significant after adjusting for ART or tenofovir disoproxil fumarate (TDF) use. Conclusions The current study suggests that circulating sclerostin is a biomarker for bone mass for both HIV seronegative and seropositive women using and not using ART. The lower coefficients of association between sclerostin and BMD by HIV status may suggest HIV-induced alternation in osteocyte function.

Background Women living with HIV (WLHIV) have lower rates of contraceptive use than noninfected peers, yet concerns regarding contraceptive efficacy and interaction with antiretroviral therapy (ART) complicate counseling. Hormonal contraceptives may increase genital tract HIV viral load (gVL) and sexual transmission risk to male partners. We compared gVL, plasma VL (pVL), and intrauterine contraceptive (IUC) continuation between the levonorgestrel intrauterine system (LNG-IUS) and copper intrauterine device (C-IUD) in Cape Town, South Africa. Methods and findings In this double-masked, randomized controlled noninferiority trial, eligible WLHIV were ages 18–40, not pregnant or desiring pregnancy within 30 months, screened and treated (as indicated) for reproductive tract infections (RTIs) within 1 month of enrollment, and virologically suppressed using ART or above treatment threshold at enrollment (non-ART). Between October 2013, and December 2016, we randomized consenting women within ART groups, using 1:1 permuted block randomization stratified by ART use, age (18–23, 24–31, 32–40), and recent injectable progestin contraceptive (IPC) exposure, and provided the allocated IUC. At all visits, participants provided specimens for gVL (primary outcome), pVL, RTI, and pregnancy testing. We assessed gVL and pVL across 6 and 24 months controlling for enrollment measures, ART group, age, and RTI using generalized estimating equation and generalized linear models (non-ART group pVL and hemoglobin) in as-treated analyses. We measured IUC discontinuation rates with Kaplan-Meier estimates and Cox proportional hazards models. We enrolled 71 non-ART (36 LNG-IUS, 31 C-IUD; 2 declined and 2 were ineligible) and 134 ART-using (65 LNG-IUS, 67 C-IUD; 1 declined and 1 could not complete IUC insertion) women. Participant median age was 31 years, and 95% had 1 or more prior pregnancies. Proportions of women with detectable gVL were not significantly different comparing LNG-IUS to C-IUD across 6 (adjusted odds ratio [AOR]: 0.78, 95% confidence interval [CI] 0.44–1.38, p = 0.39) and 24 months (AOR: 1.03, 95% CI: 0.68–1.57, p = 0.88). Among ART users, proportions with detectable pVL were not significantly different at 6 (AOR = 0.83, 95% CI 0.37–1.86, p = 0.65) and 24 months (AOR = 0.94, 95% CI 0.49–1.81, p = 0.85), whereas among non-ART women, mean pVL was not significantly different at 6 months (−0.10 log10 copies/mL, 95% CI −0.29 to 0.10, p = 0.50) between LNG-IUS and C-IUD users. IUC continuation was 78% overall; C-IUD users experienced significantly higher expulsion (8% versus 1%, p = 0.02) and elective discontinuation (adjusted hazard ratio: 8.75, 95% CI 3.08–24.8, p < 0.001) rates. Sensitivity analysis adjusted for differential IUC discontinuation found similar gVL results. There were 39 serious adverse events (SAEs); SAEs believed to be directly related to IUC use (n = 7) comprised 3 pelvic inflammatory disease (PID) cases and 4 pregnancies with IUC in place with no discernible trend by IUC arm. Mean hemoglobin change was significantly higher among LNG-IUS users across 6 (0.57 g/dL, 95% CI 0.24–0.90; p < 0.001) and 24 months (0.71 g/dL, 95% CI 0.47–0.95; p < 0.001). Limitations included not achieving non-ART group sample size following change in ART treatment guidelines and truncated 24 months’ outcome data, as 17 women were not yet eligible for their 24-month visit at study closure. Also, a change in VL assay during the study may have caused some discrepancy in VL values because of different limits of detection. Conclusions In this study, we found that the LNG-IUS did not increase gVL or pVL and had low levels of contraceptive failure and associated PID compared with the C-IUD among WLHIV. LNG-IUS users were significantly more likely to continue IUC use and had higher hemoglobin levels over time. The LNG-IUS appears to be a safe contraceptive with regard to HIV disease and may be a highly acceptable option for WLHIV. Trial registration ClinicalTrials.gov NCT01721798., Catherine Todd and colleagues study an intrauterine contraceptive device in women with HIV infection., Author summary Why was this study done? Women living with HIV (WLHIV) infection must consider their contraceptive options in tandem with and complicated by potential interactions between hormonal contraception and HIV disease. These issues potentially contribute to lower use of highly effective hormonal contraceptive methods among WLHIV. Global use of intrauterine contraception (IUC), specifically the levonorgestrel intrauterine system (LNG-IUS), has increased across the last decade. However, there are few trials comparing safety of the LNG-IUS with that of the copper intrauterine device (C-IUD) among WLHIV and none focusing specifically on impact on HIV disease. What did the researchers do and find? In a randomized controlled trial in Cape Town, South Africa, 199 women with confirmed HIV seropositivity and not desiring pregnancy in the next 30 months were recruited and allocated, with 98 receiving the C-IUD and 101 the LNG-IUS. Participants had genital tract samples collected by menstrual cup and blood taken for genital and plasma viral load levels at enrollment and at 3-, 6-, 12-, 18-, and 24-month visits. Women could return at any time for unscheduled visits and remained in the study even if the IUC was removed on request. Women receiving the LNG-IUS did not have any significant difference in change in detectable genital tract viral load compared with C-IUD users, regardless of ART status. However, women receiving the C-IUD were more likely to have the IUC removed than those receiving the LNG-IUS through the study period. What do these findings mean? This study is among the first comparing a hormonal to nonhormonal long-acting reversible contraceptive method with genital tract HIV RNA as the primary outcome among WLHIV. These data suggest that LNG-IUS is as safe as the C-IUD for WLHIV and will strengthen international medical eligibility guidelines. The high continuation rates of the LNG-IUS, critically important for a device with a 5-year duration of use, should prompt including this method in the available method mix to promote the ability of WLHIV to meet their fertility goals.

Introduction Foreign‐born persons comprise ~13% of the US population. Immigrants, especially women, often face a complex set of social and structural factors that negatively impact health outcomes including greater risk of HIV infection. We described socio‐demographic, clinical and immunological characteristics and AIDs and non‐AIDS death among foreign‐born women living with HIV (FBWLWH) participating in the US Women’s Interagency HIV Study (WIHS) in the US from 1994 to 2016. We hypothesized that FBW will experience higher AIDS‐related mortality compared to US‐born women (USBW). Methods The WIHS is a multicenter prospective observational cohort study of mostly women living with HIV (WLWH). The primary exposure in this analysis, which focused on 3626 WLWH, was self‐reported country of birth collapsed into foreign‐born and US born. We assessed the association of birthplace with categorized demographic, clinical and immunological characteristics, and AIDS/non‐AIDS mortality of WLWH, using chi‐squared tests. Proportional hazard models examined the association of birthplace with time from enrolment to AIDS and non‐AIDS death. Results Of the 628 FBW, 13% were born in Africa, 29% in the Caribbean and 49% in Latin America. We observed significant differences by HIV status in socio‐demographic, clinical and immunological characteristics and mortality. For both AIDS and non‐AIDS caused deaths FBW WLWH had lower rates of death. Adjusting for year of study enrolment and other demographic/clinical characteristics mitigated FBW’s statistical survival advantage in AIDS deaths Relative Hazard (RH = 0.91 p = 0.53), but did not substantively change the survival advantage in non‐AIDS deaths RH = 0.33, p

Purpose To estimate time from seroconversion to diagnosis, researchers have modeled time based on CD4 decline, assuming the square root of the CD4 count decreases linearly over time before antiretroviral treatment (ART) initiation. If true, utilizing CD4 counts reported anytime in the pre-ART period would result in estimates of diagnosis delay that are not appreciably different. Methods We applied CD4 depletion model parameters from seroconverter cohorts to New York City residents diagnosed from 2006 to 2015, having two or more pre-ART CD4 counts. Results Median diagnosis delays based on first or second pre-ART CD4 counts were similar (n = 12,849; 2.8 years, interquartile range [IQR]: 0–7.7, and 2.8 years, IQR: 0–7.6, respectively; P = .09, Wilcoxon signed-rank test). Among people whose second pre-ART CD4 count was measured more than 6 months after diagnosis (n = 2761), the average diagnosis delay based on first pre-ART CD4 count was shorter (1.5 years, IQR: 0–5.4) than the second pre-ART CD4 count (1.7 years, IQR: 0–6.0) but not significantly (P = .12). Conclusions Results are consistent with the linearity assumption of the CD4 depletion model. To estimate population-level diagnosis delay, researchers may use pre-ART CD4 counts reported more than 6 months post-diagnosis.

Young black men and transgender women (transwomen) who have sex with men or transwomen are most vulnerable in terms of risk for HIV infection, also reflected in their extremely high incidence rates. As testing rates and pre-exposure prophylaxis (PrEP) uptake remain suboptimal among these groups, primarily due to unique structural barriers, the present analyses draw on data from an online survey, administered October 2014 to August 2015, to explore social support–related predictors of knowledge and behavior around HIV prevention. Participants were 169 biological men who identified as black, with a mean age of 24 (SD = 2.97, range 17–29); 8% identified as transwomen. Logistic regression models assessed whether HIV-related social support predicted HIV testing patterns, PrEP awareness, and use. Those with higher HIV-related social support reported having been more likely to have ever tested (adjusted odds ratio (aOR) = 1.48; p < 0.001) and tested in the past 6 months (aOR = 1.22; p < 0.01). They were also more likely to intend to test in the next 6 months (aOR = 1.16; p < 0.001), including at a medical office or community-based organization (aOR = 1.20; p < 0.001), yet less likely to intend to self-test (aOR = 0.81; p < 0.001). Lastly, higher social support was significantly associated with prior knowledge of self-testing (aOR = 1.19; p < 0.05), couples testing (aOR = 1.26; p < 0.001), and PrEP (aOR = 1.22; p < 0.01), as well as prevention self-efficacy (aOR = 1.30; p < 0.001), but inversely associated with prior self-testing (aOR = 0.80; p < 0.05). For young black men and transwomen who have sex with men or transwomen, HIV-related social support, which likely has a strong peer component, appears to be a facilitator of optimal testing and intentions to test, as well as awareness of novel prevention strategies (like self-testing or PrEP). However, community resourcefulness needs to be bolstered by other mechanisms, such as changes within healthcare settings, to increase actual use of novel prevention modalities.

Background HIV testing is critical to HIV prevention and care. Infrequent HIV testing and late HIV diagnosis have been observed among young Black men who have sex with men and transwomen. Novel interventions to increase HIV testing rates among young Black men who have sex with men and transwomen are needed. Methods A randomized controlled trial among 236 young Black men and transwomen who have sex with men or transwomen evaluated the efficacy of an intervention that included completion of a brief survey and receipt of a personalized recommendation of an optimal HIV testing approach. Participants completed a computerized baseline assessment and were randomized to electronically receive either a personalized recommendation or standard HIV testing information. Follow-up surveys were conducted online at 3 and 6 months. Results Retention was 92% and 93% at 3-month and 6-month follow-up, respectively. At baseline, 41% of participants reported that they tested for HIV in the past 3 months and another 25% between 4 and 6 months ago. Intent-to-treat analyses found that participants randomized to the experimental arm (personalized recommendation) were not significantly more likely to test for HIV compared with participants in the standard HIV testing information control arm at 3 months (76% vs. 71%; P = 0.40) and 6 months (73% vs. 72%; P = 0.81), respectively. Conclusions This study evaluated an innovative intervention to increase HIV testing by matching individuals to optimal HIV testing approaches. Participants in both arms increased past 3-month HIV testing, suggesting that providing information on options and/or raising risk awareness is sufficient to significantly increase HIV testing. Trial registration ClinicalTrial.gov NCT02834572 https://clinicaltrials.gov/ct2/show/NCT02834572.

Objectives African women are disproportionately affected by HIV infection and may experience non-AIDS-related complications associated with inflammation. High-sensitivity C-reactive protein (hsCRP), d-dimer and transthyretin have been examined as inflammatory markers elsewhere, but it is unclear how they change over time in HIV-negative or HIV-positive African women with or without antiretroviral therapy (ART) initiation. Methods We examined hsCRP, d-dimer and transthyretin levels at baseline and at follow-up of ≥2 years in 185 HIV-negative and 510 HIV-positive Rwandan women who were ART naive at study entry. Generalized estimating equations for each marker were used to investigate the association with HIV infection/CD4 count, ART and follow-up time. Results Compared with HIV-negative women, HIV-positive women had higher hsCRP and d-dimer and lower transthyretin concentrations, with greater differences at lower CD4 counts. After adjusting for CD4 count and other factors, ART was not significantly associated with log hsCRP (P = 0.36) at follow-up, but was independently associated with lower log d-dimer (P = 0.03) and higher transthyretin (P = 0.0008) concentrations. At ≥ 2 years of follow-up, hsCRP had not significantly changed in any group but log d-dimer had decreased significantly in all groups. Transthyretin declined significantly over time in HIV-negative women and HIV-positive non-ART initiators, but increased significantly in HIV-positive ART initiators. Conclusions HIV infection and advanced immune suppression were associated with higher hsCRP and d-dimer and lower transthyretin concentrations. ART (independently of CD4 changes) was significantly associated with decreases in d-dimer and increases in transthyretin, but, in contrast to other studies, was not associated with decreases in hsCRP. We found no change in hsCRP over time in any group.

BACKGROUND: Data on associations between abdominal fat depot mass and subclinical atherosclerosis are limited, especially in women with HIV. METHODS: We assessed cross-sectional associations of dual X-ray absorptiometry scan-derived estimates of visceral adipose tissue (VAT) and abdominal subcutaneous adipose tissue (SAT) with 3 measures of subclinical carotid artery atherosclerosis-- carotid artery stiffness (Young’s modulus of elasticity), presence of carotid artery lesions, and carotid artery intima-media thickness (cIMT)-- in a subsample of participants in the Women’s Interagency HIV Study. Statistical models adjusted for demographic variables, HIV serostatus, behavioral variables, and cardiovascular risk factors. RESULTS: There were 244 women with and 99 without HIV infection (median age 42, 62% black). VAT mass (but not SAT) was associated with greater carotid artery stiffness in a fully adjusted linear regression model, including adjustment for SAT (β = 11.3 log 10(3) N*M(−2) per kg VAT, 95% confidence interval [1.0, 21.7]). Greater SAT mass was associated with lower odds of having a carotid artery lesion in a fully adjusted model, including adjustment for VAT (adjusted odds ratio, 0.49 per kg of SAT [0.25, 0.94]). Neither VAT nor SAT was associated with cIMT. The VAT/SAT ratio was not statistically associated with any of the outcomes after covariate adjustment. CONCLUSIONS: In our cross-sectional study of women, the majority of whom had HIV, greater VAT mass was associated with increased carotid artery stiffness whereas greater SAT mass was associated with a reduced odds of prevalent carotid artery lesions.

OBJECTIVE: To determine if adjusted mortality, walking ability or return home differed after hip fracture surgery between Canada and the USA. DESIGN: Secondary analysis of the Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS) trial data. SETTING: Data were collected from 47 American and Canadian hospitals. PARTICIPANTS: Overall, 2016 subjects with a hip fracture (USA = 1222 (60.6%); Canada = 794 (39.4%)) were randomized to a liberal or restrictive transfusion strategy. Subjects were 50 years and older, with cardiovascular disease and/or risk factors and hemoglobin

Background: Hormonal contraceptives may increase genital tract HIV viral load (gVL) and risk for sexual transmission in women living with HIV (WLHIV). We compared detectable gVL and intrauterine contraceptive (IUC) continuation between levonorgestrel intrauterine system (LNG-IUS) versus copper intrauterine device (C-IUD) in Cape Town, South Africa. Methods: In this double-masked, randomised controlled trial, eligible WLHIV were: ages 18-40, not pregnant or desiring pregnancy within 30 months, and virologically-suppressed using antiretroviral therapy (ART) or with CD4+ lymphocyte count above treatment threshold at enrolment (non-ART). At enrolment, we randomised within ART groups and provided the allocated IUC to consenting women. At all visits, participants completed questionnaires and provided specimens for gVL, plasma VL, and pregnancy testing. We assessed gVL through six and 24 months controlling for baseline gVL, ART group, age, and reproductive tract infection. Results: We enrolled 67 non-ART (36 LNG-IUS, 31 C-IUD) and 132 ART-using (65 LNG-IUS, 67 C-IUD) women. Detectable gVL did not differ between LNGIUS compared to C-IUD across six (Adjusted Odds Ratio (AOR): 0·82, 95% Confidence Interval (CI): 0·46-1·47) and 24 months (AOR: 0·96, 95% CI: 0·63-1·45). Overall IUC continuation was 80%; C-IUD users experienced higher expulsion (8% vs 1%, p=0·02) and elective discontinuation (adjusted Hazard Ratio: 8·75, 95% CI: 3·08-24·8) rates. Interpretation: The LNG-IUS has no significant effect on gVL, and higher continuation rates when compared with the C-IUD, among WLHIV. Clinical Registration Number: NCT01721798. Funding Statement: Eunice Kennedy Shriver National Institute of Child Health and Human Development, U.S. National Institutes of Health (5R01HD071804); Preventive Technologies Agreement (No. GHO‑A‑00‑09‑00016-00), U.S. Agency for International Development. Declaration of Interests: The authors declare no competing interests. Ethics Approval Statement: The University of Cape Town and FHI 360 institutional review boards approved the study, and all participants provided written informed consent prior to trial participation.

Objective The aim of this study was to determine the associations between visceral adipose tissue (VAT) and abdominal subcutaneous adipose tissue (SAT) mass with homeostatic model assessment-insulin resistance (HOMA-IR) and incidence of diabetes mellitus in women with and without HIV infection. Design Cross-sectional design for associations between abdominal fat and HOMA-IR; longitudinal design for associations between abdominal fat and incident diabetes. Methods We assessed associations between dual X-ray absorptiometry scan-derived VAT and SAT with HOMA-IR in a subsample from the Women's Interagency HIV Study (n = 226 with and n = 100 without HIV) using linear regression. We evaluated associations of VAT, SAT and HOMA-IR with incident diabetes mellitus using Cox proportional hazards models. Results VAT mass was positively associated with log HOMA-IR in fully adjusted linear regression models stratified by HIV serostatus, including adjustment for SAT. During median follow-up of 10.6 years, incidence of diabetes was 1.63 [95% confidence interval (95% CI) 1.15-2.31] and 1.32 [95% CI 0.77-2.28] cases per 100 person-years in women with and without HIV (P = 0.52). In a fully adjusted model, baseline VAT (hazard ratio 2.64 per kg; 95% CI 1.14-6.12; P = 0.023) and SAT (hazard ratio 1.34 per kg; 95% CI 0.73-2.45; P = 0.35) were associated with incident diabetes, but the latter was not statistically significant. Conclusion VAT mass was independently associated with HOMA-IR in women with and without HIV and was independently associated with future development of diabetes.

Pain is frequent and underreported among HIV+ women. We determined occurrence and severity of pain, and types of pain treatments used among HIV+ and HIV− women. Cross-sectional analyses of pain as measured by the Brief Pain Inventory Short Form, and related pain therapies nested in the Women’s Interagency HIV Study (WIHS). Multiple variable linear regression models examined differences by HIV status in pain severity and pain interference in general activity, mood, ability to walk, work, relationships with others, sleep, and enjoyment of life. Among 1393 HIV+ and 587 HIV− participants with median age 47–48 years, there was no statistically significant difference in pain reported within the past week by HIV status (HIV+ 50% vs. 49% HIV−, p = 0.70). Ratings of pain severity and interference were similar between HIV+ and HIV− women, as was receipt of pain medication (58% HIV+ vs. 56% HIV−). Pain medications most frequently used were: NSAIDS (90% HIV+, 96% HIV−), opioids (65% HIV+, 67% HIV−), topical anesthetics (46% HIV+, 56% HIV−), muscle relaxants (23% HIV+, 14% HIV−), and anticonvulsants (23% HIV+, 14% HIV−). Nearly half of predominantly low income, minority women reported pain in the past week, and two-thirds reported opioid use for pain management. The occurrence, severity, and treatment of pain did not differ by HIV status, nor did report of pain interference with mood or function. Additional research is needed to better characterize pain etiology among HIV+ women in the era of potent antiretroviral therapy, and determine the extent to which pain severity and type of medication used for pain treatment impact HIV disease outcomes.

Background: HIV testing is a critical component of HIV prevention and care. Interventions to increase HIV testing rates among young black men who have sex with men (MSM) and black transgender women (transwomen) are needed. Personalized recommendations for an individual’s optimal HIV testing approach may increase testing. Objective: This randomized trial tests the hypothesis that a personalized recommendation of an optimal HIV testing approach will increase HIV testing more than standard HIV testing information. Methods: A randomized trial among 236 young black men and transwomen who have sex with men or transwomen is being conducted. Participants complete a computerized baseline assessment and are randomized to electronically receive a personalized HIV testing recommendation or standard HIV testing information. Follow-up surveys are conducted online at 3 and 6 months after baseline. Results: The All About Me randomized trial was launched in June 2016. Enrollment is completed and 3-month retention is 92.4% (218/236) and has exceeded study target goals. Conclusions: The All About Me intervention is an innovative approach to increase HIV testing by providing a personalized recommendation of a person’s optimal HIV testing approach. If successful, optimizing this intervention for mobile devices will widen access to large numbers of individuals. Trial Registration: ClinicalTrial.gov NCT02834572; https://clinicaltrials.gov/ct2/show/NCT02834572 (Archived by WebCite at http://www.webcitation.org/6vLJWOS1B) [JMIR Res Protoc 2017;6(12):e254]

Summary Background Blood transfusion might affect long-term mortality by changing immune function and thus potentially increasing the risk of subsequent infections and cancer recurrence. Compared with a restrictive transfusion strategy, a more liberal strategy could reduce cardiac complications by lowering myocardial damage, thereby reducing future deaths from cardiovascular disease. We aimed to establish the effect of a liberal transfusion strategy on long-term survival compared with a restrictive transfusion strategy. Methods In the randomised controlled FOCUS trial, adult patients aged 50 years and older, with a history of or risk factors for cardiovascular disease, and with postoperative haemoglobin concentrations lower than 100 g/L within 3 days of surgery to repair a hip fracture, were eligible for enrolment. Patients were recruited from 47 participating hospitals in the USA and Canada, and eligible participants were randomly allocated in a 1:1 ratio by a central telephone system to either liberal transfusion in which they received blood transfusion to maintain haemoglobin level at 100 g/L or higher, or restrictive transfusion in which they received blood transfusion when haemoglobin level was lower than 80 g/L or if they had symptoms of anaemia. In this study, we analysed the long-term mortality of patients assigned to the two transfusion strategies, which was a secondary outcome of the FOCUS trial. Long-term mortality was established by linking the study participants to national death registries in the USA and Canada. Treatment assignment was not masked, but investigators who ascertained mortality and cause of death were masked to group assignment. Analyses were by intention to treat. The FOCUS trial is registered with ClinicalTrials.gov, number NCT00071032. Findings Between July 19, 2004, and Feb 28, 2009, 2016 patients were enrolled and randomly assigned to the two treatment groups: 1007 to the liberal transfusion strategy and 1009 to the restrictive transfusion strategy. The median duration of follow-up was 3·1 years (IQR 2·4–4·1 years), during which 841 (42%) patients died. Long-term mortality did not differ significantly between the liberal transfusion strategy (432 deaths) and the restrictive transfusion strategy (409 deaths) (hazard ratio 1·09 [95% CI 0·95–1·25]; p=0·21). Interpretation Liberal blood transfusion did not affect mortality compared with a restrictive transfusion strategy in a high-risk group of elderly patients with underlying cardiovascular disease or risk factors. The underlying causes of death did not differ between the trial groups. These findings do not support hypotheses that blood transfusion leads to long-term immunosuppression that is severe enough to affect long-term mortality rate by more than 20–25% or cause of death. Funding National Heart, Lung, and Blood Institute.

BACKGROUND Initiation of antiretroviral therapy (ART) in the advanced stages of HIV infection remains a major challenge in sub-Saharan Africa. This study was conducted to better understand barriers and enablers to timely ART initiation in Rwanda where ART coverage is high and national ART eligibility guidelines first expanded in 2007-2008. METHODS Using data on 6326 patients (≥15 years) at five Rwandan clinics, we assessed trends and correlates of CD4 cell count at ART initiation and the proportion initiating ART with advanced HIV disease (CD4

For women, the high-risk sex script of condomless sex to maintain relationships with men is concerning, particularly in regard to heterosexual HIV acquisition. This secondary analysis of data from a clinical trial evaluated the effect of a 12-episode, web-based video series intervention, entitled Love, Sex, and Choices, versus a text message control on lowering the high-risk sex script. The sample comprised 238 predominately urban Black women, ages 18-29, having HIV sex risk behavior. Data were collected at baseline and 6 months post-intervention. The Sex Script Video Response score was used to measure a high-risk sex script. HIV sex risk behavior was measured by Vaginal Equivalent Episodes with high-risk partners. At baseline, lower education, younger age at first sexual intercourse, and alcohol/non-injection drug use before sex were positively associated with a high-risk sex script. At baseline, as the high-risk sex script increased by one log unit, sex risk behavior increased by 0.47 log units (p < 0.001), equivalent to a 60% increase in the geometric mean of sex risk behavior. ANCOVA analysis indicated that from baseline to 6-months post intervention, lowering the high-risk sex script by one unit was associated with an additional reduction of 0.26 units in sex risk behavior. Compared to the text messages, the LSC video series was associated with a 27% greater reduction in the geometric mean of the sex script (p = 0.03). Further investigation into the effect of lowering sex scripts to reduce sex risk behavior is recommended.

Background Although fracture rates are higher in HIV+ than HIV- women, whether HIV infection increases risk of falls is unclear. We determined the longitudinal occurrence and risk factors for falls in the Women's Interagency HIV Study (WIHS), and explored associations with cognitive complaints. Methods Recent (prior 6 months) self-reported falls were collected in 1,816 (1,250 HIV+; 566 HIV-) women over 24 months. Generalized estimating equation models using stepwise selection determined odds of any fall (versus none). Results HIV+ women were older than HIV- women (median 49 versus 47 years; P=0.0004), more likely to report neuropathy (20% versus 16%; P=0.023), and had greater central nervous system (CNS) medication use. At least one fall was reported in 41% HIV+ versus 42% HIV- women, including ≥2 falls in 25% HIV+ and 24% HIV-(overall P=0.30). Cognitive complaints were associated with falls among HIV+ (odds ratio [OR] 2.38; 95% CI 1.83, 3.09) and HIV- women (OR 3.43; 95% CI 2.37, 4.97); in adjusted models, cognitive complaints remained significant only in HIV- women (adjusted [aOR] 2.26; 95% CI 1.46, 3.48). Factors associated with any fall in adjusted analyses included: depressive symptoms and neuropathy (both HIV+ and HIV-); age, marijuana use, multiple CNS medications, and HCV infection (HIV+ only); and cognitive complaints, quality of life, hypertension and obesity (HIV- only). Conclusions Middle-aged HIV+ and HIV- women had similar fall rates. Among HIV+ women, factors affecting cognition such as age, depressive symptoms, marijuana use and multiple CNS medications were important predictors of falls, however, cognitive complaints were not.

Background: Regular human immunodeficiency virus (HIV) testing of persons at risk is critical to HIV prevention. Infrequent HIV testing and late diagnosis of HIV infection have been observed among young black men who have sex with men (MSM) and transwomen (transgender women)—two groups overrepresented in the HIV epidemic. Objective: The objective of this study was to inform the development of a brief mobile phone intervention to increase HIV testing among young black MSM and transwomen by providing a tailored recommendation of an optimal HIV testing approach. We identified demographic, behavioral, psychosocial, and sociostructural factors associated with intentions to use three specific HIV testing approaches: self-testing, testing at a clinic or other provider, and couples HIV testing and counseling (CHTC). Methods: Individuals were eligible for a Web-based survey if they were male at birth; were between the ages of 16 and 29 years; self-identified as black, African American, Caribbean black, African black, or multiethnic black; were not known to be HIV-infected; and reported insertive or receptive anal intercourse with a man or transwoman in the last 12 months. Recruitment occurred via banner advertisements placed on a range of social and sexual networking websites and apps in New York City and nationally, and via events attended by young black MSM and transwomen in New York City. Intention to test by each testing method was analyzed using logistic regression with best subset models and stepwise variable selection. Results: Among 169 participants, intention to use a self-test was positively associated with comfort in testing by a friend or a partner at home (Adjusted odds ratio, AOR, 2.40; 95% CI 1.09-5.30), and stigma or fear as a reason not to test (AOR 8.61; 95% CI 2.50-29.68) and negatively associated with higher social support (AOR 0.48; 95% CI 0.33-0.72) and having health insurance (AOR 0.21; 95% CI 0.09-0.54). Intention to test at a clinic or other provider was positively associated with self-efficacy for HIV testing (AOR 2.87; 95% CI 1.48-5.59) and social support (AOR 1.98; 95% CI 1.34-2.92), and negatively associated with a lifetime history of incarceration (AOR 0.37; 95% CI 0.16-0.89). Intention to test by CHTC was negatively associated with higher educational level (Some college or Associate’s degree vs high school graduate or less [AOR 0.81; 95% CI 0.39-1.70]; Bachelor’s degree or more vs high school graduate or less [AOR 0.28; 95% CI 0.11-0.70]). Conclusions: Unique factors were associated with intention to test using specific testing approaches. These data will be critical for the development of a tailored intervention that shows promise to increase comfort and experiences with a variety of testing approaches among young black MSM and transwomen.

Objectives Predicting mortality in middle-aged HIV-infected (HIV+) women on antiretroviral therapies (ART) is important for understanding the impact of HIV infection. Several health indices have been used to predict mortality in women with HIV infection. We evaluated: (1) an HIV biological index, Veterans Aging Cohort Study (VACS); (2) a physical index, Fried Frailty Index (FFI); and (3) a mental health index, Center for Epidemiologic Studies-Depression (CES-D). Proportional hazards regression analyses were used to predict death and included relevant covariates. Design Prospective, observational cohort. Setting Multicentre, across six sites in the USA. Participants 1385 multirace/ethnic ART-experienced HIV+ women in 2005. Primary and secondary outcomes All deaths, AIDS deaths and non-AIDS deaths up to ~8 years from baseline. Results Included together in one model, VACS Index was the dominant, significant independent predictor of all deaths within 3 years (HR=2.20, 95% CI 1.83, 2.65, χ2=69.04, p

BackgroundDespite the World Health Organization (WHO) regularly updating guidelines to recommend earlier initiation of antiretroviral therapy (ART) in children, timely enrollment into care and initiation of ART in sub-Saharan Africa in children lags behind that of adults. The impact of implementing increasingly less restrictive ART guidelines on ART initiation in Central Africa has not been described.Materials and methodsData are from the Central Africa International Epidemiologic Databases to Evaluate AIDS (IeDEA) pediatric cohort of 3,426 children (0-15 years) entering HIV care at 15 sites in Burundi, DRC, and Rwanda. Measures include CD4 count, WHO clinical stage, age, and weight-for-age Z score (WAZ), each at enrollment into HIV care and at ART initiation. Changes in the medians or proportions of each measure by year of enrollment and year of ART initiation were assessed to capture potential impacts of changing ART guidelines.ResultsMedian age at care enrollment decreased from 77.2 months in 2004-05 to 30.3 months in 2012-13. The median age at ART initiation (n = 2058) decreased from 83.0 months in 2004-05 to 66.9 months in 2012-13. The proportion of children ≤24 months of age at enrollment increased from 12.7% in 2004-05 to 46.7% in 2012-13, and from 9.6% in 2004-05 to 24.2% in 2012-13 for ART initiation. The median CD4 count at enrollment into care increased from 563 (IQR: 275, 901) in 2004-05 to 660 (IQR: 339, 1071) cells/μl in 2012-13, and the median CD4 count at ART initiation increased from 310 (IQR:167, 600) in 2004-05 to 589 (IQR: 315, 1113) cells/μl in 2012-13. From 2004-05 to 2012-13, median WAZ improved from -2 (IQR: -3.4, -1.1) to -1 (IQR: -2.5, -0.2) at enrollment in care and from -2 (IQR: -3.8, -1.6) to -1 (IQR: -2.6, -0.4) at ART initiation.Discussion and conclusionAlthough HIV-infected children ≤24 months of age accounted for half of all children enrolling in care in our cohort during 2012-13, they represented less than a quarter of all those who were initiated on ART during the same period. Further research is needed to identify barriers to timely diagnosis, linkage to care, and initiation of ART among children with HIV infection.

Background Gay, bisexual, and other men who have sex with men continue to bear a large burden of the HIV epidemic in the United States and are among the only populations with increasing incidence in recent years. Objective The Together 5000 (T5K) Study aimed to enroll a US-based, racially diverse sample of HIV-negative men, transmen, and transwomen who are not on pre-exposure prophylaxis (PrEP) into an observational cohort to inform the design, implementation, scale-up, and evaluation of HIV prevention programs. Methods We used internet-based strategies to enroll a large, racially diverse national sample of HIV-negative men, transmen, and transwomen aged 16 to 49 years at high risk of HIV acquisition via sexual networking apps. Study participants are contacted every 6 months (in between annual surveys) for a brief survey on HIV testing, HIV diagnosis, and PrEP use (ie, attempts to access, PrEP initiation, and PrEP discontinuation). Participants complete annual self-administered at-home HIV testing and Web-based surveys. Using baseline serologic data and self-reported HIV testing history, we reconstructed a cohort of persons who were HIV negative at 12 months before baseline to estimate HIV incidence leading up to cohort enrollment. Results The study sample included 8777 participants from all 50 US states, Puerto Rico, and Guam; 50.91% (4468/8777) were persons of color and 25.30% (2221/8777) were young individuals aged 16 to 24 years. Per eligibility criteria, all T5K participants reported having sex with >2 male partners in the 90 days before enrollment, self-reported not having been diagnosed with HIV, and were not actively taking PrEP. In addition, 79.39% (6968/8777) reported >2 insertive condomless anal sex (CAS) acts, 61.02% (5356/8777) reported >1 receptive CAS acts in the past 90 days. Furthermore, most (7525/8777, 85.74%) reported never having taken PrEP. In total, 70.25% (6166/8777) were sent a self-administered at-home HIV test kit and 82.29% (5074/6166) of those sent a kit returned a sample for testing. The HIV incidence rate during the 12-month period leading up to enrollment was estimated to be 2.41 (95% CI 2.02-2.90) per 100 person-years. Conclusions A large, national, and racially diverse fully Web-based cohort of HIV-negative men, transmen, and transwomen at high risk for HIV seroconversion has successfully been recruited into longitudinal follow-up. This cohort is at high risk for HIV acquisition and can provide important insights related to the real-world uptake, impact, and equity of HIV prevention interventions in the United States. Participants can be invited to participate in trials aimed at testing strategies to improve the uptake of and engagement in these interventions. International Registered Report Identifier (IRRID) RR1-10.2196/13715

BackgroundReproductive aging may impact the vaginal microbiome and genital tract mucosal immune environment and contribute to genital tract health in women living with and at-risk for HIV infection.MethodsA cross-sectional study of 102 HIV+ (51 premenopausal, 51 postmenopausal) and 39 HIV-uninfected (HIV-) (20 premenopausal, 19 postmenopausal) women was performed in Bronx and Brooklyn, NY. Cervicovaginal lavage (CVL) was collected for quantification of innate antimicrobial activity against E. coli, HSV-2 and HIV and immune mediators by Luminex and ELISA. Microbiome studies by qPCR and 16S rRNA sequencing were performed on vaginal swabs.ResultsHIV+ postmenopausal compared to premenopausal participants had lower median E. coli bactericidal activity (41% vs. 62%, p = 0.001), lower median gene copies of Lactobacillus crispatus (p = 0.005) and Lactobacillus iners (p = 0.019), lower proportions of Lactobacillus iners, higher proportions of Gardnerella and Atopobium vaginae and lower levels of human beta defensins (HBD-2, HBD-3) and secretory leukocyte protease inhibitor (SLPI), pConclusionsHIV+ postmenopausal compared to premenopausal participants have less CVL E. coli bactericidal activity, reflecting a reduction in Lactobacilli and a greater proportion of Gardnerella and A. vaginae, and more HSV-2 inhibitory activity, reflecting increased mucosal inflammation. The effect of menopause on mucosal immunity was greater in HIV+ participants, suggesting a synergistic impact. Promotion of a lactobacillus dominant vaginal microbiome and reduced mucosal inflammation may improve vaginal health and reduce risk for shedding of HIV and potential for HIV transmission in HIV+ menopausal women.

Objective: To assess the association of race with clinical outcomes in HIV-positive women on continuous HAART. Design: Prospective study that enrolled women from 1994 to 1995 and 2001 to 2002. Setting: Women's Interagency HIV Study, a community-based cohort in five US cities. Participants: One thousand, four hundred and seventy-one HIV-positive continuous HAART users. Main outcome measures: Times to AIDS and non-AIDS death and incident AIDS-defining illness (ADI) after HAART initiation. Results: In adjusted analyses, black vs. white women had higher rates of AIDS death [adjusted hazard ratio (aHR) 2.14, 95% confidence interval (CI) 1.30, 3.50; P = 0.003] and incident ADI (aHR 1.58, 95% CI 1.08, 2.32; P = 0.02), but not non-AIDS death (aHR 0.91, 95% CI 0.59, 1.39; P = 0.65). Cumulative AIDS death incidence at 10 years was 17.3 and 8.3% for black and white women, respectively. Other significant independent pre-HAART predictors of AIDS death included peak viral load (aHR 1.70 per log10, 95% CI 1.34, 2.16; P

Objective: Analyze statistical risks facing CMS and Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program (MSSP). Methods: We calculate the probability that shared savings formulas lead to inappropriate payment, payment denial, and/or financial penalties, assuming that ACOs generate real savings in Medicare spending ranging from 0–10%. We also calculate expected payments from CMS to ACOs under these scenarios. Results: The probability of an incorrect outcome is heavily dependent on ACO enrollment size. For example, in the MSSP two-sided model, an ACO with 5,000 enrollees that keeps spending constant faces a 0.24 probability of being inappropriately rewarded for savings and a 0.26 probability of paying an undeserved penalty for increased spending. For an ACO with 50,000 enrollees, both of these probabilities of incorrect outcomes are equal to 0.02. The probability of inappropriate payment denial declines as real ACO savings increase. Still, for ACOs with 5,000 patients, the probability of denial is at least 0.15 even when true savings are 5–7%. Depending on ACO size and the real ACO savings rate, expected ACO payments vary from $115,000 to $35.3 million. Discussion: Our analysis indicates there may be greater statistical uncertainty in the MSSP than previously recognized. CMS and ACOs will have to consider this uncertainty in their financial, administrative, and care management planning. We also suggest analytic strategies that can be used to refine ACO payment formulas in the longer term to ensure that the MSSP (and other ACO initiatives that will be influenced by it) work as efficiently as possible.

We examined whether established associations between HIV disease and HIV disease progression on worse health-related quality of life (HQOL) were applicable to women with severe trauma histories, in this case Rwandan women genocide survivors, the majority of whom were HIV-infected. Additionally, this study attempted to clarify whether post-traumatic stress symptoms were uniquely associated with HQOL or confounded with depression.The Rwandan Women's Interassociation Study and Assessment was a longitudinal prospective study of HIV-infected and uninfected women. At study entry, 922 women (705 HIV+ and 217 HIV-) completed measures of symptoms of post-traumatic stress and HQOL as well as other demographic, clinical, and behavioral characteristics.Even after controlling for potential confounders and mediators, HIV+ women, in particular those with the lowest CD4 counts, scored significantly worse on HQOL and overall quality of life (QOL) than did HIV- women. Even after controlling for depression and HIV disease progression, women with more post-traumatic stress symptoms scored worse on HQOL and overall QOL than women with fewer post-traumatic stress symptoms.This study demonstrated that post-traumatic stress symptoms were independently associated with HQOL and overall QOL, independent of depression and other confounders or potential mediators. Future research should examine whether the long-term impact of treatment on physical and psychological symptoms of HIV and post-traumatic stress symptoms would generate improvement in HQOL.

The United States HIV epidemic disproportionately affects Black and Hispanic men who have sex with men (MSM). This disparity might be partially explained by differences in social and sexual network structure and composition. A total of 1267 MSM in New York City completed an ACASI survey and egocentric social and sexual network inventory about their sex partners in the past 3 months, and underwent HIV testing. Social and sexual network structure and composition were compared by race/ethnicity of the egos: black, non-Hispanic (N = 365 egos), white, non-Hispanic (N = 466), and Hispanic (N = 436). 21.1% were HIV-positive by HIV testing; 17.2% reported serodiscordant and serostatus unknown unprotected anal/vaginal intercourse (SDUI) in the last 3 months. Black MSM were more likely than white and Hispanic MSM to report exclusively having partners of same race/ethnicity. Black and Hispanic MSM had more HIV-positive and unknown status partners than white MSM. White men were more likely to report overlap of social and sex partners than black and Hispanic men. No significant differences by race/ethnicity were found for network size, density, having concurrent partners, or having partners with ≥10 years age difference. Specific network composition characteristics may explain racial/ethnic disparities in HIV infection rates among MSM, including HIV status of sex partners in networks and lack of social support within sexual networks. Network structural characteristics such as size and density do not appear to have such an impact. These data add to our understanding of the complexity of social factors affecting black MSM and Hispanic MSM in the U.S.