Incidence of Hyperlipidemia among Adults Initiating Antiretroviral Therapy in the HIV Outpatient Study (HOPS), USA, 2007-2021.

Current U.S. guidelines recommend integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) as initial treatment for people with HIV (PWH). We assessed long-term effects of INSTI use on lipid profiles in routine HIV care. We analyzed medical record data from the HIV Outpatient Study's participants in care from 2007 to 2021. Hyperlipidemia was defined based on clinical diagnoses, treatments, and laboratory results. We calculated hyperlipidemia incidence rates and rate ratios (RRs) during initial ART and assessed predictors of incident hyperlipidemia by using Poisson regression. Among 349 eligible ART-naïve PWH, 168 were prescribed INSTI-based ART (36 raltegravir (RAL), 51 dolutegravir (DTG), and 81 INSTI-others (elvitegravir and bictegravir)) and 181 non-INSTI-based ART, including 68 protease inhibitor (PI)-based ART. During a median follow-up of 1.4 years, hyperlipidemia rates were 12.8, 22.3, 22.7, 17.4, and 12.6 per 100 person years for RAL-, DTG-, INSTI-others-, non-INSTI-PI-, and non-INSTI-non-PI-based ART, respectively. In multivariable analysis, compared with the RAL group, hyperlipidemia rates were higher in INSTI-others (RR = 2.25; 95% confidence interval (CI): 1.29-3.93) and non-INSTI-PI groups (RR = 1.89; CI: 1.12-3.19) but not statistically higher for the DTG (RR = 1.73; CI: 0.95-3.17) and non-INSTI-non-PI groups (RR = 1.55; CI: 0.92-2.62). Other factors independently associated with hyperlipidemia included older age, non-Hispanic White race/ethnicity, and ART without tenofovir disoproxil fumarate. PWH using RAL-based regimens had lower rates of incident hyperlipidemia than PWH receiving non-INSTI-PI-based ART but had similar rates as those receiving DTG-based ART, supporting federal recommendations for using DTG-based regimens as the initial therapy for ART-naïve PWH.

Longitudinal Changes in, and Factors Associated with, the Frequency of Condomless Sex Among People in Care for HIV Infection, HIV Outpatient Study USA, 2007-2019.

During 2007-2019, the percentage of HIV Outpatient Study participants reporting anal or vaginal condomless sex in the past 6 months ranged from a low of 17% among heterosexual males to 59% for men who have sex with men (MSM). MSM reported having had condomless sex more frequently than heterosexual males and females and were the only group in which an increase in condomless sex was observed during the study period (from 39 to 59%). Although persons with undetectable HIV viral load have effectively no risk of transmitting HIV sexually (U = U), there is still the potential risk of transmission or acquisition of other sexually transmitted infections (STIs) when engaging in condomless sex. Continuing education about risks of HIV and STI transmission as well as ongoing screening for and treatment of STIs, retention in HIV treatment, and support for sexual health are critical components of care for people living with HIV.

Rates of suicidal ideation among HIV-infected patients in care in the HIV Outpatient Study 2000-2017, USA.

BACKGROUND: Suicidal ideation (SI) refers to an individual thinking about, considering or planning suicide. Identifying and characterizing persons with HIV (PWH) at greater risk for SI may lead to better suicide prevention strategies and quality of life improvement. METHODS: Using clinical data gathered from medical chart abstraction for HIV Outpatient Study (HOPS) participants from 2000 to 2017, we assessed SI frequency among PWH in care and explored factors associated with the presence of SI diagnoses using linear mixed models analyses. RESULTS: Among 6706 participants, 224 (3.3%) had a charted diagnosis of SI. Among those with SI, median age (interquartile range [IQR]) was 43.4 years [IQR: 38.7-50.3], median (IQR) CD4+ cell count was 439 cells/mm3 (IQR: 237-686), 71.4% were male, 54% were men who have sex with men (MSM), 25.4% heterosexual, and 13.4% persons who inject drugs. In multivariable analysis, persons at increased risk for SI were more likely to be: <50 years old (adjusted rate ratio [aRR] 1.86, 95% confidence interval [95%CI] 1.36-2.53), non-Hispanic/Latino black (aRR 1.75; 95%CI 1.29-2.38), have CD4+ cell count <350 cells/mm3 (aRR 1.32; 95%CI 1.05-1.65), have a viral load ≥50 copies/mL (aRR 1.49; 95%CI 1.12-1.98), have stopped antiretroviral therapy (aRR 1.46; 95%CI 1.10-1.95), have a history of: alcohol dependence (aRR 2.75; 95%CI 1.67-4.52), and drug overdose (aRR 4.09; 95%CI 2.16-7.71). CONCLUSION: Routine mental health assessment and monitoring are needed in HIV clinical practice to better understand factors associated with SI and to inform the development of preventive interventions.

Correction: Trends of racial and ethnic disparities in virologic suppression among women in the HIV Outpatient Study, USA, 2010-2015.

[This corrects the article DOI: 10.1371/journal.pone.0189973.].

Trends of racial and ethnic disparities in virologic suppression among women in the HIV Outpatient Study, USA, 2010-2015.

In the United States, women accounted for 19% of new HIV diagnoses in 2015 and were less likely to reach virologic suppression when compared to men. We assessed trends and disparities in virologic suppression among HIV-positive women to inform HIV treatment strategies. Data were from a prospective cohort of the HIV Outpatient Study and collected at nine United States HIV clinics. We included women aged ≥18 years, with ≥1 visit, who were prescribed antiretroviral therapy, and had ≥1 viral load test performed between 2010 and 2015. We defined virologic suppression as viral load <50 copies/mL and calculated adjusted prevalence ratios (aPR) with 95% confidence intervals (CI) for virologic suppression by race/ethnicity and year of measure. Generalized estimating equations were used for multivariable analyses to assess factors associated with virologic suppression. Among 809 women (median age = 44 years), 482 (60%) were black, 177 (22%) white, 150 (19%) Hispanic/Latina. Virologic suppression was less prevalent among black women (73%) compared with Hispanic/Latina women (83%) and white women (91%). In multivariable analyses, not achieving virologic suppression was more likely among black women (aPR = 2.13; CI = 1.50-3.02) or Hispanic/Latina women (aPR = 1.66; CI = 1.08-2.56) compared with white women, and among women who attended public clinics (aPR = 1.42; CI = 1.07-1.87) compared with those who attended a private clinic. Between 2010 and 2015, virologic suppression among HIV-positive women increased from 68% to 83%, but racial/ethnic disparities persisted. Black and Hispanic/Latina women had significantly lower rates of virologic suppression than white women. Interventions targeting virologic suppression improvement among HIV-positive women of color, especially those who attend public clinics, are warranted.

Disparities in HIV Viral Load Suppression by Race/Ethnicity Among Men Who Have Sex with Men in the HIV Outpatient Study.

Maximizing the rates of virologic suppression (VS) among gay, bisexual, and other men who have sex with men (MSM) is essential to limiting HIV morbidity and sexual transmission of HIV in the United States. We analyzed data for MSM of non-Hispanic white (white), non-Hispanic black (black), or Hispanic/Latino race/ethnicity in the HIV Outpatient Study (HOPS) at nine U.S. HIV clinics. VS (HIV RNA <50 copies/ml) was measured closest to January 1, 2015. We modeled factors associated with VS among persons prescribed antiretroviral therapy (ART) for ≥6 months and assessed VS for a subset of participants with behavioral interview data. Among 1,303 MSM studied, 24% were black and 11% were Hispanic/Latino. Fewer black than white or Hispanic/Latino MSM had any documented ART use history (92% vs. 99% and 94%, respectively), and fewer had VS (72% vs. 91% and 81%), p < .001. In analyses of MSM prescribed ART, which adjusted for insurance type, duration of ART use, and CD4+ cell count, blacks had lower prevalence of VS than whites [adjusted prevalence ratio (PR) 0.87, confidence interval (95% CI) 0.81-0.93] and Hispanics/Latinos did not (PR 0.95, 95% CI 0.88-1.02). Among 331 MSM with interview data, 6% had no VS, but reported anal sex without a condom with an HIV-uninfected or unknown HIV serostatus male partner in the past 6 months. In this study of HIV-infected MSM, blacks had a significantly lower prevalence of VS than white men. Optimizing HIV care and prevention among all MSM will require addressing underlying risk factors and social determinants of health that contribute to racial/ethnic disparities in HIV outcomes.

Developing a Motion Comic for HIV/STD Prevention for Young People Ages 15-24, Part 2: Evaluation of a Pilot Intervention.

In the United States, young people (ages 15-24 years) are disproportionately affected by human immunodeficiency virus (HIV) and other sexually transmitted diseases (STDs), due at least in part to inadequate or incorrect HIV/STD-related knowledge, attitudes, beliefs, and behavioral intentions (KABI). Comic book narratives are a proven method of HIV/STD prevention communication to strengthen KABI for HIV/STD prevention. Motion comics, a new type of comic media, are an engaging and low-cost means of narrative storytelling. The objective of this study was to quantitatively evaluate the effectiveness of a pilot six-episode HIV/STD-focused motion comic series to improve HIV/STD-related KABI among young people. We assessed change in HIV/STD knowledge, HIV stigma, condom attitudes, HIV/STD testing attitudes, and behavioral intentions among 138 participants in 15 focus groups immediately before and after viewing the motion comic series. We used paired t-tests and indicators of overall improvement to assess differences between surveys. We found a significant decrease in HIV stigma (p < .001) and increases in both HIV knowledge (p = .002) and behavioral intentions to engage in safe sex (p < .001). In summary, this motion comic intervention improved HIV/STD-related KABI of young adult viewers by reducing HIV stigma and increasing behavioral intentions to engage in safer sex. Our results demonstrate the promise of this novel intervention and support its use to deliver health messages to young people.

Sexually Transmitted Disease Testing of Human Immunodeficiency Virus-Infected Men Who Have Sex With Men: Room for Improvement.

BACKGROUND: In the United States, sexually transmitted infection (STI) testing is recommended at least annually for sexually active men who have sex with men (MSM). We evaluated human immunodeficiency virus (HIV) providers' STI testing practices and frequency of positive test results. METHODS: We analyzed data from HIV Outpatient Study (HOPS) participants who, from 2007 to 2014, completed a confidential survey about risk behaviors. Using medical records data, we assessed the frequency of gonorrhea, chlamydia, and syphilis testing and positive results during the year after the survey for MSM who reported sex without a condom in the prior 6 months. We compared testing frequency and positivity for men having 1, 2 to 3, and 4 or more sexual partners. Correlates of STI testing were assessed using general linear model to derive relative risks (RR) with associated 95% confidence intervals (CI). RESULTS: Among 719 MSM, testing frequency was 74.5%, 74.3%, and 82.9% for gonorrhea, chlamydia, and syphilis, respectively, and was higher in those men who reported more sexual partners (P < 0.001 for all). In multivariable analysis, testing for gonorrhea was significantly more likely among non-Hispanic black versus white men (RR, 1.17; 95% CI, 1.03-1.33), among men seen in private versus public clinics (RR, 1.16; 95% CI, 1.05-1.28), and among men with 2 to 3 and 4 or more sexual partners versus 1 partner (RR, 1.12; 95% CI, 1.02-1.23, and RR, 1.18; 95% CI, 1.08-1.30, respectively). Correlates of chlamydia and syphilis testing were similar. Test positivity was higher among men with more sexual partners: for gonorrhea 0.0%, 3.0%, and 6.7% for men with 1, 2 to 3, and 4 or more partners, respectively (P < 0.001, syphilis 3.7%, 3.8% and 12.5%, P < 0.001). CONCLUSIONS: Among HIV-infected MSM patients in HIV care who reported sex without a condom, subsequent testing was not documented in clinic records during the following year for up to a quarter of patients. Exploring why STI testing did not occur may improve patient care.

Retention in care within 1 year of initial HIV care visit in a multisite US cohort: who's in and who's out?

Biannual attendance at medical visits is an established measure of retention in HIV care. We examined factors associated with attending at least 2 clinic visits at least 90 days apart among HIV-infected, antiretroviral therapy (ART)-naive HIV Outpatient Study participants entering care during 2000 to 2011. Of 1441 patients, 85% were retained in care during the first year of observation. Starting ART during the year was the strongest correlate of retention (adjusted odds ratio [aOR] 6.4, 95% confidence interval [CI] 4.4-9.4). After adjusting for starting ART, publicly insured patients (aOR 0.6, 95% CI 0.4-1.0), and patients with baseline CD4 counts <200 cells/mm(3) (aOR 0.5, 95% CI 0.3-0.9) or missing CD4 counts (aOR 0.3, 95% CI 0.2-0.6) were less likely to be retained in care. Although most patients had recommended biannual care visits, some ART-naive individuals may require additional interventions to remain in care. Promptly initiating ART may facilitate engagement in care.

Sexual risk behavior and viremia among men who have sex with men in the HIV Outpatient Study, United States, 2007-2010.

BACKGROUND: Recent US data on unsafe sexual behaviors among viremic HIV-infected men who have sex with men (MSM) are limited. METHOD: Using data abstracted from medical records of the participants in the HIV Outpatient Study (HOPS) and a supplemental behavioral survey, we assessed the frequency of high-risk sexual practices among HIV-infected MSM in care and examined the factors associated with risky sexual practices. We also compared the frequency of unprotected anal sex (UAS) with HIV-negative or unknown serostatus partners among viremic (HIV viral load ≥400 copies per milliliter) vs virologically suppressed (HIV viral load <400 copies per milliliter) MSM. RESULTS: Among 902 HIV-infected MSM surveyed, 704 (78%) reported having sex in the past 6 months, of whom 54% reported UAS (37% insertive, 42% receptive) and 40% UAS with a male partner who was HIV-negative or of unknown serostatus (24% insertive, 31% receptive). In multivariable regression with an outcome of engaging in any UAS with a male partner who was HIV-negative or of unknown serostatus, MSM aged <50 years, who reported injection drug use risk, had ≥2 sex partners, and who disclosed their HIV status to some but not to all of their sex partners were more likely to report this practice. Among MSM who reported any UAS, 15% were viremic; frequency of the UAS did not differ between viremic and virologically suppressed MSM. CONCLUSIONS: The high frequency of UAS with HIV-negative or unknown-status partners among HIV-infected MSM in care suggests the need for targeted prevention strategies for this population.

Immune reconstitution inflammatory syndrome: incidence and implications for mortality.

OBJECTIVE: To describe incidence of immune reconstitution inflammatory syndrome (IRIS) and its association with mortality in a large multisite US HIV-infected cohort applying an objective, comprehensive definition. DESIGN: We studied 2,610 patients seen during 1996-2007 who initiated or resumed highly active combination antiretroviral therapy (cART) and, during the next 6 months, demonstrated a decline in plasma HIV-RNA viral load of at least 0.5 log(10) copies/ml or an increase of at least 50% in CD4 cell count per microliter. We defined IRIS as the diagnosis of a type B or C condition [as per the Centers for Disease Control and Prevention (CDC) 1993 AIDS case definition] or any new mucocutaneous disorder during this same 6-month period. METHODS: We assessed the incidence of IRIS and evaluated risk factors for IRIS using conditional logistic regression and for all-cause mortality using proportional hazards models. RESULTS: We identified 370 cases of IRIS (in 276 patients). Median and nadir CD4 cell counts at cART initiation were 90 and 43 cells/µl, respectively; median viral load was 2.7 log(10) copies/ml. The most common IRIS-defining diagnoses were candidiasis (all forms), cytomegalovirus infection, disseminated Mycobacterium avium intracellulare, Pneumocystis pneumonia, varicella zoster, Kaposi's sarcoma and non-Hodgkin lymphoma. Only one case of Mycobacterium tuberculosis was observed. IRIS was independently associated with CD4 cell count less than 50 cells/µl vs. at least 200 cells/µl [odds ratio (OR) 5.0] and a viral load of at least 5.0 log(10) copies vs. less than 4.0 log(10) copies (OR 2.3). IRIS with a type B-defining or type C-defining diagnosis approximately doubled the risk for all-cause mortality. CONCLUSION: In this large US-based HIV-infected cohort, IRIS occurred in 10.6% of patients who responded to effective ART and contributed to increased mortality.

CD4 Cell Counts at HIV Diagnosis among HIV Outpatient Study Participants, 2000-2009.

Background. It is unclear if CD4 cell counts at HIV diagnosis have improved over a 10-year period of expanded HIV testing in the USA. Methods. We studied HOPS participants diagnosed with HIV infection ≤6 months prior to entry into care during 2000-2009. We assessed the correlates of CD4 count <200 cells/mm(3) at HIV diagnosis (late HIV diagnosis) by logistic regression. Results. Of 1,203 eligible patients, 936 (78%) had a CD4 count within 3 months after HIV diagnosis. Median CD4 count at HIV diagnosis was 299 cells/mm(3) and did not significantly improve over time (P = 0.13). Comparing periods 2000-2001 versus 2008-2009, respectively, 39% and 35% of patients had a late HIV diagnosis (P = 0.34). Independent correlates of late HIV diagnosis were having an HIV risk other than being MSM, age ≥35 years at diagnosis, and being of nonwhite race/ethnicity. Conclusions. There is need for routine universal HIV testing to reduce the frequency of late HIV diagnosis and increase opportunity for patient- and potentially population-level benefits associated with early antiretroviral treatment.

Increased mortality among publicly insured participants in the HIV Outpatient Study despite HAART treatment.

OBJECTIVE: Understanding mortality differences among HIV-infected patients can focus efforts to improve survival. DESIGN: We evaluated death rates, causes, and associated factors among treated patients in the HIV Outpatient Study (HOPS), a large, prospective, multicenter observational cohort of HIV-infected persons seen at a diverse set of US sites of care. METHODS: Among 3754 HOPS participants seen during 1996-2007 with at least 6 months of follow-up after initiating HAART and receiving HAART at least 75% of time under observation ('substantially treated'), we calculated hazard ratios for death using proportional hazards regression models. We also examined death causes and comorbidities among decedents. RESULTS: Substantially treated participants, followed a median 4.7 years (interquartile range, 2.2-8.5), experienced 331 deaths. In multivariable analyses, higher mortality was associated with an index CD4 cell count less than 200 cells/µl [adjusted hazard ratio (aHR), 2.86; 95% confidence interval (CI) 1.95-4.21], older age (aHR, 1.50 per 10 years; 95% CI 1.33-1.70), log(10)HIV RNA (aHR, 1.67 per log(10); 95% CI 1.51-1.85), but not race/ethnicity (aHR, 0.99 for blacks vs. whites, P = 0.92). Mortality was increased among publicly insured (PUB) vs. privately insured participants (PRV) when index CD4 cell count was at least 200 cells/µl (aHR, 2.03; 95% CI 1.32-3.14) but not when index CD4 cell count was less than 200 cells/µl (aHR, 1.3, P = 0.13). By death cause, PUB had significantly more cardiovascular events and hepatic disorders than PRV. Comorbidities more frequent among PUB vs. PRV decedents included cardiovascular disease, renal impairment, and chronic hepatitis. CONCLUSION: Among HAART-treated participants with CD4 cell counts at least 200 cells/µl, PUB experienced higher death rates than PRV. Non-AIDS death and disease causes predominated among publicly insured decedents, suggesting that treatable comorbidities contributed to survival disparities.

Rates and correlates of influenza vaccination among HIV-infected adults in the HIV Outpatient Study (HOPS), USA, 1999-2008.

BACKGROUND: We sought to describe rates of vaccination among HIV-infected adults in care and identify factors associated with vaccination. METHODS: Using data abstracted from medical records of participants in the HIV Outpatient Study (HOPS) during 8 influenza seasons (1999-2008) and negative binomial models with generalized estimating equation methods, we examined factors associated with increased prevalence of annual influenza vaccination. RESULTS: Among active patients, 25.8% to 43.3% were vaccinated for influenza each year (annual mean=35%, test for trend p=0.71). Vaccination rates peaked in October and November of each season and decreased sharply thereafter. In multivariable analysis, patients who were male (67.2%), non-Hispanic white (70%) or Hispanic (66%), had lower HIV viral loads (73.5%), were prescribed antiretroviral treatment (72.7%), or had a greater number of clinical encounters per year (86.7%) were more likely to receive influenza vaccination. DISCUSSION: The decreased likelihood of vaccination among women and non-Hispanic black patients suggests the need for focused efforts to reduce disparities. Increasing patient and clinician education on the importance of universal vaccination, and ensuring that vaccination activities continue in HIV clinics during the later months of the influenza season may improve influenza vaccine coverage.