Data from 6 human immunodeficiency virus clinics showed improvements in clinic attendance after versus before a clinic-wide intervention (7% on short-term measure; 3% on longer-term measure). Several subgroups showed larger improvements: younger patients, new or reengaging patients, and patients with elevated viral loads.
Background. Retention in care for human immunodeficiency virus (HIV)–infected patients is a National HIV/AIDS Strategy priority. We hypothesized that retention could be improved with coordinated messages to encourage patients' clinic attendance. We report here the results of the first phase of the Centers for Disease Control and Prevention/Health Resources and Services Administration Retention in Care project.
Methods. Six HIV-specialty clinics participated in a cross-sectionally sampled pretest-posttest evaluation of brochures, posters, and messages that conveyed the importance of regular clinic attendance. 10 018 patients in 2008–2009 (preintervention period) and 11 039 patients in 2009–2010 (intervention period) were followed up for clinic attendance. Outcome variables were the percentage of patients who kept 2 consecutive primary care visits and the mean proportion of all primary care visits kept. Stratification variables were: new, reengaging, and active patients, HIV RNA viral load, CD4 cell count, age, sex, race or ethnicity, risk group, number of scheduled visits, and clinic site. Data were analyzed by multivariable log-binomial and linear models using generalized estimation equation methods.
Results. Clinic attendance for primary care was significantly higher in the intervention versus preintervention year. Overall relative improvement was 7.0% for keeping 2 consecutive visits and 3.0% for the mean proportion of all visits kept (P < .0001). Larger relative improvement for both outcomes was observed for new or reengaging patients, young patients and patients with elevated viral loads. Improved attendance among the new or reengaging patients was consistent across the 6 clinics, and less consistent across clinics for active patients.
Conclusion. Targeted messages on staying in care, which were delivered at minimal effort and cost, improved clinic attendance, especially for new or reengaging patients, young patients, and those with elevated viral loads.
The success of antiretroviral therapy (ART) has led to dramatic changes in causes of morbidity and mortality in HIV-infected individuals. As chronic diseases rates have increased in HIV+ populations, modifiable risk factors such as obesity have increased in importance. Our objective was to evaluate factors associated with weight change among patients receiving ART.
ART-naïve patients initiating therapy at the University of Alabama - Birmingham 1917 HIV/AIDS Clinic from 2000– 2008 were included. Body Mass Index (BMI) was categorized as: underweight (<18.5), normal weight (18.5–24.9), overweight (25–29.9) and obese (≥30). Linear regression models were used to evaluate overall change in BMI and factors associated with increased BMI category 24 months following ART initiation.
Among 681 patients, the mean baseline BMI was 25.4 ± 6.1; 44% of patients were overweight/obese. At 24 months, 20% of patients moved from normal to overweight/obese or overweight to obese BMI categories. Greater increases in BMI were observed in patients with baseline CD4 count < 50 cells/μl (3.4 ± 4.1, P<0.01) and boosted protease inhibitor use (2.5±4.1 P=0.01), but did not account for all of the variation observed in weight change.
The findings that almost half of patients were overweight or obese at ART initiation, and 1 in 5 patients moved to a deleterious BMI category within 2 years of ART initiation are alarming. ART therapy provides only a modest contribution to weight gain in patients. Obesity represents a highly prevalent condition in patients with HIV infection and an important target for intervention.
obesity; HIV; body mass index
HIV-infected individuals frequently experience traumatic and stressful events such as sexual and physical assault; housing instability; and major financial, employment, and legal difficulties. Past trauma history predicts poorer medication adherence and health outcomes, yet little research has examined the influence of incident stressful experiences on antiretroviral medication adherence and treatment outcomes.
We prospectively measured incident stressful and traumatic events, medication adherence, and viral load over 27 months in an 8-site, 5-state study. Using multivariable logistic and generalized estimating equation modeling, we assessed the impact of incident stressful events on 27-month changes in self-reported medication adherence and virologic failure (viral load ≥400 c/mL).
Of 474 participants on antiretroviral therapy at baseline, 289 were interviewed and still on treatment at 27 months. Participants experiencing the median number of incident stressful events (n=9) had over twice the predicted odds (OR=2.32) of antiretroviral medication non-adherence at follow-up compared to those with no events. Stressful events also predicted increased odds of virologic failure during follow-up (OR=1.09 per event).
Incident stressful events are exceedingly common in the lives of HIV-infected individuals and negatively impact antiretroviral medication adherence and treatment outcomes. Interventions to address stress and trauma are needed to improve HIV outcomes.
HIV; AIDS; Stress; Adherence; Virologic failure; Disparities
To assess the association between incident stressful life events (e.g., sexual and physical assault; housing instability; and major financial, employment, and legal difficulties) and unprotected anal or vaginal sexual intercourse (unprotected sex) among people living with HIV/AIDS (PLWHA).
We assessed incident stressful events and unprotected sex over 27 months in 611 participants in an 8-site, 5-state study in the Southeast US. Using mixed-effects logistic models and separately estimating between-person and within-person associations, we assessed the association of incident stressful events with unprotected sex with all partners, HIV+ partners, and HIV−/serostatus-unknown partners.
Incident stressful events reported at one-third or more of interviews included major illness, injury or accident (non-HIV related); major illness of a family member/close friend; death of a family member/close friend; financial stresses; and relationship stresses. In multivariable models, each additional moderately stressful event an individual experienced at a given time point above his or her norm (within-person association) was associated with a 24–27% increased odds of unprotected sex for each partner type.
Risk reduction among PLWHA remains a major focus of efforts to combat the HIV epidemic. Incident stressful events are exceedingly common in the lives of PLWHA and are associated with increased unprotected sex. Efforts to either prevent the occurrence of such events (e.g., financial or relationship counseling) or address their sequelae (e.g., coping skills or other behavioral counseling) may help reduce secondary HIV transmission.
HIV; AIDS; Stress; Transmission; Risk behaviors
The AIDS Drug Assistance Program (ADAP) provides antiretroviral medications to low-income individuals with HIV infection.
A prospective cohort study of ADAP utilization, measured using medication possession ratio (MPR), was conducted during the 2008 calendar year at the University of Alabama at Birmingham 1917 HIV Clinic. Multivariable ordinal logistic regression evaluated factors associated with ADAP utilization.
Among 245 patients, MPR quartiles (Q) were the following: Q1<69 percent, Q2 = 69–83 percent, Q3 = 84–93 percent, Q4>93 percent. In ordinal logistic regression, younger age (OR = 0.59 per 10 years; 95 percent CI = 0.44–0.79), nonwhite males (2.18; 1.18–4.04), lower CD4 count (2.79 for <200 cells/mm3; 1.44–5.43), and a history of alcohol abuse (2.11; 1.02–4.37) were associated with poor ADAP utilization.
One quarter of ADAP enrollees had MPR below 69 percent, a level well below that associated with optimal HIV treatment outcomes, indicating a need for programmatic interventions to improve ADAP utilization.
HIV; adherence; public health
Traumatic life histories are highly prevalent in people living with HIV/AIDS (PLWHA) and predict sexual risk behaviors, medication adherence, and all-cause mortality. Yet the causal pathways explaining these relationships remain poorly understood. We sought to quantify the association of trauma with negative behavioral and health outcomes and to assess whether those associations were explained by mediation through psychosocial characteristics.
In 611 outpatient PLWHA, we tested whether trauma's influence on later health and behaviors was mediated by coping styles, self efficacy, social support, trust in the medical system, recent stressful life events, mental health, and substance abuse.
In models adjusting only for sociodemographic and transmission category confounders (estimating total effects), past trauma exposure was associated with 7 behavioral and health outcomes including increased odds or hazard of recent unprotected sex (OR=1.17 per each additional type of trauma, 95% CI=1.07–1.29), medication nonadherence (OR=1.13, 1.02–1.25), hospitalizations (HR=1.12, 1.04–1.22), and HIV disease progression (HR=1.10, 0.98–1.23). When all hypothesized mediators were included, the associations of trauma with health care utilization outcomes were reduced by about 50%, suggesting partial mediation (e.g., OR for hospitalization changed from 1.12 to 1.07) whereas point estimates for behavioral and incident health outcomes remained largely unchanged, suggesting no mediation (e.g., OR for unprotected sex changed from 1.17 to 1.18). Trauma remained associated with most outcomes even after adjusting for all hypothesized psychosocial mediators.
These data suggest that past trauma influences adult health and behaviors through pathways other than the psychosocial mediators considered in this model.
Trauma; Mental health; Adherence; Health outcomes; Mediation analysis
Following HIV diagnosis and linkage to care, achieving and sustaining viral load (VL) suppression has implications for patient outcomes and secondary HIV prevention. We evaluated factors associated with expeditious VL suppression and cumulative VL burden among patients establishing outpatient HIV care.
Patients initiating HIV medical care from January 2007-October 2010 at the University of Alabama at Birmingham and University of Washington were included. Multivariable Cox proportional hazards and linear regression models were used to evaluate factors associated with time to VL suppression (<50 copies/mL) and cumulative VL burden, respectively. Viremia copy-years (VCY), a novel area under the longitudinal VL curve measure, was used to estimate 2-year cumulative VL burden from clinic enrollment.
Among 676 patients, 63% achieved VL<50 copies/mL in a median 308 days. In multivariable analysis, patients with more time-updated “no show” visits experienced delayed VL suppression (HR=0.83 per “no show” visit, 95%CI=0.76,0.91). In multivariable linear regression, visit non-adherence was independently associated with greater cumulative VL burden (log10VCY) during the first two years in care (Beta coefficient=0.11 per 10% visit non-adherence, 95%CI=0.04-0.17). Across increasing visit adherence categories, lower cumulative VL burden was observed (mean ± standard deviation log10 copy × years/mL); 0-79% adherence: 4.6 ± 0.8; 80-99% adherence: 4.3 ± 0.7; and 100% adherence: 4.1 ± 0.8 log10 copy × years/mL, respectively (P<0.01).
Higher rates of early retention in HIV care are associated with achieving VL suppression and lower cumulative VL burden. These findings are germane for a test and treat approach to HIV prevention.
HIV; Viral load; Retention in care; Adherence; Engagement in care
Diagnoses of substance abuse and depression made using patient reported outcomes (PROs) correlate better with nonadherence to medication than do diagnoses captured in traditional electronic medical records. PROs are an important resource in HIV/AIDS clinics for research and clinical care.
Introduction. Computerized collection of standardized measures of patient reported outcomes (PROs) provides a novel paradigm for data capture at the point of clinical care. Comparisons between data from PROs and Electronic Health Records (EHR) are lacking. We compare EHR and PRO for capture of depression and substance abuse and their relationship to adherence to antiretroviral therapy (ART).
Methods. This retrospective study includes HIV-positive patients at an HIV clinic who completed an initial PRO assessment April 2008–July 2009. The questionnaire includes measures of depression (PHQ-9) and substance abuse (ASSIST). Self-reported ART adherence was modeled using separate logistic regression analyses (EHR vs PRO).
Results. The study included 782 participants. EHR vs PRO diagnosis of current substance abuse was 13% (n = 99) vs 6% (n = 45) (P < .0001), and current depression was 41% (n = 317) vs 12% (n = 97) (P < .0001). In the EHR model, neither substance abuse (OR = 1.25; 95% CI = 0.70–2.21) nor depression (OR = 0.93; 95% CI = 0.62–1.40) was significantly associated with poor ART adherence. Conversely, in the PRO model, current substance abuse (OR = 2.78; 95% CI = 1.33–5.81) and current depression (OR = 1.93; 95% CI = 1.12–3.33) were associated with poor ART adherence.
Discussions. The explanatory characteristics of the PRO model correlated best with factors known to be associated with poor ART adherence (substance abuse; depression). The computerized capture of PROs as a part of routine clinical care may prove to be a complementary and potentially transformative health informatics technology for research and patient care.
Grounded in a socio-ecological framework, we describe salient health care system and policy factors that influence engagement in human immunodeficiency virus (HIV) clinical care. The discussion emphasizes successful programs and models of service delivery and highlights the limitations of current, fragmented health care system components in supporting effective, efficient, and sustained patient engagement across a continuum of care. A fundamental need exists for improved synergies between funding and service agencies that provide HIV testing, prevention, treatment, and supportive services. We propose a feedback loop whereby actionable, patient-level surveillance of HIV testing and engagement in care activities inform educational outreach and resource allocation to support integrated “testing and linkage to care plus” service delivery. Ongoing surveillance of programmatic performance in achieving defined benchmarks for linkage of patients who have newly diagnosed HIV infection and retention of those patients in care is imperative to iteratively inform further educational efforts, resource allocation, and refinement of service delivery.
Co-occurring pain, mood disorders, and substance abuse are common in HIV-infected patients. Our objective was to investigate the relationship between pain, alone and in the context of mood disorders and substance abuse, on clinic utilization, antiretroviral therapy (ART) adherence, and virologic suppression.
Pain, mood disorders, and substance abuse were assessed at the first visit. No-show and urgent visits were measured over a one-year period. Models were adjusted for age, race, sex, insurance status, CD4+ T-lymphocyte count, and HIV risk factor.
Among 1521 participants, 509 (34%) reported pain, 239 (16%) had pain alone, 189 (13%) had pain and a mood disorder, and 30 (2%) had pain and substance abuse. In univariate models, participants with pain, mood disorders, and substance abuse had higher odds of a no-show visit than participants without these conditions [OR 1.4 (95% CI 1.1–1.8); OR 1.5 (95% CI 1.2–1.9); OR 2.0 (95% CI 1.4–2.8), respectively]. In the multivariable model, pain increased the odds of a no-show visit only in participants without substance abuse [OR 1.5 (95% CI 1.1–1.9)], and pain reduced the odds of a no-show visit in participants with substance abuse [OR 0.5 (95% CI 0.2–0.9), p for interaction=0.0022].
In this study, pain increased the odds of no-show visits, but only for participants without substance abuse. Because pain, mood disorders, and substance abuse are highly prevalent in HIV-infected patients, our findings have implications for HIV treatment success. Interventions that incorporate pain management may be important for improving health outcomes in patients living with HIV infection.
HIV; Pain; Psychiatric Illness; Substance Abuse; ART Adherence; Health Care Utilization
The generalizability of antiretroviral therapy (ART) clinical trial efficacy findings to routine care settings is not well studied. We compared the relative effectiveness of initial ART regimens estimated in AIDS Clinical Trial Group (ACTG) randomized controlled trials with that among patients receiving ART at Antiretroviral Therapy Cohort Collaboration (ART-CC) study sites.
Treatment-naive HIV-infected patients initiating identical ART regimens in ACTG trials (A5095 and A5142) and at 15 ART-CC cohort study sites were included. Virological failure (HIV-1 RNA >200 copies/ml) at 24- and 48-weeks, incident AIDS-defining events and mortality were measured according to study design (ART-CC cohort vs. ACTG trial) and stratified by 3rd drug [Abacavir (ABC), Efavirenz (EFV), and Lopinavir/r (LPV/r)]. We used logistic regression to estimate and compare odds ratios for virological failure between different regimens and study designs, and used Cox models to estimate and compare hazard ratios for AIDS and death.
Compared with patients receiving ABC, those receiving EFV had roughly half the odds of 24-week virologic failure (>200 copies/mL) in both ACTG 5095 (OR=0.53, 95% CI 0.36–0.79) and ART-CC (0.46, 0.37–0.57). Virologic superiority of EFV (vs. ABC) appeared comparable in ART-CC and ACTG 5095 (ratio of ORs 0.86, 95% CI 0.54–1.35). Odds ratios for 48-week virologic failure, comparing EFV with LPV/r, were also comparable in ACTG 5142 and ART-CC (ratio of ORs 0.87, 0.45–1.69).
Between ART regimen virologic efficacy of 3rd drugs ABC, EFV, and LPV/r observed in the ACTG 5095 and 5142 trials appear generalizable to the routine care setting of ART-CC clinical cohorts.
HIV; AIDS; Antiretroviral therapy; Comparative effectiveness; Viral load
Viremia copy-years predicted all-cause mortality independent of traditional, cross-sectional viral load measures and time-updated CD4+ T-lymphocyte count in antiretroviral therapy-treated patients suggesting cumulative human immunodeficiency virus replication causes harm independent of its effect on the degree of immunodeficiency.
Background. Cross-sectional plasma human immunodeficiency virus (HIV) viral load (VL) measures have proven invaluable for clinical and research purposes. However, cross-sectional VL measures fail to capture cumulative plasma HIV burden longitudinally. We evaluated the cumulative effect of exposure to HIV replication on mortality following initiation of combination antiretroviral therapy (ART).
Methods. We included treatment-naive HIV-infected patients starting ART from 2000 to 2008 at 8 Center for AIDS Research Network of Integrated Clinical Systems sites. Viremia copy-years, a time-varying measure of cumulative plasma HIV exposure, were determined for each patient using the area under the VL curve. Multivariable Cox models were used to evaluate the independent association of viremia copy-years for all-cause mortality.
Results. Among 2027 patients contributing 6579 person-years of follow-up, the median viremia copy-years was 5.3 log10 copy × y/mL (interquartile range: 4.9–6.3 log10 copy × y/mL), and 85 patients (4.2%) died. When evaluated separately, viremia copy-years (hazard ratio [HR] = 1.81 per log10 copy × y/mL; 95% confidence interval [CI], 1.51–2.18 per log10 copy × y/mL), 24-week VL (1.74 per log10 copies/mL; 95% CI, 1.48–2.04 per log10 copies/mL), and most recent VL (HR = 1.89 per log10 copies/mL; 95% CI: 1.63–2.20 per log10 copies/mL) were associated with increased mortality. When simultaneously evaluating VL measures and controlling for other covariates, viremia copy-years increased mortality risk (HR = 1.44 per log10 copy × y/mL; 95% CI, 1.07–1.94 per log10 copy × y/mL), whereas no cross-sectional VL measure was independently associated with mortality.
Conclusions. Viremia copy-years predicted all-cause mortality independent of traditional, cross-sectional VL measures and time-updated CD4+ T-lymphocyte count in ART-treated patients, suggesting cumulative HIV replication causes harm independent of its effect on the degree of immunodeficiency.
In an effort to evaluate factors associated with the development of antiretroviral (ARV) resistance, we assessed the prevalence of toxicity-related regimen changes and modeled its association to the subsequent development of ARV resistance in a cohort of treatment-naive individuals initiating ARV therapy (ART). A retrospective analysis of patients initiating ART was conducted at the UAB 1917 Clinic from 1 January 2000 to 30 September 2007. Cox proportional hazards models were fit to identify factors associated with the development of resistance to ≥1 ARV drug class. Among 462 eligible participants, 14% (n=64) developed ARV resistance. Individuals with ≥1 toxicity-related regimen change (HR=3.94, 95% CI=1.09–14.21), initiating ART containing ddI or d4T (4.12, 1.19–14.26), and from a minority race (2.91, 1.16–7.28) had increased risk of developing resistance. Achieving virologic suppression within 12 months of ART initiation (0.10, 0.05–0.20) and higher pretreatment CD4 count (0.85 per 50 cells/mm3, 0.75–0.96) were associated with decreased hazards of resistance. Changes in ART due to drug intolerance were associated with the subsequent development of ARV resistance. Understanding the role of ARV drug selection and other factors associated with the emergence of ARV resistance will help inform interventions to improve patient care and ensure long-term treatment success.
The CDC released revised HIV testing guidelines in 2006 recommending routine, opt-out HIV testing in acute care settings including emergency departments (ED). Patient attitudes have been cited as a barrier to implementation of routine HIV testing in the ED. We assessed patients' perceptions of HIV testing in the ED through a contextual qualitative approach. The study was conducted during a 72-h period. All adults presenting to the ED without life-threatening trauma or psychiatric crisis completed a standardized questionnaire. The questionnaire explored HIV testing history, knowledge of testing resources, and qualitative items addressing participant perceptions about advantages and disadvantages to ED testing. After completion of the interview, participants were offered a free, confidential, rapid HIV test. Among 329 eligible individuals approached, 288 (87.5%) completed the initial interview. Participants overwhelmingly (n=247, 85.8%) reported support for testing and identified increased knowledge (41%), prevention (12.5%), convenience (11.8%), and treatment (4.9%) among the advantages. Fear and denial about one's HIV status, reported by <5% of patients, were identified as the most significant barriers to ED testing. Bivariate analysis determined race and ethnicity differences between individuals completing the interview and those who refused (p<0.05). Among individuals consenting for testing (n=186, 64.6%), no positives were detected. Most patients support HIV testing in the ED, noting knowledge of status, prevention, convenience, and linkage to early treatment as distinct advantages. These data are of particular benefit to decision makers considering the addition of routine HIV testing in EDs.
This study compared the effectiveness and toxicity of different statins among 700 HIV-infected patients in routine clinical care. Findings suggest that atorvastatin and rosuvastatin are preferable to pravastatin leading to greater declines in lipid levels with similar low rates of toxicity.
Background. Dyslipidemia is common and is often treated with 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors (statins). Little is known about the comparative effectiveness of statins among human immunodeficiency virus (HIV)–infected patients. This study compared the effectiveness and toxicity of statins among HIV-infected patients in clinical care.
Methods. We conducted a retrospective cohort study of patients starting their initial statin medications at 2 large HIV clinics (N = 700). The primary observation was change in lipid levels during statin therapy. Secondary observations included whether individualized National Cholesterol Education Program (NCEP) goals for low density lipoprotein cholesterol (LDL-C) and non–high density lipoprotein cholesterol (non-HDL-C) levels were reached, and toxicity rates. We used linear regression to examine change in lipid levels, controlling for baseline lipid values and demographic and clinical characteristics. We conducted secondary analyses using propensity scores to address confounding by indication.
Results. The most commonly prescribed statins were atorvastatin (N = 303), pravastatin (N = 280), and rosuvastatin (N = 95). One year after starting a statin therapy, patients who received atorvastatin or rosuvastatin had significantly greater decreases in total cholesterol, LDL-C, and non-HDL-C than patients on pravastatin. The likelihood of reaching NCEP goals for LDL-C levels was higher with the use of rosuvastatin (OR 2.1; P = .03) and atorvastatin (odds ratio [OR], 2.1; P = .001) compared with that of pravastatin. The likelihood of reaching NCEP goals for non-HDL-C levels was higher for rosuvastatin (OR 2.3; P = .045) but not atorvastatin (OR, 1.5; P = .1) compared with pravastatin. Toxicity rates were similar for all 3 statins: 7.3% for atorvastatin, 6.1% for pravastatin, and 5.3% for rosuvastatin.
Conclusions. Our findings suggest that atorvastatin and rosuvastatin are preferable to pravastatin for treatment of HIV-infected patients with dyslipidemia, due to greater declines in total cholesterol, LDL-C, and non-HDL-C, with similar lower toxicity rates.
Depression affects 20–30% of people living with HIV/AIDS (PLWHA) in the US and predicts greater sexual risk behaviors, lower antiretroviral (ARV) medication adherence, and worse clinical outcomes. Yet little experimental evidence addresses the critical clinical question of whether depression treatment improves ARV adherence and clinical outcomes in PLWHA with depression. The Strategies to Link Antidepressant and Antiretroviral Management at Duke, UAB, and UNC (SLAM DUNC) Study is a randomized clinical effectiveness trial funded by the National Institute for Mental Health. The objective of SLAM DUNC is to test whether a depression treatment program integrated into routine HIV clinical care affects ARV adherence. PLWHA with depression (n=390) are randomized to enhanced usual care or a depression treatment model called Measurement-Based Care (MBC). MBC deploys a clinically supervised Depression Care Manager (DCM) to provide evidence-based antidepressant treatment recommendations to a non-psychiatric prescribing provider, guided by systematic and ongoing measures of depressive symptoms and side effects. MBC has limited time requirements and the DCM role can be effectively filled by a range of personnel given appropriate training and supervision, enhancing replicability. In SLAM DUNC, MBC is integrated into HIV care to support HIV providers in antidepressant prescription and management. The primary endpoint is ARV adherence measured by unannounced telephone-based pill counts at 6 months with follow-up to 12 months and secondary endpoints including viral load, health care utilization, and depressive severity. Important outcomes of this study will be evidence of the effectiveness of MBC in treating depression in PLWHA and improving HIV-related outcomes.
HIV; depression; adherence; Measurement-Based Care; randomized controlled trial; effectiveness trial
Engagement in HIV care is increasingly recognized as a crucial step in maximizing individual patient outcomes. The recently updated HIV Medicine Association primary HIV care guidelines include a new recommendation highlighting the importance of extending adherence beyond antiretroviral medications to include adherence to clinical care. Beyond individual health, emphasis on a “test and treat” approach to HIV prevention highlights the public health importance of engagement in clinical care as an essential intermediary between the putative benefits of universal HIV testing (“test”) followed by ubiquitous antiretroviral treatment (“treat”). One challenge to administrators, researchers and clinicians who want to systematically evaluate HIV clinical engagement is deciding on how to measure retention in care. Measuring retention is complex as this process includes multiple clinic visits (repeated measures) occurring longitudinally over time. This article provides a synthesis of five commonly used measures of retention in HIV care, highlighting their methodological and conceptual strengths and limitations, and suggesting situations where certain measures may be preferred over others. The five measures are missed visits, appointment adherence, visit constancy, gaps in care, and the Human Resources and Services Administration HIV/AIDS Bureau (HRSA HAB) performance measure for retention in HIV care. As has been noted for antiretroviral medication adherence, there is no gold standard to measure retention in care, and consideration of the advantages and limitations of each measure, particularly in the context of the desired application, should guide selection of a retention measure.
Late diagnosis of HIV infection is detrimental to infected persons and to the public health. The objective of this study was to identify factors associated with late diagnosis of HIV infection, defined as an initial CD4 T lymphocyte count < 200 cells/µL, in a cohort of recently diagnosed persons. Additionally, we evaluated factors associated with HIV infection being diagnosed during hospitalization.
Cross-sectional study of a university-based HIV clinic in the southeastern U.S. Patients with newly diagnosed HIV infection evaluated at the Duke University HIV clinic between October 2002 and August 2004 were included in this analysis. Socio-demographic variables, site of HIV diagnosis, opportunistic infections present at diagnosis, initial CD4 T lymphocyte count and initial HIV RNA level were recorded for study subjects.
49% of subjects met the immunologic definition of AIDS at the time of HIV diagnosis (CD4 count < 200 cells/µL). In multivariable logistic regression analyses, older patients were more likely to be diagnosed with a CD4 count < 200 cells/µL (OR=1.72, 95% CI= 1.12,2.64, p=0.01), and older patients (OR=1.79, 95% CI= 1.07,3.12, p=0.03) and women (OR=6.74, 95% CI= 2.08,21.81, p=0.001) were more likely to be diagnosed during hospitalization.
Late diagnosis of HIV infection is a considerable problem, particularly for older patients. Inpatient diagnosis of HIV infection is significantly more common among women and older patients. Improved HIV testing strategies may allow for more timely diagnosis of HIV infection, which may benefit both the infected individual and society.
HIV; AIDS; Prevention; Diagnosis; Rural; South
Since the advent of highly active antiretroviral therapy (HAART), the treatment of human immunodeficiency virus (HIV) infection has become more potent and better tolerated. While the current treatment regimens still have limitations, they are more effective, more convenient, and less toxic than regimens used in the early HAART era, and new agents, formulations and strategies continue to be developed. Simplification of therapy is an option for many patients currently being treated with antiretroviral therapy (ART). The main goals are to reduce pill burden, improve quality of life and enhance medication adherence, while minimizing short- and long-term toxicities, reducing the risk of virologic failure and maximizing cost-effectiveness. ART simplification strategies that are currently used or are under study include the use of once-daily regimens, less toxic drugs, fixed-dose coformulations and induction-maintenance approaches. Improved adherence and persistence have been observed with the adoption of some of these strategies. The role of regimen simplification has implications not only for individual patients, but also for health care policy. With increased interest in ART regimen simplification, it is critical to study not only implications for individual tolerability, toxicity, adherence, persistence and virologic efficacy, but also cost, scalability, and potential for dissemination and implementation, such that limited human and financial resources are optimally allocated for maximal efficiency, coverage and sustainability of global HIV/AIDS treatment.
Point your smartphone at the QR code to the left. If you have a QR code reader the video abstract will appear. Or use: http://dvpr.es/nachega
ART; simplification; adherence; persistence; once-daily; coformulations; healthcare cost; quality of life
The implementation of routine computer-based screening for suicidal ideation and other psychosocial domains through standardized patient reported outcome instruments in two high volume urban HIV clinics is described. Factors associated with an increased risk of self-reported suicidal ideation were determined.
HIV/AIDS continues to be associated with an under-recognized risk for suicidal ideation, attempted as well as completed suicide. Suicidal ideation represents an important predictor for subsequent attempted and completed suicide. We sought to implement routine screening of suicidal ideation and associated conditions using computerized patient reported outcome (PRO) assessments.
Two geographically distinct academic HIV primary care clinics enrolled patients attending scheduled visits from 12/2005 to 2/2009. Touch-screen-based, computerized PRO assessments were implemented into routine clinical care. Substance abuse (ASSIST), alcohol consumption (AUDIT-C), depression (PHQ-9) and anxiety (PHQ-A) were assessed. The PHQ-9 assesses the frequency of suicidal ideation in the preceding two weeks. A response of “nearly every day” triggered an automated page to pre-determined clinic personnel who completed more detailed self-harm assessments.
Overall 1,216 (UAB= 740; UW= 476) patients completed initial PRO assessment during the study period. Patients were white (53%; n=646), predominantly males (79%; n=959) with a mean age of 44 (± 10). Among surveyed patients, 170 (14%) endorsed some level of suicidal ideation, while 33 (3%) admitted suicidal ideation nearly every day. In multivariable analysis, suicidal ideation risk was lower with advancing age (OR=0.74 per 10 years;95%CI=0.58-0.96) and was increased with current substance abuse (OR=1.88;95%CI=1.03-3.44) and more severe depression (OR=3.91 moderate;95%CI=2.12-7.22; OR=25.55 severe;95%CI=12.73-51.30).
Suicidal ideation was associated with current substance abuse and depression. The use of novel technologies to incorporate routine self-reported screening for suicidal ideation and other health domains allow for timely detection and intervention for this life threatening condition.
The generalizability of clinical trial findings (efficacy) to routine care (effectiveness) may be limited. The present study found similar first year virologic and CD4 outcomes among antiretroviral-naïve patients treated through routine care vs. those participating in clinical trials.
The generalizability of clinical trial findings (efficacy) to routine care (effectiveness) may be limited due to study eligibility criteria and volunteer bias. While well chronicled in many conditions, the efficacy vs. effectiveness of antiretroviral therapy (ART) remains understudied.
A retrospective study of the UAB 1917 Clinic Cohort evaluated naïve patients starting ART between 1/1/00–12/31/06. Patients received ART through clinical trials or routine care. Multivariable logistic and linear regression models were fit to evaluate factors associated with virologic failure (VF=VL>50 copies/mL) and change from baseline CD4 count 6 and 12 months after ART initiation. Sensitivity analyses evaluated the impact of missing data on outcomes.
Among 570 patients starting ART during the study period, 121 (21%) enrolled in clinical trials vs. 449 (79%) receiving ART via routine care. ART receipt through routine care was not associated with VF at either 6 (OR=1.00;95%CI=0.54–1.86) or 12 (OR=1.56;95%CI=0.80–3.05) months in primary analyses. No significant differences in CD4 count responses at 6 and 12 months were observed.
Though marked differences in efficacy vs. effectiveness have been observed in the therapeutic outcomes of other conditions, our analyses found no evidence of such divergence among our patients initiating antiretroviral therapy for HIV.
Efficacy; effectiveness; ART; HIV
Plasma human immunodeficiency virus type 1 (HIV-1) viral load is a valuable tool for HIV research and clinical care but is often used in a noncumulative manner. The authors developed copy-years viremia as a measure of cumulative plasma HIV-1 viral load exposure among 297 HIV seroconverters from the Multicenter AIDS Cohort Study (1984–1996). Men were followed from seroconversion to incident acquired immunodeficiency syndrome (AIDS), death, or the beginning of the combination antiretroviral therapy era (January 1, 1996); the median duration of follow-up was 4.6 years (interquartile range (IQR), 2.7–6.5). The median viral load and level of copy-years viremia over 2,281 semiannual follow-up assessments were 29,628 copies/mL (IQR, 8,547–80,210) and 63,659 copies × years/mL (IQR, 15,935–180,341). A total of 127 men developed AIDS or died, and 170 survived AIDS-free and were censored on January 1, 1996, or lost to follow-up. Rank correlations between copy-years viremia and other measures of viral load were 0.56–0.87. Each log10 increase in copy-years viremia was associated with a 1.70-fold increased hazard (95% confidence interval: 0.94, 3.07) of AIDS or death, independently of infection duration, age, race, CD4 cell count, set-point, peak viral load, or most recent viral load. Copy-years viremia, a novel measure of cumulative viral burden, may provide prognostic information beyond traditional single measures of viremia.
acquired immunodeficiency syndrome; HIV; HIV infections; viral load; viremia
Syphilis outbreaks in the United States have been reported since 2000 with highest rates in the South and many cases among HIV-infected individuals. We evaluated incident syphilis cases and concurrent gonorrhea and chlamydia screening at a southern HIV clinic. A retrospective cohort study included HIV-infected patients with at least one reactive plasma reagin (test for serum reagin antibodies to cardiolipin-cholesterol-lecithin antigen) and primary care visit from July 2004 to June 2007. Primary, secondary, and early latent syphilis cases were identified as incident syphilis and evaluation for gonorrhea and chlamydia within 1 month were described. Logistic regression was performed to determine factors associated with incident syphilis. Among 1544 patients, 40 incident syphilis cases were identified (5 primary, 29 secondary, and 6 early latent). The majority of patients were not virologically suppressed and only 25% had gonorrhea and chlamydia testing. In adjusted analyses, younger age (0.57 per 10 years, 95% confidence interval [CI] 0.41–0.80) and minority race (2.26, 95% CI 1.12–4.59) were associated with incident syphilis. Among 40 incident syphilis cases, only 1 in 4 were further tested for gonorrhea and chlamydia. These low rates are concerning as concurrent sexually transmitted infections (STIs) increase risk for HIV transmission. HIV care provider education with emphasis on STI testing in the setting of incident syphilis is key in prevention.
To determine if differences in short-term virologic failure among commonly used ART regimens translate to differences in clinical events in antiretroviral-naïve patients initiating ART.
Observational cohort study of patients initiating ART between January 2000 and December 2005.
The Antiretroviral Therapy Cohort Collaboration (ART-CC) is a collaboration of 15 HIV cohort studies from Canada, Europe, and the United States.
A total of 13,546 antiretroviral-naïve HIV-positive patients initiating ART with efavirenz (EFV), nevirapine (NVP), lopinavir/ritonavir (LPV/r), nelfinavir (NFV), or abacavir (ABC) as third drugs in combination with a zidovudine and lamivudine NRTI backbone.
Main outcome measures
Short-term (24-week) virologic failure (>500 copies/mL) and clinical events within 2 years of ART initiation (incident AIDS-defining event, death, and a composite measure of these two outcomes).
Compared with EFV as initial third drug, short-term virologic failure was more common with all other third drugs evaluated; NVP (adjusted odds ratio=1.87, 95%CI=1.58,2.22), LPV/r (1.32, 95%CI=1.12–1.57), NFV (3.20, 95%CI=2.74,3.74), and ABC (2.13, 95%CI=1.82,2.50). However, the rate of clinical events within 2 years of ART initiation appeared higher only with NVP (adjusted hazard ratio for composite outcome measure 1.27, 95%CI=1.04,1.56) and ABC (1.22, 95%CI=1.00,1.48).
Among antiretroviral-naïve patients initiating therapy, between-ART regimen differences in short-term virologic failure do not necessarily translate to differences in clinical outcomes. Our results should be interpreted with caution because of the possibility of residual confounding by indication.
Adolescent; Adult; Anti-Retroviral Agents; therapeutic use; Disease-Free Survival; Drug Interactions; Drug Resistance, Viral; Drug Therapy, Combination; Epidemiologic Methods; Female; HIV Infections; drug therapy; immunology; virology; HIV-1; Humans; Male; Middle Aged; Odds Ratio; RNA, Viral; metabolism; Reverse Transcriptase Inhibitors; therapeutic use; Treatment Outcome; Viral Load; Young Adult; HIV; AIDS; Antiretroviral Therapy; Highly Active; Cohort analysis; Viral load; AIDS-related Opportunistic Infections; Mortality