Rob J. Fredericksen

A Structural Equation Model of HIV-Related Stigma, Depressive Symptoms, and Medication Adherence

HIV-related stigma has a damaging effect on health outcomes among people living with HIV (PLWH), as studies have associated it with poor HIV medication adherence and depressive symptoms. We investigated whether depressive symptoms mediate the relationship between stigma and medication adherence. In a cross-sectional study, 720 PLWH completed instruments measuring HIV-related stigma, depressive symptoms, and HIV medication adherence. We used structural equation modeling (SEM) to investigate associations among these constructs. In independent models, we found that poorer adherence was associated with higher levels of stigma and depressive symptoms. In the simultaneous model that included both stigma and depressive symptoms, depression had a direct effect on adherence, but the effect of stigma on adherence was not statistically significant. This pattern suggested that depressive symptoms at least partially mediated the association between HIV-related stigma and HIV medication adherence. These findings suggest that interconnections between several factors have important consequences for adherence.

The role of technical advances in the adoption and integration of patient-reported outcomes in clinical care

Background:Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (eg, touchscreen tablets, Internet accessibility, and electronic health records), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. Objectives:To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. Methods:Five practical case studies across diverse health care settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, previsit screening, effective evaluation, and electronic health record integration. Conclusions:These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems.

Integrating a web-based, patient-administered assessment into primary care for HIV-infected adults.

Providers routinely under diagnose at risk behaviors and outcomes, including depression, suicidal ideation, substance abuse, and poor medication adherence. To address this, we developed a web-based, self-administered patient-reported assessment tool and integrated it into routine primary care for HIV-infected adults. Printed results were delivered to providers and social workers immediately prior to patient appointments. The assessment included brief, validated instruments measuring clinically relevant domains including depression, substance use, medication adherence, and HIV transmission risk behaviors. Utilizing the Institute for Healthcare Improvements Plan-Do-Study-Act (PDSA) approach to quality improvement, we addressed issues with clinic flow, technology, scheduling, and delivery of assessment results with the support of all levels of clinic staff. We found web-based patient-reported assessments to be a feasible tool that can be integrated into a busy multi-provider HIV primary care clinic. These assessments may improve provider recognition of key patient behaviors and outcomes. Critical factors for successful integration of such assessments into clinical care include: strong top-level /ort from clinic management, provider understanding of patient-reported assessments as a valuable clinical tool, tailoring the assessment to meet provider needs, communication among clinic staff to address flow issues, timeliness of delivery, and sound technological resources.

Patient and provider priorities for self-reported domains of HIV clinical care.

We sought to understand how HIV-infected patients, their providers, and HIV care researchers prioritize self-reported domains of clinical care. Participants rank-ordered two lists of domains. A modified Delphi process was used for providers and researchers. Approximately 25% of patients were interviewed to discuss rationale for rank order choices. List 1 included anger, anxiety, depression, fatigue, physical function, pain, and sleep disturbance. List 2 included alcohol abuse, cognitive function, HIV stigma, HIV and treatment symptoms, medication adherence, positive affect, sexual risk behavior, sexual function, social roles, spirituality/meaning of life, and substance abuse. Seventy-four providers, 80 HIV care researchers, and 66 patients participated. Patients ranked context-based domains, such as HIV stigma, more highly than providers, while health behaviors, such as drug or alcohol use, ranked lower. Patients described a need to address wider-context challenges such as HIV stigma in order to positively impact health behaviors. Divergent patient and provider priorities highlight the importance of incorporating views from all stakeholders and suggests the need for a care approach that more effectively addresses contextual barriers to adverse health behaviors.

Disparities in Depressive Symptoms and Antidepressant Treatment by Gender and Race/Ethnicity among People Living with HIV in the United States.

Objective To describe disparities along the depression treatment cascade, from indication for antidepressant treatment to effective treatment, in HIV-infected individuals by gender and race/ethnicity. Methods The Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) cohort includes 31,000 HIV-infected adults in routine clinical care at 8 sites. Individuals were included in the analysis if they had a depressive symptoms measure within one month of establishing HIV care at a CNICS site. Depressive symptoms were measured using the validated Patient Health Questionnaire-9 (PHQ-9). Indication for antidepressant treatment was defined as PHQ-9 ≥ 10 or a current antidepressant prescription. Antidepressant treatment was defined as a current antidepressant prescription. Evidence-based antidepressant treatment was considered treatment changes based on a person’s most recent PHQ-9, in accordance with clinical guidelines. We calculated the cumulative probability of moving through the depression treatment cascade within 24 months of entering CNICS HIV care. We used multivariable Cox proportional hazards models to estimate associations between gender, race/ethnicity, and a range of depression outcomes. Results In our cohort of HIV-infected adults in routine care, 47% had an indication for antidepressant treatment. Significant drop-offs along the depression treatment cascade were seen for the entire study sample. However, important disparities existed. Women were more likely to have an indication for antidepressant treatment (HR 1.54; 95% CI 1.34, 1.78), receive antidepressant treatment (HR 2.03; 95% CI 1.53, 2.69) and receive evidence-based antidepressant treatment (HR 1.67; 95% CI 1.03, 2.74), even after accounting for race/ethnicity. Black non-Hispanics (HR 0.47, 95% CI 0.35, 0.65), Hispanics (HR 0.63, 95% CI 0.44, 0.89) and other race/ethnicities (HR 0.35, 95% CI 0.17, 0.73) were less likely to initiate antidepressant treatment, compared to white non-Hispanics. Conclusions In our cohort of HIV-infected adults depressive symptoms were common. Important disparities in the prevalence of depressive symptoms and receipt of antidepressant treatment existed by gender and race/ethnicity.

Unannounced Telephone-Based Pill Counts: A Valid and Feasible Method for Monitoring Adherence

Phone-based unannounced pill counts to measure medication adherence are much more practical and less expensive than home-based unannounced pill counts, but their validity has not been widely assessed. We examined the validity of phone versus home-based pill counts using a simplified protocol streamlined for studies embedded in clinical care settings. A total of 100 paired counts were used to compare concordance between unannounced phone and home-based pill counts using interclass correlations. Discrepancy analyses using χ2 tests compared demographic and clinical characteristics across patients who were concordant between phone and home-based pill counts and patients who were not concordant. Concordance was high for phone-based and home-based unannounced total pill counts, as well as individual medication counts and calculated adherence. This study demonstrates that a simplified phone-based pill count protocol can be implemented among patients from a routine clinical care setting and is a feasible means of monitoring medication adherence.ResumenLos conteos no anunciados de comprimidos por teléfono, con el propósito de medir el cumplimiento con respecto a los medicamentos, es mucho más práctico y menos costoso que los conteos no anunciados de comprimidos en el hogar, pero su validez no se ha evaluado en forma amplia. Examinamos la validez de los conteos no anunciados de comprimidos en el hogar, mediante el uso de un protocolo racionalizado para estudios integrados en ambientes de atención clínica. Un total de 100 conteos en pares se usaron para comparar la concordancia entre los conteos no anunciados de comprimidos por teléfono y en el hogar con correlaciones entre clases. Los análisis de discrepancia mediante pruebas χ2 compararon características demográficas y clínicas en los pacientes que fueron concordantes entre los conteos de comprimidos por teléfono y en el hogar y los pacientes que no fueron concordantes. Hubo una alta concordancia para los conteos no anunciados totales de comprimidos por teléfono y en el hogar, al igual que para los conteos de medicamentos individuales y para el cumplimiento calculado. Este estudio demuestra que se puede implementar un protocolo simplificado de conteo de comprimidos por teléfono entre los pacientes de un entorno de atención clínica de rutina y que es un medio factible para controlar el cumplimiento con respecto a los medicamentos.

Mind the gap: Gaps in antidepressant treatment, treatment adjustments, and outcomes among patients in routine HIV care in a multisite U.S. Clinical cohort

Background Depression affects 20–30% of HIV-infected patients and is associated with worse HIV outcomes. Although effective depression treatment is available, depression is largely untreated or undertreated in this population. Methods We quantified gaps in antidepressant treatment, treatment adjustments, and outcomes among US patients in routine HIV care in the nationally distributed CNICS observational clinical cohort. This cohort combines detailed clinical data with regular, self-reported depressive severity assessments (Patient Health Questionnaire-9, PHQ-9). We considered whether participants with likely depression received antidepressants, whether participants on antidepressants with persistently high depressive symptoms received timely dose adjustments, and whether participants achieved depression remission. We considered a cross-sectional analysis (6,219 participants in care in 2011–2012) and a prospective analysis (2,936 participants newly initiating CNICS care when PHQ-9 screening was active). Results The cross-sectional sample was 87% male, 53% Caucasian, 25% African American, and 18% Hispanic; the prospective sample was similar. In both samples, 39–44% had likely depression, with 44–60% of those receiving antidepressants. Of participants receiving antidepressants, 20–26% experienced persistently high depressive symptoms; only a small minority of those received antidepressant dose adjustments. Overall, 35–40% of participants on antidepressants achieved full depression remission. Remission among participants with persistently high depressive symptoms was rare regardless of dose adjustments. Conclusions In this large, diverse cohort of US patients engaged in routine HIV care, we observed large gaps in antidepressant treatment, timely dose adjustment to address persistently high depressive symptoms, and antidepressant treatment outcomes. These results highlight the importance of more effective pharmacologic depression treatment models for HIV-infected patients.

Not all non-drinkers with HIV are equal: demographic and clinical comparisons among current non-drinkers with and without a history of prior alcohol use disorders*

ABSTRACT Studies of persons living with HIV (PLWH) have compared current non-drinkers to at-risk drinkers without differentiating whether current non-drinkers had a prior alcohol use disorder (AUD). The purpose of this study was to compare current non-drinkers with and without a prior AUD on demographic and clinical characteristics to understand the impact of combining them. We included data from six sites across the US from 1/2013 to 3/2015. Patients completed tablet-based clinical assessments at routine clinic appointments using the most recent assessment. Current non-drinkers were identified by AUDIT-C scores of 0. We identified a prior probable AUD by a prior AUD diagnosis in the electronic medical record (EMR) or a report of attendance at alcohol treatment in the clinical assessment. We used multivariate logistic regression to examine factors associated with prior AUD. Among 2235 PLWH who were current non-drinkers, 36% had a prior AUD with more patients with an AUD identified by the clinical assessment than the EMR. Higher proportions with a prior AUD were male, depressed, and reported current drug use compared to non-drinkers without a prior AUD. Former cocaine/crack (70% vs. 25%), methamphetamine/crystal (49% vs. 16%), and opioid/heroin use (35% vs. 7%) were more commonly reported by those with a prior AUD. In adjusted analyses, male sex, past methamphetamine/crystal use, past marijuana use, past opioid/heroin use, past and current cocaine/crack use, and cigarette use were associated with a prior AUD. In conclusion, this study found that among non-drinking PLWH in routine clinical care, 36% had a prior AUD. We found key differences between those with and without prior AUD in demographic and clinical characteristics, including drug use and depression. These results suggest that non-drinkers are heterogeneous and need further differentiation in studies and that prior alcohol misuse (including alcohol treatment) should be included in behavioural health assessments as part of clinical care.

Provider perceptions of the value of same-day, electronic patient-reported measures for use in clinical HIV care

ABSTRACT Strong evidence suggests that patient-reported outcomes (PROs) aid in managing chronic conditions, reduce omissions in care, and improve patient–provider communication. However, provider acceptability of PROs and their use in clinical HIV care is not well known. We interviewed providers (n = 27) from four geographically diverse HIV and community care clinics in the US that have integrated PROs into routine HIV care, querying perceived value, challenges, and use of PRO data. Perceived benefits included the ability of PROs to identify less-observable behaviors and conditions, particularly suicidal ideation, depression, and substance use; usefulness in agenda setting prior to a visit; and reduction of social desirability bias in patient–provider communication. Challenges included initial flow integration issues and ease of interpretation of PRO feedback. Providers value same-day, electronic patient-reported measures for use in clinical HIV care with the condition that PROs are (1) tailored to be the most clinically relevant to their population; (2) well integrated into clinic flow; and (3) easy to interpret, highlighting chief patient concerns and changes over time.

Development and Content Validation of a Patient-Reported Sexual Risk Measure for Use in Primary Care

BackgroundPatient-provider sexual risk behavior discussions occur infrequently but may be facilitated by high-quality sexual risk screening tools.ObjectiveTo develop the Sexual Risk Behavior Inventory (SRBI), a brief computer-administered patient-reported measure.DesignQualitative item development/quantitative instrument validation.ParticipantsWe developed SRBI items based on patient interviews (n = 128) at four geographically diverse US primary care clinics. Patients were diverse in gender identity, sex, sexual orientation, age, race/ethnicity, and HIV status. We compared sexual risk behavior identified by the SRBI and the Risk Assessment Battery (RAB) among patients (n = 422).ApproachWe constructed an item pool based on validated measures of sexual risk, developed an in-depth interview guide based on pool content, and used interviews to elicit new sexual risk concepts. We coded concepts, matched them to item pool content, and developed new content where needed. A provider team evaluated item clinical relevance. We conducted cognitive interviews to assess item comprehensibility. We administered the SRBI and the RAB to patients.Key ResultsCommon, clinically relevant concepts in the SRBI included number of sex partners; partner HIV status; partner use of antiretroviral medication (ART)/pre-exposure prophylaxis (PrEP); and recent sex without barrier protection, direction of anal sex, and concern regarding HIV/STI exposure. While 90% reported inconsistent condom use on the RAB, same-day SRBI administration revealed that for over one third, all their partners were on ART/PrEP.ConclusionThe SRBI is a brief, skip-patterned, clinically relevant measure that ascertains sexual risk behavior across sex, sexual orientation, gender identity, partner HIV serostatus, and partner treatment status, furnishing providers with context to determine gradations of risk for HIV/STI.