David Huh

Peer support and pager messaging to promote antiretroviral modifying therapy in Seattle: a randomized controlled trial.

Objective:To determine the relative efficacy of peer support and pager messaging strategies versus usual care to improve medication adherence and clinical outcomes among HIV-positive outpatients initiating or switching to a new highly active antiretroviral therapy regimen. Design:A 2 × 2 factorial randomized controlled trial of a 3-month intervention with computer-assisted self-interviews and blood draws administered at baseline, 3, 6, and 9 months. Methods:HIV-positive patients at a public HIV specialty clinic in Seattle, WA (N = 224) were randomly assigned to peer support, pager messaging, both strategies, or usual care. The main outcomes were adherence according to self-report and electronic drug monitoring, CD4 count, and HIV-1 RNA viral load. Results:Intent-to-treat analyses suggested the peer intervention was associated with greater self-reported adherence at immediate postintervention. However, these effects were not maintained at follow-up assessment; nor were there significant differences in biological outcomes. The pager intervention, on the other hand, was not associated with greater adherence but was associated with improved biological outcomes at postintervention that were sustained at follow-up. Conclusions:Analyses indicate the potential efficacy of peer support and pager messaging to promote antiretroviral adherence and biological outcomes, respectively. More potent strategies still are needed.

Racial/Ethnic Disparities in ART Adherence in the United States: Findings From the MACH14 Study

Background:Minority race/ethnicity is generally associated with antiretroviral therapy nonadherence in US-based studies. Limitations of the existing literature include small samples, subjective adherence measures, and inadequate control for potential confounders such as mental health and substance use, which have been consistently associated with poorer adherence. Methods:Individual-level data were pooled from 13 US-based studies employing electronic drug monitoring to assess adherence. Adherence was operationalized as percent of prescribed doses taken from the first 12 (monthly) waves of data in each study. Depression symptoms were aggregated from several widely used assessments, and substance use was operationalized as any use of cocaine/stimulants, heroin/opiates, ecstasy, hallucinogens, or sedatives in the 30–365 days preceding baseline. Results:The final analytic sample of 1809 participants ranged in age from 18 to 72 years and was 67% male. Participants were 53% African American, 14% Latino, and 34% White. In a logistic regression adjusting for age, gender, income, education, and site, race/ethnicity was significantly associated with adherence (P < 0.001) and persisted in a model that also controlled for depression and substance use (P < 0.001), with African Americans having significantly lower adherence than Latinos [odds ratio (OR) = 0.72, P = 0.04] and whites (OR = 0.60, P < 0.001). Adherence did not differ between whites and Latinos (OR = 0.84, P = 0.27). Conclusions:Racial/ethnic differences in demographics, depression, and substance abuse do not explain the lower level of antiretroviral therapy adherence in African Americans observed in our sample. Further research is needed to explain the persistent disparity and might examine factors such as mistrust of providers, health literacy, and inequities in the health care system.

Buffering Effects of General and Medication-Specific Social Support on the Association Between Substance Use and HIV Medication Adherence

The success of highly active antiretroviral therapy (HAART) among persons living with HIV is largely dependent on strict medication adherence. Recent research suggests that alcohol and other drug use (AOD) may be an important barrier to HAART adherence. In this study, we examined the impact of AOD on HAART adherence as well as the moderating effects of general and medication-specific social support. The data were collected as part of a longitudinal randomized control trial with 224 HIV-positive patients at an HIV primary care clinic in the northwestern United States. Findings indicated that AOD use was negatively associated with HAART adherence and that medication-specific (but not general) social support moderated the AOD-adherence association at 3 (but not at 6 or 9) months. Results indicate the importance of medication-specific social support to treat comorbid AOD use and HIV; implications for future research and intervention programs for HIV-positive AOD users are discussed.

Two-Way Text Messaging for Health Behavior Change Among Human Immunodeficiency Virus–Positive Individuals

BACKGROUND text-messaging systems have been used to promote a range of health behaviors, including medication adherence among human immunodeficiency virus-positive individuals. However, little is currently known about the specific characteristics of messaging systems that promote user engagement. OBJECTIVE using data from a randomized controlled trial involving a pager-based text messaging system, this study sought to examine the overall usability of the system, user evaluation of the system, demographic and psychosocial correlates of usability, and its performance as an adherence assessment tool. MATERIALS AND METHODS the messaging system consisted of an alphanumeric pager capable of sending and receiving individualized text messages and the software necessary to program and track communication. The system was evaluated using behavioral outcomes (pager message response rate), self-report survey responses, focus group discussions, and data from electronic medication monitoring pill bottles. RESULTS Although the majority of participants reported that the system was effective in reminding them to take medication doses, the overall response rate to system messages was relatively low (42.8%) and dropped significantly over the course of the 3-month intervention period. In addition, user engagement did not differ significantly by most demographic and psychosocial variables. CONCLUSIONS the pager-based text messaging system was received well by participants and appears to be applicable to a broad population; however, the system did not actively engage all participants over the course of the trial. Future research should determine whether systems customized to personal preference in notification style, frequency, and user device can increase use and provide further assistance to achieve optimal medication adherence.

Dis-placement and Dis-ease: Land, Place, and Health Among American Indians and Alaska Natives

The major aim of this chapter is to stimulate scholarship in the area of place and health, specifically examining how American Indian and Alaska Natives’ (AIAN) health outcomes can be understood in light of historical trauma losses and disruptions tied to place or land. Although classic social determinants of health, such as poor socioeconomic status, substandard housing, and poor access to appropriate health care all contribute to poor health among AIAN, these factors do not sufficiently explain the high rates of poor health. As a result, indigenous scholars have turned their attention to examining how historical and societal determinants of health, particularly the role of historically traumatic events related to land-based events (e.g., forced relocation and land loss), land-based environmental microaggressions (discrimination distress related to land-based destruction), and disproportionate exposures to high rates of contemporary trauma are health hazards for the present and descendant AIAN generations. After reviewing the literature on indigenous place and health, this chapter shares empirical findings related to land and place loss on physical and mental health outcomes among a national sample of 447 gay, lesbian, bisexual, or transgender AIAN. Findings indicate that after controlling for contemporary lifetime trauma, historical trauma related to land loss, dis-placement, and neglect had a significant effect on physical and mental health.

The Validity of Self-Reported Medication Adherence as an Outcome in Clinical Trials of Adherence-Promotion Interventions: Findings from the MACH14 Study

In medication adherence-promotion trials, participants in the intervention arm are often cognizant of the researcher’s aim to improve adherence; this may lead to their inflating reports of their own adherence compared to control arm participants. Using data from 1,247 HIV-positive participants across eight U.S. Studies in the Multi-site Adherence Collaboration on HIV (MACH14) collaboration, we evaluated the validity of self-reported adherence by examining whether its association with two more objective outcomes [1], electronically monitored adherence and [2] viral load, varied by study arm. After adjusting for potential confounders, there was no evidence of greater overestimation of self-reported adherence among intervention arm participants, supporting its potential as a trial outcome indicator.ResumenEn ensayos clínicos de promoción de la adherencia a los medicamentos, los participantes del grupo de intervención suelen estar enterados de que el objetivo del investigador es mejorar la adherencia. Este conocimiento podría resultar en informes exagerados sobre la adherencia en comparación con los participantes del grupo de control. Evaluamos la validez de la adherencia autodeclarada examinando si su asociación con dos medidas de resultados más objetivos, [1] la adherencia monitoreada electrónicamente y [2] la carga viral, es diferente en los dos grupos. Utilizamos los datos del proyecto colaborativo MACH14 sobre 1.247 participantes VIH positivos de 8 estudios en los EE. UU. Después del ajuste por variables de confusión, no hubo evidencia de mayor sobreestimación de la adherencia autodeclarada en los participantes del grupo de intervención. Este resultado apoya a la adherencia autodeclarada como una medida de resultado válida para los ensayos clínicos.

Project INTEGRATE: An integrative study of brief alcohol interventions for college students

This article provides an overview of a study that synthesizes multiple, independently collected alcohol intervention studies for college students into a single, multisite longitudinal data set. This research embraced innovative analytic strategies (i.e., integrative data analysis or meta-analysis using individual participant-level data), with the overall goal of answering research questions that are difficult to address in individual studies such as moderation analysis, while providing a built-in replication for the reported efficacy of brief motivational interventions for college students. Data were pooled across 24 intervention studies, of which 21 included a comparison or control condition and all included one or more treatment conditions. This yielded a sample of 12,630 participants (42% men; 58% first-year or incoming students). The majority of the sample identified as White (74%), with 12% Asian, 7% Hispanic, 2% Black, and 5% other/mixed ethnic groups. Participants were assessed 2 or more times from baseline up to 12 months, with varying assessment schedules across studies. This article describes how we combined individual participant-level data from multiple studies, and discusses the steps taken to develop commensurate measures across studies via harmonization and newly developed Markov chain Monte Carlo (MCMC) algorithms for 2-parameter logistic item response theory models and a generalized partial credit model. This innovative approach has intriguing promises, but significant barriers exist. To lower the barriers, there is a need to increase overlap in measures and timing of follow-up assessments across studies, better define treatment and control groups, and improve transparency and documentation in future single intervention studies.

Optimizing the Analysis of Adherence Interventions Using Logistic Generalized Estimating Equations

Interventions aimed at improving HIV medication adherence could be dismissed as ineffective due to statistical methods that are not sufficiently sensitive. Cross-sectional techniques such as t tests are common to the field, but potentially inaccurate due to increased risk of chance findings and invalid assumptions of normal distribution. In a secondary analysis of a randomized controlled trial, two approaches using logistic generalized estimating equations (GEE)—planned contrasts and growth curves—were examined for evaluating percent adherence data. Results of the logistic GEE approaches were compared to classical analysis of variance (ANOVA). Robust and bootstrapped estimation was used to obtain empirical standard error estimates. Logistic GEE with either planned contrasts or growth curves in combination with robust standard error estimates was superior to classical ANOVA for detecting intervention effects. The choice of longitudinal model led to key differences in inference. Implications and recommendations for applied researchers are discussed.ResumenLas intervenciones con el propósito de mejorar la toma de medicamentos para el VIH podrían ser estimadas como ineficaces debido a métodos estadísticos que no son suficientemente sensitivos. Las técnicas transversales tal como la prueba t son comunes en el estudio de campo, pero potencialmente inexactas debido a un aumento del riesgo en los resultados por la casualidad y las suposiciones incorrectas en la distribución normal. A través de un análisis secundario de una prueba controlada aleatoria, fue examinado para evaluar adherencia como porcentaje, el método de la ecuación de estimación generalizada (GEE) logística, a través de dos especificaciones: los contrastes planeados y las curvas de crecimiento. Los resultados de ambas especificaciones fueron comparados con el análisis de la varianza (ANOVA) clásico. La estimación robusta y el bootstrapping fueron usados para obtener cálculos empíricos de error estándar. La GEE logística con estimación robusta, ya sea con contrastes planeados o curvas de crecimiento, fue superior al ANOVA clásico. La elección de método longitudinal produjo diferencias claves con respecto a la inferencia. Las implicaciones y recomendaciones para investigadores aplicados son discutidas.

Patient-level moderators of the efficacy of peer support and pager reminder interventions to promote antiretroviral adherence.

Antiretroviral therapy (ART) greatly reduces morbidity and mortality for people with HIV/AIDS. However, for optimal effectiveness patients must achieve strict adherence to dosing regimens, which is difficult to maintain over the long term. Interventions to improve adherence have shown promising results, but with small effects. One explanation for small overall effects is that some patient subgroups are less able to benefit from current interventions; however, this explanation lacks empirical support. This study used multilevel modeling of data from a randomized controlled trial in an exploratory analysis to assess whether patient factors moderated the impact of peer support and pager reminders on ART adherence and biological markers of HIV. According to 272 interaction models using an alpha-corrected significance criteria, none of 34 patient characteristics significantly moderated either intervention. Findings suggest that intervention research might more profitably focus on other ways of improving effects, like individual patient needs, rather than target subgroups.ResumenLa terapia antirretroviral reduce considerablemente la morbilidad y la mortalidad para las personas con VIH/SIDA. Sin embargo, para eficacia óptima, los pacientes deben lograr la adhesión estricta a los regímenes de dosificación, que es difícil mantener a largo plazo. Las intervenciones para mejorar la adherencia han mostrado resultados prometedores, pero con efectos pequeños. Una explicación para los pequeños efectos globales es que algunos subgrupos de pacientes son menos capaces de beneficiarse de las intervenciones actuales. Sin embargo, esta explicación carece de sustento empírico. Este estudio utilizó modelos multinivel de los datos de un estudio aleatorizado y controlado en un análisis exploratorio para determinar si los factores del paciente moderado el impacto del apoyo y recordatorios paginador en la adhesión la terapia antirretroviral y los marcadores biológicos del VIH. De acuerdo a 272 modelos de interacción con un alfa-corregido los criterios de importancia, ninguna de las 34 características de los pacientes significativamente moderado cualquiera intervención. Los resultados sugieren que la investigación de intervención sería más rentable centrarse en otras formas de mejorar los efectos como las necesidades de cada paciente, en lugar de centrarse en los subgrupos.

Prospective prediction of viral suppression and immune response nine months after ART initiation in Seattle, WA.

Abstract Knowing at antiretroviral therapy (ART) initiation which patients might be at greatest risk for failure to achieve viral suppression would enable providers to target patients most in need and tailor their care appropriately. This study involved multilevel modeling of data from a randomized controlled trial among outpatients in Seattle, WA, USA. The 224 participants initiating or switching ART at baseline were 24% female, 34% heterosexual, and 47% Caucasian. Of 24 baseline demographic and psychosocial patient-level variables modeled in separate generalized estimating equations, only employment predicted changes in HIV-1 RNA viral load or CD4 lymphocyte count over the course of the 9-month trial. Although the findings require replication, they suggest adherence support strategies should emphasize close monitoring and support for all patients initiating ART.