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Adherence to pharmacological interventions. Current trends and future directions. The Pharmacological Intervention Working Group.

The complexity of adherence to pharmacological interventions is frequently underestimated. Consequently, little research has been done to understand, improve, or evaluate the effects of adherence to drug protocols. While efforts to better measure and increase adherence require dedicated resources, improved adherence in existing clinical research can potentially cut costs in trial size and length. This paper outlines strategies to facilitate research on adherence to pharmacological interventions including: reporting of adherence data, changing how we conceptualize adherence to pharmaceuticals, understanding issues unique to older adults' pill-taking behavior, and creating standardized methodologies to measure adherence. Further, we describe some promising research areas that may lead to effective interventions: adherence "typologies" and modality matching. Control Clin Trials 2000;21:218S-225S

Aged↗

Standard of care: promoting antiretroviral adherence in clinical care.

Although there has long been demand for programs and procedures that support or enhance adherence to antiretroviral therapy (ART) among HIV+ patients, there is scant evidence about the extent to which medical clinics have been able to incorporate adherence interventions into their standard care. A survey of clinical care settings in New York and Connecticut indicated that the current standard of care is to provide only minimal levels of adherence services, with ad hoc adherence support being offered on an as-needed basis, often by overburdened primary care staff. These results suggest a strong need for the development of ART adherence interventions that are not only easily translatable to real-life clinical settings, but also offer an organized compendium of resources for HIV+ patients, from initiation to maintenance.

Anti-HIV Agents↗

Overview and implementation of an intervention to prevent adherence failure among HIV-infected adults initiating antiretroviral therapy: lessons learned from Project HEART.

Project HEART, an acronym for Helping Enhance Adherence to Retroviral Therapy, was a prospective, controlled study to develop, implement, and evaluate a clinic-based behavioural intervention to prevent adherence failure among HIV-infected adults beginning their first highly active antiretroviral therapy (HAART) regimen (N = 227). In this paper, we describe the conceptualisation of the Project HEART adherence intervention, characteristics of the participants, and lessons learned implementing HEART in an inner-city clinic setting. A multi-component intervention, HEART combined enhanced education, reminders, adherence feedback, social support and adherence-focused problem solving in an integrated manner to address common cognitive, motivational, and social barriers to adherence. Unique components of the intervention included use of participant-identified adherence support partners and a standardized adherence barriers assessment to develop and implement individualised adherence plans. Lessons learned regarding the feasibility of using participant-identified support partners were as follows. Few participants eligible for the study had trouble identifying a support partner. Over 90% of support partners attended at least one intervention visit. Support partners were most available and amenable to participate early in the initiation of therapy. Participants' experiences as the 'supported' partner were generally positive. Though many participants faced barriers not easily addressed by this intervention (for example, housing instability), formally integrating support partners into the intervention helped to address many other common adherence barriers. Family and friends are an under-utilised resource in HIV medication adherence. Enlisting the help of support partners is a practical and economical approach to adherence counselling.

Adult↗

Substance abuse and psychiatric disorders in HIV-positive patients: epidemiology and impact on antiretroviral therapy.

There is a high prevalence of substance abuse and psychiatric disorders among HIV-infected individuals. Importantly, drug and alcohol-use disorders are frequently co-morbid with depression, anxiety and severe mental illness. Not only do these disorders increase the risk of contracting HIV, they have also been associated with decreased highly active antiretroviral therapy (HAART) utilisation, adherence and virological suppression. The literature evaluating the relationship between substance abuse and HIV outcomes has primarily focused on injection drug users, although there has been increasing interest in alcohol, cocaine and marijuana. Similarly, the mental health literature has focused largely on depression, with a lesser focus on severe mental illness or anxiety. To date, there is little literature evaluating the association between co-occurring HIV, substance abuse and mental illness on HAART uptake, adherence and virological suppression. Adherence interventions in these populations have demonstrated mixed efficacy. Both directly observed therapy and pharmacist-assisted interventions appear promising, as do integrated behavioural interventions. However, the current intervention literature has several limitations: few of these studies are randomised, controlled trials; the sample sizes have generally been small; and co-occurring substance abuse and mental illness has not specifically been targeted in these studies. Future studies examining individual substances of abuse, psychiatric disorders and co-occurring substance abuse and psychiatric disorders on HIV outcomes will inform targeted adherence interventions.

Antiretroviral Therapy, Highly Active↗

Kitchen table wisdom: a Freirian approach to medication adherence.

Most interventions to promote medication adherence are based on psychological theories of individual behavior. In contrast, this article describes the theory and practice of a socially based adherence intervention that is guided by the educational principles of Paolo Freire. This approach asserts that adherence is influenced by the patient's social context and attempts to improve adherence through identifying social constraints on adherence behavior. The program builds on the traditions of patient education through home nursing visits. Using a dialectic process of dialogue and problem solving and working with a team that includes a nurse and a peer-educator, patients are encouraged to act to change their social environment to support their desire to achieve high levels of medication adherence. This strategy does not replace, but rather supplements, traditional methods of understanding individual patient behavior and allows the patient and the nurse to consider potential solutions to adherence challenges in the larger social context.

Anti-HIV Agents↗

Adherence to antiretroviral therapy in a home-based AIDS care programme in rural Uganda.

BACKGROUND: Poverty and limited health services in rural Africa present barriers to adherence to antiretroviral therapy that necessitate innovative options other than facility-based methods for delivery and monitoring of such therapy. We assessed adherence to antiretroviral therapy in a cohort of HIV-infected people in a home-based AIDS care programme that provides the therapy and other AIDS care, prevention, and support services in rural Uganda. METHODS: HIV-infected individuals with advanced HIV disease or a CD4-cell count of less than 250 cells per muL were eligible for antiretroviral therapy. Adherence interventions included group education, personal adherence plans developed with trained counsellors, a medicine companion, and weekly home delivery of antiretroviral therapy by trained lay field officers. We analysed factors associated with pill count adherence (PCA) of less than 95%, medication possession ratio (MPR) of less than 95%, and HIV viral load of 1000 copies per mL or more at 6 months (second quarter) and 12 months (fourth quarter) of follow-up. FINDINGS: 987 adults who had received no previous antiretroviral therapy (median CD4-cell count 124 cells per muL, median viral load 217,000 copies per mL) were enrolled between July, 2003, and May, 2004. PCA of less than 95% was calculated for 0.7-2.6% of participants in any quarter and MPR of less than 95% for 3.3-11.1%. Viral load was below 1000 copies per mL for 894 (98%) of 913 participants in the second quarter and for 860 (96%) of 894 of participants in the fourth quarter. In separate multivariate models, viral load of at least 1000 copies per mL was associated with both PCA below 95% (second quarter odds ratio 10.6 [95% CI 2.45-45.7]; fourth quarter 14.5 [2.51-83.6]) and MPR less than 95% (second quarter 9.44 [3.40-26.2]; fourth quarter 10.5 [4.22-25.9]). INTERPRETATION: Good adherence and response to antiretroviral therapy can be achieved in a home-based AIDS care programme in a resource-limited rural African setting. Health-care systems must continue to implement, evaluate, and modify interventions to overcome barriers to comprehensive AIDS care programmes, especially the barriers to adherence with antiretroviral therapy.

Acquired Immunodeficiency Syndrome↗

A brief motivational intervention to improve dietary adherence in adolescents. The Dietary Intervention Study in Children (DISC) Research Group.

Motivational interviewing offers health care professionals a potentially effective strategy for increasing a patient's readiness to change health behaviors. Recently, elements of motivational interviewing and the stages of change model have been simplified and adapted for use with patients in brief clinical encounters. This paper describes in detail a brief motivational intervention model to improve and renew dietary adherence with adolescents in the Dietary Intervention Study in Children (DISC). DISC is a randomized, multi-center clinical trial assessing the efficacy and safety of lowering dietary fat to decrease low-density lipoprotein cholesterol in high-risk children. In the first 3 years of follow-up covering ages 8-13, intervention participants (n = 334) were exposed to a family-based group intervention approach to change dietary choices. To address adherence and retention obstacles as participants moved into adolescence (age 13-17), an individual-level motivational intervention was implemented. The DISC motivational intervention integrates several intervention models: stages of change, motivational interviewing, brief negotiation and behavioral self-management. A preliminary test of the intervention model suggests that it was acceptable to the participants, popular with interventionists and appeared to be an age-appropriate shift from a family-based intervention model.

Adolescent↗

A brief psychological intervention to improve adherence following transplantation.

Poor adherence is recognized as a major contributor to morbidity, mortality, decreased quality of life, higher medical costs, and over-utilization of health care services among transplant recipients. While there is universal recognition that poor adherence negatively impacts transplant outcomes, interventions designed to improve adherence have not been the focus of much attention in the transplant literature. The purpose of this article is to describe a brief, theory-based and individually tailored intervention to promote adherence. This intervention is currently used with all liver transplant recipients at our institution. The main goal of the intervention is to reduce the effects of known barriers to adherence by providing recipients with the education, skills, and resources needed to optimize adherence. Adherence is measured at 1, 3, 6, and 12 months post-transplant and additional adherence booster sessions are provided as needed. This intervention has been very favorably received by patients, caregivers, transplant physicians, and nurse coordinators.

Adaptation, Psychological↗

Baseline predictors of three types of antiretroviral therapy (ART) adherence: a 2-year follow-up.

The purposes of the study were to measure adherence with antiretroviral therapy to dose, schedule, and dietary instructions in a sample of patients with HIV infection in Stockholm, Sweden, over a 2-year period and identify baseline predictors of the three types of adherence. The study cohort consists of 144 patients who completed at least six out of seven follow-up self-reported adherence questionnaires. Baseline self-administrated questionnaire examined socio-demographics, medication-related, psychological, cognitive, and social context factors and self-reported adherence. Biomedical data were obtained through patients' medical records. Summary dose, schedule, and dietary instructions adherence scores provided outcome measures reflecting 100% adherence across all time points or not 100% adherence during at least one measurement period. A total of 61% maintained consistent full-dose adherence throughout baseline and all follow-up visits and equivalent proportion of 100% schedule adherence was 39%. Among patients with dietary instructions, 37% retained consistent adherence at all visits. Only schedule adherence was predicted by baseline data; perceived pressures from those close to the patient to take HIV medications (OR 0.51, p<.05), life stress (OR 0.13, p 0.009), ART health concerns (OR 0.19, p 0.003), and ART prolongs one's life (OR 0.39, p 0.04) predicted reduced schedule adherence over time. Perceived medication pressures from medical staff (OR 1.76, p<.05), post-traumatic stress disorder symptoms (OR 1.07 p<.01), and adherence self-efficacy (OR 3.50, p<.05) predicted positive schedule adherence over time. These results clearly illustrate difficulties in sustaining ART adherent behaviour, in particular schedule and dietary restrictions, over time and thus emphasizes the importance of multiple periodic assessments of all three types of adherence. Interventions aimed at improving schedule adherence should in particular focus on psychological and cognitive factors.

Adult↗

Baseline predictors of three types of antiretroviral therapy (ART) adherence: A 2-year follow-up.

The purposes of the study were to measure adherence with antiretroviral therapy to dose, schedule, and dietary instructions in a sample of patients with HIV infection in Stockholm, Sweden, over a 2-year period and identify baseline predictors of the three types of adherence. The study cohort consists of 144 patients who completed at least six out of seven follow-up self-reported adherence questionnaires. Baseline self-administrated questionnaire examined socio-demographics, medication-related, psychological, cognitive, and social context factors and self-reported adherence. Biomedical data were obtained through patients' medical records. Summary dose, schedule, and dietary instructions adherence scores provided outcome measures reflecting 100% adherence across all time points or not 100% adherence during at least one measurement period. A total of 61% maintained consistent full-dose adherence throughout baseline and all follow-up visits and equivalent proportion of 100% schedule adherence was 39%. Among patients with dietary instructions, 37% retained consistent adherence at all visits. Only schedule adherence was predicted by baseline data; perceived pressures from medical staff to take HIV medications (OR 0.51, p < .05), life stress (OR 0.13, p < .01), ART health concerns (OR 0.19, p < .01), and ART prolongs one's life (OR 0.39, p < .05) predicted reduced schedule adherence over time. Perceived medication pressures from those close to the patient (OR 1.76, p < .05), post-traumatic stress disorder symptoms (OR 1.07 p<.01), and adherence self-efficacy (OR 3.50, p < .05) predicted positive schedule adherence over time. These results clearly illustrate difficulties in sustaining ART adherent behaviour, in particular schedule and dietary restrictions, over time and thus emphasizes the importance of multiple periodic assessments of all three types of adherence. Interventions aimed at improving schedule adherence should in particular focus on psychological and cognitive factors.

Adult↗

Reported adherence as a determinant of response to highly active antiretroviral therapy in children who have human immunodeficiency virus infection.

OBJECTIVE: The complexity of highly active antiretroviral therapy (HAART), with multiple medications, formulations, and dosing intervals, makes adherence challenging. Little is known about the adherence of children to HAART. The objective of this study was to identify correlates of adherence to HAART and the relationship between adherence and study outcomes in a pediatric clinical trial. METHODS: Pediatric AIDS Clinical Trials Group 377 is a phase I/II randomized trial of 4 HAART regimens in antiretroviral-experienced, clinically stable children aged 4 months to 17 years. The 4 treatment arms include various 3- or 4-drug combinations of d4T, 3TC, nevirapine, ritonavir, and nelfinavir. After informed consent was obtained, 193 children were enrolled between December 1997 and September 1998. Questionnaires were developed to collect subject- or caregiver-reported adherence to study medications and to identify problems associated with medication administration. Every 3 months, the number of doses of each medication missed during the 3 days preceding the study visit was recorded. Full adherence (FA) and non-full adherence were defined as missing no doses and missing at least 1 dose, respectively. RESULTS: Adherence data from study week 48 or the most recent study visit were available for 125 children (week 48 for 109 children). Overall, 70% of children reported FA and 30% reported non-full adherence. Adherence did not differ by treatment arm, age, or the child's knowledge of his or her human immunodeficiency virus infection status. There was a suggestion that adherence was less for white than nonwhite children (40% vs 73% FA) and did not differ between black and Hispanic children. Rates of FA were 82% for d4T, 79% for 3TC, 83% for nevirapine, 84% for ritonavir, and 68% for nelfinavir. Despite the similar rates of FA, difficulties with taking specific medications were reported most frequently for ritonavir and nelfinavir. These included poor taste, patient refusal, and scheduling problems. Adherence was associated with the virologic response: FA was seen in 92% of children with > or =2 log10 drop in viral load and in 64% with <2 log10 drop in viral load. CONCLUSION: In children, reported adherence predicts the virologic response to HAART therapy and is a useful measure of adherence. Interventions and regimens to increase adherence to HAART should result in an improved outcome.

Acquired Immunodeficiency Syndrome↗

BMT4me En Espa&#xf1;ol: Multisite Feasibility and Usability Testing of a Spanish-Language mHealth Adherence Support App for Spanish-Speaking Caregivers of Children After Hematopoietic Stem Cell Transplantation and Cancer Treatment.

BACKGROUND: Medication nonadherence during the first 100 days after pediatric hematopoietic stem cell transplantation (HSCT) and during oncology treatment increases risk for complications. BMT4me is a caregiver-facing mobile health (mHealth) application providing medication reminders, symptom tracking, and note-taking features to support medication management. Spanish-speaking caregivers are frequently excluded from digital adherence interventions due to the lack of language-accessible tools. PROCEDURE: We conducted a multisite, mixed-methods usability testing of a Spanish-language version of BMT4me ("BMT4me en Espa&#xf1;ol") with Spanish-speaking caregivers of children (ages 2-17 years) post-HSCT or with an oncology diagnosis on active treatment. Caregivers completed a facilitated, three-step usability session (unobtrusive observation, interactive observation, and debriefing), followed by a semi-structured interview, and then completed the system usability scale (SUS). Quantitative outcomes were summarized descriptively; qualitative data were analyzed using content analysis with constant comparison. RESULTS: Fifteen participants enrolled at each site for a total of 30 participants. Across both sites, the recruitment rate was 91%. All participants completed all parts of the study. The SUS score (M&#xa0;=&#xa0;80.09; SD&#xa0;=&#xa0;17.35) was above average (>68). Two key qualitative themes emerged: (1) the perceived positive impact of BMT4me on managing a serious illness and (2) the acceptance and sociocultural relevance of BMT4me for Spanish-speaking families. Caregivers also shared suggestions to add educational content and multiuser functionalities to BMT4me. CONCLUSIONS: The acceptance and perceived positive impact of the Spanish BMT4me app indicates that socioculturally relevant, Spanish mHealth interventions have strong potential to support Spanish-speaking caregivers in pediatric oncology and HSCT settings. CLINICAL TRIALS NCT: NCT06361173.

Adolescent↗

Social relationships, stigma and adherence to antiretroviral therapy for HIV/AIDS.

Research on adherence to combination antiretroviral therapy has up to now focused largely upon problems of definition and measurement, and on the identification of barriers and supports. This paper examines the intersection between taking HAART and building a life with HIV/AIDS. Data consist of 214 qualitative interviews with 52 HIV-positive, active illegal drug users. A interpretive analysis drawing upon stigma and fear of disclosure as analytical constructs was applied to explain working tensions between efforts to develop social relationships on the one hand, and attempts to safeguard health through adherence on the other. The analysis specifies a mechanism through which stigma as a social process results in marginalization and exclusion. The hierarchical organization of multiple stigma is also noted. Loneliness and the desire for relatedness is intensified by drug use. Results suggest that persons with HIV/AIDS will not consistently subordinate other interests to prioritize adherence. Interventions aimed at supporting long-term adherence must address experienced conflicts between 'health' and 'life'.

Activities of Daily Living↗

Efficacy of a self-guided online resilience intervention for improving mental health among university students: A randomized controlled trial.

Epidemiological data indicates that university students are an at-risk population for the development of mental disorders. Online interventions have been proposed as promising tools for reducing barriers to treatment and establishing easily accessible health-care services promoting mental health and resilience. This study investigated the efficacy of a Learning Management System (LMS)-based self-guided online resilience intervention. 216 university students took part in a randomized controlled trial with an intervention and a waitlist control group and three measurement points (pre, post and follow-up). We conducted per-protocol (PP) and intention-to-treat (ITT) analyses with mental distress as primary outcome, and self-reported resilience and resilience factors as secondary outcomes. Further, attitudes towards online interventions, adherence, satisfaction and possible negative effects were explored. Satisfaction with the intervention was high and PP analyses (n&#x2009;=&#x2009;150) revealed significant improvements in mental distress and self-compassion at post-test and acceptance at follow-up. No favourable effects were found for self-reported resilience and resilience factors. Adherence was low and ITT analyses revealed no significant effects. Overall, the study provides preliminary evidence for the LMS-based self-guided online intervention as a potentially valuable tool for university mental health services under optimal adherence conditions. Further research into determinants of adherence is needed to improve intervention reach.

Humans↗

Reduction in acquisition of vancomycin-resistant enterococcus after enforcement of routine environmental cleaning measures.

BACKGROUND: The role of environmental contamination in nosocomial cross-transmission of antibiotic-resistant bacteria has been unresolved. Using vancomycin-resistant enterococci (VRE) as a marker organism, we investigated the effects of improved environmental cleaning with and without promotion of hand hygiene adherence on the spread of VRE in a medical intensive care unit. METHODS: The study comprised a baseline period (period 1), a period of educational intervention to improve environmental cleaning (period 2), a "washout" period without any specific intervention (period 3), and a period of multimodal hand hygiene intervention (period 4). We performed cultures for VRE of rectal swab samples obtained from patients at admission to the intensive care unit and daily thereafter, and we performed cultures of environmental samples and samples from the hands of health care workers twice weekly. We measured patient clinical and demographic variables and monitored intervention adherence frequently. RESULTS: Our study included 748 admissions to the intensive care unit over a 9-month period. VRE acquisition rates were 33.47 cases per 1000 patient-days at risk for period 1 and 16.84, 12.09, and 10.40 cases per 1000 patient-days at risk for periods 2, 3, and 4, respectively. The mean (+/-SD) weekly rate of environmental sites cleaned increased from 0.48+/-0.08 at baseline to 0.87+/-0.08 in period 2; similarly high cleaning rates persisted in periods 3 and 4. Mean (+/-SD) weekly hand hygiene adherence rate was 0.40+/-0.01 at baseline and increased to 0.57+/-0.11 in period 2, without a specific intervention to improve adherence, but decreased to 0.29+/-0.26 in period 3 and 0.43+/-0.1 in period 4. Mean proportions of positive results of cultures of environmental and hand samples decreased in period 2 and remained low thereafter. In a Cox proportional hazards model, the hazard ratio for acquiring VRE during periods 2-4 was 0.36 (95% confidence interval, 0.19-0.68); the only determinant explaining the difference in VRE acquisition was admission to the intensive care unit during period 1. CONCLUSIONS: Decreasing environmental contamination may help to control the spread of some antibiotic-resistant bacteria in hospitals.

Anti-Bacterial Agents↗

A pilot study of the effects of a behavioural intervention on treatment adherence in HIV-infected patients.

A pilot study was carried out in a group of six HIV-infected non-adherent men testing the effects of a behavioural medication management intervention on adherence with antiretroviral drugs. The study was prospective, using a one-group repeated-measures design. Adherence was measured using two self-reports. The intervention was a behaviourally-based programme that lasted for three months and included individualized education about antiretroviral medication and their side effects; positive reinforcement and encouragement; individualized counselling weekly; follow-up calls; and lifestyle assessment and the identification of adherence barriers. Assessments were carried out at recruitment, immediately after the initiation of the intervention, one month, three months and six months later. Results suggested that the intervention enhanced adherence rates from a mean percentage of 80.27 at baseline to a mean of 97.5% at the end of follow-up (six months time point). Similar improvement was observed in the scores of the scale measuring adherence difficulties. Further, CD4+ counts also slightly improved. Interviews with four of the participants at the end of the study highlighted the problems experienced by patients in taking their medication and supported the usefulness of the intervention. Because of the complexity of the factors behind adherence, it is important that patients are supported with individualized medication management programmes.

Adult↗

Dietary adherence: characteristics and interventions.

This paper reviews issues regarding dietary adherence. Issues and barriers unique to dietary adherence, in contrast to adherence to physical activity or medication regimens, are discussed. These include decision making, social and cultural contexts, perceptions and preferences, and environmental barriers. We review factors known to increase adherence in dietary interventions, including education, motivation, behavioral skills, new and modified foods, and supportive interactions. We conclude with directions for future study, such as improved measurement of diet-related behavior and longitudinal, culturally sensitive interventions. Control Clin Trials 2000;21:206S-211S

Aged↗