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Background: Effective and easy to implement interventions to improve adherence to antiretroviral therapy are needed., Objective: To compare site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy to the study site's standard of care., Methods: A randomized controlled trial of site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy. Subjects were randomized to receive site nurse-initiated telephone calls (intervention) or no additional calls to the site's standard of care (control). Subjects received calls 1 to 3 days after initiating antiretrovirals, on weeks 1, 2, 3, 6, 10, 14, 18, 22, and 26, and every 8 weeks thereafter. Self-reported adherence was captured during study visits., Results: A total of 333 subjects starting antiretrovirals as part of ACTG 384 were co-enrolled into ACTG 5031. Subjects were followed for up to 160 weeks and were contacted for 74% of scheduled calls. There was no significant difference in proportion of patients with ≯95% mean total adherence (87.9% and 91.2%; P = .34) and mean self-reported total adherence (97.9% and 98.4%) in the intervention and control groups, respectively, or in symptom distress and clinical endpoints., Conclusions: In the context of a clinical trial where self-reported adherence was exceptionally high, the site nurse-initiated telephone calls did not further improve self-reported adherence, symptom distress, or clinical outcomes.

The purpose of this study was to assess personal beliefs about the causes and meaning of having HIV disease and personal beliefs about medication adherence in persons living in rural southeastern North Carolina. Of the total sample of 34 participants, 29 (85%) were African American. The sample included 21 men (62%) and 13 women (38%), with a self-reported mean CD4 count of 499.38 (SD = 377.69) and a mean duration of HIV of 8.0 years. The majority of participants held beliefs that HIV was a serious and chronic condition and that the disease could be controlled by HIV therapies. Participants offered disparate views about whether or not the course of HIV disease was amenable to personal control. The persons who held the belief that the cause of HIV/AIDS was because of chance/bad luck (p = .03) or God's will (p < .001) were also most likely to believe that the progression of their HIV disease depended on chance or fate. The respondents currently taking HIV medication were also more likely to believe that HIV was caused by chance or bad luck (p = .038) or God's will (p = .016). The results reflect the important role of spirituality on self- regulation of illness and treatment in the rural southern culture.

Objective: To determine whether proactive telephone support improves adherence to antiretroviral therapy (ART) and clinical outcomes when compared to standard care., Methods: A multisite, randomized controlled trial (RCT) was conducted with 109 ART-naive subjects coenrolled in AIDS Clinical Trials Group (ACTG) 384. Subjects received standard clinic-based patient education (SC) or SC plus structured proactive telephone calls. The customized calls were conducted from a central site over 16 weeks by trained registered nurses. Outcome measures (collected over 64 weeks) included an ACTG adherence questionnaire and 384 study endpoints., Results: For the primary endpoint, self-reported adherence, a significantly better overall treatment effect was observed in the telephone group (P = 0.023). In a post hoc analysis, composite adherence scores, taken as the first 2 factor scores from a principal components analysis, also found significant intervention benefit (P = 0.023 and 0.019 respectively). For the 384 primary study endpoint, time to regimen failure, the Kaplan-Meier survival curve for the telephone group remained above the SC group at weeks 20 to 64; a Cox proportional hazard model that controlled for baseline RNA stratification, CD4, gender, age, race/ethnicity, and randomized ART treatment arm suggested the telephone group tended to have a lower risk for failure (hazard ratio = 0.68; 95% confidence interval: 0.38 to 1.23)., Conclusions: Findings indicate that customized, proactive telephone calls have good potential to improve long-term adherence behavior and clinical outcomes.

Background/objective: The AIDS Clinical Trials Group (ACTG) Adherence Questionnaire is used extensively, but investigators frequently only use the first item of the questionnaire (4-day recall)., Design/methods: A secondary analysis was conducted to (1) estimate the validity and reliability of each of the 5 scale items and (2) compare the approach commonly used to summarize adherence data collected with the instrument (average 4-day recall) with alternate approaches derived using principal component (PC) analysis and the full questionnaire. We hypothesized that an estimate of adherence taking all items of the questionnaire into account would provide a stronger measure of adherence., Results: Logistic regression analyses showed that the first PC identified (PC1) was significantly correlated with plasma HIV RNA outcome (P < 0.0001 for ACTG 370 data and P = 0.006 for ACTG 398 data) and correlated with plasma HIV RNA better than average 4-day recall. An adherence index formulated using weights of PC1 showed substantially greater variability in the range of adherence scores in comparison to average 4-day adherence recall alone. PC1 compared favorably with 2 indices derived from medication event monitoring system data as well., Conclusions: Findings indicate that a superior assessment of antiretroviral adherence may be obtained with the ACTG Adherence Questionnaire by using the method employed in this analysis.

Compliance is the extent to which a patient follows the prescribed regimen. Here we investigate the statistical properties of two popular measures of compliance - percentage of compliant days and percentage of doses taken. We use a stationary Markov chain to model the dependence structure of successive data points for each subject. We illustrate our model using discrete compliance data collected from an AIDS Clinical Trial Group study (ACTG 398). We check the model assumptions and evaluate the small sample as well as large sample properties of our estimators. We show that ignoring the within-subject dependence will usually underestimate the standard errors of the estimates of these compliance measures. Our model allows the application of meta-analytic approaches to assess the variation across subjects in these compliance indices and changes in them due to intervention., (((c) 2007 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim).)

HIV-related morbidity and mortality have been dramatically improved in populations treated with combination antiretroviral therapy. Although it is widely recognized that adherence to the antiretroviral medication regimens is vital to treatment success, rates of adherence to the regimens are often poor. There is a large body of research exploring the problem of adherence to antiretroviral medications. The literature is, to date, dominated by reports identifying factors that are predictive or associated with antiretroviral adherence. Adherence is increasingly understood as a dynamic behavior influenced by a matrix of interrelated factors that change over time. Preliminary reports suggest varying degrees of success with strategies designed to improve adherence. Multifaceted strategies appear to be the most promising; however, there are few controlled studies substantiating the effectiveness of these approaches and the mechanisms by which the interventions promote adherence are not well understood. More well powered, rigorously evaluated antiretroviral adherence intervention trials are urgently needed. Further, problems in the field exist because of limitations in the available adherence measures. This paper provides a comprehensive review and analysis of the state-of-the-science of this body of work. Despite substantial attention to antiretroviral adherence in recent years, there remain significant gaps in our understanding., (Copyright 2004 Bentham Science Publishers Ltd.)

It is widely recognized that adherence to antiretroviral therapy is critical to long-term treatment success, yet rates of adherence to antiretroviral medications are frequently subtherapeutic. Beliefs about antiretroviral therapy and psychosocial characteristics of HIV-positive persons naive to therapy may influence early experience with antiretroviral medication adherence and therefore could be important when designing programs to improve adherence to antiretroviral therapy. As part of a multicenter AIDS Clinical Trial Group (ACTG 384) study, 980 antiretroviral-naive subjects (82% male, 47% White, median age 36 years, and median CD4 cell count 278 cells/mm3) completed a self-administered questionnaire prior to random treatment assignment of initial antiretroviral medications. Measures of symptom distress, general health and well-being, and personal and situational factors including demographic characteristics, social support, self-efficacy, depression, stress, and current adherence to (nonantiretroviral) medications were recorded. Associations among variables were explored using correlation and regression analyses. Beliefs about the importance of antiretroviral adherence and ability to take antiretroviral medications as directed (adherence self-efficacy) were generally positive. Fifty-six percent of the participants were "extremely sure" of their ability to take all medications as directed and 48% were "extremely sure" that antiretroviral nonadherence would cause resistance, but only 37% were as sure that antiretroviral therapy would benefit their health. Less-positive beliefs about antiretroviral therapy adherence were associated with greater stress, depression, and symptom distress. More-positive beliefs about antiretroviral therapy adherence were associated with better scores on health perception, functional health, social-emotional-cognitive function, social support, role function, younger age, and higher education (r values = 0.09-0.24, all p < .001). Among the subset of 325 participants reporting current use of medications (nonantiretrovirals) during the prior month, depression was the strongest correlate of nonadherence ( r = 0.33, p < .001). The most common reasons for nonadherence to the medications were "simply forgot" (33%), "away from home" (27%), and "busy" (26%). In conclusion, in a large, multicenter survey, personal and situational factors, such as depression, stress, and lower education, were associated with less certainty about the potential for antiretroviral therapy effectiveness and one's perceived ability to adhere to therapy. Findings from these analyses suggest a role for baseline screening for adherence predictors and focused interventions to address modifiable factors placing persons at high risk for poor adherence prior to antiretroviral treatment initiation.

Purpose: We evaluated the feasibility, acceptability and preliminary efficacy of a standardized nurse delivered mobile phone intervention to improve adherence to antiretroviral treatment and clinical outcomes. Methods: Feasibility and acceptability of the phone intervention was assessed with rates of eligibility, completed visits, and attritions. Intervention fidelity was assessed by checking recorded calls and feedback. Efficacy was assessed using a randomized controlled trial in which 120 women living with HIV and psychosocial vulnerabilities, were randomized to Treatment as Usual (TAU = 60) or TAU plus the mobile phone intervention (N = 60). Trained basic nurses delivered the theory-guided, standardized mobile phone intervention for mental health issues and psychosocial risk factors to improve antiretroviral treatment (ART) adherence and retention in care and improve clinical outcomes. Blind raters performed the assessments at 6, 12 and 24 weeks post-randomization. Results: Adherence diminished over time in the TAU only group, while it was sustained in the TAU Plus group, only dropping at 24 weeks after the intervention had been discontinued. Among participants with depressive symptoms (CESD ≥ 16), the intervention had significant improvement in adherence rates (p < 0.01), psychological quality of life (p < 0.05) and illness perception (p < 0.05) compared to those in the TAU only group. Greater improvements of quality of life subscales were observed in the TAU Plus group among participants with less psychological vulnerability (PSV < 2). HIV RNA was not significantly different between the groups at week 24. Conclusions: The mobile-delivered counseling intervention was feasible and acceptable and shows promise among women living with HIV and psychosocial vulnerabilities in rural South India. Trial Registration: ClinicalTrials.gov Identifier: NCT02319330 [Registered on: December 18, 2014]. [ABSTRACT FROM AUTHOR]

BackgroundEffective and easy to implement interventions to improve adherence to antiretroviral therapy are needed.ObjectiveTo compare site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy to the study site's standard of care.MethodsA randomized controlled trial of site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy. Subjects were randomized to receive site nurse-initiated telephone calls (intervention) or no additional calls to the site's standard of care (control). Subjects received calls 1 to 3 days after initiating antiretrovirals, on weeks 1, 2, 3, 6, 10, 14, 18, 22, and 26, and every 8 weeks thereafter. Self-reported adherence was captured during study visits.ResultsA total of 333 subjects starting antiretrovirals as part of ACTG 384 were co-enrolled into ACTG 5031. Subjects were followed for up to 160 weeks and were contacted for 74% of scheduled calls. There was no significant difference in proportion of patients with ≯95% mean total adherence (87.9% and 91.2%; P = .34) and mean self-reported total adherence (97.9% and 98.4%) in the intervention and control groups, respectively, or in symptom distress and clinical endpoints.ConclusionsIn the context of a clinical trial where self-reported adherence was exceptionally high, the site nurse-initiated telephone calls did not further improve self-reported adherence, symptom distress, or clinical outcomes.

The opportunity to eliminate hepatitis C virus (HCV) is at hand, but challenges remain that negatively influence progress through the care continuum, particularly for persons co‐infected with HIV who are not well engaged in care. We conducted a randomized controlled trial to test the effect of nurse case management (NCM) on the HCV continuum among adults co‐infected with HIV compared to usual care (UC). Primary outcomes included linkage to HCV care (attendance at an HCV practice appointment within 60 days) and time to direct‐acting antiviral (DAA) initiation (censored at 6 months). Sixty‐eight participants were enrolled (NCM n = 35; UC n = 33). Participants were 81% Black/African American, 85% received Medicaid, 46% reported illicit drug use, 41% alcohol use, and 43% had an undetectable HIV viral load. At day 60, 47% of NCM participants linked to HCV care compared to 25% of UC participants (P =.031; 95% confidence bound for difference, 3.2%‐40.9%). Few participants initiated DAAs (12% NCM; 25% UC). There was no significant difference in mean time to treatment initiation (NCM = 86 days; UC = 110 days; P =.192). Engagement in HCV care across the continuum was associated with drinking alcohol, knowing someone who cured HCV and having a higher CD4 cell count (P <.05). Our results support provision of NCM as a successful strategy to link persons co‐infected with HIV to HCV care, but interventions should persist beyond linkage to care. Capitalizing on social networks, treatment pathways for patients who drink alcohol, and integrated substance use services may help improve the HCV care continuum. [ABSTRACT FROM AUTHOR]

Adherence to antiretroviral therapy (ART) remains one of the greatest obstacles in pediatric HIV care. We sought to determine the prevalence of adherence to ART among undisclosed HIVinfected children and adolescents in Ghana. We analyzed baseline data from HIV-infected children and adolescents aged 7-18 years old enrolled in the SANKOFA Pediatric HIV disclosure intervention study in Ghana. Antiretroviral medication adherence was measured using caregiver 3-day recall; child 3-day recall; and pharmacy records for antiretroviral time-to-refill. Four hundred and twenty child-caregiver dyads were enrolled from January 2013 to June 2016. The median adherence (interquartile range), as measured by time-to-refill, was 93.2% (68.0%-- 100.0%). However, only 47.5% of children had ≥95% adherence ("good adherence") using timeto- refill data. Children of caregivers who had received secondary or higher level of education versus no school (aOR, 2.90, 95% Confidence Interval, CI 1.29-6.56), p = 0.010) or elementary education only (aOR, 2.20, CI, 1.24-3.88, p = 0.007) were more likely to have "good adherence" (≥95%). In this cohort of children unaware of their HIV positive status, median ART adherence rate was sub-optimal (by World Health Organization definition) while 38% had poor adherence (<85%). [ABSTRACT FROM AUTHOR]

We assessed the acceptability of nurse-delivered mobile phone-based counseling to support adherence to antiretroviral treatment (ART) and self-care behaviors among HIV-positive women in India. We conducted open-ended, in-depth interviews with 27 HIV-positive women and 19 key informants at a government ART center in Karnataka, India. Data were analyzed with interpretive techniques. About half of the HIV-positive women owned a mobile phone and many had access to mobile phones of their family members. Most women perceived phone-based counseling as a personalized care approach to get information on demand. Also, women felt that they could discuss mental health issues and ask sensitive information that they would hesitate to discuss face-to-face. Findings indicate that, when compared with text messaging, mobile phone-based counseling could be a more acceptable way to engage with women on ART, especially those with limited literacy. Future studies should focus on testing mobile phone-based information/counseling and adherence interventions that take the local context into account. [ABSTRACT FROM AUTHOR]

Background: Women living with HIV are vulnerable to a variety of psychosocial barriers that limit access and adherence to treatment. There is little evidence supporting interventions for improving access and treatment adherence among vulnerable groups of women in low- and middle-income countries. The M obile Phone-Based A pproach for H ealth I mprovement, L iteracy and A dherence (MAHILA) trial is assessing the feasibility, acceptability and preliminary efficacy of a novel, theory-guided mobile health intervention delivered by nurses for enhancing self-care and treatment adherence among HIV-infected women in India.Methods/design: Women (n = 120) with HIV infection who screen positive for depressive symptoms and/or other psychosocial vulnerabilities are randomly assigned in equal numbers to one of two treatment arms: treatment as usual plus the mobile phone intervention (experimental group) or treatment as usual (control group). In addition to treatment as usual, the experimental group receives nurse-delivered self-care counselling via mobile phone at fixed intervals over 16 weeks. Outcome measures are collected at baseline and at 4, 12, 24 and 36 weeks post-baseline. Outcomes include antiretroviral treatment adherence, HIV-1 RNA, depressive symptoms, illness perceptions, internalized stigma and quality of life.Discussion: The MAHILA trial will provide information about how a mobile health counselling intervention delivered by non specialist nurses may improve access to care and support the adherence and clinical outcomes of women with HIV infection living in low- and middle-income countries such as India.Trial Registration: NCT02319330 (First received: July 30, 2014; Last verified: January 2016). [ABSTRACT FROM AUTHOR]