Efficacy of an educational and counseling intervention on adherence to highly active antiretroviral therapy: French prospective controlled study. Adherence to antiretroviral therapy in HIV-infected pediatric patients improves with home-based intensive nursing intervention. Influencing medication adherence among women with AIDS. Prospective randomized two-Arm controlled study to determine the efficacy of a specific intervention to improve long-term adherence to highly active antiretroviral therapy. Using motivational interviewing to promote adherence to antiretroviral medications: a pilot study. Multidisciplinary HIV adherence intervention: a randomized study. Impact of a patient education program on adherence to HIV medication: a randomized clinical trial. Impact of an adherence clinic on behavioral outcomes and virologic response in treatment of HIV infection: a prospective, randomized, controlled pilot study. Use of an on-line pager system to increase adherence to antiretroviral medications. A medication self-management program to improve adherence to HIV therapy regimens. Results of a pilot intervention trial to improve antiretroviral adherence among HIV-positive patients. A randomized controlled trial to enhance antiretroviral therapy adherence in patients with a history of alcohol problems. [Adherence to very active antiretroviral treatment: impact of individualized assessment]. Program to enhance health literacy and treatment adherence in low-income HIV-infected Latino men and women. Effect of individual cognitive behaviour intervention on adherence to antiretroviral therapy: prospective randomized trial. The efficacy of an integrated risk reduction intervention for HIV-positive women with child sexual abuse histories. Impact of an educational program on efficacy and adherence with a twice-daily lamivudine/zidovudine/abacavir regimen in underrepresented HIV-infected patients.
The objective was to evaluate the impact of an intervention for improving adherence to antiretroviral therapies (HAART) in HIV-infected patients.
                We designed a prospective, controlled, randomized trial to assess the impact of an educational and counseling intervention in addition to standard of care. At M0, the study enrolled 244 HAART-treated patients who attended a medical consultation between September and December 1999 who were not included in another protocol. Patients in the intervention group (IG) were offered three individual sessions by trained nurses. The proportions of adherent patients at 6 months followup (M6) and the change in HIV RNA between M0 and M6 were measured.
                Between M0 and M6, HIV RNA significantly decreased in the 123 patients of the IG (mean difference = -0.22 log [+/-0.86], p =.013), while it increased (+0.12 log [+/-0.90], p =.14) in the 121 patients of the control group. However, the proportion of patients with HIV RNA <40 copies/mL remained similar in both groups. In an intent-to-treat analysis, the only significant predictor of 100% adherence at M6 was the intervention group (p =.05) after adjustment for baseline adherence (p =.001). Among the 202 patients with available data on adherence, the proportion of adherent patients was similar in both groups at M0 (58% vs. 63%, p =.59) but became higher in the IG at M6 (75% vs. 61%, p =.04).
                The educational and counseling intervention was efficient for increasing adherence to HAART and could be implemented in most clinical settings. Adherence to combination antiretroviral therapy (ART) has been shown to be a determining factor in controlling viral replication, maintaining immunologic function and long-term survival in HIV-positive individuals. Little information is available on strategies to improve adherence in pediatric HIV-infected patients. We conducted a randomized, nonblinded, pilot study to determine if a home-based nursing intervention would improve medication adherence. The study was offered to all eligible HIV-positive patients receiving care at Connecticut Children's Medical Center's (CCMC) Pediatric and Youth HIV Program. Sixty-seven percent (37/55) of the patients and their caretakers participated. We randomized participants to either standard of care or the intervention trial. The intervention was designed to improve knowledge and understanding of HIV infection and HIV medications and to resolve or modify barriers to adherence. Both groups completed pre- and post-intervention questionnaires, assessing their knowledge and understanding of HIV, ART, and adherence. Adherence was estimated objectively from medication refill history and subjectively from a self-report score. We also inferred adherence from pre- to post-test plasma viral load and CD4+ T-cell percentages. The knowledge score (p = 0.02) and medication refill history (p = 0.002) improved significantly in the intervention group. The adherence self-report score improved, although not significantly (p = 0.07). We did not observe statistical differences in CD4+ T-cell counts or viral load between groups. We conclude that our home-based nursing intervention helped HIV-positive children and their families in better adhering to prescribed medication regimens. This study examined the effects of a ten-session cognitive-behavioural stress management/expressive supportive therapy (CBSM+) intervention on adherence to antiretroviral medication. Although the intervention was not designed to influence adherence, it was theorized that improved coping and social support could enhance adherence. Women with AIDS (N = 174) in Miami, New York and New Jersey, USA, were randomized to a group CBSM+ intervention or individual control condition. Participants were African American (55%), Latina (18%) and Caribbean (18%) with drug (55%) and/or alcohol (32%) histories. Participants were assessed on self-reported medication adherence over seven days, HIV-related coping strategies and beliefs regarding HIV medication. Baseline overall self-reported adherence rates were moderate and related to coping strategies and HIV medication beliefs. Low adherent (80%) participants in the intervention condition increased their mean self-reported medication adherence (30.4% increase, t44 = 3.1, p < 0.01), whereas low adherent women in the control condition showed a non-significant trend (19.6% increase, t44 = 2.0, p > 0.05). The intervention did not improve adherence in this population; conditions did not differ significantly on self-reported adherence. Low adhering intervention participants significantly decreased levels of denial-based coping (F1,88 = 5.97, p < 0.05). Results suggest that future interventions should utilize group formats and address adherence using coping and medication-knowledge focused strategies. Nearly perfect compliance seems to be indispensable to obtain the maximum benefit from highly active antiretroviral therapy (HAART). Interventions to ensure a high level of adherence during a relatively long-term period of therapy are necessary.
                This is a prospective, randomized, two-arm controlled study including patients starting their first-or second-line HAART who were randomized to receive psychoeducative intervention to implement adherence (experimental group [EG]) or a usual medical follow-up (control group [CG]). We aimed to study the efficacy of a psychoeducative intervention to ensure long-term adherence to HAART, its relation with the virologic efficacy of treatment, and to determine the variables related to long-term adherence. Visits were made at weeks 0, 4, 24, and 48 for data collection. Self-reported adherence was registered at each visit and its veracity was tested by randomized blood analyses performed without previous warning to 40% of patients. Appropriate adherence was defined as the consumption of >/=95% of medication prescribed. Statistical analyses were performed both by the as treated (AT) and the intention to treat missing = failure (ITT) methods.
                In all, 116 patients were included. At week 48, 94% of patients in the EG versus 69% controls achieved adherence >/=95% (p =.008); 89% of patients in the EG versus 66% controls had HIV-1 RNA levels <400 copies/ml (p =.026). Overall, 85% of patients with adherence >/=95% but only 45% of those with adherence <95% had viral load (VL) <400 copies/ml (p =. 008). In multivariate analysis, variables significantly related to adherence were having received a psychoeducative intervention (odds ratio [OR], 6.58; p =.04), poor effort to take medication (OR, 5.38; p =.03), and high self-perceived capacity to follow the regimen (OR, 13.76; p =.04). Self-reported adherence and drug plasma levels coincided in 93% of cases. However, differences in adherence did not reach statistical significance in the ITT analysis although a clear tendency toward benefit was observed in EG.
                Specific and maintained psychoeducative interventions based on excellence on clinical practice are useful to keep high levels of adherence as well as high levels of viral suppression. There is a clear relation between high adherence levels and virologic success. Assessment of certain specific variables related to adherence may be helpful to monitor patient's compliance in the clinical setting. This report describes a pilot study of a nursing intervention to increase adherence to combination therapy. The intervention was based on motivational interviewing (MI). Participants completed a baseline assessment using the computer-administered self-interview with audio (ACASI) data collection method and then were randomly assigned to the MI intervention or control condition. Nurse counselors met with participants in the MI intervention group for three adherence sessions. Two months following baseline, participants completed a follow-up assessment. Mean scores on ratings of missed medications were lower for participants in the intervention group than those in the control group. Although there were no significant differences in the number of medications missed during the past 4 days, participants in the MI group reported being more likely to follow the medication regimen as prescribed by their health care provider. The pilot study provided useful information about the acceptability of ACASI and the adequacy of intervention procedures. The results of this pilot study show promise for the use of MI as an intervention to promote adherence to antiretroviral medications. Maintaining greater than 95% adherence to antiretroviral medication is necessary in order to have the greatest therapeutic impact on HIV infection. Furthermore, evidence suggests that adherence rates of between 70% and 89% are significantly associated with viral rebound and the development of drug resistance. Adherence rates at and above the 95% level are difficult for patients to achieve and maintain. Our aim was to determine if an adherence intervention could improve adherence among patients attending an ambulatory care clinic at a large public hospital. The intervention was delivered by a multidisciplinary team of health care professionals and consisted of education coupled with the provision of devices designed to assist patient memory and adherence. A crucial component of the intervention consisted of the identification of patient specific barriers to adherence and the development of strategies to circumvent these problems. Adherence was assessed using patient self-report over the past 4, 7, and 28 days and by calculation of the Morisky score. The study was conducted as a randomised controlled trial using the stepped wedge design with a total of 68 subjects randomised to receive the intervention over a 20-week period. Adherence before and after the intervention formed the analysis. There was a significant decrease in the number of missed doses over the past 4 (1.9 to 1.0, p < 0.001), 7 (3.0 to 1.8, p < 0.001) and 28 (7.4 to 4.2, p < 0.001) days and a decrease in the Morisky score, indicating an improvement in medication taking behaviour (1.3 to 0.5 p < 0.001). Patients' knowledge of their HIV condition and its treatment, which has been recognized as a factor that influences adherence to antiretroviral therapy, can be improved through educational programs. This prospective, randomized, controlled trial compared an experimental group that participated in an educational program and a control group with standard care. The study evaluated the impact of an educational intervention on adherence to antiretroviral therapy, patients' knowledge, quality of life, and therapeutic response in patients treated with highly active antiretroviral therapy. Three hundred twenty-six patients were analyzed at inclusion. A higher level of adherence was associated with patients who were older, had higher incomes, and did not smoke. CD4 cell count and plasma viral load were correlated with adherence at entry. The educational intervention had an impact on adherence and knowledge in the experimental group at 6 months, which was maintained at 12 and 18 months. A delayed increase in adherence was observed in the control group at 12 months. No significant impact on quality of life was observed over time. The patients' health status improved in 56% of the experimental group subjects and 50% of the control subjects. However, no significant impact was shown on CD4 cell count and plasma viral load. This study shows that an educational intervention improves adherence to antiretroviral regimens and health status and suggests that it should be initiated early in therapy. The aim of this randomized, controlled pilot study was to examine the impact of a pharmacist operated adherence clinic on adherence to highly active antiretroviral therapy (HAART) and viral suppression in patients with HIV over 28 weeks.
                Consecutive eligible patients initiating HAART at an indigent-care clinic were randomized to an adherence clinic or to standard care (information provided by physician or nurse practitioner) for education and monitoring. Group assignment was stratified before randomization according to regimen complexity and potential tolerability. Adherence (electronic monitoring and patient self-report) and viral load (reverse-transcription polymerase chain reaction) were assessed at weeks 4, 16, and 28.
                Thirty-three randomized patients (adherence clinic, n = 16; standard care, n = 17) comprised the intent-to-treat population. The groups were well-matched for demographics and antiretroviral regimen. The median age was 38.0 years in both groups. Most patients were male (85%), had previously used HAART (78%), and had an AIDS diagnosis (79%). Mean (SD) adherence at weeks 4, 16, and 28 was 86% (27%), 77% (28%), and 74% (31%) in the adherence clinic group versus 73% (32%), 56% (39%), and 51% (41%) in the standard care group (week-16 difference, 21% [90% CI, 1%-42%]; week-28 difference, 23% [90% CI, 1%-44%]). Sixty-nine percent of patients in the adherence clinic group took their medication on schedule versus 42% in the standard care group (P = 0.025); mean decline in adherence from weeks 4 to 28 was 12% in the adherence clinic group (P = 0.15) versus 22% in the standard care group (P = 0.002). HIV-1 RNA levels were <400 copies/mL at weeks 4, 16, and 28 in 63%, 100%, and 94% of the adherence clinic group and 29% (P = NS), 71% (P = 0.04), and 65% (P = NS) of the standard care group.
                In this preliminary trial, an adherence clinic model improved adherence to HAART and virologic response over 28 weeks in the patients studied. Adherence to antiretroviral therapy is critical for treatment success. Antiretroviral therapy typically requires multiple pills at multiple dosing times. To address this, we tested the feasibility, utility, and efficacy of a customizable reminder system using pagers, which were programmed using web-based technology, to increase and maintain proper adherence in patients with pre-existing adherence problems. After a two-week monitoring period with an electronic pill-cap, participants with less than 90% adherence were randomized to continue monitoring or to receive a pager. The group who received the pagers had greater improvements in adherence from baseline to Week 2 and Week 12 than those who monitored their medications only. However, adherence in both groups at the outcome assessments points was still poor. While the provision of a reminder system helped improve adherence, it is likely that more intensive interventions are required for patients with pre-existing problems. This study examined whether a self-management intervention based on feedback of adherence performance and principles of social cognitive theory improves adherence to antiretroviral dosing schedules. Forty-three individuals with HIV/AIDS who were starting or switching to a new protease inhibitor regimen were randomly assigned to be in a medication self-management program or usual care control group. The self-management program included skills development exercises, three monthly visits for medication consultations, and monthly feedback of adherence performance using electronic monitors on medication bottles. Participants also completed a 40-item questionnaire that measured self-efficacy to take medications, on schedule, in a variety of situations. Logistic regression analysis indicated that individuals in the self-management group were significantly more likely to take 80% or more of their doses each week than individuals in the control group (n=29, OR=7.8, 95% CI=2.2-28.1). Self-management training with feedback of adherence performance is a potentially useful model for improving adherence to complex regimens in HIV/AIDS care. A small pilot trial of a multicomponent (behavioral strategies, simplified patient information, and social support) and multidisciplinary (cognitive-behavioral therapy and nursing) medication adherence intervention was conducted for HIV-infected adults prescribed antiretrovirals. Patients (N = 33) were randomly assigned to the intervention condition or standard care. Compared to the control group, patients in the intervention condition had significantly higher self-efficacy to communicate with clinic staff (p = .04) and to continue treatment (p = .04), were significantly more likely to be using behavioral and cognitive strategies (p = .01 and p = .04), reported significantly higher life satisfaction (p = .03), reported significantly increased feelings of social support (p = .04), and showed a trend toward an increase in taking their medications on schedule (p = .06). The intervention, however, did not appear to affect health-related anxiety or to significantly improve adherence to dose. Implications for future intervention planning are discussed. To assess the effectiveness of an individualized multicomponent intervention to promote adherence to antiretroviral therapy (ART) in a cohort of HIV-infected individuals with a history of alcohol problems.
                We conducted a randomized controlled trial to compare the usual medical follow-up with an adherence intervention.
                The principal enrolment site was Boston Medical Center, a private, not-for-profit, academic medical institution.
                HIV-infected patients with a history of alcohol problems on ART. A total of 151 were enrolled and 141 (93%) were assessed at follow-up. Intervention: A nurse, trained in motivational interviewing, completed the following over 3 months in four encounters: addressed alcohol problems; provided a watch with a programmable timer to facilitate pill taking; enhanced perception of treatment efficacy; and delivered individually tailored assistance to facilitate medication use.
                Prior 30-day adherence > or =95%, prior 3-day adherence of 100%, CD4 cell count, HIV RNA and alcohol consumption, each at both short- and long-term follow-up.
                At follow-up, no significant differences in medication adherence, CD4 cell count, HIV RNA or alcohol consumption were found (all P values >0.25).
                A multicomponent intervention to enhance adherence among HIV-infected individuals with a history of alcohol problems was not associated with changes in medication adherence, alcohol consumption or markers of HIV disease progression. The failure to change adherence in a group at high risk for poor adherence, despite utilizing an intensive individual-focused patient intervention, supports the idea of addressing medication adherence with supervised medication delivery or markedly simplified dosing regimens. To determine if the intervention of individual advice improves adherence and effectiveness to highly active antiretroviral therapy.
                Randomized open trial. Patients treated with zidovudine + lamivudine + indinavir were assigned (2/1) to conventional care or individual advise. Individual advise consists in adaptation to treatment to patient style of live and detailed information of therapy. Adherence were estimated with structured interview and pillo counts and were considered correct when more than 90% of prescribed drugs were taken.
                Patients 170, conventional care: 110 and IA: 60. Follow-up: 24 weeks. Baseline characteristics were similar in both groups. Correct adherence were estimated in 52.7% of conventional care and in 76.7% of individual advise (p = 0.002, relative risk: 1.45; CI 95%: 1.16-1.82). Undetectable viral load (NASBA < 50 copies/ml) in 54.5% of conventional care and in 65% of individual advise (p = 0.18, relative risk: 1.19; CI 95%: 0.93-1.53). Reduction of viral load in the conventional care group 1.02 +/- 0.5 log10/ml, and in the individual advise group 1.98 +/- 0.7 log10/ml.
                The individual advice improve adherence with a tendency to improve effectiveness of highly active antiretroviral therapy. This paper reports the initial results of a pilot study to evaluate the acceptability and effectiveness of a program to enhance health literacy in low-income HIV-infected Latino men and women receiving antiretroviral therapy. Participants rated the program highly on measures of satisfaction, providing evidence of its acceptability. The effectiveness of the program was assessed in comparisons of the intervention (n = 41) and standard care only (n = 40) groups at baseline and 6-week intervals. Program participants showed significant improvement over comparison group participants on measures of HIV/AIDS and treatment-related knowledge and recognition and understanding of HIV terms. Although there were no significant changes in adherence mastery and behaviors during the 6-week follow up period, there were significant changes in program participants' knowledge about medication adherence. Future steps to examine the sustainability of the program in the medical management of patients are planned in addition to determining its long-range relative impact. A high level of adherence to antiretroviral therapy is required for complete suppression of HIV replication, immunological and clinical effectiveness. We investigated whether cognitive behaviour therapy can improve medication adherence.
                Prospective randomized 1-year trial.
                Collaboration of HIV university outpatient clinic and psychotherapists in private practice.
                60 HIV-infected persons on stable antiretroviral combination therapy and viral load below 50 copies/ml.
                Cognitive behaviour intervention in individual patients, in addition to standard of care.
                Feasibility and acceptance of intervention; adherence to therapy assessed using medication event monitoring system (MEMS) and self-report questionnaire; virological failure; psychosocial measures.
                The median number of sessions for cognitive behaviour intervention per patient during the 1-year trial was 11 (range 2-25). At months 10-12, mean adherence to therapy as assessed using MEMS was 92.8% in the intervention and 88.9% in the control group (P=0.2); the proportion of patients with adherence > or = 95% was 70 and 50.0% (P=0.014), respectively. While there was no significant deterioration of adherence during the study in the intervention arm, adherence decreased by 8.7% per year (P=0.006) in the control arm. No differences between the intervention group and standard of care group were found regarding virological outcome. Compared with the control group, participants in the intervention group perceived a significant improvement of their mental health during the study period.
                Cognitive behavioural support in addition to standard of care of HIV-infected persons is feasible in routine practice, and can improve medication adherence and mental health. Child sexual abuse (CSA) is associated with HIV risk behaviors [Bensley, L., Van Eenwyk, J., and Simmons, K. W., 2003.] and more prevalent among women living with HIV than in the general population [Koenig, L. J., and Clark, H., 2004]. This randomized Phase~I clinical trial tested the impact of a culturally congruent psychoeducational intervention designed to reduce sexual risks and increase HIV medication adherence for HIV-positive women with CSA histories. An ethnically diverse sample of 147 women were randomized to two conditions: an 11-session Enhanced Sexual Health Intervention (ESHI) or an attention control. Results based on "intent to treat'' analyses of pre-post changes are reported here. Additional analyses explored whether the observed effects might depend on "intervention dose,'' i.e., number of sessions attended. Women in the ESHI condition reported greater sexual risk reduction than women in the control condition. Although there were no differences between women in the ESHI and control groups on medication adherence, women in the ESHI condition who attended 8 or more sessions reported greater medication adherence at posttest than control women. The findings provide initial support for this culturally and gender-congruent psychoeducational intervention for HIV-positive women with CSA, and highlight the importance of addressing the effects of CSA on sexual risk reduction and medication adherence in preventive interventions for women. A 24-week open-label clinical trial was conducted in 195 HIV-infected adults commonly underrepresented in research (35% female, 71% African American, 21% Hispanic, and 20% injection drug users [IDUs]) to evaluate the effect of an HIV educational program on efficacy and adherence with a simple, compact, twice-daily triple nucleoside regimen containing a lamivudine (150 mg)/zidovudine (300 mg) combination (COM) tablet plus abacavir (ABC), 300 mg. At baseline, the patients' median plasma HIV-1 RNA level was 4.18 log10 copies/mL and the median CD4+ cell count was 379 cells/mm3. Patients were randomized 1:1 to 4 modules of the Tools for Health and Empowerment HIV education intervention plus routine counseling (EI + RC; n = 96) or to routine counseling alone (RC; n = 99). No differences between the EI + RC and RC treatment arms were observed with respect to the proportion of patients achieving plasma HIV-1 RNA levels <40 copies/mL (60% [33/55] vs. 55% [38/69]; P = 0.529) or <400 copies/mL (80% [44/55] vs. 80% [55/69]; P = 0.689) at week 24 (intent-to-treat observed analysis), increase in median CD4 cell count above baseline at week 24 (78.3 vs. 104.8 cells/mm3; P = 0.498), or mean overall adherence rates as measured by the Medication Event Monitoring System (MEMS) (70% vs. 74%). COM + ABC was generally well tolerated, and no association was observed between interruptions in treatment and the development of ABC hypersensitivity (5 suspected cases). In conclusion, in underrepresented patients, the EI used in this study did not affect the efficacy and adherence results with ABC + COM to any greater degree than did RC.
We found evidence to support the effectiveness of patient support and education interventions intended to improve adherence to antiretroviral therapy. Interventions targeting practical medication management skills, those interventions administered to individuals vs groups, and those interventions delivered over 12 weeks or more were associated with improved adherence outcomes. There is a need for standardization and increased methodological rigour in the conduct of adherence trials.