Results From a Randomized Controlled Trial of a Peer-Mentoring Intervention to Reduce HIV Transmission and Increase Access to Care and Adherence to HIV Medications Among HIV-Seropositive Injection Drug Users Impact of an Adherence Program on the Health and Outlook of HIV-Infected Patients Failing Antiretroviral Therapy Results of an Antiretroviral Adherence Intervention: STAR (Staying Healthy: Taking Antiretrovirals Regularly) Effects of a treatment adherence enhancement program on health literacy, patient-provider relationships, and adherence to HAART among low-income HIV-positive Spanish-speaking Latinos. The Efficacy of an Integrated Risk Reduction Intervention for HIV-Positive Women With Child Sexual Abuse Histories Life stress and adherence to antiretroviral therapy among HIV-positive individuals: a preliminary investigation. A medication self-management program to improve adherence to HIV therapy regimens. Impact of an educational program on efficacy and adherence with a twice-daily lamivudine/zidovudine/abacavir regimen in underrepresented HIV-infected patients. Effects of a Behavioral Intervention on Antiretroviral Medication Adherence Among People Living With HIV: The Healthy Living Project Randomized Controlled Study Effect of a Brief Antiretroviral Adherence Intervention Delivered by HIV Care Providers Using motivational interviewing to promote adherence to antiretroviral medications: a pilot study. The acceptability of a directly-administered antiretroviral therapy (DAART) intervention among patients in public HIV clinics in Los Angeles, California Improved adherence with contingency management. Couple-focused support to improve HIV medication adherence: a randomized controlled trial Randomized controlled trial of an intervention to prevent adherence failure among HIV-infected patients initiating antiretroviral therapy. A randomized controlled trial to enhance antiretroviral therapy adherence in patients with a history of alcohol problems. Voucher reinforcement improves medication adherence in HIV-positive methadone patients: a randomized trial. Hazardous Alcohol Use: A Risk Factor for Non-Adherence and Lack of Suppression in HIV Infection Cigarette smoking is an independent predictor of nonadherence in HIV-infected individuals receiving highly active antiretroviral therapy. Patterns and predictors of changes in adherence to highly active antiretroviral therapy: longitudinal study of men and women. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. Impact of an adherence clinic on behavioral outcomes and virologic response in treatment of HIV infection: a prospective, randomized, controlled pilot study. Efficacy of a Group Medication Adherence Intervention Among HIV Positive Women: The SMART/EST Women’s Project Age-associated predictors of medication adherence in HIV-positive adults: health beliefs, self-efficacy, and neurocognitive status. A randomized controlled trial of a peer support intervention targeting antiretroviral medication adherence and depressive symptomatology in HIV-positive men and women. Cognitive-behavioral intervention to enhance adherence to antiretroviral therapy: a randomized controlled trial (CCTG 578) Results of a pilot intervention trial to improve antiretroviral adherence among HIV-positive patients. Testing a Nurse-Tailored HIV Medication Adherence Intervention Motivational Interviewing and Cognitive-Behavioral Intervention to Improve HIV Medication Adherence Among Hazardous Drinkers: A Randomized Controlled Trial Home Visits to Improve Adherence to Highly Active Antiretroviral Therapy: A Randomized Controlled Trial Using motivational interviewing to promote adherence to antiretroviral medications: A randomized controlled study A 2-Arm, Randomized, Controlled Trial of a Motivational Interviewing-Based Intervention to Improve Adherence to Antiretroviral Therapy (ART) Among Patients Failing or Initiating ART Adherence to Antiretroviral Medication Regimens: A Test of a Psychosocial Model Effect of incentives for medication adherence on health care use and costs in methadone patients with HIV. Nurse‐Delivered Antiretroviral Treatment Adherence Intervention for People With Low Literacy Skills and Living With HIV/AIDS Complex interventions: how “out of control” can a randomised controlled trial be? Brief motivational interviewing to improve adherence to antiretroviral therapy: development and qualitative pilot assessment of an intervention. Telephone Support to Improve Antiretroviral Medication Adherence: A Multisite, Randomized Controlled Trial Modified directly observed antiretroviral therapy compared with self-administered therapy in treatment-naive HIV-1-infected patients: a randomized trial. Impact of Drug Abuse Treatment Modalities on Adherence to ART/HAART Among a Cohort of HIV Seropositive Women
Background : There is a lack of effective behavioral interventions for HIV-positive injection drug users ( IDUs ) . We sought to evaluate the efficacy of an intervention to reduce sexual and injection transmission risk behaviors and to increase utilization of medical care and adherence to HIV medications among this population . Methods : HIV-positive IDUs ( n = 966 ) recruited in 4 US cities were r and omly assigned to a 10-session peer mentoring intervention or to an 8-session video discussion intervention ( control condition ) . Participants completed audio computer-assisted self-interviews and had their blood drawn to measure CD4 cell count and viral load at baseline and at 3-month ( no blood ) , 6-month , and 12-month follow-ups . Results : Overall retention rates for r and omized participants were 87 % , 83 % , and 85 % at 3 , 6 , and 12 months , respectively . Participants in both conditions reported significant reductions from baseline in injection and sexual transmission risk behaviors , but there were no significant differences between conditions . Participants in both conditions reported no change in medical care and adherence , and there were no significant differences between conditions . Conclusions : Both interventions led to decreases in risk behaviors but no changes in medical outcomes . The characteristics of the trial that may have contributed to these results are examined , and directions for future research are identified Background : We prospect ively studied the impact of an adherence counselor on the outcome of patients failing antiretroviral therapy because of nonadherence . Methods : Forty-six patients , identified as chronically nonadherent were enrolled . Individual attention was provided using the information , motivation and behavioral methodology .  HIV RNA ( viral load , in copies/mL ) , CD4 count ( in cells/mm 3 ) , and body weight before and after the adherence counselor were measured . Qualitative outcome and patient satisfaction were assessed by deidentified third-party interviews . Results : Over half completed at least 1 year ; only 8 patients were lost to follow-up . Mean CD4 counts increased significantly ( P < .05 ) for completers at 6 and 12 months . Viral loads decreased between baseline and 6 months . Most clients reported subjective benefit from working with the adherence counselor . Conclusion : Although few clients showed complete virologic suppression , the value of an adherence counselor was vali date d. Longer term adherence programs should be evaluated A r and omized 2-group medication adherence intervention is evaluated with HIV-infected adults ( N = 141 ) assessed at baseline , 3- , and 9-month follow-ups . Cognitive ( self-efficacy , behavioral intent ) , mental health ( depression , well-being ) , and substance use indicators were the outcome measures . In addition , a posttest-only analysis from 3 to 9 months evaluates intervention impact on antiretroviral adherence , measured through Medication Event Monitoring System and pill counts . Compared to the st and ard care group , the intervention group showed significant increases in adherence self-efficacy and behavioral intent at 3 and 9 months and marginal improvements in mental health . Although the st and ard care group had higher adherence at 3 months ( no baseline data were available prior to intervention ) , intervention group patients showed significant increases in adherence from 3 to 9 months . Although adherence levels achieved by intervention patients may not be sufficient for virological control , this is one of the first studies to provide promising results of longer term effectiveness of a behavioral adherence intervention The impact of an adherence enhancement program for low income HIV-infected Spanish-speaking Latinos on health literacy , patient-provider relationships , and adherence to HAART was examined . Evaluations were conducted at baseline , 6 weeks , and 6 months for participants ( n = 85 ) r and omly assigned to either the intervention group or a comparison group ; 69 ( 81 % ) remained in the study for the entire 6-month duration . The intervention group scored significantly better than the comparison group on 3 of 5 measures of HIV health literacy at 6 weeks and on 2 of 5 measures , at 6 months . While there was a weak trend for the intervention group to report an increase in self-efficacy of medication adherence management , baseline to 6 weeks , no other changes were significant . Perceptions of the quality of relationship and communications with their HIV-treating physicians improved both at 6 weeks ( p = 0.04 ) and at 6 months ( p < 0.001 ) . The comparison group showed little change baseline to 6 weeks and baseline to 6 months . While there was a trend for the pilot group to report better medication adherence , these differences were not statistically significant . Further evaluation of the impact of this adherence enhancement program is needed 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 r and omized Phase ~ I clinical trial tested the impact of a culturally congruent psychoeducational intervention design ed to reduce sexual risks  and increase  HIV medication adherence for HIV-positive women with CSA histories . An ethnically diverse sample of 147 women were r and omized to two conditions : an 11-session Enhanced Sexual Health Intervention ( ESHI ) or an attention control . Results based on “ intent to treat ’ ’ analysesof pre – post changes are reported here . Additional analyses explored whether theobserved 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 medicationadherence in preventive interventions for women The present study sought to investigate the impact of life stress on treatment adherence and viral load of HIV-positive individuals . Three different aspects of life stress were examined in this investigation ( perceived stress , acute life events unrelated to the HIV illness , and HIV-related acute life events ) . Furthermore , we examined whether these relationships were moderated by depressive severity , self-esteem , and neuroticism . Participants ( n = 24 ) were treatment- seeking HIV-positive individuals who completed a series of question naires for this investigation . The majority of the participants in this sample were middle-aged , Caucasian males who identified themselves as either homosexual or bisexual , had contracted HIV via sexual contact , and met criteria for AIDS ( mean CD4 count = 324 ) . This sample was highly self-selected and varied from the county HIV-positive population in terms of gender , ethnicity , and HIV risk factor . Information on their adherence and viral load was collected from their medical records 6 to 9 months after completion of the psychological measurements . Results indicated that perceived stress , but not acute events , prospect ively predicted adherence . Moreover , marginal trends suggested that depressive symptoms and neuroticism moderated the effect of perceived stress on adherence . Neither perceived stress nor acute life events were associated with viral load 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 r and omly 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 question naire 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 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 r and omized 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 Objective : To examine the effect of a 15-session individually delivered cognitive behavioral intervention on antiretroviral ( ART ) medication adherence . Design : A multisite , 2-group , r and omized controlled trial . Participants : Two hundred four HIV-infected participants with self-reported ART adherence < 85 % from a total of 3818 participants screened were r and omized into the trial . Potential participants were recruited for the main trial based on sexual risk criteria in Los Angeles , Milwaukee , New York , and San Francisco . Intervention : The primary outcome of the intervention was a reduction in HIV transmission risk behaviors . Fifteen 90-minute individually delivered sessions were divided into 3 modules : Stress , Coping , and Adjustment ; Safer Behaviors ; and Health Behaviors , including an emphasis on ART adherence . Controls received no intervention until trial completion . Both groups completed follow-up assessment s at 5 , 10 , 15 , 20 , and 25 months after r and omization . Main Outcome Measure : Self-reported ART adherence as measured by 3-day computerized assessment . Results : A significance difference in rates of reported adherence was observed between intervention and control participants at months 5 and 15 , corresponding to the assessment s after the Stress , Coping , and Adjustment module ( 5-month time point ) and after the Health Behaviors module ( 15-month time point ) . The relative improvements among the intervention group compared with the control group dissipated at follow-up . Conclusions : Cognitive behavioral intervention programs may effectively improve ART adherence , but the effects of intervention may be short-lived Antiretroviral therapy ( ART ) is effective in controlling viral load in many people infected with HIV , but high levels of adherence to ART are needed for prolonged viral suppression . This study evaluated a brief adherence intervention delivered to HIV-positive patients by primary care providers during routine medical examinations . Six clinics were r and omly allocated to deliver an intervention focusing on ART adherence ( 2 clinics ) or safer sex ( 4 clinics ) . Interventions included written information ( posters , brochures , and flyers ) and brief counseling from providers and were evaluated with cohorts of r and omly selected patients ( n = 437 ) measured before and after a 10-month intervention . Among those 95 % or greater adherent at baseline , 91 % of patients who received the adherence intervention remained 95 % or greater adherent at follow-up compared with 75 % of the patients who received the safer sex intervention ( χ2 = 12.59 , P < 0.01 ) . This difference was significant in a logistic regression analysis ( odds ratio = 2.26 ; 95 % confidence interval = 1.27 - 4.04 ) , adjusting for baseline adherence , demographics , and HIV medical status . The adherence intervention did not significantly increase the prevalence of 95 % or greater adherence among patients less than 95 % adherent at baseline . Similar but nonsignificant results were observed for viral load . A brief intervention delivered to HIV patients by their primary providers helped to maintain adequate adherence to ART regimens . More intensive intervention is needed to improve adherence among patients who are initially less than 95 % adherent 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 r and omly 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 Abstract Directly administered antiretroviral therapy ( DAART ) is an intensive adherence support strategy for highly active antiretroviral therapy ( HAART ) that requires patient acceptance to be effective . In one arm of a r and omized adherence study , community workers ( CW ) delivered and observed ingestion of one HAART dose to participants five days a week for six months . We evaluated acceptability by study participation , retention , attendance and a satisfaction survey . Chi-square and nonparametric tests were used to examine differences between participants who did and did not complete DAART . Between November 2001 and March 2004 , 416 eligible participants were identified ; 250 were enrolled and 166 refused to participate ( 22 of these ( 13 % ) because of DAART specifically ) . Of the 82 r and omized to DAART ( 70 % Latino , 20 % African American , 27 % female and 69 % foreign-born ) , 65 ( 79 % ) completed six months of DAART . Participants attended 6,953/7,390 ( 94 % ) appointments . Latinos were more likely to complete DAART  compared to African Americans ( OR=4.76 , 95%CI=1.38 , 16.44 , p=0.01 ) . In addition , foreign-born participants were more likely to complete DAART  than US-born participants ( OR=3.38 , 95%CI=1.11–10.22 , p=0.03 ) . Participants completing DAART reported high rates of satisfaction . Retention , attendance and participant satisfaction suggest that DAART is an acceptable adherence support strategy in this public clinic population , particularly among Latino and foreign-born participants Contingency management ( CM ) based interventions that reinforce adherence to prescribed medications have shown promise in a variety of disadvantaged population s. Fifty-six participants with histories of illicit substance use who were prescribed antiretroviral medication but evidence d suboptimal adherence during a baseline assessment were r and omly assigned to 16 weeks of weekly CM-based counseling or supportive counseling , followed by 16 additional weeks of data collection and adherence feedback to providers . The CM intervention involved review of data generated by electronic pill-bottle caps that record bottle opening ( MEMS ) and brief substance abuse counseling . CM participants were reinforced for MEMS-measured adherence with drawings from a bowl for prizes and bonus drawings for consecutive weeks of perfect adherence . Potential total earnings averaged $ 800 . Mean MEMS-measured adherence to the reinforced medication increased from 61 % at baseline to 76 % during the 16-week treatment phase and was significantly increased relative to the supportive counseling group ( p = 0.01 ) . Furthermore , mean log-transformed viral load was significantly lower in the CM group . However , by the end of the 16-week follow-up phase , differences between groups in adherence and viral load were no longer significantly different . Proportions of positive urine toxicology tests did not differ significantly between the two groups at any phase . A brief CM-based intervention was associated with significantly higher adherence and lower viral loads . Future studies should evaluate methods to extend effects for longer term benefits Objective : To assess the efficacy of a couple-based intervention to improve medication-taking behavior in a clinic population with demonstrated adherence problems . Design : A r and omized controlled trial ( SMART Couples Study ) conducted between August 2000 and January 2004 . Setting : Two HIV/AIDS outpatient clinics in New York City . Participants : Heterosexual and homosexual HIV-serodiscordant couples ( n = 215 ) in which the HIV-seropositive partner had < 80 % adherence at baseline . The sample was predominantly lower-income racial/ethnic minorities . Intervention : Participants were r and omly assigned to a four-session couple-focused adherence intervention or usual care . The intervention consisted of education about treatment and adherence , identifying adherence barriers , developing communication and problem-solving strategies , optimizing partner support , and building confidence for optimal adherence . Outcome measures : Medication adherence at week 8 ( 2 weeks after the intervention ) compared with baseline , assessed with a Medication Event Monitoring System cap . Results : Intervention participants showed higher mean medication adherence at post-intervention when compared with controls whether adherence was defined as proportion of prescribed doses taken ( 76 % versus 60 % ) or doses taken within specified time parameters ( 58 % versus 35 % ) . Also , participants in the intervention arm were significantly more likely to achieve high levels of adherence ( > 80 % , > 90 % , or > 95 % ) when compared with controls . However , in most cases , effects diminished with time , as seen at follow-up at 3 and 6 months . Conclusion : The SMART Couples program significantly improved medication adherence over usual care , although the level of improved adherence , for many participants , was still suboptimal and the effect was attenuated over time OBJECTIVE Compare the efficacy of a multicomponent social support intervention to st and ard-of-care counseling on medication adherence among HIV-infected patients initiating antiretroviral therapy . DESIGN R and omized controlled trial . Generalized estimating equations tested for differences in the percentage of participants achieving 90 % adherence . MAIN OUTCOME MEASURES Pill-taking , electronically monitored over 6 consecutive months ; plasma viral load ( VL ) , assessed at 3 and 6 months following initiation of therapy . RESULTS Of 226 participants who were r and omized and began the trial , 87 ( 38 % ) were lost to the study by 6 months . The proportion of adherent participants declined steadily over time , with no time by group interaction . Sustained adherence was associated with increased odds of achieving an undetectable VL ( OR=1.78 ; 95 % CI=1.01 , 3.13 ) . In intention-to-treat analyses , a larger proportion of the intervention group than the control group was adherent ( 40.15 % vs. 27.59 % , p=.02 ) and achieved an undetectable VL p=.04 ) . However , the majority of participants who remained on study experienced some reduction in VL ( > or=1-log drop or undetectable ) , regardless of experimental condition . CONCLUSION The multicomponent social support intervention significantly improved medication adherence over st and ard-of-care counseling ; evidence for improved virologic outcomes was inconsistent . Early discontinuation of care and treatment may be a greater threat to the health of HIV patients than imperfect medication-taking OBJECTIVE 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 . DESIGN We conducted a r and omized controlled trial to compare the usual medical follow-up with an adherence intervention . SETTING The principal enrolment site was Boston Medical Center , a private , not-for-profit , academic medical institution . SUBJECTS 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 . MAIN OUTCOME MEASURES 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 . RESULTS At follow-up , no significant differences in medication adherence , CD4 cell count , HIV RNA or alcohol consumption were found ( all P values > 0.25 ) . CONCLUSIONS 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 This clinical trial evaluated a contingency management intervention design ed to improve medication adherence among HIV-positive methadone maintenance patients . After a 4-week baseline observation phase , eligible participants ( N=66 ) were r and omly assigned to : ( a ) medication coaching sessions every other week to assist with adherence strategies ( comparison group ) or ( b ) medication coaching plus voucher reinforcement for opening electronic medication caps on time ( voucher group ) . Baseline adherence ( percent doses taken/percent total possible doses ) was 51 % using electronic measurement , 75 % using self-report and 75 % using pill count . The intervention was provided for 12 weeks , with a 4-week follow-up . The primary outcome results of the clinical trial indicated effectiveness during the intervention , with significant mean adherence differences between voucher and comparison groups using electronic measurement ( 78 % versus 56 % ) , pill count ( 86 % versus 75 % ) , and self-report ( 87 % versus 69 % ) . Differences between groups faded after vouchers were discontinued . Contingency management shows promise as a strategy to promote antiretroviral medication adherence in this population Objective : We examined the independent effect of alcohol and combined effects of drug and alcohol use on antiretroviral ( ART ) utilization , adherence , and viral suppression in an urban cohort of HIV-infected individuals . Methods : In an observational clinical cohort , alcohol use , active drug use , and adherence were prospect ively assessed at 6-month intervals . We classified hazardous alcohol use as > 7 drinks/week or > 3 drinks/occasion in women , and > 14 drinks/week or > 4 drinks/occasion in men and active drug use as any use in the previous 6 months . Our outcomes included ART utilization , 2-week adherence , and viral suppression . We used generalized estimating equations to analyze the association between independent variables and outcomes . Analyses were adjusted for age , sex , race , years on ART , and clinic enrollment time . Results : Between 1998 and 2003 , 1711 individuals participated in 5028 interviews . 1433 of these individuals received ART accounting for 3761 interviews . The prevalence of any alcohol use at the first interview was 45 % , with 10 % classified as hazardous drinkers . One-third of the sample used illicit drugs . In multivariate analyses adjusting for age , sex , race , active drug use , years on ART , and clinic enrollment time , hazardous alcohol use was independently associated with decreased ART utilization ( AOR , 0.65 ; 95 % CI : 0.51 to 0.82 ) , 2-week adherence ( AOR , 0.46 ; 95 % CI : 0.34 to 0.63 ) , and viral suppression ( AOR , 0.76 ; 95 % CI : 0.57 to 0.99 ) compared to no alcohol use . Concurrent injection drug use ( IDU ) exacerbated this negative effect on ART use , adherence , and suppression . Conclusions : Hazardous alcohol use alone and combined with IDU was associated with decreased ART uptake , adherence , and viral suppression .  Interventions targeting alcohol use may improve HIV outcomes in individuals with hazardous alcohol use Current treatment guidelines for the management of HIV-infected individuals emphasize the importance of excellent adherence to antiretroviral medications . We conducted a prospect i ve 24-week study of adherence to lopinavir/ritonavir in a group of 64 subjects using the Medication Event Monitoring System ( MEMS ) . A range of demographic and clinical information , including cigarette smoking status , was collected from each participant . The overall mean adherence rate of the study cohort was 72.8 % ( SD = 22.2 % ) . Current smokers took 63.5 % ( SD = 22.1 ) of prescribed doses , compared with 84.8 % ( SD = 15.8 % ) in nonsmokers ( p<.001 ) . We found no difference in adherence rates between ex-smokers and subjects who had never smoked . In a multiple linear regression model , factors independently associated with lower adherence rates included current smoking ( p = .001 ) , lower CD4 + lymphocyte count at enrollment ( p = .04 ) , and lower educational attainment ( p = .04 ) . Depression and history of illicit substance use were not associated with nonadherence . In our study cohort , current cigarette smoking was an important and significant marker of inferior adherence to antiretroviral medication BACKGROUND Adherence to therapy is a dynamic behavior . However , few studies have identified factors associated with changes in adherence to  highly active antiretroviral therapy ( HAART ) among men and women . METHODS From 1999 through 2004 , self-reported adherence  to  HAART was recorded twice yearly as part of 2 prospect i ve cohort studies . At each study visit , participants were categorized as being 100 % adherent if they reported full adherence with their HAART regimen over the past 4 days ( for men ) and 3 days ( for women ) . Repeated- measures logistic regression models were used to identify predictors for changes in adherence between consecutive visits . RESULTS Of the participants , 640 men and 1304 women contributed 2803 and 5972 visit-pairs , respectively . Among white men , the prevalence of 100 % adherence decreased from 91 % in 1998 to 80 % in 2003 . Among women and African American men , the prevalence of full adherence was lower ( 75 % and 77 % on average , respectively ) and stable over time ( P>.6 ) . In both cohorts , the presence of clinical symptoms was independently associated with decreasing adherence ( odds ratio [ OR ] , 1.38 in men and 1.48 in women ) . Depression in men ( OR , 1.44 ) and use of alcohol in women ( OR , 1.81 , 1.52 , and 1.29 , for binge drinking , moderate-to-heavy drinking , and low consumption , respectively ) also predicted decreasing adherence . In addition , the use of drugs by men and women ( OR , 0.61 and 0.58 , respectively ) and alcohol binging by women ( OR , 0.41 ) were negatively associated with improving adherence . CONCLUSIONS Adherence to antiretroviral treatment is a dynamic process ; modifiable risk factors are associated with increasing and decreasing adherence , suggesting specific interventions . Moreover , the association of these risk factors with changes in adherence may differ by sex OBJECTIVE To evaluate cognitive-behavioral therapy to enhance medication adherence and reduce depression ( CBT-AD ) in individuals with HIV . DESIGN A two arm , r and omized , controlled , cross-over trial comparing CBT-AD to enhanced treatment as usual only ( ETAU ) . ETAU , which both groups received , included a single-session intervention for adherence and a letter to the patient 's provider documenting her or his continued depression . The intervention group also received 10 to 12 sessions of CBT-AD . MAIN OUTCOME MEASURES Adherence to antiretroviral therapy  as assessed by Medication Event Monitoring Systems ( MEMs ) and depression as assessed by blinded structured evaluation . RESULTS At the acute outcome assessment ( 3-months ) , those who received CBT-AD evidence d significantly greater improvements in medication adherence and depression relative to the comparison group . Those who were originally assigned to the comparison group who chose to cross over to CBT-AD showed similar improvements in both depression and adherence outcomes . Treatment gains for those in the intervention group were generally maintained at 6- and 12-month follow-up assessment s. By the end of the follow-up period , those originally assigned CBT-AD demonstrated improvements in plasma HIV RNA concentrations , though these differences did not emerge before the cross-over , and hence there were not between-groups differences . CONCLUSIONS CBT-AD is a potentially efficacious approach for individuals with HIV struggling with depression and adherence .  Replication and extension in larger efficacy trials are needed OBJECTIVE The aim of this r and omized , 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 . METHODS Consecutive eligible patients initiating HAART at an indigent-care clinic were r and omized to an  adherence clinic or  to  st and ard care ( information provided by physician or nurse practitioner ) for education and monitoring . Group assignment was stratified before r and omization 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 . RESULTS Thirty-three r and omized patients ( adherence clinic , n = 16 ; st and ard 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 st and ard 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 st and ard 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 st and ard 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 st and ard care group . CONCLUSIONS In this preliminary trial , an adherence clinic model improved adherence to HAART and virologic response over 28 weeks in the patients studied This intervention sought to improve overall quality of life and health behavior in women living with human immunodeficiency virus ( HIV ) . We contrasted the effect of a group cognitive behavioral stress management expressive supportive therapy ( CBSM+ ) intervention plus a healthier lifestyles ( HL ) component with an individual educational/informational format plus HL on  HIV-medication adherence .  Women , n = 237 , predominantly African-American and Latina , living with HIV were recruited from Miami , New York and New Jersey and r and omized to group or individual conditions ( ten weekly sessions ) plus group or individual HL , i.e. , four conditions . Women reported relatively high levels of adherence at baseline . Participants in any of the group conditions increased self-reported adherence and emotion-focused coping skills in comparison with individual participation . This study suggests that group interventions may be an important adjunct in increasing medication adherence for HIV positive women OBJECTIVE Although most agree that poor adherence to antiretrovirals is a common problem , relatively few factors have been shown to consistently predict treatment failure . In this study , a theoretical framework encompassing demographic characteristics , health beliefs/attitudes , treatment self-efficacy , and neurocognitive status was examined in relationship to highly active antiretroviral therapy adherence . DESIGN Prospect i ve , cross-sectional observational design . MAIN OUTCOME MEASURES Neuropsychological test performance , health beliefs and attitudes , and medication adherence tracked over a 1-month period using electronic monitoring technology ( Medication Event Monitoring System caps ) . RESULTS The rate of poor adherence was twice as high among younger participants than with older participants ( 68 % and 33 % , respectively ) . Results of binary logistic regression revealed that low self-efficacy and lack of perceived treatment utility predicted poor adherence among younger individuals , whereas decreased levels of neurocognitive functioning remained the sole predictor of poor adherence among older participants . CONCLUSION These data support components of the health beliefs model in predicting medication adherence among younger HIV-positive individuals . However , risk of adherence failure in those ages 50 years and older appears most related to neurocognitive status OBJECTIVE To determine the efficacy of a peer-led social support intervention involving support groups and telephone contacts compared with st and ard clinical care to enhance antiretroviral medication adherence . DESIGN R and omized controlled trial with follow-up . Participants were 136 HIV-positive indigent mainly African American and Puerto Rican men and women recruited from an outpatient clinic in the Bronx , New York . The 3-month intervention was delivered by other HIV-positive clinic patients trained in addressing barriers to adherence and sensitively providing appraisal , spiritual , emotional , and informational adherence-related social support . MAIN OUTCOME MEASURES Medical chart- abstract ed HIV-1 RNA viral load , antiretroviral adherence according to electronic drug monitoring and participant self-report , and social support and depressive symptomatology . All assessment s conducted at baseline , 3 months , and 6 months . RESULTS Intent-to-treat and as-treated analyses indicated no between-conditions intervention effects on the primary outcome of HIV-1 RNA viral load or any of the secondary outcomes at immediate postintervention or follow-up . Post hoc analyses within the intervention condition indicated greater intervention exposure was associated with higher self-reported adherence , higher social support , and lower depressive symptomatology at follow-up , even after controlling for baseline adherence . CONCLUSION Null findings , consistent with the limited literature on efficacious highly active antiretroviral therapy ( HAART ) adherence interventions , may be due to insufficient exposure to the intervention , its low intensity , or the nature of the sample -a heterogeneous HAART-experienced group of patients with high levels of substance use and multiple other competing stressors . Overall , findings highlight the need for more comprehensive and intensive efforts to battle nonadherence Objective : We conducted a r and omized , multi-site , controlled trial of a cognitive-behavioral adherence intervention for patients initiating or changing an antiretroviral ( ART ) regimen . Design : A 3 × 2 factorial design was used with the primary r and omization assigning patients ( 1 : 1 : 1 ) to one of two adherence interventions or usual care . Methods : The five-session adherence interventions consisted of cognitive – behavioral and motivational components , with or without a 2-week pre-treatment placebo practice trial . Intent-to-treat analysis used probability weights and regression tree analysis to account for missing data . Results : A total of 230 patients were r and omized ; 199 started ART , of whom 74 % completed the 48-week study .  Electronic monitored adherence outcomes between the two intervention groups did not differ significantly and were thus pooled in analyses . At week 4 , 82 % of intervention patients had taken at least 90 % of their prescribed ART doses , compared with 65 % of controls ( P < 0.01 ) ; this group difference dropped to 12 % at week 12 ( 72 versus 60 % ; P = 0.15 ) and 11 % at week 24 ( 66 versus 55 % ; P = 0.28 ) . Mean adherence in the intervention group was significantly higher than the control group at week 24 ( 89 versus 81 % ; P < 0.05 ) only . There were no group differences with respect to HIV-1 RNA throughout the study . Conclusions : The effects of the cognitive – behavioral intervention on adherence were modest and transient , and no effects were observed on viral load or CD4 cell count . More robust effects may require a more intense intervention that combines ongoing adherence monitoring and individualized intervention ‘ dosage ’ that matches the need and performance of each patient 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 r and omly assigned to the intervention condition or st and ard 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 . Implication s for future intervention planning are discussed Background : The relationship between patient adherence and treatment outcomes has been documented across chronic health conditions , but the evidence base for effective adherence interventions in human immunodeficiency virus ( HIV ) and acquired immune deficiency syndrome ( AIDS ) requires more rigorous research and reporting . Objectives : The aims of this study were to determine whether a tailored , nurse-delivered adherence intervention program-Client Adherence Profiling and Intervention Tailoring (CAP-IT)-improved adherence to HIV medications , compared with st and ard care , and to identify the relationship among adherence measures . Methods : A r and omized controlled trial ( RCT ) with repeated measures was used to test the efficacy of CAP-IT over a 6-month period . A convenience sample of 240 participants was recruited from a freest and ing public HIV/AIDS clinic in Houston , TX , that provides medical , psychological , and pharmaceutical services for over 5,000 clients . Study instruments and measures included demographics ; chart audit to capture CD4 count , viral load , and prescribed medications ; health literacy ; and five measures of adherence ( AIDS Clinical Trial Group-Revised Reasons for Missing Medications , Morisky Self-Report of Medication Non-Adherence , Pill Count , Medication Event Monitoring System [ MEMS ] caps , and Pharmacy Refill ) . Results : A logistic regression using generalized estimating equations method showed no significant differences over time on the five medication-adherence measures between the experimental and control groups . Little correlation was documented among the five different adherence measures , and there was minimal correlation with clinical markers . Discussion : It is unclear why the tailored adherence intervention was not efficacious in improving medication adherence . The findings suggest that these measures of medication adherence did not perform as expected and that , perhaps , they are not adequate measures of adherence . Effective and efficient adherence interventions are needed to address the barriers to medication adherence in HIV/AIDS Objective : To assess the efficacy of a behavioral intervention design ed to improve HIV medication adherence and reduce alcohol consumption among HIV-positive men and women . Design : A r and omized controlled trial conducted between July 2002 and August 2005 . Setting : A behavioral research center in New York City . Participants : HIV-positive men and women ( n = 143 ) who were on HIV antiretroviral medication and met criteria for hazardous drinking . Intervention : Participants were r and omly assigned to an 8-session intervention based on motivational interviewing and cognitive-behavioral skills building or a time- and content-equivalent educational condition . Outcome Measures : Viral load , CD4 cell count , and self-reported adherence and drinking behavior were assessed at baseline and at 3- and 6-month follow-ups . Results : Relative to the education condition , participants in the intervention demonstrated significant decreases in viral load and increases in CD4 cell count at the 3-month follow-up and significantly greater improvement in percent dose adherence and percent day adherence . There were no significant intervention effects for alcohol use , however , and effects on viral load , CD4 cell count , and adherence were not sustained at 6 months . Conclusions : An 8-session behavioral intervention can result in improvement in self-report and biologic markers of treatment adherence and disease progression . This type of intervention should be considered for dissemination and integration into HIV clinics providing comprehensive care for HIV-positive persons with alcohol problems . Although the effect was attenuated over time , future studies might test the added effectiveness of booster sessions or ongoing adherence counseling Background : Few rigorously design ed studies have documented the efficacy of interventions to improve medication adherence among patients prescribed highly active antiretroviral . Data are needed to justify the use of limited re sources for these programs . Methods : A 2-arm , r and omized , controlled trial evaluated the efficacy of a community-based , home-visit intervention to improve medication adherence .  Participants were 171 HIV-infected adults prescribed a minimum of 3 antiretroviral agents . The majority had a past or current history of substance abuse . Subjects were r and omly assigned to receive home visits for 1 year or usual care .  Medication adherence was assessed with Medication Event Monitoring stem caps at 3-month intervals from r and omization through 3 months after the conclusion of the intervention . Results : A larger proportion of subjects in the intervention group demonstrated adherence greater than 90 % compared with the control group at each time point after baseline . The difference over time was statistically significant ( Extended Mantel-Haenszel test : 5.80 , P = 0.02 ) . A statistically significant intervention effect on HIV-RNA level or CD4 cell count was not seen , but there was a statistically significant association between greater than 90 % adherence and an undetectable HIV-RNA over time ( P < 0.03 ) . Conclusion : Home visits from a nurse and a community worker were associated with medication adherence greater than 90 % among a cohort of socially vulnerable people living with HIV/AIDS in northeastern United States Abstract The primary aim of this study was to test an intervention to support antiretroviral medication adherence among primarily low-income men and women with HIV . The study was a r and omized controlled trial ( Get Busy Living ) with participants assigned to treatment ( Motivational Interviewing [ MI ] ) and control groups . Participants were recruited from an HIV/AIDS clinic in Atlanta , Georgia , US . Of those referred to the study , 247 completed a baseline assessment and were enrolled with 125 r and omized to the intervention group and 122 to the control group . Participants were patients beginning antiretroviral therapy or changing to a new drug regimen .  The intervention consisted of five MI sessions delivered by registered nurses in individual counselling sessions . Participants were paid for each session attended . The intervention sought to build confidence , reduce ambivalence and increase motivation for ART medication-taking . Medication adherence was measured by the Medication Event Monitoring System ( MEMS ® ) from the time of screening until the final follow-up conducted approximately 12 months following the baseline assessment . Participants in the intervention condition showed a trend towards having a higher mean percent of prescribed doses taken and a greater percent of doses taken on schedule when compared to the control group during the months following the intervention period . This effect was noted beginning at about the eighth month of the study period and was maintained until the final study month . Although the finding was weaker for overall percent of prescribed doses taken , the results for the percent of doses taken on schedule suggests that the MI intervention may be a useful approach for addressing specific aspects of medication adherence , such as adherrence to a specified dosing schedule Rationale and Purpose : Motivational interviewing ( MI ) is a counseling technique that has been used effectively to change a number of health-related behaviors . We sought to assess the impact on patients ' antiretroviral therapy ( ART ) adherence of a multicomponent , MI-based ART adherence intervention compared with that of an HIV informational control program . Study Design : Two-arm , r and omized , controlled trial . Sample : One hundred forty adult HIV-infected patients attending a large , academic center infectious diseases clinic who were either failing or newly initiating an ART regimen . Study Endpoints : ( 1 ) Mean adherence level ( % of prescribed doses take in the prior month ) at the week 12 visit , ( 2 ) change in mean adherence , ( 3 ) percentage of patients achieving > 95 % adherence in the third 4-week block , and ( 4 ) change in viral load . Main Findings : The MI group 's mean adherence improved by 4.5 % compared with a decrease in the control group 's adherence by 3.83 % ( P = 0.10 ) . In the treatment group , 29 % achieved > 95 % adherence compared with only 17 % in the control group ( P = 0.13 ) . When we controlled for ethnicity , the intervention group had 2.75 times higher odds of achieving more than 95 % adherence than did the controls ( P = 0.045 ; 95 % confidence interval : 1.023 , 7.398 ) . Although a number of mediating variables ( beliefs about ART , coping style , social support , and goals set ) had statistically significant changes in the expected direction in the MI group compared with controls , in the intent-to-treat analysis , the mean adherence at study exit for the intervention group was 76 % ( SD = 27 % ) and 71 % ( SD = 27 % ) for the control group ( P = 0.62 ) . Conclusion : Although not definitive , this study provides some evidence that MI offers an effective approach to improving adherence . Future studies able to build MI into the intervention for longer than 3 months may have a greater impact Objective The primary aim of this study was to test a psychosocial model of medication adherence among people taking antiretroviral medications . This model was based primarily on social cognitive theory and included personal ( self-efficacy , outcome expectancy , stigma , depression , and spirituality ) , social ( social support , difficult life circumstances ) , and provider ( patient satisfaction and decision-making ) variables . Design The data for this analysis were obtained from the parent study , which was a r and omized controlled trial ( Get Busy Living ) design ed to evaluate an intervention to foster medication adherence . Factor analysis was used to develop the constructs for the model , and structural equation modeling was used to test the model . Only baseline data were used in this cross sectional analysis . Methods Participants were recruited from a HIV/AIDS clinic in Atlanta , GA . Prior to group assignment , participants were asked to complete a question naire that included assessment of the study variables . Results A total of 236 participants were included in the analysis . The mean age of the participants was 41 years ; the majority were male , and most were African-American . In the final model , self-efficacy and depression demonstrated direct associations with adherence ; whereas stigma , patient satisfaction , and social support were indirectly related to adherence through their association with either self-efficacy or depression . Conclusion These findings provide evidence to reinforce the belief that medication-taking behaviors are affected by a complex set of interactions among psychosocial variables and provide direction for adherence interventions BACKGROUND The potential benefits of anti-retroviral therapy for HIV is not fully realized because of difficulties in adherence with dem and ing treatment regimens , especially among injection drug users . METHODS HIV-positive methadone patients who were less than 80 % adherent with their primary anti-retroviral therapy  were r and omized to a trial of incentives for on-time adherence . Adherence was rewarded with an escalating scale of vouchers redeemable for goods . Both intervention and control group visited a medication coach twice a month . The cost of the intervention was determined by micro-costing . Other costs were obtained from administrative data and patient report of out-of-system care . RESULTS During the 12-week intervention period , the incremental direct cost of the intervention , including treatment vouchers , was $ 942 . The voucher group incurred $ 2572 in anti-retroviral drug cost , significantly more than the $ 1973 incurred by the comparison group ( p<.01 ) . Adherence , as measured by on-time openings of an electronically monitored vial , was 78 % in the intervention group and 56 % in the control group . CONCLUSIONS The incremental direct cost of voucher incentives was $ 292 per month . If the observed increase in adherence from voucher incentives can be sustained in the long-term , the literature suggests that disease progression will be slowed . Further research is needed to evaluate if the improvement can be sustained or achieved at lower cost . Mitigation of treatment resistance and reduction in HIV transmission are additional benefits that favor adoption People living with HIV/AIDS who have lower health literacy show poorer treatment adherence and more adverse health outcomes . The authors undertook the development and pilot testing of a brief HIV treatment adherence improvement counseling intervention for people with lower health literacy who were taking antiretroviral medications . Guided by a theory of health behavior change , health education principles for lower literacy population s , and formative research , the authors design ed a two-session plus one booster session nurse-delivered HIV treatment adherence intervention . Results from a pilot test with 30 HIV-positive men and women with lower health literacy showed that the intervention increased HIV/AIDS knowledge , intentions to improve adherence , and self-efficacy for adhering to medications . Participants exposed to the intervention also showed improvement in medication adherence , with reductions in numbers of missed pills and reductions in numbers of doses taken off-schedule . These results suggest that relatively brief behavioral interventions that are tailored for people with lower health literacy may have a significant impact on health-related behaviors Complex interventions are more than the sum of their parts , and interventions need to be better theorised to reflect this Many people think that st and ardisation and r and omised controlled trials go h and in h and . Having an intervention look the same as possible in different places is thought to be paramount . But this may be why some community interventions have had weak effects . We propose a radical departure from the way large scale interventions are typically conceptualised . This could liberate interventions to be responsive to local context and potentially more effective while still allowing meaningful evaluation in controlled design s. The key lies in looking past the simple elements of a system to embrace complex system functions and processes . The suitability of cluster r and omised trials for evaluating interventions directed at whole communities or organisations remains vexed.1 It need not be.2 Some health promotion advocates ( including the WHO European working group on health promotion evaluation ) believe r and omised controlled trials are inappropriate because of the perceived requirement for interventions in different sites to be st and ardised or look the same.1 3 4 They have ab and oned r and omised trials because they think context level adaptation , which is essential for interventions to work , is precluded by trial design s. An example of context level adaptation might be adjusting educational material s to suit various local learning styles and literacy levels . Lead thinkers in complex interventions , such as the UK 's Medical Research Council , also think that trials of complex interventions must “ consistently provide as close to the same intervention as possible ” by “ st and ardising the content and delivery of the intervention.”5 By contrast , however , they do not see this as a reason to reject r and omised controlled trials . These divergent views have led to problems on two fronts . Firstly , the field of health promotion is being turned away from r and omised Because successful HIV treatment requires exceptional adherence to antiretroviral therapy ( ART ) , interventions to improve ART adherence are essential . We developed and pilot-tested an intervention to improve ART adherence , based on brief motivational interviewing ( MI ) , which has successfully improved selected health behaviors but has not been tested for ART adherence . We administered the 15- to 30-minute MI session to 20 HIV-positive adults and assessed its usefulness and relevance . Then , we content-analyzed the session for HIV care issues and strategies most salient to patients in the MI session . During the session , all participants chose an HIV-care-related topic that they wanted to discuss , and talked about issues , barriers , and facilitators related to their topic . Most participants ( 70 % ) developed strategies to help improve their health . Questions asked after the MI session revealed that almost all ( 95%-100 % ) participants found the session useful and helpful . This theoretically based , empowering health counseling approach for HIV-positive persons warrants further research Objective : To determine whether proactive telephone support improves adherence to antiretroviral therapy ( ART ) and clinical outcomes when compared to st and ard care . Methods : A multisite , r and omized controlled trial ( RCT ) was conducted with 109 ART-naive subjects coenrolled in AIDS Clinical Trials Group ( ACTG ) 384 . Subjects received st and ard 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 question naire 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 r and omized 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 Success of antiretroviral therapy depends on high rates of adherence , but few interventions are effective . Our objective was to determine if modified directly observed therapy ( mDOT ) improves initial antiretroviral success . METHODS In an open-label , r and omized trial comparing mDOT ( Monday-Friday for 24 weeks ) and self-administered therapy with lopinavir/ritonavir soft gel capsules ( 800 mg/200 mg ) , emtricitabine ( 200 mg ) , and either extended-release stavudine ( 100 mg ) or tenofovir ( 300 mg ) , all taken once daily , 82 participants received mDOT and 161 , self-administered therapy .  Participant eligibility included a plasma human immunodeficiency virus RNA level higher than 2000 copies/mL and being naïve to antiretroviral therapy . A total of 243 participants were predominantly male ( 79 % ) ( median age , 38 years ) , with 84 Latinos ( 35 % ) , 74 non-Latino blacks ( 30 % ) , and 79 non-Latino whites ( 33 % ) . The study was conducted at 23 AIDS Clinical Trials Group ( ACTG ) sites in the United States and 1 site in South Africa between October 2002 and January 2006 . The primary outcome was virologic success at week 24 and secondary outcomes were virologic success , clinical progression , and adherence at week 48 . RESULTS Over 24 weeks , mDOT had greater virologic success ( 0.91 ; 95 % confidence interval [ CI ] , 0.81 to 0.95 ) than self-administered therapy ( 0.84 ; 95 % CI , 0.77 to 0.89 ) , but the difference ( 0.07 ; lower bound 95 % CI , -0.01 ) did not reach the prespecified threshold of 0.075 . Over 48 weeks , virologic success was not significantly different between mDOT ( 0.72 ; 95 % CI , 0.61 to 0.81 ) and self-administered therapy ( 0.78 ; 95 % CI , 0.70 to 0.84 ) ( difference , -0.06 ; 95 % CI , -0.18 to 0.07 [ P = .19 ] ) . CONCLUSIONS The potential benefit of mDOT was marginal and not sustained after discontinuation . Modified DOT should not be incorporated routinely for care of treatment-naïve human immunodeficiency virus type 1-infected patients Methadone maintenance is associated with improved adherence to antiretroviral therapies  among HIV-positive illicit drug users ; however , little information exists on whether adherence is associated with different drug abuse treatment modalities . Using longitudinal data from the Women 's Interagency HIV Study , we evaluated the relationship between drug abuse treatment modality and  adherence to antiretroviral therapies .  In prospect i ve analyses , individuals who reported accessing any drug abuse treatment program were more likely to report adherence to antiretroviral regimens  ≥ 95 % of the time ( AOR = 1.39 , 95 % CI = 1.01–1.92 ) . Involvement in either a medication-based or medication-free program was similarly associated with improved adherence . Drug abuse treatment programs , irrespective of modality , are associated with improved adherence to antiretroviral therapies  among drug users . Concerted efforts to enroll individuals with drug use histories in treatment programs are warranted to improve HIV disease outcomes
Greater underst and ing of the mechanisms ( mediators ) by which  behavioral-change interventions  work is critical to developing theory and refining interventions .
Although systematic review s have been advocated as a method for exploring mediators , this is rarely done .
One challenge is that intervention research ers typically test only two paths of the mediational model : the effect of the intervention on mediators and on outcomes .