Analyze and appraise the following article in 150-200 word

26 Jun Analyze and appraise the following article in 150-200 word

Question
AIDS PATIENT CARE and STDs

Volume 23, Number 3, 2009

ªMary Ann Liebert, Inc.

DOI: 10.1089=apc.2008.0170

Development and Efficacy of an Intervention

to Enhance Readiness for Adherence among Adults Who Had Previously Failed HIV Treatment

Maithe Enriquez, Ph.D., R.N.,1 An-Lin Cheng, Ph.D.,1 David S. McKinsey, M.D.,2 and James Stanford, M.D.3

Abstract

This paper outlines the development and initial testing of the READY intervention that was designed to enhance readiness for adherence among adults with a history of nonadherence to HIV treatment. Participants in this study were adults (n ¼ 28) who ranged in age from 24 to 57: most were male (75%) and African American (64%). Participants had failed an average of four prior HIV treatment regimens due to nonadherence and were beginning a new regimen of protease inhibitor (PI)-based antiretroviral medications. The study was conducted from 2003 to 2006, prior to the standard use of boosted PI regimens. Results indicated that 50% of participants became adherent and had suppressed viral loads to less than 50 copies per milliliter at the 3-month postintervention follow-up time point. Of those who became adherent, 79% remained adherent at the 12-month postintervention follow-up time point. Implementation of the intervention was found to be feasible in a real-world setting and participants reported that they liked the intervention. A 6-session length of the intervention was found to have the same impact on adherence outcomes as a 12-session length. No differences were found in outcomes with regard to the interven-tion’s start time: before or at the same time the new antiretroviral regimen was initiated. These results suggest that the READY intervention may have merit and that the 6-session length may be more acceptable. However, a larger controlled study is indicated to examine intervention efficacy further.

Introduction

Despite substantial advancements in the efficacy of antiretroviral (ARV) therapy, nonadherence remains a clinical challenge that can lead to HIV treatment failure. Al-though HIV infection can be managed effectively for many years, successful HIV treatment typically requires lifelong medication adherence. Missing scheduled doses or starting and stopping ARV drugs can lead to the acquisition of resis-tance mutations with subsequent treatment failure and poor HIV-related health outcomes.1,2 Newer ARV medication regimens are more ‘‘forgiving’’ and do not require the strict level of adherence, more than 95%, needed with older ARV medications to achieve and maintain suppression of viremia and to avoid the development of resistance.3 Nevertheless, suboptimal adherence persists as an important health issue

for a subset of individuals living with HIV infection.4 Nonadherence, the inability to adhere to HIV medications

as prescribed, has been attributed to several etiologies.5 Fac-tors associated with nonadherence include psychosocial is-sues such as depression and substance use; intolerance of

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ARV medications; and disease specific symptoms.6–8 Con-versely, adherence has been enhanced by the presence of positive patient–health care provider relationships, social support and readiness for HIV treatment.9–13

The critical need for diligent adherence to ARV medications by HIV-infected individuals has prompted the development of several successful HIV treatment adherence interven-tions.14–16 However, few interventions have specifically tar-geted the challenging population of HIV-infected individuals who have a history of repeated nonadherence.17 Furthermore, although readiness has been determined to be necessary for successful HIV treatment adherence,18 researchers have fo-cused little attention on its potential role in enhancing ad-herence in this population.

Practical interventions are needed that can help HIV-infected individuals who experience nonadherence overcome their barriers to HIV treatment adherence. Identifying such individuals as early as possible in the course of antiretroviral therapy is likely to enhance long-term treatment success and health outcomes.19 This paper describes the development and initial testing of the READY intervention from 2003 to 2006.

1Department of Nursing,3Department of Medicine, Infectious Diseases, University of Missouri-Kansas City, Kansas City, Missouri. 2Department of Medicine, Infectious Diseases, University of Kansas, Kansas City, Kansas.

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The intervention aimed to enhance readiness for adherence among a particularly difficult to treat group of adults who previously had failed ARV treatment in a real-world setting.

Intervention Development

Formative studies contributed to the development of the READY intervention. First, in-depth interviews were con-ducted with adults (n¼ 13) who had been nonadherent to HIV treatment but later became adherent without formal in-tervention. Readiness was found to be a key phenomenon that triggered the ability to adhere to treatment.12 In a prospective study, a significant correlation between higher baseline levels of readiness and subsequent HIV treatment adherence was found among HIV-infected men (n¼ 19) who were started on a new ARV regimen after a treatment failure related to non-adherence.13 Based on these findings, development of the READY intervention commenced.

Most research has addressed readiness to cease a behavior that is considered to be unhealthy, such as quitting smoking,20 as opposed to initiating a healthy behavior. Readiness is ac-knowledged as a phenomenon that is needed for a health behavior change to occur, but generally has been described as synonymous with change.21 Conversely, readiness also has been viewed as a necessary antecedent that occurs in prepa-ration of change.22 In this study, readiness was conceptual-ized as a separate process that precedes the behavior of HIV treatment adherence. Wellness Motivation theory,23 which purports that readiness is an essential first stage of behavior change and occurs as a three-step process, guided interven-tion development. First, a reevaluation of lifestyle occurs, next barriers to a desired health behavior are identified, then strategies are created to overcome identified barriers, and fi-nally the individual accepts responsibility for the desired health behavior and sets goals. These steps lead to an ade-quate level of readiness that results in the ability of the indi-vidual to proceed with healthful behavior change.

READY was designed as an individual level intervention delivered by a nurse in the outpatient clinical setting. The in-tervention activities were based on the three steps that lead to readiness, as defined by Wellness Motivation theory, reeva-luation of lifestyle, identification of barriers and creation of strategies, and goal setting. Identified barriers are addressed in a rank order process, from least to most manageable, in the intervention. The READY intervention activities, together with their respective theoretical underpinnings, are shown in Table 1.

The initial development of READY occurred with a con-venience sample of HIV-infected men (n ¼ 12) receiving care

ENRIQUEZ ET AL.

in one Midwestern infectious diseases clinic. The men, who had documented nonadherence by medical record review and HIV drug resistance on genotype testing, were beginning a new twice daily nonboosted protease inhibitor-based ARV medication regimen. The individual intervention was deliv-ered to all participants by the same nurse and initiated on the day the participant began the new ARV regimen. Intervention sessions occurred weekly for 6 months. Viral load, measured monthly, was used as the primary measure of adherence. At the end of the 6-month period eight (67%) participants had suppressed viral loads, and all had suppressed their viral loads by the eighth intervention session. Because an inter-vention 6 months in length would require significant re-sources and would be impractical in a real-world setting, two questions were raised: (1) would a shorter READY interven-tion be acceptable and efficacious? and (2) would beginning READY prior to the initiation of a new HIV medication regi-men enhance intervention effectiveness?

Efficacy Study

A study was then undertaken to examine acceptability, length (6 sessions or 12 sessions), timing (before or at initiation of a new ARV medication regimen), and efficacy of the READY intervention. Suppression of HIV viral load (HIV-1 RNA by polymerase chain reaction [PCR]< 50 copies per milliliter) was used as the main outcome measure of adher-ence. Data about personal and health characteristics, CD4 cell count, depressive symptoms, disease symptom distress, and readiness also were collected. Individual interviews were held with randomly selected participants post-intervention and intervention nurses kept detailed field notes in an effort to better understand the workings of the intervention. The research questions guiding the study were: (1) What is the acceptable, tolerable and effective length of the READY in-tervention, 6 or 12 sessions?; (2) What is the best timing for READY, before or at initiation of a new ARV treatment regi-men? and (3) What is the relationship between readiness, depressive symptoms, disease symptom distress, and adher-ence? Methods Participants and setting Recruitment occurred in three community-based infectious diseases clinics in one midwestern city. Inclusion criteria were carefully selected to target individuals who might benefit most from the intervention in order to enhance study design sensitivity and decrease variability in the sample.24 To enroll Table 1. Intervention Activities and Theoretical Underpinnings Theoretical component Intervention activities Reevaluation of lifestyle Discussion of participant’s physical, emotional and lifestyle issues perceived as barriers to HIV treatment adherence in the past Identification of barriers Create list of barriers to adherence, participant ranks the barriers from most manageable to least manageable. List is revised throughout the intervention period. Creation of strategies Beginning with the most manageable barrier, strategies are created and implemented to overcome each barrier. At each intervention session, new barrier(s) are addressed until the list of barriers is exhausted. Goal setting Participant sets HIV-related health goals. READY INTERVENTION in the study, participants must have had (1) medical record documentation of one or more previous episodes of non-adherence that had resulted in HIV treatment failure; (2) documented HIV drug resistance by genotype testing; and (3) access to a viable new ARV medication regimen prescribed by an infectious diseases physician experienced in treating HIV infection. Study design The study utilized a pre–post no control group design with two groups randomized to receive the READY intervention for 6 or 12 once-weekly sessions. Participants in the 6-session group began the intervention upon initiation of a new ARV medication regimen while participants in the 12-session group begantheinterventionpriortotheinitiationofanewARVmedi-cation regimen. All participants were prescribed twice daily protease inhibitor (PI)-based medication regimens. Because our study was conducted prior to the standard practice of prescribing only boosted PIs, less than a third of the partici-pants (9=28) were treated with a ritonavir-containing regimen. Procedures Three clinic nurses, two registered nurses and one licensed practical nurse, were trained as the interventionists. Each nurse interventionist received two days of individual training by the same investigator and was provided with a detailed intervention manual which included information about the study protocol and each session’s content and activities. Training consisted of didactic content based on an in-depth review of the literature surrounding HIV treatment adherence and focused on factors known to be associated with both adherence and nonadherence. In addition, content included strategies from the literature that had been shown to enhance adherence. Two checklists guided the intervention nurse’s discussion with participants about the following issues: (1) past experiences taking HIV medications, (2) prior obsta-cles to ARV medication adherence, and (3) the creation of strategies to overcome adherence barriers. Intervention nur-ses also were provided with information about community resources that a participant could access, if needed, as po-tential strategies to overcome barriers. For example, if a par-ticipant identified problems with remembering to take doses as a barrier to adherence, the nurse had access to a community resource that would provide a medication alarm watch to the participant at no charge. Intervention fidelity was maintained through random visits by an investigator to the three clinic study sites and by phone communication with the interven-tion nurses. Participants (n ¼ 28) received the READY intervention once weekly for 6 or 12 sessions. The 6-session group (n¼ 14) began the intervention on the day the new ARV regimen was initi-ated. The 12-session group (n¼ 14) started the intervention 3 weeks prior to the initiation of the new ARV regimen, began ARV medications at the fourth intervention session, and then continued the intervention weekly for a total of 12 sessions. For both groups, each intervention session lasted between 30 and 60 minutes with the first few sessions lasting closer to 60 minutes and subsequent sessions being of shorter du-ration. All sessions occurred at the clinic where the participant obtained HIV care. The nurses met with participants at a mutually agreed upon day and time. Participants were pro- 179 vided with travel assistance in the form of bus passes or taxi vouchers, if needed, and received a $10.00 gift card at each data collection point for their time completing paper-and-pencil outcome measurement questionnaires. Measures=data collection Outcome measures included the hypothesized theoretical mediator of behavior change (readiness), factors that had been shown by previous research to impact on an individual’s ability to adhere to ARV treatment (depression symptoms and disease symptom distress), and adherence. Readiness, depressive symptoms, and symptom distress measurements were collected at two time points: preinter-vention and 3 months postintervention. Adherence was col-lected at these same two time points; in addition, for those participants with a viral load of less than 50 copies per milli-liter at 3 months postintervention, a third adherence measure was again collected at 12 months postintervention. Viral load, HIV-1 RNA by PCR, was used as a proxy measure of adherence. Due to budget constraints, we were not able to use MEMS caps. Hence, a suppressed viral load, that is HIV-1 RNA by PCR less than 50 copies per milliliter, was operationalized as adherence. Rates of adherence to ARV medications were calculated based on HIV viral load (HIV-1 RNA by PCR) measures completed by the participants’ health care provider. Adherence was further examined through a review of the intervention nurses’ field notes. Intervention nurses encouraged participants to use pill box organizers for their ARV medications and at each intervention session asked them to report how many doses of ARVs had been missed in the previous week. The nurses then noted the par-ticipants’ reports about missed doses in their field notes. Information about personal and health characteristics in-cluding age, ethnicity, gender, number of years living with HIV infection, years of education, prior number of ARV reg-imens prescribed, and CD4 cell count was collected via self-report and from the participant’s health care provider at preintervention only. The Symptom Distress Scale (SDS) was used to measure disease distress symptoms. In studies examining participants with HIV infection, reliability of the SDS has been 0.92.25 The scale has 11 items which are summed for a total score. Higher scores indicate more symptom distress. The Center for Epidemiologic Studies Depression Scale (CES-D) was used as the measure of depression. The CES-D is a measure of depression symptoms in the general population. The scale has been found reliable with Cronbach a> 0.85 in previous research26 and has been used extensively with populations of individuals living with HIV. The CES-D con-sists of 20 items that are summed with a total score of greater than 16 indicating depressive symptoms.

The Index of Readiness (IR) was used to measure readiness for the health behavior change of adherence.27 The IR was constructed based on the readiness stage of Wellness Moti-vation Theory, the conceptual framework for the READY in-tervention. The IR consisted of 30 items with three subscales that represent the three steps of the readiness stage accord-ing to the theory: reevaluation of lifestyle, identification of barriers=creation of strategies, and goal commitment. The mean of each subscale is calculated as is the mean for all items for a total readiness score. Higher scores indicate higher levels

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of readiness for healthful behavior change. The IR was shown to have internal consistency reliability estimates of 0.89 for the total scale, and reliability estimates of 0.80, 0.81, and 0.67 for the three subscales in a study conducted with HIV-infected males.13

Semistructured individual interviews were conducted by one investigator with randomly selected participants imme-diately postintervention. At the beginning of the interview, the investigator stated the purpose of the interview: to un-derstand the workings of the READY intervention and to gather information that would be used to refine the READY intervention in the future. The interview was guided by three categories of questions: past experiences taking ARVs, expe-rience taking ARVs during the READY intervention, and the acceptability of the READY intervention including length and timing.

Data analysis

Viral load data was collected at preintervention and 3 months postintervention. For participants with a viral load of less than 50 copies per milliliter at the 3-month post-intervention time point, a third viral load measure was again collected at 12 months postintervention. A profile plot for each participant’s log10 of viral load (HIV-1 RNA by PCR) across these time points was generated. A two-sample pro-portion test was conducted to test the adherence rate be-tween the preintervention, 3 months postintervention, and 12 months postintervention time points.

Readiness, depressive symptoms, and symptom distress data were only collected at two time points: preintervention and 3 months postintervention. Pearson correlations between viral load, readiness, depressive symptoms and symptom distress were calculated at these two time points. In order to account for each participant’s repeated measurements across time points, a mixed effect model was utilized for data anal-ysis. Time and group effects were treated as a fixed effect and repeated measures were treated as a random effect. The mixed effect model provided a robust mechanism for handling the missing values, a common issue for longitudinal studies.28 All analyses were conducted with an a of 0.1 as the criterion for statistical significance with the statistical package SAS, Ver-sion 9.1 (SAS Institute Inc., Cary, NC).

Data from the individual interviews (n ¼ 14) conducted postintervention were transcribed verbatim and analyzed using content analysis.29 Two investigators conducted the data analysis: one had conducted the interviews while the other did not have direct participant contact. The investiga-tors looked for patterns in the data with regard to partici-pants’ prior experiences taking ARV medications and their impressions about the length, timing, and acceptability of the READY intervention.

Information about past barriers to adherence, reports about missed ARV doses and feelings about the acceptability of the intervention itself was extracted from the intervention nurses’ field notes. Each participant’s field note data was then com-piled and reviewed.

Results

A total of 28 participants enrolled in the study: 21 men and 7 women who ranged in age from 24 to 57. Most (64.3%) were African American and the remainder were Caucasian with

ENRIQUEZ ET AL.

education levels that ranged from 9 to 16 years. The partici-pants had lived with HIV infection approximately 9 years and had experienced an average of 4 failed ARV medication reg-imens. The mean CD4 cell count for all 28 participants was 237 and mean HIV-1 RNA by PCR was 145,552 copies per milli-liter preintervention (Table 2).

All 28 participants were included in the analysis. From the profile plot (Fig. 1) an overall trend of decreasing log10 viral load across time was observed. There were statistically sig-nificant differences among comparisons of adherence rates from preintervention (0%) to postintervention (50%) and 12 months postintervention (42%;p < 0.0001,p < 0.0001). A review of the intervention nurses’ field notes indicated that participants who self-reported missing several doses per week of ARV did not reach viral suppression. Furthermore, for two participants, ARV therapy was stopped by their physician due to drug toxicities and hence viral suppression was not attained. A significant inverse relationship was identified between viral load level and readiness scores at baseline and 3 months postintervention (r¼_0.3969,p¼ 0.0674), i.e., a higher read-iness score was associated with lower viral load. Furthermore, a significant positive relationship was observed between viral load and disease distress symptoms (i.e., a higher symptom distress score was associated with higher viral load;r ¼0.4172, p ¼0.0534). No relationship was found betweendepressive symptoms and viral load. No significant differences were observed with regard to adherence (viral load suppression to less than 50 copies per milliliter) between the participants who received the READY intervention for either 6 or 12 sessions at 3 months post-intervention (64% and 36%,p ¼ 0.1227). Furthermore, there were no significant differences between the groups on mea-sures of readiness, symptom distress, or depressive symp-toms (Table 3). The mean number of sessions attended was 5.6 for the 6-session group, and 9.1 for the 12-session group. All 28 participants completed the intervention and there was 100% attendance by both groups at the 3-month postintervention follow-up visit. Attrition (21%) did, however, occur at the 12-month postintervention follow-up time point. Participant feedback about the intervention was obtained through individual interviews (n ¼ 14) conducted immedi-ately post intervention and from a review of the intervention nurses’ field notes. A research assistant approached seven participants from each group (6 sessions and 12 sessions), at random, and asked if he=she would volunteer to be inter-viewed when the intervention ended; all approached agreed to do so. Participants received a $25.00 gift card for their time and travel expenses to the interview. Overall the intervention was well received and feedback was positive. Without hesitation, all interview participants discussed past problems with nonadherence and their experiences as a participant in the READY study. Participants described past problems such as forgetting to take ARV medications or skipping doses due to unpleasant side effects. Many also spoke about feelings of isolation, having ‘‘no one to talk to,’’ alcohol and substance use, and a lack of social support which often contributed to their inability to ‘‘stay on track’’ with ARV medications. Participants did not seem to have an opinion with regard to the intervention’s length (6 sessions or 12 sessions), timing or READY INTERVENTION 181 Table 2. Personal and Health Characteristics by Intervention Group Six session group Twelve session group Characteristic (n ¼ 14) (n ¼ 14) Ethnicity, number (%) Caucasian (white) 4 (29%) 6 (43%) African American (black) 10 (71%) 8 (57%) Gender, number (%) Male 12 (86%) 9 (64%) Female 2 (14%) 5 (36%) Age Range 32 to 47 24 to 57 Mean (SD) 39.0 (4.5) 42.6 (8.1) Years living with HIV Range 1 to 18 3 to 17 Mean (SD) 9.7 (6.1) 9.14 (4.2) Years of education Range 9 to 15 9 to 16 Mean (SD) 12.4 (1.7) 12.8 (2.2) Prior # of prior ARV regimens Range 1 to 8 1 to 10 Mean (SD) 4.1 (2.4) 3.9 (2.3) CD4 cell count Range 42 to 676 11 to 484 Mean (SD) 281.0 (167.0) 193.2 (141.5) HIV-1 RNA by PCR (viral load) 594 to 750,000a Range 79 to 449,000 Mean (SD) 70,030 (133,722) 215,855 (286,005) .gif">

a750,000 was utilized for HIV-1 RNA by PCR results of> 750,000.

SD, standard deviation; ARV, antiretroviral; PCR, polymerase chain reaction.

session duration. When asked directly about the interven-tion’s length, most participants stated that they had been pleased with the intervention length and timing. A few de-sired a longer intervention length. One 6-session participant stated: ‘‘I think it (the intervention) needs to be a little bit longer, I was thinking at least 12 weeks’’ and a 12-session participant said: ‘‘I wish it had been longer, coming in every week kept me on the ball with taking my meds.’’ However, two 12-session participants and one 6-session participant stated that while the intervention was helpful, weekly visits became a burden at times.

All participants who were interviewed stated that they liked coming in to visit with the nurse and many viewed the nurse as a source of social support. The ongoing weekly meetings with the same nurses resulted in relationships of trust, which appeared to be a key component of the inter-vention’s success for several participants. The interaction with the nurse was described by a participant as follows: ‘‘I thought all of it (the interaction with the nurse) was helpful. . . . I was able to come down here and talk to somebody who knew what was going on with me.’’

Discussion

This paper describes the development and testing of an adherence intervention named READY in a real-world set-ting. Participants were HIV-infected adults (n¼ 28) who were considered particularly challenging to treat because they had experienced multiple failures with prior ARV medication regimens due to nonadherence. Acceptability, feasibility, in-tervention length and timing, and efficacy were assessed. The

study was implemented in 3 midwestern community clinic settings and 3 clinic nurses were trained as interventionists. All participants completed the intervention and returned for 3-month postintervention follow-up. At the 12-month follow-up time point attrition occurred and the retention rate drop-ped to 79%.

In this group of adults who were failing HIV treatment due to nonadherence at the time of study enrollment and who had experienced an average of four previous ARV medication failures, half (50%) became adherent. Of those who became adherent, as defined by suppression of HIV viral load to less than 50 copies per milliliter, 79% remained adherent at the 12-month postintervention follow-up time point. Consistent with previous studies, a significant correlation was found be-tween higher readiness and suppression of HIV viral load.13

With regard to intervention length and timing, there was no difference in the proxy measure for adherence, viral load suppression to less than 50 copies per milliliter, between participants who received the intervention for 6 sessions and began the intervention at the onset of a new ARV regimen and those who received it for 12 sessions and began the inter-vention prior to starting a new ARV regimen. Postinterven-tion interviews indicated that participants liked the READY intervention regardless of which length and timing strategy received. As expected, participants with higher viral loads reported more symptom distress.

When interpreting the results of this study, several limita-tions must be considered. Foremost, there was no control group. In addition, because the sample was small and re-cruitment occurred in one Midwestern city, the findings from this study are not generalizable. Furthermore, our data

182 ENRIQUEZ ET AL.

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FIG. 1. Log10 polymerase chain reaction (PCR) profile plot. Pre-, 3-months, and 12-months postintervention,n¼ 28.

analysis did not yield a clear mediator of the relationship between viral load suppression, readiness, symptom distress and depressive symptoms. Perhaps our sample size was too small and power was not sufficient to detect a difference. Another possible explanation is that a different variable, which was not examined, also mediated the relationship. A possible mediator could have been social support, which is another a component of Wellness Motivation Theory, has been identified in previous research as a factor contributing to

adherence and was identified by participants as being con-ferred by the intervention nurse.

Another limitation of the study was the reliance on the participant’s health care provider to provide adherence data (HIV-1 RNA by PCR laboratory results) and reliance on the participant to attend health care provider appointments. This adherence data collection method was challenging, particu-larly at the 12-month follow-up period when viral load data could not be captured from 21% of the participants. Our

Table 3. Results from Mixed Model Analysis on Symptom Distress, Depressive Symptoms (CES-D), and Readiness

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Symptom Distress

CES-D

Index of Readiness

Estimate (SE)

Estimate (SE)

Estimate (SE)

p

p

p

Fixed Effects

Preintervention

2.4675

(0.18)

1.1071

(0.19)

3.6779

(0.10)

<0.0001 <0.0001 <0.0001 Postintervention 2.1469 (0.19) 0.8846 (0.20) 3.7531 (0.11) <0.0001 <0.0002 <0.0001 Group Effect _0.0779 (0.26) _0.0179 (0.27) _0.1300 (0.15) Preintervention 0.7645 0.9484 0.3882 Postintervention 0.0699 (0.27) 0.1077 (0.28) _0.2385 (0.15) 0.7955 0.7072 0.1339 Repeated Effects Individual 0.4619 (0.09) 0.5207 (0.10) 0.1526 (0.03) <0.0001 <0.0001 <0.0001 READY INTERVENTION efficacy study was conducted prior to the standard use of boosted protease inhibitors and the general availability of the newest ARV agents, integrase inhibitors and CCR5 antago-nists. Because viral load suppression was used as a proxy measure of adherence, some participants who experienced a viral load reduction, but did not suppress viral load to less than 50 copies per milliliter, may truly have been adherent. A careful review of the intervention nurses field notes indicated that there were five participants who reported no missed doses at their intervention sessions yet they did not suppress their viral load. Hence, for these five participants, the inabil-ity to suppress HIV viral load could have been related to the level of the individual’s drug resistance or to the lack of effi-cacy of the ARV medication regimen rather than non-adherence. Had these participants been treated with one of the newer antiretroviral regimens, they may have reached viral suppression with the READY intervention. A direct measure of adherence, such as MEMS caps, may have been more sensitive. A further limitation of this study was the failure to collect data about the mode of HIV infection. The nature of HIV acquisition may have played a role in the behavior of non-adherence. While some data about HIV acquisition risk, such as substance abuse, was captured within the intervention nurses’ field notes, this information was only available if the participant had identified substance abuse as a past barrier to adherence during an intervention session. Hence, we were not able to analyze the relationship between the nature of HIV acquisition and adherence in our study. Despite these limitations, the results of this preliminary study indicate that READY has promise as an intervention that may help non-adherent individuals improve their ability to take ARV medications as prescribed. Clinicians who treat HIV-infected individuals are committed to help those who are nonadherent to ARV medications become adherent. How-ever, given the fast paces and limited resources of many HIV clinical care settings, the only adherence interventions that are likely to be implemented are those that are practical, can be delivered with existing personnel, and do not require exces-sive resources. READY may be one such intervention. As there were no differences in outcomes or participant accept-ability between the participants who received 6 sessions of READY versus 12 sessions, the 6-session format probably is preferable as a shorter intervention would likely be more cost-effective. Refinement of the intervention, based on the preliminary findings presented herein, is warranted as is a randomized controlled study to further examine the efficacy of READY. Acknowledgments The authors are indebted to the individuals who partici-pated in this study, American Nurses Foundation for financial support, Drs. Mary O’Connor and Paul Gore for their assis-tance and support, research assistants Julie Kirkpatrick and Charles R. Morales, and intervention nurses Florinda Merry, Mitch Wood, and Ursula Cedeno and Drs. Margaret S. Mikes and Merle Mischel for guidance in developing the READY intervention. Author Disclosure Statement No competing financial interests exist. 183 References 1. Mills E, Nachega JB, Buchan I, et al. Adherence to anti-retroviral therapy in sub-saharan Africa and North America. JAMA 2006;296:679–690. 2. Bangsberg DR, Perry S, Charlebois ED, et al. Nonadherence to highly active ntiretroviral therapy predicts progression to AIDS. AIDS 2001;15:1181–1183. 3. Shuter J. Forgiveness of non-adherence to HIV-1 anti-retroviral therapy. J Antimicrob Chemother 2008;61:769–773. 4. Bangsberg D. Preventing HIV antiretroviral resistance through better monitoring of treatment adherence. J Infect Dis 2008;197:S272–278. 5. Golin CE, Honghu L, Hays RD, et al. A prospective study of predictors of adherence to combination antiretroviral medi-cation. J Gen Intern Med 2002;17:756–765. 6. 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