JAIDS Journal of Acquired Immune Deficiency Syndromes:
Moving From Theory to Research to Practice: Implementing an Effective Dyadic Intervention to Improve Antiretroviral Adherence for Clinic Patients
Remien, Robert H PhD*; Stirratt, Michael J PhD*; Dognin, Joanna PsyD†; Day, Emily MA‡; El-Bassel, Nabila DSW§; Warne, Patricia PhD*
From the *HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University New York, NY; †Department of Family and Social Medicine, Montefiore Medical Center, Bronx, NY; ‡New School for Social Research, New York NY; and §School of Social Work, Columbia University, New York, NY.
Funded by the National Institute of Mental Health (grant R01 MH61173), with additional support from the Columbia-Rockefeller Center for AIDS Research (National Institute of Allergy and Infectious Diseases grant P30 AI42848).
Reprints: Robert H. Remien, PhD, HIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York NY 10032 (e-mail: firstname.lastname@example.org).
Summary: There is a dearth of evidence on the relative efficacy of intervention modalities to improve and maintain patient adherence to antiretroviral medications. Although empiric findings from research on HIV/AIDS, other diseases, and chronic medical conditions consistently demonstrate that social support plays an important role in facilitating adherence, few HIV/AIDS interventions have directly targeted this factor. Ewart's social action theory emphasizes the role of social relationships in behavior change and provides a comprehensive and useful guide to the development of interventions for adherence. We describe the development, content, and testing of SMART Couples, an effective antiretroviral adherence intervention that is grounded in social action theory and designed to enhance social support for ART adherence. Finally, we discuss some of the challenges of translating findings from the randomized clinical trial of this intervention into clinical practice and offer recommendations for integration of lessons learned into ongoing clinical care.
Medication adherence is the strongest predictor of HIV suppression1-3 and, conversely, of drug resistance,4-9 progression to AIDS,10 and death.11,12 Although early studies suggested that near-perfect adherence to antiretroviral therapy (ART) was necessary to achieve sustained viral suppression,1 recent research indicates that viral suppression with more potent drug regimens is possible at lower levels of adherence. In separate studies, Maggiolo et al13 and Bangsberg et al14 found reliable viral suppression at moderate levels of adherence to nonnucleoside reverse transcriptase inhibitor (NNRTI) regimens. Similarly, King et al5 found that the improved potency of lopinavir/ritonavir was associated with better viral suppression than nelfinavir at each level of adherence. Although these findings indicate that average levels of adherence can lead to full viral suppression with more potent regimens, it is important to underscore that improving adherence to any extent increases the probability of suppressing the virus, preventing drug resistance, and postponing disease progression. Striving for the highest possible level of adherence therefore remains essential to optimizing HIV treatment outcomes.
A variety of effective ART adherence interventions have been identified, but there is presently no strong evidence supporting specific approaches. Elsewhere in this issue, Simoni et al report a meta-analysis of 19 published and rigorously conducted randomized controlled trials. Most of these tested interventions employed educational, cognitive-behavioral, or behavioral strategies to improve ART adherence, and 74% of the studies incorporated multiple intervention strategies. Interventions were delivered in an individual or group format by a variety of types of health and mental health professionals. Although these interventions represented a broad range of modalities, commonly employed a mix of approaches, and were generally helpful, the meta-analysis showed no single modality to be more effective than others.
Given the critical need to improve and maintain patient ART adherence and the lack of definitive evidence supporting specific approaches, the field must consider innovative avenues of intervention. In the SMART Couples Project, we developed a promising intervention through coordinated examination of empiric findings and application of theory. In this article, we (1) triangulate these sources to conclude that a social support approach would be promising for enhancing adherence, (2) detail the theory-based development and content of the SMART Couples intervention to enhance instrumental social support for ART adherence, and (3) elaborate on the clinical applications of this effective curriculum and the wider clinical implications of such an approach. The outcomes of the randomized clinical trial that tested this intervention are briefly noted but are presented in detail elsewhere.15 In offering greater elaboration of our intervention theory, content, and practice, we aim to demonstrate the promise and challenges associated with conducting a dyadic intervention to improve ART adherence.
EMPIRIC RESEARCH FINDINGS UNDERSCORE THE IMPORTANCE OF SOCIAL SUPPORT
Empiric research has identified a variety of predictors and correlates of adherence to ART. In a systematic review of existing determinant studies, Ammassari et al16 identified 5 factors consistently associated with poor ART adherence: absence of social support, low adherence self-efficacy, regimen complexity, patient-reported symptoms and side effects, and stressful life events. The review found inconsistent associations between adherence and various patient characteristics (age, race/ethnicity, and socioeconomic/housing status) or psychosocial factors (substance use, depression, knowledge and beliefs about treatments, and satisfaction with patient-provider relationship).
Although adherence is multiply determined and is dynamic and its correlates differ among individuals and across time for a given individual,17 the importance of social support is particularly evident. The amount of social support received, satisfaction with that support, and extent of a person's social network are related to health status and clinical outcome in patients with a wide range of chronic illness,18-28 and social support can be a significant factor in enhancing adherence to treatment, leading to better health outcomes.29-34 Greater social support has been associated with higher levels of HIV/AIDS medical adherence35-45 as well as with better psychologic adjustment and slower progression to AIDS.46-55
The relation between social support and health behaviors such as adherence is complex and a function of the specific type of social support.23,57 Social network members may facilitate behavioral change by transmitting to the patient beliefs and motivations concerning treatment.58 Significant people in the patient's life may also enhance adherence by reminding, prompting, aiding, and supporting the patient; by assisting the patient in expressing feelings and finding meaning and a sense of belonging; and by offering feedback and encouragement that reinforces adherence success.59 In HIV/AIDS, research indicates that the relation between forms of social support and ART adherence may be mediated by positive and negative affect, coping strategies, and self-efficacy.38,60,61 More broadly, a recent meta-analysis of 122 studies across multiple medical conditions29 determined that adherence was more strongly and consistently associated with receipt of functional support (ie, practical/emotional support) than with the presence of structural support (ie, living arrangement/relationship status). Within the domain of functional support, the study found that the provision of practical support had a significantly greater influence on adherence than the provision of emotional support.
Interactions with friends and family, however, can be detrimental as well as helpful. In a recent study among a large diverse sample of HIV-positive men and woman in 4 cities, having a primary partner was associated with worse adherence.62 Coyne and colleagues63-66 described the effect of spousal overinvolvement, the costs and constraints of relationships, and the interdependence and interactional nature of social support in coping with stress involved in chronic illness and care. Thus, interventions must not only enhance effective support from social network members but prevent counterproductive or even potentially harmful interactions.
Recognizing that social support is an important factor associated with health behaviors and outcomes, interventions have been developed to include patients' families or other social network members to cope with health care situations such as chronic mental illness,67-70 drug addiction,71,72 mental retardation,73 diabetes,74 learning disabilities,75,76 cancer,77,78 deafness,79 senile dementia of the Alzheimer type,80 and chronic disabilities and long-term care.81 Most family-based interventions provide information and support, using a structured framework within which a range of adaptive coping mechanisms are considered and mobilized to support the health of the “ill” patient. More recently, social support intervention research has moved beyond a family focus to consider social networks, particularly in the substance use field,82-86 and interventions involving a member of a patient's broader social network have been successful in reducing addictive behaviors.87-92
THEORIES FROM PSYCHOLOGY SPECIFY TARGETS OF INTERVENTION
Comprehensive theories of health behavior offer important tools for the development of effective interventions. The role of social support in adherence, as identified within the empiric literature, led us to look for theoretic bases that incorporated this issue. Some of the major theories employed in health research include the social cognitive theory;93 health belief model;94 theory of reasoned action;95 and information, motivation, and behavior skills (IMB) model.96 Interestingly, relatively few rigorously tested antiretroviral adherence interventions have been developed based on existing theories of behavior change. In our own systematic review of the 19 ART adherence intervention trials targeted by a recent meta-analysis by Simoni et al (as reported elsewhere in this issue), we found that most interventions lacked a clear and robust theoretic underpinning. The few studies that explicitly and comprehensively translated theory into their intervention content employed the social cognitive theory97,98 and IMB model.99 Many of the remaining studies offered a nominal conceptual rationale for their intervention approach but tended to draw on isolated elements of particular theories, the empiric literature, or prior intervention research. Others did not mention behavior change theories at all. Other researchers have similarly underscored the relatively atheoretic character of ART adherence research60 and interventions.100
HIV prevention and treatment researchers increasingly cite the need for interventions based on broader theoretic models that address the social and environmental context.101-103 Yet, existing theory-driven research in ART adherence principally describes behavior change in terms of individual-level factors. Thus, although social support has consistently been highlighted as an important variable associated with higher levels of adherence, most studies have included it as an independent construct that is not embedded within a comprehensive theory.
SOCIAL ACTION THEORY
An innovative approach to promoting ART adherence that directly incorporates social support can be found in Ewart's social action theory (SAT).104 The SAT uniquely focuses on behavior change and factors such as social context and support that can help to foster and maintain that change. The SAT has been used to elucidate the role of social interdependence in HIV prevention and condom use105 and in the development of interventions to promote healthy behaviors and to reduce substance use and unprotected sex for HIV-positive youth106 and adults.107 We used the SAT to develop an intervention to improve ART adherence among clinic patients by facilitating support from their relationship partners.
According to the SAT, health behaviors result from the interplay of 3 domains: (1) self-regulation as an action state, characterized by equilibrium between an action or script and its consequences; (2) factors affecting the processes of self-change that create new or modified action scripts; and (3) the larger social-environmental and specific intrapersonal context.
First, behaviors or habits affecting health (whether beneficially or adversely) may be thought of as routines or scripts (action states) that reflect the interplay between an action and its biologic, emotional, or social consequences as experienced by the individual. Most behaviors are part of automatic scripts that are highly integrated rather than consciously attended to; many of these scripts are also shared with another person in a close relationship, reflecting social interdependence of individual behavior. This is most problematic when the behavior targeted for change also disrupts such a shared script. Because social interdependence may be a barrier to as well as a facilitator of change, including the partner is an important part of modifying action scripts. In our intervention, the primary relationship partner, with whom many scripts are likely shared, is involved directly so as to improve the likelihood that scripts promoting health behaviors (eg, adherence) are agreed on and adopted.
Specific mechanisms of behavior change addressed by the SMART Couples intervention may be mapped onto the second aspect of the SAT, which holds that health behaviors are the result of self-change processes by which an individual makes transitions from old action states to new ones. This involves (1) problem-solving, (2) motivation, (3) the generative capabilities that enable these, and, finally, (4) social interaction processes. The ability to problem solve is related to social and emotional adjustment, and that adjustment can, in turn, be enhanced by problem-solving training. Motivational processes include outcome expectancies, evaluating one's capabilities (self-efficacy), and generating goals that have the priorities necessary to stimulate behavior change. Generative capabilities comprise the cognitive, factual knowledge, and procedural schemata that allow one to envisage new goals and become motivated and to engage in problem solving to reach them. Providing useful new knowledge and skills or altering inaccurate schemata represents an important intervention strategy for health behavior change. Social interaction processes affect all other elements of self-change processes. When a behavior change threatens a valued relationship (ie, by disrupting shared scripts), success often depends on the couple's ability to communicate and collaborate to plan and commit to strategies that bring about the change. In this manner, they create new shared scripts, creating attainable goals and developing action plans, and the partner offers emotional and practical social support.
Finally, health behaviors are shaped by broader social environmental systems and intrapersonal factors representing contextual influences that facilitate or impede change. For instance, external influences, biologic conditions, and temperament all contribute to mood states that affect self-change processes. External factors include demographics, living circumstances, social networks, organizational systems, and physical environmental factors. For our intervention, these included social norms and attitudes toward being HIV-positive, the poor urban neighborhoods in which many patients live, the larger health care system, and combination medication therapies. Individual biologic and temperament factors included specific reactions to medication regimens (eg, viral response, side effects), psychologic functioning (eg, depression), cognitive functioning, and substance use.
RESEARCH ON INTERVENTION WITH COUPLES
To help translate SAT constructs into specific activities within our couple-focused intervention curriculum, we drew on the literature on couple distress and satisfaction, which reveals the following critical components of an effective dyadic intervention: (1) clarify attributions and encourage positive ones, (2) increase expressiveness and foster effective communication, (3) create positive experiences, (4) develop strategies to protect the couple's investment in the relationship, (5) improve problem-solving skills, and (6) increase conflict management skills.108-110 Relationship-focused coping struggles with a primary dilemma: “How does one contribute to the partner's well-being, avoid unnecessary conflict, and yet look after oneself, balancing concern for the partner with one's own needs?”65 Coyne and his colleagues63-66 identified 2 broad classes of relationship-focused coping: active engagement, which involves open discussion and joint decision-making, inquiries into the partner's feelings, and problem solving, and protective buffering, in which concerns are hidden, worries are denied, and accommodation is employed to avoid disagreements. These approaches informed the development of our couples-based intervention.
SMART COUPLES INTERVENTION
The SMART Couples intervention was the first intervention guided by the SAT to improve adherence to ART. This brief intervention was targeted to serodiscordant couples and aimed to improve patients' adherence to HIV/AIDS medical care regimens by addressing their self-regulation capabilities and the larger social environmental context, specifically by fostering support for adherence from a relationship partner. In addition, the intervention sought to help couples address issues of sex, intimacy, and transmission risk behaviors.
The intervention was individually administered to each couple by a nurse practitioner in an outpatient treatment setting through 4 45- to 60-minute sessions held over 5 weeks. The session content included structured discussions and instruction as well as specific problem-solving and couple-communication exercises. Couples additionally monitored and reviewed the adherence of the HIV-seropositive partner over the course of the intervention through the use of the medication event monitoring system (MEMS). Key intervention components included educating about HIV, its treatment, and the importance of adherence to avoid viral resistance and maintain health; teaching self-monitoring, including identifying patterns of nonadherence; identifying barriers to adherence and developing communication and problem-solving strategies to overcome them; improving adherence motivation and self-efficacy by reframing beliefs and attitudes about treatment; optimizing partner support; and building the couple's confidence in achieving and maintaining improved adherence. Facilitators were trained to provide referrals as needed for the couple or for either individual for mental health treatment, substance abuse treatment, sexual risk reduction counseling, and public assistance.
INTERVENTION CURRICULUM: ACTIVITIES AND THEORETIC CONSTRUCTS ADDRESSED
Session 1: What Are My Partner and I to Do?
Session 1 has the following specific objectives: (1) set the ground rules for session attendance and participation for both partners, (2) establish rapport and discuss current priorities and concerns, (3) increase the amount and clarity of factual information related to medical adherence, (4) increase motivation for and commitment to adherence, and (5) increase couple-level support for adherence and mutual care taking. Key theoretic components addressed in this session are knowledge (ie, knowledge of the treatment regimen, general knowledge of HIV, and consequences of nonadherence) and motivation (ie, commitment to adhere).
In the first session, the facilitator introduces the couple to components of medical care adherence, underscoring its importance by discussing its relation to medical concepts such as viral resistance, bioavailability, absorption, viral load, and T cells. Adherence-related behaviors are clarified by reviewing the patient's medication regimen, medical appointment schedule, and prescription plan. The facilitator then explains methods of monitoring medication effects (eg, CD4+ cell count and viral load) and adherence (ie, MEMS caps). Together, the couple and facilitator discuss medication side effects and their management, and the facilitator answers any questions. To increase motivation and commitment to adherence, the facilitator then asks the couple to list the advantages and disadvantages of strictly adhering to the medication regimen. To introduce the role the partner can play, the session ends with establishing a clear, reasonable, and easily monitored goal focused on taking care of each other that is to be completed before the next session.
Session 2: How Can We Improve?
Session 2 addresses the following specific objectives: (1) identify barriers to adherence, (2) increase problem-solving skills, (3) apply problem-solving skills to an identified barrier; and (4) increase skills in couple communication. Key theoretic components addressed are adherence monitoring and contextual and intrapersonal barriers to adherence, communication and problem-solving skills, regimen-specific support, couple-level motivation and commitment to adherence, and adherence self-efficacy.
The second session identifies and addresses adherence barriers and facilitating couple-level support to improve adherence. The facilitator first reviews the couple's experience with the between-session task, praising the couple's efforts and/or addressing any barriers encountered. After discussing the couple's recollection of medication-taking behavior, the facilitator and couple download MEMS cap information; identify specific days when medication doses were missed and/or fell outside the targeted window (eg, 12 hours apart for dosing twice daily or 8 hours apart for dosing 3 times daily); and review the emotional, cognitive, or behavioral obstacles they encountered and factors that facilitated good adherence. The facilitator then describes key steps involved in problem solving (eg, defining the problem, deciding on a goal, brainstorming and evaluating options for potential solutions, developing a specific action plan). Together, they apply these steps to a specific adherence barrier in the couple's life. The facilitator also explains devices that might aid in adherence (eg, beeper, timer), facilitates access to them, and instructs the couple on their proper use.
The facilitator then introduces the principles of effective couple communication (eg, skills for effective expressing and listening) and has the couple practice these skills, starting with the expression of what each partner finds supportive from the other. The session ends with setting and committing to a between-session task of “the royal treatment,” in which each partner does something special for the other during the coming week. This is meant to be a simple activity that the 2 individuals have not recently shared and that the partner would appreciate.
Session 3: How Do We Work Together?
Session 3 has the following specific objectives: (1) reinforce the importance of adherence and good health care, and apply problem-solving skills to address an adherence barrier; (2) increase relationship-coping skills, including the ability to deal with issues of sexual risk-taking, to protect the health of the HIV-negative partner just as the focus on adherence aims to protect the health of the HIV-positive partner; and (3) further explore what it means to care for each other. Key theoretic components addressed are knowledge (ie, about health indicators); adherence self-efficacy, communication, and problem-solving attitudes (eg, toward combination therapy in relation to sexual behaviors); regimen-specific support; self-monitoring of adherence; relationship coping; and commitment/motivation to adhere.
After reviewing the couple's experience of giving each other the royal treatment and encouraging couple communication and expressions of caring for each other, the facilitator reviews the HIV-positive's partner's recent CD4+ cell count and viral load test results to reinforce knowledge about these health indicators and to underscore the importance of adherence. The couple reviews the MEMS cap data to examine medication adherence during the past week and practices problem-solving skills to address a specific barrier to adherence that was encountered.
The couple is encouraged to discuss questions and concerns about risk behaviors for transmission of HIV and other sexually transmitted diseases (STDs). In this process, the facilitator normalizes the “desire” for intimate (ie, unprotected) sex while reinforcing the importance of not allowing HIV to be transmitted in the couple. For heterosexual couples, this discussion may include decisions related to the desire for pregnancy. As an extension of the discussion on sexual intimacy, the facilitator asks the partners to communicate to each other the many ways in which they take care of each other, thus practicing communication skills that were taught in the previous session. The couple then decides on a specific time before the next intervention session when they are going to have a “communication date” to share their thoughts and feelings about the ways in which they experience support within their relationship.
Session 4: How Well Are We Doing?
Session 4 has the following specific objectives: (1) increase adherence monitoring skills, (2) increase problem-solving skills, (3) increase commitment to maintaining adherence over the long term, and (4) increase self-efficacy for these behaviors. Key theoretic components addressed are adherence self-efficacy, communication and problem-solving skills, regimen-specific support, self-monitoring of adherence, and commitment/motivation for adherence.
The final session of the intervention is held 2 weeks after the third session and focuses on building the couple's commitment, enhancing self-efficacy for the maintenance of adherence behaviors, and utilizing effective communication skills in the context of providing mutual support. The session includes a final review of the MEMS cap data, identifying persisting barriers to adherence, practicing the steps of problem solving, and planning for future sustained adherence. The session concludes with activities aimed at reinforcing the couple's commitment to adherence and caring for each other.
This final session begins by reviewing the between-session task of communicating and sharing with each other. The facilitator then reviews any new clinical indicator test results (ie, CD4+ cell count and viral load) and addresses any questions about these biologic markers and management of side effects. As in the past 2 sessions, the couple reviews MEMS cap data since the last session and, once again, problem solving for adherence barriers. They then make a list of potential “triggers” for nonadherence based on past experiences and future expectations and discuss ways of avoiding them. They also review adherence strategies that worked well for them in the past, and the facilitator links these successes to reinforce self-efficacy for success. The facilitator then reinforces the partners' connection by asking them to share the things that they value in each other. Finally, the facilitator provides positive reinforcement for their dedication and commitment to each other and for addressing the challenges of high levels of adherence and good health care. Before ending the final session, the couple is asked to make an ongoing commitment to each other to maintain good adherence, keep all their medical appointments, maintain a steady supply of medications, work hard at effectively communicating with each other, and continue to engage in mutually supportive care-taking behaviors.
TESTING INTERVENTION EFFICACY: A RANDOMIZED CONTROLLED TRIAL
We developed and tested this theory-based and couple-focused intervention in a randomized controlled trial conducted between August 2000 and January 2004 at 2 HIV/AIDS outpatient treatment clinics of St. Luke's-Roosevelt Hospital Center (SLRHC) in New York City. The study protocol was approved by the Institutional Review Boards of the New York State Psychiatric Institute and SLRHC, and all participants provided written informed consent.
Participants were eligible if they were an HIV-serodiscordant couple (self-report) with a relationship duration of 6 months or more and both partners were English-speaking adults (at least 18 years old). The HIV-seropositive partner needed to be in primary care and on ART for at least 1 month.
The primary measure of adherence was assessed through the MEMS. MEMS data were used to calculate adherence summary scores for the percentage of prescribed doses taken without regard to timing and the percentage of prescribed doses taken within specified time windows (eg, for twice-daily regimens, intended dosage times were set 12 hours apart, with 2-hour windows around each intended dosage time). These scores were adjusted through participant self-reports of errors in MEMS use (eg, number of occasions on which doses were dispensed from a container other than the MEMS bottle, number of times the MEMS bottle was opened without removing a dose).
Clinic providers throughout New York City were informed about the study, given recruitment flyers, and encouraged to refer patients. Recruitment flyers were also posted in hospital outpatient HIV/AIDS treatment clinics, private medical practices, and community-based organizations. Potential participants called the study office and completed a 10-minute telephone prescreening interview to assess basic eligibility. Couples that met these criteria were scheduled for an in-person main screening appointment.
The couple's relationship status was confirmed at the in-person screening appointment with a series of questions posed to the partners independently assessing when and how they met, whether they considered themselves to be in a “committed” relationship, and whether they expected to be in this relationship for at least another year. If the couple was eligible and interested in participation, each partner provided informed consent, the antiretroviral regimen of the HIV-seropositive partner was reviewed, and a MEMS cap was provided for electronic monitoring of antiretroviral adherence.
Couples returned for a final screening appointment after 2 weeks of MEMS cap use and were eligible for the intervention trial if fewer than 80% of prescribed doses were taken on time during the 2-week observation period. Patients with adherence of 80% or greater were informed that they were ineligible for the study and were referred to their health care providers for routine follow-up. Eligible couples were administered the baseline interview before randomization.
Couples were randomly assigned to one of the following conditions: (1) the brief intervention, a 4-session couple-focused adherence program, or (2) the control condition, usual care through the medical provider of the HIV-seropositive partner. Follow-up assessments were conducted at weeks 8, 20, and 32. A full description of study assessments and assessment procedures is provided elsewhere.15
Intervention facilitators (2 nurse practitioners from the SLRHC) received training from the Principal Investigator and Project Director regarding the theoretic basis for the intervention, the intervention curriculum, and the use of the MEMS. Both facilitators satisfactorily completed the full intervention curriculum with a pilot couple before meeting with trial participants. All intervention sessions were audiotaped with the permission of study participants, and curriculum fidelity was maintained through systematic reviews of session audiotapes and weekly supervision meetings with the Principal Investigator and Project Director. The facilitators additionally completed process evaluations for each session, including a checklist of implemented curriculum components.
As reported elsewhere,15 the intervention significantly improved adherence over and above “usual” clinic care in the short term. Although adherence was equivalent in the 2 groups at baseline, intention-to-treat analyses showed significant group differences in adherence change between baseline and the primary outcome time point (week 8; 2 weeks after the intervention) in terms of the proportion of prescribed doses taken (change score: b = −10.84; P = 0.021) and the proportion of doses taken within specified time windows (change score: b = −22.38; P < 0.001). There were differences in adherence change between the study change in arms at week 20 (3 months after the intervention), but only the proportion of doses taken within specified time windows was significant (change score: b = −13.17; P = 0.028). There were no significant differences in adherence change between the 2 groups at the week 32 assessment (6 months after the intervention) on either adherence outcome.
A more clinically meaningful outcome may be the percentage of study participants who achieved high levels of adherence after the intervention. By design, all randomized patients had a baseline adherence level of <80% of prescribed doses taken within specified time windows. Figure 1 shows significant group differences at the primary outcome time point (week 8) in the percentage of participants who took >80%, 90%, and 95% of doses (irrespective of dosage timing), and Figure 2 shows significant group differences in the percentage of participants who took >80%, 90%, and 95% of doses within specified time windows. For both outcomes, the proportion of participants achieving these 3 adherence levels was significantly higher in the treatment group than in the control group.
Intervention arm participants also showed significantly greater improvement than control arm participants in measures of couple communication (dyadic consensus and affectional expression) and treatment support from the relationship partner, and improved treatment support was associated with higher adherence overall.111 Participants who demonstrated greater adherence at baseline also reported greater instrumental support from their relationship partners and higher rates of serostatus disclosure to members of their social network.112
Process measures completed by participants in the intervention arm indicated that the intervention was well received. Both partners reported being “very satisfied” with the intervention content overall (mean of 1.3 on a scale of 1-5, with 1 = very satisfied and 5 = very dissatisfied). Across the 4 sessions, 84% to 93% of HIV-positive partners and 95% to 97% of HIV-negative partners thought that the intervention was very helpful with their adherence. Participants also endorsed adding sessions to the brief intervention. One third of the HIV-negative partners and 40% of the HIV-positive partners stated that the intervention had too few sessions; only 1 HIV-negative partner and no HIV-positive partner thought that the invention contained too many sessions.15
INTEGRATING A COUPLE-BASED THEORY-DRIVEN INTERVENTION INTO CLINICAL CARE: LESSONS LEARNED
Although conducting a theory-based and couples-focused randomized controlled trial within an HIV primary care setting proved to be challenging, it also provided clinical information that can inform models of care. Generally, standard clinical practice is focused on the HIV-infected individual, and any specific interventions addressing adherence are at the individual level. Involving both partners raised concerns and enthusiasm among providers. For instance, at the start of the project, providers expressed concern about potential mental health or social work needs that might arise for the HIV-negative partner, and some clinicians (and administrators) thought that they were not equipped to deal with care that might be needed for individuals who were not clinic patients. There were, in fact, occasions on which clinicians needed to make outside referrals for mental health services for partners; however, there were neither emergencies requiring immediate clinical attention nor significant disruptions of clinic activities.
Despite these initial concerns, including partners in the care of the HIV-infected patient was cited by the participants and facilitators as one of the most important intervention components. In the process evaluation that followed the intervention, participants reported improved communication within their relationship as one of the most valuable parts of the intervention. Similarly, the intervention facilitators reported that fostering concrete support from the partner was one of the most effective program elements. Therefore, despite initial concerns that a couple-focused intervention might result in disruptions in ongoing care in the clinic and might create extra burdens for the providers, inclusion of a primary partner in care was viewed as an advantage in that it strengthened the couple unit by improving communication and increasing mutual care taking, and thereby improving adherence.
Another element of the intervention that initially posed some practical difficulties but was ultimately seen as an asset was the use of the MEMS cap. For patients, the size and weight of the MEMS cap made it a burden to carry around and posed concerns about being able to conceal it while out of the house. The MEMS cap, however, also provided valuable feedback to participants and facilitators. The couple and the intervention facilitators said that examining MEMS data during the intervention sessions provided excellent feedback on patterns of pill-taking (or pill-missing) behaviors. Facilitators commented that participants often perceived their adherence to be higher than the evidence observed in the MEMS cap review, and the study participants were surprised when seeing gaps in medication taking that they had not recalled. This objective feedback in the sessions enabled participants and facilitators to track behavior patterns and problem-solve ways to improve adherence and strengthen partner support, thus improving communication and problem-solving skills around adherence.
Because aspects of this research intervention proved to be clinically relevant, we considered which elements could be adapted for clinical care. An obvious challenge in adapting a program of this nature into clinical practice is posed by the time constraints inherent in clinic settings. Primary care providers often have 20 minutes or less to see an individual patient rather than the 45 minutes that this intervention entails. Adapting the intervention would require streamlining it to include only those elements that are clinically relevant and responsive to the needs of the community. Another difficulty faced in clinical settings is the lack of adherence monitoring systems such as MEMS caps, which provide patients and their providers with direct feedback on patterns of adherence. Lessons learned from this research suggest that developing and incorporating such technology into “user-friendly” systems for tracking adherence patterns would be useful to address medication adherence in clinical settings.
Targeting serodiscordant couples in primary relationships also limits the applicability of the SMART Couples intervention to the wider range of patients seen in HIV care settings. Can this intervention be adapted to accommodate the needs of HIV-infected patients who are not in a serodiscordant relationship and, further, to those who may not be in a primary romantic relationship at all? Many HIV-positive people experience significant isolation from committed romantic relationships not only as a result of their HIV status but because of substance use, poverty, and other factors inherent in vulnerable communities. Some of these are the same issues that contribute to adherence problems. Our clinical partners in this study believed that the intervention could be adapted for patients without a primary partner if the patient could identify a significant person within his or her social network who would commit to attending sessions and providing ongoing support with adherence. A most likely “supportive partner” would be someone who is in daily contact with the patient, preferably living within the same household. Attention would need to be paid to the relationship's interpersonal and “power” dynamics, which are likely to differ with type of support partner (eg, sibling, child, parent, friend, neighbor). An important added dynamic would be present if the “support partner” were also infected with HIV. These issues need to be formally tested in clinical research studies. In the meantime, however, clinicians should consider the possibility of including a support partner in the context of ongoing clinical care for their patients experiencing difficulties with medication adherence.
CONCLUSIONS: CLINICAL RECOMMENDATIONS
Our experience of implementing and testing this couple-based adherence intervention trial leads us to the following recommendations for clinicians interested in integrating this type of intervention into their ongoing practice. First, consider using this intervention not only for patients who are in primary relationships but for other types of dyads. This may include patients with seroconcordant partners, family members, close friends, or any other identified support person who lives with a patient and/or has close daily contact. Clearly, the intervention would need to be modified so that the focus on couples-related caring and communication is replaced with concepts of caring and communicating in a more general sense. If it is not possible to apply this specific intervention formally, we suggest that providers routinely encourage their patients to bring a partner or family member to routine clinic appointments to help foster concrete support. Doing so enables the partner or family member to become an effective member of the patient's team and allows the patient to feel more understood and supported by the important people in his or her life. This can also serve to enhance personal motivation to adhere and adherence self-efficacy, which are key components of effective behavior change.
It is also recommended that providers consider integrating a focus on problem-solving activities with the patient and his or her support partner rather than “prescribing” solutions. Our intervention facilitators identified the problem-solving training and exercises as one of the most effective parts of the intervention. Although it may be challenging, we believe that training HIV health care providers to do this is feasible and potentially advantageous to patient care. Clinicians should also consider using various types of adherence feedback tools. In the absence of MEMS caps, providers and patients should think of other creative ways in which to monitor adherence patterns and incorporate these rituals in their lives. For some, this may entail writing in a journal, using a pillbox, or any other way that would integrate concrete monitoring with social support. Finally, clinicians need to maintain a focus on adherence support for patients throughout the course of treatment, because adherence is likely to decline with time in the absence of ongoing attention. ART is a lifelong treatment, and as noted in prior research, adherence is a dynamic phenomenon subject to change (decline and improvement) as a consequence of changeable life factors and circumstances.17
The authors thank Sutherland Miller for his contributions to the development of the intervention and Robert Warford and Tiffany Jung for their expert facilitation of the intervention sessions. They are also grateful to Victoria Sharp and the clinical staff at the SLRHC for their collaboration on this project and to the men and women who participated in this study.
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antiretroviral adherence; couples; HIV; intervention; social action theory; social support
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