Usual clinical care
Usual care procedures to enhance adherence at the clinics will continue to be implemented for all participants. Strategies for assessing adherence readiness at the study sites include educating the patient about the importance of adherence, evaluating patient commitment and motivation to adhere to treatment, and assessing whether barriers to adherence need to be addressed before initiating treatment (e.g., unstable housing, substance abuse). Once ART is initiated, routine inquiries about adherence occur at regular follow-up visits (once or twice in the first month of treatment, and then every 3–6 months). What varies across individual patients is the staff member who discusses these issues with the patient (e.g., nurse, physician, case manager) and the amount of time spent on these issues. Structured, systematic counseling protocols and practice trials are not part of usual care. We will measure adherence support received by patients as part of usual care in the participant surveys, as described below.
START intervention
START is a comprehensive program of adherence training based on the IMB model of health behavior [
13], which asserts that
information about ART and the importance of adherence is a prerequisite but in itself is insufficient to alter behavior, and that
motivation for adherence and
behavioral skills to adhere well and overcome barriers are critical determinants of adherence. Motivation is fed by beliefs that the medication will be helpful (treatment efficacy) and confidence that one can adhere even in difficult circumstances (adherence self-efficacy). Behavioral skills such as problem-solving and adherence self-monitoring help to identify adherence barriers and effective solutions to these barriers. While not emphasized in the traditional IMB model, the social context in which adherence occurs and the support the patient receives can be important to all three of these components, both positively and negatively. One’s support network can be a source of information and can transmit beliefs about treatment that affect motivation. Social support can maintain or break down psychological well-being and psychosocial functioning, thereby impacting the patient’s ability to develop and use behavioral skills needed to adhere well. Each component of the IMB model is present in the START components and specific sessions, as shown in Table
1.
Table 1
Mapping of the START intervention’s conceptual framework and session content
Information | Provide information about HIV, ART, and the importance of adherence for treatment success and limiting resistance | Pre-ART session 1 |
Motivation | Discuss attitudes and beliefs regarding ART and adherence, and use MI to reframe and build positive attitudes | Pre-ART session 1, early ART week 2, maintenance phase |
Use of problem-solving and confidence rulers to improve adherence self-efficacy and sense of autonomy | Each session after the first one |
Behavioral skills | Practice trials to practice adherence to planned regimen | Pre-ART sessions |
Review adherence results (self-management) | Each session after the first one |
Use problem-solving to identify adherence barriers and generate and evaluate solutions to these barriers | Each session after the first one |
Integrate regimen into daily routine | Pre-ART session 2 |
Side effect management | Early ART and maintenance |
Social support | Review source of social support (positive and negative) and discuss ways to enhance support for adherence | Pre-ART session 1, early ART week 2, maintenance phase |
START consists of pretreatment (including practice trials to determine readiness for and timing of ART initiation), early treatment, and ongoing maintenance training (using a performance-based dose regulation mechanism to tailor the amount and intensity) phases, each of which is outlined below. Sessions are administered to individual patients by the interventionist, who will be a trained research coordinator with adherence counseling experience (but who does not provide usual care). Each session lasts approximately 30 minutes. Exercises often involve completing worksheets or the use of handouts, which are given to the patient to use as a reference at home. Sessions are structured and manualized but still allow flexibility for tailoring the content of the exercises to the needs of the individual patient. Figure
1 depicts the flow of participation through each phase of the intervention.
Pretreatment training phase
This phase is composed of a series of up to four 1-week practice trials accompanied by adherence counseling and a dose regulation mechanism in which patients discontinue the practice trials and initiate ART once >85 % dose-taking adherence is achieved in a single practice trial, thus demonstrating adherence readiness. Using 85 % adherence to define readiness is consistent with what the literature indicates is needed for optimal treatment benefits with the new, more potent ART regimens [
1‐
3]. With today’s common once-daily regimens, this threshold allows the patient to miss one dose over the course of the week and still meet the criteria for readiness. Early exercises and sessions will be focused on enhancing motivation and confidence to help prepare the patient for later skill-building exercises that may call for behavior change to overcome adherence barriers.
Session 1 Following an introduction and description of the ART regimen, the counselor will provide education about concepts such as viral load, drug resistance, and the importance of dose-timing to ensuring a constant adequate drug level. The importance of being ready to adhere well before starting treatment will be emphasized. Motivational interviewing (MI) techniques [
16] will be used to help the patient develop or strengthen positive attitudes toward treatment and adherence, with the goal of improving adherence self-efficacy and motivation to adhere well. Exercises will be devoted to enhancing social support (reminders, transportation to clinic, provide reinforcement for successful adherence) provided by the patient’s social network. The practice trial will be introduced as an opportunity to experience what it is like to follow the prescribed ART regimen and to evaluate the patient’s readiness to start treatment. The practice trial regimen will mimic what the patient’s provider intends to prescribe. A 1-week supply of vitamins, with the electronic monitoring cap attached to one of the pill bottles, will be given to the patient to complete over the coming week.
Sessions 2–5 The number of sessions depends on the number of practice trials the patient needs to complete. Electronically monitored adherence results during the preceding week’s practice trial are reviewed with the patient. The electronic monitoring printout provides a chronology graph that depicts exactly the time that doses were taken each day. Good adherence is reinforced, and missed doses are identified, including any patterns that may be apparent. Patients are asked to identify barriers that contributed to missed or late doses, and antecedents to these scheduled doses are discussed. The stages of problem-solving are introduced (define the problem, decide on a goal, generate a list of possible solutions, compare and select a solution to try, plan the implementation of the solution, evaluate the effectiveness of the solution). MI techniques will be used, and the patient will be encouraged to take a leading role in identifying key barriers, coming up with potential solutions, and evaluating his or her experience in using these solutions, all of which are designed to maximize the patient’s feelings of autonomy and self-efficacy and increase the likelihood that these strategies will be successfully adopted.
If dose-taking adherence during the practice trial is 85 % or greater
, the patient will be considered ready to start ART, no further practice trials will be completed, and ART will be prescribed. The specific ART regimen planned for the patient will be reviewed. The patient will be asked to describe his or her daily routine and optimal ways for integrating the medication doses into his or her daily life. Doses will be connected with specific daily activities or behaviors so that these routinized activities can serve as reminder triggers for taking medication doses. Common side effects associated with the specific antiretrovirals prescribed will be discussed; side effect management handouts outlining possible strategies to manage specific side effects will be reviewed; and the patient will be encouraged to identify strategies that are feasible for to adopt if side effects occur.
If dose-taking adherence to the practice trial is <85 %
, the patient will be given another 1-week supply of vitamins for the next practice trial and encouraged to use the strategies identified in the session to overcome adherence barriers during the coming week. Linking the doses to routinized daily activities will be discussed. For those who are unable to achieve 85 % adherence after completing four practice trials, the decision whether to start treatment will be left up to the patient and his or her provider. Adherence results from the practice trials are shared with the patient’s provider to assist in making this decision. Similarly, adherence data once the patient is on ART, but none of the survey data, will also be shared with the provider.