Individuals motivated to participate in adherence, care and treatment (imPACT): development of a multi-component intervention to help HIV-infected recently incarcerated individuals link and adhere to HIV care

Our research team developed Project imPACT (individuals motivated to Participate in Adherence, Care and Treatment), a multi-component approach for HIV-Infected recently incarcerated individuals that specifically targets their care linkage, retention, and medication adherence by addressing multiple barriers to care engagement. The ultimate goals of this intervention are to improve the health of HIV-infected individuals recently released from prison and reduce HIV transmission to their communities by maintaining viral suppression. This paper describes the intervention and technology development processes, based on best practices for intervention development and process evaluation [29]. As shown in Fig. 1, this process included: 1) identifying the target population; 2) clarifying the theoretical basis for intervention design; 3) describing features of its foundational interventions; 4) conducting formative qualitative research; 5) integrating and adapting foundational interventions to create and refine intervention content based on target audience feedback. These stages are described in more detail below along with the final intervention product.

We designed the intervention for HIV-infected men and women who were English-speaking, age 18 years and older, incarcerated within the Texas or North Carolina state prison systems [Texas Department of Criminal Justice (TDCJ) or the North Carolina Department of Public Safety (NCDPS)], treated with ART with a recorded plasma HIV RNA level of < 400 copies/mL and expected to be released to the community within approximately 12 weeks. We elected to focus on individuals in these two states because these were settings with a strong research focus and a relatively large number of HIV-infected individuals who faced documented challenges to care engagement after release. Additionally, combined, the two states incarcerate approximately 1 in 7 of all individuals incarcerated in a U.S. state prison system in the US [30]. In each of these settings, it is standard practice for prison staff to conduct routine discharge planning before release, which is limited to the provision of referrals to community clinics, housing, and other services based on availability and need.

Given that incarcerated individuals have higher rates of HIV infection than the general population and that they face unique challenges during community reentry, we chose to design an intervention that targeted HIV-infected individuals in the two months before and three months after release from incarceration. Individuals with a suppressed viral load at the time of prison release comprised the target population for the imPACT intervention. The imPACT intervention also targets the high risk reentry period, as the target population had demonstrated an ability to adhere sufficiently to ART and care during incarceration. A lack of control of HIV, despite the structured prison environment, suggested the presence of biological or behavioral factors that would be best addressed by different interventions.

Because of the complexity of the intervention and the extensive resources that would be needed to administer each component in multiple languages, we limited this initial evaluation to English-speaking individuals with plans to adapt it for monolingual Spanish-speakers if it found to be effective. We designed imPACT for both men and women, and given that the HIV and incarceration epidemics also disproportionately affect racial and ethnic minorities [9], the research team felt that creating a intervention that could appeal to demographically diverse group of men and women, rather than targeting a particular ethnic, racial, gender or sexual orientation group, would be important for future uptake of the intervention among the populations most in need.

Adapting from our previous work designing motivational interviewing-based medication adherence interventions [30‐36], we used a socio-ecological framework to ground the imPACT intervention in two leading health behavior theories: The Social Cognitive Theory [37] and the Information-Motivation-Behavioral (IMB) Skills model [38]. Social Cognitive Theory (SCT) posits that whether an individual successfully carries out and maintains a learned behavior is determined by the reciprocal interactions among the individual’s beliefs about his/her self-efficacy to perform the behavior, experienced responses to the behavior which generate outcome expectancies, and environmental factors that influence one’s ability to carry out the behavior [37]. The role of self-efficacy is a core tenet of SCT, such that individuals with high self-efficacy are more likely to adopt observed behaviors. Enhancing self-efficacy can increase a behavior, and mastery experiences, social modeling, and verbal encouragement can enhance self-efficacy. Hence, from SCT, a key approach to enhancing behaviors like attending clinic visits or adhering to medication is to incorporate activities that use mastery, modeling, and encouragement to enhance self-efficacy. The SCT also emphasizes the importance of reciprocal interactions of the individual with aspects of his/her environment, such as institutional or community-level barriers that HIV-infected individuals face. The IMB model asserts direct pathways between HIV-related information, motivation, and necessary behavioral skills, including medication-taking proficiency [39], as predictors of engagement and adherence. Knowledge about the medical condition including regarding available effective strategies for its management, is considered necessary but insufficient to improve behavior alone [38, 40, 41]. Motivation includes personal attitudes towards medication adherence, perceived social support for the behavior, and perceptions of how others believe people with the condition should behave. Motivation and knowledge together directly affect adherence, but also in the IMB, they act on behavior primarily through enhancing behavioral skills, particularly when the behavior is complex and involves new skills, such as with medication adherence. Information and motivation provide building blocks for the client to gain the specific behavioral tools and strategies needed to adhere. These are comprised of tactics like enlisting social support, responding to side effects, using medication reminders or other self-regulation strategies [41]. Interventions that have used the IMB model have been show to effectively improve many health-related behaviors, including antiretroviral adherence [41‐43]. In the Deep South in particular, the IMB model has been shown to characterize relationships among determinants of ART adherence [44]. Being informed, socially supported, and perceiving fewer negative consequences of adherence were independently related to stronger behavioral skills for taking ART, which in turn was associated with adherence [44]. Both the SCT and IMB have demonstrated predictive validity in explaining medication and medical visit adherence [45].

Given the extensive literature demonstrating that numerous barriers to antiretroviral adherence and HIV care access occur at multiple levels of a socioecological framework, the research team integrated the IMB, SCT, and existing empirical evidence into a theoretically and empirically-grounded conceptual framework (Fig. 2) for designing the imPACT intervention (described below). The conceptual model targets both the client’s motivation and self-efficacy to adhere by providing opportunities to gain knowledge (both via interactions with a counselor and from models who are representative of the target population), clarify values, modify beliefs and attitudes, identify and address institutional and community level barriers and facilitators, and master behavioral skills, including use of medication reminders.

In addition to these health behavior theories, our intervention was informed by concepts in cognitive psychology demonstrating that graphical displays and visual representations are generally more effective in communicating complex systems of interrelated feelings, thoughts and actions, are more readily remembered, and better facilitate a shared understanding between two individuals, than language [46, 47]. Some studies have shown visual representations to be particularly useful among individuals with limited education or cognitive capacities, including among individuals involved with the criminal justice system [48].

The imPACT intervention combines elements from three existing theory-based interventions our group had previously developed and tested. We elected to use a multi-component intervention based on extensive evidence of the multi-level challenges faced by formerly incarcerated individuals as well as studies demonstrating that comprehensive, multi-component medication adherence interventions are more effective than single-focus interventions [45, 49]. Given the complexity of barriers occurring at multiple levels (individual, institutional, community) of a social ecological framework for individuals released from prison both accessing medical care and adhering to ART (Fig. 2), a comprehensive approach was considered particularly imperative for the imPACT intervention. We adapted previously-developed motivational interviewing counseling interventions, integrated them with TCU cognitive mapping elements, and designed accompanying videos and electronic medication reminders primarily to influence individual-level behavior to support ART adherence and engagement and participation in care, respectively. These components acted mainly by enhancing motivation and self-efficacy to engage in these behaviors (Fig. 2), including seeking out and utilizing needed and available institutional and community resources (e.g., filling prescriptions, attending mental health or substance abuse treatment). To address institutional and community-level obstacles to accessing ART and care, we designed the imPACT intervention to integrate the fundamental components of an effective Link Coordinator program called Project CONNECT (described below). Below we describe each of the foundational interventions that we adapted and integrated to create the final imPACT intervention.

During our initial formative work, we first conducted in-depth, semi-structured interviews and focus groups in Texas and North Carolina among HIV-infected formerly incarcerated patients, and community-based HIV service providers whose clients included formerly incarcerated men and women (full details reported previously, [56, 57]). Data showed that justice-involved individuals often had a reduced sense of agency over their own lives and health after incarceration, and the importance of the system facilitating initial linkage to care after release also declined. Findings highlighted the importance of getting individuals into a medical home soon after release to address a key individual-level barrier to adherence to medication and appointments: substance abuse. Numerous community and policy level barriers that would need to be addressed included lack of housing, employment, transportation, and enrollment in safety net programs. At the same time, interpersonal and community social support were identified as key facilitators that could be built upon in an intervention at the community and institutional levels. In addition, the assemblage of barriers generated a set of competing demands and disorder in participants’ lives that made it challenging for them to attend to their health care needs consistently [57].

Health care providers (case managers, mental health care professionals, nurses, nurse practitioners, and physicians) of formerly incarcerated individuals identified similar individual, community, and organization/institutional-level obstacles to HIV care and treatment adherence and offered additional insight into the ways that these multilevel factors affect formerly incarcerated HIV-infected individuals’ abilities to engage in care and access necessary social services.

Additional barriers that providers identified included the inability of individuals who had been locked up previously to do things for themselves after not doing so during confinement, a lack of familiarity with new technology, competing demands of required reintegration activities. HIV-related stigma was discussed as causing clients to have difficulty accessing transportation to and from medical care because they feared doing so would disclose their HIV status. Providers highlighted the negative effects on health care access of poor coordination between prison and community care systems (including lack of appointment scheduling before release), as well as negative environments/social networks and lack of essential services and community resources needed to address housing, transportation or behavioral health problems, such as substance abuse.

Taken together our formative studies indicated that it is essential that the imPACT intervention have an impact multiple levels to successfully engage formerly incarcerated individuals in HIV care after release. Our research team identified several specific targets that were important for the imPACT intervention to address. ART adherence challenges stemming from the chaotic nature of releasees’ lives and competing priorities confirmed the likely benefit of MI for medication-adherence skills-building and an automated medication reminder system. The need to enhance individuals’ self-efficacy and motivation to stay health confirmed the importance of including pre- and post-release MI sessions. The lack of care coordination between prison and community settings indicated the need for assisting with linkage to care immediately after release. The multiple unmet basic needs of released inmates suggested the need for a mechanism to better assess and refer these needs to appropriate community resources. The wide variability of barriers for each releasee indicated a need for individualized assessment and tailoring of strategies to achieve health goals, like that found in MI. The small supply of ART given upon release and reports of limited support from prisons for completing drug assistance and insurance paperwork prior to release, indicated the need for routine assistance completing AIDS Drug Assistance Program (ADAP) applications before release. We also developed the Link Coordination component to some extent by meeting with community clinics throughout the state to orient them to the intervention and the Link Coordinator. This socialization of the project was helpful. Clinics were those that were identified by the prison as being commonly mentioned by inmates as sources of care, and were receptive to being at receiving end of the referrals. Reports of formerly incarcerated individuals’ inconsistent experience with technology pointed to the need to provide training in the use of any technology required for participation in the intervention. And, finally, releasee experiences with stigma and discrimination that impacted their ability to engage in care, emphasized the importance of providing compassionate, non-judgmental, non-stigmatizing support through this intervention.

During the intervention development process, we conducted one additional focus group among seven HIV-infected former inmates to obtain their input regarding specific aspects of the intervention in development. Focus group members endorsed the idea that receiving support from others to facilitate the transition back to the community would greatly enhance releasees’ abilities to avoid lapses in medical care. In particular, they strongly recommended that the intervention schedule the first post-release clinic appointment for the patient. As one participant put it, “But it would have been better if they had actually made the appointment for me from prison … it would have been better than me having to get a referral that’s sent to the halfway house and allowed them to make the appointment. If the appointment had already been set up [when] I got out, then I wouldn’t have had, run out of medicine and I wouldn’t have had to wait.” Participants supported the use of videos and emphasized that the videos should indicate the need for former inmates to take ownership of their health. Participants also recommended that the intervention start before release to motivate prisoners to plan for their post-incarceration care and living situation. Participants endorsed the potential utility of cell phone reminders but stressed the need for significant training in using the technology, particularly for those incarcerated for longer stays who would be less familiar with this technology.

To adapt the audio-booklet materials from the foundational interventions for use with prisoners, we created videos which our formative studies indicated would be more appealing and comprehensible for this population. In total, two videos were created that used the same approaches--conversations with realistic patient and counselor characters, demonstration of empathy and modeling mastery over behavior change, testimonials and individual stories--to achieve similar goals, namely introducing the intervention and enhancing participant self-efficacy and motivation to access and adhere to community-based HIV care. We worked collaboratively with The Studio, Inc. to complete the technical design, filming, editing, and final production of the videos. The Studio, Inc. is a Chapel Hill, NC production company that applies state-of-the-art techniques to the development of educational videos, including interventions aimed at health promotion and disease prevention. The Studio, Inc. team included a script writer, graphic designer, music producer, videographer, director and several actors. In collaboration with The Studio, Inc., our research group spent approximately 12 months in an iterative process developing the content, creating realistic characters, finalizing the script, filming, incorporating music and editing to produce a final product that achieved the goals of this intervention component and won a 2012 Telly Award for Best Educational Video, the premier award honoring the finest video productions. As described below, the videos were shown to individual inmates at two successive intervention visits before release.

To update the reminder skills taught in the PACT intervention (prior to the rise in popularity of text messaging) to help clients overcome forgetfulness, we incorporated into imPACT a text message reminder system. This approach was consistent with the formative data we obtained, where releasees indicated they were unaccustomed to managing their own care after having spent months or years in a prison system with set schedules, and that scheduled reminders would, thus, be beneficial during the transition period. Moreover, at the time we developed imPACT we had planned to give flip-phone to trial participants to facilitate study retention and data were beginning to emerge demonstrating that text reminders could be effective for enhancing ART adherence, particularly when partnered with other intervention components [58]. We worked with computer programmers at the Cecil G. Sheps Center for Health Services Research to develop an automated, individually tailorable SMS system to deliver medication reminders. During the development process, we faced decisions regarding the type and frequency of reminders and the degree of interactivity of the SMS program. Considerations included: how often to send the messages (e.g., link them to each dose, once daily or weekly?); whether the messages should just be reminders or also be inspirational; whether to use standard or self-authored messages; how many follow-up texts per dose should be sent and at what intervals; how long after release should the texts be continued; and whether to require clients to respond to messages, and if so, using words or numbers. Because input from our formative work indicating that prisoners, particularly those who had been incarcerated for long time periods or with low literacy, would face significant challenges to using complex technology, and might find intermittent reminders confusing, we elected to send dose-based reminders that required minimal reading, writing, or interaction (Fig. 5). Because there was little evidence at the time regarding the relative advantages of standardized versus self-authored, or reminder-based versus inspirational messaging, and because our formative work indicated significant concerns regarding HIV-associated stigma and unintended serostatus disclosure, we designed the intervention to offer participants a menu of standard reminding, inspirational messages, or an option to design their own. Once the SMS system was programmed, our team conducted beta-test of the programing and made minor programming adjustments to address logical errors that came to light during testing. The final intervention is described below.

Integrating our previously developed interventions with each other and findings from our formative work, we designed the final imPACT intervention to have four main components: 1) motivational interviewing counseling augmented by cognitive mapping; 2) two relatively short videos, one to immediately precede each face-to-face in-prison MI session; 3) Link Coordination with needs assessment; and 4) medication adherence SMS reminders. Figure 3 illustrates the temporal relationship among the four components relative to each other and to the time of prison release. Below we describe each component of the final intervention.