Adherence interventions should address nonadherence and a set of co-occurring problems that undermine adherence and engagement in care. Addressing adherence directly and indirectly by reducing co-occurring problems and improving self-management skills could increase the potency of interventions. We will test an innovative 8-week patient-centered self-management intervention that will improve adherence among non- urban PLWH who experience high rates of stigma, low social support, substance use, and depression. In this 2-year R34 project, we will build a prototype eHealth Internet intervention program, evaluate it with patients and clinicians, refine it, and test it for feasibilty and promise to determine if a subsequent RCT is warranted. In Phase 1, we will build the prototype, eHealth Positive, on a successful Internet intervention platform, using principles of responsive design, to enable delivery to patient devices. Programming of the infrastructure and content development will proceed simultaneously. The prototype includes online assessments with diaries to track medication taking. It features 8 Cores that deliver 20-30 minute evidence-based interventions weekly. Logins are prompted by automated emails. Cores will target knowledge and encourage usage of strategies for nonadherence, depression, smoking, drug use, drinking, stigma, and low social support/fears of disclosure. Cores will build self-management skills with interactions that engage the user, tailor feedback, and motivate them to identify problems, practice skills, and use strategies. Each Core will also feature video vignettes depicting non-urban HIV+ peers managing the targeted issue, and demonstrating active coping. Video vignettes will be created using visual participatory research methods guided by a CAB, ensuring materials are patient-centered. Phase 2 is a small evaluation study testing the usability and acceptability of the eHealth Positive prototype among 10 patients and 10 clinicians, followed by improvements to the prototype. In Phase 3, we will conduct a single arm pilot and feasibility trial with 50 PLWH recruited from 2 rural- serving clinics. The trial will provide dataon acceptability, feasibility, and effects on knowledge and usage of coping strategies for adherence and each target problem. Feasibility will be measured by recruitment, refusal vs. consent, and retention, along with usage data that are gathered unobtrusively by the backend of the web program, such as exposure to intervention components (i.e., logins, Cores completed, components repeated, time spent on interactions, etc.) Effects will be measured from online pre-and post-Core knowledge tests and reports of usage of coping strategies for adherence and other behavioral targets. We will evaluate the performance of candidate objective outcome markers of adherence and engagement in care, such as pharmacy refill rate and missed visit proportion, along with questionnaire data on illicit drug use and problem drinking, for a subsequent RCT to determine the required sample size. If the eHealth intervention meets benchmarks for feasibility and promise, it will be recommended for an RCT.
This project will develop a new web program that is personalized and interactive to help non-urban PLWH manage adherence and common life problems that reduce adherence including substance use, stigma, low social support, and depression. The study will show whether the eHealth intervention is feasible, acceptable, and improves knowledge and use of coping strategies. This study will prepare us for a future randomized clinical trial if the data show that the eHealth intervention is feasible, acceptable, and promising.
| Modipane, Mahlatse B; Waldman, Ava Lena; Ritterband, Lee et al. (2016) Technology Use Among Patients in a Nonurban Southern U.S. HIV Clinic in 2015. Telemed J E Health 22:965-968 |
