Feasibility of an Electronic Patient-Reported Outcome System in People Living With HIV: Retrospective Analysis of a Mobile App-Based Pilot Study

Introduction

Advances in HIV treatment have transformed it from incurable to a manageable disease, requiring continuous use of medication to suppress viral growth. However, as people living with HIV live longer, the risk of lifestyle diseases such as diabetes increases with age [Schouten J, Wit FW, Stolte IG, et al. Cross-sectional comparison of the prevalence of age-associated comorbidities and their risk factors between HIV-infected and uninfected individuals: the AGEhIV cohort study. Clin Infect Dis. Dec 15, 2014;59(12):1787-1797. [CrossRef] [Medline]1]. Additionally, previous studies have shown that stigma and discrimination remain prevalent, potentially leading to psychological issues [Chenneville T, Kosyluk K, Gabbidon K, Franke M, Serpas D, Galea JT. Positive, Open, Proud: an adapted disclosure-based intervention to reduce HIV stigma. Front Glob Womens Health. 2024;5:1469465. [CrossRef] [Medline]2]. This has increased the demand for patient-centered medicine beyond viral suppression.

Patient-reported outcome (PROs) are gaining attention as tools for patient-centered care. PROs are based on patients’ direct responses to questionnaires. Their validity has been evaluated in various studies, and PROs can assess symptoms, functioning, health status, and quality of life (QOL) [McKenna SP. Measuring patient-reported outcomes: moving beyond misplaced common sense to hard science. BMC Med. Jul 14, 2011;9:1-12. [CrossRef] [Medline]3]. PROs can be disease-specific or general, applicable across conditions. Clinicians can select appropriate PROs for care and research.

PROs are increasingly used for diseases affecting long-term QOL, including malignancies. Studies have revealed gaps between patients and providers in assessing treatment side-effects. Patient-centered evaluations are crucial for improving health-related QOL (HRQOL) in cancer care [Basch E, Iasonos A, McDonough T, et al. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol. Nov 2006;7(11):903-909. [CrossRef] [Medline]4]. In collagen diseases, PROs are used to evaluate symptoms like pain and improve care quality and HRQOL. Thus, PROs are valuable for enhancing care and supporting patient-centered medicine.

PROs have rarely been evaluated in infectious diseases, particularly acute infections, which often resolve with short-term treatment. We previously assessed PROs to measure QOL in patients with community-acquired influenza [Yoshino Y, Kitazawa T, Ota Y. Clinical efficacy of baloxavir marboxil in the treatment of seasonal influenza in adult patients: a prospective observational study. Int J Gen Med. 2020;13:735-741. [CrossRef] [Medline]5]. After antiviral treatment for influenza, mental QOL worsened during the course. Physical QOL was higher in vaccinated than in nonvaccinated patients [Yoshino Y, Wakabayashi Y, Kitazawa T. The clinical effect of seasonal flu vaccination on health-related quality of life. Int J Gen Med. 2021;14:2095-2099. [CrossRef] [Medline]6]. These findings suggest PROs may benefit HIV care, as HIV has become a chronic disease.

In Europe and the United States, PROs are used in HIV trials to evaluate efficacy and adverse effects. Experts report that PROs improve HRQOL in people living with HIV when applied in practice. Recently, an electronic patient-reported outcome (ePRO) system was developed for real-time health assessment via tablets or computers in clinics. The European AIDS Clinical Society 2023 guidelines recommend this ePRO system [Ambrosioni J, Levi L, Alagaratnam J, et al. Major revision version 12.0 of the European AIDS Clinical Society guidelines 2023. HIV Med. Nov 2023;24(11):1126-1136. [CrossRef] [Medline]7]. In 2022, we collaborated with Integrity Healthcare Corporation and Gilead Sciences Inc. to develop a home-based mobile ePRO app. Here, we present a feasibility study of our prototype mobile ePRO app and its utility.

Methods

Study Design and Setting

The responses of a postuse questionnaire and the impact of the ePROs on clinical practice were retrospectively evaluated among outpatients who visited the Teikyo University Hospital, Tokyo, Japan, between July and September 2022. Participants had agreed to use the ePRO app, particularly during their clinic visits. First, the participants were asked to install the newly developed mobile app on their phones. Informed consent to use the app was obtained from all participants. They responded to the PRO through the app during the week preceding their clinic visit. During the visit, the clinician reviewed the PRO results and treated the participants. All people living with HIV visiting the clinic during the observation period were introduced to the app, and those who agreed to use it on the same day were included in the analysis.

After the clinic visit, the PROs answered via the app were evaluated through a survey of questions concerning the clarity of content, time required to answer, satisfaction with use, changes in quality of communication with the clinician, and desire to use PROs in the future. Satisfaction was assessed with the following question, rated on a 5-point scale (very satisfied, satisfied, neutral, somewhat dissatisfied, dissatisfied): “How was your experience with the consultation after answering the HIV-SI via the app and sharing the results with your doctor in advance?” In addition, medical records from the consultation when the PRO was used were reviewed to identify any new symptoms or findings that had not existed in the past two years, or if any additional medical procedures initiated. The ePRO results were also summarized.

The ePRO content was based on the HIV symptom index [Justice AC, Holmes W, Gifford AL, et al. Development and validation of a self-completed HIV symptom index. J Clin Epidemiol. Dec 2001;54 Suppl 1:S77-S90. [CrossRef] [Medline]8], comprising 20 items, including those on physical findings, psychological problems, sexual activity, and body image. Each item was rated on a five-point scale: (1) I did not have this symptom, (2) I was not bothered, (3) I was a little bothered, (4) I was indeed bothered, and (5) I was bothered a lot. Responses to the questions were available to the responsible physician immediately after the people living with HIV submitted them online.

The number of participants (n) and corresponding percentages (%) are reported in this paper.

Ethical Considerations

This study was conducted in accordance with the Declaration of Helsinki and approved by the Teikyo University Ethics Committee (approval number: 23‐009). Due to the retrospective nature of the study and the use of anonymized data, the requirement for written informed consent was waived. Instead, an opt-out method was used to inform patients about the study via the institution’s website, providing them with the opportunity to decline participation. All data were fully anonymized prior to analysis, and no identifying information was included. No financial compensation or other incentives were provided to participants.

Results

Twenty-seven patients used the mobile app in clinical practice. All patients were male, with a median age of 46 years. All were taking antiretroviral treatment, had maintained a CD4-positive lymphocyte count >200/μL for the past six months, and had a viral load <200 copies.

Twenty-five patients returned the postuse questionnaire. Nineteen of 25 (76%) respondents reported it took 5 minutes to complete; 5 (20%) reported 5-10 minutes, and one (4%) reported >15 minutes. Regarding satisfaction, 19 (76%) patients were very satisfied or satisfied, 5 (20%) were neutral, and one (4%) was somewhat dissatisfied. Nineteen (76%) patients found the questionnaire very or mostly useful for communication; 6 (24%) patients reported it to be neutral. Regarding future use, 19 (76%) patients wished to continue, 5 (20%) preferred use with improvements, and 1 did not.

Medical record review showed that 17/27 (63%) patients had additional information not recorded in the past two years. Of these, 7 (26%) reported mental health–related symptoms and 7 (26%) had skin problems. In 6 (22%) patients, PRO usage led to new treatments or actions not taken in the previous two years. Three patients were referred to dermatology, and 1 was newly diagnosed with chronic obstructive pulmonary disease following a complaint of respiratory symptoms.

Over 40% (n=11) patients reported symptoms including anxiety, sleep issues, rashes, dry or itchy skin, and appearance changes from weight or fat gain.

Discussion

This study demonstrated the feasibility and clinical utility of a newly developed ePRO smartphone app for people living with HIV. The system was well accepted, with most users completing the questionnaire in under 5 minutes and reporting high satisfaction. The ePRO facilitated improved communication between patients and clinicians and led to documentation of new clinical information in nearly two-thirds of participants. These findings support the hypothesis that an ePRO system tailored for people living with HIV can enhance patient-centered care and identify unrecognized issues.

The short completion time and favorable user responses suggest that the app’s design featuring fewer questions and a simplified interface, contributed to its high acceptability. This aligns with studies emphasizing minimal patient burden when implementing PROs in chronic disease care [McKenna SP. Measuring patient-reported outcomes: moving beyond misplaced common sense to hard science. BMC Med. Jul 14, 2011;9:1-12. [CrossRef] [Medline]3]. The enhanced documentation of mental and dermatological symptoms highlights how ePROs can uncover patient concerns that may be under-reported during standard consultations. These findings align with literature showing PROs improve HRQOL by better capturing subjective symptoms [Yoshino Y, Kimura Y. Clinical value of patient-reported outcomes for people living with HIV: mini-review. Re:GEN Open. Jan 1, 2024;4(1):34-38. [CrossRef]9].

Notably, mental health issues common among people living with HIV often go undiagnosed due to their subjective nature and limited psychiatric training among providers. Similarly, skin-related concerns such as rashes or appearance changes are frequently under-recognized in routine care. ePROs appear to bridge this gap by allowing patients to express symptoms that may not surface during clinician-led interviews. Compared to paper- or tablet-based PROs, smartphone apps offer greater accessibility and real-time symptom reporting from any location. As smartphone use increases globally, especially among younger generations, app-based ePROs hold promise for broader implementation in HIV care and beyond.

This study has limitations. First, the small sample from a single center may limit generalizability. Second, the retrospective design and lack of a control group prevent causal inference. Third, only the HIV symptom index was used; the utility of other PRO tools remains unexplored. While most participants expressed satisfaction, some suggested improvements, indicating room for optimization. Finally, the short observation period limits assessment of long-term utility and sustainability.

The findings of this study underscore the feasibility and clinical relevance of incorporating smartphone-based ePRO systems into HIV outpatient care. By enabling the identification of otherwise undocumented symptoms and improving communication between patients and providers, ePROs may contribute to more holistic and person-centered care models. These findings support the integration of digital health tools in HIV management and highlight the potential for ePROs to address unmet needs in clinical communication and symptom assessment. Future research should refine the app, broaden use, and evaluate long-term outcomes of routine ePRO implementation.