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BackgroundLongitudinal follow-up of older persons living with HIV is essential for the ascertainment of aging-related clinical and behavioral outcomes, and self-administered questionnaires are necessary for collecting behavioral information in research involving persons living with HIV. Web-based self-reported data collection results in higher data quality than paper-and-pencil questionnaires in a wide range of populations. The option of remote web-based surveys may also increase retention in long-term research studies. However, the acceptability and feasibility of web-based data collection in clinical research involving older persons living with HIV have never been studied. ObjectiveThis study aims to assess the acceptability and feasibility of a web-based survey to collect information on sexual, substance use, and physical activity behaviors; compare the data quality of the web-based survey with that of a paper-and-pencil questionnaire; and summarize web-based survey metrics. MethodsThis pilot study took place within the AIDS Clinical Trials Group A5322 study, a longitudinal cohort of men and women living with HIV (aged ≥40 years), followed at 32 clinical sites in the United States and Puerto Rico. A total of 4 sites participated in this study. A web-based survey was created using self-administered questionnaires typically completed in A5322 via paper and pencil. Pilot study participants completed these questionnaires via web-based survey at one research visit in lieu of paper-and-pencil administration. Two questions were added to assess feasibility, defined as participants’ perception of the ease of web-based survey completion (very hard, hard, easy, very easy), and their preferred format (computer or tablet, paper and pencil, no preference) for completing the questions in the future (acceptability). Feasibility and acceptability were summarized overall and by demographic and clinical characteristics; the proportion of evaluable data by web-based survey versus previously administered paper-and-pencil questionnaires (data quality) was compared for each question. ResultsAcceptability and feasibility were high overall: 50.0% (79/158) preferred computer or tablet, 38.0% (60/158) reported no preference, and 12.0% (19/158) preferred paper and pencil; 93.0% (147/158) reported survey completion easy or very easy. Older age was associated with lower odds of preferring computer or tablet to paper and pencil (odds ratio per 1-year increase in age: 0.91, 95% CI 0.85-0.98). Individuals who found the survey hard or very hard had a lower median neurocognitive test score than those who found it easy or very easy. Data quality with web-based survey administration was similar to or higher than that with paper-and-pencil administration for most questions. ConclusionsWeb-based survey administration was acceptable and feasible in this cohort of older adults living with HIV, and data quality was high. Web-based surveys can be a useful tool for valid data collection and can potentially improve retention in long-term follow-up studies.

Purpose: This real-world study investigated the impact of patient-reported disease burden and health-related quality of life (HRQoL) on switching from systemic nonbiologic to biologic therapy in patients with plaque psoriasis. Patients and Methods: Biologic therapy–naive (biologic-naive) patients aged ≥ 18 years who were using systemic nonbiologic treatment and who enrolled in the CorEvitas Psoriasis Registry between April 2015 and August 2022 were included. Measures of patient-reported disease burden and HRQoL were collected at Registry enrollment. The primary outcome of interest was initiation of biologic therapy within 45 days of enrollment. Multivariable logistic regression models were fitted separately for each patient-reported measure, adjusting for patient, disease, and treatment characteristics, including physician-rated disease severity. Adjusted odds ratios of switching to biologic therapy were estimated for greater versus lesser burden for each measure. Results: Of 848 included patients, 323 (38.1%) switched to biologic treatment. Greater patient-reported burden was independently associated with switching, with significantly higher adjusted odds ratios (95% confidence interval) for greater versus lesser burden as measured by the Dermatology Life Quality Index (1.55 [1.08– 2.23], P=0.017), visual analog scale (VAS) for itch (2.14 [1.49– 3.08], P< 0.001), VAS for skin pain (2.18 [1.45– 3.29], P< 0.001), VAS for fatigue (1.66 [1.15– 2.40], P=0.007), Patient Global Assessment-VAS (3.09 [1.94– 4.91], P< 0.001), and with activities impairment on the Work Productivity and Activity Impairment questionnaire (2.51 [1.72– 3.65], P< 0.001). Conclusion: In addition to clinically assessed disease severity, patient-reported disease burden and quality of life may drive the switch to biologic treatment in real-world patients with plaque psoriasis. [ABSTRACT FROM AUTHOR]

AIDS Clinical Trials Group study A5308 found reduced T-cell activation and exhaustion in human immunodeficiency virus (HIV) controllers start antiretroviral therapy (ART). We further assessed HIV-specific T-cell responses and post-ART viral loads. Before ART, the 31% of participants with persistently undetectable viremia had more robust HIV-specific T-cell responses. During ART, significant decreases were observed in a broad range of T-cell responses. Eight controllers in A5308 and the Study of the Consequences of the Protease Inhibitor Era (SCOPE) cohort showed no viremia above the level of quantification in the first 12 weeks after ART discontinuation. ART significantly reduced HIV-specific T-cell responses in HIV controllers but did not adversely affect controller status after ART discontinuation. [ABSTRACT FROM AUTHOR]

Background Despite low plasma human immunodeficiency virus (HIV) RNA, HIV controllers have evidence of viral replication and elevated inflammation. We assessed the effect of antiretroviral therapy (ART) on HIV suppression, immune activation, and quality of life (QoL). Methods A5308 was a prospective, open-label study of rilpivirine/emtricitabine/tenofovir disoproxil fumarate in ART-naive HIV controllers (N = 35), defined as having HIV RNA <500 copies/mL for ≥12 months. The primary outcome measured change in %CD38+HLA-DR+ CD8+ T cells. Residual plasma viremia was measured using the integrase single-copy assay. QoL was measured using the EQ-5D questionnaire. Outcomes were evaluated using repeated measures general estimating equations models. Results Before ART, HIV controllers with undetectable residual viremia <0.6 HIV-1 RNA copies/mL had higher CD4+ counts and lower levels of T-cell activation than those with detectable residual viremia. ART use was effective in further increasing the proportion of individuals with undetectable residual viremia (pre-ART vs after 24–48 weeks of ART: 19% vs 94%, P <.001). Significant declines were observed in the %CD38+HLA-DR+CD8+ T cells at 24–48 (−4.0%, P =.001) and 72–96 (−7.2%, P <.001) weeks after ART initiation. ART use resulted in decreases of several cellular markers of immune exhaustion and in a modest but significant improvement in self-reported QoL. There were no significant changes in CD4+ counts or HIV DNA. Conclusions ART in HIV controllers reduces T-cell activation and improves markers of immune exhaustion. These results support the possible clinical benefits of ART in this population. [ABSTRACT FROM AUTHOR]

Purpose: This real-world study investigated the impact of patient-reported disease burden and health-related quality of life (HRQoL) on switching from systemic nonbiologic to biologic therapy in patients with plaque psoriasis., Patients and Methods: Biologic therapy-naive (biologic-naive) patients aged ≥18 years who were using systemic nonbiologic treatment and who enrolled in the CorEvitas Psoriasis Registry between April 2015 and August 2022 were included. Measures of patient-reported disease burden and HRQoL were collected at Registry enrollment. The primary outcome of interest was initiation of biologic therapy within 45 days of enrollment. Multivariable logistic regression models were fitted separately for each patient-reported measure, adjusting for patient, disease, and treatment characteristics, including physician-rated disease severity. Adjusted odds ratios of switching to biologic therapy were estimated for greater versus lesser burden for each measure., Results: Of 848 included patients, 323 (38.1%) switched to biologic treatment. Greater patient-reported burden was independently associated with switching, with significantly higher adjusted odds ratios (95% confidence interval) for greater versus lesser burden as measured by the Dermatology Life Quality Index (1.55 [1.08-2.23], P =0.017), visual analog scale (VAS) for itch (2.14 [1.49-3.08], P <0.001), VAS for skin pain (2.18 [1.45-3.29], P <0.001), VAS for fatigue (1.66 [1.15-2.40], P =0.007), Patient Global Assessment-VAS (3.09 [1.94-4.91], P <0.001), and with activities impairment on the Work Productivity and Activity Impairment questionnaire (2.51 [1.72-3.65], P <0.001)., Conclusion: In addition to clinically assessed disease severity, patient-reported disease burden and quality of life may drive the switch to biologic treatment in real-world patients with plaque psoriasis., Competing Interests: Ms Park, Dr Zhong, and Dr Becker are employees of and may own stock options in Bristol Myers Squibb. Dr Sima is an employee of CorEvitas, LLC (formerly Corrona). Ms Roberts-Toler was an employee of CorEvitas at the time of the study. Dr Patel and Dr Hovland were employees of Bristol Myers Squibb at the time of the study and may be shareholders in the company. Dr Hovland is currently affiliated with Chiesi USA, Inc., Boston, MA. Dr Strober has served as a consultant with honoraria for AbbVie, Acelyrin, Alamar, Almirall, Alumis, Amgen, Arcutis, Arena Pharmaceuticals, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Capital One, Celltrion, CorEvitas, Dermavant, Inmagene, Janssen/J&J Innovative Medicine, Kangpu Biopharmaceuticals, Leo Pharma, Lilly, Maruho, Meiji Seika Pharma, Monte Rosa Therapeutics, Novartis, Pfizer, Protagonist, RAPT Therapeutics, Regeneron, Sanofi, Sun Pharma, Takeda, TD Cowen, UCB, Union Therapeutics, Ventyx Biosciences, and vTv Therapeutics; as a speaker for AbbVie, Arcutis, Dermavant, Incyte, Janssen/J&J Innovative Medicine, Lilly, Regeneron, and Sanofi; as a co-scientific director (consulting fee) and investigator for the CorEvitas Psoriasis Registry; as editor-in-chief with an honorarium for the Journal of Psoriasis and Psoriatic Arthritis; he holds stock options in Connect Biopharma and Mindera Health. The authors report no other conflicts of interest in this work., (© 2024 Patel et al.)