Psychometric Validation of the Perception of Injection (PIN) Questionnaire Using Data From Two Phase III, Open-Label, Active-Controlled, Non-Inferiority Studies in People Living With HIV
Year: 2023
Type: article
Abstract: INTRODUCTION: Currently, there are no patient-reported outcome tools specifically validated for use in people living with human immunodeficiency virus (PLHIV) to measure treatment injection acceptance and experience. The Perception of Injection (PIN) questionnaire was modified with consent from the Vaccinees' Perception of Injection (VAPI), a validated instrument developed by Sanofi Pasteur. The objective of developing the PIN was to provide information on participant experience with injectable therapies, including acceptance of pain, injection-site reactions, and tolerability following injections in PLHIV. METHODS: This post hoc analysis used data from participants who received the long-acting intramuscular cabotegravir plus rilpivirine combination treatment every 4 weeks, as part of the ATLAS (NCT02951052) and FLAIR (NCT02938520) studies, to evaluate the psychometric properties of the PIN questionnaire. RESULTS: These findings support the reliability, validity, and responsiveness to change for the PIN questionnaire in PLHIV. CONCLUSION: As a clinical trial endpoint, the PIN questionnaire could provide valuable evidence around the acceptance and experience of injections in PLHIV which could have implications for treatment adherence in this population. TRIAL REGISTRATION: ATLAS (NCT02951052); 1 November, 2016. FLAIR (NCT02938520); 19 October, 2016.
Source: Advances in Therapy
Authors: Vasiliki Chounta, Hilary F. Byrnes, Mickael Henry-Szatkowski, Dominy Browning, Christina Donatti, Jeremy Lambert
Institution: ViiV Healthcare (United Kingdom)
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,390
Funder: ViiV Healthcare
OpenAlex ID: W4387219404