Setting
Acne, telephone/video, acne, acne vulgaris
RECRUITMENT, ACNE VULGARIS, SECONDARY, ACNE, ACNE
This was a qualitative sub-study conducted alongside a UK primary and secondary care phase III, double-blind, placebo-controlled trial of Spironolactone for persistent (at least 6 months) facial acne vulgaris for women aged 18 and over (Spironolactone for Adult Female Acne (SAFA) trial, Fig. SAFA trial schemaThe SAFA trial recruited participants from 05 Jun 2019 to 31 Aug 2022, with an enforced pause to recruitment from 23 Mar 2020 to 11 Jun 2020 due to the COVID-19 pandemic. Participants were recruited through primary care (search and mail-out or opportunistic recruitment), secondary care (opportunistic recruitment) and community and social media advertising.The SAFA trial was designed as a pragmatic trial with minimal burden (e.g. in-person visits, number of spironolactone retrievals from pharmacy) for participants, and required three in-person visits (baseline, 6 weeks and 12 weeks) with postal questionnaires at 24 weeks and up to 52 weeks. Due to the COVID-19 pandemic, the trial further decentralised to reduce in-person contact, specifically: all visits except the baseline visit could be replaced with telephone calls or video calls, acne assessment photos could be taken and sent to staff by participants, and trial medication that originally required on-site collection by participants was delivered to their home where necessary. Baseline visits required blood and pregnancy tests, so these remained in-person visits at research sites. These changes were sustained beyond government-enforced lockdown for the duration of the trial.This qualitative sub-study aimed to explore participants’ experiences of taking part in the SAFA trial, in particular their experience of recruitment to the trial, the experience of appointments during the trial and/or telephone/video appointments and any difficulties participating in the trial to inform dermatology trial methodology targeted towards women aged 18 and over. Standards for reporting qualitative research (SRQR) guidelines have been followed (Supplementary file 