跳至主要内容
临床试验/NCT05306769
NCT05306769Unknown不适用

Leaving Nobody Out: a Mixed-Methods Study to Inform Implementation of Diverse and Representative Recruitment to HIV Clinical Studies at a Central London Clinic

Guy's and St Thomas' NHS Foundation Trust0 个研究点目标入组 3,520 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
3,520
主要终点
Is being female associated with a lower chance of participating in the research study in Harrison Wing, Guy's Hospital, London

研究概览

简要总结

Established recruitment methods will be used to recruit participants. The study will be non-blinded. Eligibility will be checked and consent taken by a delegated study clinician. Participants will attend a 30 minute virtual individual semi-structured interview. Additionally, all patients attending an appointment within Harrison Wing will be invited to complete an anonymous, self-administered survey on attitudes towards participation in HIV clinical studies.

详细描述

Study description and population to be studied:

Researchers will employ Implementation Science methodology to understand and act upon the determinants of representation in HIV clinical studies in order to improve the diversity of study recruitment at the central London clinic-embedded research unit such that it better represents the clinic population. The setting is the Harrison Wing service: a specialist outpatient service for over 3500 people living with HIV based at Guy's and St Thomas' NHS Foundation Trust. This study will evaluate the extent and characteristics of study underrepresentation in the context of our clinic; identify and engage key stakeholder communities including both patients and clinicians, and collaboratively design a strategy to facilitate uptake of diverse recruitment and diverse participation using participatory methods.

Rationale and potential benefits of this study:

The demographic characteristics of participants in HIV clinical studies do not match those of the wider population of people living with HIV (PLHIV), from clinic-level to global scales.

Women and ethnic minorities are chronically underrepresented. Those at the intersections including ethnic minority or socially excluded women have particularly low participation rates.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria for initial analysis to identify groups who are underrepresented:
  • HIV positive
  • ≥18 years old
  • Registered to receive care under Harrison Wing (and thus potential candidates for Harrison Wing clinical studies) at any point in the period between 01/01/2017 and 31/12/2019 inclusive. The period 01/01/2017 and 31/12/2019 has been selected because it is recent, occurred prior to the disruption caused by the Covid-19 pandemic and there exists complete data regarding HIV clinical study participation during this time.
  • Inclusion criteria for Groups 1 and 2 of the virtual semi-structured interview aspect of this study:
  • HIV positive
  • ≥18 years old
  • Currently registered to receive care under Harrison Wing (and thus potential candidates for Harrison Wing clinical studies)
  • Has ≥ 1 demographic identified to be underrepresented as specified in 'trial statistics'
  • Able and willing to provide written or witnessed informed consent to participate
  • HIV positive
  • ≥18 years old
  • Currently registered to receive care under Harrison Wing
  • Currently participating in any clinical study in which Harrison Wing is the/ a participating centre
  • Able and willing to provide written or witnessed informed consent to participate
  • Inclusion criteria for self-administered surveys:
  • HIV positive
  • ≥18 years old
  • Registered to receive care under Harrison Wing (and thus potential candidates for Harrison Wing clinical studies)

排除标准

  • 未提供

结局指标

主要结局

Is being female associated with a lower chance of participating in the research study in Harrison Wing, Guy's Hospital, London

时间窗: 12 months

The primary outcome measure for the initial data analysis will be whether being female is associated with lower chance of taking part in a study within Harrison Wing, during the three year period 1st January 2017 to 31st December 2019.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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