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Completed

NCT Number: NCT04655560

Understanding Barriers and Facilitators to the Participation of Women Living With HIV in Clinical Trials : a Mixed-method Study (EVA)

To identify the most important barriers and facilitators to the participation of cisgender women living with HIV in clinical trials (perceived and real) and to establish possible mechanisms leading to refusal of trial participation. Specifically, psychosocial factors and/or cultural environments that enhance or undermine HIV-positive cisgender women's participation. These can include social inclusion, confidence in research, perceived personal vulnerability, cultural, familial and professional environment.

The investigators expect to propose pragmatic solutions to enhance participation of HIV-positive cisgender women in clinical trials.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hôpitaux Universitaires de Genève

Geneva, 1205, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cisgender women
  • Adult (>18 years) HIV-infected
  • Informed consent documented by signature
  • Patients under stable antiretroviral therapy
  • French speaking (sufficient fluency for a conversation)

Exclusion criteria

  • Having participated in a previous qualitative study about Cure Trials acceptability among HIV patients
  • Incapable of discernment

Treatment and study plan

No intervention

Other

qualitative study

Primary outcomes

  1. Evaluation of barriers and facilitators to the participation of women in clinical trials (HIV) through a questionnaire

    Time frame: through study completion, an average of 1 year

    Specific questions will be asked during a face-to-face interview to identify factors favoring or barriers to the participation of women in clinical trials.

  2. Evaluation of mechanisms leading to refusal of trial participation through a questionnaire

    Time frame: through study completion, an average of 1 year

    Specific questions will be asked during a face-to-face interview to understand mechanisms leading to refusal of trial participation.

    Specifically, psychosocial factors and/or cultural environments that enhance or undermine HIV-positive cisgender women's participation. These can include social inclusion, confidence in research, perceived personal vulnerability, cultural, familial and professional environment.

Secondary outcomes

  1. Offering solutions for a better inclusion of HIV-women in clinical trials - qualitative study

    Time frame: through study completion, an average of 1 year

    Analysis of questionnaires allowing recommendations to be made

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
  • Merck Sharp & Dohme LLC

Registry information

Acronym: EVA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 7, 2020
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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