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

University Hospitals (UH)

Status: Completed

Conditions: HIV

Treatments: Other: no intervention

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04655560

2020-02286

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Women living with HIV

Treatment:

Other: no intervention