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

HIV Clinical Trial

— EVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04655560
• Other study ID #: 2020-02286
• Status: Completed
• Start date: December 18, 2020
• Est. completion date: April 8, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 8, 2021
• Est. primary completion date: April 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• no intervention
qualitative study

Locations

Country	Name	City	State
Switzerland	Hôpitaux Universitaires de Genève	Geneva

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Geneva	Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of barriers and facilitators to the participation of women in clinical trials (HIV) through a questionnaire	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.	through study completion, an average of 1 year
Primary	Evaluation of mechanisms leading to refusal of trial participation through a questionnaire	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.	through study completion, an average of 1 year
Secondary	Offering solutions for a better inclusion of HIV-women in clinical trials - qualitative study	Analysis of questionnaires allowing recommendations to be made	through study completion, an average of 1 year