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

Completed

• Conditions: HIV
• Interventions: Other: no intervention

• Registration Number: NCT04655560
• Lead Sponsor: University Hospital, Geneva

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-12-04
• Study First Posted: 2020-12-07
• Study Start: 2020-12-18
• Primary Completion: 2021-04-08
• Study Completion: 2021-04-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women living with HIV	no intervention	-

Primary Outcome Measures

Name	Time	Method
Evaluation of barriers and facilitators to the participation of women in clinical trials (HIV) through a questionnaire	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.
Evaluation of mechanisms leading to refusal of trial participation through a questionnaire	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 Outcome Measures

Name	Time	Method
Offering solutions for a better inclusion of HIV-women in clinical trials - qualitative study	through study completion, an average of 1 year	Analysis of questionnaires allowing recommendations to be made

Trial Locations

Locations (1)

Hôpitaux Universitaires de Genève; 🇨🇭 Geneva, Switzerland