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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women living with HIV<br> | Other: no intervention<br>* qualitative study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Clinical trials, Women, qualitative study