HIV
Conditions
Keywords
HIV, Clinical trials, Women, qualitative study
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.
Interventions
OTHERno intervention
qualitative study
Sponsors
Merck Sharp & Dohme LLC
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
University Hospital, Geneva
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Switzerland
Outcome results
None listed