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

NCT04655560 | Completed

• 1 other identifier: 2020-02286
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; Clinical trials; Women; qualitative study

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Offering solutions for a better inclusion of HIV-women in clinical trials - qualitative study

  through study completion, an average of 1 year

Study Arms (1)

Women living with HIV

Other: no intervention

Interventions

no intervention OTHER

qualitative study

Women living with HIV

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women living with HIV Note: ethnicity will not represent a selection's criteria. However, special care will be payed to assure a certain heterogeneity in the sample concerning this aspect.

You may qualify if:

• Cisgender women
• Adult (\>18 years) HIV-infected
• Informed consent documented by signature
• Patients under stable antiretroviral therapy
• French speaking (sufficient fluency for a conversation)

You may not qualify if:

• Having participated in a previous qualitative study about Cure Trials acceptability among HIV patients
• Incapable of discernment

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Merck Sharp & Dohme LLC: collaborator
• Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland: collaborator

Study Sites (1)

Hôpitaux Universitaires de Genève

Geneva, 1205, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: December 7, 2020
• Study Start: December 18, 2020
• Primary Completion: April 8, 2021
• Study Completion: April 8, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)