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

NCT ID: NCT04655560

Last Updated: 2021-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-18

Study Completion Date

2021-04-08

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.

Detailed Description

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Conditions

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HIV

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Women living with HIV

no intervention

Intervention Type OTHER

qualitative study

Interventions

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no intervention

qualitative study

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

OTHER

Sponsor Role collaborator

Responsible Party

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Calmy Alexandra

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2020-02286

Identifier Type: -

Identifier Source: org_study_id

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