HIVEVANCT04655560
Understanding Barriers and Facilitators to the Participation of Women Living With HIV in Clinical Trials : a Mixed-method Study (EVA)
An observational study of HIV, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Dec 2020to 8 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Cisgender women
- Adult (>18 years) HIV-infected
- Informed consent documented by signature
- Patients under stable antiretroviral therapy
- French speaking (sufficient fluency for a conversation)
Who cannot join
- Having participated in a previous qualitative study about Cure Trials acceptability among HIV patients
- Incapable of discernment
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- no intervention
- Keywords
- HIV, Clinical trials, Women, qualitative study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
qualitative study
| Study group | Role | What they receive |
|---|---|---|
| Women living with HIV | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Analysis of questionnaires allowing recommendations to be made
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start18 Dec 2020
- Primary completion8 Apr 2021
- Study completion8 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
- Responsible party
- Principal investigator, Calmy Alexandra, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655560
- Sponsor's protocol ID
- 2020-02286
- Acronym
- EVA
- Status last verified
- Sep 2021
- First submitted
- 13 Nov 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Barriers and Facilitators to the Participation of Women Living With HIV in Clinical Trials : a Mixed-method Study (EVA)
- ClinicalTrials.gov ID
- NCT04655560
- Acronym / sponsor ID
- EVA / 2020-02286
- Conditions
- HIV
- Keywords
- HIV, Clinical trials, Women, qualitative study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women living with HIV | – | Other: no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Cisgender women
- Adult (>18 years) HIV-infected
- Informed consent documented by signature
- Patients under stable antiretroviral therapy
- French speaking (sufficient fluency for a conversation)
Key exclusion criteria (2 listed)
- Having participated in a previous qualitative study about Cure Trials acceptability among HIV patients
- Incapable of discernment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionqualitative study | Other | Women living with HIV |
Primary outcome
Evaluation of barriers and facilitators to the participation of women in clinical trials (HIV) through a questionnaire
Time frame: 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
Time frame: 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.
1 secondary outcome
Offering solutions for a better inclusion of HIV-women in clinical trials - qualitative study
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of barriers and facilitators to the participation of women in clinical trials (HIV) through a questionnaire (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.