Representations and Acceptability of HIV Therapeutic Vaccine in a Cohort of HIV-1 Infected Outpatients Followed at Hospital (RAVVIH)
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|ClinicalTrials.gov Identifier: NCT02077101|
Recruitment Status : Completed
First Posted : March 4, 2014
Last Update Posted : January 19, 2015
The main objective of the study is to assess the acceptability of a future therapeutic vaccine against HIV in patients living with HIV-1.
Secondary objectives concern the validation of a specific questionnaire for self-perception and acceptability of therapeutic vaccination against HIV-1 (RAVVIH), the development of a composite score for acceptability based on this questionnaire, and the analysis of critical factors related to: representations of vaccination in general, representations of therapeutic vaccination specific to HIV, perception of disease severity, health-related quality of life, doctor-patient relationship.
|Condition or disease||Intervention/treatment||Phase|
|HIV||Other: Questionnaire Other: Interview||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Representations and Acceptability of HIV Therapeutic Vaccine in a Cohort of HIV-1 Infected Outpatients Followed at Hospital : Multicentric Interventional Study Qualitative and Quantitative|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Quantitative study group
Patients complete questionnaires validated and published in the literature: Brief IPQ R and HIV PROQOL [28, 29]. The questionnaire RAVVIH therapeutic vaccine has been designed from the literature review and advice of the Scientific Council in particular Dr. Pierre Verger social scientist vaccination and experts on the perception of patients. It was tested on a sample of 15 PWLHA
Qualitative study group
An interview guide was developed from the literature and expert community. Data will be collected through qualitative interviews with a psychologist trained to conduct interviews. Volunteers will be recruited according to the different categories of people representative of the HIV population in France.
These interviews will be conducted at the Foch Hospital. The physician investigator propose participation in the investigation and agree on a day appointment with the psychologist. Consent will be collected at that time after reading the prospectus . All interviews will be recorded orally with the agreement of the participants , and transcribed in full . They will be completely anonymous .
The average length of the interviews will be 45-60 minutes. Textual data from these interviews will be analysis.
- VAS scale of acceptability [ Time Frame: For a given participant, study procedure is about 60 minutes. Total period of the study is 12 months. ]
A graduated visual analogue scale (VAS) from 0 (Whatever my situation, I never accept the use of a therapeutic vaccine) to 10 (I totally agree, and I see no problem use a therapeutic vaccine soon there will be one available).
The VAS scale of acceptability is a classic visual analogue scale horizontal scale length 10 cm, graduated from 0 to 10, on which the patient turns his level of agreement with the proposal by a checkmark. The score can then be converted to a 100-point scale to facilitate interpretation of scores.
Which to associate an overall acceptability score compiled from questionnaires.
- score of quality of life [ Time Frame: For a given participant, study procedure is about 60 minutes. Total period of the study is 12 months. ]with the PROQOL-HIV questionnaire
- confidence score of the patient-physician relationship [ Time Frame: For a given participant, study procedure is about 60 minutes. Total period of the study is 12 months. ]with the RAVVIH questionnaire
- perception score of the severity of the disease [ Time Frame: For a given participant, study procedure is about 60 minutes. Total period of the study is 12 months. ]with the Brief IPQ-R questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077101
|Centre Hospitalo-Universitaire Louis Mourier|
|Colombes, Hauts de Seine, France, 92700|
|Suresnes, Hauts de Seine, France, 92150|
|Centre Hospitalier Regional d'Orléans|
|Orleans, France, 45000|
|Principal Investigator:||David Zucman, MD||HOPITAL FOCH Service de Medecine Interne|