Representations and Acceptability of HIV Therapeutic Vaccine in a Cohort of HIV-1 Infected Outpatients Followed at Hospital (RAVVIH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Hopital Foch
Sponsor:
Collaborators:
Saint-Louis Hospital, Paris, France
INSERM UMR912-SE4S, Marseille, France
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT02077101
First received: February 21, 2014
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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 Intervention
HIV
Other: Questionnaire
Other: Interview

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • VAS scale of acceptability [ Time Frame: For a given participant, study procedure is about 60 minutes. Total period of the study is 12 months. ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    with the Brief IPQ-R questionnaire


Estimated Enrollment: 220
Study Start Date: December 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: Questionnaire
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.

Other: Interview

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infected with HIV-1
  • older than 18 and younger than 75 years
  • speaking , reading french
  • with medical coverage (SS, CMU, AME)

Exclusion Criteria:

  • protected adults (adults under guardianship, trusteeship)
  • infected with HIV-2
  • pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02077101

Contacts
Contact: David Zucman, MD d.zucman@hopital-foch.org
Contact: Svetlane Dimi, MD s.akpe@hopital-foch.org

Locations
France
Centre Hospitalo-Universitaire Louis Mourier Recruiting
Colombes, Hauts de Seine, France, 92700
Contact: Emmanuel Mortier, MD    +33147606184    emmanuel.mortier@lmr.aphp.fr   
Principal Investigator: Emmanuel Mortier, MD         
Sub-Investigator: Martine Bloch, MD         
Sub-Investigator: Isabelle Cahitte, MD         
Sub-Investigator: Erk Lafon, MD         
Sub-Investigator: Veronique Manceron, MD         
Sub-Investigator: Françoise Meier, MD         
Sub-Investigator: Anne Marie Simonpoli, MD         
Hopital Foch Recruiting
Suresnes, Hauts de Seine, France, 92150
Contact: David Zucman, MD    +331 46 25 20 93    d.zucman@hopital-foch.org   
Principal Investigator: David Zucman, MD         
Sub-Investigator: Catherine Majerholc, MD         
Sub-Investigator: Erwann Fourn, MD         
Centre Hospitalier Regional d'Orléans Recruiting
Orleans, France, 45000
Contact: Thierry Prazuck, MD    +33238229593    thierry.prazuck@chr-orleans.fr   
Principal Investigator: Thierry Prazuck, MD         
Sub-Investigator: Laurent Hocqueloux, MD         
Sub-Investigator: Jennifer Buret, MD         
Sub-Investigator: Catherine Mille, MD         
Sub-Investigator: Mohamadou Niang, MD         
Sponsors and Collaborators
Hopital Foch
Saint-Louis Hospital, Paris, France
INSERM UMR912-SE4S, Marseille, France
  More Information

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02077101     History of Changes
Other Study ID Numbers: 2013/35
Study First Received: February 21, 2014
Last Updated: February 28, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Hopital Foch:
HIV
Therapeutic vaccine
acceptability
representations

ClinicalTrials.gov processed this record on July 22, 2014