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

NCT02077101 | Completed

• 1 other identifier: 2013/35
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

HIV

Keywords

HIV; Therapeutic vaccine; acceptability; representations

Outcome Measures

Primary Outcomes (1)

• VAS scale of acceptability

  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.

  For a given participant, study procedure is about 60 minutes. Total period of the study is 12 months.

Secondary Outcomes (3)

• score of quality of life

  For a given participant, study procedure is about 60 minutes. Total period of the study is 12 months.

• confidence score of the patient-physician relationship

  For a given participant, study procedure is about 60 minutes. Total period of the study is 12 months.

• perception score of the severity of the disease

  For a given participant, study procedure is about 60 minutes. Total period of the study is 12 months.

Study Arms (2)

Quantitative study group

OTHER

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

OTHER

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

Interventions

Questionnaire OTHER

Quantitative study group

Interview OTHER

Qualitative study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• protected adults (adults under guardianship, trusteeship)
• infected with HIV-2
• pregnant women

Sponsors & Collaborators

• Hopital Foch: lead
• Saint-Louis Hospital, Paris, France: collaborator
• INSERM UMR912-SE4S, Marseille, France: collaborator

Study Sites (3)

Centre Hospitalo-Universitaire Louis Mourier

Colombes, Hauts de Seine, 92700, France

Location

Hopital Foch

Suresnes, Hauts de Seine, 92150, France

Location

Centre Hospitalier Regional d'Orléans

Orléans, 45000, France

Location

Related Publications (1)

• Dimi S, Zucman D, Chassany O, Lalanne C, Prazuck T, Mortier E, Majerholc C, Aubin-Auger I, Verger P, Duracinsky M. Patients' high acceptability of a future therapeutic HIV vaccine in France: a French paradox? BMC Infect Dis. 2019 May 9;19(1):401. doi: 10.1186/s12879-019-4056-6.

  PMID: 31072394 DERIVED

MeSH Terms

Interventions

Surveys and Questionnaires; Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• David Zucman, MD

  HOPITAL FOCH Service de Medecine Interne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: March 4, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 19, 2015

Record last verified: 2015-01

Locations

FR (3)