Representations and Acceptability of HIV Therapeutic Vaccine in a Cohort of HIV-1 Infected Outpatients Followed at Hospital : Multicentric Interventional Study Qualitative and Quantitative
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- VAS scale of acceptability
研究概览
简要总结
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.
详细描述
Since 2000, the study of the acceptability of HIV vaccine candidates is one of four major areas recommended by the WHO. Presently, there are several studies in HIV field on the theme " Cure ". However, no study has yet addressed the question of the acceptability of therapeutic vaccine candidates against HIV who are currently already in clinical trials phase 2 and 3 In addition, many aspects of the disease, its treatment and living conditions of PLWHA could affect the acceptability of such a vaccine
Description of the study population :
The study population has the characteristics of the HIV population living in France [ 26, 27 ] .The French population reported by the database of the French Hospital in 2011 FHDH comparable to the population of their study ( three centers combined ) :- 36% of MSM- 9.1% of injection drug users (IDUs) 45% of heterosexuals : Europe including France 23.7% of immigrants from sub-Saharan Africa. 88 % were receiving antiretroviral therapy and 95% are undetectable .- 40 % are between 40-49 years
Description of the research methodology
Quantitative study : 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 the opinions ofScientific Council in particular Dr. Pierre Verger social scientist vaccination and experts on the perception of patients. It was tested on a sample of 15 PHAs.The questionnaire takes into account several important dimensions that could affect therapeutic vaccine acceptability :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infected with HIV-1
- •older than 18 and younger than 75 years
- •speaking , reading french
- •with medical coverage (SS, CMU, AME)
排除标准
- •protected adults (adults under guardianship, trusteeship)
- •infected with HIV-2
- •pregnant women
研究组 & 干预措施
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
干预措施: Questionnaire (Other)
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.
干预措施: Interview (Other)
结局指标
主要结局
VAS scale of acceptability
时间窗: 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.
次要结局
- score of quality of life(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.)
- 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.)