National Survey on Missed Opportunities to Pre-exposure Prophylaxis for Prevention of Human Immunodeficiency Virus-infection.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 596
- 试验地点
- 1
- 主要终点
- Percentage of patients eligible for PrEP at the time of HIV infection
研究概览
简要总结
Missed opportunity to pre-exposure prophylaxis is a survey study that will be addressed to newly infected with human immunodeficiency virus (HIV) persons. The purposes of this study is to understand why despite the fact that pre-exposure prophylaxis exist, these persons have been contaminated with HIV.
详细描述
Pre-exposure prophylaxis is a new strategy to prevent the occurrence of new cases of HIV. This prophylaxis strategy is based on taking antiretroviral drugs (ARV) before and after exposition to a risk of HIV infection which can reduce drastically the contamination with HIV. A certain groups of population based on their sexual orientation, for instance man who have sex with man (MSM), is among the groups that are highly exposed to this risk. To reduce this risk, French national regulatory authority (ANSM), firstly through temporary usage recommendation followed by a marketing authorization extension, allowed the prescription of these antiretroviral molecules to persons presenting eligibility criteria as defined by regulatory authority. Despite these preventive measures, the incidence of HIV such as the MSM group still high. The missed opportunity studies has as objectives to try to disentangle real obstacles of PrEP use in France and to optimize PrEP criteria if needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Understanding and speaking French
- •Affiliated in or beneficiary of a Social Security (excluding State Medical Aid or AME that aren't considered as Social Security coverage)
- •Men and women with a diagnosis of HIV infection known for less than three months and with recent HIV infection established on:
- •a diagnostic confirmation test by Western Blot (WB) or Immuno Blot showing incomplete pattern.
- •OR Previous HIV negative screening test performed within 6 months of diagnosis.
排除标准
- •Less than 18 years old
- •Unable to understand French
- •Not affiliated to a social security coverage
- •Under guardianship or under curatorship
研究组 & 干预措施
Recently infected with HIV
Men and women recently infected with HIV and have been eligible for PrEP based on the recommendation of french national regulatory agency regarding the prescription of Truvada® in prophylaxis to HIV exposure. The potential reasons behind these missed opportunity of Pre-exposure prophylaxis will be studied through a self-administrated questionnaire.
干预措施: self-administrated questionnaire (Behavioral)
结局指标
主要结局
Percentage of patients eligible for PrEP at the time of HIV infection
时间窗: The needed time to answer to the questionnaire : 40 min to 1 hour.
Quantify and describe among newly diagnosed people with HIV the missed opportunities for PrEP treatment for HIV infection prevention
次要结局
- Access to care(The needed time to answer to the questionnaire : 40 min to 1 hour.)
- Taking a risky behaviour for HIV infection(The needed time to answer to the questionnaire : 40 min to 1 hour.)
- Awareness and level of knowledge of the PrEP strategy(The needed time to answer to the questionnaire : 40 min to 1 hour.)
- Availability of PrEP(The needed time to answer to the questionnaire : 40 min to 1 hour.)