Assisted Notification of Partners of Men Having Sex With Men Discovering Their Seropositivity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- The percentage of partners notified one month after the intervention, among the number of exposed partners stated by index patients
研究概览
简要总结
The context of HIV has changed dramatically this last two decades with the availability of highly active and well tolerated antiretroviral therapies, and the extension of prevention methods to include treatment as prevention of onward transmissions. It is time to test and treat as many HIV infected people as possible. HIV testing that target people known to have been exposed to HIV is an interesting option to explore to curb the spread of the epidemic. Notifying HIV exposed sexual partner for them to get an HIV test and treatment contribute to reduce HIV transmissions. The partner notification (PN) gives the opportunity to HIV positive partners to access to care and negative partners, access to prevention services.
Several tools have been developed worldwide, in particular in the United Kingdom and the US, to help HIV or index patients to notify their sexual partner or needle-sharing people. This approach is new in France and PN intervention has to be assessed.
The present study aimed to assess the effectiveness of a digital PN tool or a counselling interview to help men having sex with men (MSM) newly diagnosed for HIV to notify their exposed partners. The study also aimed to evaluate the acceptability of these PN intervention in index patients and their notified partners in the French context.
To meet the objectives, an interventional study was developed in index patients (described above) coupled with :
- an observational study in notified partners to assess their PN acceptability and their HIV testing uptake after being notified
- a qualitative study in a sample of index patients and notified partner to assess more in depth their PN acceptability.
Expected results and perspectives Feasible and effective, assisted PN services may complete HIV testing offer (and by extension sexually transmitted infections screening) as well as the prevention offer Pre-Exposure Prophylaxis (PrEP) for MSM.
The study will provide information enabling the best practice guides. In a next step, PN interventions adapted to other key populations will be studied.
详细描述
Interventional study (supplementary information)
This is a cluster-randomised interventional study that will compare two interventional arms:
- The provision of a partner notification (PN) digital tool allowing the sending of anonymous or personalised standardised text messages to partners (Tool arm).
- In addition to the provision of the PN digital tool, a PN approach assisted by a counsellor during a specific counselling interview and the option for the index patient to entrust the notification of some of their partners to the counsellor (Tool + Counselling arm). Notification of partners by the counsellor should be anonymous and reserved for partners for whom the risk of re-identification of the index case is very low.
Randomisation of the centres 1:1.
The PN intervention will be offered to index patients at the time of HIV diagnosis or antiretroviral treatment initiation. They will have the option to use the available tools and to notify all or some of their partners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •having sex with ≥2 men in the last 12 months
- •diagnosed for HIV since ≤3 months at the time of inclusion
- •Exclusion criteria:
- •Persons who do not provide an email address, needed to receive the study questionnaires
- •Persons who do not speak or read French
- •Persons subject to a legal protection measure (guardianship, safeguard of justice)
排除标准
- 未提供
结局指标
主要结局
The percentage of partners notified one month after the intervention, among the number of exposed partners stated by index patients
时间窗: One month after the intervention
An emailed invitation to complete an online self-administered questionnaire will be send to index patients to carry out an assessment of the notification process (number of partners exposed, contacted, notified, etc). Up to 3 reminders will be sent if no response.
次要结局
- Percentage of acceptability of partner notification by index patients(One month after the intervention)
- Percentage of adverse events of partner notification reported by index patients(One month after the intervention)