An Open-label Randomized Trial Evaluating the Acceptability, Quality of Care, Patient Satisfaction, and Cost-effectiveness of Monitoring Provided by Nurses or Physicians for People Using HIV Pre-exposure Prophylaxis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 504
- 主要终点
- Compliance to PrEP
研究概览
简要总结
Assess the quality of care and the satisfaction of patients and caregivers when the monitoring of people on HIV pre-exposure prophylaxis (PrEP) is provided by nurses instead of physicians
详细描述
The HIV/AIDS epidemic remains uncontrolled in France, with approximately 5,000 to 6,000 new cases reported each year. Since January 2016, HIV pre-exposure prophylaxis (PrEP)-which involves taking a single oral tablet containing two antiretroviral drugs-has been available in France. The effectiveness of this PrEP has been demonstrated, with a relative reduction in HIV incidence of nearly 97% when PrEP is taken correctly.
However, only nearly 50,000 people are using PrEP in France in 2024, which is far short of the targets needed to control the epidemic. Indeed, the population of men who have sex with men (MSM) at risk of HIV infection is estimated at over 200,000, and the number of heterosexuals on PrEP is negligible, even though 40% of new HIV diagnoses involve heterosexuals from countries with high prevalence (Sub-Saharan Africa).
Furthermore, these 50,000 people on PrEP represent only 64% of the >120,000 people who have started PrEP since 2016, indicating that many have discontinued this prophylaxis over time. One of the challenges in implementing PrEP stems from the small number of trained hospital and primary care physicians and their limited time availability to provide a PrEP care.
Since 2022, PrEP training programs in medical settings, involving nurses, have been implemented to train them to monitore people on PrEP. This involvement of nurses would help increase the availability of PrEP, free up doctors' time for complex cases, and enhance the value of nursing work.
However, there has been no evaluation of this care provided by nurses to people on PrEP in terms of quality, acceptability, satisfaction among people on PrEP, nurses, and doctors, or its cost-effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male sex assigned at birth, aged ≥ 18 years
- •Individual at risk of HIV infection
- •Currently receiving PrEP care and willing to continue follow-up in a hospital setting
- •Receiving care at a hospital setting by a physician and not objecting to follow-up by a nurse
- •Having received complete information about the study and having provided a free written informed consent
- •Affiliated with a social security system (beneficiary or entitled individual) or covered by State Medical Aid (AME).
排除标准
- •Individual with confirmed HIV infection
- •Currently receiving nurse care in a hospital setting
- •Having renal impairment (creatinine clearance < 60 mL/min)
- •Unable to provide informed consent
- •Not affiliated with a social security system or not covered by State Medical Aid (AME)
- •Under legal guardianship or curatorship
- •Deprived of liberty by judicial or administrative decision, or individuals receiving psychiatric care under Article L1121-6 of the French Public Health Code
研究组 & 干预措施
Follow-up visits for PrEP prescription conducted by a physician.
干预措施: Monitoring of PrEP by physicians (Other)
Follow-up visits for PrEP prescription conducted by a nurse under the same conditions.
干预措施: Monitoring of PrEP by nurses (Other)
结局指标
主要结局
Compliance to PrEP
时间窗: Up to 12 months
Compliance to PrEP is defined by a composite criterion comprising: * Presence at scheduled follow-up visits at 0, 6, and 12 months AND * Undergoing an HIV screening test before each visit to allow for the prescription of PrEP if the result is negative (+/-14 days) AND * Prescription of PrEP at each visit
次要结局
- Occurrence of sexually transmitted infection (STI)(At baseline)
- Tolerability of PrEP(At baseline)
- Tolerability of PrEP(At 6 months)
- Occurrence of sexually transmitted infection (STI)(At 6 months)
- Tolerability of PrEP(At 12 months)
- Occurrence of sexually transmitted infection (STI)(At 12 months)
- PrEP adherence(At 12 months)
- Treatment acceptability among participants(Up to 12 months)
- Incidence of HIV infection(Up to 12 months)
- Cost of care(Up to 12 months)
- Patient and caregiver satisfaction(At 12 months)