HIV-positive Patients Under Tenofovir, Emtricitabine and Efavirenz Therapy Switching From a Two-pill Regimen to a Single Pill Regimen: Patients'Opinion Survey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Patient adherence
研究概览
简要总结
The purpose of this study is to assess adherence, tolerability and satisfaction of each eligible HIV subjects switching from a two- or three-pill tenofovir-emtricitabine-efavirenz (TDF-FTC-EFV) to a one-pill TDF-FTC-EFV treatment.
详细描述
Each eligible patient will be screened from de SHCS database. Each refusal and drop-out will be documented. A pre-visit (V-1) will be scheduled for informed consent, V0 for inclusion (V-1 and V0 may occur on the same day), V1 one month post-inclusion and V2 4 to 7 months post-inclusion. V0, V1 and V2 will be planned during regular medical visits.
Eligible patients either get their cART in their usual pharmacy according to standard of care, or take part in a routine adherence-enhancing program(adherence subgroup)run by the pharmacists of the outpatient medical clinic.
In the adherence subgroup, adherence is assessed electronically by MEMS (Medication event monitoring system) monitors on a regular basis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •patients under TDF-FTC-EFV
- •followed up at the Service of Infectious Disease of the University Hospital of Lausanne
- •enrolled in the SHCS
排除标准
- •patients receiving TDF-FTC-EFV in combination with other ARTs
- •patients under TDF-FTC-EFV for less than 3 months
- •patients not fluent in French
结局指标
主要结局
Patient adherence
时间窗: V0, V1, V2
by questionnaire in both subgroups and by MEMS data in the adherence subgroup
Adverse events and symptoms
时间窗: V0, V1, V2
by questionnaires
Treatment management
时间窗: V0, V1, V2
Treatment management according to meals, timing, disruptive daily schedule By questionnaire
Patient satisfaction of the switch
时间窗: V1, V2
By questionnaire
次要结局
- Impact of switch on clinical outcomes(V0, V1, V2)
- Patients' acceptance of switch(V-1)
研究者
Marie Schneider
Pharmacist, PhD
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland