HIV-positive Patients Under Tenofovir, Emtricitabine and Efavirenz Therapy Switching From a Two-pill Regimen to a Single Pill Regimen: Patients'Opinion Survey
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV Infection
- Sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- Patient adherence
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Marie Schneider
Pharmacist, PhD
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Eligibility Criteria
Inclusion Criteria
- •patients under TDF-FTC-EFV
- •followed up at the Service of Infectious Disease of the University Hospital of Lausanne
- •enrolled in the SHCS
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Patient adherence
Time Frame: V0, V1, V2
by questionnaire in both subgroups and by MEMS data in the adherence subgroup
Adverse events and symptoms
Time Frame: V0, V1, V2
by questionnaires
Treatment management
Time Frame: V0, V1, V2
Treatment management according to meals, timing, disruptive daily schedule By questionnaire
Patient satisfaction of the switch
Time Frame: V1, V2
By questionnaire
Secondary Outcomes
- Impact of switch on clinical outcomes(V0, V1, V2)
- Patients' acceptance of switch(V-1)