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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire Vaudois | OTHER |
| Swiss HIV Cohort Study | NETWORK |
| Gilead Sciences | INDUSTRY |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Patient adherence | by questionnaire in both subgroups and by MEMS data in the adherence subgroup | V0, V1, V2 |
| Adverse events and symptoms | by questionnaires | V0, V1, V2 |
| Treatment management | Treatment management according to meals, timing, disruptive daily schedule By questionnaire | V0, V1, V2 |
| Patient satisfaction of the switch | By questionnaire | V1, V2 |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of switch on clinical outcomes | Clincal outcomes = viral load, CD4 count, resistance, EFV blood level. By medical file | V0, V1, V2 |
| Patients' acceptance of switch | V-1 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients under TDF-FTC-EFV followed up at the Service of Infectious Disease of the University Hospital of Lausanne and enrolled in the Swiss HIV Cohort Study (SHCS) Adherence subgroup: patients enrolled in the HIV adherence program at the pharmacy of the Department of Ambulatory Care & Community Medicine in Lausanne.
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Cavassini, M.D | Centre Hospitalier Universitaire Vaudois | Study Chair |
| Marie-Paule Schneider, PhD | Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland | Principal Investigator |
| Olivier Bugnon, Professor | Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland | Study Chair |
| Aurélie Gertsch, PhD Student | Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois et Policlinique Medicale Universitaire | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D055118 | Medication Adherence |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |