HIV Disclosure and Medication Adherence, a Pilot Study | NCT01621412

Studies
HIV Disclosure and Medication Adherence, a Pilot Study

NCT01621412

Sponsor

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Status

Completed

Last Update Posted

Dec 22, 2015Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

HIV Infection

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

May 31, 2012

First Submission Date that Met QC Criteria

Jun 13, 2012

First Posted Date

Jun 18, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2015

Last Update Posted Date

Dec 22, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marie Schneider, Pharmacist, PhD, Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandPrincipal Investigator

Lead Sponsor

Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandOTHER

Collaborators

Name	Class
Centre Hospitalier Universitaire Vaudois	OTHER
Swiss HIV Cohort Study	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators believe that disclosure of HIV status could influence medication adherence. If disclosure leads to social support, adherence could be improved. This study purpose is to assess correlation between disclosure and medication adherence, and to describe people whose HIV status has been disclosed to.

Detailed Description

Pharmacists administer a questionnaire to each consecutive subject taking part in the adherence-enhancing program at the pharmacy of the Department of Ambulatory Care And Community Medicine in Lausanne. This questionnaire assesses disclosure, response to disclosure, and living situation.

Adherence is measured by electronic monitoring and pill count.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient Adherence	Electronic monitoring of adherence during 30 days before survey	30 days before survey

Secondary Outcomes

Measure	Description	Time Frame
Patient Adherence	Electronic monitoring of adherence during 90 days before survey	90 days before survey

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV Infection
Enrolled in the adherence-enhancing program

Exclusion Criteria:

Inclusion visit
Not french or english speaker

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients enrolled in the adherence-enhancing program at ther pharmacy of Department of Ambulatory Care and Community Medicine in Lausanne

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie-Paule Schneider, PhD	Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland	Principal Investigator
Aurélie Gertsch, PhD-Student	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
Matthias Cavassini, MD	Centre Hospitalier Universitaire Vaudois	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Policlinique Médicale Universitaire		Lausanne	Canton of Vaud	1011	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections
D055118	Medication Adherence

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided