Antiretroviral Adherence Evaluation in HIV Pregnant and Postpartum Women

December 21, 2015 updated by: Marie Schneider, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Retrospective Study: Evaluation of Antiretroviral Adherence During Pregnancy and Postpartum Using Electronic Monitoring Data

The purpose of this study is to compare adherence to antiretroviral therapy during pregnancy and postpartum, and to record adherence barriers and facilitators.

Study Overview

Status

Completed

Conditions

Detailed Description

Data of all consecutive pregnant women included in the adherence enhancing program of the Pharmacy, Department of ambulatory care & community medicine, are collected. In this program, adherence is measured and enhanced by electronic monitoring, pill count, motivational interviewing and interdisciplinary collaboration. Electronic monitoring data are collected during pregnancy and postpartum, and compared. Barriers and facilitators are collected using interview's marks.

Study Type

Observational

Enrollment (Anticipated)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Policlinique Medicale Universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant and Postpartum Women enrolledin the HIV adherence program at the pharmacy of Department of Ambulatory Care and Community Medicine in Lausanne

Description

Inclusion Criteria:

  • Pregnant Women
  • HIV-positive
  • Antiretroviral medication delivered in electronical monitors

Exclusion Criteria:

  • Monitored period during pregnancy < 1 month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient adherence during pregnancy and postpartum
Time Frame: before delivery (1 to 9 month) and postpartum (6 month)
By electronic drug monitoring, pill count and subject interviews' marks
before delivery (1 to 9 month) and postpartum (6 month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence barriers and facilitators
Time Frame: pregnancy and postpartum (6 months)
Data recorded in subject's interview marks
pregnancy and postpartum (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Centre Hospitalier Universitaire Vaudois
Swiss HIV Cohort Study

Investigators

  • Study Chair: 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
  • Study Chair: Olivier Bugnon, Professor, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
  • Principal Investigator: Odile Michel, Student, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
  • Study Chair: Matthias Cavassini, M.D, Centre Hosppitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

May 31, 2012

First Submitted That Met QC Criteria

June 13, 2012

First Posted (Estimate)

June 18, 2012

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 21, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 48/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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