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Antiretroviral Adherence Evaluation in HIV Pregnant and Postpartum Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01621347
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : December 22, 2015
Information provided by (Responsible Party):

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

Condition or disease
HIV Infection Pregnancy

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 Design

Study Type : Observational
Estimated Enrollment : 26 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Study: Evaluation of Antiretroviral Adherence During Pregnancy and Postpartum Using Electronic Monitoring Data
Study Start Date : March 2012
Primary Completion Date : August 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Adherence barriers and facilitators [ Time Frame: pregnancy and postpartum (6 months) ]
    Data recorded in subject's interview marks

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Inclusion Criteria:

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

Exclusion Criteria:

  • Monitored period during pregnancy < 1 month
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621347

Policlinique Médicale Universitaire
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Policlinique Médicale Universitaire
Centre Hospitalier Universitaire Vaudois
Swiss HIV Cohort Study
Study Chair: Marie-Paule Schneider, PhD Policlinique Médicale Universitaire
Principal Investigator: Aurélie Gertsch, PhD-Student Policlinique Médicale Universitaire
Study Chair: Olivier Bugnon, Professor Policlinique Médicale Universitaire
Principal Investigator: Odile Michel, Student Policlinique Médicale Universitaire
Study Chair: Matthias Cavassini, M.D Centre Hosppitalier Universitaire Vaudois
More Information

Responsible Party: Marie Schneider, Pharmacist, PhD, Policlinique Médicale Universitaire
ClinicalTrials.gov Identifier: NCT01621347     History of Changes
Other Study ID Numbers: 48/12
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015

Keywords provided by Marie Schneider, Policlinique Médicale Universitaire:
Medication Adherence

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases