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Antiretroviral Adherence Evaluation in HIV Pregnant and Postpartum Women

This study is currently recruiting participants.
Verified June 2012 by Policlinique Médicale Universitaire
Sponsor:
Collaborators:
Centre Hospitalier Universitaire Vaudois
Swiss HIV Cohort Study
Information provided by (Responsible Party):
Marie Schneider, Policlinique Médicale Universitaire
ClinicalTrials.gov Identifier:
NCT01621347
First received: May 31, 2012
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition
HIV Infection
Pregnancy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Study: Evaluation of Antiretroviral Adherence During Pregnancy and Postpartum Using Electronic Monitoring Data

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Policlinique Médicale Universitaire:

Primary Outcome Measures:
  • Change in patient adherence during pregnancy and postpartum [ Time Frame: before delivery (1 to 9 month) and postpartum (6 month) ] [ Designated as safety issue: No ]
    By electronic drug monitoring, pill count and subject interviews' marks


Secondary Outcome Measures:
  • Adherence barriers and facilitators [ Time Frame: pregnancy and postpartum (6 months) ] [ Designated as safety issue: No ]
    Data recorded in subject's interview marks


Estimated Enrollment: 26
Study Start Date: March 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Monitored period during pregnancy < 1 month
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01621347

Contacts
Contact: Aurélie Gertsch, PhD-Student +41213144846 aurelie.gertsch@hospvd.ch
Contact: Marie-Paule Schneider, PhD +41213144845 Marie-Paule.Schneider@hospvd.ch

Locations
Switzerland
Policlinique Médicale Universitaire Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Aurelie Gertsch, PhD student     +41213144846     Aurelie.Gertsch@hospvd.ch    
Contact: Marie-Paule Schneider, PhD     +41213144845     marie-paule.schneider@hospvd.ch    
Policlinique Médicale Universitaire Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Aurélie Gertsch, PhD-Student     +41213144846     aurelie.gertsch@hospvd.ch    
Principal Investigator: Aurelie Gertsch, PhD-Student            
Sponsors and Collaborators
Policlinique Médicale Universitaire
Centre Hospitalier Universitaire Vaudois
Swiss HIV Cohort Study
Investigators
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

No publications provided

Responsible Party: Marie Schneider, Pharmacist, PhD, Policlinique Médicale Universitaire
ClinicalTrials.gov Identifier: NCT01621347     History of Changes
Other Study ID Numbers: 48/12
Study First Received: May 31, 2012
Last Updated: June 13, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Policlinique Médicale Universitaire:
HIV
Pregnancy
Postpartum
Women
Medication Adherence

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

ClinicalTrials.gov processed this record on May 19, 2013