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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
Sponsor:
Collaborators:
Centre Hospitalier Universitaire Vaudois
Swiss HIV Cohort Study
Information provided by (Responsible Party):
Marie Schneider, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

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.

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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
Actual Primary Completion Date : August 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine





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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Monitored period during pregnancy < 1 month

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


Locations
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Switzerland
Policlinique Médicale Universitaire
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Centre Hospitalier Universitaire Vaudois
Swiss HIV Cohort Study
Investigators
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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

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Responsible Party: Marie Schneider, Pharmacist, PhD, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
ClinicalTrials.gov Identifier: NCT01621347    
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, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland:
HIV
Pregnancy
Postpartum
Women
Medication Adherence
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents