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NCT01621347 Clinical Trial

Antiretroviral Adherence Evaluation in HIV Pregnant and Postpartum Women

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01621347
Other study ID # 48/12
Secondary ID
Status Completed
Phase N/A
First received May 31, 2012
Last updated December 21, 2015
Start date March 2012
Est. completion date September 2012

Study information
Verified date December 2015
Source Policlinique Médicale Universitaire
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date September 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Pregnant Women

- HIV-positive

- Antiretroviral medication delivered in electronical monitors

Exclusion Criteria:

- Monitored period during pregnancy < 1 month

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Policlinique Médicale Universitaire Lausanne Vaud

Sponsors (3)
Lead Sponsor Collaborator
Policlinique Médicale Universitaire Centre Hospitalier Universitaire Vaudois, Swiss HIV Cohort Study

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in patient adherence during pregnancy and postpartum By electronic drug monitoring, pill count and subject interviews' marks before delivery (1 to 9 month) and postpartum (6 month) No
Secondary Adherence barriers and facilitators Data recorded in subject's interview marks pregnancy and postpartum (6 months) No
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