NCT01621347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

5 months

First QC Date

May 31, 2012

Last Update Submit

December 21, 2015

Conditions

Keywords

HIVPregnancyPostpartumWomenMedication Adherence

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Adherence barriers and facilitators

    pregnancy and postpartum (6 months)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Monitored period during pregnancy \< 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinique Médicale Universitaire

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

HIV InfectionsMedication Adherence

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Marie-Paule Schneider, PhD

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

    STUDY CHAIR
  • Aurélie Gertsch, PhD-Student

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

    PRINCIPAL INVESTIGATOR
  • Olivier Bugnon, Professor

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

    STUDY CHAIR
  • Odile Michel, Student

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

    PRINCIPAL INVESTIGATOR
  • Matthias Cavassini, M.D

    Centre Hosppitalier Universitaire Vaudois

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacist, PhD

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 18, 2012

Study Start

March 1, 2012

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

December 22, 2015

Record last verified: 2015-12

Locations