HIV InfectionNCT01621347
Antiretroviral Adherence Evaluation in HIV Pregnant and Postpartum Women
An observational study of HIV Infection and Pregnancy, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infection, Pregnancy
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2012to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant and Postpartum Women enrolledin the HIV adherence program at the pharmacy of Department of Ambulatory Care and Community Medicine in Lausanne
Who may be able to join
- Pregnant Women
- HIV-positive
- Antiretroviral medication delivered in electronical monitors
Who cannot join
- Monitored period during pregnancy < 1 month
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Policlinique Médicale Universitaire
Lausanne, Canton of Vaud, 1011
About this study
Official title: Retrospective Study: Evaluation of Antiretroviral Adherence During Pregnancy and Postpartum Using Electronic Monitoring Data
The purpose of this study is to compare adherence to antiretroviral therapy during pregnancy and postpartum, and to record adherence barriers and facilitators.
Read the 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.
- Conditions
- HIV Infection, Pregnancy
- Keywords
- HIV, Pregnancy, Postpartum, Women, Medication Adherence
- Medical subject headings
- HIV Infections, Medication Adherence
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient adherence during pregnancy and postpartum
By electronic drug monitoring, pill count and subject interviews' marks
Measured: before delivery (1 to 9 month) and postpartum (6 month)
Secondary outcomes (1)
Adherence barriers and facilitators
Data recorded in subject's interview marks
Measured: pregnancy and postpartum (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois, Swiss HIV Cohort Study
- Responsible party
- Sponsor
- Investigators
- Marie-Paule Schneider, PhD, Study chair, Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandAurélie Gertsch, PhD-Student, Principal investigator, Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandOlivier Bugnon, Professor, Study chair, Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandOdile Michel, Student, Principal investigator, Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandMatthias Cavassini, M.D, Study chair, Centre Hosppitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621347
- Sponsor's protocol ID
- 48/12
- Status last verified
- Jul 2026
- First submitted
- 31 May 2012
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study: Evaluation of Antiretroviral Adherence During Pregnancy and Postpartum Using Electronic Monitoring Data
- ClinicalTrials.gov ID
- NCT01621347
- Acronym / sponsor ID
- 48/12
- Conditions
- HIV Infection, Pregnancy
- Keywords
- HIV, Pregnancy, Postpartum, Women, Medication Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois, Swiss HIV Cohort Study
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare adherence to antiretroviral therapy during pregnancy and postpartum, and to record adherence barriers and facilitators.
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant and Postpartum Women enrolledin the HIV adherence program at the pharmacy of Department of Ambulatory Care and Community Medicine in Lausanne
Key inclusion criteria (3 listed)
- Pregnant Women
- HIV-positive
- Antiretroviral medication delivered in electronical monitors
Key exclusion criteria (1 listed)
- Monitored period during pregnancy < 1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Adherence barriers and facilitators
Time frame: pregnancy and postpartum (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Paule Schneider, PhD study chair
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Aurélie Gertsch, PhD-Student principal investigator
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Olivier Bugnon, Professor study chair
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection and Pregnancy, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient adherence during pregnancy and postpartum (time frame: before delivery (1 to 9 month) and postpartum (6 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.