HIVNCT01190605
Evaluating Factors That Impact Loss to Follow-up Among Postpartum HIV-infected Women in Mississippi
An observational study of HIV, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
Women with HIV infection in Mississippi who are pregnant or who have had their baby in the past year can agree to fill out a questionnaire about what helps or hurts return to care for HIV infection after having a baby. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- HIV
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 2013
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women in Mississippi with HIV infection who have been pregnant and received perinatal HIV care at University of Mississippi Medical Center are eligible to participate in a questionnaire study on the factors that affect entry into HIV care after delivery
Who may be able to join
- age 18 years or older
- women with HIV infection who are pregnant or up to 2 months postpartum
- English speaking
- able to give informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
About this study
Women with HIV infection in Mississippi who are pregnant or who have had their baby in the past year can agree to fill out a questionnaire about what helps or hurts return to care for HIV infection after having a baby. The combined results should show the most common things that keep women from getting care for HIV infection after having a baby. This will help design another study in order to help more women get into care for HIV infection after having a baby.
Read the detailed description
Following recruitment and completion of informed consent, a participant will be given a questionnaire to look at factors that help or hinder access to HIV care after delivery. After finishing the initial questionnaire the participant will get a Wal-Mart gift card for $15. The participant may then be asked to complete a longer interview for which she would receive an additional gift card for $25. The combined results will be used to design an interventional study to improve entry into HIV care after delivery.
- Conditions
- HIV
- Keywords
- HIV, postpartum, postpartum entry into HIV care
What is being measured
The primary outcome is the main question the study is designed to answer.
linked to long-term HIV care
retrospective chart review for documentation of visit attendance
Measured: within six months of delivery
Secondary outcomes (4)
assessment for depression
use of Edinburgh depression screening tool
Measured: cross-sectional at time of study visit
assessment of intimate partner violence
use of WEB (Women's Experience with Battering) screening tool
Measured: cross-sectional at time of study visit
assessment of stigma
use of HIV Related Experiences screening tool
Measured: cross-sectional at time of study visit
attended a postpartum visit
retrospective chart review for documentation of visit attendance
Measured: within six months of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Cross-sectional
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Principal investigator, Binford Nash, University of Mississippi Medical Center
- Investigators
- Binford T Nash, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190605
- Sponsor's protocol ID
- 2010-0131
- Status last verified
- Dec 2014
- First submitted
- 26 Aug 2010
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Factors That Impact Loss to Follow-up Among Postpartum HIV-infected Women in Mississippi
- ClinicalTrials.gov ID
- NCT01190605
- Acronym / sponsor ID
- 2010-0131
- Conditions
- HIV
- Keywords
- HIV, postpartum, postpartum entry into HIV care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- Jul 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Aug 2010 (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.
Women with HIV infection in Mississippi who are pregnant or who have had their baby in the past year can agree to fill out a questionnaire about what helps or hurts return to care for HIV infection after having a baby. The combined results should show the most common things that keep women from getting care for HIV infection after having a baby. This will help design another study in order to help more women get into care for HIV infection after having a baby.
Detailed description
Following recruitment and completion of informed consent, a participant will be given a questionnaire to look at factors that help or hinder access to HIV care after delivery. After finishing the initial questionnaire the participant will get a Wal-Mart gift card for $15. The participant may then be asked to complete a longer interview for which she would receive an additional gift card for $25. The combined results will be used to design an interventional study to improve entry into HIV care after delivery.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women in Mississippi with HIV infection who have been pregnant and received perinatal HIV care at University of Mississippi Medical Center are eligible to participate in a questionnaire study on the factors that affect entry into HIV care after delivery
Key inclusion criteria (4 listed)
- age 18 years or older
- women with HIV infection who are pregnant or up to 2 months postpartum
- English speaking
- able to give informed consent
Key exclusion criteria (0 listed)
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
linked to long-term HIV care
Time frame: within six months of delivery
retrospective chart review for documentation of visit attendance
4 secondary outcomes
assessment for depression
Time frame: cross-sectional at time of study visit
assessment of intimate partner violence
Time frame: cross-sectional at time of study visit
assessment of stigma
Time frame: cross-sectional at time of study visit
attended a postpartum visit
Time frame: within six months of delivery
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 9 Dec 2014.
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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.
Binford T Nash, MD principal investigator
University of Mississippi Medical Center
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, run by University of Mississippi Medical Center at 1 site in United States.
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 4 inclusion and 0 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 9 Dec 2014. 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 United States. 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?
linked to long-term HIV care (time frame: within six months of delivery). 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 9 Dec 2014.