HIV InfectionNCT01853917
Evaluation of Barriers to Postpartum Care in HIV Infected Women
An observational study of HIV Infection and Pregnancy, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate why the majority of HIV infected women in the Harris County Health District system who are pregnant do not come to clinic for their HIV disease after they have a baby through questionaires administered prepartum and questionaires and structured interviews postpartum. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- HIV Infection, Pregnancy
- What is being tested?
- questionaires and structured interviews
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Nov 2014
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: HIV infected pregnant women
Who may be able to join
- HIV-infected women who are pregnant by confirmatory tests or an HIV positive woman who has had a baby within the last 6 months and is coming to care postpartum.
- Women who intend to get care at Harris County Hospital District.
- Subjects must be >18 years old.
Who cannot join
- Women unable to complete questionnaires.
- Women who are unable to speak, read, or understand English or Spanish.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Harris County Hospital District Clinics-Thomas Street Clinic, Northwest Clinic
Houston, Texas, 77009
Harris County Hospital District Clinics-LBJ hospital
Houston, Texas, 77026
About this study
The purpose of this study is to evaluate why the majority of HIV infected women in the Harris County Health District system who are pregnant do not come to clinic for their HIV disease after they have a baby through questionaires administered prepartum and questionaires and structured interviews postpartum. The study will ask subjects questions about HIV, drug use, depression and social problems.
Read the detailed description
This study is evaluating information pre and postpartum to assess what are barriers to patients coming into care for HIV after they have a baby. We will try to evaluate recurrent themes in questionaires and interviews to try and identify the barriers to care.
- Conditions
- HIV Infection, Pregnancy
- Being tested
- questionaires and structured interviews
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionaires and structured interviewsOther
We will do questionaires on pregnant women before they have their baby and after they have their baby. We will do structured interviews after they have their baby
| Study group | Role | What they receive |
|---|---|---|
| questionaires and structured interview | HIV infected women who are pregnant and receiving care in Harris County Hospital District single arm study Single arm study Receives: Other: questionaires and structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate results from qualitative interviews
we will ask and record responses and enter into an NIVIVO program to evaluate for emergent themes
Measured: women seen after they have their baby
Secondary outcomes (1)
evaluate results from questionaires
we will evaluate responses from questionaires There will be 8 areas that there are questionnaires about. These include basic information about yourself, about stress, about your support system, about your sense of control, about tobacco use, about for alcohol/drug use, about taking your HIV medications, and about depression.
Measured: before they have a baby and after they have a baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startJan 2012
- Primary completionFeb 2014
- Study completionNov 2014
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.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston
- Investigators
- Tanvir Bell, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853917
- Sponsor's protocol ID
- HSC-MS-11-0503
- Status last verified
- Dec 2014
- First submitted
- 19 Jun 2012
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Barriers to Postpartum Care in HIV Infected Women
- ClinicalTrials.gov ID
- NCT01853917
- Acronym / sponsor ID
- HSC-MS-11-0503
- Conditions
- HIV Infection, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- Jan 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 15 May 2013 (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 evaluate why the majority of HIV infected women in the Harris County Health District system who are pregnant do not come to clinic for their HIV disease after they have a baby through questionaires administered prepartum and questionaires and structured interviews postpartum. The study will ask subjects questions about HIV, drug use, depression and social problems.
Detailed description
This study is evaluating information pre and postpartum to assess what are barriers to patients coming into care for HIV after they have a baby. We will try to evaluate recurrent themes in questionaires and interviews to try and identify the barriers to care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| questionaires and structured interview | – | Other: questionaires and structured interviewsHIV infected women who are pregnant and receiving care in Harris County Hospital District single arm study Single arm study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected pregnant women
Key inclusion criteria (3 listed)
- HIV-infected women who are pregnant by confirmatory tests or an HIV positive woman who has had a baby within the last 6 months and is coming to care postpartum.
- Women who intend to get care at Harris County Hospital District.
- Subjects must be >18 years old.
Key exclusion criteria (2 listed)
- Women unable to complete questionnaires.
- Women who are unable to speak, read, or understand English or Spanish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionaires and structured interviewsWe will do questionaires on pregnant women before they have their baby and after they have their baby. We will do structured interviews after they have their baby | Other | questionaires and structured interview |
Primary outcome
evaluate results from qualitative interviews
Time frame: women seen after they have their baby
we will ask and record responses and enter into an NIVIVO program to evaluate for emergent themes
1 secondary outcome
evaluate results from questionaires
Time frame: before they have a baby and after they have a baby
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 4 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.
Tanvir Bell principal investigator
The University of Texas Health Science Center, Houston
2 sites 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 The University of Texas Health Science Center, Houston at 2 sites 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 3 inclusion and 2 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 4 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 2 sites 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?
evaluate results from qualitative interviews (time frame: women seen after they have their baby). 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 4 Dec 2014.