Evaluation of Barriers to Postpartum Care in HIV Infected Women
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| ClinicalTrials.gov Identifier: NCT01853917 |
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Recruitment Status
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Completed
First Posted
: May 15, 2013
Last Update Posted
: December 4, 2014
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Sponsor:
The University of Texas Health Science Center, Houston
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston
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Brief 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. The study will ask subjects questions about HIV, drug use, depression and social problems.
| Condition or disease | Intervention/treatment |
|---|---|
| HIV Infection Pregnancy | Other: questionaires and structured interviews |
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 Type : | Observational |
| Actual Enrollment : | 38 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Evaluation of Barriers to Postpartum Care in HIV Infected Women |
| Study Start Date : | January 2012 |
| Actual Primary Completion Date : | February 2014 |
| Actual Study Completion Date : | November 2014 |
| Group/Cohort | Intervention/treatment |
|---|---|
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questionaires and structured interview
HIV infected women who are pregnant and receiving care in Harris County Hospital District single arm study Single arm study
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Other: questionaires and structured interviews
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
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Primary Outcome Measures
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- 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
Secondary Outcome Measures
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- evaluate results from questionaires [ Time Frame: before they have a baby and after they have a baby ]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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV infected pregnant women
Criteria
Inclusion Criteria: HIV infected pregnant women who
- 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.
Exclusion Criteria:
- Women unable to complete questionnaires.
- Women who are unable to speak, read, or understand English or Spanish.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853917
Locations
| United States, Texas | |
| Harris County Hospital District Clinics-Thomas Street Clinic, Northwest Clinic | |
| Houston, Texas, United States, 77009 | |
| Harris County Hospital District Clinics-LBJ hospital | |
| Houston, Texas, United States, 77026 | |
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Tanvir Bell | The University of Texas Health Science Center, Houston |
| Responsible Party: | Tanvir K. Bell, MD, Associate Professor of Medicine, The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT01853917 History of Changes |
| Other Study ID Numbers: |
HSC-MS-11-0503 |
| First Posted: | May 15, 2013 Key Record Dates |
| Last Update Posted: | December 4, 2014 |
| Last Verified: | December 2014 |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |