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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01853917
Other study ID # HSC-MS-11-0503
Secondary ID
Status Completed
Phase N/A
First received June 19, 2012
Last updated December 2, 2014
Start date January 2012
Est. completion date November 2014

Study information

Verified date December 2014
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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. The study will ask subjects questions about HIV, drug use, depression and social problems.


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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date November 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Harris County Hospital District Clinics-LBJ hospital Houston Texas
United States Harris County Hospital District Clinics-Thomas Street Clinic, Northwest Clinic Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary evaluate results from qualitative interviews we will ask and record responses and enter into an NIVIVO program to evaluate for emergent themes women seen after they have their baby No
Secondary 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. before they have a baby and after they have a baby No
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