Evaluation of Barriers to Postpartum Care in HIV Infected Women

December 2, 2014 updated by: Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77009
        • Harris County Hospital District Clinics-Thomas Street Clinic, Northwest Clinic
      • Houston, Texas, United States, 77026
        • Harris County Hospital District Clinics-LBJ hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

HIV infected pregnant women

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
questionaires and structured interview
HIV infected women who are pregnant and receiving care in Harris County Hospital District single arm study Single arm study
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
women seen after they have their baby

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before they have a baby and after they have a baby

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Tanvir Bell, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

June 19, 2012

First Submitted That Met QC Criteria

May 10, 2013

First Posted (Estimate)

May 15, 2013

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-11-0503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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