Evaluation of Barriers to Postpartum Care in HIV Infected Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01853917
First received: June 19, 2012
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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 Intervention
HIV Infection
Pregnancy
Other: questionaires and structured interviews

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Barriers to Postpartum Care in HIV Infected Women

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • evaluate results from qualitative interviews [ Time Frame: women seen after they have their baby ] [ Designated as safety issue: No ]
    we will ask and record responses and enter into an NIVIVO program to evaluate for emergent themes


Secondary Outcome Measures:
  • evaluate results from questionaires [ Time Frame: before they have a baby and after they have a baby ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: August 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 19, 2012
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 16, 2014