NCT01853917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2012

Completed
11 months until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

2.1 years

First QC Date

June 19, 2012

Last Update Submit

December 2, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • evaluate results from questionaires

    before they have a baby and after they have a baby

Study Arms (1)

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

Interventions

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

questionaires and structured interview

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV infected pregnant women

You may qualify if:

  • 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.

You may not qualify if:

  • Women unable to complete questionnaires.
  • Women who are unable to speak, read, or understand English or Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harris County Hospital District Clinics-Thomas Street Clinic, Northwest Clinic

Houston, Texas, 77009, United States

Location

Harris County Hospital District Clinics-LBJ hospital

Houston, Texas, 77026, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Tanvir Bell

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

June 19, 2012

First Posted

May 15, 2013

Study Start

January 1, 2012

Primary Completion

February 1, 2014

Study Completion

November 1, 2014

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations