Evaluating Factors That Impact Loss to Follow-up Among Po... | NCT01190605

Studies
Evaluating Factors That Impact Loss to Follow-up Among Postpartum HIV-infected Women in Mississippi

NCT01190605

Sponsor

University of Mississippi Medical Center

Status

Completed

Last Update Posted

Dec 9, 2014Estimated

Enrollment

53Actual

Phase

Not provided

Conditions

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Sep 2012Actual

Completion Date

Jul 2013Actual

First Submitted Date

Aug 26, 2010

First Submission Date that Met QC Criteria

Aug 26, 2010

First Posted Date

Aug 27, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2014

Last Update Posted Date

Dec 9, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Binford Nash, Asst. Professor, Pediatrics, School of Medicine, University of Mississippi Medical CenterPrincipal Investigator

Lead Sponsor

University of Mississippi Medical CenterOTHER

Collaborators

Name	Class
Brown University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Women with HIV infection in Mississippi who are pregnant or who have had their baby in the past year can agree to fill out a questionnaire about what helps or hurts return to care for HIV infection after having a baby. The combined results should show the most common things that keep women from getting care for HIV infection after having a baby. This will help design another study in order to help more women get into care for HIV infection after having a baby.

Detailed Description

Following recruitment and completion of informed consent, a participant will be given a questionnaire to look at factors that help or hinder access to HIV care after delivery. After finishing the initial questionnaire the participant will get a Wal-Mart gift card for $15. The participant may then be asked to complete a longer interview for which she would receive an additional gift card for $25. The combined results will be used to design an interventional study to improve entry into HIV care after delivery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
linked to long-term HIV care	retrospective chart review for documentation of visit attendance	within six months of delivery

Secondary Outcomes

Measure	Description	Time Frame
assessment for depression	use of Edinburgh depression screening tool	cross-sectional at time of study visit
assessment of intimate partner violence	use of WEB (Women's Experience with Battering) screening tool

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18 years or older
women with HIV infection who are pregnant or up to 2 months postpartum
English speaking
able to give informed consent

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Women in Mississippi with HIV infection who have been pregnant and received perinatal HIV care at University of Mississippi Medical Center are eligible to participate in a questionnaire study on the factors that affect entry into HIV care after delivery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Binford T Nash, MD	University of Mississippi Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Mississippi Medical Center		Jackson	Mississippi	39216-4505	United States