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Enhancing Oral Health Care Use by HIV Positive Individuals

Primary Purpose

Oral Health Care, HIV Infections, Mouth Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Case-management linkage intervention
Sponsored by
Lisa Metsch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Health Care focused on measuring HIV positive persons, Not received oral health care in the preceding 12 months., treatment naive, treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women 18 years and older
  • Documented HIV infection
  • Currently in medical care (defined as having seen an HIV primary care provider in the previous six months)
  • Eligible for Ryan White title I funding
  • Plans to remain in Miami for the next 24 months
  • Provide the name of two verifiable locator persons

Exclusion Criteria:

  • Persons not meeting the inclusion criteria as delineated above

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Case-management linkage intervention

Standard of Care

Arm Description

The intervention represents a brief, "real world" intervention that could easily be adopted by HIV care clinics to facilitate linkage and increase use of oral services by their HIV+ patients (if shown to be effective). We are seeking to compare this intervention to usual practice in these clinics.

Subjects will receive standard of care services.

Outcomes

Primary Outcome Measures

dental visit and screening resulting from case management

Secondary Outcome Measures

Full Information

First Posted
March 6, 2007
Last Updated
July 3, 2013
Sponsor
Lisa Metsch
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT00444977
Brief Title
Enhancing Oral Health Care Use by HIV Positive Individuals
Official Title
Enhancing Oral Health Care Use by HIV-Positives
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lisa Metsch
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the efficacy of a case management linkage intervention designed to increase utilization of oral health care services among HIV+ individuals enrolled in HIV primary care that have not seen a dental provider in the preceding twelve months.
Detailed Description
Recent national studies demonstrate that oral health is one of the highest unmet health needs for HIV-positive (HIV+) individuals, although it is recognized as playing a less critical role in the medical management of HIV/AIDS. Social and economic factors have contributed to less than optimal use of oral health services for HIV+s in the United States. According to recent data, from Miami-Dade County, Florida, only 24% of HIV+s served by Ryan White-funded medical clinics had obtained oral health services in the past 12 months. To address the underutilization of oral health care services, we propose to develop, implement, and evaluate an intervention to assist low-income HIV+s in obtaining access to oral health services as well as increase appropriate utilization of these services. The case management intervention is adapted from an intervention that had been previously tested in a CDC-funded, multi-site study designed to link recently diagnosed HIV+s to primary medical care. A two-arm randomized trial among HIV+ individuals who are currently enrolled in HIV primary medical care, but not receiving oral health care, will be conducted to test the intervention. The two arms will consist of a case management intervention and standard-of-care. Participants will be assessed at baseline and at 6, 12 and 18 months after baseline to document their utilization of oral health services. An interdisciplinary team of behavioral and clinical research scientists with experience in developing and evaluating health care and prevention intervention targeting low income, HIV+s will conduct this research.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Health Care, HIV Infections, Mouth Diseases
Keywords
HIV positive persons, Not received oral health care in the preceding 12 months., treatment naive, treatment experienced

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Case-management linkage intervention
Arm Type
Experimental
Arm Description
The intervention represents a brief, "real world" intervention that could easily be adopted by HIV care clinics to facilitate linkage and increase use of oral services by their HIV+ patients (if shown to be effective). We are seeking to compare this intervention to usual practice in these clinics.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Subjects will receive standard of care services.
Intervention Type
Behavioral
Intervention Name(s)
Case-management linkage intervention
Intervention Description
dental care
Primary Outcome Measure Information:
Title
dental visit and screening resulting from case management
Time Frame
6, 12 and 18 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women 18 years and older Documented HIV infection Currently in medical care (defined as having seen an HIV primary care provider in the previous six months) Eligible for Ryan White title I funding Plans to remain in Miami for the next 24 months Provide the name of two verifiable locator persons Exclusion Criteria: Persons not meeting the inclusion criteria as delineated above
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa R Metsch, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Enhancing Oral Health Care Use by HIV Positive Individuals

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