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Enhancing Oral Health Care Use by HIV Positive Individuals

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lisa Metsch, Columbia University
ClinicalTrials.gov Identifier:
NCT00444977
First received: March 6, 2007
Last updated: July 3, 2013
Last verified: July 2013

March 6, 2007
July 3, 2013
April 2005
December 2009   (final data collection date for primary outcome measure)
dental visit and screening resulting from case management [ Time Frame: 6, 12 and 18 Months ] [ Designated as safety issue: No ]
  • dental visit and screening resulting from case management
  • intervention
Complete list of historical versions of study NCT00444977 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Enhancing Oral Health Care Use by HIV Positive Individuals
Enhancing Oral Health Care Use by HIV-Positives

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Oral Health Care
  • HIV Infections
  • Mouth Diseases
Behavioral: Case-management linkage intervention
dental care
  • Experimental: Case-management linkage intervention
    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.
    Intervention: Behavioral: Case-management linkage intervention
  • No Intervention: Standard of Care
    Subjects will receive standard of care services.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00444977
AAAK3159, R01DE015523
Yes
Lisa Metsch, Columbia University
Lisa Metsch
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Lisa R Metsch, PhD Columbia University
Columbia University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP