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Enhancing Oral Health Care Use by HIV Positive Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00444977
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : July 8, 2013
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Lisa Metsch, Columbia University

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.

Condition or disease Intervention/treatment Phase
Oral Health Care HIV Infections Mouth Diseases Behavioral: Case-management linkage intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Enhancing Oral Health Care Use by HIV-Positives
Study Start Date : April 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Behavioral: Case-management linkage intervention
dental care

No Intervention: Standard of Care
Subjects will receive standard of care services.

Primary Outcome Measures :
  1. dental visit and screening resulting from case management [ Time Frame: 6, 12 and 18 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00444977

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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
Lisa Metsch
National Institute of Dental and Craniofacial Research (NIDCR)
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Principal Investigator: Lisa R Metsch, PhD Columbia University

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Responsible Party: Lisa Metsch, Stephen Smith Professor of Sociomedical Sciences and Chair, Department of Sociomedical Sciences, Columbia University Identifier: NCT00444977     History of Changes
Other Study ID Numbers: AAAK3159
R01DE015523 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: July 8, 2013
Last Verified: July 2013

Keywords provided by Lisa Metsch, Columbia University:
HIV positive persons
Not received oral health care in the preceding 12 months.
treatment naive
treatment experienced

Additional relevant MeSH terms:
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Mouth Diseases
HIV Infections
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Stomatognathic Diseases