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
  Purpose

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 Intervention
Oral Health Care
HIV Infections
Mouth Diseases
Behavioral: Case-management linkage intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Enhancing Oral Health Care Use by HIV-Positives

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • dental visit and screening resulting from case management [ Time Frame: 6, 12 and 18 Months ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: April 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444977

Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
Lisa Metsch
Investigators
Principal Investigator: Lisa R Metsch, PhD Columbia University
  More Information

No publications provided

Responsible Party: Lisa Metsch, Stephen Smith Professor of Sociomedical Sciences and Chair, Department of Sociomedical Sciences, Columbia University
ClinicalTrials.gov Identifier: NCT00444977     History of Changes
Other Study ID Numbers: AAAK3159, R01DE015523
Study First Received: March 6, 2007
Last Updated: July 3, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 26, 2014