Enhancing Oral Health Care Use by HIV Positive Individuals

This study is currently recruiting participants.
Verified November 2012 by University of Miami
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lisa R Metsch, University of Miami
ClinicalTrials.gov Identifier:
NCT00444977
First received: March 6, 2007
Last updated: November 9, 2012
Last verified: November 2012
  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 Hygiene
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: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Enhancing Oral Health Care Use by HIV-Positives

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • dental visit and screening resulting from case management [ Time Frame: 9 to 18 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 640
Study Start Date: May 2004
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Case-management linkage intervention
    dental care
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 9 months 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444977

Contacts
Contact: Lisa R Metsch, PhD 305.243.6352 YJeanty@med.miami.edu
Contact: Yves Jeanty, MPH 305.243.6352 YJeanty@med.miami.edu

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Lisa R Metsch, PhD     305-243-6352     YJeanty@med.miami.edu    
Contact: Yves Jeanty, MPH     305.243.6352     YJeanty@med.miami.edu    
Principal Investigator: Lisa R Metsch, PhD            
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Lisa R Metsch, PhD University of Miami
  More Information

No publications provided

Responsible Party: Lisa R Metsch, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00444977     History of Changes
Other Study ID Numbers: NIDCR-15523, R01DE015523
Study First Received: March 6, 2007
Last Updated: November 9, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Miami:
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 March 10, 2013