Enhancing Oral Health Care Use by HIV Positive Individuals
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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 |
- 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) |
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Behavioral: Case-management linkage intervention
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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
Contact: Lisa R Metsch, PhD | 305.243.6352 | YJeanty@med.miami.edu |
Contact: Yves Jeanty, MPH | 305.243.6352 | YJeanty@med.miami.edu |
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 |
Principal Investigator: | Lisa R Metsch, PhD | University of Miami |
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