Clinical trial NCT00444977: Enhancing Oral Health Care Use by HIV Positive Individuals
Official title: Enhancing Oral Health Care Use by HIV-Positives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Health Care
HIV Infections
Mouth Diseases
Keywords: HIV positive persons
Not received oral health care in the preceding 12 months.
treatment naive
treatment experienced
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2007-03-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: dental visit and screening resulting from case management
timeFrame: 6, 12 and 18 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: Columbia University
name: Lisa R Metsch, PhD
role: PRINCIPAL_INVESTIGATOR
References: