Enhancing Oral Health Care Use by HIV Positive Individuals

HIV Infections Clinical Trial

Official title:

Enhancing Oral Health Care Use by HIV-Positives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444977
• Other study ID #: AAAK3159
• Secondary ID: R01DE015523
• Status: Completed
• Phase: N/A
• First received: March 6, 2007
• Last updated: July 3, 2013
• Start date: April 2005
• Est. completion date: December 2009

Study information

• Verified date: July 2013
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• HIV Seropositivity
• Mouth Diseases
• Oral Health Care

Intervention

Behavioral:
• Case-management linkage intervention
dental care

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Lisa Metsch	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dental visit and screening resulting from case management		6, 12 and 18 Months	No