NCT00444977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 8, 2013

Status Verified

July 1, 2013

Enrollment Period

4.7 years

First QC Date

March 6, 2007

Last Update Submit

July 3, 2013

Conditions

Oral Health CareHIV InfectionsMouth Diseases

Keywords

HIV positive personsNot received oral health care in the preceding 12 months.treatment naivetreatment experienced

Outcome Measures

Primary Outcomes (1)

  • dental visit and screening resulting from case management

    6, 12 and 18 Months

Study Arms (2)

Case-management linkage intervention

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Subjects will receive standard of care services.

Interventions

Case-management linkage interventionBEHAVIORAL

dental care

Case-management linkage intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

HIV InfectionsMouth Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesStomatognathic Diseases

Study Officials

  • Lisa R Metsch, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Stephen Smith Professor of Sociomedical Sciences and Chair, Department of Sociomedical Sciences

Study Record Dates

First Submitted

March 6, 2007

First Posted

March 8, 2007

Study Start

April 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

July 8, 2013

Record last verified: 2013-07

Locations

US(1)