Project TEAM: Teaching HIV Prevention in the HIV Clinic | NCT00164320

Studies
Project TEAM: Teaching HIV Prevention in the HIV Clinic

NCT00164320

Sponsor

Centers for Disease Control and Prevention

Status

Completed

Last Update Posted

Sep 14, 2005Estimated

Enrollment

600

Phase

Phase 2

Conditions

Interventions

TEAM

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R18/CCR420971-01

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

May 2006

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2005

Last Update Posted Date

Sep 14, 2005Estimated

Description Module

Brief Summary

The purpose of this study is to determine if the TEAM prevention intervention delivered by a physician and an HIV-positive counselor is effective. It is hypothesized that those who receive the intervention will report a higher reduction in risky sex than those who were in the standard-care condition.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600

Name	Type	Description	Arm Group Labels	Other Names
TEAM	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self-reported unprotected (without condoms)anal or vaginal sex with HIV-negative or unknown-status persons.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1) 18 years or older, 2) HIV-infected, 3) Sexually active, 3)Receiving HIV primary care at participating clinic, 4) Can communicate in English or Spanish, 5) No previous enrollment in the TEAM study or intervention.

Exclusion Criteria:

1) Participation in a similar study run by the TEAM PI.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dogan Eroglu, PhD.	Centers for Disease Control and Prevention	Study Director
Lisa Metsch, PhD.	University of Miami	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami School of Medicine		Miami	Florida	33136	United States