The Treatment Advocacy Program | NCT00164333

Studies
The Treatment Advocacy Program

NCT00164333

Sponsor

Centers for Disease Control and Prevention

Status

Completed

Last Update Posted

Sep 27, 2012Estimated

Enrollment

300

Phase

Phase 2

Conditions

Interventions

TAP: Treatment Advocacy Program

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
R 18/CCR520972-01

Status Module

Record Verification Date

Sep 2012

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

Sep 2004

Primary Completion Date

May 2007Actual

Completion Date

Apr 2008Actual

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 26, 2012

Last Update Posted Date

Sep 27, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to test the efficacy of TAP, a behavioral intervention, in improving sexual safety and treatment adherence among gay and bisexual men infected with HIV. It is hypothesized that those who are in the intervention group will report reductions in unprotected sex with HIV-negative and unknown-status partners; and will show stricter adherence to their treatment regimens, compared to the individuals in the standard-of-care, control group.

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

300

Name	Type	Description	Arm Group Labels	Other Names
TAP: Treatment Advocacy Program	Behavioral

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Self-reported incidences of missed doses of treatment regimen.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV+ men who have sex with other men, age 18 or over, in HIV care at one of the collaborating clinics, any sexual contact within the previous six months.

Exclusion Criteria:

self-reported low likelihood of remaining in treatment or in the study location for 12 months, inability to comprehend the consent quiz administered during the Consent and Enrollment Visit, or unwilling to provide required locator information

Accepts Healthy Volunteers

Not provided

Sex

Male

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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Howard Brown Medical Center		Chicago	Illinois	60613	United States