NCT00164333

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2 hiv

Timeline
Completed

Started Sep 2004

Typical duration for phase_2 hiv

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

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

Enrollment Period

2.7 years

First QC Date

September 9, 2005

Last Update Submit

September 26, 2012

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Self-reported incidences of missed doses of treatment regimen.

Interventions

TAP: Treatment Advocacy ProgramBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Howard Brown Medical Center

Chicago, Illinois, 60613, United States

Location

Study Officials

  • Dogan Eroglu, PhD.

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

September 1, 2004

Primary Completion

May 1, 2007

Study Completion

April 1, 2008

Last Updated

September 27, 2012

Record last verified: 2012-09

Locations

US(1)