NCT00611429

Brief Summary

This study will develop and test the effectiveness of an educational and supportive counseling program called Preparing Patients to Start Antiretroviral Therapy in helping people with HIV make informed decisions about their health care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable 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

First Submitted

Initial submission to the registry

February 6, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

5 years

First QC Date

February 6, 2008

Last Update Submit

December 1, 2014

Conditions

HIV

Keywords

TreatmentAdherenceInterventionQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Treatment uptake

    Measured at Month 12

Secondary Outcomes (1)

  • Treatment adherence

    Measured at Month 12

Study Arms (2)

Group A

EXPERIMENTAL

Participants will receive treatment consisting of at least three individual counseling sessions and one group workshop over 12 months

Behavioral: Counseling sessionsBehavioral: Group workshop

Group B

ACTIVE COMPARATOR

Participants will receive treatment consisting of one individual counseling session and one group workshop during the last month of the study

Behavioral: Counseling sessionsBehavioral: Group workshop

Interventions

Counseling sessionsBEHAVIORAL

The individual counseling sessions will last 60 minutes and will involve discussion about health care options and information on the latest advances in HIV treatment.

Group AGroup B
Group workshopBEHAVIORAL

During the 3-hour group workshop, doctors, nurses, and case managers will talk to participants about HIV treatments and what it is like to undergo treatment. Participants will also hear from other people with HIV and their experiences with treatment.

Group AGroup B

Eligibility Criteria

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

You may qualify if:

  • HIV infected
  • Not taking antiretroviral medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Study Officials

  • Mallory O. Johnson, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 11, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2013

Study Completion

April 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations

US(1)