Supportive Therapy for Adherence to ART(STAART)

This study has been completed.

Sponsor:

Collaborator:

Ontario HIV Treatment Network

Information provided by:

Ottawa Hospital Research Institute

ClinicalTrials.gov Identifier:

NCT00212940

First received: September 13, 2005

Last updated: July 25, 2007

Last verified: July 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

July 25, 2007

Start Date ^ICMJE

October 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

psycho-educational intervention can help people living with HIV handle the changes of treatment adherence

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00212940 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Supportive Therapy for Adherence to ART(STAART)

Official Title ^ICMJE

Increasing Patient Adherence to HIV Medications: A Prospective Intervention Study

Brief Summary

The purpose of this study is to determine whether a psycho-educational intervention can help people living with HIV handle the changes of treatment adherence.

Detailed Description

Participants will be randomly assigned to one of two study groups:

Group 1: participants in this group will engage in weekly psycho-educational sessions with an HIV therapist for four weeks prior to starting their regimens. The sessions will cover topics such as becoming active in treatment care, improving coping abilities and developing skills for treatment adherence. They will also involve questionnaires and readings.
Group 2 (the control group):participants in this group will simply receive their regular treatment regimens.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Behavioral: Supportive Therapy for Adherence to ART (behavior)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

112

Completion Date

September 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

be at least 18 years of age
have viral load above 500 copies/ml
not be currently on HAART
be able to read and speak English/French

Exclusion Criteria:

current Substance Abuse
actively psychotic or suicidal

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00212940

Other Study ID Numbers ^ICMJE

1999565-01H, CIHR app# 1262000 ICE:

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Ottawa Hospital Research Institute

Collaborators ^ICMJE

Ontario HIV Treatment Network

Investigators ^ICMJE

Principal Investigator:

William Cameron, MD

OHRI

Information Provided By

Ottawa Hospital Research Institute

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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