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NCT00212940 Clinical Trial

Supportive Therapy for Adherence to ART(STAART)

HIV Infections Clinical Trial

Official title:
Increasing Patient Adherence to HIV Medications: A Prospective Intervention Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00212940
Other study ID # 1999565-01H
Secondary ID CIHR app# 126200
Status Completed
Phase N/A
First received September 13, 2005
Last updated July 25, 2007
Start date October 2000
Est. completion date September 2006

Study information
Verified date July 2007
Source Ottawa Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 112
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Supportive Therapy for Adherence to ART (behavior)

Locations
Country Name City State
Canada The Ottawa Hospital, General Campus Ottawa Ontario

Sponsors (2)
Lead Sponsor Collaborator
Ottawa Hospital Research Institute Ontario HIV Treatment Network

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary psycho-educational intervention can help people living with HIV handle the changes of treatment adherence
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