Supportive Therapy for Adherence to ART(STAART) | NCT00212940

Studies
Supportive Therapy for Adherence to ART(STAART)

NCT00212940

Sponsor

Ottawa Hospital Research Institute

Status

Completed

Last Update Posted

Jul 26, 2007Estimated

Enrollment

112Estimated

Phase

Not Applicable

Conditions

HIV Infections

Interventions

Supportive Therapy for Adherence to ART (behavior)

Countries

Canada

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
CIHR app# 1262000 ICE:

Status Module

Record Verification Date

Jul 2007

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

Oct 2000

Primary Completion Date

Not provided

Completion Date

Sep 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 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

Jul 25, 2007

Last Update Posted Date

Jul 26, 2007Estimated

Name	Class
Ontario HIV Treatment Network	NETWORK

Description Module

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.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

112Estimated

Name	Type	Description	Arm Group Labels	Other Names
Supportive Therapy for Adherence to ART (behavior)	Behavioral

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

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
William Cameron, MD	OHRI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ottawa Hospital, General Campus		Ottawa	Ontario	K1H 8L6	Canada

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010166	Palliative Care

Ancestor Terms

ID	Term
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided