Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408642
Status:
COMPLETED
Last Update Posted:
2016-02-01
First Post:
2006-12-06
Brief Title:
An Enhanced Adherence Support Programme for Highly Active Antiretroviral Therapy HAART
Sponsor:
Centre for the AIDS Programme of Research in South Africa
Organization:
Centre for the AIDS Programme of Research in South Africa
Study Overview
Official Title:
An Enhanced Adherence Support Programme for HAART
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eASP
Brief Summary:
In southern Africa TB is the most common first AIDS-defining condition Initiating Antiretroviral therapy ART in HIV positive TB patients will lead to the inclusion of the majority of HIVAIDS patients currently fulfilling the criteria for therapy Establishing an effective intervention to increase treatment adherence in this group is essential for the successful roll out of ART in the region This proposed randomized controlled study aims to compare the effectiveness of two adherence support programmes ASP for use in patients with HIV-related TB in the context of CAPRISA AIDS Treatment CATprogramme in KwaZulu-Natal South Africa the enhanced adherence support programme E-ASP or the standard adherence support programme S-ASP
S-ASP consists of three counselor presented group education sessions E-ASP is an extension of S-ASP and is based on the Information-Motivation-Behavioral Skills IMB Model of Adherence to Antiretroviral Therapy a theoretical model initially developed to reduce HIV risk behavior The E-ASP will consist of several interconnected components 1 development and maintenance of an educational and supportive milieu at the CDC Clinic 2 provision of five structured educational support and behavioral skills building sessions and 3 three weekly ART planning sessions
S-ASP consists of three counselor presented group education sessions E-ASP is an extension of S-ASP and is based on the Information-Motivation-Behavioral Skills IMB Model of Adherence to Antiretroviral Therapy a theoretical model initially developed to reduce HIV risk behavior The E-ASP will consist of several interconnected components 1 development and maintenance of an educational and supportive milieu at the CDC Clinic 2 provision of five structured educational support and behavioral skills building sessions and 3 three weekly ART planning sessions
Detailed Description:
Enhanced Adherence Support E-ASP
All patients will receive sessions one and two of the Standard ASP Following randomization the intervention experimental arm patients receive the E-ASP described below and the standard of care control arm patients receive session three of the S-ASP
Two health educators are employed and trained to administer E-ASP The goal of the E-ASP is to identify and address patient deficits in information motivation and behavioural skills that inhibit consistent and correct self-administration of ARV medications including those skills required to adhere to the clinic visit schedule By using specific motivational techniques Motivational Interviewing and structured one-on-one sessions the health educator empower patients to pre-empt situations that have been shown to lead to non-adherence and make plans for situations in which they are less likely to adhere
Components of the E-ASP
The E-ASP augments S-ASP and consistS of several interconnected components 1 development and maintenance of an educational and supportive milieu at the CDC Clinic 2 provision of five structured education support and behavioural skills building sessions and 3 three weekly ART planning sessions
Development and Maintenance of an Educational and Supportive Milieu
A separate room is available for exclusive use of the E-ASP This room has educational materials available at all times and is a comfortable area for patients to relax and socialize with one another during the course of their time at the CDC clinic
Provision by Study Health Educator of 5 Structured Education Support and Behavioural Skills Sessions
The educational support and behavioural skills building sessions consist of five one-on-one interactive sessions that will be conducted by the health educator The sessions take place at five important times during patients early ART
1 On the day of commencement of ART - Preparing to take ART medications
2 2 weeks after starting ART - Adjusting to taking ART medications
3 2 months after starting ART - Feeling good and staying healthy taking ART medications
4 3 months after starting ART - Planning for ongoing HIV care and daily ART medications
5 6 months after starting ART - Preparation for lifelong HIV care and daily ART medications
The content matter key educational support and skills pointsmessages for the sessions is conveyed by the study health educator using specially designed story board flip charts put into table-standing easel display books the front side faces the patient and the backside faces the health educator Posters including all pertinent images and messages will be put onto the walls for ease of summarizing the information and for providing an overview of important messages All messages will also be conveyed in pictorial form to ensure that literacy levels of the cohort do not negatively affect understanding
The other important educational motivation and skills building tool available is a double-sided Adherence Problem Solving Pocket Card This tool lists commonly occurring medication adherence problems on the front side and practical solutionsstrategies on the back
All patients will receive sessions one and two of the Standard ASP Following randomization the intervention experimental arm patients receive the E-ASP described below and the standard of care control arm patients receive session three of the S-ASP
Two health educators are employed and trained to administer E-ASP The goal of the E-ASP is to identify and address patient deficits in information motivation and behavioural skills that inhibit consistent and correct self-administration of ARV medications including those skills required to adhere to the clinic visit schedule By using specific motivational techniques Motivational Interviewing and structured one-on-one sessions the health educator empower patients to pre-empt situations that have been shown to lead to non-adherence and make plans for situations in which they are less likely to adhere
Components of the E-ASP
The E-ASP augments S-ASP and consistS of several interconnected components 1 development and maintenance of an educational and supportive milieu at the CDC Clinic 2 provision of five structured education support and behavioural skills building sessions and 3 three weekly ART planning sessions
Development and Maintenance of an Educational and Supportive Milieu
A separate room is available for exclusive use of the E-ASP This room has educational materials available at all times and is a comfortable area for patients to relax and socialize with one another during the course of their time at the CDC clinic
Provision by Study Health Educator of 5 Structured Education Support and Behavioural Skills Sessions
The educational support and behavioural skills building sessions consist of five one-on-one interactive sessions that will be conducted by the health educator The sessions take place at five important times during patients early ART
1 On the day of commencement of ART - Preparing to take ART medications
2 2 weeks after starting ART - Adjusting to taking ART medications
3 2 months after starting ART - Feeling good and staying healthy taking ART medications
4 3 months after starting ART - Planning for ongoing HIV care and daily ART medications
5 6 months after starting ART - Preparation for lifelong HIV care and daily ART medications
The content matter key educational support and skills pointsmessages for the sessions is conveyed by the study health educator using specially designed story board flip charts put into table-standing easel display books the front side faces the patient and the backside faces the health educator Posters including all pertinent images and messages will be put onto the walls for ease of summarizing the information and for providing an overview of important messages All messages will also be conveyed in pictorial form to ensure that literacy levels of the cohort do not negatively affect understanding
The other important educational motivation and skills building tool available is a double-sided Adherence Problem Solving Pocket Card This tool lists commonly occurring medication adherence problems on the front side and practical solutionsstrategies on the back
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None