An Enhanced Adherence Support Programme for Highly Active Antiretroviral Therapy (HAART)

HIV Infections Clinical Trial

— eASP  

Official title:

An Enhanced Adherence Support Programme for HAART

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408642
• Other study ID #: CAP 058
• Status: Completed
• Phase: Phase 3
• First received: December 6, 2006
• Last updated: January 29, 2016
• Start date: August 2007
• Est. completion date: March 2011

Study information

• Verified date: January 2016
• Source: Centre for the AIDS Programme of Research in South Africa
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: National Health Research Ethics Council
• Study type: Interventional

Clinical Trial 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 HIV/AIDS 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 (CAT)programme 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.

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 points/messages) 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 solutions/strategies on the back.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: March 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients enrolled in the CAPRISA CAT programme and the CDC.

• Willing and able to provide written consent to take part in the study.

• > 18 years of age (to give consent for participation)

• Eligible for initiation of HAART (currently CD4+ <200)

Exclusion Criteria:

• Unwillingness or inability to adhere to the study schedule

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Enhanced adherence support
The enhanced adherence support intervention consists of 5 one-on-one, Information-Motivation-Behavioral Skills (IMB) theory-based counseling sessions, as well as a problem-solving card which summarizes key messages and strategies. The counseling sessions are given at key points post-initiation of therapy: at baseline, 2 weeks, 2 months, 3 months, and 6 months. Three brief weekly ART planning sessions are conducted post-initiation of therapy.
• Standard adherence support
The control arm receives the standard of care adherence support which consists of three group counseling adherence sessions conducted prior to initiation of therapy.

Locations

Country	Name	City	State
South Africa	CAPRISA eThekwini Clinical Research Site	Durban	KwaZulu-Natal

Sponsors (2)

Lead Sponsor	Collaborator
Centre for the AIDS Programme of Research in South Africa	Doris Duke Charitable Foundation

Country where clinical trial is conducted

South Africa, 

References & Publications (2)

Amico KR, Toro-Alfonso J, Fisher JD. An empirical test of the information, motivation and behavioral skills model of antiretroviral therapy adherence. AIDS Care. 2005 Aug;17(6):661-73. — View Citation

van Loggerenberg F, Grant AD, Naidoo K, Murrman M, Gengiah S, Gengiah TN, Fielding K, Abdool Karim SS. Individualised motivational counselling to enhance adherence to antiretroviral therapy is not superior to didactic counselling in South African patients — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	suppressed viral load at 9 months	Those participants with suppressed viral load at 9 months will be classed as treatment success, all others will be classed as treatment failures for the purposes of this outcome.	9 months	No
Secondary	feasibility of E-ASP in this resource constrained setting		one year	No
Secondary	Secondly to describe the relationship between adherence and viral load and CD4+counts		2 months, 9 months and 12 months	No
Secondary	describe factors associated with poor/good adherence in this group		one year	No
Secondary	describe the relationship between early adherence and adherence at subsequent timepoints		2 weeks, and 2 and 9 months after start ART and 12 months	No
Secondary	to establish the validity of self-reported adherence (in relation to pill counts) in this context		one year	No
Secondary	to assess the long-term impact of E-ASP on adherence		18 months	No
Secondary	suppressed viral load at 12 months	Those participants with suppressed viral load will be classed at treatment successes, all others will be classed as treatment failures for this secondary outcome measure.	12 months	No
Secondary	adherence at 6 months		6 months	No

External Links

•   Primary outcome paper