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

This study has been completed.
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by:
Centre for the AIDS Programme of Research in South Africa
ClinicalTrials.gov Identifier:
NCT00408642
First received: December 6, 2006
Last updated: April 4, 2011
Last verified: April 2011

December 6, 2006
April 4, 2011
August 2007
March 2010   (final data collection date for primary outcome measure)
suppressed viral load at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
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.
  • 12 months)
  • The primary objective of this study is to assess the impact of E-ASP on patient
  • adherence at 12 months. For the purpose of this objective, adherence is the
  • percentage pill count data and percentage of completed scheduled study visits
  • (that is, missed study visits will indicate poor adherence to the clinic visit
  • schedule). It is hypothesized that adherence at baseline will not differ
  • significantly but that the 12 month adherence of the E-ASP group will be
  • significantly higher than that of the S-ASP group. High adherence is expected
  • be associated with lowered resistance to ART (as determined by viral load at
Complete list of historical versions of study NCT00408642 on ClinicalTrials.gov Archive Site
  • feasibility of E-ASP in this resource constrained setting [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Secondly to describe the relationship between adherence and viral load and CD4+counts [ Time Frame: 2 months, 9 months and 12 months ] [ Designated as safety issue: No ]
  • describe factors associated with poor/good adherence in this group [ Time Frame: one year ] [ Designated as safety issue: No ]
  • describe the relationship between early adherence and adherence at subsequent timepoints [ Time Frame: 2 weeks, and 2 and 9 months after start ART and 12 months ] [ Designated as safety issue: No ]
  • to establish the validity of self-reported adherence (in relation to pill counts) in this context [ Time Frame: one year ] [ Designated as safety issue: No ]
  • to assess the long-term impact of E-ASP on adherence [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • suppressed viral load at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.
  • adherence at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • This study will also assess several secondary objectives:
  • Firstly to establish the feasibility of E-ASP in this resource constrained setting,
  • Secondly to describe the relationship between adherence and viral load and CD4+
  • counts at 2 months, 3 months and 12 months; Thirdly to describe factors associated
  • with poor/good adherence in this group; Fourthly to describe the relationship between
  • early adherence (2 weeks, and 2 and 3 months after start ART) and adherence at
  • 12 months; Fifthly to establish the validity of self-reported adherence (in relation
  • to pill counts) in this context; and lastly to assess the long-term impact of E-ASP on
  • adherence by relating early adherence to adherence at 18 months (this measure
  • may be obtained post the funding period of this study).
Not Provided
Not Provided
 
An Enhanced Adherence Support Programme for Highly Active Antiretroviral Therapy (HAART)
An Enhanced Adherence Support Programme for HAART

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
HIV Infections
  • 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.
  • Behavioral: 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.
  • Experimental: 1
    enhanced adherence support for patients initiating antiretroviral therapy
    Intervention: Behavioral: Enhanced adherence support
  • Active Comparator: 2
    standard adherence support
    Intervention: Behavioral: Standard adherence support
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
297
March 2011
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00408642
CAP 058
No
Francois van Loggerenberg, CAPRISA, University of KWaZulu-Natal
Centre for the AIDS Programme of Research in South Africa
Doris Duke Charitable Foundation
Principal Investigator: Francois van Loggerenberg, MA(ResPsych) CAPRISA, University of KwaZulu-Natal
Centre for the AIDS Programme of Research in South Africa
April 2011

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