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Completed

NCT Number: NCT00408642

An Enhanced Adherence Support Programme for Highly Active Antiretroviral Therapy (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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CAPRISA eThekwini Clinical Research Site

Durban, KwaZulu-Natal, 4001, South Africa

About this study

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:

  • On the day of commencement of ART - "Preparing to take ART medications"
  • 2 weeks after starting ART - "Adjusting to taking ART medications"
  • 2 months after starting ART - "Feeling good and staying healthy taking ART medications"
  • 3 months after starting ART - "Planning for ongoing HIV care and daily ART medications"
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced adherence support

Behavioral

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

Behavioral

The control arm receives the standard of care adherence support which consists of three group counseling adherence sessions conducted prior to initiation of therapy.

Primary outcomes

  1. suppressed viral load at 9 months

    Time frame: 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.

Secondary outcomes

  1. feasibility of E-ASP in this resource constrained setting

    Time frame: one year

  2. Secondly to describe the relationship between adherence and viral load and CD4+counts

    Time frame: 2 months, 9 months and 12 months

  3. describe factors associated with poor/good adherence in this group

    Time frame: one year

  4. 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

  5. to establish the validity of self-reported adherence (in relation to pill counts) in this context

    Time frame: one year

  6. to assess the long-term impact of E-ASP on adherence

    Time frame: 18 months

  7. suppressed viral load at 12 months

    Time frame: 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.

  8. adherence at 6 months

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Centre for the AIDS Programme of Research in South Africa

Network

Collaborators

  • Doris Duke Charitable Foundation

Registry information

Official study title

An Enhanced Adherence Support Programme for HAART

Acronym: eASP

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Dec 7, 2006
Registry last updated
Feb 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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