An Enhanced Adherence Support Programme for Highly Active Antiretroviral Therapy (HAART)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

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.
    

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 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.
    

Intervention name(s): Enhanced adherence support; Standard adherence support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; The control arm receives the standard of care adherence support which consists of three group counseling adherence sessions conducted prior to initiation of therapy.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: adherence; treatment; antiretroviral; HAART; HIV; Treatment Naive