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

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.

Conditions

• HIV Infections

Interventions

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.

Sponsors & Collaborators

• Doris Duke Charitable Foundation

  collaborator OTHER

• Centre for the AIDS Programme of Research in South Africa

  lead NETWORK

Principal Investigators

• Francois van Loggerenberg, MA(ResPsych) · CAPRISA, University of KwaZulu-Natal

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-08-31

Primary Completion

2010-03-31

Completion

2011-03-31

Countries

• South Africa

Study Locations