Clinical trial NCT00408642: An Enhanced Adherence Support Programme for Highly Active Antiretroviral Therapy (HAART)
Official title: An Enhanced Adherence Support Programme for HAART
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: adherence
treatment
antiretroviral
HAART
HIV
Treatment Naive
Lead sponsor: Centre for the AIDS Programme of Research in South Africa
Sponsor class: NETWORK
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2006-12-07
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: suppressed viral load at 9 months
timeFrame: 9 months
Secondary outcomes:
measure: feasibility of E-ASP in this resource constrained setting
timeFrame: one year
measure: Secondly to describe the relationship between adherence and viral load and CD4+counts
timeFrame: 2 months, 9 months and 12 months
measure: describe factors associated with poor/good adherence in this group
timeFrame: one year
measure: describe the relationship between early adherence and adherence at subsequent timepoints
timeFrame: 2 weeks, and 2 and 9 months after start ART and 12 months
measure: to establish the validity of self-reported adherence (in relation to pill counts) in this context
timeFrame: one year
measure: to assess the long-term impact of E-ASP on adherence
timeFrame: 18 months
measure: suppressed viral load at 12 months
timeFrame: 12 months
measure: adherence at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: CAPRISA eThekwini Clinical Research Site
state: KwaZulu-Natal
Study officials:
affiliation: CAPRISA, University of KwaZulu-Natal
name: Francois van Loggerenberg, MA(ResPsych)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1080/09540120500038058.
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: findings of the CAPRISA 058 randomised controlled trial. AIDS Behav. 2015 Jan;19(1):145-56. doi: 10.1007/s10461-014-0763-6.