An Enhanced Adherence Support Programme for Highly Active Antiretroviral Therapy (HAART)
NCT ID: NCT00408642
Last Updated: 2016-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
297 participants
INTERVENTIONAL
2007-08-31
2011-03-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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1
enhanced adherence support for patients initiating antiretroviral therapy
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.
2
standard adherence support
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Doris Duke Charitable Foundation
OTHER
Centre for the AIDS Programme of Research in South Africa
NETWORK
Responsible Party
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Dr Salim S Abdool Karim
Director
Principal Investigators
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Francois van Loggerenberg, MA(ResPsych)
Role: PRINCIPAL_INVESTIGATOR
CAPRISA, University of KwaZulu-Natal
Locations
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CAPRISA eThekwini Clinical Research Site
Durban, KwaZulu-Natal, South Africa
Countries
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References
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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.
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.
Related Links
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Primary outcome paper
Other Identifiers
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CAP 058
Identifier Type: -
Identifier Source: org_study_id
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