An Enhanced Adherence Support Programme for Highly Active Antiretroviral Therapy (HAART) - Full Text View

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Behavioral: Enhanced adherence support Behavioral: Standard adherence support	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	An Enhanced Adherence Support Programme for HAART

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Centre for the AIDS Programme of Research in South Africa:

Primary Outcome Measures:

suppressed viral load at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
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 Outcome Measures:

feasibility of E-ASP in this resource constrained setting [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondly to describe the relationship between adherence and viral load and CD4+counts [ Time Frame: 2 months, 9 months and 12 months ] [ Designated as safety issue: No ]
describe factors associated with poor/good adherence in this group [ Time Frame: one year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
to establish the validity of self-reported adherence (in relation to pill counts) in this context [ Time Frame: one year ] [ Designated as safety issue: No ]
to assess the long-term impact of E-ASP on adherence [ Time Frame: 18 months ] [ Designated as safety issue: No ]
suppressed viral load at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
adherence at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]


Enrollment:	297
Study Start Date:	August 2007
Study Completion Date:	March 2011
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 enhanced adherence support for patients initiating antiretroviral therapy	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.
Active Comparator: 2 standard adherence support	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.

Arms

Assigned Interventions

Experimental: 1

enhanced adherence support for patients initiating antiretroviral therapy

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.

Active Comparator: 2

standard adherence support

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.

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408642

Locations


South Africa
CAPRISA eThekwini Clinical Research Site
Durban, KwaZulu-Natal, South Africa, 4001

Sponsors and Collaborators

Centre for the AIDS Programme of Research in South Africa

Doris Duke Charitable Foundation

Investigators


Principal Investigator:	Francois van Loggerenberg, MA(ResPsych)	CAPRISA, University of KwaZulu-Natal

More Information

Additional Information:

Primary outcome paper This link exits the ClinicalTrials.gov site

Publications:

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.

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.


Responsible Party:	Dr Salim S Abdool Karim, Director, Centre for the AIDS Programme of Research in South Africa
ClinicalTrials.gov Identifier:	NCT00408642 History of Changes
Other Study ID Numbers:	CAP 058
Study First Received:	December 6, 2006
Last Updated:	October 1, 2014
Health Authority:	South Africa: National Health Research Ethics Council

Keywords provided by Centre for the AIDS Programme of Research in South Africa:


adherence treatment antiretroviral	HAART HIV Treatment Naive

ClinicalTrials.gov processed this record on March 03, 2015

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