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

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ClinicalTrials.gov Identifier: NCT00408642
Recruitment Status : Completed
First Posted : December 7, 2006
Last Update Posted : February 1, 2016
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
Dr Salim S Abdool Karim, Centre for the AIDS Programme of Research in South Africa

Study Description
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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.


Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Enhanced adherence support Behavioral: Standard adherence support Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 297 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: An Enhanced Adherence Support Programme for HAART
Study Start Date : August 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. suppressed viral load at 9 months [ Time Frame: 9 months ]
    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 :
  1. feasibility of E-ASP in this resource constrained setting [ Time Frame: one year ]
  2. Secondly to describe the relationship between adherence and viral load and CD4+counts [ Time Frame: 2 months, 9 months and 12 months ]
  3. describe factors associated with poor/good adherence in this group [ Time Frame: one year ]
  4. 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 ]
  5. to establish the validity of self-reported adherence (in relation to pill counts) in this context [ Time Frame: one year ]
  6. to assess the long-term impact of E-ASP on adherence [ Time Frame: 18 months ]
  7. suppressed viral load at 12 months [ Time Frame: 12 months ]
    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.

  8. adherence at 6 months [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Primary outcome paper  This link exits the ClinicalTrials.gov site

Publications of Results:

Other Publications:

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
First Posted: December 7, 2006    Key Record Dates
Last Update Posted: February 1, 2016
Last Verified: January 2016

Keywords provided by Dr Salim S Abdool Karim, Centre for the AIDS Programme of Research in South Africa:
adherence
treatment
antiretroviral
 HAART
HIV
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases