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

NCT00408642 | Completed Phase 3

• 1 other identifier: CAP 058
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

adherence; treatment; antiretroviral; HAART; HIV; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• suppressed viral load at 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.

  9 months

Secondary Outcomes (8)

• feasibility of E-ASP in this resource constrained setting

  one year

• Secondly to describe the relationship between adherence and viral load and CD4+counts

  2 months, 9 months and 12 months

• describe factors associated with poor/good adherence in this group

  one year

• describe the relationship between early adherence and adherence at subsequent timepoints

  2 weeks, and 2 and 9 months after start ART and 12 months

• to establish the validity of self-reported adherence (in relation to pill counts) in this context

  one year

Study Arms (2)

1

EXPERIMENTAL

enhanced adherence support for patients initiating antiretroviral therapy

Behavioral: Enhanced adherence support

2

ACTIVE COMPARATOR

standard adherence support

Behavioral: Standard adherence support

Interventions

Enhanced adherence support BEHAVIORAL

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.

1

Standard adherence support BEHAVIORAL

The control arm receives the standard of care adherence support which consists of three group counseling adherence sessions conducted prior to initiation of therapy.

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Unwillingness or inability to adhere to the study schedule

Sponsors & Collaborators

• Centre for the AIDS Programme of Research in South Africa: lead
• Doris Duke Charitable Foundation: collaborator

Study Sites (1)

CAPRISA eThekwini Clinical Research Site

Durban, KwaZulu-Natal, 4001, South Africa

Location

Related Publications (2)

• 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.

  PMID: 16036253 BACKGROUND

• 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.

  PMID: 24696226 RESULT

Related Links

• Primary outcome paper

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Francois van Loggerenberg, MA(ResPsych)

  CAPRISA, University of KwaZulu-Natal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 6, 2006
• First Posted: December 7, 2006
• Study Start: August 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2011
• Last Updated: February 1, 2016

Record last verified: 2016-01

Locations

ZA (1)