跳至主要内容
临床试验/NCT00408642
NCT00408642
已完成
3 期

An Enhanced Adherence Support Programme for HAART

Centre for the AIDS Programme of Research in South Africa1 个研究点 分布在 1 个国家目标入组 297 人2007年8月

概览

阶段
3 期
干预措施
未指定
疾病 / 适应症
HIV Infections
发起方
Centre for the AIDS Programme of Research in South Africa
入组人数
297
试验地点
1
主要终点
suppressed viral load at 9 months
状态
已完成
最后更新
10年前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2007年8月
结束日期
2011年3月
最后更新
10年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

Dr Salim S Abdool Karim

Director

Centre for the AIDS Programme of Research in South Africa

入排标准

入选标准

  • 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)

排除标准

  • Unwillingness or inability to adhere to the study schedule

结局指标

主要结局

suppressed viral load at 9 months

时间窗: 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.

次要结局

  • 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)
  • to assess the long-term impact of E-ASP on adherence(18 months)
  • suppressed viral load at 12 months(12 months)
  • adherence at 6 months(6 months)
  • feasibility of E-ASP in this resource constrained setting(one year)

研究点 (1)

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