An Enhanced Adherence Support Programme for HAART
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 297
- 试验地点
- 1
- 主要终点
- suppressed viral load at 9 months
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
研究组 & 干预措施
1
enhanced adherence support for patients initiating antiretroviral therapy
干预措施: Enhanced adherence support (Behavioral)
2
standard adherence support
干预措施: Standard adherence support (Behavioral)
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
- 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)
- 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)
研究者
Dr Salim S Abdool Karim
Director
Centre for the AIDS Programme of Research in South Africa