Controlled Clinical Trial Comparing the Efficacy of Trial-Based Cognitive Therapy and Standard Care for the Treatment of HIV+ Patients With Antiretroviral Therapy Failure, Bogotá, Colombia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in adherence levels to antiretroviral treatment
研究概览
简要总结
Highly active antiretroviral therapy (HAART) has been the greatest achievement to control the HIV/AIDS epidemic in the world. HAART has been shown to reduce virus replication to undetectable levels and to favor the recovery of immune function, avoiding the occurrence of opportunistic diseases. Although existing treatments have been shown to lower AIDS-related morbimortality and to increase patients' quality of life, the success of HAART requires high levels of adherence to the prescribed treatment regimen.
Adherence to HAART has become the major challenge for global public policy managers and healthcare teams involved in the care of HIV/AIDS patients. Mental healthcare professionals should use structured and effective intervention as strategies to facilitate a better approach, increase patients' autonomy and achieve optimal adherence.
Trial-Based Cognitive Therapy (TBCT) is a new, structured, and short-term version of cognitive behavior therapy developed by de Oliveira (2011). TBCT is an active approach that aims to change negative cognitions, especially dysfunctional core beliefs, that negatively influence patient's life in different domains. TBCT helps patients recognize situationally based thoughts, unhelpful beliefs and maladaptive behaviors that exacerbate emotional distress.
This study aims to assess the efficacy of TBCT in helping the patients to identify thoughts, emotions, assumptions and behaviors associated with non-adherence to antiretroviral therapy, and to improve adherence to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The last two detectable CV > 500 copies
- •At least one year of antiretroviral treatment
- •Age between 18 and 65 years
- •Literate person.
排除标准
- •Difficulty to read and to write
- •Being currently in psychotherapy
- •Clinical diagnoses of neurocognitive or psychotic disorders
结局指标
主要结局
Change in adherence levels to antiretroviral treatment
时间窗: Baseline, seven, ten and thirteen months after the baseline
The primary efficacy measure is the improvement in adherence to antiretroviral therapy, measured by self-registration of adherence follow-up questionnaire (QOL 702) ACTG (the Clinical Trials Group). This questionnaire assesses the percentage of self-reported adherence in the last 4 days and the reasons for not taking medicines. Individuals who take 95% or more of the prescribed doses are considered adherent. The analyses will be carried out comparing baseline measures with those observed as at seven, ten and thirteen months after the baseline measures in each group; also, comparisons between the intervention group and the control group will be carried out.
次要结局
- Change in HIV-1 Viral Load(Baseline, seven, ten and thirteen months after the baseline)
- Change in depression levels(Baseline, seven, ten and thirteen months after the baseline)
- Changing anxiety levels(Baseline, seven, ten and thirteen months after the baseline)
- Change in health-related quality of life measured by The Short Form Health Survey questionnaire , SF36(Baseline, seven, ten and thirteen months after the baseline)
- Change in health-related quality of life measured by WHOQOL-VIH BREF(Baseline, seven, ten and thirteen months after the baseline)
研究者
Monica Bibiana Narvaez Betancur
Principal investigator
Fundação Bahiana de Infectologia