Increasing Motivation for Antiretroviral Therapy Initiation: A Pilot Intervention
研究概览
地位
条件
详细说明
Many persons with HIV refuse recommended treatment or delay initiation of antiretroviral therapy (ART). Widespread belief in conspiracy theories regarding the origin and treatment of HIV may complicate the ART decision-making process. Research has found that conspiracy beliefs and mistrust in the mainstream medical system are common among African-Americans attending an HIV primary care clinic and that conspiracy beliefs are more likely to be held by patients who are not on ART. Moreover, research shows that conspiracy beliefs and other maladaptive cognitions predict subsequent readiness to begin ART. The investigators have developed an intervention called PATCH: Personal Approaches to Treatment Choices for HIV. PATCH is a brief intervention designed to support participants' decision-making processes and enhance intrinsic motivation to initiate ART, using motivational interviewing (MI) techniques. The intervention targets HIV-positive African-American adults in inner-city Baltimore, Maryland who are suboptimally engaged in care and who endorse conspiracy beliefs about HIV or low readiness to begin ART.
In this project the investigators will conduct a small randomized controlled pilot trial to test the potential efficacy of PATCH in producing positive attitudinal changes, including a reduction in conspiracy beliefs and perceived barriers to ART and an increase in stated readiness to begin ART. The investigators will compare PATCH to an attentional control. Participants will be recruited from outpatient HIV clinics settings but will be individuals who are not taking ART. Assessments will be conducted at baseline, post-treatment (estimated 4-8 weeks post-baseline), and at 3-month post-baseline follow-up. The specific aims are: (1) Develop and refine a manual for a brief MI intervention to support ART decision-making and reduce the likelihood of ART refusal: (2) Evaluate the feasibility and acceptability of implementing the PATCH intervention in a small sample of individuals who are African-American, recommended for ART but who are not current taking it, and who experience multiple barriers to ART adherence; and (3) Conduct a small randomized controlled pilot to test the potential efficacy of the PATCH intervention in producing positive attitudinal changes, including a reduction in conspiracy beliefs and perceived barriers to ART and stated readiness to begin ART.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Maryland
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Baltimore、Maryland、美国、21201
- University of Maryland School of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Known to the recruitment site to be HIV-positive
- African-American or multiracial with African-American heritage.
- Able to speak and understand English.
At least one of the following:
- Sub-optimally involved in HIV care (defined as no regular source of HIV primary care, clinically eligible for ART but not taking it, or received an offer of ART in the last year but not currently taking it.
- Non-adherent to ART (defined as being offered ART but not taking it or not appropriately adhering to it (as reflected by a score of 10 or less on screening questionnaire) at the time of enrollment.
- Conspiracy beliefs (defined as a score of 10 or more on screening questionnaire or states that would not be ready to take ART if recommended).
Exclusion Criteria:
- Known diagnosis of mental retardation or dementia.
- Active psychosis or suicidality evident in initial interview.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Personal Approaches to Treatment Choices for HIV
PATCH is a brief intervention designed to support participants' decision-making processes and enhance intrinsic motivation to initiate ART.
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其他名称:
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有源比较器:Stress Reduction Skills Program
SRSP includes training in stress reduction skills such as relaxation, problem solving, and expressing negative feelings.
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其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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positive attitudinal changes
大体时间:baseline, week 6
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Positive attitudinal changes includes a reduction in conspiracy beliefs and perceived barriers to ART.
Attitudes will be assessed via questionnaires completed at the baseline, post treatment, and follow-up assessments.
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baseline, week 6
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Stated readiness to begin ART
大体时间:baseline, week 6
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Stated readiness to begin ART will be assessed via questionnaires and interviews completed at the post treatment assessment.
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baseline, week 6
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Beginning ART
大体时间:baseline, week 16
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Beginning ART will be assessed via questionnaires and interviews completed at the follow-up assessment, as well as by review of the medical record.
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baseline, week 16
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合作者和调查者
调查人员
- 首席研究员:Melanie E Bennett, Ph.D.、University of Maryland, Baltimore
- 首席研究员:Seth Himelhoch, MD, MPH、University of Maryland, Baltimore
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- HP-00047473
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