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临床试验/NCT02764853
NCT02764853已完成不适用

Striving Towards EmPowerment and Medication Adherence (STEP-AD)

University of Miami4 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
184
试验地点
4
主要终点
ART Medication Adherence

研究概览

简要总结

Striving Towards Empowerment and Medication Adherence (STEP-AD) is a research study aimed at developing an intervention for Black women living with HIV to address psychosocial factors (i.e. abuse/trauma histories, racial discrimination, HIV stigma/discrimination, and prescribed traditional gender roles) that have been associated with medication nonadherence or poor HIV outcomes (e.g. viral load, CD4), but are unaddressed in existing interventions.

详细描述

Among Black women with HIV in the U.S, generally low rates of adherence to ART are likely due to relevant psychosocial and contextual factors facing Black women with HIV, such as having a history of physical, sexual, and emotional abuse, post traumatic stress, racial discrimination, and contextual variables related to traditional gender roles; each of which are associated with worse HIV outcomes.

Despite the need, there is currently no evidenced-based psychosocial intervention for Black women with HIV that addresses these contextual factors to improve adherence to HIV self-care. A psychosocial intervention including content on reducing the effects of trauma and discrimination and increasing resilient coping strategies and gender empowerment may be most culturally appropriate, and therefore effective, in improving quality of life and increasing treatment adherence in Black women living with HIV/AIDS.

Striving Towards Empowerment and Medication Adherence (STEP-AD) is a research study aimed at developing an intervention for Black women living with HIV to address psychosocial factors (i.e. abuse/trauma histories, racial discrimination, HIV stigma/discrimination, and prescribed traditional gender roles) that have been associated with medication nonadherence or poor HIV outcomes (e.g. viral load, CD4), but are unaddressed in existing interventions.

Individual, in-depth qualitative interviews (n=30) were conducted with Black women with HIV and community stakeholders to gather information on the perceived acceptability and to inform the development of a manualized intervention of an integrated treatment to improve ART adherence by addressing trauma symptoms, racial discrimination, HIV discrimination, and gender related stressors experienced by Black women with HIV. This information was used to develop the resulting intervention.

An open pilot trial (n=5) of the resulting intervention was conducted (December 2015 through August 2016) in order to initially assess the feasibility of all study procedures and intervention delivery, acceptability, and a potential clinically significant improvement on ART adherence and hypothesized psychosocial mediators.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • HIV-positive
  • Identify as Black and/or African American
  • Age 18 or older
  • Biologically female
  • English speaking
  • Prescribed ART medication for at least the last two months
  • Low ART adherence (<80%) or detectable viral load within the past six months or
  • History of abuse/trauma (e.g. sexual, physical, and/or emotional abuse, experienced a traumatic event)
  • Capable of completing and fully understanding the informed consent process and the study procedures

排除标准

  • Significant mental health diagnosis requiring treatment (e.g., unstable bipolar disorder; any psychotic disorder)
  • Inability (e.g., due to cognitive or psychiatric difficulties) or unwillingness to provide informed consent
  • Recent (past 6 months) behavioral treatment for ART adherence or trauma

结局指标

主要结局

ART Medication Adherence

时间窗: Change from Baseline until study completion (~ 9 months)

Adherence to antiretroviral therapy (ART) as captured by the Wisepill electronic adherence monitor. Change from baseline adherence.

次要结局

  • Trauma Symptoms(Change from Baseline until study completion (~ 9 months))
  • HIV Viral Load(Change from Baseline until study completion (~ 9 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sannisha K Dale

Assistant Professor of Psychology

University of Miami

研究点 (4)

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