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临床试验/NCT01350544
NCT01350544已完成不适用

Treatment Advocacy Intervention for HIV-Positive African Americans

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2013年4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
216
试验地点
2
主要终点
Medication Adherence

研究概览

简要总结

The investigators hypothesize that participants in the treatment advocacy intervention will show significantly better HIV treatment adherence than will participants in the no-treatment (wait-list) control group.

详细描述

Compared to other races/ethnicities, African Americans with HIV have lower levels of engagement in care, are less likely to be on antiretroviral treatment (ART), and are more likely to delay care and ART initiation; those on ART are less likely to be adherent at high enough levels for the treatment to be effective. We propose to test an innovative, culturally relevant treatment advocacy (TA) intervention for African Americans with HIV that targets social, cultural, and structural issues contributing to poor HIV treatment behaviors. TA, which has been sustained in many community organizations throughout the HIV epidemic, has never been systematically evaluated. TA facilitates patient navigation through the medical system and provides tailored HIV treatment education and client-centered counseling to improve adherence and engagement in care. TA targets structural issues in healthcare and patients' lives by advocating to providers to improve patient-provider relationships, recommending changes in treatment and/or providers (if needed), and referring patients to mental health and social services. TA is particularly appropriate for African Americans with HIV, who may be mistrustful of providers: it can be conducted outside of the medical system in a safe, neutral community setting by individuals not associated with patients' healthcare. We developed a culturally relevant TA program that additionally discusses factors such as racism that undermine healthcare in Black communities, by acknowledging and directly addressing patients' medical mistrust and stigma as coping strategies that arise in response to oppression. The specific aims are to (1) conduct a randomized controlled trial to examine the effects of a culturally relevant TA program on adherence among African Americans with HIV; (2) identify culturally relevant mediators that explain the effects of treatment advocacy on antiretroviral treatment adherence among African Americans with HIV (e.g., improved behavioral adherence skills, coping with stress/discrimination, mental health, and patient satisfaction; lower levels of HIV misconceptions, internalized HIV stigma/homophobia, medical mistrust, and substance use); and (3) explore culturally relevant moderators of the effects of treatment advocacy on antiretroviral treatment adherence among African Americans with HIV (e.g., access to care, discrimination, incarceration, poverty, social support, spirituality, and trauma). A sample of 200 African Americans with HIV will be randomly assigned to a TA intervention or wait-list control group. Participants will complete surveys at screening, and at 3- and 6-months post-baseline, to assess pre-, intra-, and post-intervention effects on adherence.

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 (Investigator)

入排标准

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

入选标准

  • 18 years of age or older;
  • self-identify as African American or Black
  • client of APLA
  • they are on ART and missed at least 1 dose in the past month
  • they have a currently detectable or unknown HIV viral load (or have not had a viral load test within the last six months).

排除标准

  • received treatment advocacy in last 6 months

结局指标

主要结局

Medication Adherence

时间窗: Baseline, 1.5 months, 3 months, 4.5 months, and 6 months

We used a repeated measures linear regression modeling continuous adherence with intervention, linear time, and their interaction, and demographic covariates. Continuous adherence is measured as average percentages of doses taken.

次要结局

未报告次要终点

研究者

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

Laura Bogart

Senior Behavioral Scientist

RAND

研究点 (2)

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