A Randomized Control Trial of Striving Towards EmPowerment and Medication Adherence (STEP-AD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Change in viral suppression
研究概览
简要总结
This is a study for Black women living with HIV to test a counseling program for Black women living with HIV. This participant may be a good fit if the participant is a Black woman, living with HIV, has a history of trauma, and is currently taking Antiretroviral Therapy (ART) medicines
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
- 否
入选标准
- •Living with HIV
- •Cis-gender female
- •Age 18 or older
- •English speaking
- •Viral load non-suppression (>200 ml) within the past year or a lack of HIV viral load measure for 6 consecutive months or more during the past 12 months
- •History of trauma/abuse
- •Capable of completing and fully understanding the informed consent process and study procedures
排除标准
- •Unable to completely and fully understand the informed consent process and the study procedures
- •Significantly interfering mental health symptoms (e.g., active psychosis that is untreated)
研究组 & 干预措施
STEP-AD
Participants in this arm will receive the manualized 10 session behavioral medicine intervention titled "Striving Towards EmPowerment and Medication Adherence". Participants will be in this group for a total of up to 1.5 years.
干预措施: STEP-AD (Behavioral)
Enhanced treatment as usual
Participants in the comparison condition will also complete 10 in person sessions. The first session will consist of a session on healthy living with HIV. The remaining 9 sessions will consist of neutral (daily events) writing. Participants will be in this group for a total of up to 1.5 years.
干预措施: Enhanced treatment as usual (E-TAU) (Behavioral)
结局指标
主要结局
Change in viral suppression
时间窗: Baseline up to 1.5 years
HIV viral load \<200 copies/ml time averaged. Measured by blood specimen.
次要结局
- Change in Post-traumatic cognitions measured by PTCI(Baseline up to 1.5 years)
- Change in antiretroviral (ART) adherence(Baseline up to 1.5 years)
- Change in PTSD as measured by PCL-5(Baseline up to 1.5 years)
- Change in adherence to anti-retroviral medications questionnaire(Baseline up to 1.5 years)
- Change in engagement in HIV care(Baseline up to 1.5 years)
- Change in Post-traumatic Stress Disorder Diagnosis(Baseline up to 1.5 years)
研究者
Sannisha K Dale
Associate Professor
University of Miami