Optimizing PrEP Uptake for African American Women in the South by Empowering Women to Make Informed HIV Prevention and Sexual Health Choices
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Feasibility of EMPOWER Intervention
研究概览
简要总结
Pilot testing of EMPOWER, a group sexual health intervention, to increase uptake and persistence of PrEP
详细描述
This study will pilot test the telehealth intervention EMPOWER (Enhancing and Motivating PrEP Options among Women through Empowerment and Resilience) by adapting an evidence-informed intervention, POWER (Progressing Our Well-Being, Emotions, and Relationships) based on mindfulness and cognitive behavioral therapy, to improve PrEP uptake and persistence by Black women in the South.
Conduct a waitlist-controlled, randomized pilot trial of the 6-session group intervention using a crossover design with 80 Black women. Clinical outcomes will be the PrEP uptake and PrEP persistence measured by TDF via the dried blood spot at baseline, 3- and 6-months post-intervention. We will also assess the intervention's feasibility, acceptability, and usability. The outcomes will be compared with the usual standard of care (opt-out PrEP) at the intervention site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Identification as cis-gendered Black woman;
- •Age 18 and older;
- •Engaging in risky sexual behavior in prior 3 months (condomless vaginal or anal sex with a non-main partner, or a partner with known or suspected risk behavior such as injection drug use or HIV/STI, multiple sex partners, transactional sex);
- •Access to a device with a screen, a web browser, and adequate internet speed (e.g., smartphone, computer) for videoconferencing;
- •Able to speak and read English; and
- •No plans to leave the Atlanta, GA area during the duration of study participation.
排除标准
- •Cognitive or mental health condition that limits the ability to provide informed consent;
- •Self-reported use of PrEP or PEP medication in the past three months;
- •Unable to speak and read English; and
- •Currently living with HIV.
研究组 & 干预措施
Intervention Arm
This arm will receive the intervention first.
干预措施: EMPOWER (Behavioral)
Waitlist Control
This arm will receve the intervention after the wait period
干预措施: EMPOWER (Behavioral)
结局指标
主要结局
Feasibility of EMPOWER Intervention
时间窗: From enrollment to the end of data collection and analysis at 6 months
Enrollment rate will be used an indicator of the feasibility of the intervention
Acceptability of EMPOWER Intervention
时间窗: From enrollment to the end of data collection and analysis at 6 months
Acceptability of the intervention based on participant satisfaction using the Client Satisfaction Questionnaire scores
次要结局
未报告次要终点
研究者
Mohammad Rifat Haider
Assistant Professor
University of Georgia