Evaluating an Interactive Digital Toolkit for Women's PrEP Implementation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 4
- 主要终点
- Feasibility: Toolkit completion rate
研究概览
简要总结
The goal of this study is to test if a Digital PrEP Toolkit helps cisgender women learn about and access PrEP in Alabama and Mississippi. PrEP is a medication that prevents HIV infection. The main questions it aims to answer are: Can participants complete the Digital PrEP Toolkit in under 10 minutes? Do participants find the Digital PrEP Toolkit useful and easy to use? Does the Digital PrEP Toolkit increase the number of women who start taking PrEP?
Investigators will work with up to 125 women at 3 HIV and STI clinics in Alabama and Mississippi.
Participants will use the Digital PrEP Toolkit on a tablet at the clinic. They will answer questions about their HIV knowledge before and after using the Toolkit. Participants will then discuss PrEP options with a healthcare staff member and decide if they want to start PrEP. Participants will answer follow-up questions at 3 months. Investigators will also review participants' medical records at 6 months to see if they started PrEP and are still taking it.
详细描述
Cisgender women in the rural southeastern United States face substantial HIV risk. Despite this, pre-exposure prophylaxis (PrEP) use among women remains alarmingly low. PrEP is a medication that prevents HIV infection. Barriers to PrEP use among women include limited PrEP awareness and knowledge, low HIV risk perception, challenging client-provider conversations about sexual health, and structural challenges like transportation difficulties and time constraints.
This study will test an Interactive Digital PrEP Toolkit that includes HIV prevention education tailored to women in the Southeast, information about different PrEP medication options (i.e., daily oral pills, monthly injections, and twice-yearly injections), questions to help identify HIV prevention preferences, and testimonials from women using PrEP. The study will enroll up to 125 cisgender women at 3 HIV and STI clinic locations in Alabama and Mississippi over approximately 12 months.
Study Outcomes:
Primary outcomes include feasibility, acceptability, and preliminary efficacy. Feasibility will be measured by Toolkit completion rate, average time to complete the Toolkit, proportion of participants who initiate PrEP, and changes in HIV and PrEP knowledge. Acceptability will be measured through participant satisfaction surveys assessing how valuable and easy to use participants find the Digital PrEP Toolkit. Preliminary efficacy will be measured by comparing clinic-level PrEP uptake rates during up to 12 months preceding the study start to those during the approximately 12-month study period among all eligible female clients seen at participating clinics.
Secondary outcomes will include documentation of participants' sexual health priorities, HIV prevention preferences, and PrEP modality choices across the clinic sites. Investigators will also assess retention in PrEP care at 6 months post-enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •HIV-negative
- •Cisgender women
- •18 years or older
- •English-speaking
- •Report sexual activity in the last six months or anticipate sexual activity in the next six months.
排除标准
- •Younger than 18 years of age
- •Do not identify as female and/or were not biologically assigned female at birth
- •Living with HIV
- •Report no sexual activity in the past six months and no anticipated sexual activity in the next six months
- •Unable or unwilling to provide informed consent
研究组 & 干预措施
Implementation of interactive digital PrEP toolkit for increased PrEP uptake
The goal of the intervention is to strengthen the PrEP care continuum by developing and testing an interactive digital PrEP toolkit designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use.
干预措施: Interactive Digital PrEP Toolkit (Behavioral)
结局指标
主要结局
Feasibility: Toolkit completion rate
时间窗: Throughout 12-month enrollment period
Percentage of eligible women who complete the PrEP Toolkit out of women screened and enrolled
Feasibility: Toolkit Completion Time
时间窗: Throughout 12-month enrollment period
Average time needed to complete PrEP Toolkit activities
Acceptability: Participant Satisfaction
时间窗: From enrollment to the end of the 3 month follow-up period at 15-months
Participant satisfaction will be assessed using a study-specific satisfaction questionnaire measuring perceived value and ease of use of the Digital PrEP Toolkit. The questionnaire includes Likert-scale items (range: 1-5, with higher scores indicating greater satisfaction) evaluating Toolkit usability, perceived usefulness, and overall satisfaction.
Preliminary Efficacy: Participant PrEP Uptake
时间窗: From enrollment to the end of the 3 month follow up period at 15-months
Proportion of eligible women who initiate PrEP after using the PrEP Toolkit to eligible clients screened
Preliminary Efficacy: Clinic-level PrEP uptake
时间窗: From enrollment to the end of the 3 month follow up period at 15-months
Comparison of PrEP uptake rates up to 12-months prior to study start to PrEP uptake rates during the approximately 12-month study enrollment period among eligible women at the partnering clinic sites
Preliminary Efficacy: HIV and PrEP Knowledge
时间窗: From enrollment to the end of the 3 month follow up period at 15-months
Changes in HIV and PrEP knowledge will be assessed using an adapted version of the updated HIV Knowledge Questionnaire (range: 0-31, with higher scores indicating greater knowledge).
次要结局
- Number of Participants by PrEP Modality Choice(From enrollment to the end of the 3 month follow up period at 15-months)
- Number of Participants by Sexual Health Priority(Throughout 12-month enrollment period)
- Number of Participants by HIV Prevention Preference(Throughout 12-month enrollment period)
- PrEP Persistence(From enrollment to the end of the 6 month follow up period at 18-months)
研究者
Mirjam-Colette Kempf
University Professor
University of Alabama at Birmingham