Feasibility and Preliminary Effectiveness of PrEPwise Intervention on PrEP Initiation Among Black Women in Eastern Virginia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Acceptability to Participants of PrEPwise Intervention
研究概览
简要总结
HIV is a virus that affects many people, but Black women in the U.S. are a population at a much higher risk of getting it compared to white women-about 18 times higher. Pre-exposure prophylaxis (PrEP), a medicine if taken as recommended by a clinician can prevent HIV almost completely (99% effective). The problem is that many Black women, especially those living in the Southern U.S., don't know about this medicine called PrEP or find it hard to access it. To address this, healthcare providers sometimes use "decision aids" which are tools, like brochures or videos, designed to help people understand their medical options and make informed choices based on what's important to them. While these tools have worked well for other health issues, they haven't been widely used for preventing HIV. The challenges are doctors do not have enough time to explain PrEP fully to patients during clinic visits and also some Black women do not trust the healthcare system because of a long history of unfair treatment toward Black communities.
Community health workers (CHWs) are trained health workers from the same communities as their patients and can facilitate their ability to provide culturally appropriate health education and information consistent with patients' values and needs. Because of this, patients are often more comfortable talking to them. This project aims to test the acceptability and effectiveness of a decision tool to be integrated into HIV testing services to help Black women decide if PrEP is right for them. The investigators are calling this intervention PrEPwise. A tool originally designed for women dealing with opioid addiction will be adapted to fit the needs of Black women living in the South. The long-term goal of this project is to make it easier for Black women to learn about PrEP and decide whether to use it, ultimately helping lower the number of new HIV cases in Black women.
详细描述
The study will follow a type-1 effectiveness-implementation hybrid design as a single-site, single-blinded randomized controlled trial. The following procedures detail the study conduct and masking approach:
Baseline Visit:
- Informed consent process
- Collection of demographic information
- Administration of baseline survey assessing: Perceived HIV risk, PrEP knowledge, PrEP attitudes, PrEP stigma, Discrimination/racism experiences, PrEP norms, Decisional conflict, and Self-efficacy
Randomization and Intervention Delivery:
- Random assignment will be conducted at the individual level with 1:1 allocation using random block sizes of 2
- Randomization assignments will be generated through REDCap's randomization module by the study data analyst
- Only participants will be blinded to their study arm assignment. Study staff delivering the intervention cannot be blinded due to the nature of the behavioral intervention
- Participants will be informed they will receive either enhanced or standard HIV prevention information, without specifying their assigned arm
- The research assistant conducting outcome assessments will be different from the staff delivering the intervention
- Immediate post-intervention survey assessing implementation outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Black women seeking HIV testing services at the community HIV testing clinic
- •Eligible for PrEP according to CDC guidelines
- •Willing to be followed for 3 months
- •Able to provide contact information
- •Able to provide informed consent
排除标准
- •Participated in the development of the intervention (provided input in the adaptation of PrEP decision aid)
- •Unable to provide informed consent
- •Unable to provide contact information
- •Currently using PrEP
研究组 & 干预措施
PrEPwise (PrEPdecision aid)
Participants randomized to this arm who are HIV negative will receive the behavioral intervention PrEPwise at the HIV testing clinic.
干预措施: PrEPwise (Behavioral)
Usual care
Participants randomized to this arm will receive usual care including standard HIV testing, general HIV information, prep information and information about other available services.
干预措施: Usual care (Other)
结局指标
主要结局
Acceptability to Participants of PrEPwise Intervention
时间窗: 3 months
Acceptability will be assessed using the client satisfaction survey (CSQ-8), an 8-item instrument with 4 possible responses for each item (1-4). Total scores range from 8 to 32; higher scores indicating greater satisfaction.
Acceptability to Community Health Workers (CHWs) of PrEPwise Intervention
时间窗: 3 months
Acceptability will be assessed using the client satisfaction survey (CSQ-8), an 8-item instrument with 4 possible responses for each item (1-4). Total scores range from 8 to 32; higher scores indicating greater satisfaction.
PrEPwise intervention Feasibility
时间窗: 3 months
Feasibility will be assessed though process measures including number of participants contacted, number screened for eligibility, number enrolled, and number lost to follow-up.
PrEPwise Intervention Fidelity
时间窗: 3 months
Fidelity will be assessed measured using a 10-item fidelity checklist, completed by participants after intervention delivery. Each item on the checklist indicates whether a specific component was delivered as expected (e.g., "The CHW discussed PrEP side effects with me") Items are scores as "yes=1" or "no=0". Total scores range from 0-10, with higher scores indicating higher fidelity to the intervention protocol.
次要结局
- PrEP initiation(3 months)
- PrEP persistence(3 months)
- Perceived HIV risk(3 months)
- PrEP knowledge(3 months)
- PrEP attitude(3 months)
- PrEP stigma(3 months)
- Decisional conflict(3 months)
- Intersectional discrimination experiences(3 months)